Method for removal of chronically implanted leads and leads optimized for use therewith

• US 5,807,399 A
• Filed: 10/23/1996
• Issued: 09/15/1998
• Est. Priority Date: 10/23/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dollimer, Michael R., Laske, Timothy G., Meregotte, Pedro A.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/736,000
• Time in Patent Office: 692 Days
• Field of Search: 607/119, 607/122, 607/126-132, 600/374, 600/375, 606/1, 606/108
• US Class Current: 607/126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A method of removing chronically implanted pacing leads and leads specifically adapted to be removed using the method. The leads are constructed so that upon tension applied to the electrode, it is withdrawn to a first location, so that upon further application of tension, the sheath located distal to the withdrawn electrode may collapse, enhancing its removability. In some embodiments of leads particularly adapted for use in conjunction with the method, the leads are provided with a mechanism for allowing breakage of the lead adjacent the points to which the electrode has been withdrawn, upon application of further tension to the electrode.

Claims

1. A method of removing a fibrotically encapsulated chronically implanted endocardial cardiac lead of the type having an elongated insulating sheath having an internal lumen, an electrode extending from a distal end of the sheath, and a conductor coupled to the electrode, extending within the sheath, comprising:

applying traction to the electrode to retract the electrode proximally to a first position within the sheath; and

while the electrode is located at the first position, applying traction to the sheath to collapse the sheath distal to the electrode and remove it from encapsulating fibrotic tissue.

3. A method according to claim 1 or claim 2 wherein the step of applying traction to the electrode comprises applying traction to the conductor.

4. A method according to claim 1 or claim 2 wherein the step of applying traction to the sheath comprises applying traction to the conductor.

2. A method of removing a fibrotically encapsulated chronically implanted endocardial cardiac lead of the type having an elongated insulating sheath having an internal lumen, an electrode extending from a distal end of the sheath, and a conductor coupled to the electrode, extending within the sheath, comprising:

applying traction to the electrode to retract the electrode proximally to a first position within the sheath; and

while the electrode is located at the first position, applying traction to the sheath to separate the sheath distal to the electrode from the lead, allowing removal of the rest of the lead.

5. A method of removing a fibrotically encapsulated chronically implanted endocardial cardiac lead of the type having an elongated insulating sheath having an internal lumen and means for accomplishing passive fixation of the lead extending from the sheath adjacent its distal end, an electrode extending from the distal end of the sheath, and a conductor coupled to the electrode, extending within the sheath, comprising:

applying traction to the electrode to retract the electrode proximally to a first position within the sheath proximal to the fixation means; and

while the electrode is located at the first position, applying traction only to a portion of the sheath distal to the electrode to collapse the sheath distal to the electrode and remove it from encapsulating fibrotic tissue.

7. A method according to claim 5 or claim 6 wherein the step of applying traction to the electrode comprises applying traction to the conductor.

8. A method according to claim 5 or claim 6 wherein the step of applying traction to the sheath comprises applying traction to the conductor.

9. A method according to claim 5 or claim 6 wherein the step of applying traction to the sheath comprises applying traction only to a portion of the sheath extending 1 cm or less proximally from the fixation means.

6. A method of removing a fibrotically encapsulated chronically implanted endocardial cardiac lead of the type having an elongated insulating sheath having an internal lumen and means for accomplishing passive fixation of the lead extending from the sheath adjacent its distal end, an electrode extending from the distal end of the sheath, and a conductor coupled to the electrode, extending within the sheath, comprising:

applying traction to the electrode to retract the electrode proximally to a first position within the sheath; and

while the electrode is located at the first position, applying traction only to a portion of the sheath distal to the electrode to separate the sheath distal to the electrode from the lead, allowing removal of the rest of the lead.

10. An implantable lead, comprising:

an elongated insulating sheath having an internal lumen;

an electrode extending from a distal end of the sheath;

an elongated conductor extending along the sheath and coupled to the electrode;

means for allowing separation of the sheath at a first location in response to traction force of a first magnitude applied to the sheath;

means for allowing the electrode to retract into the sheath to a second location adjacent the first location, in response to a traction force applied to the electrode;

means for preventing retraction of said electrode into said sheath proximal to said second location in response to a traction force less than a second magnitude greater than said first magnitude.

11. A lead according to claim 10, wherein the sheath is provided with passive fixation members extending from the sheath and wherein the first and second locations are both located proximal to the passive fixation members.

12. A lead according to claim 11 wherein the first and second locations are within 1 cm of the fixation members.

16. A lead according to claim 10 or claim 13 further comprising means for easing retraction of said electrode into said sheath.

17. A lead according to claim 16 wherein said easing means comprises a chamfered surface at the distal end of the internal lumen of the sheath.

18. A lead according to claim 16 wherein said easing means comprises a beveled, proximally facing surface of the electrode.

19. A lead according to claim 16 wherein said easing means comprises an increased diameter portion of the internal lumen of the sheath.

20. A lead according to claim 19 wherein said increased diameter portion of the lumen extends to the distal end of the sheath.

21. A lead according to claim 10 or claim 13, further comprising means for preventing inadvertent retraction of the electrode into the internal lumen of the sheath.

13. An implantable lead, comprising:

an elongated insulating sheath having an internal lumen open to a distal end of the sheath, a weakened zone allowing separation of the sheath in response to a traction force of a first magnitude and enclosing a distally facing internal surface adjacent the weakened zone;

an electrode extending from a distal end of the sheath, having a proximally facing surface and retractable proximally into the lumen of the sheath until the proximally facing surface of the electrode contacts the distally facing internal surface within the sheath, and not further retractable in response to traction force less than a second magnitude greater than the first magnitude; and

an elongated conductor extending along the sheath and coupled to the electrode.

14. A lead according to claim 13, wherein the sheath is provided with passive fixation members extending from the sheath and wherein the weakened zone and distally facing internal surface are both located proximal to the passive fixation members.

15. A lead according to claim 13 wherein the weakened zone and distally facing internal surface are within 1 cm of the fixation members.

22. An implantable lead, comprising:

an elongated insulating sheath having an internal lumen and having fixation members extending therefrom;

an electrode extending from a distal end of the sheath and retractable into the sheath to a first location proximal to the fixation members, in response to traction applied to the electrode;

an elongated conductor extending along the sheath and coupled to the electrode; and

reinforcements extending from the first location, coupled to the fixation members.

23. A lead according to claim 22 further comprising means for preventing retraction of the electrode beyond the first point, coupled to the reinforcements.

24. A lead according to claim 22 or 23 wherein the reinforcements are filaments.

25. A lead according to claim 24 wherein the preventing means is a ring, through which the conductor passes.