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WO2014016819A1 - Dispositif et procédé pour l'application d'une composition de fluide durcissable sur un organe corporel - Google Patents

Dispositif et procédé pour l'application d'une composition de fluide durcissable sur un organe corporel Download PDF

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Publication number
WO2014016819A1
WO2014016819A1 PCT/IL2013/000060 IL2013000060W WO2014016819A1 WO 2014016819 A1 WO2014016819 A1 WO 2014016819A1 IL 2013000060 W IL2013000060 W IL 2013000060W WO 2014016819 A1 WO2014016819 A1 WO 2014016819A1
Authority
WO
WIPO (PCT)
Prior art keywords
organ
bodily organ
length dimension
flexible material
piece
Prior art date
Application number
PCT/IL2013/000060
Other languages
English (en)
Inventor
Erez Ilan
Yotam GURMAN
Moti Meron
Original Assignee
Omrix Biopharmaceuticals Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Omrix Biopharmaceuticals Ltd. filed Critical Omrix Biopharmaceuticals Ltd.
Priority to CA2879933A priority Critical patent/CA2879933A1/fr
Priority to CN201380039333.9A priority patent/CN104470445B/zh
Priority to EP13750943.6A priority patent/EP2877101A1/fr
Priority to JP2015523654A priority patent/JP6275712B2/ja
Priority to AU2013294557A priority patent/AU2013294557B2/en
Publication of WO2014016819A1 publication Critical patent/WO2014016819A1/fr
Priority to IL236821A priority patent/IL236821B/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00884—Material properties enhancing wound closure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective

Definitions

  • the invention relates to the field of devices for application of a curable fluid composition to a bodily organ, and more particularly, to a device for applying a curable fluid composition to encircle a bodily organ, and methods of use thereof.
  • sealant such as fibrin sealant
  • fibrin sealant is useful for preventing leakage of fluids, such as air and/or liquid from tissues.
  • fibrin sealant may be applied to wounds, including bleeding or non-bleeding wounds in a bodily organ e.g. by dripping or spraying the sealant onto the wound.
  • fibrin sealant can be used during an anastomosis procedure, wherein the organ is sutured or stapled around the entire incision line and fibrin sealant is applied along the staple or suture line for reinforcement and to prevent leakage.
  • Fibrin sealant is typically a plasma derived product obtained from either commercial sources or some regional blood transfusion centers. Components that are commonly used in preparations of fibrin sealants are predominantly a fibrinogen component [supplemented with various quantities of Factor VIII, Factor XIII, flbronectin, vitronectin and von Willebrand factor (vWF)] and a thrombin component.
  • the fibrinogen component is typically activated by the thrombin component which is the last protease of the coagulation cascade.
  • Fibrin sealant is formed by an enzymatic reaction involving inter alia, fibrinogen, thrombin and Factor XIII.
  • the thrombin converts the fibrinogen to fibrin by enzymatic action at a rate determined by the concentration of thrombin.
  • Factor XIII is typically present in the fibrinogen component of the sealant and is an enzyme of the blood coagulation system that cross-links and stabilizes the fibrin clot. This process bypasses most of the steps of normal coagulation and mimics its last phase.
  • Fibrin sealant is commonly applied by spraying the fibrinogen component and the thrombin component by air assisted spraying, airless spray, or by dripping application.
  • Air assisted spraying from a close proximity is challenging due to effect of air on pre-cured fibrin which yields a variable fibrin layer with irregularities (i.e. thick and thin areas) and uncovered regions at the application site.
  • the edge of the tip may be positioned too close to the tissue surface such that adequate spraying is not attainable. Furthermore, airless spray applicators and air assisted spray applicators may clog.
  • US 2011/0238097 discloses an apparatus for applying sealant to a target tissue of a luminal tissue at a surgical site.
  • the apparatus includes a handle, conduit and an end effector e.g. a clamp, which may comprise two jaw members.
  • the handle has means configured and adapted for operating the end effector and dispensing biological sealant to the surgical site via the end effector.
  • a mechanism to open and close the device is typically located in a handle to cause approximating the ends of the jaws one to the other to wrap around the tissue.
  • the conduit stores and/or carries sealant towards the end effector.
  • the invention in some embodiments thereof, relates to a device for applying a curable fluid composition to encircle a bodily organ, and methods of use thereof. Aspects and embodiments of the invention are described in the specification hereinbelow and in the appended claims.
  • a device [10, 40] suitable for application of a curable fluid composition to encircle a bodily organ comprising a monolithic piece of a flexible material [12] having a length dimension [14] with a first end [22] and a second end [24], an inner surface [18] and an outer surface [20], a width dimension [16], and two spaced-apart sides [26a, 26b], wherein a portion of the length dimension [14] proximal to the first end [22] is configured to contact a portion of the length dimension [14] proximal to the second end [24].
  • the inner surface [18] defines a hollow area [31] between the two spaced-apart sides [26a, 26b].
  • the device further comprises at least one inlet [28] providing fluid communication between the outer surface [20] and the inner surface [18], for introduction of fluid into the hollow area [31].
  • the device [10, 40] is deployable around the bodily organ [30] such that when the portion of the length dimension proximal to the first end [22] contacts the portion of the length dimension proximal to the second end [24], an outer surface [33] of the bodily organ [30] and the hollowed area [31] define an enclosed volume [32] encircling the bodily organ [30], the enclosed volume [32] being suitable for containing the fluid therein.
  • the piece of flexible material is biased to curl to form a planar spiral, such that a portion of the length dimension proximal to the first end overlaps a portion of the length dimension proximal to the second end when unconstrained.
  • the device is configured so that when deployed around the bodily organ, a portion of the length dimension between the first end and the second end encircles the bodily organ, and an inner surface of the piece of flexible material proximal to the first end intimately contacts an inner surface of the piece of flexible material proximal to the second end, thereby defining the enclosed volume.
  • the piece of flexible material is straight when unconstrained.
  • the device further comprises a plurality of raised, parallel, spaced-apart bands [42] along at least a portion of the outer surface, arranged substantially perpendicular to the length dimension, for providing mechanical strength.
  • each band has a height in the range of from 1 to 7 mm, a width in the range of from 1 to 10 mm, and a length in the range of from 28 to 34 mm (or to fit the entire width of the device).
  • the device further comprises at least one plastically deformable strip [44] attached to the inner surface.
  • the device further comprises two plastically deformable strips, each attached to one of the two spaced-apart sides.
  • the plastically deformable strips comprise a metal.
  • the width of the piece of flexible material is substantially constant along the length dimension. In some embodiments, the width of the piece of flexible material proximal to the second end is less than the width proximal to the first end.
  • the device comprises at least two inlets.
  • the curable fluid composition comprises at least two components.
  • a first of at least two components is activated by a second of at least two components.
  • the first component comprises fibrinogen.
  • the second component for activation of fibrinogen, comprises thrombin.
  • a concentration of fibrinogen is 51.5 mg/ml and a concentration of thrombin is 180 IU/ml.
  • the flexible material is selected from the group consisting of a nonbiodegradable material (such as, for example, at least one of silicone rubber, fluoroelastomer, polychloroprene, and combinations thereof), a biodegradable material (such as, for example, at least one of collagen, fibrin, gelatin and combinations thereof).
  • a nonbiodegradable material such as, for example, at least one of silicone rubber, fluoroelastomer, polychloroprene, and combinations thereof
  • a biodegradable material such as, for example, at least one of collagen, fibrin, gelatin and combinations thereof.
  • the piece of flexible material along at least a portion of the length is in the range of from 1 to 8 cm wide, such as in the range of from 4 to 6 cm wide.
  • the piece of flexible material is in the range of from 4 to 100 cm long, such as in the range of from 7 to 20 cm long.
  • the bodily organ is a hollow organ.
  • the bodily organ is selected from the group consisting of a blood vessel, an organ of the digestive system, an organ of the urinary system, and a dura.
  • an organ of the digestive system is selected from the group consisting of an esophagus, a stomach, a small intestine (such as, for example, a duodenum, a jejunum, or an ileum), a large intestine (such as, for example, a colon, a cecum, a rectum, or an anus), a bowel, and a pancreas.
  • the piece of flexible material is about 7 cm long. In some embodiments, wherein the organ of the digestive system is the small intestine of a human adult, the piece of flexible material is about 13 cm long.
  • the piece of flexible material is about 20 cm long.
  • the device of any of the embodiments described herein is provided for use in applying a curable fluid composition to encircle a bodily organ and/or for defining a chamber comprising an enclosed volume around an exposed bodily organ [30].
  • a method for applying a curable fluid composition to encircle a bodily organ comprising providing a device according to any of the embodiments described herein, deploying the device around the bodily organ so that a portion of the length dimension proximal to the first end contacts a portion of the length dimension proximal to the second end, thereby defining, between an outer surface [33] of the bodily organ and the hollowed area, an enclosed volume encircling the bodily organ; and introducing the curable fluid composition into the enclosed volume through at least one inlet.
  • the curable fluid composition comprises at least two components, wherein the two components are introduced through the same of at least one inlet. In some such embodiments, the at least two components are introduced substantially simultaneously through at least one inlet. In some embodiments, the at least two components are introduced sequentially through at least one inlet.
  • introducing the curable fluid composition comprises injecting the curable fluid composition through at least one inlet.
  • the method further comprises allowing the curable fluid composition to cure. In some such embodiments, the method further comprises removing the device subsequent to curing of the curable fluid composition.
  • the bodily organ is a hollow organ.
  • the hollow organ is in a rigid state.
  • the rigid state is achieved by inflation of the bodily organ with a fluid.
  • the bodily organ is an anastomized bodily organ.
  • the bodily organ is anastomized by a method selected from the group consisting stapling and suturing.
  • the stapler is present in the organ during said applying of the curable fluid composition to provide a rigid state of the bodily organ.
  • a method for defining a chamber comprising an enclosed volume encircling an exposed bodily organ [30], the enclosed volume capable of retaining therein a curable fluid composition, the method comprising providing a device according to any of the embodiments described herein, deploying the device around the bodily organ so that a portion of the length dimension proximal to the first end contacts a portion of the length dimension proximal to the second end, thereby defining, between an outer surface [33] of the bodily organ and the hollowed area, an enclosed volume encircling the bodily organ.
  • the device according to the present invention has at least one of the following advantages: enables application of the curable fluid composition onto an entire outer cross-sectional dimension of a target organ e.g. a cylindrical organ; is sufficiently flexible to be easily conformed to the shape of the bodily organ; a single device may be self-adaptable for use with a range of bodily organs of different sizes and shapes, or at different locations on a non-uniform organ; enables uniform application of the curable fluid composition even on an area of a target organ which is difficult or impossible to access using other means; easy to use; cheap and simple to produce; enables application of a fluid to areas inaccessible to spray/drip and/or against gravity e.g.
  • some embodiments of the device described herein can be used on a rigid and/or non-rigid organ.
  • the device and method described herein enable a user, such as a surgeon or other medical practitioner, to uniformly apply a curable fluid composition around a complete circumference of a bodily organ, without leakage of the substance out of the device prior to curing, and enable the user to easily apply the substance to sections of the organ which may be difficult or impossible to access using prior art methods, such as spray or drip application.
  • the device and method described herein are particularly useful for accurate application of a sealant, such as a fibrin sealant, to a bodily organ following anastomosis by suturing or stapling.
  • a sealant such as a fibrin sealant
  • the method described herein facilitates superior sealing and prevents leakage along the suture/staple line.
  • the device and method described herein enable a desired volume of sealant to be applied, resulting in a seal of a desired height, width, and length.
  • the sealant is formed in situ upon curing of a curable fluid composition. It was shown according to the present invention that optimal sealing strength is obtained with a fibrin sealant formed with a fibrinogen comprising component having 51.5 mg/ml fibrinogen and a thrombin comprising component having 180 IU/ml thrombin.
  • curable in connection with a fluid composition, refers to a composition which can undergo an interaction between its components leading to an increase in viscosity of the composition. Such interactions include polymerization and/or cross-linking of components, achieved by means that include, but are not limited to, use of activating agents such as catalysts, or physical activators such as heat, radiation e.g. ultraviolet radiation, electron beams, or combinations thereof.
  • FIG. 1A is a perspective view of an embodiment of the device as described herein in an open, constrained configuration
  • FIG. IB is a cross-sectional view of the embodiment of the device depicted in FIG. 1A, parallel to the width dimension;
  • FIG. 1C is a cross-sectional side view of the embodiment of the device depicted in FIG. 1A, deployed on a bodily organ;
  • FIG. ID is a perspective view of the embodiment of the device depicted in FIG. 1 A, deployed on a bodily organ;
  • FIG. 2A is a top perspective view of an alternative embodiment of the device as described herein, in an open configuration
  • FIG. 2B is a bottom perspective view of the embodiment of the device depicted in FIG. 2A in an open configuration
  • FIG. 2C is a cross-sectional side view of the embodiment of the device depicted in FIG. 2A in an open configuration
  • FIG. 2D is a cross-sectional side view of the embodiment of the device depicted in FIG. 2A, deployed on a bodily organ.
  • the invention in some embodiments thereof, relates to a device for applying a curable fluid composition to encircle a bodily organ, and methods of use thereof.
  • FIGs. 1A-1D there is shown an exemplary embodiment 10 of a device suitable for applying a curable fluid composition to encircle a bodily organ.
  • Fig. 1A is a perspective view of device 10, in an open, constrained configuration, prior to deployment on a bodily organ.
  • Device 10 comprises a monolithic piece of a flexible material 12, which can be unwound and constrained to provide a strip having a length dimension 14 and a width dimension 16, with an inner surface 18 and an outer surface 20, and two spaced-apart sides 26a, 26b, such that a hollow area 31 is defined between inner surface 18 and sides 26a and 26b.
  • Length dimension 14 has a first end 22 and a second end 24.
  • Flexible material 12 is or may comprise any non-degradable or degradable material, optionally a synthetic or semi-synthetic material.
  • the material is optionally any suitable biocompatible material.
  • suitable materials include, but are not limited to, poly(ethylene); polyesters; poly(propylene), poly(propylene) polyesters such as poly(propylene) fumarate; polystyrene; polytetrafluoro ethylene (PTFE); nylon; polypropylene/cellulose; polypropylene/PTFE; polypropylene/monochryal; polyester/collagen; poly(acrylate); poly(methyl methacrylate); poly(hydroxy ethyl methacrylate); poly(vinyl alcohol); poly(carbonate); poly(trimethylene carbonate); poly(ethylene-co-vinyl acetate); poly(ester urethane); poly(ether urethane); poly(arylate); polyrimide); poly(anhydride-co-imide); poly(amino acid); polydepsipeptide;
  • suitable biocompatible materials are optionally non-degradable materials selected from the group consisting of silicone rubber, fluoroelastomer, polychloroprene, and the like, or biodegradable materials selected from the group consisting of collagen, fibrin, gelatin and the like, or any combinations thereof.
  • Length dimension 14 of device 10 is optionally in the range of from about 4 to about 100 cm long, such as in the range of from about 7 to about 20 cm long.
  • Width dimension 16 is optionally in the range of from about 1 to about 8 cm wide, or in the range of from about 4 to about 6 cm wide.
  • Length dimension 14 is optionally from 0.5 to 100 times the width dimension 16.
  • width dimension 16 may be constant along the entire length dimension 14 of piece of material 12, or piece of material 12 may taper along length dimension 14 such that width dimension 16 is narrower at first end 22 than at second end 24.
  • Piece of material 12 optionally has a thickness in the range of from about 0.3 to about 15 mm. In some embodiments, the thickness is constant along length 12.
  • the ratio of length:thickness of piece of material 12 is in the range of from about 3:1 to about 200:1, and the ratio of width:thickness is optionally in the range of from about 6: 1 to about 40: 1.
  • the width of sides 26a and 26b is in the range of from about 0.5 mm to about 15 mm.
  • Device 10 further comprises at least one inlet 28, such as, for example one, two, three, four, or more inlets.
  • the inlet can have a height 25 above outer surface 20 in the range of about 0.5 to about 30 mm.
  • An inlet 28 provides fluid communication between outer surface 20 and inner surface 18, such that a fluid can be introduced into hollow area 31, for example by injection. Fluid introduced via inlet 28, is thereby directed to the target site (an area on the outer surface 33 of a bodily organ 30) along a short fluid path.
  • Inlet 28 is optionally an aperture having dimensions sufficient for insertion of a narrow tip, such as a tip of a syringe needle.
  • the syringe needle has a gauge number of from 12 to 25, i.e.
  • such an aperture is self- sealing, that is to say, is such that a component like an injection needle can be forced thereinto, but when the component is withdrawn, the aperture closes to substantially prevent reflux of a fluid.
  • piece of flexible material 12 was prepared from Polyurethane and has length dimension 14 of about 73 mm long and width dimension 16 of about 36.4 mm wide, and three inlets 28 (the distance between the centers of the inlets is 20 mm), each inlet 28 having a height 25 above outer surface 20 of about 3.5 mm, and an aperture diameter of about 1.1 mm.
  • the thickness of the material 12 is between 0.3 to 1.5 mm, and the inner volume of the device is about -9770 mm 3 .
  • Fig. IB is a cross- sectional view of device 10, parallel to width dimension 16. In Figure IB, spaced-apart sides 26a and 26b, and hollow area 31 therebetween are clearly seen.
  • Fig. 1C is a cross-sectional side view of device 10 in an unconstrained state, deployed on a bodily organ 30.
  • Piece of flexible material 12 is biased to curl to form a closed, planar spiral around at least 360 degrees around itself in an unconstrained state, such that a portion of inner surface 18 of length dimension 14 proximal to first end 22, contacts a portion of outer surface 20 of length dimension 14 proximal to second end 24 by overlapping along a portion 23 of length 14.
  • Device 10 as shown in Fig. 1C has three inlets, 28a, 28b, 28c.
  • a gap 29, for example of height about 2 mm is constituted between an outer surface 33 of organ 30 and inner surface 18, such that an enclosed volume 32, suitable for containing a fluid, is defined between outer surface 33 of bodily organ 30 and hollow area 31 formed between inner surface 18 and sides 26a, 26b.
  • Fig. ID is a perspective view of device 10 deployed on a cylindrical bodily organ 30.
  • the inner diameter 34 of device 10 (shown in Fig. 1C) adjusts itself to the dimensions of outer surface 33 of an organ on which it is deployed, such as the outer diameter of cylindrical organ 30, such that a single device 10 may be suitable to encircle a variety of organs 30 having different outer dimensions, to implement embodiments of the teachings herein.
  • the elasticity and bias of piece of flexible material 12 is optionally such that the bottom portions of each of sides 26a and 26b maintain uninterrupted contact around a substantially complete circumference of outer surface 33 of organ 30.
  • inner diameter 34 is relatively small, and portion of overlap 23 is relatively long.
  • inner diameter 34 is relatively large, the point where first end 22 first overlaps second end 24 is relatively close to the tip of first end 22, and portion of overlap 23 is relatively short.
  • the device can be delivered to the desired location by any suitable means including, but not limited to, open surgery, and minimally invasive procedures (MIS) such as laparoscopy.
  • MIS minimally invasive procedures
  • an incision is made proximal to the target organ and the device is deployed on the target organ via the incision.
  • the patient can receive local, regional or general anesthesia.
  • open surgery typically refers to surgery wherein the surgeon gains direct access to the target organ via a relatively large incision.
  • minimally invasive procedure typically means a procedure wherein the surgeon gains access to the target organ via small incisions or through a body cavity or anatomical opening e.g. via laparoscopy.
  • the device can be delivered to the target organ through a narrow lumen e.g. trocar in a folded form and unwound during deployment on the target organ.
  • piece of material 12 of device 10 is first unwound, for example manually, so that ends 22 and 24 do not overlap and there is an open gap between ends 22 and 24, so that piece of material 12 is in the shape of an open curve.
  • Piece of material 12 is maneuvered so that ends 22 and 24 pass on either side of organ 30.
  • Piece of material 12 is released from constraint so that spaced-apart curved sides 26a and 26b contact and encircle outer surface 33 of organ 30, substantially as depicted in Figure 1C, where first end 22 overlaps second end 24 along portion of overlap 23 to take up any excess length.
  • a curable fluid composition can then be introduced via inlet 28 into gap 29 defined by inner surface 18 of device 10 and outer surface 33 of organ 30 between sides 26a and 26b.
  • flexible material 12 is a shape memory material that "remembers" its original, cold-forged shape.
  • FIG. 2A is a top perspective view of device 40.
  • Fig. 2B is a perspective bottom view of device 40.
  • Fig. 2C is a cross-sectional side view of device 40.
  • Fig. 2D is a cross-sectional side view of device 40 deployed on a bodily organ 30.
  • Device 40 comprises a monolithic piece of a flexible material 12, having a length dimension 14, and a width dimension 16, an inner surface 18 and an outer surface 20, forming a substantially straight, quadrilateral strip e.g. a rectangular strip in an undeployed state.
  • Length dimension 14 has a first end 22 and a second end 24.
  • Width dimension 16 has two spaced-apart sides 26a, 26b, such that a hollow area 31 is formed between inner surface 18 and sides 26a and 26b.
  • Device 40 further comprises at least one inlet 28, such as, for example one, two, three, four, or more inlets.
  • Inlet 28 provides fluid communication between outer surface 20 and inner surface 18, such that a fluid can be introduced into the hollow area, for example, by injection. Fluid introduced via inlet 28, is thereby directed to the target site along a short fluid path.
  • Device 40 optionally further comprises a plurality of raised, parallel, spaced-apart bands 42 along at least a portion of outer surface 20, arranged perpendicular to length dimension 14, for providing mechanical strength, and preventing flexible material 12 from collapsing inwards when device 40 is deployed on organ 30 and/or excessively ballooning outwards when a fluid is introduced.
  • bands 42 have a height in the range of from about 3 to about 7 mm, a width in the range of from about 1 to about 3 mm, and a length in the range of from about 28 to about 34 mm.
  • Bands 42 may be formed of the same material as piece of flexible material 12 as specified above, or of a different material.
  • device 40 optionally further comprises at least one plastically deformable strip 44 functionally associated with inner surface 18 and/or with a surface (e.g. a lower surface) of at least one of spaced-apart sides 26a, 26b.
  • Strip 44 optionally is or comprises a metal, such as, for example, copper, aluminum, tin, platinum, zinc, iron and nickel, or alloys comprising such metals.
  • device 40 comprises two plastically deformable strips 44, each functionally associated with a lower surface of one of spaced-apart sides 26a, 26b. Further alternatively, each of sides 26a, 26b is optionally formed with a longitudinal slot 27 for insertion therein of strip 44.
  • Strip 44 is optionally provided along the entire length of inner surface 18 and/or a surface of at least one or sides 26a, 26b, or along part of surface 18 and/or sides 26a, 26b. Strip 44 allows the lower surfaces of sides 26a and 26b, that contact outer surface 33 of an organ 30 during use of device 40, to be bent into a desired shape, in order to fit the shape of a specific organ 30, including a non-cylindrical, a rigid and/or a non-rigid organ 30.
  • a portion 18a of the inner surface of the flexible material 12, located between ends 22 and 24 is configured to encircle an outer surface of a bodily organ 30.
  • a portion 18b of the inner surface proximal to first end 22 is configured to intimately contact or overlap a portion 18c of the inner surface proximal to second end 24, such that inner portions 18b and 18c proximal to ends 22 and 24, respectively, are pressed one against the other when deployed on organ 30, as shown in side view in Fig. 2D.
  • an enclosed volume 32 is defined between hollowed area 31 of device 40 and an outer surface 33 of organ 30.
  • device 40 is wound around an outer surface 33 of organ 30, and portions 18b and 18c are brought into intimate contact along a length 35 such that an enclosed volume 32 is defined.
  • ends 22 and 24 are bent to secure one to the other.
  • ends 22 and 24 are secured one to the other using a locking mechanism (not shown).
  • Length dimension 14 of device 40 is optionally in the range of from about 4 to about 100 cm long, such as in the range of from about 7 to about 20 cm long.
  • Width dimension 16 is optionally in the range of from about 1 to about 8 cm wide, or in the range of from about 4 to about 6 cm wide.
  • the width of sides 26a and 26b is in the range of from about 0.5 mm to about 15 mm.
  • Length dimension 14 is optionally from 0.5 to 100 times the length of width dimension 16.
  • width dimension 16 may be constant along the entire length dimension 14 of piece of material 12, or piece of material 12 may taper along length dimension 14 such that width dimension 16 is narrower at first end 22 than at second end 24.
  • Piece of material 12 optionally has a thickness in the range of from about 2 to about 15 mm. In some embodiments, the thickness is constant along length 12.
  • the ratio of length:thickness of piece of material 12 is in the range of from about 3:1 to about 500:1, and the ratio of width:thickness is optionally in the range of from about 6: 1 to about 40: 1.
  • organ 30 may be a blood vessel (including an artery, such as an aorta, or a vein, such as a vena cava); an organ of the digestive system, including an esophagus, a stomach or part thereof (such as a cardia, a fundus, a body, or a pylorus), a small intestine or part thereof, (such as a duodenum, a jejunum or an ileum), a large intestine or part thereof (such as a colon, a cecum, a rectum, or an anus), a bowel, or a pancreas; a dura; an organ of the respiratory system such as a trachea; or an organ of the urinary system (such as a ureter, a urethra, a kidney, or a urinary bladder).
  • an organ of the digestive system including an esophagus, a stomach or part thereof (such as a cardia, a fund
  • the device may be used to apply a curable substance to encircle a surface of a bodily organ of a patient.
  • a surface of a body part of a patient refers to an external surface of the body that can be seen by unaided vision and to a surface of an internal body part which is a part of the internal anatomy of an organism.
  • the surface can be a bleeding or a non-bleeding site.
  • the device can be used for applying a curable substance to encircle a bodily organ in order to decrease the risk of postoperative adhesion formation.
  • adhesion refers to an abnormal attachment between tissues and/or organs. Typically, adhesions occur after surgical procedures such as following rough manipulation of tissues; following tissue surface drying; and/or due to the presence of reactive foreign bodies (e.g. suture materials, talc powder or lint residues) in the operated area.
  • reactive foreign bodies e.g. suture materials, talc powder or lint residues
  • Organ 30 may be an anastomized organ (i.e. an organ that was subjected to an anastomosis surgical procedure), wherein anastomosis was achieved, for example, by stapling or suturing, and a curable fluid composition is applied onto the staple/suture line for reinforcement and/or to prevent leakage from the anastomized organ.
  • anastomized organ i.e. an organ that was subjected to an anastomosis surgical procedure
  • a curable fluid composition is applied onto the staple/suture line for reinforcement and/or to prevent leakage from the anastomized organ.
  • anastomosis typically refers to a surgical procedure which is used to reconnect two or more sections of an organ or tissue.
  • staple or suture includes any fastener which is used for closing a wound such as, but not limited to, staple, clip, pin, hook, suture and the like.
  • the terms “leak” and “leakage” refer to the escape or passage of a substance e.g. fluid, viscous material and/or air e.g. through a tear, aperture, bore, fissure, puncture, hole, crack, opening, slit, gap, perforation, fracture, puncture or rupture in a tissue.
  • the device is used to encircle a blood vessel with the curable fluid composition for hemostasis.
  • hemostasis refers to the ability of an agent to stop the bleeding from an injured blood vessel and/or to contribute to keeping the blood contained within the blood vessel.
  • organ 30 is a hollow organ, i.e. an organ comprising a cavity.
  • a hollow organ can be filled with air, fluid, and/or solids.
  • organ 30 is brought to a rigid state, for example, by inflating with a fluid.
  • the fluid may comprise a liquid and/or a gas.
  • a rigid state is achieved by keeping the stapler inside the cavity of the hollow organ while the device as described herein is deployed to encircle the organ, and the curable fluid is introduced into the gap 29.
  • device 10 is for use on a rigid organ, while device 40 is for use on a rigid or non-rigid organ.
  • length dimension 14 of flexible material 12 is optionally about 7 cm long.
  • length dimension 14 of flexible material 12 is optionally about 13 cm long.
  • length dimension 14 of flexible material 12 is about 20 cm long.
  • a single device 10 may optionally be used with organs of different dimensions, such that in the case of a smaller organ, a greater degree of overlap of first end 22 over second end 24 will occur.
  • the length of inner portions of 18b and 18c which are brought into intimate contact when device 40 is deployed on organ 30, may be increased or decreased in accordance with the dimensions of the outer surface of organ 30, such that a single device 40 may be used with organs of different dimensions, such that in the case of a smaller organ, a greater length 35 of inner portions 18b and 18c are brought into intimate contact.
  • curable fluid compositions useful for application using embodiments of the device described herein comprise a single component, which may be cured, for example, by application of heat, ultraviolet radiation or electron beams.
  • fluid refers to any biological fluid (e.g. fluid which derives from living organisms or which is manufactured by recombinant technology) and/or chemical fluid (e.g. fluid which is chemically synthesized).
  • curing of the curable fluid composition occurs within a time range of from a few miliseconds to a few minutes, for example in the range of from 2 miliseconds to 10 minutes.
  • the curable fluid composition comprises at least two components.
  • a first of the two components is activated by a second of the two components.
  • the first component optionally comprises fibrinogen
  • the second component optionally comprises an agent which activates fibrinogen, such as, for example, thrombin or a substance obtainable from snake venom, such that a fibrin polymer is formed upon curing of the curable fluid composition.
  • additional, non- limiting examples of two components of the curable fluid composition described herein include alginate and calcium; chondroitin sulphate and an acid such as hyaluronic acid.
  • the curable fluid composition comprises fibrinogen and thrombin components
  • one or both of the components can optionally be prepared from an initial blood composition.
  • the blood composition can be whole blood or blood fractions, i.e. a fraction of whole blood such as plasma.
  • the origin of the fibrinogen and thrombin can be autologous whereby they would be manufactured from the patient's own blood or from pooled blood or blood fractions. It is also possible that the protein components are prepared by recombinant methods.
  • the fibrinogen component comprises a biologically active component (BAC) which is a solution of proteins derived from blood plasma, optionally further comprising anti fibrinolytic agents such as tranexamic acid and/or stabilizers such as arginine, lysine, pharmaceutically acceptable salts thereof, or mixtures thereof.
  • BAC is optionally derived from cryoprecipitate, in particular concentrated cryoprecipitate.
  • cryoprecipitate refers to a blood component which is obtained from frozen plasma prepared from whole blood, recovered plasma or from source plasma which is collected by plasmapheresis.
  • a cryoprecipitate is optionally obtained when frozen plasma is slowly thawed in the cold, typically at a temperature of 0-4°C, resulting in the formation of precipitate that contains fibrinogen and factor XIII.
  • the precipitate can be collected, for example, by centrifugation and dissolved in a suitable buffer such as a buffer containing 120 mM sodium chloride, 10 mM trisodium citrate, 120 mM glycine, 95 mM arginine hydrochloride, 1 mM calcium chloride.
  • the solution of BAC optionally comprises additional factors such as for example factor VIII, fibronectin, von Willebrand factor (vWF), vitronectin, etc. for example as described in US 6,121 ,232 and W09833533.
  • composition of BAC optionally comprises stabilizers such as tranexamic acid and arginine hydrochloride.
  • stabilizers such as tranexamic acid and arginine hydrochloride.
  • the amount of tranexamic acid in the solution of BAC is optionally in the range of from about 80 to about 110 mg ml.
  • the amount of arginine hydrochloride is optionally in the range of from about 15 to about 25 mg/ml.
  • the solution is buffered to a physiological compatible pH value.
  • the buffer comprises glycine, sodium citrate, sodium chloride, calcium chloride and water for injection as a vehicle.
  • Glycine is optionally present in the composition at a concentration in the range of from about 6 to about 10 mg/ml; sodium citrate is optionally present at a concentration in the range of from about 1 to about 5 mg/ml; sodium chloride is optionally present at a concentration in the range of from about 5 to about 9 mg/ml; and calcium chloride is optionally present at a concentration in the range of from about 0.1 to about 0.2 mg/ml.
  • the fibrinogen component is derived from blood.
  • the concentration of plasminogen and/or plasmin in the blood derived component comprising fibrinogen is lowered.
  • the removal of plasmin and plasminogen from the blood derived component can be carried out as described in US 7,125,569 and WO02095019.
  • the thrombin component optionally comprises human thrombin (800-1200 IU/ml), calcium chloride, human albumin, mannitol, sodium acetate and water for injection.
  • fibrinogen and thrombin are available from manufacturers such as OMRIX e.g. EVICEL®, QUIXIL®, Baxter e.g. TISEEL®; CSL e.g. Beriplast® and the like.
  • the fibrinogen and thrombin components are manufactured from pooled human source plasma and provided as a single use kit consisting of two vials: one vial contains the fibrinogen component (BACl or BAC2) and another vial contains the thrombin component.
  • the components of the fibrin sealant may be mixed in any desired range of ratios in the method of the invention.
  • the two components can be mixed in a ratio of 11:1, 7:1, 6.5:1, 5:1, 3:1, 1:1, respectively, and so on.
  • the concentration of the fibrinogen used in the method of the invention is about 30.5 mg/ml, and the concentration of the thrombin used in the method of the invention is about 584 IU/ml.
  • the mentioned concentrations are following mixing of the two components.
  • the concentration of the fibrinogen used in the method of the invention is about 51.5 mg/ml, and the concentration of the thrombin used in the method of the invention is about 180 IU/ml.
  • the mentioned concentrations are following mixing of the two components.
  • the components of the fibrin sealant can comprise one or more additives such as, but not limited to, biologically active molecules such as antibiotics, anti inflammatory agents, chemotherapy agents, growth factors, anti-cancer drugs analgesics, proteins, hormones, antioxidants and the like.
  • each of the components may optionally be introduced into volume 32 via the same inlet 28, either simultaneously or sequentially.
  • the components may be introduced via inlet 28 by injection, with the two components injected simultaneously e.g. using a double lumen tip, or sequentially e.g. by use of two single lumen tips.
  • the two components may be mixed before injected.
  • the components may optionally be introduced simultaneously, sequentially or mixed via at least two different inlets 28a, 28b.
  • the components may be introduced via a tube e.g. having a bi-lumen arrangement which is connected to the inlet.
  • a first portion of one or both components of the curable fluid composition is optionally introduced into volume 32 via a first inlet 28a and a subsequent portion of one or both components is introduced via at least a second inlet 28b.
  • Second inlet 28b is optionally located diametrically opposite to first inlet 28a, or separated from first inlet 28a by, for example, 90-180 degrees when the device is deployed, such that delivery of the fluid composition around the entire circumference of the organ is achieved more efficiently.
  • the remainder of the fluid composition may be introduced via second inlet 28b.
  • a double lumen tip may be inserted into a first inlet 28a to introduce a first portion of each of the two components into volume 32, then the tip can be removed and inserted into a second inlet 28b for introduction of the remaining portion of each of the two components.
  • two or more tips/injectors may optionally be inserted simultaneously or sequentially into at least two different inlets 28a, 28b, for introduction of at least two portions of the fluid into volume 32.
  • Each injector optionally comprises a double lumen tip for simultaneous introduction of each of the at least two components, or a single lumen tip for introduction of one of the at least two components, such that at least one additional single lumen tip is required for sequential introduction of a second component.
  • the fluid following introduction of the curable fluid composition into volume 32, the fluid is allowed to cure.
  • device 10, 40 may be removed.
  • device 10, 40 may be allowed to remain deployed around organ 30.
  • the fibrinogen component used in the experiments described below is the Biological Active Component 2 (BAC2) of Evicel® fibrin sealant (Omrix Biopharmaceuticals Ltd.), and the thrombin component used is the thrombin component of Evicel® fibrin sealant (Omrix Biopharmaceuticals Ltd.).
  • the two components were used in a 1:1 volume ratio - the final fibrinogen concentration applied was 30.5 mg/ml, and the final thrombin concentration applied was 584 IU/ml.
  • the burst pressure provides an indication of the ability of a tested formulation to adhere to an organ tissue and maintain its mechanical integrity up to the pressure point in which a burst of the seal occurs, resulting in immediate loss of pressure and visible water leakage.
  • the burst pressure test was carried out essentially as described in Vilela et al. ["What Is Important For Continent Catheterizable Stomas: Angulations or Extension?” Int Braz J Urol. 2007; Vol. 33(2): 254-263] to determine and evaluate the ability of the sealant to effectively seal the organ and withstand pressure. Briefly, a specially designed aluminum pipe of length 27 cm, provided with holes, was inserted into a tubular segment of pig ileum of length 25-30 cm.
  • the tubular segment was sealed at both ends by attachment to the pipe using plastic discs, which were tightened using metal screws, such that a void area was formed between the segment of ileum and the aluminum pipe.
  • a 5-10 mm incision was formed perpendicular to the intestine length using a sharp blade, and then the fibrin sealant formulation to be tested (the formulations are elaborated below) was applied onto the incision area.
  • the fibrin was left to cure at room temperature (about 20-25°C) for 10 minutes.
  • the aluminum pipe was connected to a water source, and water was allowed to flow into the aluminum pipe, such that water entered into the void area through the holes provided in the pipe, in a way that backflow of water into the aluminum pipe was prevented.
  • Example 1 The structure of the device according to the invention.
  • a device as shown in Fig. 1A-1D was used in Examples 2-4 below.
  • the device was prepared from Polyurethane.
  • the thickness of the device was between 0.3 to 1.5 mm.
  • the device had a length of 73 mm and a width of 36.4 mm.
  • the device had 3 inlets.
  • the distance between the centers of the inlets was 20 mm.
  • the height of the inlets above the outer surface of the device was 3.5 mm and the diameter of the aperture was 1.1 mm.
  • the inner volume was about ⁇ 9770 mm 3 .
  • Example 2 Application of fibrin sealant onto an incision area by using the device of Figure 1.
  • Evicel® applied by spraying equal volumes of fibrinogen and thrombin components, with a total volume of 2.4 ml;
  • Table 1 Burst pressure obtained following application of fibrin sealant in different application methods.
  • Example 3 Application of different fibrin sealant formulations onto a sutured incision line by using the device of Figure 1.
  • Evicel® applied by spraying equal volumes of fibrinogen and thrombin components in a total volume of 2 ml.
  • Evicel® applied by introducing equal volumes of fibrinogen and thrombin in a total volume of 4 ml using the device of Example 1.
  • Ill Concentrated fibrin sealant applied by introducing fibrinogen and thrombin components in a total volume of 4 ml using the device of Example 1.
  • Table 2 Burst pressure obtained following application of different fibrin sealant formulations in different methods.
  • Example 4 Application of concentrated fibrin sealant formulation to an incision area using spray or the device according to the invention.
  • Table 3 Burst pressure obtained following application of different fibrin sealant formulations onto an incision area in different methods.

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Abstract

L'invention concerne un dispositif (10, 40) approprié pour l'application d'une composition de fluide durcissable pour encercler un organe corporel. Le dispositif comprend un morceau monolithique d'un matériau souple (12) ayant une dimension de longueur ayant une surface interne (18) et une surface externe (20), une première extrémité (22) et une seconde extrémité (24), une dimension de largeur et deux côtés espacés (26a, 26b), une partie de la dimension de longueur proximale à la première extrémité étant configurée pour entrer en contact avec une partie de la dimension de longueur proximale à la seconde extrémité, la surface interne définissant une zone creuse (31) entre les deux côtés espacés; et au moins une entrée (28) créant une communication fluidique entre la surface externe et la surface interne pour l'introduction du fluide dans la zone creuse. Le dispositif peut être déployé autour de l'organe corporel de telle sorte que, lorsque la partie de la dimension de longueur proximale à la première extrémité entre en contact avec la partie de la dimension de longueur proximale à la seconde extrémité, une surface externe de l'organe corporel et la zone creuse définissent un volume fermé encerclant l'organe corporel, le volume fermé étant approprié pour contenir le fluide à l'intérieur de celui-ci.
PCT/IL2013/000060 2012-07-24 2013-07-21 Dispositif et procédé pour l'application d'une composition de fluide durcissable sur un organe corporel WO2014016819A1 (fr)

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CA2879933A CA2879933A1 (fr) 2012-07-24 2013-07-21 Dispositif et procede pour l'application d'une composition de fluide durcissable sur un organe corporel
CN201380039333.9A CN104470445B (zh) 2012-07-24 2013-07-21 用于将可固化的流体组合物施加到身体器官的装置和方法
EP13750943.6A EP2877101A1 (fr) 2012-07-24 2013-07-21 Dispositif et procédé pour l'application d'une composition de fluide durcissable sur un organe corporel
JP2015523654A JP6275712B2 (ja) 2012-07-24 2013-07-21 身体器官への硬化性流体組成物の適用のための装置及び方法
AU2013294557A AU2013294557B2 (en) 2012-07-24 2013-07-21 Device and method for the application of a curable fluid composition to a bodily organ
IL236821A IL236821B (en) 2012-07-24 2015-01-20 Device and method for the application of a liquid compound that hardens to a body part

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JP6275712B2 (ja) 2018-02-07
AU2013294557A1 (en) 2015-03-05
EP2877101A1 (fr) 2015-06-03
JP2015525641A (ja) 2015-09-07
IL236821A0 (en) 2015-03-31
IL236821B (en) 2020-01-30
CN104470445A (zh) 2015-03-25
CA2879933A1 (fr) 2014-01-30
CN104470445B (zh) 2019-08-06
AU2013294557B2 (en) 2017-05-25

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