Lead extraction system and methods thereof

• US 5,779,715 A
• Filed: 07/28/1997
• Issued: 07/14/1998
• Est. Priority Date: 07/28/1997
• Status: Expired due to Fees

• Current Assignee: Irvine Biomedical, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Irvine Biomedical, Inc. (Abbott Laboratories Incorporated)
• Inventors: Tu, Hosheng
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/901,500
• Time in Patent Office: 351 Days
• Field of Search: 607/101, 607/113, 607/116, 606/108, 606/50
• US Class Current: 606/108
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

An improved lead extraction system having multiple-jaw cutting edge that is useful for extraction and removal of unwanted lead by a minimal invasive procedure. A lead extraction system suitable for radiofrequency ablation of scar tissues surrounding the implanted lead comprises a catheter sheath having a distal end, a proximal end and at least one lumen extending therebetween, wherein a locking stylet is provided. In one embodiment, the lead extraction system has fluid infusion and irrigation means at its distal tip section and a set of ablation electrodes for loosening the target tissue by applying radiofrequency energy and cooled fluid to said electrode and its contacted tissue.

Claims

1. A lead extraction system comprising:

a catheter sheath having a distal tip section, a distal end, a proximal end, and at least one lumen extending therebetween;

a handle attached to the proximal end of the catheter sheath;

a locking stylet located within the lumen of said catheter sheath; and

an electrode deployment means including a retractable tip section, comprising a set of deployable jaw electrodes each having a sharp end.

2. The lead extraction system as in claim 1, further comprising RF energy is delivered to the deployable jaw electrodes.

3. The lead extraction system as in claim 2, further comprising fluid being supplied to the distal tip section of the catheter sheath and disposed out of the hollow opening at the distal end of the multiple-jaw electrodes means.

4. The lead extraction system as in claim 3, further comprising fluid being selected from the group of saline, heparin, antibiotics, chemotherapy and therapeutics fluids.

5. The lead extraction system as in claim 4, further comprising a method and system for controlling the flow rate of fluid through the lumen to optimize the cooling of the electrode of the catheter, wherein the control system preferably regulates the flow rate based on signals representative of the temperature of the catheter tip and/or tissue impedance.

6. The lead extraction system as in claim 2, further comprising an electrode deployment means positioned at the distal end of said catheter sheath, wherein said electrode deployment means including a retractable tip section, comprising a non-deployed state for said retractable tip section when said tip section being positioned in the catheter sheath, and further comprising a distended deployed state for said retractable tip section when said tip section being advanced out of the distal end of said catheter sheath.

7. The lead extraction system as in claim 6, further comprising a preformed shape for said deployed tip section, whereby a set of multiple jaw electrodes on said tip section extending outwardly to each respective side of said catheter sheath when being deployed.

8. The lead extraction system as in claim 2, further comprising at least one deployable jaw electrode having a sharp side edge.

9. The lead extraction system as in claim 2, further comprising at least one deployable jaw electrode having a sharp end, wherein said sharp end comprises plurality of sharp points.

10. The lead extraction system as in claim 2, further comprising at least one temperature sensing means and a close-loop temperature control mechanism for the lead extraction system.

11. The lead extraction system as in claim 2, further comprising at least one ultrasonic visible marker being disposed at the distal tip section.

12. The lead extraction system as in claim 2, further comprising the material of the electrode being selected from the group of platinum, iridium, gold, silver, stainless steel, and Nitinol.

13. A method for operating a lead extraction system having a distal tip section under a non-deployed state, into the body, comprising:

(a) sliding the system over an existing lead wire;

(b) using the ultrasonic viewing markers to locate the target tissue;

(c) intimately contacting the distal end of the catheter sheath with the target tissue;

(d) deploying the multiple-jaw electrodes means;

(e) applying RF energy to the electrodes while cutting through the tissue;

(f) engaging the locking stylet onto the lead wire; and

(g) extracting the lead by pulling the system out of a patient.

14. The method for operating the lead extraction system as in claim 13, further comprising fluid being supplied to the distal tip section of the catheter sheath and disposed out of the opening.

15. A lead extraction application using a lead extraction system comprising:

a catheter sheath having a distal tip section, a distal end, a proximal end, and at least one lumen extending therebetween;

a handle attached to the proximal end of the catheter sheath;

a locking stylet located within the lumen of said catheter sheath;

an electrode deployment means including a retractable tip section, comprising a set of deployable jaw electrodes each having a sharp end; and

applying RF energy to said electrodes.

16. The lead extraction application as in claim 15, further comprising fluid being supplied to the distal tip section of the catheter sheath and disposed out of the opening.

17. The lead extraction application as in claim 15, further comprising fluid being selected from the group of saline, heparin, antibiotics, chemotherapy and therapeutics fluids.

18. The lead extraction application as in claim 15, further comprising an electrode deployment means positioned at the distal end of said catheter sheath, wherein said electrode deployment means including a retractable tip section, comprising a non-deployed state for said retractable tip section when said tip section being positioned in the catheter sheath, and further comprising a distended deployed state for said retractable tip section when said tip section being advanced out of the distal end of said catheter sheath.

19. The lead extraction application as in claim 18, further comprising a preformed shape for said deployed tip section, whereby a set of multiple jaw electrodes on said tip section extending outwardly to each respective side of said catheter sheath when being deployed.

20. The lead extraction application as in claim 15, further comprising at least one ultrasonic visible marker being disposed at the distal tip section.