# US 10,499,933 B2 · Alignment devices and methods

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- Number: US 10,499,933 B2
- Document ID: US10499933B2
- Status: Granted
- Kind: B2
- Application number: 14/433,866
- Filed: 2013-10-18
- Published: 2015-09-24
- Granted: 2019-12-10
- Earliest claimed: 2012-10-18
- Assignees: Smith & Nephew, Inc.
- Applicants: Smith & Nephew, Inc.
- Inventors: Zachary Christopher Wilkinson
- Web page: https://patentgrep.com/patent/US10499933B2

## 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 implanting an arthroplasty device, comprising:
securing a first instrument to an unresected distal portion of a femur bone of a patient, the first instrument comprising a body including a bone facing surface configured to partially contact the unresected portion of the femur bone, and an offset portion extending from the body in a coronal plane of the patient;
inserting a trochanter probe into the patient at a position lateral to a greater trochanter of the femur bone;
connecting a rod to the trochanter probe and the offset portion, wherein the rod is in the coronal plane of the patient;
aligning, using the rod, the first instrument with two or more physiological reference points that define an axis from between the patient's femoral condyles through the patient's hip center;
resecting a distal portion of the femur bone through an aperture within the body of the aligned first instrument to receive a femoral component of the arthroplasty device;
aligning a first body of a second instrument with the resected distal portion of the femur bone;
securing the first body of the second instrument to the resected distal portion of the femur bone by inserting interface pins projecting from the first body into one or more holes in the resected portion of the femur bone; and
resecting a portion of a tibia bone of the patient through an aperture within a second body of the second instrument to receive a tibia component when the patient's femur and tibia bones are aligned.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
positioning tissue adjacent to the second instrument such that tissue adjacent to the first instrument is positioned appropriately relative to the tissue adjacent to the second instrument;
removing tissue adjacent to the second instrument to prepare the portion of the tibia bone to receive the second component;
implanting a first component of the arthroplasty device; and
implanting a second component of the arthroplasty device.

### Claim 3 (depends on 2)

The method of claim 2, wherein removing the tissue adjacent to the first instrument to prepare the portion of the femur bone to receive the first component comprises resecting the distal portion of the femur; and
wherein removing tissue adjacent to the second instrument to prepare the portion of the tibia bone to receive the second component comprises resecting the portion of the tibia.

### Claim 4 (depends on 1)

The method of claim 1, wherein the aperture within the second body of the second instrument further comprises a resection slot.

### Claim 5 (depends on 1)

The method of claim 1, wherein aligning the second instrument with the resected distal portion of the femur bone comprises aligning medial and lateral condyle paddles with the resected distal portion of the femur.

### Claim 6 (depends on 1)

The method of claim 1, wherein securing the second instrument with the resected distal portion of the femur bone comprises inserting the pins projecting from medial and lateral condyle paddles of the first body of the second instrument into the holes in the resected distal portion of the femur.

### Claim 7 (depends on 1)

The method of claim 1, further comprising aligning the first instrument based at least in part on engagement of the first instrument with the unresected distal portion of the femur;
performing the distal resection on the femur based of the position of the first instrument when aligned with the two or more physiological reference points; and
making one or more holes in the femur based on the position of the first instrument when aligned with the two or more physiological reference points.

### Claim 8 (depends on 7)

The method of claim 7, further comprising removing the first instrument from the femur after performing the distal resection and making the one or more holes in the femur;
providing the second instrument.

### Claim 9 (depends on 8)

The method of claim 8, wherein the one or more holes in the femur comprises making a hole in a medial condyle of the femur through an opening in the first instrument, and making another hole in a lateral condyle of the femur through the opening in the lateral portion; and
wherein inserting the one or more outwardly-projecting pins into the one or more holes in the femur comprises inserting a first outwardly-projecting pin of the second instrument into the opening in the medial condyle, and inserting a second outwardly-projecting pin of the second instrument into the opening in the lateral condyle.

### Claim 10 (depends on 1)

The method of claim 1, further comprising constraining rotational displacement in a sagittal plane of the patient of the offset portion and the body of the first instrument.

### Claim 11 (depends on 1)

The method of claim 1, further comprising providing the first instrument having a receiving portion including the bone facing surface configured to engage the femur, the first instrument defining a window; and
wherein aligning the first instrument with the two or more physiological reference points comprises aligning the first instrument based on a reference visible through the window while a distal end of a femur is received in the receiving portion of the first instrument.

### Claim 12

A method of implanting an arthroplasty device, comprising:
securing a femoral implant alignment guide to an unresected distal portion of a femur of a patient, the femoral implant alignment guide comprising a body including a bone facing surface configured to partially contact the unresected portion of the femur bone, and an offset portion extending laterally from the body and away from the patient;
inserting a trochanter probe into the patient at a position lateral to a greater trochanter;
connecting a rod to the trochanter probe and the offset portion, wherein the rod is in a coronal plane of the patient;
aligning, using the rod, the femoral implant alignment guide with two or more physiological reference points that define an axis from between the patient's femoral condyles through the patient's hip center;
resecting a portion of the femur bone through an aperture within the body of the aligned femoral implant alignment guide to receive a femoral component of the arthroplasty device;
aligning a tibial implant alignment guide with the resected distal portion of the femur bone;
securing the tibial implant alignment guide to the resected distal portion of the femur bone by inserting interface pins projecting from the tibial implant alignment guide into one or more holes in the resected portion of the femur bone;
resecting a proximal portion of a tibia bone of the patient through an aperture within the tibial implant alignment guide to receive a tibial component when the patient's femur and tibia are aligned.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
positioning tissue adjacent to the tibial implant alignment guide such that tissue adjacent to the femoral implant alignment guide is positioned appropriately relative to the tissue adjacent to the tibial implant alignment guide;
removing the tissue adjacent to the tibial implant alignment guide to resect the proximal portion of the tibia to receive the tibial component;
implanting the femoral component of the arthroplasty device; and
implanting the tibial component of the arthroplasty device.

### Claim 14 (depends on 12)

The method of claim 12, wherein the aperture within the tibial implant alignment guide comprises a resection slot.

### Claim 15 (depends on 12)

The method of claim 12, wherein aligning the tibial implant alignment guide with respect to the resected distal portion of the femur bone comprises aligning medial and lateral condyle paddles of the tibial implant alignment guide with the resected distal surface of the femur.

### Claim 16 (depends on 12)

The method of claim 12, wherein aligning the tibial implant alignment guide with the resected distal portion of the femur bone comprises aligning the interface pins projecting from medial and lateral condyle paddles of the tibial implant alignment guide with holes in the resected surface of the femur.

### Claim 17 (depends on 12)

The method of claim 12, further comprising aligning the femoral implant alignment guide based at least in part on engagement of the femoral implant alignment guide with an unresected distal end of the femur;
performing the distal resection on the femur based of the position of the femoral implant alignment guide when aligned with the two or more physiological reference points; and
making the one or more holes in the femur based on the position of the femoral implant alignment guide when aligned with the two or more physiological reference points.

### Claim 18 (depends on 17)

The method of claim 17, further comprising removing the femoral implant alignment guide from the femur after performing the distal resection and making the one or more holes in the femur;
aligning the tibial implant alignment guide having the one or more outwardly-projecting interface pins with the resected femur prepared to receive the first component; and
inserting the one or more outwardly-projecting pins into the one or more holes in the femur.

### Claim 19 (depends on 18)

The method of claim 18, wherein the one or more holes in the femur comprises making a hole in a medial condyle of the femur through an opening in the femoral implant alignment guide, and making another hole in a lateral condyle of the femur through the opening in the lateral portion; and
wherein inserting the one or more outwardly-projecting pins into the one or more holes in the femur comprises inserting a first outwardly-projecting pin of the second instrument into the opening in the medial condyle, and inserting a second outwardly-projecting pin of the second instrument into the opening in the lateral condyle.

### Claim 20

A method of implanting an arthroplasty device, comprising:
securing a femoral implant alignment guide to an unresected portion of a femur of a patient, the femoral implant alignment guide comprising a body including a bone facing surface configured to partially contact the unresected portion of the femur bone, and an offset portion extending laterally from the body and away from the patient;
inserting a trochanter probe into the patient at a position lateral to a greater trochanter;
connecting a rod to the trochanter probe and the offset portion, wherein the rod is in a coronal plane of the patient;
aligning, using the rod, the femoral implant alignment guide with two or more physiological reference points that define an axis from between the patient's femoral condyles through the patient's hip center;
resecting a portion of the femur bone through an aperture within the body of the aligned femoral implant alignment guide to receive a femoral component of the arthroplasty device;
aligning a tibial implant alignment guide with the resected distal portion of the femur bone;
securing the tibial implant alignment guide to the resected distal portion of the femur bone by inserting interface pins projecting from the tibial implant alignment guide into one or more holes in the resected portion of the femur bone;
resecting a portion of a tibia bone of the patient through an aperture within the tibial implant alignment guide to receive a tibial component when the patient's femur and tibia are aligned.
