SYSTEMS AND METHODS FOR DETECTING A LOSS OF ELECTRICAL CONNECTIVITY BETWEEN COMPONENTS OF IMPLANTABLE MEDICAL LEAD SYSTEMS

• US 20100106204A1
• Filed: 10/24/2008
• Published: 04/29/2010
• Est. Priority Date: 10/24/2008
• Status: Active Grant

• Current Assignee: Mitsui Chemicals America Incorporated (Riken Technos (Jiangsu) Corp.)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Aghassian, Daniel, Moffitt, Michael A., Parramon, Jordi, Gin, Marco Henry, Gould, Christopher B.
• Granted Patent: US 8,260,424 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• 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;

an external trial system configured and arranged to electrically couple with the first trial system cable; 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.

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

a pair of conductor pins disposed at the distal end of the first trial system cable, the pair of conductor pins comprising a first conductor pin and a second conductor pin, the pair of conductor pins configured and arranged to be electrically coupled to one another when the lead is fully inserted into the first trial system cable so that at least one of the terminals aligns with the pair of conductor pins and to be electrically decoupled with one another when the lead is not fully inserted into the first trial system cable, wherein the pair of conductor pins are electrically coupled to the sensor.

6. The connection monitoring system of claim 5, wherein the first conductor pin and the second conductor pin are laterally-spaced from one another so that the first conductor pin and the second conductor pin each electrically couple to opposite sides of at least one of the terminals when the lead is fully inserted into the first trial system cable.

7. The connection monitoring system of claim 5, wherein the first conductor pin and the second conductor pin are longitudinally-spaced from one another so that the first conductor pin and the second conductor pin each electrically couple to a same side of at least one of the terminals when the lead is fully inserted into the first trial system cable.

8. The connection monitoring system of claim 5, wherein the first conductor pin and the second conductor pin align with the proximal-most of the plurality of terminals disposed on the lead.

9. The connection monitoring system of claim 5, wherein the first conductor pin aligns with one of the plurality of terminals and the second conductor pin aligns with one of the plurality of terminals that is a different from the terminal with which the first conductor pin aligns.

10. The connection monitoring system of claim 5, further comprising additional conductor pins disposed at the distal end of the first trial system cable, the additional conductor pins aligning with at least one of the plurality of terminals when the lead is fully inserted into the first trial system cable.

11. The connection monitoring system of claim 5, 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 conductor electrically coupling the first conductor pin to the first connective contact; and

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

12. The connection monitoring system of claim 11, wherein the external trial system further comprises 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.

13. The connection monitoring system of claim 5, 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 cable,

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

14. 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.

15. 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.

16. The connection monitoring system of claim 15, 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.

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

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

19. The connection monitoring system of claim 18, 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.

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

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

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;

a control module configured and arranged to electrically couple with the lead extension; 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.

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.

24. A method for monitoring an implantable medical lead system for a loss of electrical connectivity, the method comprising:

implanting a distal end of a lead into a patient so that a proximal end of the lead extends from the patient, the distal end of the lead comprising a plurality of electrodes, the proximal end of the lead comprising a plurality of terminals;

electrically coupling the proximal end of the lead to a connector disposed at a distal end of a first trial system cable so that at least one of the terminals electrically couples a pair of conductor pins disposed in the connector to one another, each conductor pin of the pair of conductor pins being electrically coupled to a sensor disposed in an external trial system;

monitoring for impedance values within at least one predetermined range between the two conductor pins of the trial system cable; and

providing an indication when the sensor detects impedance values within one of the predetermined ranges.

25. The method of claim 24, further comprising ceasing electrical stimulation when the sensor detects at least one impedance value that is not with one of the predetermined ranges.

26. The method of claim 24, wherein providing an indication comprises providing at least one of a visual, tactile, audible, telemetric, or olfactory indication.

27. The method of claim 24, wherein providing an indication comprises providing a message on a display.

28. The method of claim 24, wherein providing an indication comprises transmitting a signal to another electronic device.

29. The method of claim 24, wherein providing the indication comprises indicating a loss of electrical connection.

30. The method of claim 24, wherein providing the indication comprises distinguishing between a loss of electrical connection between the lead and the trial system cable, and the trial system cable and the external trial system.

31. The method of claim 24, farther comprising electrically coupling a second trial system cable to the external trial system.

32. The method of claim 31, wherein providing the indication comprises distinguishing a connection between the first trial system cable and the external trial system from a connection between the second trial system cable and the external trial system.

33. The method of claim 32, further comprising electrically coupling an accessory device to the external trial system.

34. The method of claim 33, wherein providing the indication comprises distinguishing a connection between the first trial system cable and the external trial system from a connection between the accessory device and the external trial system, and also comprises distinguishing a connection between the second trial system cable and the external trial system from a connection between the accessory device and the external trial system.

35. The method of claim 24, wherein electrically coupling the proximal end of the lead to the connector disposed at the distal end of the trial system cable comprises electrically coupling the proximal end of the lead to a distal end of a lead extension and electrically coupling a proximal end of the lead extension to the connector disposed at the distal end of the trial system cable.

36. The method of claim 24, wherein electrically coupling the proximal end of the trial system cable to the external trial system comprises electrically coupling the proximal end of the trial system cable to a distal end of a trial system cable extension and electrically coupling a proximal end of the trial system cable extension to the external trial system.