IMPLANTABLE MEDICAL DEVICE INCLUDING MECHANICAL STRESS SENSOR

• US 20110004124A1
• Filed: 04/26/2010
• Published: 01/06/2011
• Est. Priority Date: 07/01/2009
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Litow, Micah A., Lessar, Joseph F., Neville, James D., Schendel, Michael J.
• Application Number:
  US12/767,456
• Publication Number:
  US 20110004124A1
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

Systems and techniques for determining in vivo mechanical load exerted on an implanted medical device (IMD) are described. The IMD or a device that has a substantially similar form factor as the IMD includes at least one mechanical stress sensor mechanically coupled to a housing or a component within the housing. In some examples, a patient parameter is determined based on a signal indicative of the in vivo mechanical load exerted on the IMD. In addition, in some examples, a processor determines whether a transient or cumulative mechanical load exerted on an IMD exceeded a predetermined threshold. A processor may additionally or alternatively determine whether a pattern in the mechanical loading of the IMD indicates a diversion from a manufacturing, shipping, storage or other handling process.

Claims

1. An implantable medical system comprising:

a housing;

a therapy delivery module substantially enclosed within the housing, wherein the therapy delivery module is configured to deliver therapy to a patient;

a component substantially enclosed within the housing; and

a mechanical stress sensor mechanically coupled to at least one of the housing or the component, wherein the mechanical stress sensor generates a signal indicative of a mechanical load exerted on the housing or the component.

2. The system of claim 1, wherein the component comprises a circuit board and the mechanical stress sensor is at least one of mechanically attached to the circuit board or integrated into the circuit board.

3. The system of claim 1, wherein the component comprises at least one of a processor or a power source of the therapy delivery module.

4. The system of claim 1, wherein the mechanical stress sensor is mechanically coupled to at least one of an interior surface or an exterior surface of the housing, or integrated with the interior surface or the exterior surface of the housing.

5. The system of claim 1, further comprising:

a telemetry module substantially enclosed within the housing; and

a processor substantially enclosed within the housing, wherein the processor is configured to receive the signal from the mechanical stress sensor and transmit information indicative of the signal to an external device via the telemetry module.

6. The system of claim 1, further comprising a processor that is configured to receive the signal from the mechanical stress sensor and automatically determine whether the mechanical load exerted on the housing is greater than or equal to a predetermined threshold based on the signal generated by the mechanical stress sensor.

7. The system of claim 6, wherein the processor is configured to generate an indication if the mechanical load exerted on the housing is greater than or equal to the predetermined threshold.

8. The system of claim 1, further comprising a processor that is configured to receive the signal from the mechanical stress sensor and automatically determine at least one parameter of the patient based on the signal.

9. The system of claim 8, wherein the processor is configured to control the therapy delivery module based on the determined parameter of the patient.

10. The system of claim 1, further comprising a processor and a memory, wherein the processor is configured to determine a mechanical stress signature based on the signal generated by the mechanical stress sensor and store the mechanical stress signature in the memory.

11. The system of claim 10, wherein the processor is configured to compare the mechanical stress signature to a predetermined signature template and generate an indication based on the comparison.

12. The system of claim 1, wherein the mechanical stress sensor comprises at least one of a printed circuit comprising pressure sensitive ink, a piezoresistor, a piezoelectric crystal, a load cell, a capacitive sensor, a pressure transducer, a force sensor, a displacement sensor or a strain gauge.

13. A method comprising:

implanting a mechanical stress indicator system in a patient, wherein the mechanical stress indicator system comprises;

a housing defining a form factor of an implantable medical device that delivers therapy to a patient;

a component enclosed within the housing; and

a mechanical stress sensor coupled to at least one of the housing or the component, wherein the mechanical stress sensor generates a signal indicative of a mechanical load exerted on the housing or the component; and

with a processor, determining an in vivo mechanical load exerted on the housing based on the signal generated by the mechanical stress sensor.

14. The method of claim 13, further comprising, with the processor, determining whether the mechanical load exerted on the housing is greater than or equal to a predetermined threshold based on the signal generated by the mechanical stress sensor.

15. The method of claim 13, further comprising, with the processor, determining at least one parameter of the patient based on the signal.

16. The method of claim 15, wherein the mechanical stress indicator system further comprises a therapy delivery module substantially enclosed within the housing, the method further comprising controlling therapy delivery by the therapy delivery module based on the determined parameter of the patient.

17. The method of claim 13, further comprising:

with the processor, determining a mechanical stress signature based on the signal generated by the mechanical stress sensor;

with the processor, comparing the mechanical stress signature to a predetermined signature template; and

with the processor, generating an indication based on the comparison.

18. A method comprising:

receiving a signal generated by a mechanical stress sensor implanted within a patient, wherein the signal is indicative of a mechanical load exerted on a housing that defines a form factor of an implantable medical device that delivers therapy to a patient, and wherein the mechanical stress sensor is coupled to at least one of the housing or a component enclosed within the housing;

with a processor, comparing at least one characteristic of the signal to a predetermined threshold value; and

with the processor, generating an indication based on the comparison.

19. The method of claim 18, wherein generating the indication comprises generating the indication if the at least one characteristic of the signal is greater than or equal to the predetermined threshold value.

20. The method of claim 18, further comprising, with the processor, transmitting the indication to a device separate from the mechanical stress sensor if the comparison of the at least one characteristic of the signal to the predetermined threshold value indicates the mechanical load exerted on the housing is greater than or equal to the predetermined threshold.