# US 12,178,453 B2 · Alignment instruments and methods for use in total ankle replacement

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,178,453 B2
- Document ID: US12178453B2
- Status: Granted
- Kind: B2
- Application number: 18/453,856
- Filed: 2023-08-22
- Published: 2023-12-07
- Granted: 2024-12-31
- Earliest claimed: 2018-12-13
- Assignees: Paragon 28, Inc.
- Applicants: Paragon 28, Inc.
- Inventors: Daniel J. Lee; Joseph Dogué; Randy Allard; Francis D. Barmes; Mark Ray Dalton; Albert Dacosta; Spanky Raymond
- Web page: https://patentgrep.com/patent/US12178453B2

## CPC

- A61B 17/1775: {for the foot or ankle}
- A61B 17/15: Guides therefor
- A61B 17/68: Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)}
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 90/13: guided by light, e.g. laser pointers
- A61B 90/14: Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
- A61F 2/4202: {for ankles}
- A61F 2/4606: {of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes}
- A61B 5/4595: {Evaluating the ankle}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/067: {for measuring angles}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- 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

Alignment instruments may include joint-line referencing systems having an alignment arm having a body with first and second portions defining first and second sides. The first portion has at least one first pin tube through-hole extending from the first to the second side. The second portion has a first opening on the first side. A pin tube guide member is receivable in the first through-hole. The pin tube guide member has a passageway therethrough. An angelwing alignment member includes a portion receivable in the first opening of the alignment arm. An alignment foot is secured to the second portion, and the alignment foot has a handle and a shim. The shim is positionable in a joint between a first bone and a second bone, the alignment arm is alignable relative to a first bone, and the pin tube guide is operable for securing a pin into the first bone.

## Claims

### Claim 1

A surgical method, comprising:
providing a joint-line referencing system;
placing a shim of an alignment foot of the joint-line referencing system adjacent to a joint between a tibia and a talus of a patient;
inserting a first linear member of the joint-line referencing system in at least one first through-hole of an alignment arm of the joint-line referencing system;
moving a handle of the alignment foot to position and/or or orient the alignment arm;
inserting a first pin into a passageway of the first linear member and into the tibia of the patient;
removing the joint-line referencing system from the joint and the first pin; and
attaching a cutting guide to an alignment guide installed on the first pin to resect at least a portion of the tibia or the talus.

### Claim 2 (depends on 1)

The surgical method of claim 1, wherein the alignment guide is a tibia alignment guide, and wherein the surgical method further comprises:
installing the tibia alignment guide on the installed first pin.

### Claim 3 (depends on 1)

The surgical method of claim 1, wherein the joint-line referencing system comprises:
an angelwing alignment member having a portion receivable in said at least one first through-hole of said alignment arm; and
wherein the alignment arm comprising a body having a first portion and a second portion, said first portion and said second portion defining a first side and a second side, said first portion having at least one first through-hole extending from said first side to said second side, the second portion having at least one first opening on said first side;
wherein the first linear member receivable in said at least one first through-hole;
wherein the alignment foot is secured to said second portion; and
wherein said handle of said alignment foot extending away from said first side and the shim extending away from said second side.

### Claim 4 (depends on 3)

The surgical method of claim 3, wherein the first linear member is a pin tube guide member.

### Claim 5 (depends on 1)

The surgical method of claim 1, further comprising:
inserting a second linear member in a second through-hole of the alignment arm.

### Claim 6 (depends on 5)

The surgical method of claim 5, wherein the second through-hole is positioned below the first through-hole.

### Claim 7 (depends on 6)

The surgical method of claim 6, wherein the second linear member is a pin tube guide member and comprises a passageway extending therethrough.

### Claim 8

A surgical method, comprising:
providing a joint-line referencing system;
placing a shim of an alignment foot of the joint-line referencing system adjacent to a joint between a tibia and a talus of a patient;
inserting a first linear member of the joint-line referencing system into a first through-hole and a second linear member of the joint-line referencing system in a second through-hole;
moving a handle of the alignment foot to position or orient an alignment arm;
removing the joint-line referencing system from the joint leaving at least one pin; and
attaching a cutting guide to an alignment system installed on the at least one pin to resect at least a portion of the joint.

### Claim 9 (depends on 8)

The surgical method of claim 8, wherein the joint-line referencing system further comprises:
an angelwing alignment member having a portion receivable in at least one opening of said alignment arm; and
wherein the alignment arm comprises:
a body having a first portion and a second portion, wherein said first portion and said second portion defining a first side and a second side, wherein the first portion comprises at least one first through-hole and at least one second through-hole, and
wherein the second portion comprises the at least one opening;
wherein the alignment foot is secured to said second portion of the body, wherein the shim extends away from the alignment foot.

### Claim 10 (depends on 9)

The surgical method of claim 9, wherein the handle extends away from the first side and the shim extends away from the second side.

### Claim 11 (depends on 8)

The surgical method of claim 8, wherein the first and second linear members are pin tube guide members.

### Claim 12 (depends on 11)

The surgical method of claim 11, further comprising:
inserting a first pin of the at least one pin into a passageway of the first linear member; and
inserting a second pin of the at least one pin into a passageway of the second linear member.

### Claim 13 (depends on 12)

The surgical method of claim 12, further comprising:
installing the alignment system on at least one of the first and second pins, wherein at least one of the first and second pins are coupled with a tibia of a patient.

### Claim 14 (depends on 8)

The surgical method of claim 8, wherein removing the joint-line referencing system further comprises:
simultaneously removing the shim from a position adjacent to the joint and the alignment arm from the first pin.

### Claim 15

A surgical method comprising:
providing a joint-line referencing system;
placing a shim of an alignment foot adjacent to a joint between a tibia and a talus of a patient;
inserting a first linear member into a first through-hole of an alignment arm;
inserting a first pin into a passageway of the first linear member;
inserting a second linear member into a second through-hole of the alignment arm;
inserting a second pin into a passageway of the second linear member;
moving a handle of the alignment foot to position or orient the alignment arm;
removing the joint-line referencing system from the joint; and
attaching a cutting guide to an alignment guide installed on at least one of the first pin and the second pin to resect at least a portion of the tibia or the talus.

### Claim 16 (depends on 15)

The surgical method of claim 15, wherein the joint-line referencing system further comprises:
an angelwing alignment member;
wherein the alignment foot is secured to said alignment arm; and
wherein the first and second linear members are pin tube guide members.

### Claim 17 (depends on 15)

The surgical method of claim 15, wherein the moving is based on a position or an orientation of an angelwing alignment member operably attached to the alignment arm.

### Claim 18 (depends on 15)

The surgical method of claim 15, wherein the moving is based on a position or an orientation of a rod operably attached to an angelwing alignment member.

### Claim 19 (depends on 15)

The surgical method of claim 15, further comprising projecting a laser line from a laser device operably attached to the alignment arm, and wherein the moving is based on a position or an orientation of the laser line.