Biomaterial system for in situ tissue repair

• US 6,306,177 B1
• Filed: 12/18/1997
• Issued: 10/23/2001
• Est. Priority Date: 05/06/1994
• Status: Expired due to Fees

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Advanced Bio Surfaces, Inc.
• Inventors: Arsenyev, Alexander, Felt, Jeffrey C., Rydell, Mark A., Zdrahala, Richard J.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/993,468
• Time in Patent Office: 1,405 Days
• Field of Search: 623/11, 623/16, 623/18, 623/66, 623/901, 623/18.11, 128/898, 433/223, 433/226
• US Class Current: 623/23.6
• 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 repairing a tissue site, the method comprising three steps of:

(a) providing a sterile curable polyurethane biomaterial composition comprising a plurality of parts adapted to be mixed at the time of use in order to provide a flowable composition and to initiate cure,

(b) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition to the tissue site, and

(c) completely curing the delivered composition to provide a permanent repair of the tissue site,

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

2. A method according to claim 1 wherein the composition parts comprise:

(1) a quasi-prepolymer component comprising the reaction product of one or more polyols, one or more isocyanates, and one or more reactive hydrophobic additives, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts, and the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive component.

3. A method according to claim 2 wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

4. A method according to claim 1 wherein the curing composition provides an surface exotherm of between about 50 and about 80 C.

5. A method according to claim 1 wherein the method is used to repair an orthopedic joint selected from the group consisting of diarthroidal and amphiarthroidal joints.

6. A method according to claim 5 wherein the amphiarthroidal joints are selected from the group consisting of synphysoidal joints and syndemoidal joints.

7. A method according to claim 6 wherein the synphysiodal joints are intervertebral joints.

8. A method according to claim 5 wherein the method is performed using endoscopic/arthroscopic surgical instrumentation and under fiberoptic visualization.

9. A method according to claim 8 wherein the instrumentation comprises a static mixer and delivery cannula to mix and deliver the composition.

10. A method according to claim 1 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, one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site by minimally invasive means and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material.

11. A method according to claim 10 wherein the curing composition provides a surface exotherm of between about 50 and about 80 C.

12. A method according to claim 10 wherein the quasi-prepolymer further comprises a reactive hydrophobic additive and the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive component.

13. A method according, to claim 12 wherein the reactive hydrophobic additive is selected from the group consisting of hydroxyl- or amine-terminated compounds selected from the group consisting of polybutadiene, polyisobutylene, silicones, polyisoprene, copolymers of butadiene with acryolnitrile, copolymers of butadiene with styrene, copolymers of isoprene with acrylonitrile, copolymers of isoprene with styrene, and mixtures thereof.

14. A method according to claim 10 wherein the polyols in each component independently comprise polyether polyols.

15. A method according to claim 14 wherein the polyether polyols independently comprise polytetramethylene oxides provided in the form of a blend of two or more different molecular weights selected from the group consisting of 250, 650, 1000, 1400, 2000, and 2900.

16. A method according to claim 10 wherein the chain extender consists essentially of linear chain extenders.

17. A method according to claim 16 wherein the linear chain extenders comprise 1,4-butanediol.

18. A method according to claim 14 wherein within the prepolymer the polyether component is selected from the group consisting of linear or branched polyols with polyether backbones of polyoxyethylene, polyoxypropylene, and polytetramethylene oxide (polyoxytetramethylene), and copolymers thereof, and wherein the composition further comprises a hydrophobic polymer additive selected from the group consisting of hydroxyl- or amine-terminated compounds selected from the group consisting of polybutadiene, 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.

19. A method according to claim 18 wherein the improved cured properties include a hardness of about 60 Shore A to about 95 Shore A.

20. A method according to claim 18 wherein the isocyanate is present in excess in the prepolymer component and consists essentially of 4,4′

-diphenylmethanediisocyanate (MDI).

21. A method according to claim 10 wherein the catalyst comprises a combination of tin catalyst and a tertiary amine.

22. A method according to claim 21 wherein the composition cures within on the order of 5 minutes or less.

23. A method according to claim 12 wherein wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

24. A method according to claim 12 wherein the polyols in each component independently comprise polyether polyols selected from the group consisting of polytetramethylene oxides provided in the form of a blend of two or more different molecular weights selected from the group consisting of 250, 650, 1000, 1400, 2000, and 2900;

the reactive hydrophobic additives comprise hydroxyl- or amine-terminated compounds selected from the group consisting of polybutadiene, polyisobutylene, silicones, polyisoprene, copolymers of butadiene with acryolnitrile, copolymers of butadiene with styrene, copolymers of isoprene with acrylonitrile, copolymers of isoprene with styrene, and mixtures thereof;

the chain extender consists essentially of linear chain extender, and the isocyanates consist essentially of 4,4′

-diphenylmethanediisocyanate (MDI).