Apparatus for treating venous insufficiency

• US 7,967,782 B2
• Filed: 12/28/2009
• Issued: 06/28/2011
• Est. Priority Date: 03/05/1996
• Status: Expired due to Fees

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Zikorus, Arthur W., Parker, Mark P., Schulz, Grace Y., Laufer, Michael D., Farley, Brian E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/648,242
• Publication Number:
  US 20100106156A1
• Time in Patent Office: 547 Days
• Field of Search: 604 9501- 9505, 604104-109, 60416401-17003, 604523-532
• US Class Current: 604/105
• 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; and

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 bowable members when extended defining an effective diameter of the catheter, the plurality of bowable members having sufficient strength while extended to resist a reduction in the effective diameter of the catheter, thereby enabling a controlled 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 tissue at the treatment site, wherein heating the tissue causes a reduction in the diameter of the hollow anatomical structure at the treatment site; and

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 enable a controlled 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 shrinkage of the hollow anatomical structure adjacent to the electrode;

a plurality of bowable members located at the working end of the catheter and capable of extending radially outward away from the catheter shaft, the bowable members when extended defining an effective diameter of the catheter, wherein the shrinkage of the hollow anatomical structure is limited to the effective diameter defined by the plurality of bowable members; and

a balloon located between the bowable member and the catheter, wherein the balloon engages and forces the bowable members 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, 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.

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.

8. 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 or the bowable member radially.

9. The apparatus of claim 3, further comprising a movable portion at he 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.

10. The apparatus of claim 9, 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.

11. The apparatus of claim 9, 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.

12. The apparatus of claim 9, wherein the bowable member includes a first end connected to the catheter.

13. 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.

14. 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.

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

16. 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.

17. 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.

18. The apparatus of claim 3, further comprising a sensor located on the catheter, the sensor providing a signal representative of a condition of the hollow anatomical structure;

and

a microprocessor receiving the signal from the sensor in order to determine either the amount of shrinkage of the hollow anatomical structure based on the signals or when sufficient vein shrinkage is achieved based on the signals.

19. The apparatus of claim 3, further comprising at least one impedance measuring electrode located on the catheter between an active electrode and a 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.

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

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

22. The apparatus of claim 3, wherein the catheter includes a lumen for injecting a contrast medium.

23. The apparatus of claim 3, further comprising a return electrode configured to be 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 return electrode.