Medical device with force monitoring features and method therefor

• US 7,072,703 B2
• Filed: 04/30/2003
• Issued: 07/04/2006
• Est. Priority Date: 12/31/2002
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yongxing, Zarembo, Paul E., Heil, Ronald W. Jr.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US10/429,180
• Publication Number:
  US 20040127889A1
• Time in Patent Office: 1,161 Days
• Field of Search: 606/108, 606/127, 606/129, 600372-375, 600377-383, 600/585, 607115-132, 607/5, 604/19, 604 27- 28
• US Class Current: 600/374
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

A medical device for use with an implantable lead includes a force monitoring system coupled with the device. The force monitoring system monitors force placed on the medical device and/or the lead. Optionally the system compares the force with a preset limit, and notifies a user once the preset limit has been reached.

Claims

1. A method comprising:

implanting a lead within a patient, the lead for conducting monitoring or stimulating signals through at least a portion of the patient;

placing an extracting force on the lead with a lead extraction device and at least partially extracting the lead from the patient, the lead extraction device including a force monitoring system coupled therewith; and

monitoring the extracting force placed on the lead during extraction with the force monitoring system while placing the extracting force on the lead.

2. The method as recited in claim 1, wherein the lead extraction device further includes a display, and further comprising displaying information regarding the extracting force on the display on the lead extraction device after placing the extracting force on the lead.

3. The method as recited in claim 2, further comprising setting a preset force limit, comparing the extracting force with the preset force limit, and providing a notification when the preset force limit is reached or surpassed.

4. The method as recited in claim 3, wherein providing the notification includes providing an audible notification.

5. A method comprising:

coupling a force monitoring system with a lead tunneling device;

coupling the lead tunneling device with a lead, the lead adapted for conducting monitoring or stimulating signals through at least a portion of a patient;

implanting at least a portion of the lead within the patient including placing a tunneling force on the lead tunneling device, tunneling through subcutaneous tissue with the tunneling device; and

monitoring the tunneling force placed on the tunneling device with the force monitoring system.

6. The method as recited in claim 5, wherein the tunneling device further includes a display, and further comprising displaying information regarding the tunneling force on the display on the tunneling device.

7. The method as recited in claim 5, further comprising comparing the tunneling force with a preset force limit, and providing a notification when the preset force limit is reached or surpassed.

8. The method as recited in claim 7, wherein providing a notification includes providing an audible notification.

9. A method comprising:

implanting a lead within a patient with a catheter, the catheter including a force monitoring system coupled therewith, implanting the lead includes placing an implantation force on the lead thereby manipulating the lead through one or more portions of the patient; and

monitoring the implantation force placed on the lead with the force monitoring system.

10. The method as recited in claim 9, further comprising measuring curvature change in the lead body.

11. The method as recited in claim 9, wherein the catheter further includes a display, and further comprising displaying information regarding the implantation force on the display on the catheter.

12. The method as recited in claim 9, further comprising comparing the implantation force with a preset force limit, and providing a notification when the preset force limit is reached or surpassed.

13. The method as recited in claim 9, further comprising disposing a guidewire assembly within the lead, the guidewire assembly including a guidewire force monitoring system, and monitoring forces with the guidewire force monitoring system.

14. A medical device comprising:

a handle portion extending from a handle distal end to a handle proximal end, the handle portion coupled with an implantable lead;

a force monitoring system coupled with the handle portion, the force monitoring system configured to monitor force placed on the lead as the handle portion is manipulated; and

an elongate body coupled with the handle.

15. The medical device as recited in claim 14, wherein the force monitoring system is removably coupled with the handle portion, and removing the force monitoring system from the handle portion does not result in damage to the force monitoring system.

16. The medical device as recited in claim 14, wherein the handle portion further includes a display, the display listing force monitoring information thereon.

17. The medical device as recited in claim 14, wherein the medical device is a lead tunneling device.

18. The medical device as recited in claim 14, wherein the elongate body is a catheter.

19. The medical device as recited in claim 14, wherein the medical device is a lead extraction device, and the lead extraction device includes a gripping mechanism coupled with the lead.

20. The medical device as recited in claim 14, wherein the force monitoring system further includes an indicator activatable when a preset force condition is met.

21. The medical device as recited in claim 20, wherein the indicator is a visual indicator.

22. The medical device as recited in claim 20, wherein the indicator is an audible indicator.

23. A medical device comprising:

an implantable lead including conductors adapted to send electric signals through a body;

a means for gripping the implantable lead;

a means for measuring force placed on the implantable lead while the lead is manipulated through tissue; and

a means for notifying a technician of a force measured by the means for measuring force placed on the implantable lead.

24. The medical device as recited in claim 23, further comprising a means for comparing the force against a preset force.

25. The medical device as recited in claim 23, further comprising a handle portion, and the means for measuring force is removably coupled with the handle portion, and removing the means for measuring force from the handle portion does not result in damage to the means for measuring force.

26. The medical device as recited in claim 23, wherein the means for notifying the technician is an audible indicator.

27. The medical device as recited in claim 23, wherein the means for notifying the technician is a visible indicator.

28. The medical device as recited in claim 23, further comprising a guidewire assembly disposed within the implantable lead, the guidewire assembly including a fiber optic sensor coupled therewith.