System and method for determining tissue contact of an implantable medical device within a body

• US 6,714,806 B2
• Filed: 09/14/2001
• Issued: 03/30/2004
• Est. Priority Date: 09/20/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc), University of Minnesota
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Laske, Timothy G., Iaizzo, Paul A., Choi, Woohyek
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/952,869
• Publication Number:
  US 20020046756A1
• Time in Patent Office: 928 Days
• Field of Search: 600/374, 600/375, 600/547, 600/548, 607/122, 607/126, 607/127, 607/131
• US Class Current: 600/374
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

An improved system for monitoring the status of an IMD such as a medical electrical lead during an implant procedure is provided. The system includes a signal generator for supplying a first signal such as a constant current or voltage to the IMD. A resulting voltage or current signal is generated, respectively, and may be sensed as an indication of the impedance of a portion of the body that is proximal to one or more electrodes carried by the lead. This impedance indication is converted to an audible signal having a frequency that is proportional to the amplitude of the impedance indication. The pitch of the audible signal therefore rises when measured impedance increases, and drops as the impedance decreases. These pitch changes allow a user to determine positional information associated with the IMD, including the degree of lead tissue contact and extent of fixation of a device to tissue.

Claims

1. A system for use in monitoring an implantable medical device (IMD) within a body, comprising:

a first circuit to couple to the IMD to measure an indication of impedance of a portion of the body proximate a predetermined portion of the IMD;

an audio circuit coupled to the first circuit to generate an audible signal representative of the measured impedance;

a display monitor coupled to the first circuit to provide an indication of the measured impedance; and

a processing circuit coupled to receive a signal indicative of the impedance of the portion of the body, and to provide status indicative of the IMD based on the received signal to the display monitor to create a virtual image of the IMD in the body, wherein the IMD is a lead that includes a fixation mechanism, and wherein the processing circuit includes means for generating status indicative of the extent of contact between a predetermined portion of the lead and the body and further includes means for generating status descriptive of the fixation mechanism.

2. The system of claim 1, wherein the lead is delivered to the body using a delivery system, and wherein the processing circuit includes means for generating status descriptive of a position of the lead in relation to the delivery system.

3. The system of claim 1, wherein the first circuit includes a voltage-to-frequency converter.

4. The system of claim 3, and further including an offset circuit coupled to provide an indication of the measured impedance to the voltage-to-frequency converter, the indication of the measured impedance being offset by a predetermined selectable amount.

5. The system of claim 1, wherein the first circuit further comprises a signal generator to provide a first signal to the IMD, and whereby a second signal indicative of the impedance is generated as an input to the first circuit.

6. The system of claim 5, wherein the signal generator is selected from the group consisting of a current source and a voltage source.

7. A method for monitoring a lead, having a fixation device, located within a body, comprising the steps of:

a.) measuring a signal indicative of impedance within a portion of the body proximal the lead;

b.) generating an audible signal representative of the signal measured in step a.); and

c.) utilizing the audible signal to determine status of the lead and to determine the extent of contact between the tissue and the fixation device.

8. The method of claim 7, and further including utilizing the audible signal to determine the extent of fixation between the tissue and the fixation device.

9. The method of claim 8, wherein the lead is delivered with a delivery system, and further including utilizing the audible signal to determine orientation of the lead with respect to the delivery system.

10. The method of claim 7, wherein step a.) includes providing a predetermined first signal to the IMD to generate the signal indicative of impedance.

11. The method of claim 10, wherein step a.) includes filtering the signal indicative of impedance.

12. The method of claim 11, wherein step a.) includes amplifying the signal indicative of impedance.

13. The method of claim 12, wherein step a.) includes offsetting the signal indicative of impedance by a selectable offset value.

14. The method of claim 7, wherein step b.) includes generating a signal having a frequency proportional to the amplitude of the signal indicative of impedance.

15. The method of claim 7, and further including providing a processing circuit to determine the status of the IMD.

16. The method of claim 7, and further including providing the status of the IMD to an output device.

17. The method of claim 16, wherein the output device is a display monitor, and further including providing an image of the IMD located within the body on the display monitor.

18. The method of claim 7, wherein determining status of the IMD includes utilizing input signals that are provided by a user to determine the type of the IMD.

19. The method of claim 7, and further including utilizing the audible signal to determine the type of, or condition of, tissue in the portion of the body proximal the IMD.

20. The method of claim 7, wherein the IMD has a distal tip, and further including utilizing the audible signal to determine stability of a position of the distal tip with respect to the portion of the body proximal the IMD.