Articulating joint repair

• US 6,248,131 B1
• Filed: 09/05/1997
• Issued: 06/19/2001
• Est. Priority Date: 05/06/1994
• Status: Expired due to Fees

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Advanced Bio Surfaces, Inc.
• Inventors: Bourgeault, Craig A., Felt, Jeffrey C., Baker, Matthew W.
• Primary Examiner(s): Snow, Bruce
• Application Number:
  US08/925,838
• Time in Patent Office: 1,383 Days
• Field of Search: 623/66, 623/16, 623/17.12, 623/17.16, 606/86-88, 606/92-94, 606/61
• 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 17/1671 for the spine
• CPC Class Codes: A61B 17/1682 for the foot or ankle
• CPC Class Codes: A61B 17/1684 for the shoulder
• CPC Class Codes: A61B 17/1686 for the hand or wrist
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• 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 2002/30024 : differing in coefficient of friction
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• 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: 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 606/91 : Polymer

Abstract

A method and related materials and apparatus for using minimally invasive means to repair (e.g., reconstruct) tissue such as fibrocartilage, and particularly fibrocartilage associated with diarthroidal and amphiarthroidal joints. The method involves the use of minimally invasive means to access and prepare damaged or diseased fibrocartilage within the body, and to then deliver a curable biomaterial, such as a two-part polyurethane system, to the prepared site, and to cure the biomaterial in situ in order to repair the fibrocartilage. Applications include repair and replacement of the intervertebral disc of the spine.

Claims

1. An apparatus for repairing a damaged or diseased intervertebral disc, the apparatus comprising a mold apparatus positioned within the intervertebral disc and comprising an inflated balloon containing a cured biomaterial, the apparatus being formed by a method that comprises the steps of:

a) using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

b) providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon, and using minimally invasive means to position the balloon within the disc;

c) providing a biomaterial source comprising a polyurethane system comprising a plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure;

mixing the biomaterial components upon positioning of the balloon; and

using minimally invasive techniques to deliver the flowable biomaterial by injection into the balloon under pressure sufficient to provide on the order of 3 atmospheres to on the order of 4 atmospheres pressure to distract the disc space, and

d) allowing the delivered biomaterial to cure within 5 minutes of mixing the components to permit the cannula to be removed and to provide a permanent replacement for the nucleus,

wherein the polyurethane system comprises a two-part prepolymer system and further comprises an isocyanate reactant consisting essentially of aromatic isocyanates, the method further comprising the further step of deflating the balloon as biomaterial is delivered.

2. An apparatus for repairing a damaged or diseased intervertebral disc, the apparatus comprising a mold apparatus positioned within the intervertebral disc and comprising an inflated balloon containing a cured biomaterial, the apparatus being formed by a method that comprises the steps of:

a) using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

b) providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon, and using minimally invasive means to position the balloon within the disc;

c) providing a biomaterial source comprising a polyurethane system comprising a plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure;

mixing the biomaterial components upon positioning of the balloon; and

using minimally invasive techniques to deliver the flowable biomaterial by injection into the balloon under pressure sufficient to provide on the order of 3 atmospheres to on the order of 4 atmospheres pressure to distract the disc space, and

d) allowing the delivered biomaterial to cure within 5 minutes of mixing the components to permit the cannula to be removed and to provide a permanent replacement for the nucleus,

wherein a) the polyurethane system comprises a two-part prepolymer system and further comprises an isocyanate reactant consisting essentially of aromatic isocyanates, b) the minimally invasive steps are performed using arthroscopic or endoscopic techniques including visualization, and c) the method comprises the further step of deflating the balloon as biomaterial is delivered.

3. An apparatus for repairing a damaged or diseased intervertebral disc, the apparatus comprising a mold apparatus positioned within the intervertebral disc and comprising an inflated balloon containing a cured biomaterial, the apparatus being formed by a method that comprises the steps of:

a) using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

b) providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon, and using minimally invasive means to position the balloon within the disc;

c) providing a biomaterial source comprising a polyurethane system comprising a plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure;

mixing the biomaterial components upon positioning of the balloon; and

using minimally invasive techniques to deliver the flowable biomaterial by injection into the balloon under pressure sufficient to provide on the order of 3 atmospheres to on the order of 4 atmospheres pressure to distract the disc space, and

d) allowing the delivered biomaterial to cure within 5 minutes of mixing the components to permit the cannula to be removed and to provide a permanent replacement for the nucleus,

wherein the polyurethane system comprises a two-part prepolymer system and further comprises an isocyanate reactant consisting essentially of aromatic isocyanates,

comprising the further step of deflating the balloon as biomaterial is delivered, and wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions.

4. An apparatus according to claim 3 wherein the regions comprise a more rigid outer region and a more flexible inner region.

5. An apparatus for repairing a damaged or diseased intervertebral disc, the apparatus comprising a mold apparatus positioned within the intervertebral disc and comprising an inflated balloon containing a cured biomaterial formed by a method that comprises the steps of:

a) using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

b) providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon, and using minimally invasive means to position the balloon within the disc;

c) providing a biomaterial source comprising a polyurethane system comprising a plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure;

mixing the biomaterial components upon positioning of the balloon; and

using minimally invasive techniques to deliver the flowable biomaterial by injection into the balloon under pressure sufficient to provide on the order of 3 atmospheres to on the order of 4 atmospheres pressure to distract the disc space, and

d) allowing the delivered biomaterial to cure within 5 minutes of mixing the components to permit the cannula to be removed and to provide a permanent replacement for the nucleus,

wherein a) the polyurethane system comprises a two-part prepolymer system and further comprises an isocyanate reactant consisting essentially of aromatic isocyanates, b) the minimally invasive steps are performed using arthroscopic or endoscopic techniques including visualization, and c) the method comprises the further step of deflating the balloon as biomaterial is delivered, and

wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions.

6. An apparatus according to claim 5 wherein the regions comprise a more rigid outer region and a more flexible inner region.