# US 10,945,830 B2 · Ligament fixation system, implants, devices, and methods of use

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- Number: US 10,945,830 B2
- Document ID: US10945830B2
- Status: Granted
- Kind: B2
- Application number: 16/517,295
- Filed: 2019-07-19
- Published: 2019-11-07
- Granted: 2021-03-16
- Earliest claimed: 2017-10-06
- Assignees: Paragon 28, Inc.
- Applicants: Paragon 28, Inc.
- Inventors: Albert Dacosta; Sean Gill; Richard David Hunt; Frank Bono; Thomas R. Williams; Randy Allard; Benjamin Majors
- Web page: https://patentgrep.com/patent/US10945830B2

## CPC

- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- 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 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 17/8685: {comprising multiple separate parts}
- A61B 17/8869: {Tensioning devices}
- A61B 2017/044: {with a threaded shaft, e.g. screws}
- A61B 2017/0445: {cannulated, e.g. with a longitudinal through-hole for passage of an instrument}
- A61B 2017/0448: {Additional elements on or within the anchor}
- A61B 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0461: {with features cooperating with special features on the suture, e.g. protrusions on the suture}
- A61B 2017/0496: {for tensioning sutures}
- A61F 2002/0817: {Structure of the anchor}
- A61F 2002/0829: {without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins}
- A61F 2002/0841: {Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire}
- A61F 2002/0858: {Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges}
- A61F 2002/0882: {Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone}
- 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

Devices, systems, implants and methods for achieving ligament fixation are disclosed. An implant includes a head member and an anchor member coupled to the head member. The implant includes tension member that couples the head member to the anchor member. The head member and the anchor member include a cannulation that receives the tension member therein. The implant may include a coupling member positioned between and coupling the head member and the anchor member, the coupling member including a cannulation that receives the tension member therethrough. Insertion instruments for inserting an implant for ligament fixation are also disclosed. Methods of using an implant for achieving ligament fixation are also disclosed.

## Claims

### Claim 1

An implant, comprising:
a head member, comprising:
at least one engagement protrusion;
an anchor member, comprising:
at least one engagement protrusion; and
a threaded shaft, wherein the threaded shaft comprises:
at least one transverse opening; and
at least one slot opposite and aligned with the at least one transverse opening;
a tension member coupling the head member to the anchor member, wherein the head member and the anchor member include a cannulation that receives the tension member therein, wherein the at least one transverse opening of the anchor member extends from an exterior surface of the threaded shaft into the cannulation, and wherein the at least one slot is inset in the cannulation;
a coupling member positioned between and coupling the head member and the anchor member, wherein the coupling member comprises:
at least one recess disposed at a first engagement end that receives the at least one engagement protrusion of the head member;
at least one recess disposed at a second engagement end that receives the at least one engagement protrusion of the anchor member; and
the cannulation that receives the tension member therethrough; and
at least one pin, wherein the pin is sized to be inserted into the at least one transverse opening and at least one slot, wherein the at least one pin pressingly engages the tension member into the at least one slot to secure the tension member to the anchor member.

### Claim 2 (depends on 1)

The implant of claim 1, wherein the head member pressingly engages the first engagement end of the coupling member.

### Claim 3 (depends on 2)

The implant of claim 2, wherein the cannulation extends through the head member, the coupling member and at least a portion of the anchor member, wherein the cannulation extends parallel to a longitudinal axis of the implant.

### Claim 4 (depends on 3)

The implant of claim 3, wherein the head member comprises a head portion and a shaft portion extending from the head portion, the head portion defining a free end of the implant.

### Claim 5 (depends on 4)

The implant of claim 4, wherein the head portion includes a non-circular tool engagement opening and the shaft portion includes external threads.

### Claim 6 (depends on 5)

The implant of claim 5, wherein the tool engagement opening is in communication with the cannulation of the head member.

### Claim 7 (depends on 6)

The implant of claim 6, wherein the head member further includes a first opening, wherein the first opening extends perpendicular to the cannulation.

### Claim 8 (depends on 1)

The implant of claim 1, wherein the tension member is a suture.

### Claim 9 (depends on 8)

The implant of claim 8, wherein the suture includes a loop.

### Claim 10 (depends on 9)

The implant of claim 9, wherein the suture is braided.

### Claim 11 (depends on 8)

The implant of claim 8, wherein the suture includes multiple loops.

### Claim 12 (depends on 1)

The implant of claim 1, wherein the tension member is made of a bioresorbable material.

### Claim 13 (depends on 1)

The implant of claim 1, wherein the coupling member is made of a bioresorbable material.

### Claim 14 (depends on 1)

The implant of claim 1, wherein the head member, the coupling member and the anchor member have a length, wherein the length of the anchor member is greater than the length of the coupling member and/or the head member.

### Claim 15

A system, comprising:
an implant comprising:
a head member, comprising:
a first engagement protrusion;
an anchor member, comprising:
a second engagement protrusion; and
a threaded shaft, wherein the threaded shaft comprises:
at least one transverse opening; and
at least one slot opposite and aligned with the at least one transverse opening;
a tension member coupling the head member to the anchor member, wherein the head member and the anchor member include a cannulation that receives the tension member therein and therethrough, wherein the at least one transverse opening of the anchor member extends from an exterior surface of the threaded shaft into the cannulation, and wherein the at least one slot is inset in the cannulation;
a coupling member positioned between and coupling the head member and the anchor member, wherein the coupling member comprises:
a first engagement aperture that receives the first engagement protrusion of the head member; and
a second engagement aperture that receives the second engagement protrusion of the anchor member; and at least one pin, wherein the pin is sized to be inserted into the at least one transverse opening and at least one slot, wherein the at least one pin pressingly engages the tension member into the at least one slot to secure the tension member to the anchor member; and
an insertion instrument for coupling to the implant.

### Claim 16 (depends on 15)

The system of claim 15, wherein the head member, the coupling member and the anchor member have a length, wherein the system comprises a plurality of head members having varying lengths, a plurality of anchor members having varying lengths and a coupling member of a constant length.

### Claim 17 (depends on 15)

The system of claim 15, wherein the head member, the coupling member and the anchor member have a length, wherein the system comprises a plurality of head members having varying lengths, wherein the lengths of the plurality of head members are variable ranging from 10 millimeters to 30 millimeters and the anchor member and coupling member each have a constant length.