KR20080081911A - Apparatus and methods for treating bone - Google Patents

Abstract

Implants and methods for minimally invasive augmentation and repositioning of vertebrae may comprise one or more expandable members, e.g., stents, implants, surrounding a balloon-tipped catheter or other expansion device, inserted into a vertebral body or other bone. Expansion of the expandable member within the vertebral body or other bone may reposition the fractured bone to a desired height and augment the bone to maintain the desired height. A bone cement or other filler can be added to further augment and stabilize the vertebral body or other bone.

Description

Apparatus and methods for treating bone

The present invention relates to surgical implants and, more particularly, to minimally invasive devices and methods for the augmentation of bones, preferably vertebrae and / or restoration of vertebral lordosis.

Spine compression fractures, as shown in FIG. 1, generally exhibit normal spinal injuries and may lead to chronic disability. (F. Margerl et al: Comprehensive Classification of Chest and Lumbar Injuries, Eur Spine J 184-201, 1994) These fractures involve the collapse of one or more vertebral bodies 12 in the spine 10. Compression fractures of the spine usually occur in the lower vertebra of the thoracic vertebra or in the upper vertebra of the lumbar spine. They usually involve fractures of the anterior region 18 (as opposed to posterior 16) of the injured vertebrae 12. Spinal compression fractures can result in normal alignment or curvature of the vertebrae of the damaged regions of the spine, such as spinal lordosis. Spinal compression fractures and / or related spinal deformations may result from trauma, such as metastatic diseases of the spine, or may be associated with osteoporosis. Until recently, doctors have been limited to methods of treating deformations associated with such compression fractures. The only options available were pain medications, long-term recreation, bracing or invasive surgery.

More recently, minimally invasive surgical procedures have been developed for the treatment of spinal compression fractures. These procedures are generally associated with the insertion of a hard cannula, needle or trocar inserted into the front of the collapsed or damaged vertebral body. The biggest key to these procedures is vertebroplasty, which literally means fixing the vertebrae and can be done without first conquering the bones.

In brief, the cannula or special bone needles slowly pass through the back flexible tissues. Imaging guided x-rays along the small amount of x-ray dye allows the position of the needle to be visible at any time. Small amounts of polymethylmethacrylate (PMMA) or other surgical cement are pushed through the needle into the vertebral body. PMMA is a medical grade material that has been used for a long time in various surgical procedures. As a rule, cement is mixed with antibiotics to reduce the risk of infection and with powders containing barium or tantalum that allow it to be seen on x-rays.

Vertebroplasty is effective in reducing or alleviating fracture pain, preventing further collapse, and restoring mobility of the patient. However, this procedure may not conquer fractured bones and therefore may not cause problems with spinal deformation resulting from fractures. As a rule, it is not performed except in cases where the kyphosis between adjacent vertebral bodies of the damaged area is less than 10%. In addition, this procedure requires high-pressure cement injection with low-viscosity cement, and recent studies have shown that it can cause 30-80% cement leakage (Truumees, Kyphoplasty and Comparison of Vertebroplasty , Advances in Osteoporotic Fracture Management , Vol. 1, No. 4, 2002) In most cases, cement leakage is harmless. In rare cases, however, polymethmethacrylate or other cement leaks into the vertebral conduit or venous system around the vertebrae, causing pulmonary embolism and causing patient death. (JS Jang: Percutaneous) Pulmonary Embolism of PMMA after Vertebroplasty, Spine Vol. 27, No. 19, 2002)

Some of the more advanced therapies for vertebral compression fractures generally include two steps: (1) conquest or recovery of the initial height of the vertebral body and correction of lordosis of concomitant spinal curvature; And (2) augmentation or addition of materials to support or strengthen fractured bones.

One such treatment, balloon kyphoplasty (Kyphon, Inc), is described in FIGS. 2A-2D. A catheter with an inflatable balloon tip is a central region of the fractured vertebral body with relatively flexible spongy bones surrounded by fractured cortical bone via cannula, sheath or other guide conduit. Inserted into the stomach (FIG. 2A). Balloon scoliosis then inflates the balloon that is inflated to restore it to its original height inside the vertebral body to perform reconstruction, i.e., normal curvature, of vertebral lordosis (Figure 2b). The balloon is then removed to leave a void inside the vertebral body, and the PMMA or other filler material, such as, for example, bone cement, is injected into the void through the cannula, as described above with respect to spinal surgery. (FIG. 2C). The cannula is removed and the cement is treated to augment, fill or fix the bone (FIG. 2D).

Disadvantages of this procedure are high cost, which can damage the reduction of the endplate of the vertebral body after removal of the balloon catheter, and the possibility of forming holes in the vertebral endplates during the procedure. As in spondyloplasty, though sparse but perhaps the most frightening thing is balloon spontaneous complications associated with the leakage of bone cement. For example, neurologic deficit can result from the leakage of bone cement into the spinal canal. Such cement leakage can occur through low-resistance veins of the vertebral body or through cracks in bone that have not been previously evaluated. Other complications include additional proximal levels of vertebral fractures, infections, and cement embolization. Cement embolization is caused by a mechanism similar to cement leakage. Cement can penetrate into low-low venous systems and travel through the lungs or brain, causing pulmonary embolism or stroke. In addition, the spinal surgery balloon is elastic and not suitable for inflating stents. Because of the stent resistance, the spondyloid balloon may expand in front of and behind the stent and suddenly explode when the stent's boundaries cut the balloon. Additional details regarding balloon vertebroplasty are described, for example, in US Pat. Nos. 6,423,083, 6,248,110 and 6,235,043 (Riley et al), each of which is hereby incorporated by reference in its entirety; Gantis et al., Balloon Angioplasty for the Pathological Treatment of Spinal Compression Fractures, Eur Spine J 14: 250-260, 2005; And Lieberman et al., Early Effects and Efficacy of Balloon Vertebroplasty in the Treatment of Pain in Osteoporotic Compression Fractures, Spine 26 (14): 1631-1638, 2001.

Another approach for the treatment of vertebral composite fractures provides for minimally invasive delivery of cement or allografts or autologous grafts using an inflatable mesh bag, or containment device, within the associated vertebral body. Optimesh system (Spineology, Inc., Stillwater, MN). The balloon graft remains inside the vertebral body after inflation, preventing any loss during such reduction operations that may occur during balloon spinal surgery when the balloon is withdrawn. However, a disadvantage of this system is that the mesh implant does not integrate well into the vertebral body. This can lead to relative motion between the implant and the vertebral body, resulting in loss after conquest surgery. Additional details relating to this procedure are disclosed, for example, in US Patent Publication No. 20040073308, which is incorporated herein by reference in its entirety.

Another procedure used to treat vertebral compression fractures is an expandable polymer augmentation mass known as the SKy Bone Expander. Such a device can be extended to a cube or trapezoidal configuration of a pre-designed size in a controlled manner. Like a Kyphon balloon, once the proper vertebral height and voids are obtained, the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. Thus, this procedure involves many of the same disadvantages and deficiencies described above with respect to balloon spinal surgery.

Suggested improved procedures for the reduction and augmentation of vertebral compression fractures are described, for example, in "Spinal Body Stenting", Orthopade 31: 356-361, each of which is hereby incorporated by reference in its entirety. 2002; European Patent Application Publication No. EP1308134 A3; And vertebral stenting, as disclosed in US Patent Application Publication No. US2003 / 0088249. For example, vertebral stenting as shown in FIG. 3 involves inserting a balloon-tip catheter (such as a spine balloon) into the vertebral body, usually surrounded by a stent (such as those used for angioplasty). Related. After insertion of the balloon and the stent, for example, after the balloon is inflated using hydraulic pressure, the stent is inflated inside the vertebral body. After inflation of the stent, the balloon may be deflated and removed with the stent left inside the vertebral body in an expanded state to fill the vertebral body.

The concept of vertebral stenting provides hope for other known methods for treating compression fractures, but there remains a need for improvements in stents and other inflatable implants and related methods for the reduction and augmentation of fractured vertebral bodies and other bones. .

The present invention provides a device and method for minimally invasive augmentation of vertebral bodies. In one embodiment, the present invention provides implants and methods for the correction of vertebral fractures and other diseases of the spine. For example, one or more stents or other inflatable implants can be inserted into the vertebral body damaged by spinal compression fractures. When one or more implants are inserted and expanded into the vertebral body, they can fill the central area of the vertebral body and push against the medial sides of the end plates of the vertebral body, providing structural support and bringing the vertebrae to their original heights. Provide a tendency to restore. Optionally, one or more of the expandable implants may comprise a shape-memory alloy or other material that expands or changes configuration after implantation, which may result in complete integration of the implant into the bone and / or restoration of the height of the damaged vertebral body. May cause help. After implantation, bone cement (eg, PMMA or tricalcium phosphate (TCP), bone chips, demineralized bone, or filler material may be added to aid bone stabilization to fix the implant in situ within the bone).

Stents or other expandable implants include, for example, shape memory alloys (e.g., nitinol or other nickel-titanium alloys, copper-based alloys, zinc-based alloys, etc.), titanium, stainless steel, biocompatible polymers, other metals or metal alloys, ceramics, It may be provided with any biocompatible material having the necessary properties such as a composite or a combination thereof. The other implant may have any necessary configuration that facilitates expansion against contraction and / or imposes the necessary force on the structure during or after expansion. One or more expandable implants may be inserted into the bone individually or may be coupled or connected coaxially, in parallel or in series, to form a structure with the required properties. In some embodiments, the stent or other expandable implants may be resorbable. In addition, the stents should preferably be constraint, in particular semi-pharmaceutical, in order to expand the stent where the stent should be deformed.

In some embodiments, the bone treatment method includes inserting two or more coaxial stents that cooperate to augment the vertebral body, for example, into a fractured or osteoporotic bone such as the vertebrae. Bone cement or other fillers can be added with or without implanted devices to help stabilize the bone and secure the implant in place within the bone. For example, bone graft material, such as bone saliva or desalted bone, may be added into the bone, and a bone cement filler for the stent may be used to secure the stent to the vertebrae. In some embodiments, one or more additional implants may be used, for example, to expand the stent and / or to provide additional augmentation, such as, for example, expandable plugs, expandables, bobbins, expandable sheet metal implants, It can be used with stents such as chains, pedicle screws, and the like.

In one embodiment, the osteopathic augmentation device comprises a first expandable implant having a first configuration and a second configuration and capable of carrying out molding deformation in the second configuration, and at least a semi-pharmaceutical expansion device. And an implant surrounds at least a portion of the expansion device. The inflation device and the implant are configured to be inserted through the cannula into the area of the bone, and the implant can support a force between about 5N and 300N applied around it.

In another embodiment, the method of vertebral augmentation includes providing a balloon catheter having a shaft with a tube and a balloon portion operatively connected to the tube, the balloon catheter having a first expandable size and configuration and being greater than the first expandable size. Providing a inflatable implant mounted in a balloon portion of the balloon catheter having a size and capable of performing a molding deformation to a second inflatable size having a configuration different from the first inflatable configuration, the balloon catheter mounted thereon And inserting into the interior of the vertebrae such that the balloon and the implant are at least partially present within the vertebral body. The method further includes inflating the balloon portion of the balloon catheter to change the implant to its expandable size and configuration, and removing at least the balloon shaft from the vertebral body.

In another embodiment, the kit may have various combinations of components in accordance with the present invention. The kit includes, for example, a cannula and one or more expandable implants. The kit may additionally include one or more balloons or other inflatable members for imparting inflation force to one or more implants. The kit may additionally include a syringe or other device for injecting cement or other filler into the vertebral body. Optionally, one or more implants or devices may be included in the kit.

The invention will be explained in more detail and better understood by the following illustrative figures, wherein like reference numerals denote like elements. The drawings are merely illustrative for describing particular features that may be used independently or in combination with other features, and the invention is not limited to the illustrated embodiments.

1 is a diagram illustrating a spine with a vertical compression fracture in one vertebral body.

2A-2D illustrate prior art of a method of treating vertical compression fractures.

3 is a view for explaining the prior art of the vertebral body stent method.

4 is a perspective view of an inflatable implant according to an embodiment of the present invention.

FIG. 5 is a side shave of the implant of FIG. 4 with a balloon device for inflating the implant. FIG.

6 is a cross-sectional view of the vertebrae depicting a method of inserting the cannula through the pedicle of the vertebrae.

FIG. 7 is a side cross-sectional view of the vertebra of FIG. 6, showing a balloon-tip catheter carrying a palpable implant inserted through the cannula into the vertebrae. FIG.

FIG. 8 is a side cross-sectional view of the vertebra of FIG. 6, showing the balloon and the implant inserted over the guide wire. FIG.

9A is a top view of the vertebrae with implants inserted bilaterally into the vertebral body.

9B is another top view of the vertebrae with one or more implants inserted over a guide wire inside the vertebral body.

FIG. 10 is a side cross-sectional view of the vertebra of FIG. 7 with the balloon swollen to inflate the implant. FIG.

FIG. 11 is a side cross-sectional view of the vertebrae of FIG. 10 showing the inflated implant and balloon removed within the vertebral body. FIG.

FIG. 12 is a side cross-sectional view of the vertebra of FIG. 11 showing the insertion of a balloon carrying a second implant.

FIG. 13 is a side cross-sectional view of the vertebrae of FIG. 12 showing the inflation of the balloon carrying the second implant.

FIG. 14 is a side cross-sectional view of the vertebra of FIG. 13, illustrating removal of the balloon.

FIG. 15 is a side cross-sectional view of the vertebra of FIG. 14, illustrating the insertion of a third implant into the inflated second implant. FIG.

16A-16C are side cross-sectional views of the vertebrae illustrating the insertion of bone cement prior to insertion of the expandable implant.

FIG. 17 is a cross-sectional side view of the vertebrae showing a catheter with a tube for injection of bone cement along the balloon-implant.

18 is a side cross-sectional view of the vertebra with the expanded implant and bone cement inserted after removal of the balloon.

19 is a side cross-sectional view of the vertebrae showing a balloon filled with cement inside the inflated implant.

20A and 20B are side views illustrating embodiments of an expandable implant before and after expansion.

21 is a side view of another embodiment of an expandable implant.

22 is a side view of another embodiment of an expandable implant.

23A and 23B are perspective views of embodiments of an inflatable sheet implant before (left) and after (right) expansion.

24A and 24B are end views of each implant assembly before and after expansion.

25A-25C are end cross-sectional views of another embodiment of an implant assembly.

FIG. 26 is an end view of a ratchet mechanism of another embodiment of an implant assembly. FIG.

27 is a side view of a spiral implant according to another embodiment of the present invention.

28 is a side cross-sectional view of the helical implant of FIG. 27 inserted into the vertebral body.

29A is a side view of two spirally wound implants.

FIG. 29B is a side view of the helical implant of FIG. 29A coupled to each other. FIG.

30A-30D are side views of an implant assembly integrated with an expandable plug for inflating an outer implant.

31A-31C are side cross-sectional views illustrating the use of another embodiment of an expandable implant assembly.

32 is a side cross-sectional view of another embodiment of an expandable implant assembly inside the spine.

33A and 33B are perspective views of the expandable implant before (A) and after (B) expansion of the inner coil member.

4 is a three-dimensional view of the expandable implant 100 in an unexpanded state. Such implant 100 may be inserted into another bone to treat injury to the bone, such as a vertebral body (not shown) or a spinal compression fracture, for example. In some embodiments, a balloon catheter (e.g., for balloon spinal surgery), where lorosis of the spine remains inside the vertebral body and carries one or more inflatable implants that prevent loss of conquest after removal of the balloon catheter. As described above) or other device used to inflate the implant.

The implants are preferably expandable and resist collapse forces, for example between about 5N and about 300N. In some embodiments, the implants may have a tube shape and may have one or more portions. Various implants can be inserted into each other to achieve a stable structure that can maintain the interactive compressive forces acting on the vertebral body.

The implants can be made of biocompatible shape memory alloys, stainless steel, cobalt chromium alloys, titanium or alloys thereof, polymers, tricalcium phosphate (TCP) or any other material with the required properties. In some embodiments, the implant may be covered or coated with, for example, a biodegradable polymer.

In embodiments having a shape memory alloy (e.g. nitinol), the implants are for example in which the shape memory alloy is in a martensite state (e.g. at low temperatures) and an austensite state (e.g. , When heated to a temperature above the actuation temperature, such as when undergoing a phase change (at high temperatures). The operating temperature of the shape memory alloy fibers inside the implant is preferably between about 28 ° C. and about 36 ° C., for example. Alternatively, the implant plug may expand, contract, or change shape or configuration when it is activated by an energy source (eg, ultraviolet light, ultrasonic radiation, electromagnetic waves, heat, electric field, or magnetic field).

The unexpanded implant may have the required diameter to fit the vertebral body through the cannula's tube. For example, in some embodiments, the diameter of the implant 100 of FIG. 4 prior to insertion may be between about 2 mm and 10 mm. In the expanded state, the diameter of the implant 100 may be between about 15 mm and 25 mm. Of course, other sizes may be used without departing from the scope of the present invention.

5-15 illustrate a method of using the inflatable implant 100 to conquer and augment collapsed vertebral body 10, for example to conquer the end plates of vertebral body 10 and maintain conquest after restoration of vertebral lordosis. Methods and implants can be used to conquer and augment other bones.

In particular, FIG. 5 shows an expandable implant that is configured to fit around a balloon catheter assembly 200 or other device and is also referred to herein as an “expansion device” for imparting inflation force to the implant. The expansion catheter assembly 200 may have a catheter shaft 220 connected to the balloon 210 and one end of the balloon 210. Implant 100 is disposed in another inflation device named herein as balloon 210 or balloon-implant assembly 200. Implant 100, or a portion thereof, may in some embodiments be similar to a “stent” used to maintain the openness of blood vessels during angioplasty procedure. The stent, balloon, balloon-stent assembly, and / or balloon-catheter assembly may be coated with an adhesive, antibiotic, bone forming material, or osteoconductive material. After expansion, the user can activate the adhesive by an energy source such as heat, ultraviolet light, ultrasonic radiation, electromagnetic waves, electric field, magnetic field, or the like.

The balloon 210, which is used as an inflation mechanism for inflating the implant from its first insertion size to its second inflation size, is preferably at least semi-constrained so that the balloon 210 can exert sufficient force on the area of the implant that needs to be inflated.

Preferably, the balloon 210 or inflation device is used for balloon spinal angioplasty where it is believed that the balloon will expand around the implant without providing the force necessary to inflate the stent because of non-constrained (non-elastic) stent resistance. It is anti-pharmaceutical similar to some balloon catheters on the market such as such balloons. For example, if the balloon is too elastic it will expand in front of and behind the stent and may explode if the end of the stent cuts the balloon. In this regard, the balloon is preferably relatively inelastic so that the force from the balloon can be directed directly to the required area of the stent. Alternatively, a relatively resilient balloon used with an outer jacket to prevent resilient expansion may be sufficient as an inflation device.

The inflatable stent is preferably subjected to molding deformation when it expands to its second size so that when the balloon is deflated it returns to or near its first insertion size, thereby allowing the user to remove the balloon and If so, it allows to leave the inflated implant inside the vertebral body.

FIG. 6 shows an access hole 11 that drills through the vertebral body 10 in a transpedicular approach. Such access hole 11 may be formed through the outer cortical bone of vertebrae 10 by a drill, trocar, or other tool (not shown). After the access holes are made through one or more pedicles of the vertebral body 10, the cannula 20 can be inserted into each access hole 11 to provide passage of the expandable implant 100.

FIG. 7 illustrates a balloon catheter assembly 200 induced by a single or bilateral transpediculal approach with the inflatable implant 100 disposed over the inflatable balloon tip 211 of the catheter shaft 220. Insertion of the catheter 220 may occur with guide wires as shown in induction device 30, such as FIGS. 8 and 9B. The induction device 30 can be used to position the implant 100 in the required position or orientation inside the vertebral body 10. For example, FIGS. 9A and 9B show other possible positions of the balloon-implant assembly 300 (stent device). Both the cannula and the guide wire can be used together or separately to guide the balloon-implant assembly 300. Alternatively, neither the cannula nor the guide wire may be used to position the implant, but instead the balloon-implant assembly 300 may be inserted below the passageway formed in the bone by the physician manipulating the catheter shaft 220 from the outside of the patient. Can be.

FIG. 10 illustrates an inflatable implant that inflates balloon 210 (eg, with a radiopaque fluid) to impart a radial force around the implant 100 to inflate the implant 100 to fill the space within the vertebral body 10 and restore the height of the vertebral body 10. An exemplary method of conquering and augmenting vertebral body 10 using 100 is described.

After the implant 100 is inflated to the required diameter, the balloon 210 can be evacuated and removed from the cannula 20, for example, as shown in FIG. The implant 100 is preferably configured to maintain its expanded dimensions and to maintain the height of the vertebral body 10 after the balloon 210 is removed. Alternatively, the balloon-implant assembly 300 remains in the bone because the balloon 210 and the implant can be separated from the catheter shaft 220.

As shown in FIG. 12, the second expandable balloon-implant assembly 300 '(as compared to the catheter shaft 220', and the balloon catheter assembly 200 'with the implant 100B), for example, provides additional support. To be inserted into the tube of the first expandable implant 100A. After insertion, the inner balloon or external inflation device may swell or may be inflated to inflate the second implant 100B as shown in FIG. 13, for example, so that it contacts the inner surface of the first implant 100A. The second implant 100B may be coaxially located inside the first implant 100A to increase resistance against collapse of the vertebral body 10. As shown in FIG. 11, after insertion of the second implant 100B, the internal expansion device may be removed as shown in FIG. 14. FIG. 15 shows insertion of a third balloon-implant assembly 300 '' (compared to a catheter shaft 220 '' and a balloon catheter assembly 200 '' comprising an implant 100C) coaxially aligned with the first and second implants. Depicts. Any necessary number of implants can be inserted inside the first implant.

Bone cement, bone chip, or other filler 60 may be added to further augment vertebral body 10 and to fix one or more implants (stents) in position. Filler 60 may further comprise an antibiotic, bone morphogenic protein (BMP), growth hormone, and the like. Such bone cement or other filler 60 may be inserted into the vertebral body 10 before, during or after insertion of the implant. For example, in some embodiments, cement or other filler 60 may be inserted into the vertebral body 10 prior to insertion of the implant or expansion of the implant, for example, as shown in FIG. 16A. FIG. 16B illustrates the expanded balloon-implant assembly 300 inside the vertebral body 10 where cement or other filler 60 is scattered around the expanded implant after balloon 210 is removed. In other embodiments, bone cement or other filler 60 may be injected into the interior of the implant after its expansion and removal of the balloon catheter assembly. In other embodiments, bone cement or other filler 60 may be injected into the vertebral body space during expansion of the implant. In yet other embodiments, bone cement or other filler 60 may be injected into balloon catheter assembly 200 to inflate the balloon and consequently inflate the implant. The catheter shaft 220 can then be separated from the balloon and the balloon tied with the filler as well as the inflated implant can remain in the bone. After catheter shaft 220 is removed from the balloon, passage 225 of catheter shaft 220 can be used to inject additional filler 60 or other filler 60 'into the bone and help surround or stabilize the expanded implant.

In some embodiments, the catheter may have a number of tubes, for example two tubes 221, 222, and may be used to provide access to the vertebral body 10 and to provide a passageway for injecting another substance into the bone. . Bone cement or filler 60 may be inserted through tube 221. The material inserted through the tube 221 may contact the inflatable implant, the outer surface of the balloon 210, or both. The substance may be inserted through the second tube 222 prior to the inflation of the balloon so that the substance may be distributed inside the bone void when the balloon 210, the implant, or both expand.

The distribution material outside of the balloon 210, the implant, or the balloon-implant combination, or inside the bone void, can help stabilize the implant upon its expansion in the bone. Additionally or alternatively, a material, such as a biocompatible polymer, may be inserted through the tube 221 into the bone void space or on the outer surface of the balloon 210, the implant 100, or both, and a fence, or balloon, upon inflation of the balloon 210. Filler material may be distributed over the bone voids to form a bag to avoid leaving the bone voids. The biocompatible polymer can act to seal the porous reticular bone that prevents any leakage of balloon filler material. Cement or other filler 60 may also be inserted after removal of balloon 210 (but with the implant remaining in the bone, as shown in FIG. 18), for example using syringe 40. In another embodiment, the balloon 210 may be directly filled with bone cement or other filler 60, as shown in FIG. For example, balloon 210 may be inflated within vertebral body 10 until balloon 210 bursts. Alternatively, the balloon 210 can be filled with bone cement or other filler 60 and inflated by them, which remains in the patient because the expanded balloon 210 is then separated from the catheter shaft 220. Since the balloon can be formed of a biocompatible material, it will be absorbed by the human body over time. In addition, the balloon 210 can be perforated with holes as disclosed by WO 03/099171 A1 (PCT / EP03 / 05407) (Groenemeyer et al). The balloon 210 may be filled with curable cement to be cured in situ. After the cement has cured in the balloon 210, the balloon 210 can be separated from the catheter shaft 220.

20A-33 illustrate implants, or stents, comprising a continuous cylinder with perforations and having other configurations and / or patterns. It is important to withstand the pressure exerted by the environment in which the expanded implant is inserted. For example, when placed inside the vertebral body, the expandable implant is preferably able to withstand the forces that will be applied to the vertebral body during the daily activities of the patient following the insertion of the implant. Preferably the implant will not be extremely short after inflation (eg the deviation between L1-L0 needs to be small). 20-22 illustrate various mesh patterns that may be used by the expandable implants. In FIG. 20A, the mesh pattern of the unexpanded implant may form an angle α. When the implant is inflated (FIG. 20B), the mesh pattern forms an angle β and β is greater than α. 23A and 23B show an expandable implant formed of sheet metal folded for insertion. FIG. 23A depicts the implant 400 before expansion and FIG. 23B depicts the implant 400 'after expansion. In a preferred embodiment, such folded sheet metal insertion device is made of a shape memory alloy (eg, nitinol).

Those skilled in the art will appreciate that the structure of the implants can be selected in the manner of various implants that can push each other when they are inflated. Thus, the implants can withstand higher compressive forces when they are in the swollen state. 24 to 26 illustrate various principles of the manner of the cross-section of the implants / stents 100 ′ and 100 ″ which may be configured to wedge the implants relative to one another, for example. In FIG. 26, the implant A, the inner implant and the implant B, the outer implant may be cone shaped with a serrated surface. If implant B is pulled from "x1" to "x2", the outer diameter can be expanded from "h1" to "h3". Because of the tooth surface, the outer implant B retains its expanded shape.

As shown in FIGS. 27-29, one or more implants may have a helical configuration. Since various helical implants can be screwed together, a stable implant is obtained. In particular, FIGS. 27 and 28 depict helical implants with coils in the same direction. 29A and 29B show helical implants with coils in different directions. Regardless of the direction of the coil, the helical implants are configured to screw into each other, thereby making the implant stronger.

30-33 illustrate alternatives of the balloon 210 to provide inflation force to inflate the implant 100. For example, FIGS. 30A-30D show another embodiment of the implant 110, using an inflatable plug 50 instead of the balloon 210 to inflate the implant 110. Plug 50 may be comprised of an expansion mechanism 51, such as a screw (FIGS. 30A and 30C) or an L-handle (FIGS. 30B and 30D). Other configurations of the expansion mechanism 51 are envisioned. Plug 50 may also have a plurality of expansion supports 54 connecting distal end 52, proximal end 53, and distal end 52 to proximal end 53. Since the expansion mechanism 51 is screwed into both the distal end 52 and the proximal end 53, the user rotates the expansion mechanism 51 to inflate the implant 110 by causing the plurality of expansion supports 54 to expand outward when the distal end 52 moves toward the proximal end 53. . The user continues to rotate the expansion mechanism 51 until the implant 110 reaches its required diameter. Implant 110 and plug 50 may be inserted into the vertebral body (not shown) in an unexpanded state as described in FIGS. 30A and 30B. The implant 110 can then be expanded as shown in FIGS. 30C and 30D by rotating the expansion mechanism (eg, screw) of the plug 50. After inflation of the implant 110, the plug 50 can move. In other embodiments, plug 50 may remain in the bone.

31A-31C show another mechanism for inflating an implant. In particular, the implant can be inflated using, for example, a jack mechanism 70 which works similarly to an automobile jack. As shown in FIG. 31A, the implant assembly 500 may be inserted into the vertebral body 10 through the cannula 20. The implant assembly may be comprised of the implant 120 and the jack mechanism 70. The jack mechanism 70 may consist of a plurality of expansion members 71, preferably at least two expansion members 71, a plurality of diagonal braces 72, and a driving mechanism 73. Operation of the drive mechanism 73 causes the plurality of diagonal posts 72 to extend outward from the drive mechanism 73, thereby pushing the plurality of expansion members 71 similarly outward from the drive mechanism 73. The outward movement of the inflation members 71 causes the implant 120 to expand until the required diameter of the implant 120 is obtained (FIG. 31B). After the implant 120 is inflated to the required diameter, the drive mechanism is removed leaving the expansion members 71 and the diagonal strut 72 (FIG. 31C).

FIG. 32 illustrates the use of bobbin complex 80 to expand the height of implant 130 and thus the vertebral body. Such bobbin complexes 80 are disclosed in more detail in, for example, US Patent Application No. 11 / 471,169, which is incorporated herein by reference. 33 illustrates a method of inflating implant 140 using, for example, sheet metal coil 90 also disclosed in US Patent Application No. 11 / 471,169.

Although the devices and methods described so far herein have been described in terms of conquering and augmenting vertebrae in terms of spinal compression fractures and spinal curvatures, various other uses and methods are contemplated. For example, in some embodiments, one or more implants may have inflatable stents that can be used to conquer and / or augment other damaged bone areas, such as fractured or soft proximal femurs.

In such embodiments, for example, one or more implants may be inserted into the head of the femur, for example for cannula or other guide conduit, or tibia plateau fracture repostion. Can be. Once inserted, the implants provide a rigid support that expands and compresses the material inside the head of the femur to enlarge the head. In some embodiments, the implant may be provided with a shape memory alloy and expand after insertion (eg, heated to a temperature above the operating temperature) or otherwise change its configuration. Bone cement or other fillers may also be used to aid in the buildup. In other embodiments, other implants, such as screws or other devices, may be used in addition to or instead of one or more implants.

In some embodiments, the implants and methods described herein may be used in combination with other devices and methods to repair mania and augment the vertebral body. For example, one or more expandable implants may be used in combination with known procedures such as balloon spinal surgery, which may be used, for example, to initiate conquest of the vertebral body and / or to form a space inside the vertebral body for implantation. . In other embodiments, one or more of the implants disclosed herein may be used in combination with other tools and devices, such as an external fixation device that may help to manipulate or fix the vertebrae or other bones in a desired position. .

In another embodiment, the kit may be provided with various combinations of components in accordance with the present invention. The kit may, for example, have a cannula and one or more expandable implants. The kit may additionally include one or more balloons, balloon catheters or other expandable members for imparting inflation force to one or more implants. The kit may additionally include a syringe or other device for injecting cement or other filler into the vertebral body or into a balloon or balloon catheter. Optionally, one or more other implants or devices may be included in the kit. Those skilled in the art will appreciate that various other combinations of devices, components, and assemblies can be made and they are within the scope of the present invention.

In other embodiments, various minimally invasive implants and methods for alleviating pain associated with the spinal column may employ an inflatable implant having one or more features disclosed herein. For example, an inflatable implant or other implant may be a shaped firm alloy that can be implanted between the spinous processes of adjacent vertebrae, and the swelled or otherwise distracted spines and caused by pain and, for example, spinal stenosis, cotton joint disease, etc. It is equipped with an implant whose configuration can be changed to alleviate other problems. For example, the augmentation systems disclosed herein can be used in place of or in addition to the inflatable intervertebral synchronization devices and methods disclosed in US Patent Publication No. 2004/018128 and US Patent No. 6,419,676 to Zucherman et al.

While the foregoing description and drawings illustrate preferred embodiments of the invention, it will be understood that various modifications, additions, and substitutions are possible without departing from the scope and spirit of the invention as defined in the appended claims. In particular, it will be apparent to those skilled in the art that the present invention may be embodied in specific forms, structures, arrangements, proportions, and other components, materials, and parts without departing from the basic features or spirit thereof. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive of the scope of the invention, which is represented by the appended claims, and is not limited to the foregoing description.

All references cited in this specification are equivalent to all of their purposes by reference, and all purposes correspond to all such purposes by reference as if each individual publication or patent or patent application specifically and individually indicated. All the contents are incorporated in this specification.

Claims (22)

A first expandable implant having a first configuration and a second configuration and capable of undergoing molding deformation in the second configuration; And At least semi-constraint, having an expansion device such that the implant encloses at least a portion, The expansion device and the implant are configured for insertion into a region of the bone via a cannula, The device for osteopathic augmentation, characterized in that the implant can withstand a force between about 5N and 300N applied to its periphery. The method of claim 1, The implant is osteopathic enhancement device, characterized in that it comprises a shape enterprise alloy, titanium, stainless steel, metal alloys, resorbable polymers, non-resorbable polymers, ceramics or combinations thereof. The method of claim 2, And the shape memory alloy comprises nitinol. The method of claim 1, And said first expandable implant is a stent configured as a continuous cylinder with perforations. The method of claim 1, And a second expandable implant configured for coaxial insertion within said first expandable implant. The method of claim 1, Osteopathic augmentation device, characterized in that the expansion device can provide a force of about 300N. The method of claim 1, Osteopathic augmentation device, characterized in that the region of the bone includes tibia plateau fracture repostion. The method of claim 1, And said inflation device is a balloon catheter having a shaft with an inflation tube and a balloon portion connected to the distal end of said shaft. The method of claim 8, Osteopathic augmentation device, characterized in that the balloon is detachable from the shaft. The method of claim 1, The inflatable implant has a size and configuration that can be disposed outside the balloon catheter and can be inserted through a cannula, the inflatable implant has an inflatable configuration, and the implant is molded into a larger circumferential size than the inflatable size Osteopathic augmentation apparatus, characterized in that the modification. The method of claim 1, The expansion device can be coated with an adhesive, After said expansion, said adhesive is operated by an energy source such as heat, ultraviolet light, ultrasonic radiation, electromagnetic waves, electric fields or magnetic fields. a) providing a balloon catheter having a shaft with the tube and a balloon portion operatively connected with the tube; b) a first implantable size and configuration that is capable of undergoing a molding deformation with a second inflatable size that is larger than the implantable size and has an inflatable configuration that is different from the implantable configuration and has an inflatable configuration that is different from the implantable configuration and wherein the balloon catheter Providing an inflatable implant mounted to the balloon portion of the; c) inserting the balloon catheter with the implant mounted therein into the vertebral body such that the balloon portion and the implant are at least partially placed inside the vertebral body; d) inflating said balloon portion of said balloon catheter to vary said inflatable size and configuration of said implant; And e) removing at least the balloon shaft from the vertebral body. The method of claim 12, Before the step e), reducing the balloon after the implant has been changed to its expandable size. The method of claim 12, And removing the balloon catheter from the vertebral body. The method of claim 12, The balloon portion of the balloon catheter is removable from the shaft of the balloon catheter, Separating the balloon from the shaft and removing only the catheter shaft from the vertebral body. The method of claim 12, And expanding the balloon portion by inserting a substance having bone cement through the tube. The method of claim 16, Expanding the balloon portion with flowable bone cement to harden the bone cement in situ in the vertebral body. The method of claim 12, And inserting bone cement into the vertebral body before the balloon catheter is inserted into the vertebral body. The method of claim 12, And inserting bone cement into the interior of the inflatable implant. The method of claim 12, And injecting bone cement into the inflatable implant after the balloon portion of the balloon catheter is removed from the inside of the inflatable implant. The method of claim 12, a) preparing a cannula having a longitudinal passage therethrough; b) inserting the cannula into the vertebral body such that the tract communicates with the inside of the vertebral body and the outside of the patient; And c) removing said cannula from said vertebral body. The method of claim 12, The shaft of the balloon catheter has at least one tube in communication with the outside of the balloon so that bone cement can be inserted through the second tube to the outside of the balloon and to the outside of the balloon to tote the implant. .

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