# US 9,433,404 B2 · Method and apparatus for closing fissures in the annulus fibrosus

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- Number: US 9,433,404 B2
- Document ID: US9433404B2
- Status: Granted
- Kind: B2
- Application number: 14/068,406
- Filed: 2013-10-31
- Published: 2014-05-01
- Granted: 2016-09-06
- Earliest claimed: 2012-10-31
- Assignees: Suture Concepts Inc.
- Applicants: Suture Concepts Inc.
- Inventors: Bret A. Ferree
- Web page: https://patentgrep.com/patent/US9433404B2

## CPC

- 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)}
- 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)}
- 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)}
- 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}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36071: {Pain}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/0404: {Buttons}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0427: {having anchoring barbs or pins extending outwardly from the anchor body}
- A61B 2017/0446: {Means for attaching and blocking the suture in the suture anchor}
- A61B 2017/045: {snug fit within the anchor}
- A61B 2017/0451: {Cams or wedges holding the suture by friction}
- A61B 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0459: {Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied}
- A61B 2017/0462: {One way system, i.e. also tensioning the suture}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0474: {Knot pushers}
- A61B 2017/0475: {using sutures having a slip knot}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/06028: {by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip}
- 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}
- A61B 2090/034: {abutting on parts of the device itself}
- A61F 2002/4435: {Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes}
- A61F 2002/4635: {using minimally invasive surgery}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS 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 (dental prosthetics A61C)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A filament laterally spans a tear, fissure or other defect in an annulus. One portion of the filament is anchored to the annulus by passing at least one first anchor through the annulus and into the nucleus on one side of the fissure, and with a second portion of the filament being anchored to the annulus by passing at least one second anchor through the annulus and into the nucleus on a second side of the fissure, with the at least one first and second anchors being drawn back through the nucleus and against the inner surface of the posterior annulus by the application of a significant (e.g., about 15N to 25N) axial tension applied perpendicular to the posterior wall of the annulus, and with the fissure being drawn closed by the subsequent application of a significant axial tension applied perpendicular to the posterior wall of the annulus.

## Claims

### Claim 1

A method of closing a fissure or other defect in an annulus fibrosus (AF) having an outer surface and an inner surface, the method comprising the steps of:
providing a flexible longitudinal fixation component terminating in a distal end coupled to a first anchor component, and a proximal second anchor component slidingly coupled along the flexible longitudinal fixation component, wherein at least one of the first anchor component and the second anchor component comprise a hole for receiving the flexible longitudinal fixation component and a projection for (i) permitting the flexible longitudinal fixation component to slide through the hole in a first direction, and (ii) preventing the flexible longitudinal fixation component from sliding through the hole in a second direction;
inserting the first anchor component through a first insertion point in the AF from the inside out on one side of the defect in the AF such that the first anchor component passes the inner surface of the AF and a first exposed portion of the flexible longitudinal fixation component extends outwardly from the first insertion point;
applying tension to the first exposed portion of the flexible longitudinal fixation component such that the first anchor component becomes firmly seated against the inner surface of the AF;
inserting the second anchor component through a second insertion point in the AF from the inside out on the other side of the defect in the AF such that the first exposed portion crosses over the defect and into the second insertion point, and a second exposed portion of the flexible longitudinal fixation component extends outwardly from the second insertion point; and
applying tension to the second exposed portion such that the flexible longitudinal fixation component slides through the second anchor component, applying tension to the first exposed portion, thereby closing the defect in the AF and causing the second anchor to become firmly seated against the inner surface of the AF.

### Claim 2 (depends on 1)

The method of claim 1, wherein the tension applied to the first exposed portion is in the range of about 15 N to 25 N.

### Claim 3 (depends on 1)

The method of claim 1, wherein the tension applied to the second exposed portion is in the range of about 15 N to 25 N.

### Claim 4 (depends on 1)

The method of claim 1, wherein the flexible longitudinal fixation component is a surgical suture.

### Claim 5 (depends on 1)

The method of claim 1, wherein the projection prevents further sliding of the flexible longitudinal fixation component following the step of applying tension to the second exposed portion.

### Claim 6 (depends on 1)

The method of claim 1, wherein the process is repeated with one or more additional anchors slidingly coupled at different points along the flexible longitudinal fixation component such that two or more exposed portions cross of the defect when the process is completed.

### Claim 7 (depends on 1)

The method of claim 1, wherein the one or both of the anchor components are elongated such that they penetrate the AF axially and turn once past the inner surface of the AF to better prevent pull-out.

### Claim 8 (depends on 1)

The method of claim 1, wherein the one or both of the anchor components are inserted with a pointed, cannulated insertion instrument that penetrates the AF and deploys each anchor component with a stylus or push rod.

### Claim 9 (depends on 1)

The method of claim 1, including the step of anchoring the flexible longitudinal fixation component to one of an upper and lower vertebral body.

### Claim 10 (depends on 1)

The method of claim 1, including the step of trimming the second exposed portion of the flexible longitudinal fixation component.

### Claim 11 (depends on 1)

The method of claim 1 wherein the hole is substantially perpendicular to the longitudinal axis of the anchor component.

### Claim 12 (depends on 1)

The method of claim 1 wherein the anchor component comprises two holes, and further wherein the two holes are substantially perpendicular to the longitudinal axis of the anchor component.