Spinal disc annulus repair system and methods

• US 7,993,405 B2
• Filed: 12/08/2006
• Issued: 08/09/2011
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Wessman, Bradley J., Wales, Lawrence W., Burns, Matthew M., Burmeister, Paul, Houfburg, Rodney L., Cauthen, Joseph C. III, Dukart, Brian L.
• Primary Examiner(s): RAMANA, ANURADHA
• Application Number:
  US11/608,480
• Publication Number:
  US 20070100354A1
• Time in Patent Office: 1,705 Days
• Field of Search: 623 1711- 1716, 606139-148
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• 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 2002/0072 Delivery tools therefor
• 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 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30158 : trapezoidal
• CPC Class Codes: A61F 2002/30299 : umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• 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 2002/4627 : 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2310/00011 : Metals or alloys

Abstract

The present invention provides methods and devices for annulus disc repair. The methods and devices are particularly suited to the repair and/or reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, with reduced failure rate as compared to conventional surgical procedures.

Claims

1. A method for treating an intervertebral disc having an aperture, a weakened portion, or a thin walled portion in the annulus fibrosus of said intervertebral disc, comprising the steps of:

providing a treatment device and a treatment device delivery tool,

said delivery tool comprising an elongate delivery member having a proximal portion, and a distal portion;

said distal portion comprising a tissue piercing element,

said proximal portion connected to a handle device,

said treatment device comprising a first anchor, a second anchor, and an interconnecting assembly connecting said first and second anchors, wherein the treatment device is at least partially disposed within the distal portion of the delivery tool elongate delivery member and the interconnecting assembly is at least partially disposed exterior to the delivery tool elongate delivery member, prior to delivery of the treatment device,

said delivery tool comprising an ejection rod disposed at least partially within the delivery tool elongate delivery member, and

actuating said ejection rod to expel said treatment device from the distal portion of said delivery tool into tissue surrounding said aperture, weakened portion, or thin walled portion in the annulus fibrosus.

2. The method of claim 1, wherein said interconnecting assembly comprises at least one loop and locking member.

3. The method of claim 1, wherein said interconnecting assembly comprises a cinch loop with slip knot.

4. The method of claim 1, further comprising the step of pushing the ejection rod a first distance to eject the first anchor and pushing the ejection rod an additional distance to eject the second anchor.

5. The method according to claim 1, wherein said interconnecting assembly comprises a band, tether, wire, filament or suture line positioned between the first and second anchors, and further comprising the step of locking said interconnecting member into a loop with a knot.

6. The method of claim 5, further comprising the step of extending one end of the band, tether, wire, filament or suture line from the first and second anchors to the proximal portion of the delivery tool elongate delivery member.

7. The method of claim 1, further comprising the step of connecting a center portion of the first anchor and a center portion of the second anchor with said interconnecting assembly.

8. The method of claim 1, wherein the distal portion of said delivery tool comprises a tissue stop element, and further comprising the step of limiting the degree to which distal piercing element may pass into disc tissue with said tissue stop element.

9. The method of claim 1, wherein the interconnecting assembly of said treatment device is comprised of one of a filament, a band, a wire, a tether, a suture, or a line.

10. The method of claim 1, further comprising the step of shortening at least a portion of the interconnecting assembly between said two anchors.

11. The method of claim 10, wherein said treatment device further comprises a locking element, and wherein said step of shortening at least a portion of the interconnecting assembly further comprises locking the interconnecting member with said locking element to maintain the length of the interconnecting member.

12. The method of claim 11, wherein said locking element is a knot, clip, fastener or retainer.

13. The method of claim 10, wherein said step of shortening at least a portion of the interconnecting assembly further comprises providing a knot pusher.

14. The method of claim 13, wherein said knot pusher is integral with the treatment device delivery tool.

15. The method of claim 1, wherein at least a portion of the treatment device is comprised of biodegradable or bioabsorbable material.

16. The method of claim 1, wherein at least a portion of the treatment device is comprised of biocompatible material.

17. The method of claim 1, wherein at least a portion of the treatment device is comprised of polymeric material.

18. The method of claim 1, wherein at least a portion the treatment device is comprised of material to facilitate regeneration of tissue.

19. The method of claim 1, wherein said anchors comprise barbs or t-anchors.

20. The method according to claim 1, further comprising the step of providing multiple repair systems to effect a treatment of an aperture, a weakened portion, or a thin walled portion in the annulus fibrosus of an intervertebral disc.

21. A method for repair of a defect of an annulus fibrosus of an intervertebral disc comprising the steps of:

providing a treatment device and a treatment device delivery tool,

said delivery tool comprising two elongate delivery members, each elongate delivery member having a proximal portion, and a distal portion;

said distal portion of each of said elongate delivery members comprising a tissue piercing element and configured to at least partially receive at least one anchoring element of a treatment device, prior to the delivery of the treatment device,

said treatment device comprising at least two anchoring elements and an interconnecting assembly between said at least two anchoring elements, wherein in use said interconnecting assembly is capable of being shortened and retained in a shortened state so as to cause tension between said anchoring elements,

said delivery tool provided with an ejection member, and actuating said ejection member to release at least one anchoring element of the treatment device from the distal portion of each of said elongate delivery members into disc tissue surrounding the annular defect.

22. The method of claim 21, wherein the interconnecting assembly comprises at least one loop and locking member.

23. The method of claim 21, wherein the interconnecting assembly comprises a cinch loop with slip knot.

24. The method of claim 21, wherein the interconnecting assembly comprises one of a band, a tether, a wire, a filament or a suture line positioned between the at least two anchoring elements, and further comprising the step of locking said interconnecting assembly into a loop by a knot.

25. The method of claim 24, further comprising the step of extending one end of one of the band, tether, wire, filament or suture line from the two anchoring elements to the proximal portion of the delivery tool.

26. The method according to claim 21, wherein the distal portion of said delivery members comprise tissue stop elements, and further comprising the step of limiting the degree to which distal piercing element may pass into disc tissue with said tissue stop elements.

27. The interconnecting assembly according to claim 21, wherein the interconnecting assembly is comprised of one of a filament, a band, a wire, a tether, a suture, or a line.

28. The method of claim 21, wherein at least a portion of the treatment device is comprised of biodegradable or bioabsorbable material.

29. The method of claim 21, wherein at least a portion of the treatment device is comprised of biocompatible material.

30. The method of claim 21, wherein at least a portion of the treatment device is comprised of polymeric material.

31. The method of claim 21, wherein at least a portion the treatment device is comprised of material to facilitate regeneration of tissue.

32. The method of claim 21, wherein said interconnecting assembly further comprises a locking element, and further comprising the step of maintaining said shortening of at least a portion of the interconnecting assembly with said locking element.

33. The method of claim 32, wherein said locking element is a knot, clip, fastener or retainer.

34. The method of claim 21, wherein said step of shortening at least a portion of the interconnecting assembly further comprises the step of providing a knot pusher.

35. The method of claim 34, wherein said knot pusher is integral with the treatment device delivery tool.