Mold apparatus and kit for in situ tissue repair

• US 6,443,988 B2
• Filed: 11/18/1998
• Issued: 09/03/2002
• Est. Priority Date: 05/06/1994
• Status: Expired due to Fees

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Disc Dynamics, Inc.
• Inventors: Arsenyev, Alexander, Felt, Jeffrey C., Rydell, Mark A., Zdrahala, Richard J.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/193,973
• Publication Number:
  US 20010004710A1
• Time in Patent Office: 1,385 Days
• Field of Search: 623/17.11, 623/17.12, 623/16.11, 623/18.11, 433/223, 433/226
• US Class Current: 623/17.12
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3099 for temporo-mandibular [TM, TMJ] joints endoprostheses for mandibular reconstruction A61F2/2803
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/945 : hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2002/30016 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30024 : differing in coefficient of friction
• CPC Class Codes: A61F 2002/3008 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4233 : for metatarso-phalangeal joints, i.e. MTP joints
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/041 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: B01F 2101/2305 : Mixers of the two-component package type, i.e. where at least two components are separately stored, and are mixed in the moment of application
• CPC Class Codes: C08G 18/10 : Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step
• CPC Class Codes: C08G 18/3206 : aliphatic
• CPC Class Codes: C08G 18/4854 : Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/69 : Polymers of conjugated dienes hydrogenated polymers of conjugated dienes C08G18/6208
• CPC Class Codes: C08L 23/00 : Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/02 : Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

A method, and related composition and apparatus for repairing a tissue site. The method involves the use of a curable polyurethane biomaterial composition having a plurality of parts adapted to be mixed at the time of use in order to provide a flowable composition and to initiate cure. The flowable composition can be delivered using minimally invasive means to a tissue site and there fully cured provide a permanent and biocompatible prosthesis for repair of the tissue site. Further provided are a mold apparatus, e.g., in the form of a balloon or tubular cavity, for receiving a biomaterial composition, and a method for delivering and filling the mold apparatus with a curable composition in situ to provide a prosthesis for tissue repair.

Claims

1. A method for forming a prosthesis in situ comprising providing an apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, and

a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure,

wherein the composition parts comprise:

(1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts,

wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material,

b) inserting the mold apparatus into a tissue site,

c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412,

d) permitting the biomaterial composition to completely cure, and

e) employing the molded biomaterial in situ as a prosthesis at the tissue site,

wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

2. A method according to claim 1, wherein the apparatus is adapted for use by minimally invasive means and the cavity is a provided in the form of an inflatable balloon for use in preparing an intact prosthesis.

3. A method according to claim 1 wherein the balloon is adapted for use in repairing an intervertebral disc.

4. A method according to claim 1 further comprising distal control valves for the biomaterial conduit and air passageway, respectively.

5. A method according to claim 1 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

6. A method according to claim 1 wherein the apparatus is provided in the form of a balloon adapted to be collapsed by the application of vacuum in the course of delivery to the tissue site.

7. A method according to claim 1 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

8. A method according to claim 7 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

9. A method according to claim 8 wherein the thickness is on the order of 0.02 cm to about 0.03 cm.

10. A method according to claim 1 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

11. A method according to claim 10 wherein the reinforcing material is selected from the group consisting of meshes formed of natural or synthetic materials.

12. A method according to claim 1, wherein the apparatus is adapted for use in repairing an intervertebral disc.

13. A method according to claim 12 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

14. A method according to claim 13 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

15. A method according to claim 14 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

16. A method according to claim 15 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

17. A method according to claim 14 wherein the mold apparatus is between about cm to about 3 cm in its longest dimension, about 1.5 cm to about 2.5 cm in width, and about 0.5 cm to about 1.5 cm in thickness, once filled with biomaterial.

18. A surgical kit comprising a biomaterial source and a mold apparatus for forming a prosthesis in situ, the apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, wherein the mold apparatus is adapted for use in a method that comprises the steps of:

a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure,

wherein the composition parts comprise;

(1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts,

wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material,

b) inserting the mold apparatus into a tissue site,

c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412.

d) permitting the biomaterial composition to completely cure, and

e) employing the molded biomaterial in situ as a prosthesis at the tissue site

wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

19. A kit according to claim 18 wherein the curable polyurethane composition further comprises one or more reactive hydrophobic additives.

20. A kit according to claim 19 wherein the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive.

21. A kit according to claim 19 wherein the hydrophobic polymer additive is present at a concentration of between about 1% and about 50% by weight, and is selected from the group consisting of hydroxyl- or amine-terminated compounds selected from the group consisting of poybutadiene, polyisoprene, polyisobutylene, silicones, polyethylenepropylenediene, copolymers of butadiene with acryolnitrile, copolymers of butadiene with styrene, copolymers of isoprene with acrylonitrile, copolymers of isoprene with styrene, and mixtures thereof.

22. A kit according to claim 20 wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

23. A kit according to claim 18 wherein the biomaterial provides an induction period of about thirty seconds to two minutes upon mixing of the composition parts.

24. A kit according to claim 18 wherein the cured biomaterial provides a hardness of about 60 Shore to about 95 Shore.

25. A kit according to claim 18 wherein the biomaterial source comprises a curable polyurethane biomaterial composition comprising a plurality of parties adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise:

(1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts.

26. A kit according to claim 25 wherein the polyol component is present at a concentration of between about 2% and about 10%, by weight, based on the weight of the composition, and is selected from the group consisting of linear or branched polyols with polyether backbones of polyoxyethylene, polyoxypropylene, and polytetramethylene oxide (polyoxytetramethylene), and copolymers thereof.

27. A kit according to claim 26 wherein the polyol comprises one or more polytetramethylene oxides having molecular weights in the range of 250 to 2900.

28. A kit according to claim 25 wherein the isocyanate is present in excess in the prepolymer component and comprises an aromatic (poly)isocyanate selected from the group consisting of 2,2′

-, 2,4′

-, and 4,4′

-diphenylmethanediisocyanate (MDI), and combinations thereof.

29. A kit according to claim 18 the mold apparatus comprises a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

30. A kit according to claim 29 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

31. A kit according to claim 18 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

32. A mold apparatus according to claim 18, wherein the apparatus is adapted for use in repairing an intervertebral disc.

33. A kit according to claim 32 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

34. A kit according to claim 32 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

35. A kit according to claim 34 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

36. A kit according to claim 18 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

37. A kit according to claim 18 wherein the mold apparatus is between about cm to about 3 cm in its longest dimension, about 1.5 cm to about 2.5 cm in width, and about 0.5 cm to about 1.5 cm in thickness, once filled with biomaterial.

38. A kit according to claim 25 wherein:

a) the mold apparatus comprises a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site,

b) the balloon is formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas,

c) the material has a thickness of on the order of 0.01 cm to about 0.05 cm, and

d) within the prepolymer of the biomaterial, the polyether component is present at a concentration of between about 2% and about 10%, by weight, based on the weight of the composition, and is selected from the group consisting of linear or branched polyols with polyether backbones of polyoxyethylene, polyoxypropylene, and polytetramethylene oxide (polyoxytetramethylene), and copolymers thereof, the polyol comprises one or more polytetramethylene oxides having molecular weights in the range of 250 to 2900, and the isocyanate is present in excess in the prepolymer component and comprises an aromatic (poly)isocyanate selected from the group consisting of 2,2′

-, 2,4′

-, and 4,4′

-diphenylmethanediisocyanate (MDI), and combinations thereof.