Detection of proper insertion of medical leads into a medical device

• US 8,730,032 B2
• Filed: 04/28/2010
• Issued: 05/20/2014
• Est. Priority Date: 04/30/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Torgerson, Nathan A., Zimmerman, James A.
• Primary Examiner(s): MCNALLY, KERRI L
• Application Number:
  US13/265,028
• Publication Number:
  US 20120038477A1
• Time in Patent Office: 1,483 Days
• Field of Search: 340/539.1, 340/539.12
• US Class Current: 340/539.12
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Proper insertion of medical leads into medical devices is detected at the time the lead is being inserted. An external device initiates impedance testing by the medical device that is receiving the lead prior to the insertion of the lead being completed. The medical device reports back the results of the impedance testing so that the external device can determine whether the lead is properly inserted at the time of lead insertion and can provide an output to a user to indicate whether the lead insertion is proper. The medical device may poll only a last connector expected to be connected before responding, test other connector combinations before or after responding, and so forth.

Claims

1. A method of verifying that a lead has been fully inserted into a header of a medical device, comprising:

prior to completion of the lead being inserted, establishing a communication session between an external device and the medical device;

during the communication session and prior to completion of the lead being inserted, instructing the medical device to begin an impedance test for a set of connectors that are expected to be electrically connected to the lead where the impedance test repeatedly polls for impedance;

receiving a response from the medical device that specifies a result of the impedance testing; and

providing an output that indicates whether the lead is fully inserted based on the response.

2. The method of claim 1, wherein the external device communicates with the medical device via a radio frequency (RF) wireless telemetry.

3. The method of claim 1, further comprising implementing the instruction at the medical device by polling an impedance at at least one connector in the header.

4. The method of claim 3, wherein polling an impedance at at least one connector in the header comprises polling the impedance at a plurality of connectors in the header.

5. The method of claim 3, wherein polling the impedance at at least one connector in the header comprises polling the impedance at a connector that is a last one that is expected to be electrically connected to the lead due to the lead being fully inserted.

6. The method of claim 5, further comprising upon detecting an impedance that indicates connectivity to the lead has been established at the connector that is the last one that is expected to be connected due to the lead being fully inserted, then reporting from the medical device to the external device that the last connector has connectivity to the lead.

7. The method of claim 6, further comprising after the reporting by the medical device, sending an instruction from the external device to the medical device to perform impedance testing for all connectors that are expected to have electrical connectivity to the lead.

8. The method of claim 5, further comprising upon detecting an impedance that indicates connectivity to the lead has been established at the connector that is the last one that is expected to be connected due to the lead being fully inserted, then automatically beginning impedance testing for all connectors that are expected to have electrical connectivity to the lead.

9. The method of claim 1, wherein establishing the communication session between the external device and the medical device begins before insertion of the lead begins.

10. The method of claim 1, further comprising implementing the instruction at the medical device by beginning to poll an impedance at at least one connector in the header before insertion of the lead begins.

11. The method of claim 1, wherein the response indicates a value of the impedance measurements.

12. The method of claim 1, wherein the response comprises an audible signal from the medical device.

13. The method of claim 1, wherein the response indicates which electrical connections to the lead have a short circuit and which have an open circuit.

14. The method of claim 1, wherein instructing the medical device to begin an impedance test for the set of connectors that are expected to be electrically connected to the lead comprises instructing the medical device to respond only upon detecting an impedance value at at least one connector of the set that is indicative of an electrical connection to the lead.

15. The method of claim 1, wherein the medical device sends the response to the external device only upon detecting an impedance value of at least one connector of the set that is indicative of an electrical connection to the lead.

16. The method of claim 1, further comprising:

continuing to perform the impedance testing at the medical device after completion of lead insertion and during device implantation; and

continuing to receive the response from the medical device that indicates the result of the impedance testing.

17. An external device for verifying that a lead has been fully inserted into a header of a medical device, comprising:

communication circuitry; and

a processor controlling the communication circuitry and being configured to;

prior to completion of the lead being inserted, establish a communication session with the medical device;

during the communication session and prior to completion of the lead being inserted, instruct the medical device to begin an impedance test for a set of connectors that are expected to be electrically connected to the lead where the impedance test repeatedly polls for impedance;

receive a response from the medical device that specifies a result of the impedance testing; and

provide an output that indicates whether the lead is fully inserted based on the response.

18. The external device of claim 17, wherein the communication circuitry utilizes radio frequency (RF) wireless telemetry.

19. The external device of claim 17, wherein the processor sends an instruction to the medical device to perform impedance testing for at least one connector.

20. The external device of claim 19, wherein the processor sends the instruction to the medical device to perform impedance testing for a plurality of connectors.

21. The external device of claim 19, wherein the at least one connector is a last one that is expected to be connected due to the lead being fully inserted and wherein the processor sends an instruction to the medical device to perform impedance testing for all connectors that are expected to have electrical connectivity to the lead upon receiving a response from the medical device that indicates that electrical connectivity is detected at the connector that is the last one that is expected to be connected due to the lead being fully inserted.

22. The external device of claim 17, wherein the processor establishes the communication session with the medical device before insertion of the lead begins.

23. The external device of claim 17, wherein the processor receives the response that indicates a value of the impedance measurements.

24. The external device of claim 17, wherein processor receives the response that indicates which electrical connections to the lead have a short circuit and which have an open circuit.

25. The external device of claim 17, wherein the processor instructing the medical device to begin the impedance test for the set of connectors that are expected to be electrically connected to the lead comprises instructing the medical device to respond only upon detecting an impedance value at at least one connector of the set that is indicative of an electrical connection to the lead.

26. A medical device for verifying that a lead has been fully inserted into a header of the medical device, comprising:

communication circuitry; and

a processor that controls the communication circuitry, the processor being configured to;

prior to completion of the lead being inserted, establish a communication session with an external device;

during the communication session and prior to completion of the lead being inserted, receive an instruction to begin an impedance test for a set of connectors that are expected to be electrically connected to the lead;

implement the instruction to perform impedance testing where the impedance testing repeatedly polls for impedance; and

send a response to the external device that specifies a result of the impedance testing.

27. The medical device of claim 26, wherein the communication circuitry utilizes a radio frequency (RF) wireless telemetry.

28. The medical device of claim 26, wherein the processor implements the instruction at the medical device by polling an impedance at at least one connector in the header.

29. The medical device of claim 28, wherein the processor polls an impedance at at least one connector in the header by polling the impedance at a plurality of connectors in the header.

30. The medical device of claim 28, wherein the processor polls the impedance at at least one connector in the header by polling the impedance at a connector that is a last one that is expected to be electrically connected to the lead due to the lead being fully inserted.

31. The medical device of claim 30, wherein upon detecting an impedance that indicates connectivity to the lead has been established at the connector that is the last one that is expected to be connected due to the lead being fully inserted, the processor then reports to the external device that the last connector has connectivity to the lead.

32. The medical device of claim 30, wherein upon detecting an impedance that indicates connectivity to the lead has been established at the connector that is the last one that is expected to be connected due to the lead being fully inserted, the processor then automatically begins impedance testing for all connectors that are expected to have electrical connectivity to the lead.

33. The medical device of claim 26, wherein the processor establishes the communication session with the external device before insertion of the lead begins.

34. The medical device of claim 26, wherein the processor implements the instruction at the medical device by beginning to poll an impedance at at least one connector in the header before insertion of the lead begins.

35. The medical device of claim 26, wherein the response indicates a value of the impedance measurements.

36. The medical device of claim 26, wherein the response indicates which electrical connections to the lead have a short circuit and which have an open circuit.

37. The medical device of claim 26, wherein the processor receives an instruction from the external device to respond only upon detecting an impedance value at at least one connector of the set that is indicative of an electrical connection to the lead.

38. The medical device of claim 26, wherein the processor sends the response to the external device only upon detecting an impedance value at at least one connector of the set that is indicative of an electrical connection to the lead.