Method and apparatus for treating venous insufficiency

• US 20030191512A1
• Filed: 03/25/2003
• Published: 10/09/2003
• Est. Priority Date: 03/05/1996
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Laufer, Michael D., Zikorus, Arthur W., Parker, Mark P., Farley, Brian E., Schulz, Grace Y.
• Granted Patent: US 7,641,633 B2
• Time in Patent Office: Days
• US Class Current: 607/101
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference

Abstract

A catheter delivers an electrode within a vein for a minimally invasive treatment of varicose veins and venous insufficiency using RF energy. The catheter is introduced into a patient and positioned within the section of the vein to be treated. The electrode radiates high frequency energy towards the vein, and the surrounding venous tissue becomes heated and begins to shrink. The catheter includes a controllable member for limiting the amount of shrinkage of the vein to the diameter of the member. The electrode remains active until there has been sufficient shrinkage of the vein. The extent of shrinkage of the vein may be detected by fluoroscopy. After treating one section of the vein, the catheter and the electrode can be repositioned intraluminally within the vein to treat different sections of the vein until all desired venous sections and valves are repaired and rendered functionally competent.

Claims

1. An apparatus comprising:

a catheter having a catheter shaft and a working end, the catheter being configured to be delivered through a vein to a venous treatment site;

a plurality of electrodes located at the working end of the catheter, the plurality of electrodes being configured to produce a high frequency field to cause heating of a venous tissue at the treatment site, wherein the heating of venous tissue causes a reduction in the diameter of the vein at the treatment site;

a plurality of bowable members located at the working end of the catheter capable of extending away from the catheter shaft and into apposition with the venous tissue at the venous treatment site, wherein each bowable member includes at least one electrode from the plurality of electrodes so that the electrode is in apposition with the venous tissue when the bowable members are extended, the plurality of bowable members having sufficient strength while extended to limit the reduction in the diameter of the vein such that the vein remains patent for venous function.

2. An apparatus comprising:

a catheter having a catheter shaft and a working end, the catheter being configured to be delivered through a hollow anatomical structure to a treatment site;

a plurality of electrodes located at the working end of the catheter, the plurality of electrodes being configured to heat a venous tissue at the treatment site, wherein the heating of tissue causes a reduction in the diameter of the hollow anatomical structure at the treatment site;

a plurality of bowable members located at the working end of the catheter capable of extending away from the catheter shaft and into apposition with the tissue at the treatment site, wherein each bowable member includes at least one electrode from the plurality of electrodes so that the electrode is in apposition with the tissue when the bowable member is extended, the plurality of bowable members having sufficient strength while extended to limit the reduction in the diameter of the hollow anatomical structure such that the hollow anatomical structure remains patent.

3. An apparatus for applying energy to cause shrinkage of a hollow anatomical structure, the apparatus comprising:

a catheter having a shaft, an outer diameter and a working end, the outer diameter of the catheter is less than the inner diameter of the hollow anatomical structure;

at least one electrode located at the working end of the catheter, wherein activation of the at least one electrode causes a treatment area adjacent to the at least one electrode to be heated to cause shrinkage of the hollow anatomical structure; and

a plurality of bowable members located at the working end of the catheter, wherein the shrinkage of the hollow anatomical structure is limited to a diameter defined by the plurality of bowable members;

a balloon is located between the bowable member and the catheter, wherein the balloon engages and forces the bowable member radially outward when the balloon is inflated.

4. The apparatus of claim 3, wherein the at least one electrode is a wire mesh formed on the surface of the balloon, wherein the balloon is inflated to move the wire mesh of the electrode outward.

5. The apparatus of claim 3, further comprising an inert cap at the working end of the catheter past the electrode so as to prevent vein shrinkage past the working end of the catheter.

6. The apparatus of claim 3, further comprising an inert cap at the working end of the catheter past the electrode.

7. The apparatus of claim 3, wherein the at least one electrode further includes a plurality of longitudinal electrodes arranged along the circumference of the catheter at the working end so as to provide omnidirectional heating along a section of the catheter;

wherein the vein is shrunk circumferentially and axial shrinking is minimized.

8. The apparatus of claim 3, wherein the at least one electrode further includes a plurality of longitudinal electrodes arranged along the circumference of the catheter at the working end so as to provide omnidirectional heating along a section of the catheter.

9. The apparatus of claim 8, wherein there are an even number of the longitudinal electrodes;

wherein the longitudinal electrodes are arranged on the catheter so as to provide effective pairs of longitudinal electrodes.

10. The apparatus of claim 8, wherein there are an even number of the longitudinal electrodes;

wherein the longitudinal electrodes are arranged on the catheter so as to provide effective pairs of longitudinal electrodes.

11. The apparatus of claim 3, further comprising a movable portion at the working end;

and a control member connected to the movable portion;

wherein each bowable member having a first end, a second end, and a portion between the first end and the second end, and

the second end of the bowable member is anchored to the working end of the catheter, and the first end is connected to the movable portion so as to allow the bowable member to be manipulated by longitudinally moving the control member so as to move the portion of the bowable member radially.

12. The apparatus of claim 3, further comprising a movable portion at the working end;

and a control member connected to the movable portion;

each bowable member having a first end and a second end, the bowable member being conductive;

an insulation covering a portion of the surface of the bowable member such that an uninsulated portion is located between the first end and the second end of the bowable member wherein the uninsulated portion operates as an electrode and the uninsulated portion contacts the wall of the hollow anatomical structure when the bowable member is bowed outwardly;

wherein the first end of the bowable member is connected to the working end of the catheter, and the second end is connected to the movable portion so as to allow the bowable member to be manipulated by longitudinally moving the control member portion so as to move the uninsulated portion of the bowable member radially into apposition with the hollow anatomical structure.

13. The apparatus of claim 12, wherein there are an even number of the bowable members;

and the bowable members are arranged on the catheter so as to provide effective pairs of electrodes.

14. The apparatus of claim 3, wherein the extendable member further includes a bowable member having a first end, a second end, and a flat section between the first and second end, wherein the first end is connected to the catheter, and the flat section contains the uninsulated portion.

15. The apparatus of claim 12, wherein insulation covering the conductive bowable member covers the first end, the second end, and the surface on the side of the member opposite to the side moved radially into apposition with the vein.

16. The apparatus of claim 12, wherein the bowable member includes a first end connected to the catheter.

17. The apparatus of claim 3, wherein the balloon is inflatable with a conductive inflation medium, the balloon being formed on the working end of the catheter, wherein the at least one electrode causes the inflation medium to become heated so as to conductively transfer heat to the vein wall in apposition with the inflation medium and cause shrinkage of the vein.

18. The apparatus of claim 3, wherein the balloon is inflatable with a conductive inflation medium, the balloon being formed on the working end of the catheter, wherein the at least one electrode causes the inflation medium to become heated.

19. The apparatus of claim 3, wherein the working end of the catheter has a fixed diameter larger than the diameter of the connecting end of the catheter.

20. The apparatus of claim 3, wherein the catheter further includes a bend located between the extendable member and the electrode on the working end, whereby the bend can create a stirring effect when the catheter is rotated.

21. The apparatus of claim 3, wherein the balloon is an asymmetrical balloon formed on one side of the catheter at the working end, and the at least one electrode being on the side opposite the side having the asymmetrical balloon.

22. The apparatus of claim 3, further comprising a sensor located on the catheter, the sensor providing a signal representative of a condition of the vein;

and

a microprocessor receiving the signal from the sensor in order to determine when sufficient vein shrinkage is achieved based on the signals.

23. The apparatus of claim 3, further comprising a sensor located on the catheter, the sensor providing a signal representative of a condition of the vein;

and

a microprocessor receiving the signal from the sensor in order to determine the amount of shrinkage of the hollow anatomical structure based on the signals.

24. The apparatus of claim 3, further comprising at least one piezoelectric element located on the catheter adjacent to the electrode producing pulse-echo soundings of the hollow anatomical structure.

25. The apparatus of claim 3, further comprising at least one impedance measuring electrode located on the catheter between the active electrode and the return electrode, wherein a constant current is passed between the active electrode and the return electrode in order to determine the size of the hollow anatomical structure.

26. The apparatus of claim 3, further comprising at least one impedance measuring sensor for measuring impedance based on the voltage across the electrodes.

27. The apparatus of claim 3, further comprising a microprocessor selecting a frequency for the at least one electrode in order to control the spread of the heating effect in the venous tissue.

28. (Amended) The apparatus of claim 3, further comprising a microprocessor selecting a frequency for the at least one electrode in order to control the spread of the heating effect in the hollow anatomical structure.

29. (Amended) The apparatus of claim 3, wherein the catheter includes a lumen for injecting a contrast medium.

30. The apparatus of claim 3, further comprising an inactive electrode;

wherein the inactive electrode is placed on the skin in the region adjacent to the treatment site so that a high frequency electric field is formed between the at least one electrode and the inactive electrode.

31. The apparatus of claim 3, further comprising an inactive electrode;

wherein the inactive electrode is placed on the skin in the region adjacent to the treatment site so that a high frequency electric field is formed between the at least one electrode and the inactive electrode.