# US 11,076,872 B2 · Alignment devices and methods

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- Number: US 11,076,872 B2
- Document ID: US11076872B2
- Status: Granted
- Kind: B2
- Application number: 16/230,029
- Filed: 2018-12-21
- Published: 2019-04-25
- Granted: 2021-08-03
- Earliest claimed: 2012-10-18
- Assignees: Smith & Nephew, Inc.
- Applicants: Smith & Nephew, Inc.
- Inventors: Zachary Christopher Wilkinson
- Web page: https://patentgrep.com/patent/US11076872B2

## CPC

- A61B 17/175: {for preparing the femur for hip prosthesis insertion}
- A61B 17/155: {Cutting femur}
- A61B 17/1703: {using imaging means, e.g. by X-rays}
- A61B 17/1764: {for the knee}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61F 2/4684: {Trial or dummy prostheses}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/101: {Computer-aided simulation of surgical operations}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61F 2/3859: {Femoral components}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2002/4658: {for measuring dimensions, e.g. length}
- A61F 2002/4668: {for measuring angles}
- Y10T 29/49: Method of mechanical manufacture
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Embodiments of the invention include devices and methods for implanting arthroplasty devices. Some embodiments include designs that allow for use of x-ray images as the only images used to fully and accurately preoperatively and intraoperatively size and align arthroplasty device components and prepare all necessary tissue.

## Claims

### Claim 1

A method of knee arthroplasty device implantation, the method comprising:
evaluating one or more images of a hip and a knee of a patient to define an axis extending from between femoral condyles of a femur of the patient through a hip center of the patient;
placing a femoral implant alignment guide against the femoral condyles such that an elongated resection aperture extending through the femoral implant alignment guide has a major axis substantially perpendicular to the defined axis;
inserting a rod into a rod aperture extending through an offset portion of the femoral implant alignment guide when the offset portion is aligned with a point in a coronal plane of the patient that is shared with a greater trochanter of the patient such that a second axis of the offset portion is in the coronal plane and is substantially parallel to the major axis;
inserting a needle coupled to a second portion of the rod into the patient until a tip of the needle contacts a most lateral point of the greater trochanter;
resecting at least a portion of the femoral condyles along a plane defined by the elongated resection aperture; and
coupling a femoral component of the knee arthroplasty device to the resected portion of the femoral condyles after removing the femoral implant alignment guide from the femur subsequent to the resection.

### Claim 2 (depends on 1)

The method of claim 1, wherein the point with which the offset portion is aligned is directly lateral of the greater trochanter and the method further comprises aligning the femoral implant alignment guide with one or more physiological reference points on the distal femur that are extracted based on the evaluation of the one or more images.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
coupling a tibial implant alignment guide to the femur at least in part at a location in which at least a portion of the femoral condyles were removed during the resection;
positioning a tibia of the patient appropriately relative to the femur and coupling the tibial implant alignment guide to the tibia; and
removing at least a portion of the tibia in a configuration to receive a tibial component of the knee arthroplasty device.

### Claim 4 (depends on 3)

The method of claim 3, further comprising implanting the tibial component of the knee arthroplasty device after the removal of the at least a portion of the tibia.

### Claim 5 (depends on 1)

The method of claim 1, further comprising placing the femoral implant alignment guide such that the femoral implant alignment guide is aligned with respect to the defined axis and medial and lateral contact surfaces of the femoral implant alignment guide contact medial and lateral condyles, respectively, of the femoral condyles.

### Claim 6 (depends on 5)

The method of claim 5, further comprising:
visually aligning the femoral implant alignment guide via a window disposed between the medial and lateral contact surfaces subsequent to placing the femoral implant alignment guide against the femoral condyles; and
inserting pins through cylindrical apertures in the femoral implant alignment guide to couple the femoral implant alignment guide to the femur after the visual alignment.

### Claim 7 (depends on 1)

The method of claim 1, wherein the rod aperture comprises a slot and the method further comprises translating the rod in the slot in a medial-lateral direction when inserting the needle.

### Claim 8 (depends on 1)

The method of claim 1, wherein inserting the needle further comprises inserting the needle such that a long axis of the rod is substantially parallel to the defined axis when the tip of the needle contacts the most lateral point of the grater trochanter.

### Claim 9

A method of knee arthroplasty device implantation, the method comprising:
coupling a femoral implant alignment guide to a distal femur of a patient such that an elongated resection aperture extending through the femoral implant alignment guide has a major axis substantially perpendicular to an axis extending from between femoral condyles of the femur through a hip center of the patient and defined based on an evaluation of obtained images of anatomy of the patient;
inserting a first portion of a rod into a rod aperture extending through an offset portion of the femoral implant alignment guide, when the offset portion is aligned with a point in a coronal plane of the patient that is shared with a greater trochanter of the patient and a second axis of the offset portion is in the coronal plane and is substantially parallel to the major axis, such that a long axis of the rod is substantially parallel to the defined axis;
inserting a needle coupled to a second portion of the rod into the patient until a tip of the needle contacts a most lateral point of the grater trochanter; and
coupling a femoral component of the knee arthroplasty device to the distal femur subsequent to inserting the needle and after resecting at least a portion of the femoral condyles along a plane defined by the elongated resection aperture and removing the femoral implant alignment guide from the femur subsequent to the resection.

### Claim 10 (depends on 9)

The method of claim 9, wherein the one or more images comprise at least one medial-lateral or anterior-posterior radiograph, and
wherein the method further comprises aligning the femoral implant alignment guide with one or more physiological reference points on the distal femur that are extracted based on the evaluation of the one or more images.

### Claim 11 (depends on 9)

The method of claim 9, further comprising:
coupling a tibial implant alignment guide to the resected femur; and
removing at least a portion of the tibia using the tibial implant alignment guide.

### Claim 12 (depends on 11)

The method of claim 11, further comprising implanting the tibial component of the knee arthroplasty device after the removal of the at least a portion of the tibia.

### Claim 13 (depends on 9)

The method of claim 9, further comprising placing the femoral implant alignment guide such that medial and lateral contact surfaces of the femoral implant alignment guide contact medial and lateral condyles, respectively, of the femoral condyles.

### Claim 14 (depends on 13)

The method of claim 13, further comprising:
visually aligning the femoral implant alignment guide via a window disposed between the medial and lateral contact surfaces; and
inserting pins through cylindrical apertures in the femoral implant alignment guide to couple the femoral implant alignment guide to the femur.

### Claim 15 (depends on 9)

The method of claim 9, wherein the rod aperture comprises a slot and the method further comprises
translating the rod in the slot in a medial-lateral direction when inserting the needle.

### Claim 16

A method of knee arthroplasty device implantation, the method comprising:
evaluating one or more images of a hip and a knee of a patient to define an axis extending from between femoral condyles of a femur of the patient through a hip center of the patient;
placing a femoral implant alignment guide against the femoral condyles such that an elongated resection aperture extending through the femoral implant alignment guide has a major axis substantially perpendicular to the defined axis;
inserting a first portion of a rod into a rod aperture extending through an offset portion of the femoral implant alignment guide, when the offset portion is aligned with a point in a coronal plane of the patient that is shared with a greater trochanter of the patient and a second axis of the offset portion is in the coronal plane and is substantially parallel to the major axis, such that a long axis of the rod is substantially parallel to the defined axis;
inserting a needle coupled to a second portion of the rod into the patient until a tip of the needle contacts a most lateral point of the grater trochanter;
resecting at least a portion of the femoral condyles along a plane defined by the elongated resection aperture subsequent to inserting the needle; and
coupling a femoral component of the knee arthroplasty device to the resected portion of the femoral condyles after removing the femoral implant alignment guide from the femur subsequent to the resection.
