Heart synchronized extractor for an implanted object

• US 5,674,217 A
• Filed: 11/16/1993
• Issued: 10/07/1997
• Est. Priority Date: 10/01/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Williams, Terrell M., Wahlstrom, Dale A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/153,715
• Time in Patent Office: 1,421 Days
• Field of Search: 607/122, 607/126, 607/127, 607/128, 607/131, 607/115, 607/116, 606/7, 606/15, 606/108, 606/1, 606/10, 606/11, 606/12, 606/14, 606/17
• US Class Current: 606/15
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 lead extraction device synchronized to the cardiac cycle which utilizes laser light to separate an implanted object, such as a pacemaker lead, from fibrous scar tissue and thereby permit the implanted object to be extracted from a body. The extraction device features a catheter having a central lumen dimensioned so a pacemaker lead will fit within. The catheter is thereby guided by the lead. The catheter has at least one optical fiber to emit laser light from the distal end and thereby separate the lead from fibrous scar tissue. A means for generating a control pulse in response to a sensed ECG signal permits the catheter to by synchronized to the cardiac cycle. In such a manner laser light may be controlled so as to avoid striking the heart at a vulnerable period in the cardiac cycle.

Claims

1. A device for removing an object from the venous system comprising:

an elongated catheter, said catheter having a catheter body, said catheter body having a catheter body diameter, said catheter body having a lumen therethrough, said lumen sized to permit said object to be introduced into said lumen, said catheter body having a distal end, said distal end having means for transmitting laser energy from said distal end of said catheter in a direction parallel to said catheter body, said means for transmitting comprising means for preventing the photo degradation of an object disposed through said lumen from the transmission of laser energy from said distal end of said catheter, wherein the means for preventing the photo degradation of an object disposed through said lumen from the transmission of laser energy from the distal end of said catheter comprises a guard assembly, said guard assembly comprising a guard band positioned about an exterior surface of said elongated catheter and a guard ring positioned about an interior surface of said elongated catheter;

at least one optical fiber supported by said catheter body, said optical fiber extending to a region proximate said distal end of said catheter; and

a source of laser energy communicating with said optical fiber.

2. The device of claim 1 further comprising means for sensing cardiac signals integral with said catheter, said means for sensing having a proximal end;

and means for synchronizing the transmission of said laser energy to said sensed cardiac signals, said means for synchronizing coupled with said proximal end of said means for sensing cardiac signals.

3. The device of claim 2 wherein said means for synchronizing the transmission of said laser energy to said sensed cardiac signals further comprises a means to generate a trigger pulse for the laser in response to the sensed cardiac signals coupled to said proximal end of said means for sensing cardiac signals.

4. The device of claim 2 wherein said means for synchronizing the transmission of said laser energy to said sensed cardiac signals further comprises a means to position the leading edge of the trigger pulse at a specified time coupled to the means to generate a trigger pulse, a means to define the width of the trigger pulse coupled to the means to generate a trigger pulse, and a means to control the firing of the laser in response to the trigger pulse and for said defined width coupled to the means to generate a trigger pulse.

5. The device of claim 2 wherein the means for sensing cardiac signals comprises an electrical lead.

6. The device of claim 1 further comprising said optical fiber extending to said region proximate said distal end in a direction parallel with said catheter.

7. The device of claim 1 further comprising said distal end of said catheter being radiopaque.

8. The device of claim 1 wherein said optical fiber extends between said guard band and said guard ring;

said optical fiber has a distal end, said guard assembly has a distal end, said optical fiber distal end is spaced proximally from said guard assembly distal end.

9. A method for removing an implanted object affixed to a body by fibrous scar tissue comprising the steps of:

introducing a catheter having a lumen and at least one optical fiber into said venous system, said catheter having a proximal end and a distal end, said distal end having a guard assembly, said guard assembly comprising a guard band positioned about an exterior surface of said elongated catheter and a guard ring positioned about an interior surface of said elongated catheter, said optical fiber extending between said guard band and said guard ring, said optical fiber has a distal end, said guard assembly has a distal end, said optical fiber distal end is spaced proximally from said guard assembly distal end;

positioning said implanted object within said lumen of said catheter;

positioning a distal end of said catheter proximate said fibrous scar tissue;

sensing cardiac signals;

synchronizing the transmission of said laser energy through said optical fiber to said fibrous scar tissue to said sensed cardiac signals; and

removing said object from said venous system.

10. A method for removing an implanted object affixed by fibrous scar tissue in a body comprising the steps of:

providing a catheter body having a tubular portion supporting at least one optical fiber, said catheter body having a lumen therethrough, said catheter body having a proximal end and a distal end, said distal end having a guard assembly, said guard assembly comprising a guard band positioned about an exterior surface of said catheter body and a guard ring positioned about an interior surface of said catheter, said optical fiber extending between said guard band and said guard ring, said optical fiber has a distal end, said guard assembly has a distal end, said optical fiber distal end is spaced proximally from said guard assembly distal end;

placing the catheter body around said implanted object;

moving said catheter body along said implanted object until a distal end of said catheter body is positioned adjacent fibrous scar tissue which affixes said implanted object;

sensing cardiac signals;

synchronizing to said sensed cardiac signals the energizing of a laser connected to said optical fiber to cause laser energy to be emitted into said fibrous scar tissue;

moving the catheter body along said implanted object as the fibrous scar tissue releases said implanted object; and

removing said implanted object from said venous system.

11. The method of claim 10 further comprising providing an electrical connection with said heart.

12. The method of claim 11 further comprising providing an electrical lead.

13. The method of claim 10 further comprising the step of providing a stylet lumen in said catheter body.

14. The method of claim 13 further comprising the step of providing a steerable stylet within said stylet lumen.

15. The method of claim 10 further comprising the step of steering said catheter body along said implanted object.

16. The method of claim 10 wherein said implanted object is a pacemaker lead.

17. A method for removing an implanted object affixed to a body by fibrous scar tissue comprising the steps of:

introducing a catheter having a lumen and at least one optical fiber into the venous system, the catheter having a proximal end and a distal end having a guard assembly, the guard assembly comprising a guard band positioned about an exterior surface of the catheter and a guard ring positioned about an interior surface of the catheter, at least one optical fiber extending to a region proximate the distal end of the catheter, the optical fiber extending between the guard band and the guard ring, the optical fiber having a radial thickness, the guard ring having a radial thickness equal to or less than the radial thickness of the optical fiber;

positioning the implanted object within the lumen of the catheter;

positioning the distal end of the catheter proximate the fibrous scar tissue;

sensing cardiac signals;

synchronizing the transmission of the laser energy through the optical fiber to the fibrous scar tissue to the sensed cardiac signals; and

removing the object from the venous system.

18. A method for removing an implanted object affixed by fibrous scar tissue in a body comprising the steps of:

providing a catheter having a lumen and at least one optical fiber into the venous system, the catheter having a proximal end and a distal end having a guard assembly, the guard assembly comprising a guard band positioned about an exterior surface of the catheter and a guard ring positioned about an interior surface of the catheter, at least one optical fiber extending to a region proximate the distal end of the catheter, the optical fiber extending between the guard band and the guard ring, the optical fiber having a radial thickness, the guard ring having a radial thickness equal to or less than the radial thickness of the optical fiber;

placing the catheter body around the implanted object;

moving the catheter body along the implanted object until a distal end of the catheter body is positioned adjacent fibrous scar tissue which affixes the implanted object;

sensing cardiac signals;

synchronizing to the sensed cardiac signals the energizing of a laser connected to the optical fiber to cause laser energy to be emitted into the fibrous scar tissue;

moving the catheter body along the implanted object as the fibrous scar tissue releases the implanted object; and

removing the implanted object from the venous system.

19. The method of claim 18 further comprising providing an electrical connection with the heart.

20. The method of claim 19 further comprising providing an electrical lead.

21. The method of claim 18 further comprising the step of providing a stylet lumen in the catheter body.

22. The method of claim 21 further comprising the step of providing a steerable stylet within the stylet lumen.

23. The method of claim 18 further comprising the step of steering the catheter body along the implanted object.

24. A method for removing an implanted object affixed to a body by fibrous scar tissue comprising the steps of:

introducing a catheter having a lumen and at least one optical fiber into said venous system, said catheter having a proximal end and a distal end, said distal end having means for preventing the photo degradation of said implanted object disposed through said lumen from the transmission of laser energy;

positioning said implanted object within said lumen of said catheter;

positioning a distal end of said catheter proximate said fibrous scar tissue;

transmitting laser energy through said optical fiber to said fibrous scar tissue; and

removing said object from said venous system reinforcing.

25. A method for removing an implanted object according to claim 24 wherein the means for preventing the photo degradation of said implanted object disposed through said lumen from the transmission of laser energy comprises a guard assembly, said guard assembly comprising a guard band positioned about an exterior surface of said elongated catheter and a guard ring positioned about an interior surface of said elongated catheter, said optical fiber extending between said guard band and said guard ring, said optical fiber has a distal end, said guard assembly has a distal end, said optical fiber distal end is spaced proximally from said guard assembly distal end.

26. A method for removing an implanted object according to claim 24 further comprising the steps of:

sensing cardiac signals;

synchronizing the transmission of said laser energy through said optical fiber to said fibrous scar tissue to said sensed cardiac signals.

27. A method for removing an implanted object affixed by fibrous scar tissue in a body comprising the steps of:

providing a catheter body having a tubular portion supporting at least one optical fiber, said catheter body having a lumen therethrough, said catheter body having a proximal end and a distal end, said distal end having means for preventing the photo degradation of said implanted object disposed through said lumen from the transmission of laser energy;

placing the catheter body around said implanted object;

moving said catheter body along said implanted object until a distal end of said catheter body is positioned adjacent fibrous scar tissue which affixes said implanted object;

sensing cardiac signals;

synchronizing to said sensed cardiac signals the energizing of a laser connected to said optical fiber to cause laser energy to be emitted into said fibrous scar tissue;

moving the catheter body along said implanted object as the fibrous scar tissue releases said implanted object; and

removing said implanted object from said venous system.

28. A method for removing an implanted object according to claim 27 wherein the means for preventing the photo degradation of said implanted object disposed through said lumen from the transmission of laser energy comprises a guard assembly, said guard assembly comprising a guard band positioned about an exterior surface of said catheter body and a guard ring positioned about an interior surface of said catheter, said optical fiber extending between said guard band and said guard ring, said optical fiber has a distal end, said guard assembly has a distal end, said optical fiber distal end is spaced proximally from said guard assembly distal end.