Implant for reinforcing and annulus fibrosis

• US 7,220,281 B2
• Filed: 09/05/2002
• Issued: 05/22/2007
• Est. Priority Date: 08/18/1999
• Status: Expired due to Term

• Current Assignee: Intrinsic Therapeutics, Inc.
• Original Assignee: Intrinsic Therapeutics, Inc.
• Inventors: Moore, Robert Kevin, Banks, Thomas, Vidal, Claude A., Lambrecht, Gregory H., Redmond, Russel J.
• Primary Examiner(s): BARRETT, THOMAS C
• Application Number:
  US10/237,380
• Publication Number:
  US 20030014118A1
• Time in Patent Office: 1,720 Days
• Field of Search: 623 1711- 1716
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• 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 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• 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 2002/30571 : Leaf springs
• 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 2002/30677 : 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 2002/4435 : 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 2002/4635 : 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 2210/0061 : 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• 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 2310/00293 : 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

Reinforcement of annulus fibrosis tissue within an intervertebral disc can be achieved through implantation of a support member also functioning as a barrier to resist damage to the tissue or herniation of tissue outside of the disc. The device may be anchored to the surrounding tissue. The device is compressible and may be delivered in a minimally invasive manner through a cannula.

Claims

1. An implant for reinforcing an annulus of an intervertebral disc, comprising:

a barrier having a first surface for placement against an interior surface of an annulus lamella and a second opposing surface, wherein said barrier is adapted to be sealably positioned against the lamella via the exertion of force on at least a portion of the second surface sustained by a pressurized intervertebral disc environment;

wherein the barrier has a length corresponding to at least the length of the posterior annulus and a height corresponding to at least the distance between opposing vertebral endplates adjacent the intervertebral disc,

wherein a natural flow or egress of material from the nucleus to the anulus occurs along a longitudinal axis, wherein said longitudinal access is parallel to the height of said barrier;

wherein said material comprises endogenous nucleus pulposus or prosthetic augmentation material;

wherein said barrier has a thickness in a range of about 0.025 mm to about 2.5 mm;

wherein said barrier provides a seal and comprises a rigidity that prevents natural flow or egress of material beyond said barrier along said longitudinal axis,

wherein said barrier closes or barricades the area to be sealed to recreate the closed isobaric environment of a healthy disc nucleus;

wherein said length is greater than said height;

wherein the implant has a pre-formed concavity and is thereby inherently concave along at least a portion of said length; and

wherein the barrier comprises an enlarger,

wherein the enlarger expands the barrier and

wherein the enlarger contacts a substantial portion of the barrier and supports the barrier at its midpoint.

2. The implant of claim 1, wherein the implant is concave along at least a portion of said first surface and convex along at least a portion of said second surface.

3. The implant of claim 1, wherein said length and said height are dimensioned to prevent the barrier from slipping after insertion in the intervertebral disc.

4. The implant of claim 1, wherein said length and said height are dimensioned to distribute pressure along the annulus.

5. The implant of claim 1, wherein said length corresponds to a length of a posterior annulus.

6. The implant of claim 1, wherein the length is within the range of from about 0.5 cm to about 3 cm.

7. The implant of claim 1, wherein the height is within the range of from about 0.2 cm to about 1.5 cm.

8. The implant of claim 1, wherein at least a portion of the implant is operable to resist or promote tissue ingrowth.

9. The implant of claim 1, wherein said thickness is in the range of 0.127 mm to 1.600 mm.

10. The implant of claim 1, wherein said thickness is in the range of 0.0762 mm to 0.381 mm.

11. The implant of claim 1, wherein said barrier prevents the flow of all endogenous or prosthetic material beyond said barrier along said longitudinal axis.

12. The implant of claim 1, wherein said barrier completely prevents the passage of said material around the barrier.

13. The implant of claim 1, wherein said barrier prevents the passage of said material around either side of the barrier and beyond said barrier.

14. An implant for reinforcing an annulus of an intervertebral disc, comprising:

a support member having a first surface for placement against an interior surface of an annulus lamella and a second opposing surface, wherein said support member is adapted to be sealably positioned against the lamella via the exertion of force on at least a portion of the second surface sustained by a pressurized intervertebral disc environment;

wherein the support member has a length that is oriented along the circumference of the disc and a height that is oriented along the distance separating the surrounding vertebral bodies;

wherein said length is greater than said height;

wherein the implant is concave along at least a portion of said first surface and convex along at least a portion of said second surface; and

wherein the support member has a pre-formed concavity and is thereby inherently concave along at least a portion of said length;

wherein the support member comprises a membrane and a metal latticed frame that expands the membrane, wherein the frame contacts a substantial portion of the membrane and centrally supports the membrane; and

wherein a natural flow or egress of material from the nucleus to the anulus occurs along a longitudinal axis, wherein said longitudinal access is parallel to the height of said support member;

wherein said material comprises endogenous nucleus pulposus or prosthetic augmentation material;

wherein said support member has a thickness in a range of about 0.025 mm to about 2.5 mm;

wherein said support member provides a seal and comprises a rigidity that prevents the natural flow or egress of material beyond said support member along said longitudinal axis;

wherein said support member closes or barricades the area to be sealed to recreate the closed isobaric environment of a healthy disc nucleus.

15. An implant for reinforcing an annulus of an intervertebral disc, comprising:

a support member having a first surface for placement against an interior surface of an annulus lamella and a second opposing surface, wherein said support member is adapted to be sealably positioned against the lamella via the exertion of force on at least a portion of the second surface sustained by a pressurized intervertebral disc environment;

wherein the support member has a length that is oriented along the circumference of the disc and a height that is oriented along the distance separating the surrounding vertebral bodies;

wherein said length is greater than said height;

wherein said length and said height are dimensioned to prevent the barrier from slipping after insertion in the intervertebral disc;

wherein the support member has a pre-formed concavity and is thereby inherently concave along at least a portion of said length;

wherein the support member comprises a membrane and a sheet-like frame that expands the membrane, wherein the frame contacts a substantial portion of the membrane and supports at least the central portion of said membrane; and

wherein a natural flow or egress of material from the nucleus to the anulus occurs along a longitudinal axis, wherein said longitudinal access is parallel to the height of said support member;

wherein said material comprises endogenous nucleus pulposus or prosthetic augmentation material;

wherein said support member has a thickness in a range of about 0.025 mm to about 2.5 mm;

wherein said support member provides a seal and comprises a rigidity that prevents natural flow or egress of material beyond said support member along said longitudinal axis; and

wherein said support member closes or barricades the area to be sealed.

16. An implant for reinforcing an annulus of an intervertebral disc, comprising:

a support member having a first surface for placement against an interior surface of an annulus lamella and a second opposing surface, wherein said support member is adapted to be sealably positioned against the lamella via the exertion of force on at least a portion of the second surface sustained by a pressurized intervertebral disc environment;

wherein the support member has a length that is oriented along the circumference of the disc and a height that is oriented along the distance separating the surrounding vertebral bodies;

wherein said length is greater than said height;

wherein said length and said height are dimensioned to distribute pressure along the annulus;

wherein the support member has a pre-formed concavity and is thereby inherently concave along at least a portion of said length;

wherein the support member comprises a membrane and a sheet-like latticed enlarging means that expands the membrane, wherein the enlarging means contacts a substantial portion of the membrane and supports at least the central portion of said membrane; and

wherein a natural flow or egress of material from the nucleus to the anulus occurs along a longitudinal axis, wherein said longitudinal access is parallel to the height of said support member;

wherein said material comprises endogenous nucleus pulposus or prosthetic augmentation material;

wherein said support member has a thickness in a range of about 0.025 mm to about 2.5 mm;

wherein said support member provides a seal and comprises a rigidity that prevents natural flow or egress of material beyond said support member along said longitudinal axis; and

wherein said support member closes or barricades the area to be sealed.

17. An implant for reinforcing an annulus of an intervertebral disc, comprising:

a support member having a first surface for placement against an interior surface of an annulus lamella and a second opposing surface, wherein said support member is adapted to be sealably positioned against the lamella via the exertion of force on at least a portion of the second surface sustained by a pressurized intervertebral disc environment;

wherein the support member has a length that is oriented along the circumference of the disc and a height that is oriented along the distance separating the surrounding vertebral bodies;

wherein said length is greater than said height;

wherein the implant is concave along at least a portion of said length; and

wherein the support member has a pre-formed concavity and is thereby inherently concave along at least a portion of said length;

wherein the support member comprises a membrane and a sheet-like metallic enlarging means that expands the membrane, wherein the enlarging means contacts a substantial portion of the membrane and supports at least the central portion of said membrane; and

wherein a natural flow or egress of material from the nucleus to the anulus occurs along a longitudinal axis, wherein said longitudinal access is parallel to the height of said support member;

wherein said material comprises endogenous nucleus pulposus or prosthetic augmentation material;

wherein said support member has a thickness in a range of about 0.025 mm to about 2.5 mm;

wherein said support member provides a seal and comprises a rigidity that prevents natural flow or egress of material beyond said support member along said longitudinal axis; and

wherein said support member closes or barricades the area to be sealed.