Method and apparatus for the treatment of the intervertebral disc annulus

• US 8,163,022 B2
• Filed: 09/03/2009
• Issued: 04/24/2012
• Est. Priority Date: 10/14/2008
• Status: Expired due to Fees

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Bentley, Ishmael, Burns, Matthew M., Cauthen, Joseph C. III, Dukart, Brian L., Houfburg, Rodney L., Wales, Lawrence W., Wessman, Bradley J.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US12/553,583
• Publication Number:
  US 20100094425A1
• Time in Patent Office: 964 Days
• Field of Search: 623 1711- 1716, 606/60, 606/246, 606/99, 606/279, 606/139, 606/151, 128/898
• US Class Current: 623/17.11
• 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 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• 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 2017/0646 : for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2090/036 : abutting on tissue or skin
• 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 2/442 : 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 2/4603 : for insertion or extraction of endoprosthetic joints or of accessories thereof
• 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 2002/3008 : 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 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• 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 2002/4662 : for measuring penetration depth
• 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 2220/005 : using adhesives
• 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

Abstract

This disclosure presents methods and devices for treating a tear, rent, incision, defect, aperture or delamination of the annulus fibrosus of an intervertebral disc. The methods and devices can employ fixation delivery apparatuses, fixation apparatuses, patch delivery tools and patches positioned, at least in part, in or on aspects of an intervertebral disc for treatment of the intervertebral disc or its components. In some aspects, these techniques include the use of this includes a fixation apparatus that includes at least one bone anchor connected to at least one disc anchor by a shortenable elongate member.

Claims

1. A system for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the system comprising:

a first fixation delivery apparatus having a tubular shaft, and a proximal handle

a first fixation apparatus releasably coupled to the first fixation delivery apparatus including a bone anchor configured to be deployed at least partially into and attached to a vertebral body, and an adjustable flexible connecting element connected to the bone anchor, wherein at least a portion of the bone anchor and a portion of the adjustable connecting element are disposed within the tubular shaft of the first fixation delivery apparatus prior to deployment of the first fixation apparatus, and wherein the flexible connecting element can be manipulated by a user to adjust a length of thereof;

a second fixation delivery apparatus including a tubular shaft having a sharpened tissue-piercing distal tip, a proximal handle coupled to the tubular shaft, a releasable tab coupled to the handle, an ejection rod slidably disposed within the tubular shaft, and an actuator slidably coupled to the handle and operatively coupled to the ejection rod; and

a second fixation apparatus releasably coupled to the second fixation delivery apparatus including a pair of tissue anchors and an adjustable flexible connecting element connecting the tissue anchors, wherein the tissue anchors and a first portion of the flexible connecting element are disposed within the tubular shaft and a second portion of the flexible connecting element is coupled to the releasable tab of the second fixation delivery apparatus prior to deployment,

wherein the bone anchor is configured to be attached to the vertebral body, the tissue anchors are configured to be attached to the annulus fibrosus with the aperture located between the bone anchor and the tissue anchors, and the flexible connecting elements of the first fixation apparatus and the second fixation apparatus are configured to be interconnected and placed in tension to at least partially close the aperture in the annulus fibrosus.

2. The system of claim 1 wherein the first fixation delivery apparatus further includes an actuator slidably coupled to the handle and connected to an ejection rod slidably disposed within the tubular shaft, and a releasable tab coupled to the actuator, and wherein the actuator and the ejection rod are configured to eject the bone anchor from the tubular shaft, and wherein at least a portion of the adjustable connecting element of the first fixation apparatus is connected to the releasable tab, and wherein the tab is positioned to prevent axial movement of the actuator relative to the handle when coupled to the actuator.

3. The system of claim 2 wherein the releasable tab of the first fixation delivery apparatus is further operable by a user to change an orientation of the bone anchor after the bone anchor is ejected from the tubular shaft.

4. The system of claim 3 wherein the releasable tab of the first fixation delivery apparatus is operable by a user to at least partially rotate the bone anchor after the bone anchor is ejected from the tubular shaft of the first fixation delivery apparatus and deployed at least partially within the vertebral body.

5. The system of claim 4 wherein the bone anchor is a T-anchor having a relatively sharp end, and wherein in use, the relatively sharp end is configured to engage the vertebral body upon manipulation of the releasable tab of the first fixation delivery apparatus by the user.

6. The system of claim 1 wherein the bone anchor is a bone screw.

7. The system of claim 6 wherein the bone screw is a self-tapping bone screw.

8. The system of claim 6 wherein the portion of the adjustable connecting element disposed within the tubular shaft of the first fixation delivery apparatus exits the first fixation delivery apparatus proximate the handle.

9. The system of claim 6 wherein the bone screw has a longitudinal axis, a proximal end, a self-tapping distal tip, a threaded region between the proximal end and the distal tip, and an open lumen originating at the proximal end and exiting the bone screw laterally between the proximal end and the distal tip, and wherein the flexible connecting element of the first fixation apparatus includes a connecting segment partially disposed within the lumen and exiting therefrom at the proximal end of the bone screw.

10. The system of claim 9 wherein the lumen includes a first segment extending longitudinally from the proximal end of the bone screw generally parallel to the longitudinal axis, and a second segment extending at an oblique angle relative to the longitudinal axis.

11. The system of claim 10 wherein the first segment has a first cross-sectional dimension and the second segment has a second cross-sectional dimension larger than the first cross-sectional dimension so as to form a shoulder at an intersection of the first and second segments.

12. The system of claim 11 wherein the connecting member includes a stop feature configured to engage the shoulder to substantially prevent the connecting member from being pulled from the lumen.

13. The system of claim 1 wherein the connecting elements of the first and second fixation apparatus each include a locking element to maintain the respective connecting elements in a shortened configuration under tension.