IP Library Granted Patent US 12678300
Granted Patent B2
US 12678300 · App. 19/272,557 · Granted Jul 14, 2026

Telemetry trial for digital implant

Inventors: Kevin T. Foley (Germantown, TN); Steven D. Glassman (Louisville, KY); Adam D. Glaser (Collierville, TN); Newton H. Metcalf, Jr. (Memphis, TN); Jerald L. Redmond (Germantown, TN)
Assignee: WARSAW ORTHOPEDIC, INC.
A61F2/468A61B17/7074A61F2/4684A61B2017/00424A61B2017/00455A61B2017/00681A61F2002/4632A61F2002/4658A61F2002/4662
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Quick Facts
Patent No.
US 12678300
App. No.
19/272,557
Granted
Jul 14, 2026
Kind
B2
Abstract

Devices and methods for trial-fitting smart medical implants are disclosed. A trial fitting device for a smart implant includes a handle, a shaft extending from the handle, a head portion attached to the shaft such that the head portion rotates with the shaft, and a rotational indicator disposed on the shaft and/or the handle, the rotational indicator configured to indicate a rotational orientation of the head portion. The trial fitting device further includes a telemetry gauge disposed on the shaft and/or the handle, the telemetry gauge configured to indicate a threshold distance from the head portion.

Claims (47)

1 . A trial fitting device for a smart implant, the device comprising:

a handle;

a shaft extending from the handle;

a head portion attached to the shaft such that the head portion rotates with the shaft;

a transmitter disposed in the head portion, the transmitter configured to transmit a test signal;

a rotational indicator disposed on the shaft and/or the handle, the rotational indicator configured to indicate a rotational orientation of the head portion; and

a telemetry gauge disposed on the shaft and/or the handle, the telemetry gauge configured to indicate a threshold distance from the head portion.

2 . The trial fitting device of claim 1 , wherein the head portion is shaped and dimensioned to correspond with a smart implant.

3 . The trial fitting device of claim 2 , wherein the head portion includes a visual cue of where a longitudinal rod would interface with the smart implant.

4 . The trial fitting device of claim 1 , wherein the telemetry gauge is configured to indicate a depth of tissue that permits effective telemetry from a smart implant in the position and orientation of the head portion.

5 . The trial fitting device of claim 4 , wherein the telemetry gauge is configured to indicate a range of distances indicating a range of tissue depths that permit effective telemetry, the range of distances based on a parameter of the tissue.

6 . The trial fitting device of claim 1 , further comprising a control configured to cause the transmitter to transmit the test signal.

7 . The trial fitting device of claim 1 , wherein the transmitter is configured to transmit the test signal at one of at least two different strengths.

8 . The trial fitting device of claim 1 , wherein the handle and the shaft share a longitudinal axis.

9 . The trial fitting device of claim 1 , wherein the handle comprises an ergonomic grip.

10 . The trial fitting device of claim 1 , wherein the rotational indicator is etched into the handle.

11 . The trial fitting device of claim 1 , wherein the head portion is shaped and dimensioned to correspond with an interbody device.

12 . A method of trial-fitting an implant, the method comprising:

receiving a trial-fitting tool comprising:

a handle;

a shaft extending from the handle;

a head portion attached to the shaft such that the head portion rotates with the shaft, the head portion shaped and dimensioned to correspond with a smart implant;

a rotational indicator disposed on the shaft and/or the handle, the rotational indicator configured to indicate a rotational orientation of the head portion; and

a telemetry gauge disposed on the shaft and/or the handle, the telemetry gauge configured to indicate a threshold distance from the head portion;

using the handle of the trial-fitting tool to:

position the head portion at a trial location for an implant; and

adjust, as needed, the position and orientation of the head portion to fit available space;

confirming, using the rotational indicator, that the head portion has a desired orientation;

confirming, using the telemetry gauge, that a point of incision is within the threshold distance from the head portion to the point of incision; and

installing the implant in place of the trial-fitting tool.

13 . The method of claim 12 , further comprising, in response to the head portion not fitting at the trial location, using a trial-fitting tool having a second head portion, the second head portion shaped and dimensioned to correspond with a second smart implant, to position the second head portion at the trial location.

14 . The method of claim 13 , wherein using the trial-fitting tool having the second head portion comprises replacing the head portion of the trial-fitting tool with the second head portion.

15 . The method of claim 12 , wherein:

the trial-fitting tool further comprises a transmitter disposed in the head portion and configured to transmit a test signal; and

the method further comprises, while the head portion is positioned at the trial location, causing the transmitter to transmit the test signal.

16 . The method of claim 12 , wherein:

the method further comprises assessing attenuation characteristics of the tissue between the head portion and the telemetry gauge; and

confirming that the point of incision is within the threshold distance is based on the assessed attenuation characteristics.

17 . The method of claim 12 , wherein positioning the head portion at the trial location comprises positioning the head portion by a surgical navigation robot.

18 . A trial fitting device for a smart implant, the device comprising:

a handle;

a shaft extending from the handle;

a head portion attached to the shaft such that the head portion rotates with the shaft, wherein the head portion includes a visual cue of where a longitudinal rod would interface with the smart implant;

a rotational indicator disposed on the shaft and/or the handle, the rotational indicator configured to indicate a rotational orientation of the head portion; and

a telemetry gauge disposed on the shaft and/or the handle, the telemetry gauge configured to indicate a threshold distance from the head portion.

19 . The trial fitting device of claim 18 , wherein the telemetry gauge is configured to indicate a depth of tissue that permits effective telemetry from a smart implant in the position and orientation of the head portion.

20 . The trial fitting device of claim 18 , wherein the rotational indicator is etched into the handle.