# US 12,758,378 B2 · Connective tissue grafting

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- Number: US 12,758,378 B2
- Document ID: US12758378B2
- Status: Granted
- Kind: B2
- Application number: 18/236,335
- Filed: 2023-08-21
- Published: 2024-03-21
- Granted: 2026-10-13
- Earliest claimed: 2018-10-08
- Assignees: Kambiz Behzadi
- Applicants: Kambiz Behzadi
- Inventors: Kambiz Behzadi; Michael E. Woods
- Web page: https://patentgrep.com/patent/US12758378B2

## CPC

- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61F 2002/0841: {Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire}
- A61F 2002/0882: {Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone}
- A61F 2240/008: Means for testing implantable prostheses
- 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 system and method for an improved connective tissue repair option that reduces disadvantages of conventional fixation options. Biologic press fit fixation of a connective tissue unit may include in situ expansion of a pre-compressed connective tissue unit within a prepared bone tunnel of a portion of bone. An external opening accessing a cavity of the prepared bone tunnel may be smaller than that of the cavity such that expansion of the installed/compressed connective tissue unit increases lateral fixation forces exerted by the expanding/decompressing compressed connective tissue unit within the bone tunnel.

## Claims

### Claim 1

A method for installing a graft into a portion of bone, comprising the steps of:
a) sculpting a non-uniform bone tunnel within the portion of bone, said nonuniform bone tunnel including a bone tunnel opening defining a perimeter having a first cross-sectional area and a non-cylindrical cavity in the portion of bone beyond said bone tunnel opening;
b) precompressing the graft prior to an installation of the graft within said non-uniform bone tunnel producing a precompressed graft, said precompressed graft defining an exterior perimeter having a second cross-sectional area smaller than said first cross-sectional area; and thereafter;
c) inserting said precompressed graft into said non-cylindrical cavity; and thereafter
d) decompressing said precompressed graft within said non-cylindrical cavity producing a decompressed graft;
wherein said decompressed graft is configured to anchor the graft within the portion of bone without a foreign body.

### Claim 2 (depends on 1)

The method of claim 1 wherein said precompressed graft is configured to de-compress or expand, in situ, within the bone tunnel portion past the opening and to substantially fill said bone tunnel opening.

### Claim 3 (depends on 1)

The method of claim 1 further comprising coupling a set of sensors to said precompressed graft wherein said set of sensors are configured to assess one or more of (A) intra-tunnel interface forces (pressures), in order to determine if/when interface forces are adequate (high) enough for direct type and/or indirect type healing and (B) intra-articular ligament tensile, shear, and/or torsional forces (within the bone tunnel) to determine failure mechanisms and maximal load to failure in the case of re injury or re rupture.

### Claim 4 (depends on 1)

The method of claim 1 wherein said precompressed graft includes an encapsulation of a graft portion within a compression-retaining sheath and wherein said compression-retaining sheath is removed prior to said installation.

### Claim 5 (depends on 1)

The method of claim 1 wherein precompressed graft includes a decompressor modality configured to decompress or expand precompressed graft after said installation.

### Claim 6 (depends on 5)

The method of claim 5 wherein said decompressor modality includes a fluid absorption structure defined in said compressible portion.

### Claim 7 (depends on 6)

The method of claim 6 wherein said fluid absorption structure is configured to absorb fluid from within the bone tunnel after said installation.

### Claim 8 (depends on 5)

The method of claim 5 wherein said decompressor modality includes an expandable fluid storage structure defined within said precompressed graft, said expandable fluid storage structure is configured to respond to an introduction of a fluid, after said installation, to decompress or expand said precompressed graft in situ.

### Claim 9 (depends on 1)

The method of claim 1 wherein said precompressed graft includes a biologic tissue graft.

### Claim 10 (depends on 1)

The method of claim 1 wherein said precompressed graft includes a synthetic tissue graft.

### Claim 11 (depends on 1)

The method of claim 1 wherein said precompressed graft includes a hybrid composition having a synthetic element encapsulated by a biologic tissue exterior.

### Claim 12 (depends on 1)

The method of claim 1 wherein said precompressed graft includes a biologic ligament graft.

### Claim 13 (depends on 1)

The method of claim 1 wherein said precompressed graft includes a biologic tendon graft.

### Claim 14

A method for installing a graft into a presculpted non-uniform bone tunnel provided within a portion of bone, the non-uniform bone tunnel including a bone tunnel opening defining a perimeter having a first cross-sectional area and a non-uniform cavity in the portion of bone beyond the bone tunnel opening, comprising the steps of:
a) precompressing the graft prior to an installation of the graft within said non-uniform bone tunnel producing a precompressed graft, said precompressed graft defining an exterior perimeter having a second cross-sectional area smaller than the first cross-sectional area; and thereafter;
b) inserting said precompressed graft into the non-uniform cavity; and thereafter
c) decompressing said precompressed graft within the non-uniform cavity producing a decompressed graft;
wherein said decompressed graft is configured to anchor the graft within the portion of bone without a foreign body.

### Claim 15 (depends on 14)

The method of claim 14 wherein said precompressed graft is configured to de-compress or expand, in situ, within the bone tunnel portion past the opening and to substantially fill said bone tunnel opening.

### Claim 16 (depends on 14)

The method of claim 14 further comprising coupling a set of sensors to said precompressed graft wherein said set of sensors are configured to assess one or more of (A) intra-tunnel interface forces (pressures), in order to determine if/when interface forces are adequate (high) enough for direct type and/or indirect type healing and (B) intra-articular ligament tensile, shear, and/or torsional forces (within the bone tunnel) to determine failure mechanisms and maximal load to failure in the case of re injury or re rupture.

### Claim 17 (depends on 14)

The method of claim 14 wherein said precompressed graft includes an encapsulation of a graft portion within a compression-retaining sheath and wherein said compression-retaining sheath is removed prior to said installation.

### Claim 18 (depends on 14)

The method of claim 14 wherein precompressed graft includes a decompressor modality configured to decompress or expand precompressed graft after said installation.

### Claim 19 (depends on 18)

The method of claim 18 wherein said decompressor modality includes a fluid absorption structure defined in said compressible portion.

### Claim 20 (depends on 19)

The method of claim 19 wherein said fluid absorption structure is configured to absorb fluid from within the bone tunnel after said installation.

### Claim 21 (depends on 18)

The method of claim 18 wherein said decompressor modality includes an expandable fluid storage structure defined within said precompressed graft, said expandable fluid storage structure is configured to respond to an introduction of a fluid, after said installation, to decompress or expand said precompressed graft in situ.

### Claim 22 (depends on 14)

The method of claim 14 wherein said precompressed graft includes a biologic tissue graft.

### Claim 23 (depends on 14)

The method of claim 14 wherein said precompressed graft includes a synthetic tissue graft.

### Claim 24 (depends on 14)

The method of claim 14 wherein said precompressed graft includes a hybrid composition having a synthetic element encapsulated by a biologic tissue exterior.

### Claim 25 (depends on 14)

The method of claim 14 wherein said precompressed graft includes a biologic ligament graft.

### Claim 26 (depends on 14)

The method of claim 14 wherein said precompressed graft includes a biologic tendon graft.
