Encapsulated intervertebral disc prosthesis and methods of manufacture

• US 6,936,072 B2
• Filed: 07/10/2002
• Issued: 08/30/2005
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Stonebrook, Scott, Lambrecht, Gregory, Kavanaugh, Sean
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US10/194,428
• Publication Number:
  US 20030125807A1
• Time in Patent Office: 1,147 Days
• Field of Search: 428/138, 156 84- 85
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• 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 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30136 : undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30166 : H-shaped or I-shaped
• CPC Class Codes: A61F 2002/30172 : T-shaped
• CPC Class Codes: A61F 2002/30177 : W-shaped, M-shaped or sigma shaped
• CPC Class Codes: A61F 2002/30187 : D-shaped or half-disc-shaped
• CPC Class Codes: A61F 2002/302 : toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30289 : helically-coiled
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30566 : Helical springs
• CPC Class Codes: A61F 2002/30571 : Leaf springs
• CPC Class Codes: A61F 2002/30576 : with extending fixation tabs
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0034 : D-shaped
• CPC Class Codes: A61F 2230/0052 : T-shaped
• CPC Class Codes: A61F 2230/0056 : W-shaped, e.g. M-shaped, sigma-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

The present invention relates generally to intervertebral disc repair devices and methods of manufacture. A method of manufacturing a dynamically responsive encapsulated intervertebral disc repair device that prevents the flow of disc material out of the disc, provides support to the anulus fibrosus, and shields the nerves of the anulus and spinal cord, is provided.

Claims

1. A method of making an intervertebral prosthesis comprising the steps of:

placing a first biocompatible encapsulating material over a heatable mold with a curved face, said first biocompatible encapsulating material sized to extend from about 0.1 mm to about 0.5 mm beyond the edges of a barrier frame;

placing the barrier frame on the first encapsulating material, said barrier frame dimensioned to span beyond the distance defined by the maximum distance between an inferior and superior endplate of a normal intervertebral disc and to extend circumferentially along the lateral and posterior surfaces of an anulus, wherein at least a portion of said barrier has a curvilinear cross-section and is comprised of nickel titanium alloy;

placing a second encapsulating material on top of the barrier frame, said second biocompatible encapsulating material designed to extend from about 0.1 mm to about 5 mm beyond the edges of the barrier frame;

placing a mold cover with a concave interior corresponding to face of the mold on top of the second encapsulating material and applying force such that the edges of the first and second encapsulating material form one or more contact points with each other around the barrier frame; and

heating the base and the cover and the frame sandwiched between the first and the second encapsulating material until the first and second encapsulating material bond to each other at said one or more contact points.

2. The method of claim 1, wherein said placing a first biocompatible encapsulating material over a heatable mold with a curved face comprises placing a first biocompatible encapsulating material over a heatable mold with a curved face having a first axis and a second axis which are perpendicular to one another.

3. The method of claim 2, wherein said first axis is a longitudinal axis having a first radius of curvature and said second axis is a transverse axis having a second radius of curvature.

4. The method of claim 3, wherein said first radius of curvature has a range of about 0.2 cm to about 2.5 cm and said second radius of curvature has a range of about 3.0 cm to about 5.0 cm.

5. The method of claim 1, wherein said curvilinear cross-section is a semi-circular cross-section.

6. The method of claim 1, wherein said first biocompatible encapsulating material comprises ePTFE.

7. The method of claim 1, wherein said first biocompatible encapsulating material comprises a biological material selected from the group consisting of one or more of the following:

keratin, collagen, bio-engineered anulus fibrosus, and protein polymers.

8. The method of claim 1, wherein said first biocompatible encapsulating material comprises a synthetic material selected from the group consisting of one or more of the following:

polyamides, polyimides, silicones, polyurethane, natural rubber, latex, perfluoroalkoxy and fluorinated ethylene-propylene.

9. The method of claim 1, wherein said first biocompatible encapsulating material is constructed of the same material as said second biocompatible encapsulating material.