Implantable sensors and methods of use

• US 10,219,699 B2
• Filed: 11/10/2014
• Issued: 03/05/2019
• Est. Priority Date: 11/10/2014
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Intellirod Spine Inc.
• Inventors: Wilder, Steven E., Johnson, Daniel J., Navarro, Richard R.
• Primary Examiner(s): Henson, Devin B
• Application Number:
  US14/537,398
• Publication Number:
  US 20160128573A1
• Time in Patent Office: 1,576 Days
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/4566 Evaluating the spine A61B5/4561 takes precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: H04W 84/18 Self-organising networks, e.g. ad-hoc networks or sensor networks

Abstract

Systems, methods, and apparatus are described herein for obtaining medical diagnostic measurements from implanted sensors. In various embodiments, a spinal implant-monitoring apparatus may include: a bridge defining a first hermetically-sealed interior and two or more legs; one or more strain gauges contained within the first hermetically-sealed interior of the bridge to provide a signal indicative of strain measured between the legs of the bridge; a housing defining a second hermetically-sealed interior, the housing mounted on a surface of the bridge; and control circuitry contained within the second hermetically-sealed interior. The control circuitry may be in communication with the one or more strain gauges and may be configured to convert the signal into digital data representative of the signal. Methods of using such apparatus are also disclosed.

Claims

1. A spinal implant-monitoring apparatus, comprising:

a bridge defining a first hermetically-sealed interior and including a first leg and a second leg that extend parallel to one another and laterally from a span of the bridge;

one or more strain gauges contained within the first hermetically-sealed interior to provide a signal indicative of strain measured at the bridge;

a first clamp and a second clamp, the clamps being configured to be rigidly secured to a rod implanted in a patient'"'"'s body, wherein each of the first and second clamp defines a respective recess into which a respective first or second leg of the bridge is inserted and secured, and wherein one or both of the clamps define a platform adjacent the respective recess;

a housing defining a second hermetically-sealed interior, the housing mounted on the platform defined by one or both of the clamps, adjacent the bridge; and

control circuitry contained within the second hermetically-sealed interior, the control circuitry in communication with the one or more strain gauges and configured to convert the signal into digital data representative of the signal.

2. The spinal implant-monitoring apparatus of claim 1, further comprising an antenna contained within the second hermetically-sealed interior and spaced from the control circuitry.

3. The spinal implant-monitoring apparatus of claim 2, wherein the antenna comprises a coil wrapped around a portion of a frame that spaces the coil from the control circuitry.

4. The spinal implant-monitoring apparatus of claim 2, wherein the control circuitry is configured to wirelessly transmit, to a reader via the antenna, the digital data representative of the signal.

5. The spinal implant-monitoring apparatus of claim 4, wherein the control circuitry is further configured to wirelessly transmit the digital data during a portion of a transmission time interval that is stochastically selected from a plurality of portions of the transmission time interval.

6. The spinal implant-monitoring apparatus of claim 5, wherein the transmission time interval is one of a plurality of transmission time intervals, each divided into a plurality of sub-transmission time intervals, and wherein the control circuitry is further configured to transmit the digital data during a stochastically selected sub-transmission time interval of each of the plurality of transmission time intervals.

7. The spinal implant-monitoring apparatus of claim 5, wherein the portion of the transmission time interval is stochastically selected based at least in part on a unique identifier assigned to the spinal implant-monitoring apparatus.

8. The spinal implant-monitoring apparatus of claim 1, wherein the housing comprises a generally planar lid mounted on a ceramic cap, wherein a portion of the ceramic cap adjacent the generally-planar lid is encompassed by a metal ring, wherein the metal ring is welded to a metal portion of the generally-planar lid.

9. The spinal implant-monitoring apparatus of claim 1, wherein at least one of the one or more strain gauges is communicatively coupled with an adjacent strain gauge.

10. The spinal implant-monitoring apparatus of claim 1, wherein the one or more strain gauges comprises a plurality of strain gauges connected in series to form a series of strain gauges.

11. The spinal implant-monitoring apparatus of claim 10, wherein terminal ends of the series of strain gauges are coupled with feed-through pins that pass from within the first hermetically-sealed interior to a position exterior from the bridge.

12. The spinal implant-monitoring apparatus of claim 11, wherein the feed-through pins pass through the housing into the second hermetically-sealed interior to couple the series of strain gauges with the control circuitry.

13. The spinal implant-monitoring apparatus of claim 1, wherein at least one of the two clamps includes isolation structure that is securable to the other of the two clamps to maintain a secured connection between the two clamps, wherein the secured connection isolates strain sensed by the bridge from other forces imparted on the spinal implant-monitoring apparatus.

14. The spinal implant-monitoring apparatus of claim 13, wherein the isolation structure comprises the platform.

15. The spinal implant-monitoring apparatus of claim 1, wherein the bridge comprises a stress concentration zone in a location that is separate from the hermetically sealed interior of the bridge.