# US 12,213,871 B2 · Adjustable fixation device

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- Number: US 12,213,871 B2
- Document ID: US12213871B2
- Status: Granted
- Kind: B2
- Application number: 18/422,813
- Filed: 2024-01-25
- Published: 2024-06-27
- Granted: 2025-02-04
- Earliest claimed: 2016-06-02
- Assignees: Parcus Medical, LLC
- Applicants: Parcus Medical, LLC
- Inventors: Samuel Armington; Mark D. Brunsvold
- Web page: https://patentgrep.com/patent/US12213871B2

## CPC

- A61F 2/0811: {Fixation devices for tendons or ligaments}
- 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 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61B 17/58: for osteosynthesis, e.g. bone plates, screws or setting implements (A61B17/14, A61B17/16 take precedence)
- A61B 17/683: {comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut}
- A61F 2/4202: {for ankles}
- 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}
- A61B 2017/0404: {Buttons}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/0459: {Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied}
- A61B 2017/0477: {with pre-tied sutures}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/0618: {elastic, e.g. stretchable}
- A61B 2017/06185: {hollow or tubular}
- A61F 2002/0852: {Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes}
- A61F 2002/0882: {Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0007: for adjusting length
- A61F 2250/0012: for adjusting elasticity, flexibility, spring rate or mechanical tension
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An adjustable fixation device includes a cleat portion and a suture portion, where the suture portion has a loop portion and a suture tail. Pulling on the suture tail places in tension a graft coupled to the loop portion. The suture is arranged to convey a mechanical advantage so that substantial force can be readily and controllably applied to the graft.

## Claims

### Claim 1

A method for the adjustable fixation of an implantable medical device, comprising the steps of:
providing an adjustable fixation device, comprising:
a) a first attachment device comprising first and second apertures and lateral and medial sides;
b) a second attachment device comprising first and second apertures and lateral and medial sides;
c) said medial sides facing each other;
d) a flexible connector having first and second ends, the flexible connector connecting the first attachment device and the second attachment device;
e) the first end of the flexible connector being secured relative to the first attachment device;
f) the flexible connector forming a first sliding loop bend portion extending medially from the first attachment device and having first and second legs, the first leg extending from the secured first end and the second leg passing through the first and second apertures of the first attachment device to form a sliding elbow connection with the first attachment device;
g) the flexible connector forming a first connecting arm portion extending from the second aperture of the first attachment device to the first aperture of the second attachment device, the flexible connector continuing from the first aperture of the second attachment device to the second aperture of the second attachment device and extending medially from the second attachment device to form a second sliding loop bend portion having first and second legs;
h) the first sliding loop bend portion and the second sliding loop bend portion slidably engaging to form an intra-connector sliding loop engagement portion;
i) the second leg of the second sliding loop bend portion passing through at least one aperture of the second attachment device and forming a second connecting arm extending to the first attachment device and passing through the second aperture of the first attachment device; and,
j) the second connecting arm forming a first axial splice by threading the second end of the flexible connector through at least one selected from the group consisting of the first connecting arm and the second leg of the first sliding loop bend portion;
providing an implantable medical device connected to at least one selected from the group consisting of the first attachment device and the second attachment device;
positioning the adjustable fixation device and the implantable medical device in the body of the patient;
applying a tensioning force to the second end portion of the flexible connector to tighten and secure the adjustable fixation device and the implantable medical device in position in the body of the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the axial splice has an entry location and an exit location on the second leg of the first sliding loop bend portion.

### Claim 3 (depends on 1)

The method of claim 1, wherein the axial splice has an entry location at the sliding elbow portion of the second leg of the first sliding loop bend portion on a lateral side of the first attachment device.

### Claim 4 (depends on 3)

The method of claim 3, wherein the exit location of the axial splice is on a medial side of the first attachment device.

### Claim 5 (depends on 1)

The method of claim 1, wherein the axial splice has an entry location and an exit location on the first connecting arm.

### Claim 6 (depends on 5)

The method of claim 5, wherein the entry location of the axial splice is on a medial side of the first attachment device.

### Claim 7 (depends on 6)

The method of claim 6, wherein the exit location of the axial splice is on a lateral side of the first attachment device.

### Claim 8 (depends on 6)

The method of claim 6, wherein the exit location of the axial splice is on a medial side of the first attachment device.

### Claim 9 (depends on 8)

The method of claim 8, wherein the second end after exiting the exit location of the axial splice is transversely threaded through the sliding elbow connection.

### Claim 10 (depends on 9)

The method of claim 9, wherein the first leg of the first sliding loop bend portion is secured relative to the first attachment device by the first end of the flexible connector passing through the first and second apertures of the first attachment device and being secured to form an eye loop engagement with the first attachment device.

### Claim 11 (depends on 10)

The method of claim 10, wherein the second end after exiting the exit location of the axial splice is transversely threaded through first and second portions of the eye loop.

### Claim 12 (depends on 1)

The method of claim 1, wherein the second leg of the second sliding loop bend portion passes through the second and first apertures of the second attachment device and forms the second connecting arm.

### Claim 13 (depends on 1)

The method of claim 1, wherein the second attachment device comprises third and fourth apertures, and the second leg of the second sliding loop bend portion passes through the third and fourth apertures of the second attachment device and forms the second connecting arm.

### Claim 14 (depends on 1)

The method of claim 1, wherein the flexible connector is a suture.

### Claim 15 (depends on 1)

The method of claim 1, wherein the implantable medical device comprises a graft.

### Claim 16 (depends on 3)

The method of claim 3, wherein at least one selected from the group consisting of the first attachment device and the second attachment device comprises lateral guide holes for receiving guiding sutures.

### Claim 17 (depends on 1)

The method of claim 1, wherein the implantable medical device is a plate and the fixation is for syndesmosis repair.

### Claim 18 (depends on 1)

The method of claim 1, wherein the method is applied to at least one selected from the group consisting of ligamentum teres repair, anterior cruciate ligament repair, and syndesmosis repair.