# US 10,441,409 B2 · Femoral fixation

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- Number: US 10,441,409 B2
- Document ID: US10441409B2
- Status: Granted
- Kind: B2
- Application number: 15/891,460
- Filed: 2018-02-08
- Published: 2018-06-14
- Granted: 2019-10-15
- Earliest claimed: 2006-09-29
- Assignees: DePuy Synthes Products, Inc.
- Applicants: DePuy Mitek, LLC
- Inventors: Charles Beck, Jr.; Jose E. Lizardi
- Web page: https://patentgrep.com/patent/US10441409B2

## CPC

- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61F 2002/0835: {with deformation of anchor parts, e.g. expansion of dowel by set screw}
- A61F 2002/0852: {Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes}
- 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 2002/0888: {Anchor in or on a blind hole or on the bone surface without formation of a tunnel}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- 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

Various methods and devices are provided for a graft fixation device for fixing a graft member within a bone tunnel. In one embodiment, a graft fixation device is provided having a radially expandable sheath adapted to be disposed within a bone tunnel, and a sheath expander adapted to be received within the radially expandable sheath to expand the sheath and thereby anchor a graft between the sheath and the bone tunnel. In an exemplary embodiment, the graft fixation device is particularly useful to affix a graft within a femoral tunnel.

## Claims

### Claim 1

A graft fixation device for fixing a graft member within a bone tunnel, the device comprising:
a radially expandable sheath having proximal and distal ends and a central lumen extending therebetween, the radially expandable sheath having first, second, and third sidewalls defining a substantially triangular cross-sectional shape, the first sidewall having a stop member formed on a proximal-most end thereof, the stop member having a distal-facing surface that is distal to at least a portion of a proximal-most end of the second and third sidewalls, and the stop member being configured to prevent over-insertion of the radially expandable sheath into a bone tunnel; and
a sheath expander disposable within the central lumen of the radially expandable sheath and configured to flex the first, second, and third sidewalls to radially expand the sheath so as to fix a graft member extending along the first, second, and third sidewalls within the bone tunnel,
wherein the sheath expander and a distal-most end of the radially expandable sheath each include a lumen extending longitudinally therethrough for receiving a guide wire.

### Claim 2 (depends on 1)

The graft fixation device of claim 1, wherein the first, second, and third sidewalls are at least partially separated by first, second, and third longitudinally oriented slots extending therebetween.

### Claim 3 (depends on 2)

The graft fixation device of claim 2, wherein the first, second, and third sidewalls are each connected by a proximal attachment point and a distal attachment point, and wherein the slots extend between the proximal and distal attachment points.

### Claim 4 (depends on 1)

The graft fixation device of claim 1, wherein the first and second sidewalls have a substantially concave outer surface configured to seat a graft member.

### Claim 5 (depends on 4)

The graft fixation device of claim 4, wherein the third sidewall has a substantially convex outer surface adapted to engage the bone tunnel.

### Claim 6 (depends on 5)

The graft fixation device of claim 5, wherein the first and second sidewalls include surface features formed within the concave outer surface thereof and adapted to engage the graft member, and the third sidewall includes surface features formed on the convex outer surface thereof and adapted to engage bone within the bone tunnel.

### Claim 7 (depends on 6)

The graft fixation device of claim 6, wherein the surface features on the first, second, and third sidewalls extend in a radial direction.

### Claim 8 (depends on 1)

The graft fixation device of claim 1, wherein a proximal-most end of the radially expandable sheath is angled relative to a longitudinal axis of the radially expandable sheath.

### Claim 9 (depends on 1)

The graft fixation device of claim 1, wherein the sheath expander comprises a tapered screw.

### Claim 10 (depends on 9)

The graft fixation device of claim 9, wherein the sheath expander has a maximum outer diameter that is greater than a maximum inner diameter of the radially expandable sheath in an unexpanded state.

### Claim 11 (depends on 1)

The graft fixation device of claim 1, wherein the sheath expander and the radially expandable sheath are formed from a bioabsorbable material.

### Claim 12 (depends on 1)

The graft fixation device of claim 1, wherein the distal end of the radially expandable sheath includes a cradle for seating the graft member therein.

### Claim 13 (depends on 1)

The graft fixation device of claim 1, wherein at least one sidewall of the radially expandable sheath includes a conical taper formed on an inner surface of the proximal end thereof to align the sheath expander with the radially expandable sheath.

### Claim 14

A graft fixation device for fixing a graft member within a bone tunnel, the device comprising:
a radially expandable sheath having proximal and distal ends and a central lumen extending therebetween, the radially expandable sheath having first, second, and third sidewalls defining a substantially triangular cross-sectional shape, the first sidewall having a stop member formed on a proximal-most end thereof, the stop member having a distal-facing surface that is distal to at least a portion of a proximal-most end of the second and third sidewalls, and the stop member being configured to prevent over-insertion of the radially expandable sheath into a bone tunnel; and
a sheath expander disposable within the central lumen of the radially expandable sheath and configured to flex the first, second, and third sidewalls to radially expand the sheath so as to fix a graft member extending along the first, second, and third sidewalls within the bone tunnel,
wherein the sheath expander and the radially expandable sheath are formed from a bioabsorbable material.

### Claim 15 (depends on 14)

The graft fixation device of claim 14, wherein the first, second, and third sidewalls are at least partially separated by first, second, and third longitudinally oriented slots extending therebetween.

### Claim 16 (depends on 14)

The graft fixation device of claim 14, wherein the first and second sidewalls have a substantially concave outer surface configured to seat a graft member, and the third sidewall has a substantially convex outer surface adapted to engage the bone tunnel.

### Claim 17

A graft fixation device for fixing a graft member within a bone tunnel, the device comprising:
a radially expandable sheath having proximal and distal ends and a central lumen extending therebetween, the radially expandable sheath having first, second, and third sidewalls defining a substantially triangular cross-sectional shape, the first sidewall having a stop member formed on a proximal-most end thereof, the stop member having a distal-facing surface that is distal to at least a portion of a proximal-most end of the second and third sidewalls, the stop member being configured to prevent over-insertion of the radially expandable sheath into a bone tunnel, the distal end of the radially expandable sheath having a cradle for seating the graft member therein; and
a sheath expander disposable within the central lumen of the radially expandable sheath and configured to flex the first, second, and third sidewalls to radially expand the sheath so as to fix a graft member extending along the first, second, and third sidewalls within the bone tunnel.

### Claim 18 (depends on 17)

The graft fixation device of claim 17, wherein the first, second, and third sidewalls are at least partially separated by first, second, and third longitudinally oriented slots extending therebetween.

### Claim 19 (depends on 17)

The graft fixation device of claim 17, wherein the first and second sidewalls have a substantially concave outer surface configured to seat a graft member, and the third sidewall has a substantially convex outer surface adapted to engage the bone tunnel.
