# US 10,869,722 B2 · Method and fixture for guided pedicle screw placement

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- Number: US 10,869,722 B2
- Document ID: US10869722B2
- Status: Granted
- Kind: B2
- Application number: 15/801,975
- Filed: 2017-11-02
- Published: 2018-05-03
- Granted: 2020-12-22
- Earliest claimed: 2016-11-02
- Assignees: Rochester Institute of Technology
- Applicants: Michael R. Caldwell; Mark W. Olles; Amit Singla
- Inventors: Michael R. Caldwell; Mark W. Olles; Amit Singla
- Web page: https://patentgrep.com/patent/US10869722B2

## CPC

- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 17/1757: {for the spine}
- A61B 17/7043: {with a longitudinal element fixed to one or more transverse elements which connect multiple screws or hooks}
- B33Y 50/02: for controlling or regulating additive manufacturing processes
- B33Y 80/00: Products made by additive manufacturing
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7037: {wherein pivoting is blocked when the rod is clamped}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- 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
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A customized patient-specific combined template and implant for spinal fixation and method for use.

## Claims

### Claim 1

A method for spinal fixation comprising:
scanning an affected segment of the spine of a patient in need of spinal fixation to generate image data;
generating a 3D model of the spine from the image data;
selecting a set of screw paths in the 3D model for attachment of an implant to the affected segment of the spine;
generating a 3D digital template of a combination screw guide fixture and implant comprising screw guides corresponding to the set of selected screw paths and at least one self-alignment bar comprising a vertebra mating surface;
making the combination screw guide fixture and implant from the 3D digital template by additive manufacturing;
locating the combination screw guide fixture and implant on the affected segment of the spine aligning the screw guides with the set of selected screw paths and contacting the at least one self-alignment bar vertebra mating surface with the vertebra;
drilling a hole in the vertebra corresponding to each screw path in the set of selected screw paths using the screw guides;
placing a surgical screw through each screw guide into the corresponding hole in the vertebra; and
tightening each surgical screw until the combination screw guide fixture and implant is tightly seated to the vertebra.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
attaching a transverse process clamp onto a transverse process of the vertebra and a side rod prior to drilling a hole in the vertebra; and
removing the attached transverse process clamp after drilling the holes in the vertebra.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
attaching an extension sleeve to the screw guide prior to drilling a hole.

### Claim 4 (depends on 1)

The method of claim 1, wherein the combination screw guide fixture and implant comprises, a left-side rod; a right-side rod; and a plurality of interconnecting bars connecting the left-side rod to the right-side rod, the left-side rod comprising a self-alignment bar comprising a vertebra mating surface and extending out from the left-side rod and a plurality of screw passages corresponding to a first portion of the screw guides suitable for accepting screws capable of tightening the combination screw guide fixture and implant to vertebra, the right-side rod comprising a self-alignment bar comprising a vertebra mating surface and extending out from the right-side rod and a plurality of screw passages corresponding to a second portion of the screw guides suitable for accepting screws capable of tightening the combination screw guide fixture and implant to vertebra.

### Claim 5 (depends on 1)

The method of claim 1, wherein the screw guides comprise multiple pairs of screw guides and each pair of the multiple pairs of screw guides is attached to separate vertebra.

### Claim 6

A customized patient-specific spinal fixation combination screw guide fixture and implant comprising:
an additive manufacturing-made spinal fixation combination screw guide fixture and implant, comprising a left-side rod; a right-side rod; and a plurality of interconnecting bars connecting the left-side rod to the right-side rod, the left-side rod comprising a at least two self-alignment bars comprising a corresponding vertebra mating surface and extending out from the left-side rod and a plurality of screw passages suitable for accepting screws capable of tightening the combination screw guide fixture and implant to vertebra, the right-side rod comprising at least two self-alignment bars comprising a corresponding vertebra mating surface and extending out from the right-side rod and a plurality of screw passages suitable for accepting screws capable of tightening the combination screw guide fixture and implant to vertebra which combination screw guide fixture and implant remains screwed on the vertebra after spinal fixation, wherein one of multiple screw passages of the left-side rod plurality of screw passages are paired with a corresponding one of multiple screw passages of the right-side rod plurality of screw passages by connection to one of the plurality of interconnecting bars.

### Claim 7 (depends on 6)

The product of claim 6, wherein the combination screw guide fixture and implant comprises at least 2 paired screw passages.

### Claim 8 (depends on 6)

The product of claim 6, wherein the combination screw guide fixture and implant comprises 3 paired screw passages.

### Claim 9 (depends on 6)

The product of claim 6, wherein each screw passage of the left-side rod plurality of screw passages is paired with a corresponding one of the right-side rod plurality of screw passages by connection to one of the plurality of interconnecting bars.