# US 10,245,163 B2 · Trial prosthesis system

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- Number: US 10,245,163 B2
- Document ID: US10245163B2
- Status: Granted
- Kind: B2
- Application number: 15/325,941
- Filed: 2015-07-22
- Published: 2017-07-06
- Granted: 2019-04-02
- Earliest claimed: 2014-07-23
- Assignees: Biomet Manufacturing, LLC
- Applicants: Biomet Manufacturing, LLC
- Inventors: Austen Davenport; Kirk J. Bailey
- Web page: https://patentgrep.com/patent/US10245163B2

## CPC

- A61F 2/4684: {Trial or dummy prostheses}
- A61F 2/3609: {Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts (A61F2/3601 takes precedence)}
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61F 2002/30617: {Visible markings for adjusting, locating or measuring}
- A61F 2002/3611: {Heads or epiphyseal parts of femur}
- A61F 2002/365: {Connections of heads to necks}
- A61F 2002/3654: {Connections of heads directly to shafts}
- A61F 2002/4668: {for measuring angles}
- 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)

## Abstract

According to various embodiments, a trial system (100) and instruments can be used to assist in confirming that a planned procedure is achieved. In various embodiments, the trial or provisional portions can include markings (110) on a trial or provisional portion to compare to one or more implanted members to ensure an planned position is achieved.

## Claims

### Claim 1

A system for confirming a selected configuration of a first portion and a second portion of a prosthesis system, comprising:
a trial femoral head member having an external surface configured to be at least partially received within an acetabular component;
a patient-specific indicator viewable by a user on an exterior surface of the trial femoral head member; and
a connection region configured to provisionally connect to a portion of a femoral member;
wherein the patient-specific indicator comprises:
a circular line indicating when a preferred single selected configuration of the femoral stem relative to the acetabular system is achieved; and
a mark region disposed on either side of the circular line indicating when configurations of the femoral stem relative to the acetabular system are within a safe zone;
wherein widths of the circular line and the mark region are selected based on pre-procedure planning for a specific patient.

### Claim 2 (depends on 1)

The system of claim 1, the femoral member comprising: a femoral stem configured to be implanted into a femur and interconnect with the trial femoral head.

### Claim 3 (depends on 1)

The system of claim 1, further comprising:
an acetabular system including the acetabular component configured to be implanted into an acetabulum.

### Claim 4 (depends on 3)

The system of claim 3, wherein the patient-specific indicator illustrates a range of configurations relative to at least the single selected configuration of the femoral stem relative to the acetabular system.

### Claim 5 (depends on 4)

The system of claim 4, wherein the patient-specific indicator has a width of greater than about 3 mm.

### Claim 6 (depends on 4)

The system of claim 4, wherein the patient-specific indicator includes a width to indicate an angular variation of about 1 degree to about 5 degrees from the selected single planned configuration of the femur and the pelvis.

### Claim 7 (depends on 3)

The system of claim 3, wherein the patient-specific indicator is configured to be viewed relative to a rim of the acetabular system to indicate whether a predetermined configuration of the femur and the pelvis has been achieved.

### Claim 8

A system for confirming a selected configuration of a first portion and a second portion of a prosthesis system, comprising:
a femoral prosthesis including a stem portion and a femoral neck portion configured to be interconnected with a femur;
an acetabular component having an articulating surface; and
a trial femoral head member having an external surface configured to provisionally engage with the articulating surface, wherein the trial femoral head includes:
an annular patient-specific indicator formed on an exterior surface of the trial femoral head member configured to be viewed relative to the acetabular component when the trial femoral head is provisionally engaging the acetabular component, wherein the annular patient-specific indicator provides an indication of a varus/valgus angle between the stem portion and the trial femoral head;
wherein the annular patient-specific indicator is selected based on pre-procedure planning for a specific patient.

### Claim 9 (depends on 8)

The system of claim 8, wherein the trial femoral head further includes a bore formed in the trial femoral head to provisionally connect the trial femoral head to the femoral neck.

### Claim 10 (depends on 8)

The system of claim 8, further comprising:
an acetabular shell configured to be implanted into an acetabulum;
wherein the acetabular component is fixed to the acetabular shell.

### Claim 11 (depends on 8)

The system of claim 8, wherein the acetabular component has a rim and the annular patient-specific indicator is configured to be aligned with the rim at a selected configuration of the trial femoral head relative to the acetabular component for the varus/valgus angle.

### Claim 12 (depends on 8)

The system of claim 8, wherein the acetabular component has a rim that defines a plane, wherein the plane intersects the annular patient-specific indicator within a selected range of angular orientations of the femoral neck relative to the acetabular component for the varus/valgus angle.

### Claim 13

A method for confirming a selected configuration of a first portion and a second portion of a prosthesis system, comprising:
obtaining a blank of a trial femoral head;
evaluating a selected final configuration of a femur and a pelvis from pre-procedure data for a specific patient; and
forming a patient-specific indicator on an exterior surface of the blank to align with a rim of an acetabular component when the selected final configuration of the femur and the pelvis is achieved based on the pre-procedure data for the specific patient;
wherein the alignment of the patient-specific indicator with the rim confirms that the selected final configuration of the femur and the pelvis is achieved.

### Claim 14 (depends on 13)

The method of claim 13, further comprising:
evaluating the pre-procedure data for the specific patient to determine the selected final configuration of the femur and the pelvis; and
determining a location on the exterior surface to form the patient-specific indicator to indicate the determined selected final configuration of the femur and the pelvis.

### Claim 15 (depends on 14)

The method of claim 14, further comprising:
forming the blank of the trial femoral head for the specific patient before obtaining the pre-procedure data for the specific patient and forming the patient-specific indicator on the blank at the determined location after evaluating the selected final configuration of the femur and the pelvis from the pre-procedure data for the specific patient.

### Claim 16 (depends on 15)

The method of claim 15, wherein the pre-procedure data for the specific patient includes image data of the specific patient.

### Claim 17 (depends on 15)

The method of claim 15, wherein the patient-specific indicator is formed to identify a single configuration of the femur and the pelvis.

### Claim 18 (depends on 15)

The method of claim 15, wherein the patient-specific indicator is formed to identify a safe zone of positions of the femur relative to the pelvis relative to a single configuration of the femur and the pelvis.

### Claim 19 (depends on 13)

The method of claim 13, further comprising: forming the patient-specific indicator to be an annular mark on the exterior surface.

### Claim 20 (depends on 8)

The system of claim 8, wherein the annular patient-specific indicator comprises:
a circular line indicating when a preferred single selected configuration of the stem portion relative to the acetabular component is achieved for the varus/valgus angle; and
a mark region disposed on either side of the circular line indicating when configurations of the stern portion relative to the acetabular component are within a safe zone;
wherein widths of the circular line and the mark region are selected based on the pre-procedure planning for the specific patient.