# US 11,992,203 B2 · Tensionable and lockable micro suture anchors and anchor arrays for anatomical attachment of soft tissue to bone

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- Number: US 11,992,203 B2
- Document ID: US11992203B2
- Status: Granted
- Kind: B2
- Application number: 17/681,462
- Filed: 2022-02-25
- Published: 2022-10-13
- Granted: 2024-05-28
- Earliest claimed: 2021-04-08
- Assignees: Integrity Orthopaedics, Inc.
- Applicants: Integrity Orthopaedics, Inc.
- Inventors: Nathaniel Van Tran; Zak Zenz-Olson; Thomas A. Westling; David M. Crompton; Howard W. Harris; Patrick M. Connor
- Web page: https://patentgrep.com/patent/US11992203B2

## 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)}
- 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)}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 17/92: Impactors or extractors, e.g. for removing intramedullary devices {(insertion or extraction of artificial joints A61F2/4603)}
- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/0053: {Loading magazines or sutures into applying tools}
- 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 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0488: {Instruments for applying suture clamps, clips or locks}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/928: {a spring}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61F 2002/0852: {Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes}
- A61F 2002/0888: {Anchor in or on a blind hole or on the bone surface without formation of a tunnel}
- 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)

## Abstract

A toggle-type suture anchor that incorporates individual suture tensioning and locking without knot tying. The anchor includes an elongate toggle body having a working suture pre-threaded into a first passage and back up and out a second passage with a length running longitudinally adjacent the side of the anchor. A locking suture loop is pre-threaded into a third passage between the first and second passage and includes a collapsible loop that encircles a portion of the length of suture running longitudinally adjacent the side of the anchor. With the loop open, the working suture can slide through the anchor, however, when the loop is closed the working suture is locked in position to retain tension on the working suture. The anchor can be utilized in a pre-strung connected array of anchors.

## Claims

### Claim 1

A method for securing soft tissue to bone by creating a suture array having individually tensioned suture stitches extending over and compressing the soft tissue between sequentially implanted toggle body bone anchors, the method comprising:
providing a first toggle body having a first end of a working suture affixed thereto and a length of the working suture extending therefrom;
implanting the first toggle body through the tendon into the bone at a selected location with the length of working suture extending therefrom;
providing a second toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the first toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom;
inserting the second toggle body through the tendon into the bone, distal portion first, at a spaced distance from the first toggle body; and,
applying tension to the working suture extending from the distal hole first surface of the second toggle body to remove slack in the working suture between the first and second toggle body and form a tensioned stitch while the tension also rotates the inserted second toggle body into a secured position within the bone.

### Claim 2 (depends on 1)

The method for securing soft tissue to bone of claim 1, further comprising:
providing a third toggle body having at least a first and a second holes through the third toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the second toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom;
inserting the third toggle body through the tendon into the bone, distal portion first, at a spaced distance from the second toggle body; and
applying tension to the working suture extending from the distal hole first surface of the third toggle body to remove slack in the working suture between the second and third toggle body and form a tensioned stitch while the tension also rotates the inserted third toggle body into a secured position within the bone.

### Claim 3 (depends on 2)

The method for securing soft tissue to bone of claim 2, further comprising:
providing a fourth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the third toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom;
inserting the fourth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the third toggle body; and
applying tension to the working suture extending from the distal hole first surface of the fourth toggle body to remove slack in the working suture between the third and fourth toggle body and form a tensioned stitch while the tension also rotates the inserted fourth toggle body into a secured position within the bone.

### Claim 4 (depends on 3)

The method for securing soft tissue to bone of claim 3, further comprising:
providing a fifth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the fourth toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom;
inserting the fifth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the fourth toggle body; and
applying tension to the working suture extending from the distal hole first surface of the fifth toggle body to remove slack in the working suture between the fourth and fifth toggle body and form a tensioned stitch while the tension also rotates the inserted fifth toggle body into a secured position within the bone.

### Claim 5 (depends on 4)

The method for securing soft tissue to bone of claim 4, further comprising:
providing a sixth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the fifth toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom;
inserting the sixth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the fifth toggle body; and
applying tension to the working suture extending from the distal hole first surface of the sixth toggle body to remove slack in the working suture between the fifth and sixth toggle body and form a tensioned stitch while the tension also rotates the inserted sixth toggle body into a secured position within the bone.

### Claim 6

A method for securing soft tissue to bone by creating a suture array having individually tensioned and locked suture stitches extending over and compressing the soft tissue between sequentially implanted toggle body bone anchors, the method comprising:
providing a first toggle body having a first end of a working suture affixed thereto and a length of the working suture extending therefrom;
implanting the first toggle body through the tendon into the bone at a select location with the length of working suture extending therefrom;
providing a second toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the first toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom, with a locking loop encircling the working suture between the first and second hole having a first open position that allows sliding of the working suture relative to the toggle body and a second closed position that secures the working suture relative to the toggle body;
inserting the second toggle body through the tendon into the bone, distal portion first, at a spaced distance from the first toggle body;
applying tension to the working suture extending from the distal hole first surface of the second toggle body to remove slack in the working suture between the first and second toggle body and form a tensioned first stitch while the tension also rotates the inserted second toggle body into a secured position within the bone; and
then moving the locking loop to the second closed position to lock the first stitch.

### Claim 7 (depends on 6)

The method for securing soft tissue to bone of claim 6, further comprising:
providing a third toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the second toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom, with a locking loop encircling the working suture between the first and second hole having a first open position that allows sliding of the working suture relative to the toggle body and a second closed position that secures the working suture relative to the toggle body;
inserting the third toggle body through the tendon into the bone, distal portion first, at a spaced distance from the second toggle body;
applying tension to the working suture extending from the distal hole first surface of the third toggle body to remove slack in the working suture between the second and third toggle body and form a tensioned second stitch while the tension also rotates the inserted third toggle body into a secured position within the bone; and
then moving the locking loop to the second closed position to lock the second stitch.

### Claim 8 (depends on 7)

The method for securing soft tissue to bone of claim 7, further comprising:
providing a fourth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the third toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom, with a locking loop encircling the working suture between the first and second hole having a first open position that allows sliding of the working suture relative to the toggle body and a second closed position that secures the working suture relative to the toggle body;
inserting the fourth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the third toggle body;
applying tension to the working suture extending from the distal hole first surface of the fourth toggle body to remove slack in the working suture between the third and fourth toggle body and form a tensioned third stitch while the tension also rotates the inserted fourth toggle body into a secured position within the bone, and
then moving the locking loop to the second closed position to lock the third stitch.

### Claim 9 (depends on 8)

The method for securing soft tissue to bone of claim 8, further comprising:
providing a fifth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the fourth toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom, with a locking loop encircling the working suture between the first and second hole having a first open position that allows sliding of the working suture relative to the toggle body and a second closed position that secures the working suture relative to the toggle body;
inserting the fifth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the fourth toggle body;
applying tension to the working suture extending from the distal hole first surface of the fifth toggle body to remove slack in the working suture between the fourth and fifth toggle body and form a tensioned fourth stitch while the tension also rotates the inserted fifth toggle body into a secured position within the bone; and
then moving the locking loop to the second closed position to lock the fourth stitch.

### Claim 10 (depends on 9)

The method for securing soft tissue to bone of claim 9, further comprising:
providing a sixth toggle body having at least a first and a second holes through the toggle body extending from a first longitudinal surface to a second longitudinal surface of the toggle body, the first hole extending through a distal portion of the toggle body and the second hole through a proximal portion of the toggle body with the length of working suture extending from the fifth toggle body passing through the proximal hole from the first surface to the second surface then through the distal hole from the second surface to the first surface and continuing therefrom, with a locking loop encircling the working suture between the first and second hole having a first open position that allows sliding of the working suture relative to the toggle body and a second closed position that secures the working suture relative to the toggle body;
inserting the sixth toggle body through the tendon into the bone, distal portion first, at a spaced distance from the fifth toggle body;
applying tension to the working suture extending from the distal hole first surface of the sixth toggle body to remove slack in the working suture between the fifth and sixth toggle body and form a tensioned fifth stitch while the tension also rotates the inserted sixth toggle body into a secured position within the bone; and
then moving the locking loop to the section closed position to lock the fifth stitch.

### Claim 11

A method for creating a serial array of tensioned and independently locked anchor to anchor suture stiches to attach soft tissue to bone, the method comprising:
providing a first toggle body having a first end of a working suture affixed thereto and a length of a working suture extending therefrom;
providing a plurality of additional toggle bodies, each having an elongate body portion with a proximal, a middle and a distal passage extending from a top surface to a bottom surface, each passage located at spaced intervals along the elongate body portion with the middle passage between the proximal and distal passage and the length of working suture serially connecting the plurality of additional toggle bodies, the working suture passing into the proximal passage at the top surface and out at the bottom surface, then back up through the distal passage at the bottom surface out at the top surface of each elongate body and leaving a length of suture extending past the middle passage on the bottom surface of each elongate body, wherein each additional toggle body includes an independent locking loop extending from the middle passage at the bottom surface with each locking loop encircling a portion of the length of the working suture of each additional toggle body extending past the middle passage along the bottom surface, the locking loop having a first open position allowing the working suture to slide through the locking loop and a second closed position engaging the working suture and preventing sliding of the working suture within the locking loop;
implanting the first toggle body into the bone through the soft tissue at a selected location;
implanting a first of the additional toggle bodies with the distal passage inserted first, through the soft tissue into bone spaced a selected distance from the first toggle body;
applying tension to the working suture extending from the distal passage top surface of the first additional toggle body to remove slack in the working suture between the first toggle body and first additional toggle body to form a tensioned first stitch while the tension also rotates the first additional toggle body into a secured position within the bone;
locking the working suture in the first additional toggle body after forming the first stitch to lock the first stitch between the first and first additional toggle body;
implanting a second of the additional toggle bodies with the distal passage inserted first, through the soft tissue into bone spaced a selected distance from the first additional toggle body;
applying tension to the working suture extending from the top surface of the distal passage of the second additional toggle body to remove slack in the working suture between the first additional toggle body and the second additional toggle body to form a tensioned second stitch while the tension also rotates the second additional toggle body into a secured position within the bone;
locking the working suture in the second additional toggle body after forming the second stitch to lock the second stitch between the first additional toggle body and the second additional toggle body; and
repeating the implanting, tensioning and locking steps for each additional toggle body to create additional serial tensioned and locked stitches.

### Claim 12 (depends on 11)

The method of claim 11, wherein the plurality of additional toggle bodies includes at least three toggle bodies.

### Claim 13 (depends on 11)

The method of claim 11, wherein the plurality of additional toggle bodies includes at least five toggle bodies.

### Claim 14 (depends on 11)

The method of claim 11, wherein the working suture is a round braided suture.

### Claim 15 (depends on 11)

The method of claim 11, wherein the step of implanting each toggle body includes insertion of the toggle body into a preformed bone hole having a diameter of less than about 3.0 mm.

### Claim 16 (depends on 15)

The method of claim 15, wherein each implanted toggle body is positioned less than or equal to about 7.0 mm. from the previous implanted toggle body.

### Claim 17 (depends on 16)

The method of claim 16, wherein:
the soft tissue is a tendon to be repaired;
wherein the tendon to be repaired has been separated from an original footprint thereof on the bone; and
the toggle bodies are each implanted in the original footprint of the repaired tendon.

### Claim 18 (depends on 17)

The method of claim 17 wherein the toggle bodies are each implanted in a medial portion of the original footprint.

### Claim 19 (depends on 17)

The method of claim 17, wherein the stitches extend generally laterally across the tendon and original tendon footprint.