# US 10,500,630 B2 · Systems, devices, and methods for designing and forming a surgical implant

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- Number: US 10,500,630 B2
- Document ID: US10500630B2
- Status: Granted
- Kind: B2
- Application number: 15/496,628
- Filed: 2017-04-25
- Published: 2017-08-10
- Granted: 2019-12-10
- Earliest claimed: 2008-04-04
- Assignees: NuVasive, Inc.
- Applicants: NuVasive, Inc.
- Inventors: Robert E. Isaacs
- Web page: https://patentgrep.com/patent/US10500630B2

## CPC

- B21F 45/008: {of medical instruments, e.g. stents or corneal rings}
- A61B 1/32: Devices for opening or enlarging the visual field, e.g. of a tube of the body
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 17/02: for holding wounds open, e.g. retractors; Tractors
- A61B 17/0206: {with antagonistic arms as supports for retractor elements}
- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/7011: {Longitudinal element being non-straight, e.g. curved, angled or branched (adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs)}
- A61B 17/8863: {Apparatus for shaping or cutting osteosynthesis equipment by medical personnel}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/25: {User interfaces for surgical systems}
- G06F 30/00: Computer-aided design [CAD]
- G16H 30/40: for processing medical images, e.g. editing
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/0256: {for the spine}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61B 2034/2068: {using pointers, e.g. pointers having reference marks for determining coordinates of body points}
- G16H 50/50: for simulation or modelling of medical disorders
- B21F: WORKING OR PROCESSING OF METAL WIRE (rolling of metal wire B21B1/16; by drawing, auxiliary operations used in connection with metal-working without essentially removing material B21C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A method is provided for determining the shape of a surgical linking device that is to be attached to a bony body structure such as the spinal column based on digitized locations of a plurality of attachment elements engaged to the bony structure. The method is implemented by a computer system through a GUI to generate an initial bend curve to mate with the plurality of attachment elements. The initial bend curve may be simplified based on user input to the GUI to reduce the number of bends necessary to produce a well-fitting linking device and may be altered to help obtain the goals of surgery.

## Claims

### Claim 1

A method for shaping a surgical linking device comprising:
(a) generating a bend curve having a plurality of bend points along the length of the surgical linking device, wherein the bend curve is based on data for a location of at least one attachment element; and
(b) generating bending instructions for bends to be performed on the linking device by a bending tool at each of the bend points.

### Claim 2 (depends on 1)

The method of claim 1, further comprising developing a curve function to approximate a desired location of the at least one attachment element.

### Claim 3 (depends on 2)

The method of claim 2, further comprising calculating a location of the linking device shaped according to the curve function at the desired location of the at least one attachment element.

### Claim 4 (depends on 3)

The method of claim 3, further comprising calculating an error based on the difference in the calculated location of the linking device and the desired location of the at least one attachment element and determining if such error exceeds a tolerance range.

### Claim 5 (depends on 4)

The method of claim 4, wherein bend points are eliminated if the determined error exceeds the tolerance range.

### Claim 6 (depends on 4)

The method of claim 4, wherein the step of calculating an error includes applying a least mean squares approach over all of the desired attachment element locations.

### Claim 7 (depends on 1)

The method of claim 1, comprising a plurality of bend curves, wherein at least two bend curves are in each of two non-coplanar planes.

### Claim 8 (depends on 7)

The method of claim 7, wherein the two planes are orthogonal.

### Claim 9

A method for shaping a surgical linking device comprising:
(a) providing digitized data for a location of at least one attachment element;
(b) developing a curve function to approximate a desired location of the at least one attachment element;
(d) calculating a location of the linking device shaped according to the curve function at the desired location of the at least one attachment element;
(e) generating a bend curve having at least one bend point along the length of the linking device using the curve function, wherein the bend curve is based on the digitized data for the location of the at least one attachment element; and
(f) generating bending instructions for at least one bend to be performed on the linking device by a bending tool at the at least one bend point.

### Claim 10 (depends on 9)

The method of claim 9, further comprising calculating an error based on the difference in the calculated location of the linking device and the desired location of the at least one attachment element and determining if such error exceeds a tolerance range.

### Claim 11 (depends on 10)

The method of claim 10, wherein the at least one bend point is eliminated if the determined error exceeds the tolerance range.

### Claim 12 (depends on 10)

The method of claim 10, in which the linking device is a rod and a head portion of the attachment element includes a channel for receiving the rod, wherein the step of determining a tolerance range is based on the maximum angle through which head portion may pivot relative to the bony structure.

### Claim 13 (depends on 9)

The method of claim 9, wherein digitized data is provided for anatomical points between a plurality of attachment elements that must be avoided by the linking device when it is engaged to the attachment elements.

### Claim 14 (depends on 9)

The method of claim 9, further comprising applying a smoothing function to the curve function.

### Claim 15

A method for shaping a surgical linking device comprising:
(a) generating a bend curve having at least one bend point along the length of the linking device, wherein the bend curve is based on a desired location of at least one attachment element; and
(b) generating bending instructions for bends to be performed on the linking device by a bending tool at each of the at least one bend point.

### Claim 16 (depends on 15)

The method of claim 15, wherein the bend curve is based at least in part on digitized data of the location of the at least one attachment element.

### Claim 17 (depends on 15)

The method of claim 15, further comprising developing a curve function to approximate the desired location of the at least one attachment element.

### Claim 18 (depends on 17)

The method of claim 17, further comprising calculating the location of the linking device shaped according to the curve function at the desired location of the at least one attachment element.

### Claim 19 (depends on 18)

The method of claim 18, further comprising calculating an error based on the difference in the calculated location of the linking device and the desired location of the at least one attachment element and determining if such error exceeds a tolerance range.

### Claim 20 (depends on 17)

The method of claim 17, further comprising applying a smoothing function to the curve function.
