# US 11,109,914 B2 · Outcome-based splinting

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- Number: US 11,109,914 B2
- Document ID: US11109914B2
- Status: Granted
- Kind: B2
- Application number: 16/297,158
- Filed: 2019-03-08
- Published: 2020-09-10
- Granted: 2021-09-07
- Earliest claimed: 2019-03-08
- Assignees: DePuy Synthes Products, Inc.
- Applicants: Depuy Synthes Products, Inc.
- Inventors: Steffan Daniel; Andre Furrer; Simon Bosshard
- Web page: https://patentgrep.com/patent/US11109914B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 17/56: Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B 17/64: Devices extending alongside the bones to be positioned
- A61B 17/66: {Alignment}, compression or distraction mechanisms
- A61B 17/72: Intramedullary devices, e.g. pins or nails
- B33Y 80/00: Products made by additive manufacturing
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/0092: {for X-rays}
- A61B 2017/00964: {composite}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## Abstract

A bone fracture fixation system including reference pins inserted into bone fragments of a patient in a first configuration and an image capture device configured to capture an image of the reference pins, and the bone fragments. The system includes a processor configured to receive and pre-process the captured image data. The processor pre-processes the image data by virtually re-positioning the reference pins in the first configuration into a second configuration, wherein the re-positioning virtually re-positions the bone fragments into normal alignment; and virtually generating a support device. The system includes a point-of-care production apparatus that produces a three-dimensional model of the virtually generated support device in a form that can be applied to the patient. The three-dimensional support device generated by the point-of-care production apparatus is configured to receive the reference pins in the first configuration; and simultaneously re-positions and fixes the bone fragments into normal alignment.

## Claims

### Claim 1

A digitally-guided reduction and external fixation system for reducing and fixing a bone fracture comprising:
one or more reference pins configured to be inserted into one or more bone fragments of a patient in a first configuration;
an image capture device configured to capture an image of the one or more reference pins in the first configuration, and the one or more bone fragments,
a virtual reduction and fixation device comprising a processor configured to execute instructions to:
receive the captured image data of the one or more reference pins in the first configuration, and the one or more bone fragments;
pre-process the image data by virtually re-positioning the one or more reference pins in the first configuration into a second configuration, wherein the re-positioning of the one or more reference pins into the second configuration virtually re-positions the one or more bone fragments into normal alignment;
virtually generate a support device, wherein the support device comprises one or more apertures configured to receive the one or more reference pins in the second configuration and the support device is configured to simultaneously achieve reduction and long-term fixation by repositioning and fixing the one or more bone fragments into normal alignment; and
send a description of the virtually generated support device to a point-of-care production apparatus.

### Claim 2 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, wherein the digitally-guided reduction and external fixation system comprises two or more reference pins.

### Claim 3 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, wherein the one or more reference pins are threaded.

### Claim 4 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, wherein the one or more reference pins are manufactured from a radiolucent material.

### Claim 5 (depends on 4)

The digitally-guided reduction and external fixation system of claim 4, wherein the one or more reference pins are manufactured from a plastic-based material.

### Claim 6 (depends on 5)

The digitally-guided reduction and external fixation system of claim 5, wherein the plastic-based material is selected from a group consisting of PEEK, polysulfone, polycarbonate, glass fiber, graphite fiber, polyetherimide, polyethersulfone, polyphenylsulfone, polyphenylsulfide and combinations thereof.

### Claim 7 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, further comprising:
one or more scanning locators attached to the one or more reference pins at a proximal end.

### Claim 8 (depends on 7)

The digitally-guided reduction and external fixation system of claim 7, wherein the one or more scanning locators are manufactured from a radiopaque material.

### Claim 9 (depends on 8)

The digitally-guided reduction and external fixation system of claim 8, wherein the radiopaque material is selected from a group consisting of stainless steel, aluminum, titanium, silver, bismuth, and tantalum materials, radiopaque composite material or combinations thereof.

### Claim 10 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, further comprising:
a point-of-care production apparatus configured to reproduce the virtually generated support device into a three-dimensional form that can be applied to the patient; wherein the three-dimensional support device generated by the point-of-care production apparatus is configured to:
receive the one or more reference pins inserted into the one or more bone fragments of the patient in the first configuration.

### Claim 11 (depends on 10)

The digitally-guided reduction and external fixation system of claim 10, further comprising:
a locking device configured to fix the support device generated by the point-of-care production apparatus to the one or more reference pins inserted into the one or more bone fragments of the patient.

### Claim 12 (depends on 10)

The digitally-guided reduction and external fixation system of claim 10, wherein the point-of-care production apparatus comprises a 3D printing device or a desktop CNC mill.

### Claim 13 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, wherein the image capture device is an X-ray, MRI, CT, CBCT, or ultrasound device.

### Claim 14 (depends on 1)

The digitally-guided reduction and external fixation system of claim 1, wherein the virtually generated support device further comprises additional apertures added at the discretion of a surgeon.