Soft tissue repair methods and apparatus

• US 8,834,496 B2
• Filed: 02/01/2011
• Issued: 09/16/2014
• Est. Priority Date: 06/13/2006
• Status: Active Grant

• Current Assignee: Anova Corp.
• Original Assignee: Bret A. Ferree
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US13/018,995
• Publication Number:
  US 20120071896A1
• Time in Patent Office: 1,323 Days
• Field of Search: 606/139, 606144-148, 606/223
• US Class Current: 606/144
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof

Abstract

Instruments and methods facilitate reconstruction, repair, and the closure of apertures in soft tissues, including the anulus fibrosus (AF), heart, lung, abdomen, thorax, vascular structures and other organs. Flexible longitudinal fixation components (i.e., sutures) are positioned across apertures in soft tissues, preferably to closes the inlets and/or outlets of such apertures. Tension on the flexible longitudinal fixation components may be used to narrow or close the apertures. Knotless fixation technologies such as suture welding are preferably used to fasten the ends of the flexible longitudinal fixation components. Certain embodiments include an intra-aperture component dimensioned for positioning within a defect in the AF, with one or more components being used to maintain the intra-aperture component in position. For example, the flexible longitudinal fixation component(s) may be anchored to one of the upper and lower vertebral bodies.

Claims

1. Apparatus for repairing a void or defect in soft tissue having an outer surface and an inner surface, the apparatus comprising:

an elongated insertion instrument comprising a shaft having a proximal end and a distal end, wherein the distal end of the shaft is aligned with the proximal end of the shaft;

a resilient needle comprising a first end and a second end, wherein the resilient needle naturally assumes a first configuration in which the second end of the needle is not aligned with the first end of the needle but may be manipulated into a second configuration in which the second end of the needle is aligned with the first end of the needle, the first end of the needle being releasably mounted to the distal end of the elongated insertion instrument;

wherein the elongated insertion instrument comprises a sleeve for holding the resilient needle in its second configuration; and

a flexible longitudinal fixation component temporarily or permanently coupled to the needle;

whereby the sleeve may be positioned over the needle so as to hold the needle in its second configuration and so that the second end of the needle resides within the perimeter of the elongated insertion instrument, the distal end of the elongated insertion instrument may thereafter be inserted through the void or defect in the soft tissue, the sleeve may thereafter be withdrawn so that the needle springs into its first configuration, with the second end of the needle being disposed outside the perimeter of the elongated insertion instrument and with the second end of the needle being directed towards the inner surface of the soft tissue, the distal end of the elongated insertion instrument may thereafter be moved proximally so as to pull the needle through the soft tissue, and the first end of the needle may thereafter be released from the elongated insertion instrument so as to close or repair the void or defect with the flexible longitudinal fixation component.

2. The apparatus of claim 1, wherein the flexible longitudinal fixation component is suture material.

3. The apparatus of claim 1, wherein the flexible longitudinal fixation component is temporarily coupled through an eyelet or slot in the needle.

4. The apparatus of claim 1, wherein:

the flexible longitudinal fixation component is configured to pass through, or be attached to, an anulus fibrosis (AF) to be repaired or fortified; and

the elongated insertion instrument enables the ends of the flexible longitudinal fixation component to be connected outside of an intervertebral disc space.

5. The apparatus of claim 1, wherein the elongated insertion instrument includes a distal end that is configured to temporarily enter into an intervertebral disc space to pass the flexible longitudinal fixation component through an anulus fibrosis (AF) to be repaired or fortified.

6. Intervertebral disc treatment apparatus, the apparatus comprising:

a placement instrument comprising a shaft having a proximal end and a distal end, wherein the distal end of the shaft is aligned with the proximal end of the shaft;

a flexible longitudinal fixation component temporarily or permanently coupled to the proximal end of a resilient needle, the resilient needle comprising a first end and a second end having a pointed tip, wherein the resilient needle naturally assumes a first configuration in which the second end of the needle is not aligned with the first end of the needle but may be manipulated into a second configuration in which the second end of the needle is aligned with the first end of the needle, the first end of the needle being releasably mounted to the distal end of the placement instrument; and

wherein the placement instrument comprises a sleeve for holding the resilient needle in its second configuration;

whereby the sleeve may be positioned over the needle so as to hold the needle in its second configuration and so that the second end of the needle resides within the perimeter of the placement instrument, the distal end of the placement instrument may thereafter be inserted into an aperture in an anulus fibrosis (AF) having inner and outer walls, the sleeve may thereafter be withdrawn so that the needle springs into its first configuration, with the second end of the needle being disposed outside the perimeter of the placement instrument and with the second end of the needle being directed towards the inner wall of the AF, the distal end of the placement tool may thereafter be moved proximally so as that the needle pierces the inner wall of the AF, enabling the flexible longitudinal fixation component to be pulled through the AF from the inside out, and the first end of the needle may thereafter be released from the placement instrument.

7. The intervertebral disc treatment apparatus of claim 6, wherein the distal end of the placement instrument includes a generally diagonal hole or slot for releasably mounting the first end of the needle to the distal end of the placement instrument.

8. The intervertebral disc treatment apparatus of claim 6, further including a tool for pulling the pointed tip of the needle through the AF.