PRE-IMPLANT DETECTION

• US 20150209588A1
• Filed: 01/24/2014
• Published: 07/30/2015
• Est. Priority Date: 01/24/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Christensen, Eric M.
• Granted Patent: US 9,764,139 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

A medical device system and associated method determine an implantable medical device state prior to implantation. An impedance monitoring module monitors for a change in impedance between a pair of electrodes coupled to the impedance monitoring circuit. The system includes an enclosure for carrying the implantable medical device. The enclosure has a surface having an electrical impedance. A control module is configured to detect one of a first pre-implant state and a second pre-implant state of the implantable medical device in response to the impedance monitoring module detecting a change in impedance between the electrodes and adjust operation of the implantable medical device in response to detecting the impedance change.

Claims

1. A medical device system, comprising:

an implantable medical device comprising;

a first electrode;

a second electrode;

an impedance monitoring module coupled to the first electrode and the second electrode and configured to measure an impedance between the first electrode and the second electrode; and

a control module configured to control operation of the implantable medical device based on the measured impedance; and

an enclosure for carrying the implantable medical device, the enclosure comprising a surface having an electrical impedance and configured to contact the first electrode and the second electrode when the implantable medical device is placed within the enclosure,

wherein the control module is configured to detect one of a first pre-implant state and a second pre-implant state of the implantable medical device in response to the impedance monitoring module detecting a change in impedance between the first electrode and the second electrode and adjust operation of the implantable medical device in response to detecting the impedance change.

2. The system of claim 1, wherein the implantable medical device further comprises a telemetry module configured to transmit wireless communications,

wherein the control module is configured to control the telemetry module to transmit a signal in response to the detection of the change in impedance.

3. The system of claim 2, wherein the telemetry module comprises a transmitter without a receiver such that the implantable medical device is configured for uni-directional, transmission communication only.

4. The system of claim 1, wherein the surface comprises:

a first pair of contacts having a first electrical impedance, wherein a first contact of the first pair of contacts is configured to contact the first electrode of the implantable medical device and a second contact of the first pair of contacts is configured to contact the second electrode of the implantable medical device when the implantable medical device is placed in a first position within the enclosure; and

a second pair of contacts having a second electrical impedance different than the first electrical impedance, wherein a first contact of the second pair of contacts is configured to contact the first electrode of the implantable medical device and a second contact of the second pair of contacts is configured to contact the second electrode of the implantable medical device when the implantable medical device is placed in a second position within the enclosure.

5. The system of claim 4, wherein the enclosure comprises an advancement member configured to advance the implantable medical device from the first position to the second position.

6. The system of claim 4, wherein the enclosure comprises a stopping member for controlling advancement of the implantable medical device from the first position to the second position.

7. The system of claim 5, wherein the enclosure comprises:

an outer body, the surface defining an inner lumen of the outer body, the inner lumen configured to receive the implantable medical device; and

wherein the advancement member comprises a plunger configured to advance within the inner lumen to advance the implantable medical device from the first position to the second position.

8. The system of claim 4, wherein:

the first contact of the first pair of contacts extends along a portion of the enclosure;

the second contact of the first pair of contacts being spaced apart from the first contact;

the first contact of the second pair of contacts being the first contact of the first pair of contacts; and

the second contact of the second pair of contacts being spaced apart from the second contact of the first pair of contacts.

9. The system of claim 4, wherein the first contact of the first pair of contacts has a first longitudinal length along the enclosure, the second contact of the first pair of contacts has a second longitudinal length along the enclosure, and the second contact of the second pair of contacts has a third longitudinal length along the enclosure, the first longitudinal length being greater than the second and third longitudinal lengths.

10. The system of claim 4, wherein the enclosure comprises a locking mechanism adjustable between a first locking position to maintain the implantable medical device in a first position coupled to the first pair of contacts and a second locking position to maintain the implantable medical device in a second position coupled to the second pair of contacts.

11. The system of claim 1, wherein the surface comprises a conductive polymer.

12. The system of claim 1, wherein the surface comprises a conductive ink.

13. The system of claim 1, wherein the enclosure comprises a first component for retaining the implantable medical device in a first position along a portion of the surface having a first impedance and a second component for retaining the implantable medical device in a second position along a portion of the surface having a second impedance.

14. The system of claim 1, wherein the control module is configured to detect the one of the first pre-implant state and the second pre-implant state in response to the impedance monitoring module detecting a change between the impedance of the surface and an open circuit impedance.

15. A method for verifying an implantable medical device status prior to implantation, comprising:

monitoring an impedance between a pair of electrodes by an impedance monitoring circuit of an implantable medical device;

detecting a change in the impedance between the pair of electrodes when a position of the implantable medical device is changed relative to a surface of an enclosure for carrying the implantable medical device, the enclosure comprising a surface having an electrical impedance and configured to contact the first electrode and the second electrode when the implantable medical device is placed within the enclosure;

detecting by a control module of the implantable medical device one of a first pre-implant state and a second pre-implant state of the implantable medical device in response to the impedance monitoring module detecting the change in impedance between the first electrode and the second electrode; and

adjusting operation of the implantable medical device in response to detecting the change in impedance.

16. The method of claim 15, further comprising, responsive to detecting the impedance change transmitting a signal from a telemetry module configured to transmit wireless communications from the implantable medical device.

17. The method of claim 16, wherein transmitting the signal comprises only uni-directional, transmission communication.

18. The method of claim 15, wherein detecting the change in impedance between the first electrode and the second electrode comprises detecting a change from a first impedance of the enclosure to a second impedance of the enclosure,

the first impedance defined by a first pair of contacts along the surface of the enclosure, a first contact of the first pair of contacts configured to contact the first electrode of the implantable medical device and a second contact of the first pair of contacts configured to contact the second electrode of the implantable medical device when the implantable medical device is placed in a first position within the enclosure,

the second impedance defined by a second pair of contacts along the surface of the enclosure and different than the first impedance, a first contact of the second pair of contacts configured to contact the first electrode of the implantable medical device and a second contact of the second pair of contacts configured to contact the second electrode of the implantable medical device when the implantable medical device is placed in a second position within the enclosure.

19. The method of claim 18, further comprising advancing the implantable medical device from the first position to the second position by an advancement member of the enclosure.

20. The method of claim 19, wherein advancing the implantable medical device to the second position comprises advancing the implantable medical device from the first position to the second position held by a stopping mechanism.

21. The method of claim 18, wherein the advancing comprises advancing a plunger through an inner lumen of an outer body of the enclosure, the surface being the inner lumen.

22. The method of claim 18, wherein advancing the implantable medical device from the first position to the second position comprises:

advancing the first electrode from a first position along the first contact of the first pair of contacts to a second position along the first contact of the first pair of contacts, the first contact of the first pair of contacts also being the first contact of the second pair of contacts; and

advancing the second electrode from the second contact of the first pair of contacts to the second contact of the second pair of contacts, the second contact of the first pair of contacts and the second contact of the second pair of contacts being spaced apart from the first contact.

23. The method of claim 18, further comprising adjusting a locking mechanism of the enclosure between a first locking position to maintain the implantable medical device in a first position coupled to the first pair of contacts and a second locking position to maintain the implantable medical device in a second position coupled to the second pair of contacts.

24. The method of claim 15, wherein measuring the impedance comprises measuring the impedance through a conductive polymer of the enclosure.

25. The method of claim 15, wherein measuring the impedance comprises measuring the impedance through a conductive ink printed along the surface.

26. The method of claim 15, wherein detecting the change in impedance comprises:

detecting a change from a first impedance of a first portion of the surface of the enclosure to a second impedance of a second portion of the surface of the enclosure,

the enclosure comprising a first component for retaining the implantable medical device in a first position along the first portion of the surface having the first impedance and a second component for retaining the implantable medical device in a second position along the second portion of the surface having the second impedance.

27. The method of claim 15, wherein detecting the impedance change comprises detecting a change between the impedance of the surface and an open circuit impedance.

28. An implantable medical device system, comprising :

means for monitoring impedance between a first electrode and a second electrode of an implantable medical device;

means for coupling a first impedance to the first electrode and the second electrode and a second impedance to the first electrode and the second electrode prior to implanting the implantable medical device;

means for detecting an impedance change between the first impedance and the second impedance; and

means for controlling operation of the implantable medical device based on detecting the impedance change.

29. A non-transitory, computer-readable storage medium storing a set of instructions, which when executed by a control module of an implantable medical device causes the device to:

monitor an impedance between a pair of electrodes by an impedance monitoring circuit of the implantable medical device;

detect a change in the impedance between the pair of electrodes when a position of the implantable medical device is changed relative to a surface of an enclosure for carrying the implantable medical device, the enclosure comprising a surface having an electrical impedance and configured to contact the first electrode and the second electrode when the implantable medical device is placed within the enclosure;

detect one of a first pre-implant state and a second pre-implant state of the implantable medical device in response to the impedance monitoring module detecting the change in impedance between the first electrode and the second electrode; and

adjust operation of the implantable medical device in response to detecting the change in impedance.