CA2429149A1 - Annulus-reinforcing band - Google Patents

Annulus-reinforcing band Download PDF

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Publication number
CA2429149A1
CA2429149A1 CA002429149A CA2429149A CA2429149A1 CA 2429149 A1 CA2429149 A1 CA 2429149A1 CA 002429149 A CA002429149 A CA 002429149A CA 2429149 A CA2429149 A CA 2429149A CA 2429149 A1 CA2429149 A1 CA 2429149A1
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CA
Canada
Prior art keywords
tubular member
substantially tubular
pores
opening
fill
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002429149A
Other languages
French (fr)
Other versions
CA2429149C (en
Inventor
Stephen D. Kuslich
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Spineology Inc
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA2709878A priority Critical patent/CA2709878A1/en
Publication of CA2429149A1 publication Critical patent/CA2429149A1/en
Application granted granted Critical
Publication of CA2429149C publication Critical patent/CA2429149C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00017Iron- or Fe-based alloys, e.g. stainless steel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00035Other metals or alloys
    • A61F2310/00071Nickel or Ni-based alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics 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 (51)

1. A device for stabilizing a spinal motion segment comprising:
a substantially tubular member constructed from a generally pliable, but minimally elastic material, the substantially tubular member having a first end and a second end, the substantially tubular member defining an interior space and an opening at the first end and the second end, the substantially tubular member having a circumference sized to fit in the immediate vicinity of the outer annulus of the intervertebral disc of a mammalian spine, the substantially tubular member having a central axis, the central axis extending between the first end and the second end, the central axis constructed and arranged to be generally collinear with a cephalo-caudal axis of the mammalian spine when fitted into the immediate vicinity of the outer annulus of the intervertebral disc, the substantially tubular member having a predetermined height and a predetermined thickness.
2. The device of claim 1 wherein the predetermined height of the substantially tubular member, measured along the central axis, is between 0.25 mm and 20 mm.
3. The device of claims 1-2 wherein the predetermined thickness of the substantially tubular member is between 0.01 mm and 5 mm.
4. The device of claims 1-3 wherein the material of the substantially tubular member is non-porous.
5. The device of claims 1-4 wherein the material of the substantially tubular member is porous.
6. The device of claims 1-5 wherein the material of the substantially tubular member is electrically conductive.
7. The device of claims 1-6 wherein the substantially tubular member is characterized as a flattened or unflattened tube.
8. The device of claims 1-7 wherein the substantially tubular member is sufficiently pliable to allow its temporary deformation into an elongated loop, such that the substantially tubular member may be passed through an opening in the outer annulus of the intervertebral disc, wherein the diameter of said opening is generally equivalent to the predetermined height of the temporarily deformed substantially tubular member.
9. The device of claim 8 wherein the material of the substantially tubular member is characterized as having a shape memory such that when the substantially tubular member is sufficiently deformed to be passed through the opening in the outer annulus of the intervertebral disc and inserted into an interdiscal cavity of the intervertebral disc the substantially tubular member will expand itself against the annulus of the disc.
10. The device of claim 9 wherein the material is comprised at least partially of NITINOL.
11. The device of claims 8-9 wherein the material is selected from at least one member of the group consisting of polymeric material, metal wire, woven material, braided material, fluid impermeable material and any combination thereof.
12. The device of claims 1-11 wherein the material of the substantially tubular member includes at least one member of the group consisting of braided filaments, woven filaments, threads, cords, wires, ropes, suture materials, and any combinations thereof.
13. The device of claim 1 wherein the material of the tubular body is a polymeric material or a cement that hardens after injection to form the main body of the substantially tubular member.
14. The device of claims 1-13 wherein the substantially tubular member is constructed and arranged to be positioned within a hollowed region of the outer annulus of the intervertebral disc, the first end being immediately adjacent to a first adjacent vertebrae and the second end being immediately adjacent to a second adjacent vertebrae.
15. The device of claims 1-14 wherein the material of the substantially tubular member further comprises a plurality of pores, the plurality of pores being sized to allow ingress and egress of any materials selected from the group consisting of liquids, solutions, small particle suspensions, and any combinations thereof, the plurality of pores constructed and arranged to allow ingrowth of bony trabeculae or fibrous elements into and through the device when the device is positioned in a hollowed region of an intervertebral space, the plurality of pores being sized to retain a fill material within the interior space of the substantially tubular member.
16. The device of claim 15 wherein the plurality of pores are perforations.
17. The device of claims 1-16 wherein the interior space is filled with compounds intended to stimulate bone growth.
18. The device of claims 1-17 wherein the material at least partially includes at least one member of the group of substances designed to stimulate bone, cartilage or fibrous tissue growth consisting of at least one hormone, at least one pharmaceutical agent, at least one type of virus, genetic material and any combinations thereof.
19. A device comprising 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.
20. The device of claim 19 wherein the at least one fill opening is constructed and arranged to prevent egress of the fill material from the interior space.
21. The device of claims 19-20 wherein the flexible substantially tubular member further comprises 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.
22. The device of claim 21 wherein each of the plurality of pores having a first diameter of about 0.25 mm to about 5 mm.
23. The device of claims 21-22 wherein the at least one fill opening comprises at least one of the plurality of pores.
24. The device of claims 22-23 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.
25. The device of claims 19-24 wherein the hollowed region of a intervertebral space or intravertebral space is defined by adjacent vertebrae.
26. The device of claims 19-25 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.
27. The device of claims 19-26 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.
28. The device of claims 25-27 wherein in the expanded state the opening of the at least one end being immediately adjacent to at least one of the adjacent vertebrae.
29. The device of claims 19-28 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.
30. The device of claims 21-29 wherein the substantially tubular member is composed of a polymeric material.
31. The device of claims 21-30 wherein the substantially tubular member is composed of a woven material, wherein the woven material is comprised of at least one fiber.
32. The device of claim 31 wherein the at least one fiber is constructed at least partially from a shape-memory material.
33. The device of claims 31-32 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.
34. The device of claims 21-33 wherein the substantially tubular member is composed of a fluid impermeable material.
35. The device of claim 34 wherein the plurality of pores are perforations.
36. The device of claims 31-35 further comprising at least one longitudinally oriented support member.
37. The device of claim 36 wherein the at least one longitudinally oriented support member is constructed of the at least one fiber.
38. The device of claims 31-37 further comprising at least one latitudinally oriented support member.
39. The device of claim 38 wherein the at least one latitudinally oriented support member encircling the opening of the at least one end.
40. The device of claims 36-39 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.
41. The device of claims 22-40 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.
42. The device of claims 31-41 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.
43. The device of claim 42 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.
44. The device of claims 19-43 in combination with a delivery tube, the delivery 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.
45. The device of claims 19-44 wherein the said fill material is a bioceramic compound.
46. The device of claims 19-45 wherein the said fill material is a bioceramic compound or bone graft combined with a bone growth stimulating chemical, wherein the growth stimulating chemical is selected from the group consisting of autogenous proteins, allogeneic proteins and any combination thereof
47. The device of claim 46 wherein the growth stimulating chemical is a bone morphogenetic protein.
48. The device of claims 19-47 wherein the said fill material is combined with a virus, the virus constructed and arranged to stimulate bone formation.
49. The device of claims 19-48 wherein said fill material is subjected to electrical energy stimulation.
50. The device of claims 19-49 said device being subjected to electrical energy stimulation.
51. The device of claims 19-50 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.
CA2429149A 2000-12-15 2001-12-17 Annulus-reinforcing band Expired - Lifetime CA2429149C (en)

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Applications Claiming Priority (3)

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US25601400P 2000-12-15 2000-12-15
US60/256,014 2000-12-15
PCT/US2001/048890 WO2002056802A1 (en) 2000-12-15 2001-12-17 Annulus-reinforcing band

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EP (1) EP1341489B1 (en)
JP (2) JP4202134B2 (en)
KR (1) KR100631787B1 (en)
AT (1) ATE387163T1 (en)
AU (2) AU2002246690B2 (en)
CA (2) CA2429149C (en)
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