Systems and methods for detecting a loss of electrical connectivity between components of implantable medical lead systems

• US 8,260,424 B2
• Filed: 10/24/2008
• Issued: 09/04/2012
• Est. Priority Date: 10/24/2008
• Status: Expired due to Fees

• Current Assignee: Mitsui Chemicals Agro Inc (Mitsui Chemicals)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A., Gould, Christopher B., Aghassian, Daniel, Gin, Marco Henry, Parramon, Jordi
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): El-Kaissi, Hiba
• Application Number:
  US12/258,324
• Publication Number:
  US 20100106204A1
• Time in Patent Office: 1,411 Days
• Field of Search: 607 37- 38
• US Class Current: 607/37
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement
• CPC Class Codes: H01R 13/6683 with built-in sensor
• CPC Class Codes: H01R 2201/12 for medicine and surgery

Abstract

A connection monitoring system for an implantable medical lead system includes an implantable lead, a first trial system cable, an external trial system, and a sensor. The lead has a distal end and at least one proximal end. The lead includes a plurality of terminals disposed at each proximal end. The first trial system cable has a distal end and at least one proximal end. The distal end of the first trial system cable is configured and arranged to electrically couple with the lead. The external trial system is configured and arranged to electrically couple with the first trial system cable. The sensor is electrically coupled to the external trial system. The sensor is configured and arranged for detecting a loss of electrical connectivity between the external trial system and the lead when the lead becomes electrically decoupled from the external trial system.

Claims

1. A connection monitoring system for an implantable medical lead system, the connection monitoring system comprising:

an implantable lead with a distal end and at least one proximal end, the lead comprising a plurality of terminals disposed at each proximal end;

a first trial system cable having a distal end and at least one proximal end, the distal end of the first trial system cable configured and arranged to electrically couple with the lead, the first trial system cable comprising

a first trial system cable connector disposed at the distal end of the first trial system cable, the first trial system cable connector having a longitudinal length, the first trial system cable connector configured and arranged to receive at least one of the proximal ends of the lead, and

a pair of conductor pins disposed in the first trial system cable connector, the pair of conductor pins comprising a first conductor pin and a second conductor pin electrically isolated from one another, the pair of conductor pins are configured and arranged to become electrically coupled to one another when the lead is fully inserted into the first trial system cable connector with a first terminal of the plurality of terminals of the lead physically abutting each of the first conductor pin and the second conductor pin, wherein the first conductor pin and the second conductor pin are configured and arranged to remain electrically isolated from one another when the lead is not fully inserted into the first trial system cable connector;

an external trial system configured and arranged to electrically couple with the first trial system cable, wherein the external trial system is configured and arranged to electrically connect with the lead when the lead is electrically coupled to the first trial system cable and the first trial system cable is electrically coupled to the external trial system; and

a sensor electrically coupled to the external trial system, the sensor configured and arranged for detecting a loss of electrical connectivity between the external trial system and the lead when the lead becomes electrically decoupled from the external trial system, wherein the sensor is electrically coupled to the first conductor pin and the second conductor pin.

2. The connection monitoring system of claim 1, further comprising a lead extension, the lead extension configured and arranged to electrically couple the implantable lead to the trial system cable.

3. The connection monitoring system of claim 1, further comprising an indicator electrically coupled to the sensor, the indicator configured and arranged for providing at least one signal when the sensor detects a loss of electrical coupling between the external trial system and the lead.

4. The connection monitoring system of claim 3, wherein the indicator is configured and arranged to emit at least one of an audio signal, a visual signal, a tactile signal, an olfactory signal, or a telemetry signal to a remote electronic device.

5. The connection monitoring system of claim 1, wherein the first conductor pin and the second conductor pin align with one another along the longitudinal length of the first trial system cable connector.

6. The connection monitoring system of claim 1, wherein the first conductor pin and the second conductor pin are longitudinally offset from one another along the longitudinal length of the first trial system cable connector.

7. The connection monitoring system of claim 1, wherein the first terminal is the proximal-most terminal of the plurality of terminals disposed on the lead.

8. The connection monitoring system of claim 1, further comprising additional conductor pins disposed in the first trial system cable connector, at least one of the additional conductor pins configured and arranged for aligning with a second terminal of the plurality of terminals when the lead is fully inserted into the first trial system cable.

9. The connection monitoring system of claim 1, wherein the first trial system cable further comprises

a first connective contact disposed at the proximal end of the first trial system cable;

a second connective contact disposed at the proximal end of the first trial system cable;

at least one first conductor electrically coupling the first conductor pin to the first connective contact; and

at least one second conductor electrically coupling the second conductor pin to the second connective contact.

10. The connection monitoring system of claim 9, wherein the external trial system further comprises an external trial system connector, the external trial system connector comprising a first conductor pin and a second conductor pin, the first conductor pin configured and arranged to electrically couple with the first connective contact of the first trial system cable and the second conductor pin configured and arranged to electrically couple with the second connective contact of the first trial system cable when the first trial system cable is fully inserted into the external trial system connector.

11. The connection monitoring system of claim 1, wherein the sensor is configured and arranged to detect a loss of electrical coupling between the external trial system and the lead by detecting impedance between the first conductor pin and the second conductor pin of the first trial system cable, the impedance being

within a first impedance range when the first trial system cable is not fully inserted into the external trial system connector,

within a second impedance range when the first trial system cable is fully inserted into the external trial system connector and the lead is not fully inserted into the first trial system cable connector, the second impedance range not overlapping the first impedance range, and

within a third impedance range when the first trial system cable is fully inserted into the external trial system connector and the lead is fully inserted into the first trial system cable connector, the third impedance range not overlapping the first impedance range or the second impedance range.

12. The connection monitoring system of claim 1, further comprising a trial system cable extension electrically coupling the first trial system cable to the external trial system.

13. The connection monitoring system of claim 1, further comprising a second trial system cable, the second trial system cable having a distal end and at least one proximal end, the distal end of the second trial system cable configured and arranged to electrically couple with the lead and the at least one proximal end configured and arranged to electrically couple with the external trial system.

14. The connection monitoring system of claim 13, wherein the sensor is configured and arranged to distinguish between the first trial system cable and the second trial system cable based, at least in part, on a difference in impedance between the first trial system cable and the second trial system cable.

15. The connection monitoring system of claim 13, wherein the external trial system further comprises a multiplexer having a first input, a second input, and an output, wherein the first input of the multiplexer is electrically coupled to the first trial system cable and the second input of the multiplexer is electrically coupled to the second trial system cable, and wherein the output of the multiplexer is electrically coupled to the sensor.

16. The connection monitoring system of claim 1, further comprising an accessory device configured and arranged to electrically couple with the external trial system.

17. The connection monitoring system of claim 16, wherein the sensor is configured and arranged to distinguish between the first trial system cable and the accessory device based, at least in part, on a difference in impedance between the first trial system cable and the accessory device.

18. The connection monitoring system of claim 1, wherein the implantable medical lead system is an implantable electrical stimulation system.

19. The connection monitoring system of claim 1, wherein the implantable medical lead system is an implantable electrical recording system.

20. The connection monitoring system of claim 1, wherein the sensor is electrically coupled to the first conductor pin and the second conductor pin of the external trial system connector.

21. The connection monitoring system of claim 20, wherein the sensor is configured and arranged to detect a loss of electrical coupling between the external trial system and the lead by detecting impedance between the first conductor pin and the second conductor pin of the external trial stimulator.

22. A connection monitoring system for an implantable medical lead system, the connection monitoring system comprising:

an implantable lead with a distal end and at least one proximal end, the lead comprising a plurality of terminals disposed at each proximal end;

a lead extension having a distal end and at least one proximal end, the distal end of the lead extension configured and arranged to electrically couple with the lead, the lead extension comprising

a lead extension connector disposed at the distal end of the lead extension, the lead extension connector having a longitudinal length, the lead extension connector configured and arranged to receive at least one of the proximal ends of the lead, and

a pair of conductor pins disposed in the lead extension connector, the pair of conductor pins comprising a first conductor pin and a second conductor pin electrically isolated from the first conductor pin, the pair of conductor pins configured and arranged to become electrically coupled to one another when the lead is fully inserted into the lead extension connector with a first terminal of the plurality of terminals of the lead physically abutting each of the first conductor pin and the second conductor pin, wherein the first conductor pin and the second conductor pin are configured and arranged to remain electrically isolated from one another when the lead is not fully inserted into the lead extension connector;

a control module configured and arranged to electrically couple with the lead extension, wherein the control module is configured and arranged to electrically connect with the lead when the lead is electrically coupled to the lead extension and the lead extension is electrically coupled to the control module; and

a sensor electrically coupled to the external trial system, the sensor configured and arranged for detecting a loss of electrical connectivity between the control module and the lead when the lead becomes electrically decoupled from the control module, wherein the sensor is electrically coupled to the first conductor pin and the second conductor pin.

23. The connection monitoring system of claim 22, further comprising an indicator electrically coupled to the sensor, the indicator configured and arranged for providing at least one signal when the sensor detects a loss of electrical coupling between the control module and the lead.