# US 11,439,445 B2 · Methods of bone reduction and fixation

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- Number: US 11,439,445 B2
- Document ID: US11439445B2
- Status: Granted
- Kind: B2
- Application number: 16/821,336
- Filed: 2020-03-17
- Published: 2020-09-24
- Granted: 2022-09-13
- Earliest claimed: 2019-03-19
- Assignees: Dynorif, LLC
- Applicants: Dynorif, LLC
- Inventors: Joseph Michael Vento
- Web page: https://patentgrep.com/patent/US11439445B2

## CPC

- A61B 17/7225: {for bone compression}
- A61B 17/72: Intramedullary devices, e.g. pins or nails
- A61B 17/7208: {Flexible pins, e.g. ENDER pins}
- A61B 17/8004: {with means for distracting or compressing the bone or bones}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- C22C 19/03: based on nickel
- C22F 1/002: {by rapid cooling or quenching; cooling agents used therefor}
- C22F 1/10: of nickel or cobalt or alloys based thereon
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- C22C: ALLOYS (treatment of alloys C21D, C22F)
- C22F: CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS (surface treatment of metallic material involving at least one process provided for in class C23 and at least one process covered by this subclass, C23F17/00)

## Abstract

Provided is a method of open reduction and internal fixation of a bone of a patient using a fixation device. The method includes analyzing the bone to obtain a fracture profile, wherein the fracture profile includes data corresponding to a physical structure of the bone, shaping the fixation device using the data of the fracture profile, heat treating the fixation device by heating the fixation device to a first temperature, cooling the fixation device to a second temperature lower than the first temperature, securing the fixation device to the bone, and heating the fixation device to a third temperature lower than the first temperature and greater than the second temperature to reduce the bone.

## Claims

### Claim 1

A method of open reduction and internal fixation of a bone of a patient using a fixation device, the method comprising:
analyzing the bone to obtain a fracture profile, wherein the fracture profile includes data corresponding to a physical structure of the bone;
shaping the fixation device using the data of the fracture profile;
heat treating the fixation device by heating the fixation device to a first temperature;
cooling the fixation device to a second temperature lower than the first temperature;
securing the fixation device to the bone; and
heating the fixation device to a third temperature lower than the first temperature and greater than the second temperature to reduce the bone.

### Claim 2 (depends on 1)

The method according to claim 1, wherein heating the fixation device to the third temperature is caused at least partly by body heat of the patient.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the fixation device is a shape memory alloy.

### Claim 4 (depends on 3)

The method according claim 3, wherein the fixation device is in a flexible state at the second temperature and rigid state at the third temperature.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the fixation device is made from Nickel-Titanium.

### Claim 6 (depends on 1)

The method of claim 1, wherein the fixation device is a rod for internal fixation.

### Claim 7 (depends on 1)

The method of claim 1, wherein the fixation device is a plate for internal fixation.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the fixation device is an intramedullary Nickel-Titanium rod and securing the fixation device to the bone includes implanting the fixation device into a medullary cavity of the bone.

### Claim 9 (depends on 1)

The method according to claim 1, wherein analyzing the bone to obtain a fracture profile further includes analyzing a second bone contralateral to the bone, the fracture profile corresponding to at least a portion of physical structure of the second bone.

### Claim 10 (depends on 1)

The method of claim 1, wherein shaping the fixation device includes placing the fixation device in a mold, the fixation device remaining in the mold for shape setting and heat treating.

### Claim 11 (depends on 1)

The method of claim 1, further including re-cooling the fixation device using a compressed gas after the fixation device is at least partially secured to the bone, wherein re-cooling the fixation device using a compressed gas transitions the fixation device to a flexible state.

### Claim 12 (depends on 1)

The method of claim 1, wherein the first temperature is at least 450 degree Celsius.

### Claim 13

A method of open reduction and internal fixation of a fractured bone of a patient using a fixation device formed of a shape memory alloy, the method comprising:
analyzing the fractured bone to obtain a fracture profile, wherein the fracture profile includes data corresponding to a shape and a curvature of the fractured bone;
shaping the fixation device using a mold and the data of the fracture profile;
heat treating the fixation device by heating the fixation device to place the fixation device in a fixation state;
cooling the fixation device to place the fixation device in a positioning state;
positioning the fixation device relative to the bone when the fixation device is in the positioning state; and
heating the fixation device to return the fixation device to the fixation state to reduce the bone.

### Claim 14 (depends on 13)

The method according to claim 13, wherein heating the fixation device to return the fixation device to the fixation state is caused at least partly by body heat of the patient.

### Claim 15 (depends on 13)

The method according to claim 13, further including re-cooling the fixation device using a compressed gas to transition the fixation device to or toward the positioning state when the fixation device has been at least partially positioned relative to the bone.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the compressed gas is liquid nitrogen.

### Claim 17 (depends on 13)

The method of claim 13, wherein the fixation device is a rod for internal fixation.

### Claim 18

A method of open reduction and internal fixation of a fractured bone of a patient using an intramedullary fixation device formed of shape memory alloy, the method comprising:
analyzing the fractured bone to obtain a fracture profile, wherein the fracture profile includes data corresponding to a shape and curvature of the fractured bone;
shaping the fixation device using the fracture profile;
heat treating the fixation device by heating the fixation device to a first temperature;
cooling the fixation device to a second temperature lower than the first temperature;
implanting the fixation device into a medullary cavity of the fractured bone; and
reducing the fractured bone by heating the fixation device to a third temperature lower than the first temperature and greater than the second temperature to reduce the fractured bone.

### Claim 19 (depends on 18)

The method according to claim 18, wherein heating the fixation device to the third temperature is caused at least partly by body heat of the patient.

### Claim 20 (depends on 18)

The method according to claim 18, wherein the fixation device is a shape memory alloy, and wherein the fixation device is in a flexible state at the second temperature and rigid state at the third temperature.
