CN104739558B - Orthopaedic srugery's product and its manufacture method - Google Patents

Abstract

The present invention provides a kind of method for manufacturing orthopaedic srugery's product for supporting body area, and orthopaedic srugery's product includes composite, and composite includes：Internal layer, outer layer and Polymer interlayers, method include：Heat composite so that intermediate layer is higher than minimum formable temperature；The first edge of composite is directly connected in the second edge of composite, intermediate layer is higher than minimum formable temperature simultaneously, to form three-dimensional structure, the corresponding part of three-dimensional structure and body part is conformal, wherein three-dimensional structure includes at least two points of components opened that each free composite is formed, and wherein each component has and forms edge one of different in first edge and second edge；With separated component is connected to form three-dimensional structure.Orthopaedic srugery's product can be customized in situ fit for patient.

Description

Orthopaedic srugery's product and its manufacture method

The application is Chinese patent application No.201080017895.X divisional application, and the applying date of the female case is 2010 23 days 2 months year, entitled " composite for being used for custom fitted products ".

Related application：The application is 2 months 2010 U. S. applications 12/710,252 submitted for 22nd and on May 5th, 2009 The part continuation application of the U. S. application 12/436,089 of submission, and enjoyed 2 months 2009 according to 35 U.S.C.119 (e) requirements The U.S. Provisional Application No.61/155,138 submitted for 24th rights and interests.

Background technology

1. technical field

The present invention relates to customization to be molded product scope, and in particular to the field of compound material for orthopaedic srugery's product.

2. background technology

Often be necessary by formed product for customization shape and make its fit.An especially problematic field is to protect Shield property and muscle skeleton supportive device (such as medical science art of orthopedic surgery, sports medical science, protectiveness body equipment, animal doctor Used those in purposes and other purposes) use in.These devices need to provide different degrees of support and protection, but And it is bonded closely and comfortably body.Such as following article can all benefit from the improvement of constructing technology and material：Fit shaping Orthopaedic srugery's casts (orthopedic cast), orthopaedic srugery's brace (orthopedic brace), in sports medical science The fixation used in the support meanss that use, radiotherapy and the supportive device used in positioner and veterinary science, and Protectiveness body is equipped and the fit article of other rigidity.

Generally by winding be perfused with barras glass fibre bring on body formed orthopaedic srugery's casts and Brace, wherein the resin is activated and hardened by water.The gypsum and tissue layer that they can also be activated by water are formed.Poly- caproic acid What interior ester material such as BSM Medical were providedIt can also be used for brace.With hot water by the casts and Splint material is heated to the suitable maximum temperature of skin, about 160 degrees Fahrenheits.These materials allow casts or brace in patient Around body part on bedding and padding (padding) and elastic fabric (stockinette) formed in situ and be made.These existing materials Material in be sufficiently heated to 1) they have and be enough the ductility that is molded around body and 2) material does not scald patient Or the time of the temperature of doctor is limited.

Casts, clamping plate, brace and other products need to be shaped to the shape of complexity.For example, it is often desirable to thumb people Font casts or clamping plate are used for the support of defect of thumb.These are difficult to customization shaping and are adapted to specific user.They Usually piecemeal is molded, and is connected to clamping plate or casts body, and this produces weaker support.Fit not always especially relaxes Suitable, this causes compliance issues.Other somatic damages may need to be difficult to and implement with high costs relative Complicated shape.

Brace is particularly difficult to be shaped to the shape of customization.Brace usually need be it is flexible with allow body part (such as Knee, ankle, wrist and other mobilizable body parts) bending.Meanwhile brace needs to be rigid to prevent the body part of weakness It is injured.Therefore, most of existing braces are complicated mechanical devices, and it is difficult to manufacture and is more difficult to custom fit.

Orthopaedic srugery's product such as casts, clamping plate, brace and protectiveness equipment and other products are not only difficult to make Be shaped to complicated shape with conventional material, and they also patient can not usually be accomplished it is fit well.Because these products Generally it is made of mechanical mechanism, is either combined together with the connection of such as hook and ring or with adhesive, or can not mould Pressure, so they, which can not be directed to patient, customizes shaping.Lacking custom fit causes uncomfortable, and this influences product and complied with Property, purposes and validity.

The content of the invention

The invention provides the composite of uniqueness, and it can easily be customized to be adapted to body part, be shaped to complex shape Shape, but there is high rigidity and high intensity again at room temperature.The flat composite sheet is relatively thin, cleavable into definite shape, Heating and then suture, form the 3D shape of complexity.Then, the product of completion can be heated and cosily on body Shaping, so as to accurately be adapted to and support body part.

One preferred embodiment provides a kind of composite formed by rigid polymer material intermediate layer, described poly- Compound intermediate layer of material can be with thermoforming at a temperature of about 200 degrees Fahrenheits.The layer be clipped in high resiliency extension layer of web material and/ Or between froth bed.Gained composite can be heated until that intermediate layer is extending, and outer layer provides heat insulation, is cut, Suture and the stability of shaping, furthermore such that the composite is more durable and keeps warm and soft simultaneously.

Fabric and froth bed also allow it is material-to-be-heated easily propagate through sewing machine when hot and plastic, and it is independent to provide plastics The seam durability that can not be provided.These tissue layers can have ductility, this permission intermediate layer three dimensional molded, but the bullet of fabric Property the heating object of softness is kept compression and with its cooling and is hardened and is molded on body.In addition, the elastic layer provides The memory that plastics can not possibly individually have so that article replys its original shape to be adapted to body again when reheating.

In a preferred embodiment, the composite also can be in the one or both sides of one of fabric sandwich or replacement In addition the interlayer includes heat barrier foam layer.The foam causes the composite to be easily processed in a heated state simultaneously There is provided in wearing for the protectiveness comfort liner of body.Because the foam of relative low density is molded in suture and to body When protect hand and body not to be heated, so this extends the temperature range of available thermoformable material.In addition, heat-proof quality is prolonged Long composite has the malleable time, thus allow more time for sewn seams and by article for body into Type.

The composite of the preferred embodiment of the present invention can be heated simultaneously after basic 3D shape is stitched into And ductility and the elasticity of composite bed due to heated intermediate layer and be shaped to more complicated shape.The product can the base This shape, which is sold, to be used.Or the space to save storage and transport by the product flattened.Then, consumer can will be into Product are reheated to the temperature higher than 140 degrees Fahrenheits, can extend and around complex surface (such as, but not limited to body) Closely fit shaping.

The material is extending and surrounds surface forming without sagging deflections, because the fabric and froth bed that extend provide Memory and confining force.This provides easily and quickly material around surface comfortable and closely fit.Once material is cold But, then it forms rigid supportive structure.Intermediate layer plastic material can have different thickness and hardness, required with offer The amount of support, protection and bending is for intended purpose.

The composite of the preferred embodiment of the present invention has following key feature：With many rigid materials not Together, it can be heated to extending state and be sutured with standard sewing machine that lower shrinkage, tool ductility, complexity, comfortable is made to prop up And noticeable seam, it is very similar to suture fabrics in general coat.Fabric and/or froth bed cause heated composite wood The behavior of material is very similar to conventional extension fabric and allows material in the normal fashion by use in sewing machine machine or artificial progress Operation.

The heat-proof quality of outer froth bed extends the time that material keeps temperature and plasticity so that has sufficient time to stitch The sewing of long seam and complexity is closed, while protects hand excessively not heated.The product is repeatable to heat arbitrary number of times to complete to stitch Conjunction, shaping and manufacturing process.In addition, because the composite portions are sewn and operated so that shape height meets it is sutured Shape, so the composite can otherness extend.This enables three-dimensional objects simply to manufacture, and this is very tired before Difficulty, if not the rigid portion of cooling can not be sutured.After the cooling period, intermediate supports layer material becomes have rigidity, enters One step is strengthened by 3D shape, so as to become very firm and have supportive.The seam of suture in a continuous fashion will be firm Property block link together, which reduce other connected modes (such as rivet, adhesive or be mechanically fixed) seen in point load Lotus and fatigue.

The fabric and froth bed of one preferred embodiment also provide the comfortableness of body and knitted by what is printed or weave Artistic outward appearance caused by thing.The froth bed also provides resiliency, so as to by reducing in motion process and applying Pressure point during weight so that final fit shaped article is more comfortable.The froth bed can also be with intermediate polymer layer It is thermoformable at a temperature of identical so that they with pressure is applied in molding process by changing thickness so as to increase volume Outer shape and profile.These froth beds also have different thickness, density and composition, to provide varying level as needed Resiliency.The combination of the composite and hot suturing skill provides many preferable and unique features.

By the hereafter detailed description to preferred embodiment, claims and drawing, by show the present invention these And further feature.

Brief description of the drawings

Fig. 1 is the schematic diagram for orthopaedic srugery's brace that the composite of the preferred embodiment of the present invention is formed.

Fig. 2 is the side cross-sectional, view of Fig. 1 composites.

Fig. 3 is the schematic diagram illustrating view of Fig. 1 composites.

Fig. 4 is the side cross-sectional, view of the composite with circular edge.

Fig. 5 is the orthopaedic srugery's brace schematic diagram being arranged on arm formed by composite.

Fig. 6 is the schematic diagram of the brace with different close mechanisms.

Fig. 7 is the schematic diagram of different close mechanisms.

Fig. 8 is the elevational sectional view for showing overlapping edge.

Fig. 9 is the schematic diagram for the different orthopaedic srugery's braces being molded by the composite.

Figure 10 is the schematic diagram for the cervical orthosis being molded by the composite.

Figure 11 is the schematic diagram for the cervical orthosis being molded by the composite.

Figure 12 is the schematic diagram for the clamping plate being molded by the composite.

Figure 13 is the schematic diagram for the clamping plate being molded with patient.

Figure 14 is the schematic diagram of another clamping plate.

Figure 15 is the schematic diagram for the clamping plate being molded with patient.

Figure 16 is the schematic diagram of leg splint.

Figure 17 is another width schematic diagram of leg splint.

Figure 18 is the schematic diagram for preparing stand-by clamping plate.

Figure 19 is the schematic diagram for the heating clamping plate being molded with patient.

Figure 20 is the schematic diagram around the clamping plate of patient's compression.

Figure 21 is the schematic diagram around the clamping plate of patient's molding.

Figure 22 is the schematic diagram for the protectiveness shoulder pad being molded with by the composite.

Figure 23 is the schematic diagram for the protectiveness shin guard component being molded with by the composite.

Figure 24 is the schematic diagram of the protectiveness shin guard assembled.

Figure 25 is the schematic diagram of protective glove.

Figure 26 is the schematic diagram of the protective glove assembled.

Figure 27 is the schematic diagram in the protective glove moulded on hand.

Figure 28 is the schematic diagram of the heating unit for the composite.

Figure 29 is the sectional view of the heating unit.

Figure 30 is the schematic diagram of the heating unit of heating.

Figure 31 is the side cross-sectional, view of microwave heating unit.

Figure 32 is the side cross-sectional, view of the microwave heating unit of heating.

Figure 33 is the schematic diagram for two components being stitched together.

Figure 34 is the side cross-sectional, view that two components being molded with by the composite suture.

Figure 35 is the side cross-sectional, view of two components of specific suture connection.

Figure 36 is the schematic diagram for the suture for allowing two component activities.

Figure 37 is the schematic diagram for the suture for allowing component to be laid flat.

The schematic diagram for two components that the schematic diagram that Figure 38 is is cut open.

Figure 39 is the schematic diagram for two components being stitched together.

Figure 40 is the schematic diagram of two components sutured during heating.

Figure 41 is the schematic diagram for the component that suture forms complicated shape.

Figure 42 is the schematic diagram for the component that suture forms herringbone brace.

Figure 43 is the schematic diagram of the brace of continuous loop fabric (unbroken loop fabric) outer layer.

Figure 44 is the schematic diagram that can connect close mechanism.

Figure 45 is assembled in the schematic diagram for connecting close mechanism on brace.

Figure 46 is the schematic diagram of assembled brace with patient.

Figure 47 is the close up view that can connect close mechanism component.

Figure 48 is the side view of the component.

Figure 49 is the side view of the component opposite side.

Figure 50 is can to connect a kind of schematic diagram of construction of close mechanism.

Figure 51 is the schematic diagram that can connect another construction of close mechanism.

Figure 52 is the schematic diagram that can connect another construction of close mechanism.

Figure 53 is the schematic diagram that can connect another construction of close mechanism.

Figure 54 is the schematic diagram that can connect another construction of close mechanism.

Figure 55 is the schematic diagram of another close mechanism.

Figure 56 is the side cross-sectional, view of the close mechanism component.

Figure 57 is the schematic diagram illustrating view of close mechanism on brace.

Figure 58 is the schematic diagram for having assembled brace.

Figure 59 is the schematic diagram of brace with patient.

Figure 60 is the schematic diagram of another close mechanism.

Figure 61 is the schematic diagram of another close mechanism.

Figure 62 is the schematic diagram of another construction of the close mechanism.

Figure 63 is the schematic diagram of another close mechanism.

Figure 64 is another view of the close mechanism.

Figure 65 is the schematic diagram of another close mechanism.

Figure 66 is the schematic diagram of another close mechanism.

Figure 67 is the schematic diagram of another close mechanism.

Figure 68 is the schematic diagram of the brace with unbroken loop fabric portions.

Figure 69 is the schematic diagram of another close mechanism.

Figure 70 is assembled in the schematic diagram of the close mechanism on brace.

Figure 71 is the schematic diagram that close mechanism can be connected on the brace of back.

Figure 72 is the schematic diagram for connecting close mechanism of diverse location on brace.

Figure 73 is the schematic diagram that close mechanism can be connected on leg splint.

Figure 74 is the schematic diagram of the close mechanism at diverse location on clamping plate.

Embodiment

The preferred embodiments of the invention are shown in Fig. 1-74.It should be clearly understood that herein merely for illustrative mesh And provide illustrative embodiment, it, which is not meant to be, inadequately limits invention claimed.Exemplary The present invention is described in terms of orthopaedic srugery's product for fixing and supporting body part.It should be understood that the present invention is expected For other types of product, including but not limited to medical science, motion, protectiveness equipment, animal doctor and other type Uses.

Following term is defined as follows herein.Brace (brace) is the device for aiding in or limiting body kinematics.Firmly Matter dressing (cast) is that material is molded as into the protectiveness shell protected to fracturing or being broken limbs when it heals.Clamping plate (splint) it is fixed or the bone of stabilization of impaired, joint, the medical apparatus of limbs or backbone.KAFO (orthoses) is to be used for Support, auxiliary, positioning, prevention or correction deformity or the external orthopedic equipment for improving body movement partial function.Retention time (dwell time), which is defined as the composite, has enough ductility to allow the time of formed product.Target temperature defines It is about 165 degrees Fahrenheits to 250 degrees Fahrenheits, preferably from about 200 degrees Fahrenheits.For purposes of the present invention, ductility is defined as material Can by become it is flexible, on four direction it is highly extending and compressible may be molded to 3D shape with around body Position and other objects form the state of complicated shape.Become slightly more plastic and flexible but do not have high level The material of features described above is not considered as with ductility.For purposes of the present invention, application on human skin scald is defined as material and added If the hot heat transfer degree reached to 200 to 220 degrees Fahrenheits or when higher causes heated material being applied to body, ache The discomfort of pain cause can not easily with hand operate and cause pain rubescent and/or body skin bubble result.

Summary

Fig. 1 shows an example of orthopaedic product such as fracture of forearm brace, and the present invention can use thereon.Reason should be understood Solution, other type products include other types of brace, clamping plate, casts and other products.The present embodiment is retouched The property stated brace 10 includes internal layer 20, middle support layer 30 and outer layer 40, as shown in Figures 2 and 3.These three layers each provide uniqueness Function, when being combined into one joint product, produce unique and outstanding product.These three layers are hereafter described in detail respectively Molding or formation integrated composite compressed together.Apply closure 60 before use, it causes not by special training Health care provider the brace is easily shaped to suitable shape, and the brace is fixed to patient.Institute Brace it is more much comfortable for patient, it can increase the compliance that patient is used for.Gained brace, which has, to be better than The many additional benefits for the previous system that context is discussed.

The integral system of the preferred embodiment enables brace to be carried in the form of being layered in advance, preforming or blank For, and to be provided according to the size of desired use, such as supporting wrist, arm, knee, neck or other body parts.Then, should System is easily customized for particular patient, as discussed below.In a preferred embodiment, the system also permits Perhaps patient is adjusted to brace as needed, to adapt to swelling or other problems.The adjustable also allows brace to be directed to institute The particular body portion to be supported is customized.

Brace system is heated with xeothermic, it is become thermoformable, so as to be molded in several minutes.About 160 At a temperature of degrees Fahrenheit to 250 degrees Fahrenheits (target temperature), the brace system is extending so as to be easy to be molded, but still is able to protect A certain degree of rigidity is held, so as to which the excess flow of the glass transition temperature more than the material not occur.Then, the system can It is placed in patient, and will not scalds patient in this process or cause the discomfort of patient.In the foam of relative low density Layer separates highdensity hot intermediate plastic layer with body.Have more highdensity skin in fact can be by heat than foam than foam It is delivered to skin quickly to cool down foam, thus protects skin at the temperatures used from scald.Then, system is shaped to Definite required shape, so that particular patient easily and uses following methods with not needing technical skill.

The time that the system of one preferred embodiment is designed to permission brace and has ductility is controlled.Herein In, this is referred to as " retention time " of brace.Because this is that brace accurately must be molded in patient's body by doctor or technical staff Time on body, so the time is the crucial time.The preferred embodiment is by selecting intermediate layer material, intermediate layer material Density/caliper, intermediate materials there is temperature and the heat-insulated quality of internal layer and outer layer of ductility to control retention time. In addition, user can adjust retention time according to the temperature that article is heated to, when higher temperature obtains longer reservation Between.

In the preferred embodiment, retention time is controlled by following condition：The initial temperature of intermediate layer heating, institute The intermediate layer material of choosing, the thickness in intermediate layer and density and the insulative properties of outer layer and internal layer.The preferred embodiment uses Rigid intermediate layer material, its or about in 200 degrees Fahrenheits and at a temperature of as little as about 160 degrees Fahrenheits there is ductility.This The forming temperature scope of a little materials itself generally can not cause material to have ductility within the sufficient time, and can be right Patient causes serious discomfort or damage.These materials can cool down within the disengaging thermal source several seconds.In low-density heat barrier foam The encapsulating of layer and outer layer is to increase the important innovations of retention time, and allows to change retention time through the above way, simultaneously Patient's heat dangerous with internal layer is isolated.

Composite for product is radioparent.This allows to carry out patient in the case where not removing the product X ray and other imaging processes.This has saved substantial amounts of time and expense for the state of inspection agglutination.

The composite can be molded by heating material and to material, suture and other operations form complexity Shape, while it is extendable shape, is then allowed to cool down and retains the new shape with rigid form.

The composite may be made as " base " form, then formed in situ, so as to produce required shape and customize conjunction Body.This allows flexibility and customization, without substantial amounts of product inventory.

Material

The compound of the preferred embodiment includes soft inner foam layer 20, and it is by suppressing or moulding or other manufacturers Method is assembled into middle support layer 30.Inner foam layer 20 provides the comfort for being close to skin.It can protect the skin of patient from The friction of interbed 30 and heat, and waterproof (not absorbing).The layer can be molded under target temperature, minimum to patient to provide Details it is accurate fit.The specific foaming composition of this layer be as described above low-density with radiating so that patient in hot brace most Preserved from when being just placed in around body.In other preferred embodiments, foam can not have ductility, but can Compression is so as to cosily be fitted tightly over around body area.Foam provide the comfortableness that resiliency and increasing uses and Compliance.Foam in the preferred embodiment is hole-closing structure, but if not needing water proofing property, then alternative solution can be with It is perforate to provide respiration capability.The layer can also have foam formulations, to receive and distribute therapeutic chemical addition agent for example Antimicrobial, skin lotion or other medicines and chemicals.In addition, visco-elastic memory foam can be used for the layer, accurately to fit Fit body.

In the preferred embodiment, internal layer 20 can be including but not limited to such as llowing group of materials：Layer of closed-cell foam, perforate bubble Foam layer, gel or flexible polymer layer, barrier fabric, multilayer or the barrier fabric of superposition layer are any other with resiliency Thermal insulation layer.This layer provide in order to patient comfort buffering and in order to keep the heat insulation characteristics of intermediate layer heat with increase material into The working time of type, and the support surface of suture operation is provided.The support surface provides fixed mechanism for the line of sewn seams, And smooth surface is provided and is used to heated composite being moved through stitching devices without sticking together.In addition, the layer So that heated extending composite and stitching devices body is heat-insulated, so as to be kept for the sufficiently long extending time carry out Complicated stitching step.The base of most of stitching devices is typically big and thick metal surface, and it can be rapidly in the several seconds It is interior to be radiated from non-insulated material.When being heated to about 200 degrees Fahrenheit, this layer of coefficient of sliding friction is about 1 or smaller, it is meant that it Metal surface can be slipped over without by undue power or viscosity.

The internal layer 20 in the preferred embodiment is formed by foamed material, such as the polyethylene by a variety of crosslinkings (" PE ") and ethylene-vinyl acetate (" EVA ") foam or other suitable materials are formed.The material has under target temperature Ductility.But moulded under the higher temperature of about 300 degrees Fahrenheits that can also realize in the fabrication process of this layer.This causes It is in manufacturing process that the material is compression molded into diversified forms, sealing is heated close to the edge of outer layer, thus encapsulates intermediate layer. The layer can be handled with multi-medicament or antimicrobial treatment.

Other layer can be also added inside internal layer, to provide antimicrobial property.Also can add in these other layers Enter other curative properties.The layer can be foam, fabric, adhesive-bonded fabric or other suitable materials.

The intermediate layer 30 of the preferred embodiment is thin thermo-formable polymeric plastic material, and it becomes under target temperature It is plastic, but there is suitable rigidity at room temperature.This layer provides the considerable amount of support to body part.As needed, pass through Change the composition of polymeric material, can be transformed into in various degree flexible and rigid.Can also by material thickness or Person changes this feature by perforating or shearing.The layer may be molded as with different-thickness, tapered edges, rib, hole and feature, It provides desired stiffness, intensity and the flexibility needed for predetermined healing purpose.

The intermediate layer 30 of the preferred embodiment is formed by the special thermoplastic, polymeric materials comprising special characteristic.About The material is easy to be molded at a temperature of 165 degrees Fahrenheits to 200 degrees Fahrenheits, and the temperature below 130 degrees Fahrenheits has rigidity.The material Material preferably has lower glass transition temperatures, and it allows slowly to become with rigidity from the state with ductility.Material is thick Degree is preferably from about 0.025 inch to about 0.125 inch.When being measured according to ASTM D2240, the material, which has, is higher than Shore 70A hardness, preferably from about Shore 65D are to about 80D.The material has enough structural strengths, and it has high impact, low Breach extends and durability.For example, without restriction, the material of the preferred embodiment has 6000-9000psi (ASTM D638), preferred 7500psi tensile strength, 5% extension at break and 270,000-340,000psi, preferably 308, 000psi (ASTM D5023) bending modulus.The proportion of preferred material is about 1-1.5 grams/cc (ASTM D79).

The intermediate layer 30 of another preferred embodiment is preferably by polyvinyl chloride (" PVC ") sheet material, amorphous poly- to benzene two Formic acid glycol ester (" RPET ") or PVC foams such as Sintra^TMOr Komatex^TMFormed.Other preferred material includes But it is not limited to PCL and caprolactone.Such as low-density or high density polyethylene (HDPE) (" HDPE ") and similar material also can be used Material.It can be used on thermoformable less than at a temperature of 250 degrees Fahrenheits but be at room temperature rigid other materials.

In a preferred embodiment, outer layer 40 is formed by Stretch material, and it is easy to stretch, keeps recovering initial shape The memory of shape, there is high intensity and durability.The material includes but is not limited to：Woven nylon spandex blend, Woven polyester ammonia Synthetic fibre blend, RIPSTOP, polyester or other fibers stretched due to the design of braiding and the material of rubbery.Spandex is The general phrase of spandex.In one embodiment, it is preferred to material includes the mixed of nylon or polyester and spandex Spin thing.In addition, the preferred material of the embodiment does not become sticky when being heated to about 200 degrees Fahrenheit, it is easy when being heated to the temperature Slided in along surface.When being heated to the temperature of about 200 degrees Fahrenheits, the coefficient of sliding friction of this layer is about 1 or smaller, it is meant that It can be slided along metal surface, without excessive power or viscosity.

In a further preferred embodiment, outer layer includes Stretch material described above and another froth bed, the bubble Foam layer has many features of internal layer in a preferred embodiment, and it is carried when being included in be formed around the brace of body part For the thermal insulation for intermediate layer.In addition, it provides aesthetic property for brace, and also provide the protection to intermediate layer friction.With In for rigidity and coarse may thering is hole intermediate layer to provide durable and comfortable coating.In the preferred embodiment, the outer layer By formation of foam, such as polyurethane foam, foam rubber or eva foam, it may be molded at a temperature of higher than target temperature.This Allowing outer layer thermoforming in the fabrication process, it has release characteristic, rib, depression or ornamental shape, and with aobvious Write the edge sealed at a temperature of being higher than target temperature with respect to internal layer.This feature is unaffected in patient's forming process.At this In preferred embodiment, outer layer not thermoforming under target temperature, but stretch to adapt to the shape in intermediate layer.Because it is not hot Shaping, elastically wrapped or the marking of compressed pipe so will not leave behind, and keep the smooth and attractive in appearance of outward appearance.If this is not needed A little characteristics, then it is thermoformable under target temperature.

Outer froth bed can also be rigid foam to provide extra support and environmental protection, attractive in appearance and also in thermoforming During some supports are provided.When the outer layer is compared with Typical abrasive gypsum or glass fibre brace outer layer, can experience To significantly improving for comfort level, outward appearance, attractive in appearance, durability and ease for use.In addition, fabric, synthetic leather or other ornamental coating It can add in the outside of this layer, for attractive in appearance or durability purpose.In addition, can also apply the fabric for being known as unbroken loop, It has the surface such as Velcro suitable for common hook and look fasteners^TM.This allow closure, extra support thing, multi-section branch tool and its Its device can be connected at once using hook strip fastener.

The composite can include and penetrate three layers of hole, so as to form the hole 12 of not same amount and shape, so as to provide it is ventilative, Molding character, the path to wound or conduit etc..The needs of body part are molded into according to brace, this some holes also allows intermediate layer Extension and contraction.Integrated brace is also pierceable to be directed to hole 14 of the body part such as thumb, toe to produce.It can also wear Hole is to receive a variety of closed-system annexes.In most cases, the preferred embodiment is wound once and one around end Determine overlapping in degree.This is the different body diameters and shape in order to adapt to run into the product of every kind of size, and this It is the characteristic that typical gypsum and glass fibre brace does not have.The point that overlapping and closing device is disposed, it is being used During environment in allow brace it is open or closed.

The embodiment of alternative materials

Middle support layer can also include perforation.This layer for allowing to be easy to comply with body three-dimensional surface is perforated with adjacent each other Near aperture, obtain the open-celled structure of 25% to 50% opening.This method produce around hole matrix framework, its heating and can During modeling, by around small bore deformation, it is mobile towards aperture or open aperture stretching can be easier to be molded.Use the perforation side Method, the thicker harder material of material of shaping is not enough in the case of can be used than usually not perforating.Due to described above Deformation process so that perforation also allows plastic polymer than being molded under pantostrat lower temperature, this for the comfortable of patient and It is critically important for security.When cooling down and being molded with post type, thick dielectric frame becomes have very much rigidity, such as mostly As required for number supportive brace.In addition, alleviating weight by perforation, which increase the comfortableness of patient and comply with Property.The perforation in these intermediate layers and the passage for ventilating and cooling down purpose are to separate, and the passage has to penetrate through entirely The layer in portion and bigger and far apart.In a preferred embodiment of the invention, it is described perforation remove 25% to 60% middle layer weight.When the material in intermediate layer includes PVC sheet, APET and RPET, these perforation are particularly useful.

As an alternative, foamed material, such as PVC foams (including Sintra^TMAnd Komatex^TM) and APET can with 20% to 50% air or bubble foam when extruding or mould together, to substitute perforation.Other expanded materials can be used, such as Rigid eva foam and other high density foamable polymers.Their purposes depends on the desired stiffness and resistance to needed for every kind of purposes Long property.

Intermediate layer 30 can have a different Topological properties, such as increased by having in the region for needing additional stiffness Thickness and needing the region of more resiliencies there is reduced thickness.In another preferred embodiment of the present invention, it is whole Individual brace system is formed by homogenous material, and its behavior have with above to unusual identical mode described in multilayer brace.Should Material can have layering, and it passes through more or less bubble is introduced into foamed material to become more or less densification.Material Core there is the density higher than material outer (more bubbles) (less or without bubble).This can be by using bubble Foam extruded material realizes, in the fabrication process lather collapse or be operated so that it becomes finer and close.Then, with hot or other Mode is handled so that surface raises and bubble expands, and becomes less fine and close and softer.This can also pass through co-extrusion simultaneously Go out or common mode system multiple layers are realized, its is expandable for different density or the coextrusion material using different compositions.Net effect Fruit is the homogenous material sheet material for having hard core and buffering heat-insulated exterior section.In the forming process around body part In, low-density (more foaminess) exterior section of material can isolate interior section to protected from the heat of interior section institute Caused discomfort.This thermal insulation also provides enough retention times so that brace can surround body part shaping, portion of elongation center Divide tool the plastic time.Other layer can be also added, to provide extra treatment and aesthetic benefits.

The intermediate layer can also include the layer of multiple thermoforming materials.These different materials can include different rigidity and The feature of thermoforming ability, or they are only in some regions in intermediate layer, to increase the rigidity of intermediate layer some regions Or plasticity.In addition, the position that can need in the intermediate layer insert other material with the extra rigidity required for providing or Plasticity.

Manufacture

The manufacturing process of one preferred embodiment uses hot pressing.According to specific products to be formed, by three groups Into be placed in suitable mould or punch die.Then by with place three (or more) mould/punch die of layer is placed in In convection oven, and it is heated to 300 degrees Fahrenheits.Then mould/punch die of heating is placed in stamping machine.Stamping machine is closed, will Three are laminated the shape for being made for mould.Stamping machine remains closed until three layers are cooled to and are enough to retain its shape.It is once multiple Condensation material has been cooled sufficiently, then is taken out the composite products of molding in mould.Can carry out other end steps with Product is completed, such as forms hole, connection close mechanism etc..

Another manufacturing process also uses molding process.Intermediate layer 30 is clipped between internal layer 20 and outer layer 30, is being moulded It is embedded in journey under the edge of these layers.In this process, all layers are heated on target temperature.Mould is outside it Edge includes dead line, to cut the foam of internal layer 40 and outer layer 20 and any tissue layer.In addition, adjacent dead line, will with rod Layer height compresses.The edge of these layers is crowded together the edge so that sealed product, and tightly and permanently combines molding During all layers.This provides for brace and cleans soft, round and thin edge 42, as shown in figure 4, its is not durable, comfortably and not It is easy to chafing against skin, chafing against skin is the FAQs of traditional gypsum and glass fibre brace.

Or can on exposed edge with edge adhesive tape come sealing margin.This allows brace to be formed as blank, and is directed to Specific purpose is customized cutting.Exposed edge seal is formed soft edges by edge adhesive tape.The adhesive tape can be soft Flimsy material or foam, it has the sticking back side, and the back side is easy to be put on the edge of brace with hand when needed.

Another preparation process is cold pressing molding, and it generally includes the following steps.By tissue layer (if you are using) layer It is depressed into internal layer and/or outer layer.Then, base and the cross cutting of feature are carried out to every layer.Intermediate layer is positioned over the extrorse internal layer of the back of the body Within outer layer.Three layers are heated to critical molding temperature, it is higher than target temperature.Heating is placed on cold stamping die In, layer is suppressed wherein, to cut out the feature in layer, by suppressing rod sealing margin.The layer is cooled down by mould To form composite.

The embodiment need not be laminated, because each several part is molded together.But the embodiment can also include lamination Layer 20,30 and 40 together.Outer layer extends across intermediate layer, to form soft edges 42.The edge of outer layer can be laminated, be laminated And mould or be molded as that there is heat seal edge and point bonding.

It should be clearly understood that other laminations or manufacturing process also can be used, such as using heat adhesive, suture or appoint The method that what it fits together layer.

Closed-system

Closed-system 60 is fixed for product to be closely surrounded into body part, as illustrated, and allowing a certain degree of Compression damages so as to mitigate.The system can be placed in two sides adhesive tape between lamination, be applied to seam or its periphery Adhesive tape or mechanical closure system.These mechanical closures may include but be not limited to：Hook and look fasteners, snap-fastener, zip, ratchet system Band, skiing shoe style button etc..In a preferred embodiment, closed-system can be fixed, by the doctor in charge or technology people Member's adjusting elasticity, this is due to so that can not be adjusted by patient when brace applies with anti-tamper closure.Then, it can lead to The doctor in charge or technical staff are crossed by instrument to readjust to open the closure for preventing adjusting.If the doctor in charge or technology If personnel need, then the closure being arranged so as to, patient may only adjust to finite quantity pine or tighten brace, but can not incited somebody to action It is permanently removed.This allows patient to adjust loose brace in uncomfortable or swelling, and tightens brace when excessively loose, and without finding Doctor.In addition, the system can be arranged so that patient has the ability to adjust and remove completely brace by the doctor in charge or technical staff. This can extend the life-span of brace so that it can be used as provisional brace during strict use to protect the damage that part is healed Wound.There is suitable selection to all healing phases using controllable and adjustable systems, the doctor in charge or the technical staff, can Allow the patient to or cannot be adjusted.

Especially, a kind of connecting elements includes elasticity regulation cable system 70, as shown in Figure 5.System 70 is in brace system 10 offside uses a series of induction elements 72.As shown in figure 5, frenulum 74 ties up to alternate sides by induction element 62, then wear Cross latch member 76.Frenulum is tensed so that brace has suitable elasticity on body part, and is locked in suitable position Put.A kind of replacement strapping system shown in Fig. 6 is similar to component above, but is mechanically fastened and locked using reels mechanism 78 The frenulum of tie-down is closed, it can easily discharge and fasten by finely tuning.In this embodiment, retention mechanism 60 includes rope spool Element, such as rope disclosed in BOA Technology Inc. roll up axis connection system, in United States Patent (USP) No.6,289,558；6, (its whole is incorporated herein by reference) and US patent application publication 20080083135 in 202,953,5,934,599； 20080066346；20080066345；20080066272；20080060168；20080060167；20060156517； It is described in 20030204938 and 20020095750 (its whole is incorporated herein by reference).Rope spool 78 is rollable with tie-down Frenulum, can vertically it pull so as to loosen frenulum.Other retention mechanisms, including cord lock, cam cord lock, traditional frenulum can also be used Knot, ratchet strapping system and other frenulum methods.Use a kind of alternative system of skiing Hasps for shoes (such as ratchet straps hasp) System can also be similar to that to be used with being described in more below in the modes of the hook fabric segments of certain one end.For the doctor in charge or skill For the ability of art personnel, these systems can have feature described above, so as to prevent patient to be adjusted or allow pair Component carries out different degrees of regulation.

On the other hand, the present invention provides a kind of unique strapping system.Strapping system as shown in Figure 7 is provided along hard The edge 80 of matter dressing, brace or any other product edge.Edge 80 includes a series of the wearing along the perpendicular separation of edge 80 Hole 82.The edge can be fixed with hook and look fasteners, is sewn on product, viscosity is installed or is otherwise connected with product.Side The bottom of edge includes the hook and loop straps around product.Also can be used alternative component, such as band and hasp, or it is any its Its known bindiny mechanism.

Using pin or cone 88, monofilament lines 86 are inserted by the opposite segments of perforation 82.The end of line 86 terminates in product and faced The end of nearly hook and loop straps.End is pulled to tighten up line so that the edge of product is pulled together.Once product surrounds body Position or other objects are tightened up, then line 86 are centered around around product, fixed by hook and loop straps.Cord lock or other mechanisms also can be used To fix the line.In the present invention, rope, frenulum or other mechanisms also can be used with instead of monofilament lines.

The retention mechanism 50 of the brace system 10 of one preferred embodiment allows brace system edges overlapping.This is overlapping Amount is about 25% or less of girth.Closed-system is installed on this lamination as discussed above.Which increase brace system Controllability, so as to increase or decrease the compressibility to injured body part.Integral type brace system 10 can provide a variety of Size, to be adapted to the size of different body parts and body part.Such as Fig. 8 of the preferred embodiment integral type brace system Shown, by allowing the overlapping opposite edge 24 in brace edge 22, adjustable overlapping offer has brace to be directed to particular patient The further custom fit of particular body portion ability.Retention mechanism 50 allow brace by increase or decrease overlapping amount come Regulation so that the more closely body part of appropriate patient.

Using

Brace

The unique combination of above brace feature provides the brace of lightweight but structural rigidity, and it is easy to customization so as to pin To patient's formed in situ, without special training or technical ability.Gained brace has patient's compliance, can carry out as needed Adjust the compliance used to increase.Controllability can also reduce soft tissue injury.Dry heater can be used to be molded the brace, So many thermals source can be used.Protect patient from the injury of brace heated in forming process or discomfort.The brace is waterproof And it is durable, it can reuse and be molded as needed.The ray that material (being largely polymer) used provides height is saturating The property crossed, therefore body part can be checked by x-ray, without removing brace, glass fibre and gypsum are usual by contrast It is that ray is impermeable.It is possible to use regenerated polymer when building intermediate layer, this can influence container for drink industry.

The integral type brace system of the preferred embodiment can be with relatively flat shape or substantially with specific body Position (such as wrist, ankle, knee or other body parts) shape and with general size (such as large, medium and small) provide.Some In the case of, the brace can also be preforming with substantially suitable body position, to test size or is needing more complicated structure In the case of.Then, the system can be heated and customize shaping, with the specific suitable body part to be supported.It is as described above, adjustable The overlapping of section also contributes to this custom fit.Then, the integral type brace system can be adapted in the form of comfortable but tool is rigid Body part.

The example of the preferred embodiment of the invention used in brace type is shown in Fig. 1,5,6 and 9-11.The purposes has There is particular advantage, because this body region is especially sensitive and outer shape has being very different between people and people.This The advantages of there are purposes the durability characteristics of material therefor to bring, it is not easily tied and opens because they compare under body weight effect Split.In addition, the ability for the tension force that regulation tends in the region of swelling has particular advantage.

It dry heat source can be used to carry out thermoforming to integral type brace system 10, lived with substituting typical water used at present Change material.One shortcoming of these typical materials is body part and most wounds relevant with damage in brace installation process In it is wetted.After brace installation, they generally remain moistening many hours so that skin is uncomfortable, rubs and is easier to By microbial infection, at this moment exactly need most sterile.The example of the preferred embodiments of the invention was installed in brace Drying is kept in journey, be provided solely for of short duration and comfortable body part dries heating.Start healing under dry environment not Easily infecting and infecting by microorganism.In the dry environment, the antimicrobial treatment being introduced into brace can be more effective.

Brace system is also plastic and is fixed to body part, without a large amount of training because its be it is prefabricated and Do not built with patient.Most of work of these prefabricated braces are carried out in factory is prepared, and save preciousness Hospital and the clinic time, add significant advantage.The brace system is also waterproof, light weight and comfortable, therefore is added Compliance of patient when using the system.Much stronger than glass fibre or gypsum of the durability of polymer plastic used and Antifatigue and cracking.This is combined with regulation brace elasticated and size or to the ability that it is re-molded, and can allow whole Single brace is used in individual agglutination, conventional brace will repeatedly go to hospital or clinic to change 1-3 times in the process.

The brace must press close to the shape shaping of body hot, soft and flexible when, so as to most preferably stable healing In damage.The brace of the relaxation mathcing with space can cause undesirable movement between body and brace.Match body The brace of the optimal shaping of each details can provide stability, without tension, only contact in many cases body without Pressure.This is the construction of the most comfortable, and it will provide required support but do not limit, reduces circulation, nor stimulate.In order to Realize this preferable effect, it is necessary to introduce the unique method that the brace is directed to body shaping.Because brace lateral edge 22, 24 overlapping openings as shown in Figure 8 formed can adjust on girth, so the brace is exceeded by applying when hot and plastic The repressive tangential force of worn for long periods comfort level and be most preferably molded.Once cooled down in brace in a moment and turn into rigidity Body, then remove the compressing and adjustable closure is so as to provide required brace closing capacity for comfortableness and stability.

Casts

The casts of preferred embodiment are similar to brace as described above.Main difference is (if any) Middle support layer is formed by more rigid material.This can be higher by simply providing thicker material, or by selecting The material of hardness and tensile strength is realized.Casts are applied by following step：Casts are heated to mesh first Temperature is marked, is then applied it to around body part, and extendable material is pressed into suitable shape around body.So Afterwards, strapping system can be tensed, to apply proper amount of elasticity and fixed casts.It is elastic on adjustable casts Degree, to be adapted to swelling, itch or other problems increase or decrease.The casts of the composite are waterproofs so that Patient can have on it and have a bath or take a shower, without using the protection around casts, patient can even have on it and swim.Should Casts are easy to by the way that the elasticity of strapping system is loosened to remove, therefore casts saw what is be not required.

Clamping plate

In a preferred embodiment, the system provides integral type clamp plate system, and it is much superior to existing system.This The system as clamping plate of one preferred embodiment of invention is shown in Figure 12-17.The clamp plate system shows with cock-up splint, still It should be clearly understood that it can be used for any kind of clamping plate situation, such as, but not limited to pin clamping plate, neck clip plate, leg splint, arm Clamping plate etc..The clamp plate system 90 of the present embodiment includes interior comfortable bed course 20, middle support layer 30 and outer durable bed course 40, such as schemes Shown in 2.Three layers each provide the function of uniqueness, and unique and superior clamping plate is produced when being integrally combined formula clamping plate.Under These three layers being each described in further detail in text are molded or are laminated to together to form integral type clamping plate.Gained clamping plate pair It is more comfortable for patient, patient can be increased and use its compliance.The existing system discussed compared to context, gained Clamping plate has many other benefits.It should be clearly understood that the extra play outside these three layers as described herein also can be used.

The clamp plate system of the preferred embodiment enables clamping plate to be laminated in advance, preforming or take blank form, And provided with the size of the purposes needed for, such as supporting wrist, arm, knee, neck or other body parts.Then, the system It is easy to be customized for particular patient as described below.In a preferred embodiment, the system also allow clamping plate according to Need to be adjusted by patient to adapt to swelling or other problems.This controllability also allows clamping plate to be directed to the specific body supported Body region is customized.

Clamp plate system is heated, preferably with xeothermic (although hot water can also be used), it is become thermoformable, with It is molded in several minutes.The clamp plate system of the preferred embodiment is at a temperature of 160 degrees Fahrenheits to 250 degrees Fahrenheits (target temperature) It is plastic, is easy to be molded, but still be able to maintain a certain degree of rigidity, does not turn into excessive fluid (as more than this As the glass transition temperature of material reaches).Other target temperature ranges can also be used using other materials.Then may be used The system is placed in patient, and does not scald patient in this process or causes the discomfort of patient.The foam of relative low density Internal layer separates highdensity hot intermediate plastic layer with body.With skin more highdensity than foam actually than foam by heat Passing to skin quickly cools down foam, thus protects it at the temperatures used from scald.Then, using side described below The preferably xeothermic system is easily directed to the exact shape being shaped to needed for the particular patient by method, without special skill Energy.

Purposes

The example of different type clamping plate is shown in Figure 12-17.Figure 12 middle clamp plates 90 have flat customization profile, to Utilize the clamping arm of " L " shape top 92 or wrist.When clamping plate is heated and is molded (as described in greater detail below), L-shaped Top 92 is molded as cosily supporting the wrist and thumb of patient, as shown in figure 13.

For supporting wrist or another example of the clamping plate of arm damage to be shown in Figure 14,15.Base clamping plate 94 include compared with Big top 96, hole 98 is formed wherein.The clamping plate is heated and is molded, to customize suitable patient so that the thumb of patient can Stretched out by hole 98.

Another example of the clamping plate of the preferred embodiment is shown in figure 16.The clamping plate 100 is intended for clamping leg Damage.The clamping plate is included in the slit 102 that clamping plate bottom is formed per side, and its hinge being used as in molding process causes clamping plate Bottom can enclose pivoting, so as to produce the foot of clamping plate or root.

Another clamping plate is shown in fig. 17.The clamping plate 104 has the unbroken loop fabric suppressed on outer layer 40.This causes Two other parts of clamping plate can be connected with each other by the part of unbroken loop fabric 106 with pre-determined configurations.Therefore, can be as needed Complicated shape is produced in quick and easy method.

Clamping plate is applied

The clamping plate must press close to the shape shaping of body hot, soft and plastic when, so as to most preferably when restoring Make damage stable.The relaxation brace with space can cause undesirable movement between body and clamping plate.It is each to match body The clamping plate of the optimal shaping of details can provide stability, without tension, only contact body in many cases without pressure. This is the construction of the most comfortable, and it will provide required support but do not limit, reduces circulation, nor stimulate.In order to realize This preferable effect, it is necessary to introduce the unique method being molded for the brace of body.The clamping plate passes through when hot and plastic Apply the repressive tangential force more than worn for long periods comfort level and be most preferably molded.Oppressive force can cause clamping plate 10 comply with and Shaping.Once after a moment rear plate cools down and turns into rigidity, then removing the compressing, and adjustable closure think it is comfortable and steady It is fixed that required jaws close amount is provided.

The method for optimizing of compacting is to use elastic webbing 112, and as depicted in figures 18-20, it can quick winding at once after mounting Around hot and plastic clamping plate.The elastic webbing can be fabric or rubberized material, and it has for specific cleat style Suitable width, thickness and elasticity, its length are wound around whole clamping plate enough.Can be simply by pulling the band in winding To change pressure.The process will ensure that each part of clamping plate is molded for body, and not produce space.Geography should be understood Solution, although the process is generally used for applying pressure to wound, apply pressure in cooling procedure to be temporarily forming heat and can It is unique process that the clamping plate of modeling state, which then removes,.

In a preferred embodiment as shown in Figure 18,19, hook fastener band 110 is fixed under clamping plate 108 End, or whole surface 40 can include unbroken loop fabric.Then, elastic webbing 112 can be fixed to element 110, with initially solid The fixed band.The elastic webbing will engage with hook retaining element naturally.This to fix clamping plate and body or by multiple folder Plate segment, which links together, many selections.This allows to form the construction of complexity.

Then, elastic webbing 112 closely is wound around clamping plate, as shown in Figure 19,20 so that hot intermediate layer 20 is suitable for Body, as shown in Figure 20,21.Then, as clamping plate is cooled into rigidity supporting structure and removes elastic webbing.

The clamping plate of lightweight but structural rigidity is provided with the unique combination of train wheel bridge feature, it is easy to customization so as to pin To patient's formed in situ, without special training or technical ability.Gained clamping plate has patient's compliance, can carry out as needed Adjust the compliance used to increase.Can be used it is xeothermic make the clamping plate be molded, so many thermals source can be used.Protect patient from The injury of clamping plate is heated in forming process or is produced uncomfortable.The clamping plate is waterproof and durable, can reuse as needed and Shaping.Material (being largely polymer) used provides the radiolucency of height, therefore can check body by x-ray Position, without removing clamping plate, glass fibre and gypsum are typically that ray is impermeable by contrast.It is possible in structure Regenerated polymer is used during interbed as part or all of component, the advantages of it has environmentally.

The integral type clamp plate system of the preferred embodiment can be with relatively flat shape or substantially with specific body Position (such as wrist, ankle, knee or other body parts) shape and with general size (such as large, medium and small) provide.Some In the case of, the clamping plate can also be preforming so as to substantially be adapted to body part, with test size or is needing more complicated structure In the case of use.Then, the system can be heated and customize shaping, to be specifically adapted to the body part to be supported.

It dry heat source can be used to carry out thermoforming to integral type clamp plate system 10, lived with substituting typical water used at present Change material.One shortcoming of these typical materials is body part and most wounds relevant with damage in clamping plate installation process In it is wetted.After clamping plate installation, they generally remain moistening many hours so that skin is uncomfortable, rubs and is easier to By microbial infection, at this moment exactly need most sterile.The example of the preferred embodiments of the invention was installed in clamping plate Drying is kept in journey, be provided solely for of short duration and comfortable body part dries heating.Start healing under dry environment not It is easy to by microbial infection and infects.In the dry environment, the antimicrobial treatment being introduced into clamping plate can be more effective.

Clamp plate system is also plastic and is fixed to body part, without a large amount of training because its be it is prefabricated and Do not built with patient.Most of work of these prefabricated clamping plates are carried out in factory is prepared, and save preciousness Hospital and the clinic time, add significant advantage.The clamp plate system is also waterproof, light weight and comfortable, therefore is added Compliance of patient when using the system.Much stronger than glass fibre or gypsum of the durability of polymer plastic used and Antifatigue and cracking.

Clamping plate purposes

In use, integral type clamp plate system 10 is supplied to personal, orthopedic specialist, doctor, skill in the form of suit Art personnel, first-aider or other entities.For the suitable suit type of the body part to be supported selection and size.Following article Discussed, dry heat source is put on into clamping plate 10, until clamping plate is plastic enough to allow its shaping.This should be 160 degrees Fahrenheits extremely 300 degrees Fahrenheits (target temperature), preferably 200 degrees Fahrenheits.In the preferred embodiment, the temperature of clamping plate is maintained at required temperature Such as 200 degrees Fahrenheit about 5 to 10 minutes.Dry heat source can be baking oven, microwave or hot bag as described below, internal heating arrangements Or heat release thermal source.

Once clamping plate is warm enough and plastic, about 5-10 minutes, then it is removed from thermal source, elastoplast is additional to folder On plate.

Then, clamping plate is directly applied to body part, as shown in figs. 18-21.Form the low-density polymeric of internal layer 40 Foam radiates so that any pain or uncomfortable that individual is not come by the torrid zone.In the preferred embodiment, the clamping plate is about It is plastic in 3 to 10 minutes.This allows time enough to make clamping plate be molded around body part.Using elastic webbing 112 come Pressure is provided, so as to specifically mold whole clamping plate for body part, as shown in figs. 18-21.Elastic webbing 90 is uniform by pressure Ground is applied on whole clamping plate 10.Elastic webbing 90 can be elastic ribbon or by nylon/textile, rubber, polyurethane, spandex Or the elastic pressure bandage that any other suitable material is formed.

In forming process, it can also reduce or orientated damage.The retention time of clamping plate should be enough to allow to occur to be molded and become Shape.

The combination of plastic, heating thermoformable layer and uniform pressure causes clamping plate to be molded for body part.Intermediate layer Main shape and support are provided.If be made up of thermoforming material, internal layer is also by shaping so as to surround body part to close Body.In the preferred embodiment, outer layer is not thermoforming, but will be extended with the shape in intermediate layer.Because it is not It is thermoforming, so it will not leave behind the marking of elastic webbing, and the smooth and attractive in appearance of outward appearance will be retained.If these are not needed Characteristic, then this layer can be thermoformable under target temperature.

Animal doctor

The composite can also be used in particular for veterinary purpose, particularly for horse.To larger animal such as horse and other families Poultry and wild animal, there is provided stationary support is very difficult.Composite as described above is light weight and high intensity, and It is adapted to the ability of limbs with customization, casts/clamping plate/brace can easily customize to be fit, without being caused to animal Divide interference.It can also be shaped to the shape (as described in more detail below) of complexity in the original location so that need not transport animal.Its Can also up-sizing, or reduced the size according to the needs for less animal.

Protectiveness is equipped

In a preferred embodiment, the system provides the plastic protectiveness change system of customization, and it is far superior to Existing system.Protectiveness equipment can be used for such as sporting devices, such as shin guard, wrister etc.；Military and law enforcement protection dress It is standby, for the protection of workplace and for any other purposes for needing to customize shaping protection.

The purposes example of the material of a preferred embodiment of the present invention is shoulder protector 120, as shown in figure 22.The shoulder Protector includes some, and it is cut, heats and be then stitched together (in the method being described in more detail below).So Afterwards, the part of assembling is heated, customized to be adapted to the body of user, so as to provide protection for shoulder regions.

Another example of the composite purposes is the shield used in many sports and law enforcement and Military Application Shin, to protect the shank of people and knee from damage.As shown in Figure 23,24, some 128,130,132 is by composite shape Into, be then heated and suture to produce with low profile and close fit product, its can be subsequently heated and accurately with Body matches.Knee cap and pin protector are introduced using the boomerang with some and hot sewn seams.

Figure 25-27 shows the gloves for protection used in physical culture, law enforcement or military affairs, and it has by preferred embodiment composite wood Complicated more part internal structures, the composite are stitched together when heat made of material.This illustrates how to use Small curved edge part is stitched together when hot and plastic by standard sewing machine method.This is for being used alone rigidity modeling It is impossible for material.The gloves of completion can be heated to 200 degrees Fahrenheits and be worn on hand.Then, the flexible hand of wearer With finger to most-often used required position, such as grasping ice stick, shield or bat, the shape is kept until article is cold But, so as to provide custom fit and with strong supportive three-dimensional fit product.In addition, it is using standard material and method It is difficult to the process.For purposes of riding, industry and building equipment, the elderly protect product and many other purposes come Say, can also produce other types of protectiveness equipment.

The protectiveness change system of the preferred embodiment causes protectiveness equipment to be in advance laminated, be preforming or adopt Blank form is taken, and is provided with the size of the purposes needed for, such as supporting wrist, arm, knee, neck or other body parts. Then, the system is easy to customize for specific user as described below.In a preferred embodiment, the system also allows Protectiveness equipment is adjusted by user as needed.This controllability also allows protectiveness equipment specific for being supported Body part is customized.

Protectiveness change system is heated, preferably with xeothermic (although hot water can also be used), so as to become can heat into Type, to be molded in several minutes.The protectiveness change system of the preferred embodiment is in 160 degrees Fahrenheits to 250 degrees Fahrenheit (mesh Mark temperature) at a temperature of be plastic, be easy to be molded, but still be able to maintain a certain degree of rigidity, rather than excessive stream Body (as the glass transition temperature more than the material reaches).Other target temperature can also be used using other materials Spend scope.Then the system can be placed in patient, and scald patient in this process or cause the discomfort of patient.Relatively The inner foam layer of low-density separates highdensity hot intermediate plastic layer with body.It is actual with skin more highdensity than foam On contact the heat to skin than foam and quickly cool down foam, thus protect it at the temperatures used from scald.Then, make With process described below, by the preferably xeothermic system, easily specific aim is shaped to the exact shape needed for the specific user, Without special technical ability.

Heating system

In a preferred embodiment, the present invention is also provided for heating clamping plate to the heat of target temperature as described above Source, so that system is molded for body part.Preferred embodiment such as Figure 28 for the thermal source, include heating shown in 29 Bag 150, its easily stored and transport.The heating bag includes outer thermal insulation layer 152, the opposed heating element heater 1274 and lining bag of sheet form 156, preferably outside durable and internal adhesion, it loads heating element heater and thermal insulation layer.The heating element heater can by heating wire or add Hot paper tinsel or other electro-active designs are made.Heating bag 150 is easily upon opening, to accommodate clamping plate, and is closed in heating process. Closed-system such as shackle, slide fastener close bag so as to keep heat.Heating element heater is connected with power supply, power supply or be 110- 240 VAC standard plugs are either 12V transformers or 12V DC batteries or vehicle power, and lead to connect socket Thermostat or heat controller are crossed accurately to keep target temperature.Heating bag can also include optional temp probe, and it is monitored The temperature being applied in brace system.

In use, integral type clamp plate system 10 is placed in the box between opposed electrical heating elements.The box is activated, is caused Heating element heater heats to clamping plate 10.Once clamping plate is sufficiently heated to target temperature and plastic enough, just removed with around Body part is applied and is molded.

The thermal source box is easy to transport, and can be used in hospital, clinic, training chest or the place for even handling damage. Special baking oven or chemical reaction are not needed.

Another thermal source of a preferred embodiment of the present invention uses internal heating arrangements, and it is mounted in integral type clamping plate It is interior.This can be the power grid on the one or both sides of intermediate layer.The grid is connected with providing the power supply of electric current, so as to by intermediate layer It is heated to target temperature.Once the shaping of clamping plate is completed, then electric current is closed, clamping plate quickly cools down.Because it is in clamping plate, institute To eliminate the demand to external heating device.

Another thermal source of a preferred embodiment of the present invention utilizes heat release thermal source 160 as shown in figure 30.In the presence of production A variety of chemical reactions of heat, such as carbon/air, alkali/water, air cell etc..When two or more elements expose each other, institute Caused chemical reaction causes to discharge heat.Typical common application is carbon/air bag, and it is used as the pocket for cold snap Heater, and alkali/water receptacle, it is used for " ready meal " of army.Can be by the way that heating chemical product be added to slotting enough Enter in the polybag or sack in the space of clamping plate to use the clamping plate of similar system heating preferred embodiment to target temperature.Change After learning reaction generation, clamping plate is heated, taken out and applies.The advantages of this system is that damage frequently occurs in field, doctor or doctor Life there can not electricity consumption.The method rapidly and simply of the heating clamping plate of the mode of providing for oneself is this method provide, and using above Methods described is administered.

Other heaters include convection oven, baking box, radial burner thermal source, infrared heater and micro-wave oven.Usable pair Flow air oven.Can also be used it is damp and hot, used in example thermoforming clamping plate as in the previous.The type heating needs clamping plate immersing heat Water receptacle, until it reaches target temperature.

Heating system for another type of the present invention utilizes micro-wave oven.Generally, micro-wave oven is not equal in specified temp Even heating.The purposes that the heating system 170 as shown in Figure 31,32 is used to use micro-wave oven is described, but other heat can also be used Source, such as immerse hot water and other thermals source.In the preferred embodiment, heating system 10 includes the first obturator 172.Closing Body 172 has opening 174 and sealing mechanism 176, such as the sliding shoe used in the bag of zip closing, and it forms anti-on obturator Water-stop.Or the obturator can be sealed with other components of inner sealing during fabrication.In the preferred embodiment, Obturator 172 is bag, such as polybag, is made up of thin polypropylene or other similar materials.The size of obturator 172 causes it can Load to be heated and shaping object.

Second obturator 180 is inserted in the first obturator 172.Second obturator also has opening with containment member 186 Mouth 184.Second obturator can polybag similar with the first obturator, such as being formed by polypropylene or other materials.Two Obturator should be waterproof, and can withstand greater than the temperature of 220 degrees Fahrenheits.

Heating system 10 also includes sorbing material 188, such as sponge, paper or nonwoven layers, and it is inserted into the first obturator 20 It is interior but outside the second obturator 180.These pieces 188 are soaked before use with water.Can be by described wetting, or from envelope in advance Taken out in closure 172, soaked by user and be inserted into the first obturator.Or, it is possible to provide water is without providing sorbing material.

In a preferred embodiment, the first obturator 172, the obturator 180 of sorbing material 188 and second are connected to each other The unit of single integration is formed together.Sorbing material is connected between two obturators.

Heating system 170 can be provided with following form：User provides the heating system of object, or is packaged in institute of manufacturer Around the object of offer.In either case, to be heated and shaping object 10 is inserted into the second obturator 180, by close Envelope component 186 is sealed in wherein.Described 188 is soaked in advance or at this moment, is inserted into the first obturator 172 what is sealed Outside second obturator 180.First obturator 172 is sealed by containment member 176.

Then, the obturator of assembling is placed in thermal source, such as common microwave stove.In some instances, it is if to be formed Dimension of object is bigger than the size that common micro-wave oven can accommodate, then may need bigger micro-wave oven.Then, micro-wave oven is opened To top grade.Heating operation duration depends on the size and other factorses of the power of stove, object and obturator, but furnaceman make to Water in suction sheet 10 becomes steam.Steam ensures temperature in obturator in about 212 degrees Fahrenheits.Relatively short time with it is relative Soft obturator can cause steam superheating to minimize, so that temperature is not significantly higher than 212 degrees Fahrenheits.

Because object of the obturator in about 212 degrees Fahrenheits, the second obturator also will be about 212 degrees Fahrenheits.In the process In, the second obturator 180 causes the object to keep drying.It is thorough to ensure that the temperature range fully long time is maintained in object Bottom is heated to after the temperature, and heating system 170 is withdrawn from stove or thermal source.

If object provide in the obturator from manufacturer, then manufacturer can provide to heating obturator when Between and temperature range explanation.Otherwise, user can be tested so as to find optimal time and temperature range.

Once object is heated thoroughly, then the first obturator is sealed and opened, it is allowed to take out the second obturator.Then, may be used Second obturator is sealed and opened, it is allowed to takes out object.Then, it is suitable shape by forming objects, or is customized to be adapted to separately One object.

It should be clearly understood that other thermals source outside micro-wave oven also can be used.For example, heating system can be inserted into open In water receptacle, to produce similar process.Other thermals source, such as heat release thermal source can also be used.

Heating system can also include other embodiments.For example, single obturator can be used to replace double-enclosure system to unite. The single obturator with wetting adsorbent layer is inserted an object into, as described above heating.Carry out self-heating adsorbent in obturator Object is heated to about 212 degrees Fahrenheits by the steam of layer.Object may become to moisten in this embodiment.

Complexity shaping

Composite as described above has the special application for producing complicated shape product.Generally, complex product is by even The separation assembly being connected together is formed.Otherwise, product needs complicated molding or manufacture, and it is often infeasible.Will separation The process that component is connected is preferably by suturing (when feasible).Suture is frequently used for forming single flat sheet the three-dimensional of complexity Shape.Crack can be formed in flat sheet, it is then assembled and the be stitched together shape to be formed in product and hinge.But Also it is often very difficult, because it is difficult to seam even if it is not impossible that plastic assembly, which is linked together, by suture The pin of conjunction penetrates plastics, particularly if if plastics have rigidity and high intensity.Perforation is produced in addition, being sewn on plastics, It can cause product to tear.

As shown in figure 33, even if will be harmonious with profile, to be stitched together be not impossible for two rigid materials at edge It is and very difficult.The edge that two profiles are harmonious will not closely be in contact each other.For most of suture operations, So that rigid material is deformed into the power for causing profile to be harmonious needed for the 3D shape that edge is combined together and can not obtained.Therefore, Seldom two rigid materials are sutured before, are for the very rigid material for the shape that is harmonious very much with profile It is impossible.

The problem is resolved by the preferred embodiment.In use, it is cleavable, be molded, suture and pass through Other mode operates composite 10, becomes the 3D shape of complexity.Composite is heated, until intermediate layer 30 becomes to prolong Property.Outer layer (fabric, the combination of buffering heat-barrier material or two kinds of materials or similar material) at the elevated temperature of environment into For ductility, and stability of the intermediate layer 30 in ductility state is kept, prevent its excessive tensile.Outer layer can also carry for intermediate layer For intensity, to prevent it from being torn in shaping, suture or cutting.Stretchable outer layer provides for ductility layer prevents it in heating The structure deformed unintentionally.They, which are also provided, will allow easily by sewing machine and allows component by material firmly connected to one another The suture surface of formation.They also prevent intermediate layer due to the big metallic region with sewing device is in contact and excessively fast quickly cooling But.When being heated to above 220 degrees Fahrenheit, outer layer has low-friction coefficient.For the purpose of the application, there is low-friction coefficient Character representation be non-sticky or non-tack.

It should be clearly understood that although composite described above use among thermoforming material and insulated foam coating and Stretchable outer tissue layer, but other embodiments that claimed invention is combined including the use of different materials.For example, this is multiple Condensation material can omit fluid insulation, use the Stretch material being directly connected with intermediate layer.In addition, composite embodiment Stretchable fabric can be omitted.

It is important to note that the thermopolymer plastic layer of no fabric and froth bed covering is sutured compared to trial, Composite bed as described above provides dramatic benefit.Outer layer has low-friction coefficient, different from the polymer plastic of fusing so that Composite will slide through sewing machine surface, and otherwise it can cling the polymeric adhesive surface of fusing.Polymer plastic layer is sutured It can be perforated together on material, cause reduction and tear under tension.The stretching of preferred embodiment as shown in Figure 2 is knitted Thing material 40 includes trickle strong fiber, and it is not only provided when being additional to composite when composite heats and is molded Intensity, also provide smooth low friction suture surface.Sewing needle can pass through between trickle strong fiber, it is not damaged Wound, thus provides safe suture, even in the state of weakening when intermediate layer is heated and penetrated and be extending.These are thin Micro- strong fiber can also prevent the hole in intermediate layer from being torn after cooling and as rigidity, because they combine and form one. Once material is cooled to rigid state, the intermediate layer of ductility is actually combined with knot.

Once composite is heated to ductility temperature, then it simply can be molded and suture.It can cut at ambient temperature Composite, it is easier to cut at elevated temperatures.Then, these pattern forms can be stitched into complex three-dimensional forms.One Denier composite suture, so that it may reheat the component of connection, so as to when it is applied on body by stretch further into Type.Seam can also flatten.

One example of composite sewing process is shown in Figure 34.Two components 190,192 of composite 10 are each other It is adjacent to and Figure 34 is illustrated in section.Two components are heated to intermediate polymer layer is relatively soft and extendable temperature.Fabric Layer 40 and thermal insulation layer 20 allow heating material slip over suture surface and adhesion.Sewing machine sutures the seam of two components, excellent Elect zigzag stitch as shown in FIG. 34 and 35 as.The seam can also produce in the following manner：Component 190 and 192 is overlapping, Sutured with other more complicated stitch common in single or multiple straight common stitch or sewn product.Figure 35 shows another kind Available suturing skill.It can face-to-face place for two layers 190 of composite and 192, be sutured using zigzag stitch, it is in Z-shaped Side passes through layer, then passes through air in opposite side.Once completing suture, the component of connection can be heated again, as shown in Figure 6 Suture is opened, partially opens and opens completely as shown in figure 37.The process is particularly useful for being sutured complex shape with multiple Shape links together, the wrist thumb brace such as, but not limited to shown in Figure 42.The mode shown in Figure 35-37 of stitching step 210 Suture by two layers connection.They are sutured face-to-face, are then opened when being thermally formed flush joint as shown in figure 37 and closing.Otherwise Words, it is contemplated that the small area of molded aperture and the limited areal provided is operated by sewing machine, the suture is particularly difficult to complete.

Substantially, once composite is heated to the temperature that intermediate layer is ductility, then it can knitted similar to stretching The operation of thing is so as to forming required shape and fit coating.Then, once it is cooled to room temperature, due to intermediate layer and three The rigidity gained shape of dimension form is very rigid structure, so the curved surface of the three dimensional form provides structural strength. This provides unique composite with wide range of application.

The product of final molding can be heated repeatedly again, can be operated, connected, sutured and be shaped to complexity Shape, and be adapted to complicated surface such as body.The plastic material of heat themselves tends to stretch and do not return to initially Shape.In heating, because it suture and is applied to body or is operated, so its scald skin.They can become non- Often with toughness, and it is difficult to handle.Unique composite 10 is stretchable in heating, suppresses and bends to extremely complex Shape.The tissue layer 40 of stretching causes the composite of heating stabilized around complicated shape, and is tensed around the shape, production It is raw closely fit.Intermediate layer can also be formed by polymeric blends, and the mixture alterable is to realize different rigidity.Separately Outside, the thickness in intermediate layer also alterable to provide different rigidity.

The composite of the present invention has special purposes in medical application particularly orthopedic applications.For example, people Font brace is frequently utilized for handling thumb and wrist injury.Thumb wrist herringbone brace is a species of orthopaedic srugery's support meanss Type, it is used to fix thumb and wrist, while allows the freely activity of other fingers.It is used for for following offer support：Defect of thumb (ligament is unstable, sprain, muscle sprain and fracture of ossiculum or bone split), warrener (gamekeeper) thumb, skiing Person's thumb, osteoarthritis, de Quervain's disease (de Quervain ' s syndrome), thumb strain, Post operation use and hand/ After thumb casts remove.

Herringbone brace is difficult to completely fit in patient, is generally produced by assembling multiple material come customization in situ.For Some pre-manufactured products of this purposes can also be used, but less common.As shown in figure 42, herringbone brace has complicated shape Shape, because it must support and maintain the appropriate relation between thumb, wrist and arm, its girth is adjustable and very Closely it is bonded to prevent activity.Producing the brace of this feature in the original location needs intricately to assemble each several part on body, generally It is made up of glass fibre casts material or PCL sheet material, its manual cutting, shaping and assembling on body.Bullet Property band and shackle closure be appropriate location attachment or fixed standard criterion.The brace of this feature does not suture, it is necessary to much knowledge, Practice and time (about 30 minutes) build.The prefabricated brace of this type generally from a variety of different soft fabrics, elastic fabric, no Stuetch fabrics or frenulum suture, sometimes including soft foam/fabric laminated.Then, the rib of hardening or prefabricated or tool ductility Rigid support thing be inserted into the article of suture.Suture is generally carried out on soft material rather than rigid backing material, because It is excessively difficult that rigid material is stitched into fit desired three dimensional shape.Sometimes, soft fabric is sewn onto rigid material, but this It is extremely different with the rigid material block of complexity is sutured to each other into 3D shape.In two kinds of situations above, result is to pass through fiber crops Be connected soft and rigid, the stretching of tired mode and do not stretch and strap material complex combination, and provide and wear The some of undesirable product.

The composite of one preferred embodiment enables herringbone brace to be made up of single composite, the material Material is stitched together by clean smooth joint, forms basic shape.Can be by simple or complicated enclosed member for example Shackle, strapping system or other devices are sewn directly on hot and plastic durability composite.Then, can be to the production of completion Product heat, at once shaping and due to its draftability and plasticity be directly customized to it is fit in patient.As a result provide much more Can dress article, it is thin, supportive, perfect fit, waterproof and non-adsorbed, radiolucent, light Amount and covered with soft and coloury fabric.Compared with product in situ, work, knowledge and time needed for operator It is much less.Compared to stent preform, as a result more custom fit, more flexible and simple, and wears more comfortable.Heating and It is very nearly the same with applying other pre-manufactured products using about 5 minutes needed for the composite products of a preferred embodiment.

As shown in figure 38, the structure of thumb wrist brace 200 is from two with profile and the composite in hole 202 10 Cut in blank.Flat sheet composite portions can be punched, with scissors, the cutter of computer operation, laser, water spray or its Its mode of production is cut.The part is heated to the extendable temperature in intermediate layer.For example, hot pressing, baking oven, thermolamp can be used Or the composite is heated to 180 to 200 degrees Fahrenheit 30 seconds to 3 minutes by other heaters.At such a temperature, the material Ductility can keep the sufficiently long time, so as to allow the part to be stitched together by standard sewing machine.Zigzag seam can be used Close and carry out the block that edge connects end overstriking to border land.Zigzag suture can also be used for suturing the part face-to-face along edge, Opening is then folded when heat is still kept, so as to form flat suture.This method is particularly useful for suturing small sharp The edge of sharp camber line, such as the thumb wrist herringbone brace shown in Figure 42, otherwise it can not mutually be sutured with rigid sheet.If Need, the material is repeatable to be heated to allow further suture, connection and forming process.It is critical to note that to mistake described in this paragraph Journey can not possibly be carried out individually with the polymer plastic sheet material of heating, because it causes friction and sewing machine clamping due to surface viscosity Can not be by sewing-machine foot and feed device, and stitch can perforate and polymer is weakened.The outer fabric of lamination With foam so that internal layer is stable, reduce and rub and provide the durability for suture.

Can be by being heated to the brace of completion so that be molded and be allowed to cool around patient and determine for support patient articular Make fit rigid shape so that the brace for the completion that Figure 42 is shown is customized to fit to patient.As needed, the brace can weigh Heat is added with to realize to the cosily fit of patient.

Figure 22 is shown using another product caused by preferred embodiment.The protectiveness shoulder pad use is from flat composite wood Expect three parts of cutting, it is heated to be with plasticity and edge is sutured with zigzag stitch by each several part edge.Knot Fruit is the product of substantially shoulder shape, but when being reheated to 200 degrees Fahrenheits and being applied to shoulder, stretched so as to Body is ideally suited for, without pressure point or relaxation area.Even if the rigid sheet article is sutured as known technology It is not impossible, and very difficult.In addition, by its for body be molded without heat barrier foam layer can due to uncomfortable and Throw into question.Allow simple shaping with outside the stuetch fabrics layer and thermoforming interior layer together with intermediate polymer layer, Without applying big pressure.The simple elastic frenulum applied when heat can cause part to be accurately molded for body.

Another example of the composite purposes of a preferred embodiment of the present invention is many sports and law enforcement And the shin guard used in Military Application, to protect the shank of people and knee from damage.As shown in figure 23, some is by multiple Condensation material is formed, and is then heated, and is sutured to produce thin profile and close fit product, and it can be subsequently heated and essence It is really suitable with body.Knee cap and pin protector are introduced using the boomerang with some and hot sewn seams.

Closed-system can be connected

The closed-system 250 of the preferred embodiment can be connected to the expection site of many different products.In the description The product used in property embodiment be brace 10 (although can be used any other orthopaedic srugery's product such as casts and Non- orthopaedic srugery's product), it has lateral edges 22,24, such as a copending application 12/013, the casts disclosed in 449, It is incorporated herein by reference.The outer layer of the brace of the preferred embodiment includes the layer 260 of unbroken loop fabric, such as Figure 43 institutes The Velcro USA issues shownThe outer layer can be formed by unbroken loop fabric 260 completely, in the preferred of Figure 43 Shown in embodiment.

The property of can be adhered of unbroken loop tissue layer 260 is connected, moulds, sutures or is otherwise attached on casts.Or Person, the tissue layer are alternatively arranged as the part connection of the integration of outer layer 40.Can also be used it is other unbroken loop tissue layer is fixed or The method being molded on product.

Can connecting fastening mechanism, as shown in figure 44, including frenulum 270, there is corresponding engagement and fixed unbroken loop to knit for it The hook element of thing, it is fixed to the basal surface of retention mechanism 280.In this embodiment, retention mechanism 280 includes rope spool member Part, such as the rope volume axis connection system of BOA Technology Inc. issues, in United States Patent (USP) No.6,289,558；6,202, (its whole is incorporated herein by reference) and U.S. Patent Application Publication 20080083135 in 953,5,934,599； 20080066346；20080066345；20080066272；20080060168；20080060167；20060156517； It is described in 20030204938 and 20020095750 (its whole is incorporated herein by reference).Rope spool 280 is rollable to be Tight frenulum, can vertically it pull so as to loosen frenulum.Other retention mechanisms, including cord lock, cam cord lock, traditional frenulum can also be used Knot, ratchet strapping system and other frenulum methods.Use a kind of alternative system of skiing Hasps for shoes (such as ratchet straps hasp) System can also be similar to that to be used with being described in more below in the modes of the hook fabric segments of certain one end.

A series of elongated bands 274 that frenulum is fixed with hook are also used in the preferred embodiment as shown in figure 44. These parts 274 are arranged on selected location at certain intervals along casts or other products edge, and extend on edge.This A little parts are engaged and are fixed thereon with the unbroken loop fabric 260 on product.Then, the end of the band 274 with ring surface 276 Doubling, so as to which hook surface is bonded on the basic hook surface of band 274, so as to form the ring of elongate flexible member 290, such as It is described in more below.

Then, can be by the way that clasp joint crossed belt 270 be engaged retention mechanism for example with the complete circumferential layer 260 on casts Rope spool 280 is connected to suitable position, as shown in figure 45.By being engaged with taking hook component also by guiding band 274 in institute Position is needed to be connected with complete circumferential layer 40.Flexible elongate member such as rope or frenulum 290 may then pass through ring 276 and rolled up around rope Axle.Then, frenulum 290 can be tensed by rotating rope spool, so as to which the edge of casts be pulled together.It is expressly understood that It is that term frenulum also includes rope, line or any other elongated flexible member for being applied to the present invention.On the shackle of ring 276 and knit Tangential force on the hook joint element of nitride layer 260 and band 270 and 274 provides the power for firmly engaging shackle, because Hook and look fasteners is tended to very firm on tangential.

It should also be clear that understanding, unbroken loop as described herein can be corresponding hook element, with complete described in replacement The hook element that domain tissue layer is replaced.

Then, the product of assembling can be placed in body part, such as the example shown in Figure 46.Supporter 10 is along body Position is slided, and rotates rope spool 280 to fasten frenulum 290 by ring 276, so that the overlapping edge around body part becomes Tightly, until supporter is fixed on correct position on body part.Or can no closed-system correct position situation It is lower that brace or casts are applied to body part, then in situ as needed closed-system can be installed.

Fixing band 274 shown in Figure 47-49 is readily able to the induction element to form rope or frenulum 290.Fixing band 274 is wrapped Containing the end section with unbroken loop, it is used to engage with the hook in fixing band.End section doubling, with reference to hook, so as to Ring or induction element 276 are formed, to guide frenulum 290.

Attachable strapping system can be set in many ways, to meet specific needs.For example, such as Figure 50 institutes Show, strapping system can be connected and include the retention mechanism 280 in hook strip 270, and drawn in parallel connected five relative of position Lead hook strap 274.Another kind as shown in figure 50 is set using three guiding fixing bands 274, and it has retention mechanism 280. The guiding fixing band 274 for being set using two intervals as shown in figure 50, it is opposite with retention mechanism 280.

Strapping system can be connected and may also be arranged to angled orientation, as required for complicated shape product.The example exists Shown in Figure 53 and 54.Frenulum 290 pulls on and complete ring surface phase relative to the tension force of induction element 276 on guiding band 274 Hook even, regardless of whether angle how, so that closing will be pulled to as needed with fixed to product.Induction element 276 is orientated This flexibility allow to close at different angle and pulled, so as to realize several closed procedures at once.

Alternate embodiment

Alternate embodiment is shown in Figure 55-59.This embodiment connects band of the system using two materials 300th, 302, it has hook element in dorsal part.Retention mechanism 280 is attached to by adhesive, suture or by any other mode One of band 300.The inward flange phase of two ribbons 304,306 such as nylon wires, fabric or any other material and band 300,302 Even.Edge of the ribbon 304,306 along band 300,302 forms perforation, it is allowed to which frenulum 290 inserts it by using sewing needle or cone In, so as to which frenulum is inserted into ribbon perforation 308 with any required frenulum pattern, as shown in figure 58.Hole 308 is shown in Figure 55 In, it is formed by the perforation in the length of pin and rope along ribbon 304,306 at interval, with allow frenulum to pass and penetrate with Form frenulum pattern.Figure 56 sectional view shows the frenulum 290 for penetrating ribbon 306, and it is attached to band 302.

Then, can be by the way that the hook of band 300,302 each bottom sides be engaged in advance simply with unbroken loop 260 on product 10 The connecting elements first assembled is connected to desired position on product, as shown in Figure 57,58.Then, the product that will can be assembled completely Correct position is slipped into connecting elements, frenulum 290 is fastened so as to which it be fixed by retention mechanism 280.On frenulum 290 Tension force not only product is fixed on body, as shown in figure 58, also ring 260 on the hook and product on band 300,302 is consolidated It is scheduled on together.Then, the side of bindiny mechanism 302 can be lifted from complete ring surface, it is allowed to facilitate access for and leave shown dress Put.

Another embodiment of the connection system is shown in Figure 60.Embodiment use similarly as described above is at it The embodiment that bottom side has two parallel bands 310,312 of hook element.But the embodiment use is along band 310,312 sides Plastics (or metal) induction element 314 of edge connection.Induction element 314 passes through adhesive, suture or any other mode and institute State band connection.Retention mechanism 280 is fixed on one of described band also as described above.Then, the frenulum surrounds induction element 314 Winding, band 310,312 rise to the bait element with the engagement of loops on product to be fixed on product by the band.

Another embodiment of connection system is shown in Figure 61,62.System use similarly as described above is at it Embodiment party with the dorsal part of retention mechanism 60 two parallel bands 320,322 with hook element fixed with one of the band Case.But the embodiment uses the induction element 324 that the net along band 320,322 marginating compartments is formed.This is net guided to pass through Adhesive, suture or any other mode are fixed on the band.Frenulum 290 is inserted through guiding with described frenulum pattern.Band 320th, 322 engaged by band element of rising to the bait with the ring 260 on product to be fixed on the opposite edges of product.Product is fixed In the tension force also stay hook and ring of the frenulum of body.

In another embodiment, rope locking 340 can be used for the rope rotating shaft described in instead preceding embodiment.Hand It is dynamic to tense frenulum 290 and be fixed by the cam member in rope locking 340.Rope locking is installed on fixing band 270, such as schemes 63rd, shown in 64, or the band is installed on by suture, adhesive, molding or any other fixing means as shown in Figure 64,65 One of.As described above, guiding fixing band 274 can be used for the frenulum 290 for being inserted through guiding 276 and rope locking 340.Then, may be used Band 270,274 is set and is fixed in product by the way that the hook element on band 270,274 is engaged with the ring 260 on product. Then, product is placed on body, frenulum 290 is pulled by rope locking 340, until product is fixed on properly by enough tension force Position, and the ring on the hook and product taken is fully engaged.Cam on rope locking 340 is by fixed tensioning Band, until the time of such as release.

The alternate embodiment of rope blocking element 340 is shown in Figure 66-67.The embodiment is shown under having The purposes for the rope blocking element 340 listd, i.e.,：With the relative band 320,322 and plastic guide 324 as shown in Figure 64, With parallel band 300,302 and ribbon 304,306, it is allowed to which frenulum is drawn as described above through ribbon insertion with being formed Lead, and there is the parallel band 350,352 with grommet 354, frenulum inserts through grommet.

Another alternate embodiment is shown in Figure 68.Unbroken loop fabric portions 42 are strategically placed in required position, As shown in figure 26, which part 42 is attached to the edge 22,24 of brace.Then, band 270,274 can be simply positioned in and adhere to In the position of these complete loop sections 42.

Another embodiment that closed-system can be connected is shown in Figure 69,70.The embodiment uses ratchet hasp Component 350.A series of band 352 with spaced teeths 354 is installed on the band 356 with multiple hook elements on the downside of it.Ratchet Hasp 358 is installed on the downside of it also on the band 360 with multiple hook elements.Band 360 with ratchet hasp 358 is connected to branch On the edge 24 of tool, and the band 356 with band 352 is connected to relative side by the engagement of hook element and unbroken loop fabric 260 On edge 22.The brace is installed on the body of patient, and the ratchet of band 352 is acted on to fasten by hasp 358.Brace and band are Hook can be tightly caused further to be tightly engaged into the ring of brace.Other changes and embodiment can be used in the present invention, in claim Described, to provide the retention mechanism outside spool and rope locking, and beyond induction element as described herein.Connection system Other settings are also contained in the invention of claim.The embodiment described herein is only provided with the purpose of explanation, to solve Claim is released, is not meant to be the scope of limitation claim.

Other examples of connecting elements purposes are shown in Figure 71-72.One example is connecting elements in back brace 370 On application, as shown in Figure 71,72.Back brace 370 includes the unbroken loop 260 for being attached to back brace near opposing edges At least partly.Fastening system can be connected and be initially installed on the near opposing edges of brace 370, the system has in its bottom side buckle The opposite band 300,302 of element, by being fixed on band 300, the guiding 304,306 that the ribbon at 302 edges is formed, and fastening machine Structure 60.Then, brace can be sized to be adapted to less people, as shown in Figure 72, by discharging the tension force of frenulum 290, from Band 300,302 is removed on the brace, a part for brace 370 is cut and readjusts the position of band 302 along the length of brace, So that brace significantly diminishes.The closed-system that position can be readjusted sets product, such as the system with allowing customization, because It can easily be removed, it is allowed to which brace is customized to fit, cuts off to change size or especially set, and then as needed will Closed-system is re-applied to different positions.Closed-system is also by lifting the connection sidepiece with complete loop section 370 again 300 or 302 are divided to allow readily to pass in and out.

Another embodiment of claim purposes is shown in Figure 73,74.In this embodiment, fastening system can be connected System is arranged on legs and feet brace 380.Fastening system has retention mechanism 280, and it is arranged on brace 380 by the hook element of band 270 Top, the hook element engages with the unbroken loop 260 on brace, the fixing band for guiding the top along brace 380 to be spaced apart 274.Frenulum 290 is tensioned, with around the top of leg stabilizing brace, and in order to comfortably leave foot's split-phase to not being tensioned, Huo Zheke In bottom, addition second can connect fastening system.Figure 74 shows that the fastening system is reset so that the foot of brace is also tensioned.

Unique system allows to produce product using minimum manufacturing capacity is in situ.The product may be molded to required shape Shape, then connecting elements can be fixed on to required position, so as to provide fully functional product.The system is in copending Patent There is specific purposes on orthopaedic srugery's product disclosed in application 12/013,449 and 12/181,272.These products use only Special product, it includes the thermoformable internal layer that heat-insulating foam material and fabric (such as unbroken loop fabric) are surrounded.This is compound Material enables product to be molded and surrounds body part customization, and it surrounds body by heating product, by the product of heating Pressure is placed and applied to customize shaped article to realize in position.The connecting elements of the present invention is by allowing fastening system in situ even Connect and provide other purposes, so as to provide the additional customized to product.

In one embodiment of the invention, the part shaped article with blank or with unbroken loop fabric face Form provides orthopaedic srugery's product.Then, base is cut and is substantially molded to be suitable for body part to be supported.Then, pass through Guiding as described above or other fasteners are mutually fixed with the unbroken loop on product fastening system is connected to product.Then, Closing device can also be connected by the way that the hook on device is engaged with the ring on product, for example, rope rotating shaft, rope locking, hasp or Other devices.Afterwards, frenulum, band or other tension adjusting devices can be directed across to fastening system as described above and fixed dress Put.Then, described device can be fastened around body part with fixing device by fastening as described above.

The above-mentioned unique combination of casts feature provides connection system, orthopaedic srugery's production for orthopaedic srugery's product Product can easily be customized to be molded without special training or technical ability for patient positions.There is products obtained therefrom patient to comply with Property, it can as needed be adjusted, compliance used to increase.Controllability can also reduce soft tissue injury.

Can provide the preferred embodiment connect fastening system for relatively flat profile or be substantially spy Determine the orthopedic outer of body part profile (such as wrist, ankle, knee or other body parts) and stock size (such as large, medium and small) Section's product.As described above, it can adjust overlapping also contribute in this custom fit.

Claimed invention provides the product and generation and the method using custom fitted products of uniqueness, described Product easily can be produced and assembled in the original location.The composite provides unique product, and it is fixed and easypro that it may be tailored to offer It is adapted to the product of body.The composite can be easily formed into complicated shape.It should be clearly understood that the embodiment above is used In illustrative purpose, rather than the scope of limitation claim.

Herein below corresponds to the original claims of parent application：

1. a kind of composite for plastic orthopaedic srugery's product, the material includes：

With the first layer of the first surface type of permanent attachment of the second layer；

With the third layer of the opposing face type of permanent attachment of the second layer；

The first layer at a temperature of about 200 degrees Fahrenheits by having the low-density heat-insulating foam material shape of low-friction coefficient Into；

The thermoplastic of the second layer is formed with the hard of the Shore 65D-80D scopes according to ASTM D2240 Degree, according to the tensile strength of ASTM D638 6000-9000psi scopes；According to ASTM D638 5% elongation at break, According to ASTM D5023 270,000-340,000psi bending modulus, the second layer is in 160 degrees Fahrenheits to about 200 Fahrenheits Be at a temperature of degree ductility and be rigid at a temperature of about 130 degrees Fahrenheits；And

The stretchable heat-barrier material for forming the third layer has low-friction coefficient at a temperature of about 200 degrees Fahrenheits, makes Obtain the material not adhesiving metal surface.

2. 1 composite, wherein the composite includes：

The ductility state property feature of at least 8 minutes is kept in temperature of the initial heating to about 200 degrees Fahrenheits.

3. 1 composite, wherein when the composite is being heated to about 200 degrees Fahrenheit, the composite With about 1 or the smaller coefficient of sliding friction.

4. 1 composite, wherein the composite when being heated to about 200 degrees Fahrenheit in the feelings of no excessive force It can be slided on the metal surface under condition.

5. 1 composite, wherein the composite also includes：

The 4th layer of unbroken loop fabric, its at least a portion type of permanent attachment with the third layer.

6. 1 composite, wherein the composite also includes：

The 4th layer of unbroken loop fabric, its at least a portion type of permanent attachment with the third layer；With

Bindiny mechanism is closed, it has the hook element for being used for engaging the unbroken loop fabric, the closure to be connected Mechanism is fixed to the composite.

7. 1 composite, wherein the composite also includes：

The orthopaedic srugery's brace formed by the composite.

8. 1 composite, wherein the composite also includes：

The orthopaedic srugery's casts formed by the composite.

9. 1 composite, wherein the composite also includes：

The orthopaedic srugery's clamping plate formed by the composite.

10. 1 composite, wherein the composite also includes：

The orthopaedic srugery's KAFO formed by the composite.

11. 1 composite, wherein the composite also includes：

The orthopaedic srugery's KAFO formed by the composite.

12. 1 composite, wherein the composite also includes：

The orthopaedic srugery's veterinary products formed by the composite.

13. a kind of system for making formed product by heat, the system include：

The first obturator with opening；

For the mechanism for the opening for sealing first obturator；

For accommodating the second obturator of product to be formed；

Second obturator is arranged in first obturator；

The opening on second obturator for receiving the product to be formed；

For the mechanism for the opening for sealing second obturator；

Sorbent material between first obturator and the obturator, wherein the sorbent material contains water Point, the product to be formed is placed in second obturator, and first obturator, second obturator and described The adsorbent layer of moisture content is heated to the temperature of at least about 212 degrees Fahrenheits so that the water transform of the adsorbent layer is steaming Vapour.

14. 13 system, wherein first obturator includes：

The bag formed by thin plastic material.

15. 13 system, wherein second obturator includes：

The bag formed by thin plastic material.

16. 13 system, wherein the sorbent material includes：

Adsorbent ply of paper.

17. 13 system, wherein the sorbent material includes：

Sponge-like material.

18. 13 system, wherein the sorbent material includes：

Nonwoven material layer.

19. 13 system, wherein the system includes：

Treat by applying heat and the object of shaping；

The them impervious provided is in second obturator；And

Second obturator is sealed in together with the sorbent material in first obturator.

20. 13 system, wherein being heated using micro-wave oven to the system.

21. it is a kind of using composite produce complex three-dimensional forms method, the composite have it is stretchable every Hot first layer, with the second layer of the first layer type of permanent attachment and with the buffering of the second layer type of permanent attachment heat-insulated the Three layers, wherein the second layer is rigid and at a temperature of higher than 130 degrees Fahrenheits at a temperature of less than 130 degrees Fahrenheits Become ductility；Wherein it the described method comprises the following steps：

The composite is heated at most 220 degrees Fahrenheits；

The composite is cut into pattern block；

It is 3-D. formed body by the heated pattern block suture；

Reheat the 3-D. formed body of the suture；With

The 3-D. formed body is molded further around body part so that the heated object materials are drawn Stretch, bend and compress, to be further accurately molded for body contour.

22. one kind can connect fastening system, the system includes：

It is attached at least one complete loop section of product；

First connecting elements, it has the multiple hook elements for being used for engaging the complete loop section；

It is attached to the retention mechanism of first connecting elements；

At least one second connecting elements, it has the multiple hook elements for being used for engaging the complete loop section；

It is attached to the induction element of each second connecting elements；With

Elongated flexible member, it is inserted through each induction element and engages the retention mechanism.

23. 22 connect fastening system, wherein the retention mechanism includes：

Rope rotating shaft mechanism.

24. 23 connect fastening system, wherein first retention mechanism includes：

Frenulum lockable mechanism.

25. 22 connect fastening system, wherein first retention mechanism includes：

Ratchet buckle mechanism.

26. 22 connect fastening system, wherein the induction element includes：

A part for material with unbroken loop, the unbroken loop are fixed on second connecting elements and engage described The hook element of two connecting elements is to form guided rings.

27. 22 connect fastening system, wherein the system includes：

Also include first connecting elements of at least one induction element.

28. 22 connect fastening system, wherein the system includes：

Second connecting elements, it includes single connecting elements；Draw with single the multiple of second connecting elements are attached to Guiding element.

29. 22 connect fastening system, wherein the system includes：

First ribbon, it is connected with the edge on first connecting elements, with along the institute of first connecting elements State edge and form induction element；With

Second ribbon, it is connected with the edge on second connecting elements, with along the institute of second connecting elements State edge and form induction element, it will be inserted through the elongated flexible structure of each induction element by using pin or cone Part sutures and engages the retention mechanism and formed.

30. 22 connect fastening system, wherein the elongated flexible member includes：

Extend through the rope of the induction element and the retention mechanism of the fixation.

31. 22 connect fastening system, wherein the elongated flexible member includes：

Extend through the monofilament lines of the induction element and the retention mechanism of the fixation.

32. 22 connect fastening system, wherein the retention mechanism includes：

Extend through the induction element and be fixed to the frenulum of the retention mechanism.

33. 22 connect fastening system, wherein the retention mechanism includes：

Extend through the induction element and be fixed to the band of the retention mechanism.

Claims (47)

1. a kind of method for manufacturing orthopaedic srugery's product for supporting body area, orthopaedic srugery's product includes multiple Condensation material, the composite include：It is arranged in face of body part and there is the internal layer of circumference；It is arranged to avoid the body Position and the outer layer with circumference, the circumference of the outer layer are similar to the circumference of the internal layer；With with circumference Intermediate layer, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer coextend, and it is described in Interbed is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, and the polymeric layer is in target temperature In the range of it is thermoformable and be rigid at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits, methods described includes：

Heat the composite so that the intermediate layer is higher than the minimum formable temperature；

The first edge of the composite is directly connected in the second edge of the composite, while the middle floor height In the minimum formable temperature, to form three-dimensional structure, the three-dimensional structure and the corresponding part of the body part are total to Shape, wherein the three-dimensional structure includes the separation assembly that each freedom composite is formed, and wherein each component has Form edge one of different in the first edge and the second edge；With

It is wherein described to be directly connected to include for the first edge of the composite being sutured in described the second of the composite Edge so that the intermediate layer is stitched together along the first edge and the second edge.

2. according to the method for claim 1, produce and pass through wherein the three-dimensional structure is included in the composite The perforation of the composite, the composite limit the first edge and the second edge.

3. composite is manufacturing the purposes in being used to support orthopaedic srugery's product of body area,

The composite includes：

It is arranged in face of body part and there is the internal layer of circumference,

It is arranged to avoid the body part and the outer layer with circumference, the circumference of the outer layer is similar to the internal layer The circumference, and

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits ,

Wherein described composite, which includes at least two, can close edge；

Wherein described composite is configured to be heated so that the intermediate layer is higher than the minimum formable temperature；

Wherein described composite is included in the composite and passes through the perforation of the composite, the composite The edge that the edge and the second profile that restriction the first profile is harmonious are harmonious, the edge that the profile is harmonious is adapted to be positioned as phase each other It is adjacent；

The edge that wherein described the first profile is harmonious is configured to be directly connected in the edge that second profile is harmonious, while described Intermediate layer is higher than the minimum formable temperature, to form three-dimensional structure, the three-dimensional structure and pair of the body part Answer part conformal；

Wherein described composite is configured to be formed around the body part, at the same the intermediate layer higher than it is described it is minimum can Forming temperature；With

Wherein described at least two can close that edge is configured to that selectivity is closed and being not directly connected described can close edge.

4. purposes according to claim 3, wherein being sutured in described second by the edge that the first profile is harmonious The edge that profile is harmonious so that the intermediate layer is harmonious by the edge being harmonious along the first profile and second profile Edge is stitched together is configured to be directly connected in the side that second profile is harmonious by the edge that the first profile is harmonious Edge.

5. a kind of orthopaedic srugery's product for being used to support body part, orthopaedic srugery's product have closing system to produce Orthopaedic srugery's product that is adjustable and can readjusting position, orthopaedic srugery's product include：

Composite, including：

It is arranged in face of the body part and there is the internal layer of circumference,

It is arranged to avoid the body part and the outer layer with circumference, the circumference of the outer layer is similar to the internal layer The circumference, and the outer layer include being arranged to and one of at least one portion that hook material engages as hook and loop fastening system Part, and

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits 's；

Closing system, including：

First connecting elements；

The retention mechanism of first connecting elements is attached to, the retention mechanism is selected from locking member, reels mechanism and ratchet Buckle mechanism；

One or more second connecting elements；

It is attached to multiple guiding elements of one or more the second connecting elements；With

Elongated flexible member, the retention mechanism is each connected in its multiple guiding elements.

6. orthopaedic srugery's product according to claim 5, wherein one or more the second connecting elements includes hook Element.

7. orthopaedic srugery's product according to claim 6, wherein the guiding elements includes：Material with unbroken loop A part, the unbroken loop are fixed to one or more the second connecting elements and engage the institute of second connecting elements Hook element is stated to form guided rings.

8. orthopaedic srugery's product according to claim 5, in addition to it is attached to the guiding elements of first connecting elements.

9. orthopaedic srugery's product according to claim 5, wherein the closing system includes：

First ribbon, it is connected with the edge on first connecting elements, with along the side of first connecting elements Edge forms guiding elements；With

Second ribbon, its at least one of with one or more the second connecting elements on edge be connected, with edge The edge of one or more the second connecting elements forms guiding elements, wherein the system is by using pin or cone The elongated flexible member is sutured and formed, the elongated flexible member connects each in multiple guiding elements To the retention mechanism.

10. orthopaedic srugery's product according to claim 5, wherein the elongated flexible member is selected from：Extend through described The rope of guiding elements and the retention mechanism and extend through the guiding elements and be fixed to the retention mechanism be Band.

11. a kind of orthopaedic srugery's product for being used to support body part, including：

Composite, including：

Internal layer, it is arranged in face of the body part and has circumference；

Outer layer, it is arranged to avoid the body part and has circumference, and the circumference of the outer layer is similar to the internal layer The circumference；With

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymerization Nitride layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits 's；

The edge for being adapted at least two profiles for being positioned as the composite adjacent to each other to be harmonious；

The device being directly connected to for the edge that at least two profile of the composite is harmonious, while the centre Floor height is in the minimum plastic temperature, so as to form three-dimensional structure, the corresponding portion of the three-dimensional structure and the body part Divide conformal；

It is adapted to be positioned as the three-dimensional structure adjacent to each other when orthopaedic srugery's product is placed on the body part At least two can close edge, and the edge of closing is different from the edge that the profile is harmonious；With

Edge can be closed without being directly connected to the device that can close edge by closing described at least two for selectivity.

12. orthopaedic srugery's product according to claim 11, wherein the intermediate layer and the internal layer and the outer layer are whole It is body formed.

13. orthopaedic srugery's product according to claim 11, wherein the three-dimensional structure is selected from：Casts, brace or Clamping plate.

14. a kind of orthopaedic srugery's product for being used to support body part, including：

Closing system including adhesive tape；With

Composite, including：

It is arranged in face of the body part and there is the internal layer of circumference；

It is arranged to avoid the body part and the outer layer with circumference, the circumference of the outer layer is similar to the internal layer The circumference, and the outer layer include being arranged at least one portion engaged with the adhesive tape；With

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits ,

Wherein, the adhesive tape is configured to be attached to described at least one portion of the outer layer, by the composite wood Material is fixed to around the appropriate section of the body part, while the intermediate layer is higher than the minimum plastic temperature, so as to Three-dimensional structure is formed, the three-dimensional structure and the corresponding part of the body part are conformal.

15. orthopaedic srugery's product according to claim 14, wherein the adhesive tape is double-sided adhesive tape, wherein, The internal layer and the outer layer each include being arranged at least one portion engaged with the double-sided adhesive tape, and its In, the double-sided adhesive tape is configured to be attached to lap, and the lap is the internal layer and the outer layer It is arranged to engage with the double-sided adhesive tape so that the composite to be fixed to the part of the body part Lap, while the intermediate layer is higher than the minimum plastic temperature, so as to form three-dimensional structure, the three-dimensional structure with The corresponding part of the body part is conformal.

16. composite is manufacturing the purposes in being used to support orthopaedic srugery's product of body area, wherein described compound Material is configured to be heated so as to that its is soft and plastic, and the composite includes：

It is arranged in face of the body part and there is the internal layer of circumference,

It is arranged to avoid the body part and the outer layer with circumference, the circumference of the outer layer is similar to the internal layer The circumference,

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits , and

The device being directly connected to for the edge that at least two profiles of the composite are harmonious, while the middle floor height In the minimum plastic temperature, so as to form three-dimensional structure, the three-dimensional structure and the corresponding part of the body part are total to Shape；

Wherein described composite is configured to be formed around the body part, at the same the intermediate layer higher than it is described it is minimum can Forming temperature；

Wherein described composite is configured to when the intermediate layer cools down by the way that elastic webbing is wrapped in into the composite week Enclose and the composite is compressed on around the body part；With

Edge can be wherein closed to be configured to be connected directly.

17. purposes according to claim 16, wherein the elastic webbing is fabric or rubberized material, it has suitable Width, thickness and elasticity, its length is enough around whole gained three-dimensional structure winding.

18. a kind of suit for orthopaedic srugery's product, orthopaedic srugery's product is used to support body part, the suit bag Include：

Composite, including：

Internal layer, it is arranged in face of the body part and has circumference；

Outer layer, it is arranged to avoid the body part and has circumference, and the circumference of the outer layer is similar to the internal layer The circumference；With

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits 's；

The edge for being adapted at least two profiles for being positioned as the composite adjacent to each other to be harmonious；With

The device being directly connected to for the edge that at least two profile of the composite is harmonious, while the centre Floor height is in the minimum plastic temperature, so as to form three-dimensional structure, the corresponding portion of the three-dimensional structure and the body part Divide conformal；

Elastic webbing, it is arranged to be wrapped in when the intermediate layer cools down around gained three-dimensional structure and by gained three-dimensional structure pressure System is around the body part.

19. suit according to claim 18, in addition to internal heating arrangements, the internal heating arrangements are configured to heat Temperature in the intermediate layer to target temperature range or the temperature higher than target temperature range.

20. suit according to claim 18, in addition to heat release thermal source, the heat release thermal source is configured to heat the centre Layer is to the temperature in target temperature range or the temperature higher than target temperature range.

21. suit according to claim 18, in addition to heating bag, the heating bag is configured to receive the composite To heat the intermediate layer.

22. suit according to claim 21, wherein, the heating bag is configured to be placed in heating system.

23. suit according to claim 21, wherein, the heating bag includes heating element heater and insulator, and is configured to Heat the composite therein.

A kind of 24. veterinary orthopaedic surgery product, for supporting the body part of the animal in addition to people, the veterinary orthopaedic surgery Product includes：

Composite, including：

Internal layer, it is arranged in face of the body part and has circumference；

Outer layer, it is arranged to avoid the body part and has circumference, and the circumference of the outer layer is similar to the internal layer The circumference；With

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits 's；

The edge for being adapted at least two profiles for being positioned as the composite adjacent to each other to be harmonious；With

The device being directly connected to for the edge that at least two profile of the composite is harmonious, while the centre Floor height is in the minimum plastic temperature, so as to form three-dimensional structure, the body part of the three-dimensional structure and animal Corresponding part is conformal, wherein described is the stitch of multiple sutures for the device that is directly connected to.

25. veterinary orthopaedic surgery product according to claim 24, wherein the animal is horse.

26. the body part of veterinary orthopaedic surgery product according to claim 25, wherein animal is horse limbs.

27. a kind of orthopaedic srugery's product for being used to support body part, including：

Composite, including：

Internal layer, it is arranged in face of the body part and has circumference；

Outer layer, it is arranged to avoid the body part and has circumference, and the circumference of the outer layer is similar to the internal layer The circumference；With

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits 's；

The edge for being adapted at least two profiles for being positioned as the composite adjacent to each other to be harmonious；With

The device being directly connected to for the edge that at least two profile of the composite is harmonious, while the centre Floor height is in the minimum plastic temperature, so as to form three-dimensional structure, the corresponding portion of the three-dimensional structure and the body part It is point conformal,

Wherein described three-dimensional structure have selected from shoulder protector, shin guard, gloves, leg brace, pin brace, cervical orthosis, back brace, The structure of arm casts and knee-pad plate.

28. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of shoulder protector.

29. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of shin guard.

30. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of gloves.

31. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of leg brace.

32. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of pin brace.

33. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of cervical orthosis.

34. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of back brace.

35. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of arm casts.

36. orthopaedic srugery's product according to claim 27, wherein the three-dimensional structure has the structure of knee-pad plate.

37. a kind of system for heating and applying orthopaedic srugery's product, orthopaedic srugery's product is used to support body part, The system includes：

Composite, including：

Internal layer, it is arranged in face of the body part and has circumference,

Outer layer, it is arranged to avoid the body part and has circumference, and the circumference of the outer layer is similar to the internal layer The circumference,

Intermediate layer with circumference, the circumference of the circumference and the internal layer and the outer layer in the intermediate layer expand jointly , and the intermediate layer is clipped between the internal layer and the outer layer, and the intermediate layer includes polymeric layer, the polymer Layer is thermoformable in target temperature range and is rigidity at a temperature of the minimum plastic temperature less than 130 degrees Fahrenheits , the edge for being adapted at least two profiles for being positioned as the composite adjacent to each other to be harmonious；With

The device being directly connected to for the edge that at least two profile of the composite is harmonious, while the centre Floor height is in the minimum plastic temperature, so as to form three-dimensional structure, the corresponding portion of the three-dimensional structure and the body part It is point conformal, wherein described is the stitch of multiple sutures for the device that is directly connected to；With

It is arranged to heat the heating system in the intermediate layer.

38. the system according to claim 37, wherein the heating system be selected from heating bag, heat release thermal source, convection oven, Baking box, radial burner thermal source, infrared heater, micro-wave oven, convected air oven and damp and hot.

39. the system according to claim 38, wherein the heating system is heating bag.

40. the system according to claim 38, wherein the heating system is heat release thermal source.

41. the system according to claim 38, wherein the heating system is convection oven.

42. the system according to claim 38, wherein the heating system is baking box.

43. the system according to claim 38, wherein the heating system is radial burner thermal source.

44. the system according to claim 38, wherein the heating system is infrared heater.

45. the system according to claim 38, wherein the heating system is micro-wave oven.

46. the system according to claim 38, wherein the heating system is convected air oven.

47. the system according to claim 38, wherein the heating system is damp and hot.