BALLOON CATHETER APPARATUS WITH MICROWAVE EMITTER

• US 20140257266A1
• Filed: 03/06/2014
• Published: 09/11/2014
• Est. Priority Date: 03/08/2013
• Status: Abandoned Application

• Current Assignee: Symple Surgical, Inc.
• Original Assignee: Symple Surgical, Inc.
• Inventors: Sundaram, Balamurugan, Kasprzyk, Daniel, Preston, Justin, Crozier, Seth, Desai, Sohail, Watkins, Roger D., Sundaram, Sureshbabu
• Application Number:
  US14/199,374
• Publication Number:
  US 20140257266A1
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 18/1815 using microwaves
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/183 characterised by the type of antenna
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2018/1876 with multiple frequencies
• CPC Class Codes: A61B 2018/1884 with non-uniform emissions

Abstract

A method and balloon catheter apparatus for tissue ablation is disclosed. The apparatus comprises an elongated shaft having a proximal end, a distal end, one or more central lumens, adapted for positioning in an artery; an emitter capable of emitting microwave energy positioned at the distal end; an inflatable balloon associated with the emitter at the distal end configured to allow blood to pass through the artery while the balloon is inflated; and a control system at the proximal end. The method and balloon catheter apparatus is applicable at least to renal denervation procedures.

Claims

1. A balloon catheter apparatus, comprising:

an elongated shaft having a proximal end, a distal end, and adapted for positioning in an artery;

an emitter capable of emitting microwave energy positioned at the distal end;

an inflatable balloon associated with the emitter at the distal end; and

a control system at the proximal end.

2. The balloon catheter apparatus of claim 1, wherein the emitter includes one or more antennas.

3. The balloon catheter apparatus of claim 2, wherein a plurality of antennas are configured in an array.

4. The balloon catheter apparatus of claim 1, wherein the emitter is capable of emitting broad band frequencies.

5. The balloon catheter apparatus of claim 1, wherein the emitter emits a volumetric field of microwave energy toward a targeted tissue.

6. The balloon catheter apparatus of claim 1, wherein the emitter emits microwave energy in a plurality of 15 to 600 second pulses.

7. The balloon catheter apparatus of claim 1, wherein the emitter is capable of phase sweeping.

8. The balloon catheter apparatus of claim 1, wherein the emitter is capable of frequency sweeping.

9. The balloon catheter apparatus of claim 1, wherein the emitter is capable of emitting microwave energy to treat tissue in the range of about 0.5 millimeters to about 10 millimeters radially outward from an inner surface of the artery.

10. The balloon catheter apparatus of claim 1, wherein the artery is a renal artery.

11. The balloon catheter apparatus of claim 1, wherein the artery is an aorta.

12. The balloon catheter apparatus of claim 1, wherein the inflatable balloon contains channels to avoid vascular occlusion.

13. The balloon catheter apparatus of claim 12, wherein the channels form a passage for fluids between an arterial wall and an inflated balloon.

14. The balloon catheter apparatus of claim 12, wherein the channels are in a spiral configuration.

15. The balloon catheter apparatus of claim 1, wherein the inflatable balloon further comprises a shielding material coating the interior or exterior of the balloon.

16. The balloon catheter apparatus of claim 15, further comprising slots formed by the absence of the shielding material, wherein the slots directionally focus microwave energy from the emitter to a targeted tissue.

17. The balloon catheter apparatus of claim 1, including one or more central lumens wherein the one or more central lumens are configured for delivery of a coolant.

18. The balloon catheter apparatus of claim 17, wherein the coolant is a dielectric agent.

19. The balloon catheter apparatus of claim 1, wherein one or more central lumens are capable of delivering and circulating fluid to and from an area associated with the emitter whereby the fluid contacts the emitter.

20. The balloon catheter apparatus of claim 1, wherein one or more central lumens are capable of delivering and circulating fluid or gas to and from an area within the walls of the balloon whereby the fluid does not contact the emitter.

21. The balloon catheter apparatus of claim 1, wherein one or more central lumens terminate to form irrigation ports where fluid may be delivered to the patient'"'"'s vasculature.

22. The balloon catheter apparatus of claim 1, wherein the control system is capable of monitoring the energy delivered and temperature generated and is programmed to alter the delivery of energy if one or more power or temperature parameters is exceeded.

23. The balloon catheter apparatus of claim 1, including an emitter channel wherein the emitter can be positioned and moved along the emitter channel via a manipulation wire.

24. The balloon catheter apparatus of claim 23, wherein the emitter channel forms a linear path.

25. The balloon catheter apparatus of claim 23, wherein the emitter channel forms a spiral path.

26. A method of treating a patient via ablation of a targeted tissue, the method comprising the steps of:

intravascularly positioning a catheter having an emitter within an artery of the patient;

activating the emitter such that microwave energy is produced and transferred from the emitter to the targeted tissue; and

treating the targeted tissue with a balloon catheter apparatus as in any of claims 1-25 and with enough microwave energy to therapeutically impair the targeted tissue of the patient.

27. The method of claim 26, wherein treating the targeted tissue comprises administering a dose of microwave energy at only one location.

28. The method of claim 26, including positioning the emitter via a manipulation wire while the emitter is emitting microwave energy to treat targeted tissue longitudinally without the need to deflate the balloon or reposition the balloon catheter apparatus wherein the emitter follows a linear emitter channel within an inflated balloon.

29. The method of claim 26, including positioning the emitter via a manipulation wire while the emitter is emitting microwave energy to treat targeted tissue longitudinally without the need to deflate the balloon or reposition the balloon catheter apparatus wherein the emitter follows a spiral emitter channel within an inflated balloon.

30. A method of renal denervation of a targeted tissue of a patient, the method comprising the steps of:

intravascularly positioning a catheter having an emitter within an artery of the patient;

activating the emitter such that microwave energy is produced and transferred from the emitter to the targeted tissue; and

treating the targeted tissue with a balloon catheter apparatus as in any of claims 1-25 and with enough microwave energy to therapeutically impair one or more sympathetic nerves of the patient.

31. The method of claim 30, wherein treating the targeted tissue comprises administering a dose of microwave energy at only one location.

32. The method of claim 30, including positioning the emitter via a manipulation wire while the emitter is emitting microwave energy to treat targeted tissue longitudinally without the need to deflate the balloon or reposition the balloon catheter apparatus wherein the emitter follows a linear emitter channel within an inflated balloon.

33. The method of claim 30, including positioning the emitter via a manipulation wire while the emitter is emitting microwave energy to treat targeted tissue longitudinally without the need to deflate the balloon or reposition the balloon catheter apparatus wherein the emitter follows a spiral emitter channel within an inflated balloon.

34. A balloon catheter apparatus, comprising:

a catheter configured to house a flexible coaxial cable, a guide wire, and a sensor cable, wherein the coaxial cable and the sensor cable are in communication with a control system, and wherein the sensor cable is in communication with a sensor;

an inflatable balloon located at a distal end of the catheter, the inflatable balloon comprising a length of 20 millimeters to 35 millimeters and capable of expanding to an outside diameter of 4 millimeters to 8 millimeters;

a slot antenna positioned in the inflatable balloon and in communication with the coaxial cable, the antenna configured to emit microwave energy to a target tissue zone located 0.75 millimeters to 6.0 millimeters from an inner wall of a renal artery, wherein the antenna is radially centered in the inflatable balloon and located within a proximal half of the inflatable balloon, wherein tissue within the target tissue zone is heated by the emitted microwave energy to a temperature between 48°

C. and 65°

C.;

at least one irrigation port located at the distal end of the balloon catheter apparatus configured to allow a fluid to exit the balloon catheter apparatus after the fluid has cooled elements of the balloon catheter apparatus and tissue outside the target tissue zone that may be heated as a consequence of emitting microwave energy from the antenna; and

a control system comprising;

a fluid pump configured to introduce fluid into a proximal end of the catheter at a flow rate of between 25 mL/min and 150 mL/min to maintain inflation of the balloon;

a power amplifier capable of generating microwave energy for delivery to the target tissue zone for at least one energy application cycle ranging from 60 seconds to 240 seconds at a frequency within the range of 2.4 GHz and 2.5 GHz;

a computer system capable of monitoring and regulating the delivery of microwave energy, the fluid pump, the sensor and antenna reflected power, wherein the computer system is programmable with a safety algorithm to ensure the balloon catheter apparatus operates within acceptable temperature and power ranges.

35. The balloon catheter apparatus of claim 34, wherein the control system can alter the frequency within the range of 2.4 GHz to 2.5 GHz.

36. The balloon catheter apparatus of claim 34, wherein the temperature sensor is a thermistor.

37. The balloon catheter apparatus of claim 34, wherein the temperature sensor is an optical temperature sensor.