Annulus-reinforcing band

• US 6,712,853 B2
• Filed: 12/17/2001
• Issued: 03/30/2004
• Est. Priority Date: 12/15/2000
• Status: Expired due to Term

• Current Assignee: Spineology Incorporated
• Original Assignee: Spineology Incorporated
• Inventors: Kuslich, Stephen D.
• Primary Examiner(s): O'Connor, Cary E.
• Assistant Examiner(s): STOKES, CANDICE CAPRI
• Application Number:
  US10/022,048
• Publication Number:
  US 20020077701A1
• Time in Patent Office: 834 Days
• Field of Search: 623/17.11, 623/17.15, 623/17.16, 606/61
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• 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: 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 2002/2817 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 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• 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 2002/30593 hollow
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4495 having a fabric structure, e.g. made from wires or fibres
• 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 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• 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 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures

Abstract

A pliable band or hoop that is flexible to normal handling, but cannot stretch circumferentially once it has reached the limits of its circumferential length. The band may have a structural portal to be used for filling, or it may simply be constructed of a fabric-like material that allows a fill tube to perforate its walls to allow for filling. In the latter case, the perforated wall tends to self-seal once the fill tube is withdrawn. The band may be flat or tubular in cross-section. However, unlike a balloon, the band does not require either a bottom or a top, as we found that a top and bottom are unnecessary when using a band or hoop to enclose material injected into a reamed out intervertebral space.

Claims

1. A device comprising:

a generally flexible substantially tabular member sized to fit and expand transversely into a hollowed region of an intervetebral space or intravertebral space;

the substantially tubular member defining an interior space;

the interior space extending from a first end of the substantially tubular member to second end of the substantially tubular member;

at least one end defining an opening;

the opening in fluid communication with the interior space;

the substantially tubular member constructed and arranged to expand from a reduced state to an expanded state by the introduction of fill material into the interior space;

the substantially tubular member including a plurality of pores;

the plurality of pores being sized to allow ingress and egress of liquids, solutions or small particle suspensions and ingrowth of bony trabeculae or fibrous elements into and through the device when the device is positioned in the hollowed region of a intervertebral space or intravertebral space;

the plurality of pores being sized to retain the fill material within the interior space of the substantially tubular member;

the substantially tubular member including at least one fill opening through which the fill material may be introduced into the interior space;

the at least one fill opening including at least one of the plurality of pores.

2. The device of claim 1 wherein the at least one fill opening is constructed and arranged to prevent egress of the fill material from the interior space.

3. The device of claim 1 wherein the hollowed region of a intravertebral space is defined by a bored out region of a vertebra, the device being inserted into the bored out region of the vertebra.

4. The device of claim 1 wherein the hollowed region of an intervertebral space is defined by a bored out region of a disc, the device being inserted within the bored out region of the disc in the reduced state.

5. The device of claim 1 wherein the first end defines a top opening and the second end defines a bottom opening, the top opening and the bottom opening each being immediately adjacent to surrounding vertebral tissue.

6. The device of claim 1 wherein the substantially tubular member is composed of a polymeric material.

7. The device of claim 1 in combination with a delivery tube, the tube defining a storage chamber, the storage chamber sized to accommodate passage of the substantially tubular member in the reduced state from within the storage chamber into the hollowed region of an intervertebral space or intravertebral space.

8. The device of claim 1 wherein the said fill material is combined with a virus, the virus constructed and arranged to stimulate bone formation.

9. The device of claim 1 wherein said fill material is subjected to electrical energy stimulation.

10. The device of claim 1 said device being subjected to electrical energy stimulation.

11. The device of claim 1 wherein the substantially tubular member further comprises at least one circumferential member, the at least one circumferential member constructed and arranged to constrict a mid-portion of the substantially tubular member when the substantially tubular member is in the expanded state to provide the substantially tubular member with a substantially concave shape.

12. The device of claim 1 wherein the hollowed region of a intervertebral space or intravertebral space is defined by adjacent vertebrae.

13. The device of claim 12 wherein in the expanded state the opening of the at least one end being immediately adjacent to at least one of the adjacent vertebrae.

14. The device of claim 1 wherein the substantially tubular member is composed of a fluid impermeable material.

15. The device of claim 14 wherein the plurality of pores are perforations.

16. The device of claim 1 wherein each of the plurality of pores having a first diameter of about 0.25 mm to about 5 mm.

17. The device of claim 16 wherein the at least one fill opening has a predetermined diameter, the predetermined diameter of the fill opening being larger than the first diameter of any of the plurality of pores.

18. The device of claim 16 in combination with a fill insertion tool, the fill insertion tool constructed and arranged to be inserted into at least one of the plurality of pores, the at least one of the plurality of pores being opened from the first diameter to a second diameter, the second diameter being sized to allow the fill insertion tool to pass into the interior space of the device.

19. The device of claim 1 wherein the substantially tubular member is composed of a woven material, wherein the woven material is comprised of at least one fiber.

20. The device of claim 19 wherein the at least one fiber is constructed at least partially from a shape-memory material.

21. The device of claim 19 wherein the woven material is biocompatible material selected from at least one member of the group consisting of steel, titanium, NITINOL, and any alloys thereof.

22. The device of claim 19 further comprising at least one latitudinally oriented support member.

23. The device of claim 22, the at least one latitudinally oriented support member encircling the opening of the at least one end.

24. The device of claim 19 wherein the substantially tubular member further comprises an inner wall and an outer wall, the inner wall and the outer wall being continuous with one another, the inner wall and the outer wall defining a space therebetween.

25. The device of claim 24 wherein at least one latitudinally oriented member is positioned within the space defined by the inner wall and the outer wall, the at least one latitudinally oriented member supporting the at least one fiber.

26. The device of claim 19 further comprising at least one longitudinally oriented support member.

27. The device of claim 26 wherein the at least one longitudinally oriented support member is constructed of the at least one fiber.

28. The device of claim 26 further comprising at least one latitudinally oriented support member, the at least one latitudinally oriented support member having a perpendicular orientation relative to the longitudinally oriented support member when the device is in the expanded state.

29. A method for stabilizing a spinal motion segment comprising the following steps:

(a) providing a generally flexible substantially tubular member sized to fit and expand transversely into a hollowed region of an intervertebral space or intravertebral space, the substantially tubular member defining an interior space, the interior space extending from a first end of the substantially tubular member to a second end of the substantially tubular member, at least one end defining an opening, the opening in fluid communication with the interior space, the substantially tubular member constructed and arranged to expand from a reduced state to an expanded state by the introduction of fill material into the interior space, the substantially tubular member including at least one fill opening through which the fill material may be introduced into the interior space, the substantially tubular member including a plurality of pores, the plurality of pores being sized to allow ingress and egress of liquids, solutions or small particle suspensions and ingrowth of bony trabeculae or fibrous elements into and through the device when the device is positioned in the hollowed region of a intervertebral space or intravertebral space, the plurality of pores being sized to retain the fill material within the interior space of the substantially tubular member, the substantially tubular member including at least one fill opening through which the fill material may be introduced into the interior space, the at least one fill opening comprising at least one of the plurality of pores;

(b) inserting the substantially tubular member into the intervertebral space or intravertebral space; and

(c) inserting the fill material into the interior space of the substantially tubular member through the at least one fill opening.

30. A method for stabilizing a spinal motion segment comprising the following steps:

(a) providing a member constructed from a generally pliable, but minimally elastic material, the member having a first end and a second end;

(b) disposing the member about the outer annulus of the intervertebral disc of a mammalian spine, the substantially tubular member having a predetermined height; and

(c) securing the first end and the second end together, thereby forming the member into a substantially continuous band defining a first radius about the intervertebral disc.

31. The method of claim 30 further comprising the step of:

(d) cinching at least a portion of the band to reduce the first radius and compress the disc.