Method and apparatus for treating venous insufficiency using directionally applied energy

• US 6,033,398 A
• Filed: 03/04/1997
• Issued: 03/07/2000
• Est. Priority Date: 03/05/1996
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: VNUS Medical Technologies Incorporated (Medtronic Plc)
• Inventors: Petty, Douglas M., Laufer, Michael D., Parker, Mark P., Farley, Brian E., Henderson, Dawn A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/811,820
• Time in Patent Office: 1,099 Days
• Field of Search: 606/27, 606/40, 606/41, 606/32, 606/31, 600/373, 600/372, 604/107, 604/104, 604/105, 604/106, 604/19-21, 604/93, 604/500, 604/113, 607/1, 607/2, 607/96, 607/101, 607/103, 607/122
• US Class Current: 606/27
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00154 containing and delivering drugs
• 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 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• 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 introduces electrodes in a vein for a minimally invasive treatment of venous insufficiency by the application of energy to cause selective heating of the vein. The catheter is positioned within the vein to be treated, and the electrodes on the catheter are moved toward one side of the vein. RF energy is applied in a directional manner from the electrodes at the working end of the catheter to cause localized heating and corresponding shrinkage of the adjacent venous tissue, which may include commissures, leaflets and ostia. Fluoroscopy or ultrasound may be used to detect shrinkage of the vein. After treating one section of the vein, the catheter can be repositioned to place the electrodes to treat different sections of the vein until all desired venous valves are repaired and rendered functionally competent.

Claims

1. A method of applying energy to cause shrinkage of a vein lumen, the method comprising the steps of:

introducing a catheter having a working end with an energy application apparatus located at the working end, to a treatment site in the vein lumen;

positioning the energy application apparatus adjacent the treatment site in the vein lumen;

directionally emitting energy from the energy application apparatus to selectively heat the treatment site and cause shrinkage of a selected area of the vein lumen at the treatment site; and

terminating the emission of energy from the energy application apparatus after causing sufficient shrinkage of the vein lumen to restore valvular competency while maintaining venous patency.

2. The method of claim 1 further comprising the step of determining the occurrence of shrinkage of the vein using fluoroscopy.

3. The method of claim 1 wherein the step of positioning the energy application apparatus at the treatment site further includes the step of placing the energy application apparatus at a commissure of a venous valve of the treatment site.

4. The method of claim 3 further including the step of positioning the energy application apparatus adjacent leaflets of the valve, after the step of placing the energy application apparatus at the commissure of the venous valve of the treatment site.

5. The method of claim 1 wherein the step of directionally emitting energy further includes the step of producing at least two discrete RF fields at the working end of the catheter by the energy application apparatus to directionally heat at least two separated venous sites at the treatment site simultaneously.

6. The method of claim 1 wherein the step of directionally emitting energy further includes the step of producing a discrete RF field along a portion of the circumference of the catheter by the energy application apparatus to directionally heat the venous tissue.

7. The method of claim 6 wherein the step of producing the discrete RF field includes the step of positioning the catheter to treat the commissure of the venous valve, and then the leaflets of the venous valve.

8. The method of claim 1 wherein the step for directionally emitting energy comprises the step of passing radio frequency energy between a positive polarity electrode and a negative polarity electrode to create an RF field along a portion of the catheter.

9. The method of claim 1 wherein the step of directionally emitting energy comprises the step of directionally emitting optical energy to selectively heat the treatment site.

10. The method of claim 9 wherein the step of directionally emitting optical energy comprises the further step of reflecting optical energy at the working end of the catheter to create a directional emission of energy for selectively heating the treatment site.

11. The method of claim 1 further comprising the step of palpating the vein into apposition with the energy application apparatus of the catheter in the vein lumen.

12. The method of claim 1 further comprising the steps of locating the working end of the catheter in apposition with the vein wall adjacent a selected commissure and directionally emitting energy to the vein wall to shrink the commissure.

13. The method of claim 1 further comprising the step of expanding the energy application apparatus radially outward from the working end and into apposition with the vein wall and directionally emitting energy to the vein wall to cause preferential shrinkage of venous tissue at the wall.

14. The method of claim 13 wherein the step of expanding comprises the step of expanding at least two pairs of electrodes from the working end into apposition with the vein wall, wherein each pair of electrodes comprises a discrete pair of opposite polarity electrodes and the electrodes within each discrete pair are arranged such that an electrode in one discrete pair is adjacent a like polarity electrode of the adjacent pair.

15. The method of claim 14 wherein the step of expanding comprises the step of expanding an even number of electrodes into apposition with the vein wall, wherein said even number comprises at least four, and wherein said even number of electrodes are disposed in a plurality of discrete pairs of opposite polarity electrodes, said electrodes in each discrete pair being arranged such that an electrode in one discrete pair is adjacent a like polarity electrode of an adjacent pair.

16. The method of claim 1 further comprising the step of determining the occurrence of shrinkage of the vein using ultrasonographic imaging.

17. The method of claim 1 wherein the step of positioning the energy application apparatus at the treatment site further includes the step of placing the energy application apparatus at an ostium and applying energy to reduce the size of the ostium.

18. A method of applying energy to cause the shrinkage of a vein to restore valvular competency, the method comprising the steps of:

introducing a catheter having a working end and at least two electrodes located at the working end, to a treatment site in the vein;

positioning the at least two electrodes adjacent venous tissue at the treatment site in the vein;

applying high frequency energy from the electrodes to heat the treatment site and cause a reduction in the size of the vein; and

terminating the application of energy from the electrodes after the size of the vein is reduced so that valvular competency is restored and patency of the vein is maintained.

19. The method of claim 18 further comprising the step of determining the occurrence of shrinkage of the vein using fluoroscopy.

20. The method of claim 18 further comprising the step of determining the occurrence of shrinkage of the vein using ultrasonographic imaging.

21. The method of claim 18 wherein the step of applying high frequency energy further includes the step of applying radio frequency energy between the at least two electrodes.

22. The method of claim 18 wherein the step of emitting high frequency energy further includes the step of producing a discrete RF field along a portion of the circumference of the catheter to directionally heat the venous tissue.

23. The method of claim 22 wherein the step of producing the discrete RF field includes the step of positioning the catheter to treat the commissures of the venous valve, and then the leaflets of the venous valve.

24. The method of claim 18 wherein the step of positioning the at least two electrodes at the treatment site further includes the step of placing the at least two electrodes at a commissure of the venous valve of the treatment site.

25. The method of claim 24 further including the step of placing the electrodes adjacent the leaflets of the valve after the step of placing the electrodes at the commissure of the venous valve of the treatment site.

26. The method of claim 18 wherein the step of emitting energy further includes the step of producing at least two discrete RF fields along the circumference of the catheter to directionally heat the venous tissue so that both commissures of the venous valve at the treatment site can be treated simultaneously.

27. The method of claim 18 further comprising the step of extending the electrodes away from the catheter to increase the effective diameter of the catheter.

28. The method of claim 27 further comprising the step of deploying an expandable member coupled to the working end to selectively position the two electrodes against selected venous tissue.

29. The method of claim 28 wherein the step of extending comprises the step of expanding at least two pairs of electrodes from the working end into apposition with the vein wall, wherein each pair of electrodes comprises a discrete pair of opposite polarity electrodes and the electrodes within each discrete pair are arranged such that an electrode in one discrete pair is adjacent a like polarity electrode of the adjacent pair.

30. The method of claim 29 wherein the step of expanding comprises the step of expanding an even number of electrodes into apposition with the vein wall, wherein said even number comprises at least four, and wherein said even number of electrodes are disposed in a plurality of discrete pairs of opposite polarity electrodes, said electrodes in each discrete pair being arranged such that an electrode in one discrete pair is adjacent a like polarity electrode of an adjacent pair.

31. The method of claim 18 further comprising the step of palpating the vein into apposition with the electrodes of the catheter in the vein lumen.

32. The method of claim 18 further comprising the steps of locating the working end of the catheter in apposition with the vein wall adjacent a selected commissure and directionally emitting energy to the vein wall to shrink the commissure.

33. The method of claim 18 wherein the step of positioning the energy application apparatus at the treatment site further includes the step of placing the energy application apparatus at an ostium and applying energy to reduce the size of the ostium.