Apparatus and methods for the treatment of the intervertebral disc

• US 8,632,590 B2
• Filed: 09/26/2006
• Issued: 01/21/2014
• Est. Priority Date: 10/20/1999
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Cauthen, Joseph C. III, Burns, Matthew M., Wales, Lawrence W., Dukart, Brian L., Wessman, Bradley J., Houfburg, Rodney L., Bentley, Ishmael
• Primary Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/527,903
• Publication Number:
  US 20070100348A1
• Time in Patent Office: 2,674 Days
• Field of Search: 606142-143, 606/151, 606/72, 606/78, 606/279, 623 1711- 1716
• US Class Current: 623/17.11
• 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 17/06166 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 17/068 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• 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: 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 2/3872 Meniscus for implantation between the natural bone surfaces
• 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 2/4611 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 2002/3008 : radio-opaque, e.g. radio-opaque markers
• 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 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/305 : Snap connection
• 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 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/3097 : using laser
• 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 2002/4627 : 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 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• 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 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 : Metals or alloys

Abstract

Apparatus and methods for treating or repairing an intervertebral disc are disclosed. The apparatus and methods may be used to treat or repair a tear, rent, incision or delamination of the annulus fibrosus of an intervertebral disc. The apparatus and methods can employ anchor deployment apparatus, fixation apparatus and patches positioned in or on aspects of an intervertebral disc for treatment or repair of the intervertebral disc or its components.

Claims

1. A method of repairing tissue in an intervertebral disc comprising:

a. providing a delivery tool, said delivery tool comprising a handle portion and a distally extending elongate tubular insertion portion defining a lumen, the tubular insertion portion further comprising a longitudinally extending slot in communication with the lumen;

b. providing two or more elongate anchor members axially aligned along an axis of the lumen and within the lumen, each elongate anchor member comprising a connector which extends through the slot, said connector defining an opening, and wherein at least one of the anchor members comprises a tether, said tether being detachably received within the handle portion of the delivery tool;

c. providing at least one elongate flexible loop which extends through the openings of the connectors, each loop having a first dimension;

d. providing a displacement rod, said displacement rod being at least partially within said lumen and proximal to the elongate anchor members, said displacement rod capable of being actuated by the handle portion of the delivery tool;

e. penetrating the tissue in a first location on the intervertebral disc;

f. displacing said displacement rod distally a first distance and delivering a first anchor of said two or more elongate anchor members;

g. penetrating the tissue in a second location on the intervertebral disc;

h. displacing said displacement rod distally a second distance so as to result in a displacement, said second distance more distal than the first distance, and said displacement between said first distance and second distance including at least partial rotation of the displacement rod along its axis;

i. delivering a second anchor of said two or more elongate anchor members;

j. releasing said tether to said at least one of the anchor members;

k. removing the delivery tool;

l. modifying the loop, said modifying step resulting in the loop having a second, smaller dimension; and

m. locking the loop in said second, smaller dimension with a locking element.

2. The method of claim 1, wherein the tether comprises a line, wire, filament, band or suture.

3. The method of claim 1, wherein the loop comprises a line, wire, filament, band, or suture.

4. The method of claim 1, wherein the connector comprises a line, wire, filament, band, or suture.

5. The method of claim 1, wherein the elongate tubular insertion portion comprises a circular cross-section.

6. The method of claim 1, wherein the elongate tubular insertion portion comprises a cross-sectional shape selected from the group consisting of elliptical, hexagonal, pentagonal square, diamond, rectangular, or triangular.

7. The method of claim 1, wherein at least one of the elongate anchor members comprises a clip, retainer, or knot.

8. The method of claim 1, wherein at least one of the elongate anchor members comprises a T-anchor or barb.

9. The method of claim 1, wherein a portion of the elongate flexible loop is at least temporarily accessible for manipulation at a location away from the interveterbral disc tissue being repaired.

10. The method of claim 1, wherein said modifying and locking steps may be performed as a single step.

11. The method of claim 1, wherein the at least partial rotation of the displacement rod along its axis is guided by a displacement rod element following a guide in the delivery tool handle portion.

12. The method of claim 1, wherein the repairing of the intervertebral disc is used in combination with a patch, mesh, scaffold, barrier, filler, or other reparative constructs.

13. A method for repairing tissue of an intervertebral disc, said method comprising:

a. providing a delivery tool for delivery of two or more anchors, the delivery tool comprising a body portion having proximal and distal ends, an elongate hollow shaft extending distally from the body portion, said elongate shaft defining a lumen and a wall, and a slot extending from a distal end of the shaft and, wherein the at least two or more anchors are secured together by at least one elongated member configured to be positioned in at least a first length and a second length, where the second length is shorter than the first length,

b. providing a displacement rod disposed within the lumen of the shaft, said displacement rod having a distal end and a proximal end;

c. providing an actuator, said actuator connected to the proximal end of the displacement rod, said actuator and displacement rod configured to move longitudinally and rotationally relative to the body portion;

d. providing at least one groove, said at least one groove extending along at least a portion of a surface of the actuator;

e. providing at least one projecting element, said at least one projecting element being attached to the body portion and extending into the at least one groove, said at least one projecting element configured to limit a path of relative rotational and longitudinal movement between the actuator and the body portion;

f. placing the delivery tool in at least one first location on the intervertebral disc;

g. displacing said displacement rod and delivering at least a first anchor of said two or more anchors;

h. rotating the actuator;

i. placing the delivery tool in at least a second location on the intervertebral disc;

j. displacing said displacement rod and delivering at least one second anchor of said two or more anchors; and

k. removing the delivery tool; and

l. shortening the elongated member from the first length to the second length, wherein the shortening causes drawing together disc tissue.

14. The method of claim 13, wherein said actuator is cylindrical and extends longitudinally and has a distal end and a proximal end.

15. The method of claim 13, wherein said at least one groove has at least one longitudinally oriented segment.

16. The method of claim 13, wherein said at least one groove has at least one circumferentially oriented segment.

17. The method of claim 13, wherein said at least one groove has at least two longitudinally oriented segments.

18. The method of claim 17, wherein the at least one groove has a circumferentially oriented segment between two of the at least two longitudinally oriented segments.

19. The method of claim 17, wherein the at least one groove is configured to prescribe a relative rotational movement between the actuator and the body portion between two of the longitudinally oriented segments.

20. The method of claim 13, wherein said at least one groove has a first longitudinally oriented segment in a first location on the actuator, said first longitudinally oriented segment having a proximal and distal end.

21. The method of claim 20, wherein said at least one groove has a first circumferentially oriented segment with a first end, extending contiguously from the distal end of the first longitudinally oriented segment to a second end.

22. The method of claim 21, wherein said at least one groove has a second longitudinally oriented segment in a second location on the actuator, extending contiguously from the second end of the first circumferentially oriented segment, said second longitudinally oriented segment having a proximal end and a distal end, wherein said distal end of said second longitudinally oriented segment is distal of the first circumferentially oriented segment.

23. The method of claim 22, wherein said proximal end of second longitudinally oriented segment is proximal to the second end of said circumferentially oriented segment.

24. The method of claim 13, wherein said two or more anchors have connector elements attached to the two or more anchors and the connector elements are attached to each other by the elongated member.

25. The method of claim 24, wherein the elongated member comprises a looped configuration constructed from a filament, wire, line or suture.

26. The method of claim 24, wherein the elongated member is capable of being shortened and locked in a shortened configuration.

27. The method of claim 26, wherein the step of shortening and locking is facilitated by the use of a slipknot.

28. The method of claim 26, wherein the repairing of the tissue of the intervertebral disc is used in combination with a patch, mesh, scaffold, barrier, filler, or other reparative constructs.