Catheter device including flow sensing

• US 9,554,850 B2
• Filed: 10/02/2015
• Issued: 01/31/2017
• Est. Priority Date: 07/05/2012
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Lee, Stephen P., Liu, Clifford, Ghaffari, Roozbeh, Work, John, Quivira, Fernando, Klinker, Lauren E., Hsu, Yung-Yu
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/874,148
• Publication Number:
  US 20160095652A1
• Time in Patent Office: 487 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00863 : Fluid flow
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2018/20361 : with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2018/206 : the laser light passing along a liquid-filled conduit
• CPC Class Codes: A61B 2018/2244 : Features of optical fibre cables, e.g. claddings
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Devices and methods are provided for performing an ablation procedure on tissue with flow monitoring using flow sensors. The devices include a catheter, and at least one flow sensor disposed on the catheter, and a component for applying the ablation procedure. An assessment module provides an indication of the efficacy of the ablation procedure based on the flow measurement from the flow sensor.

Claims

1. A device, comprising:

a catheter;

an inflatable and/or expandable body coupled to the catheter;

an electronic circuit disposed on the inflatable and/or expandable body, the electronic circuit comprising a plurality of components that accommodate expanding of the inflatable and/or expandable body, the plurality of components comprising;

a plurality of electrodes, at least one electrode of the plurality of electrodes being a radiofrequency electrode configured to deliver a radiofrequency energy to a tissue proximate to the radiofrequency electrode; and

a plurality of stretchable interconnects disposed on the inflatable and/or expandable body, wherein the plurality of stretchable interconnects electrically couples at least one of the plurality of electrodes to an external circuit;

at least one flow sensor coupled to the catheter;

at least one component coupled to the catheter and configured to perform an ablation procedure on a portion of a tissue proximate to the catheter; and

an assessment module coupled to the at least one flow sensor and configured to receive data indicative of at least one flow measurement from the at least one flow sensor and provide an indication of the efficacy of the ablation procedure based on the data indicative of at least one flow measurement.

2. The device of claim 1, wherein the plurality of components further comprises a main bus, and wherein the plurality of stretchable interconnects electrically couples at least one of the plurality of electrodes to the main bus, and wherein the main bus is coupled to the external circuit.

3. The device of claim 1, wherein the tissue proximate to the catheter is a portion of a renal artery and wherein the at least one flow measurement of the at least one flow sensor provides an indication of a rate of renal blood flow.

4. The device of claim 3, wherein at least one electrode of the plurality of electrodes is a pacing electrode configured to deliver an electrical stimulation to a portion of the renal artery proximate to the pacing electrode.

5. The device of claim 4, wherein the electrical stimulation is applied to the portion of the renal artery proximate to the pacing electrode prior to performance of the ablation procedure on the portion of the renal artery proximate to the catheter.

6. The device of claim 4, wherein the electrical stimulation is applied to the portion of the renal artery proximate to the pacing electrode subsequent to performance of the ablation procedure on the portion of the renal artery proximate to the catheter.

7. The device of claim 1, wherein the tissue proximate to the catheter is a portion of a renal artery, and wherein the data indicative of at least one flow measurement comprises a change in heat output by the heating element to restore the temperature of the fluid proximate to the temperature sensor to a specified temperature.

8. The device of claim 1, wherein the inflatable and/or expandable body has a proximal end and a distal end, and the at least one flow sensor is disposed on a portion of the proximal end and/or a portion of the distal end of the inflatable and/or expandable body.

9. The device of claim 8, wherein the inflatable and/or expandable body is disposed near a distal end of the catheter.

10. The device of claim 9, wherein the catheter has a longitudinal axis, and a longitudinal axis of the distal end of the inflatable and/or expandable body coincides with the longitudinal axis of the catheter.

11. The device of claim 10, further comprising a reference flow sensor disposed on a shaft of the catheter, wherein the reference flow sensor provides an indication of a flow rate of fluid proximate to the shaft.

12. The device of claim 11, wherein the catheter further comprises a sheath, wherein the catheter is deployed through the sheath, and wherein the sheath is deployable to cover a portion of the reference flow sensor.

13. The device of claim 7, wherein the temperature sensor is a thermistor, a thermocouple, a resistance temperature detector, a junction potential temperature sensor, an integrated-circuit temperature sensor, or a semiconductor temperature sensor.

14. The device of claim 1, wherein the ablation procedure is a radiofrequency ablation, a cryo-ablation, an ultrasound ablation, a laser-light-based ablation, a drug-based ablation, an ultrasound energy ablation, an alcohol injection-based ablation, or a microwave energy ablation.

15. The device of claim 1, wherein the radiofrequency electrode is a bipolar electrode or a unipolar electrode.

16. The device of claim 1, wherein the plurality of components further comprises at least one of a light-emitting device, a contact sensor, an image detector, a mapping electrode, a pressure sensor, a biological activity sensor, and a temperature sensor.

17. The device of claim 1, wherein the inflatable and/or expandable body is a compliant balloon.

18. The device of claim 1, wherein the inflatable and/or expandable body is an expandable spiral coil, an expandable mesh, or a deployable netting.

19. The device of claim 1, further comprising:

at least four flow sensors disposed on the inflatable and/or expandable body, and wherein the plurality of components comprises at least four pacing electrodes and at least four radio frequency electrodes.

20. The device of claim 1, wherein the tissue is a portion of a tissue lumen.

21. The device of claim 1, wherein the tissue is a renal artery, a pulmonary vein, a coronary artery, or a peripheral blood vessel.

22. A method of performing a medical diagnosis and/or treatment on a tissue, the method comprising:

disposing in proximity to the tissue an apparatus comprising;

a catheter;

an inflatable and/or expandable body coupled to the catheter;

an electronic circuit disposed on the inflatable and/or expandable body, the electronic circuit comprising a plurality of components that accommodate expanding of the inflatable and/or expandable body, the plurality of components comprising;

a plurality of electrodes, at least one electrode of the plurality of electrodes is a radiofrequency electrode configured to deliver a radiofrequency energy to a tissue proximate to the radiofrequency electrode; and

a plurality of stretchable interconnects disposed on the inflatable and/or expandable body, wherein the plurality of stretchable interconnects electrically couples at least one of the plurality of electrodes to an external circuit;

at least one flow sensor disposed on a portion of the catheter, each of the at least one flow sensor comprising;

a heating element; and

a temperature sensor disposed proximate to the heating element, wherein a flow measurement of the at least one flow sensor provides an indication of a flow rate of a fluid proximate to the portion of the catheter;

at least one component coupled to the catheter and configured to perform an ablation procedure on a portion of a tissue proximate to the catheter; and

an assessment module coupled to the at least one flow sensor and configured to receive data indicative of at least one flow measurement from the at least one flow sensor and provide an indication of the efficacy of the ablation procedure based on the data indicative of at least one flow measurement;

applying the ablation procedure to the surface of the tissue proximate to the catheter; and

recording the at least one flow measurement of the at least one flow sensor.

23. The method of claim 22, further comprising the recording of the at least one flow measurement prior to and subsequent to performing the ablation procedure, and wherein the ablation procedure is a radiofrequency ablation, a cryo-ablation, an ultrasound ablation, a laser-light-based ablation, a drug-based ablation, an ultrasound energy ablation, an alcohol injection-based ablation, or a microwave energy ablation of the tissue.

24. The method of claim 22, wherein the recording of the at least one flow measurement of the at least one flow sensor is performed subsequent to the applying of the ablation procedure to the surface of the tissue proximate to the catheter.

25. The method of claim 22, wherein the recording of the at least one flow measurement of the at least one flow sensor is performed prior to the applying of the ablation procedure to the surface of the tissue proximate to the catheter.

26. The method of claim 25, further comprising:

the recording of the at least one flow measurement of the at least one flow sensor subsequent to the applying of the ablation procedure to the surface of the tissue proximate to the catheter; and

comparing data indicative of the at least one flow measurement prior to the applying of the ablation procedure to data indicative of the at least one flow measurement subsequent to the applying of the ablation procedure to provide the indication of the efficacy of the ablation procedure.

27. The method of claim 26, wherein an indication of an increase in the flow rate of the fluid provides an indication of the efficacy of the applying of the ablation procedure to the surface of the tissue.

28. The method of claim 22, wherein the catheter further comprises a pacing electrode configured to deliver an electrical stimulation to a portion of a tissue proximate to the pacing electrode.

29. The method of claim 28, further comprising delivering the electrical stimulation to the portion of the tissue proximate to the pacing electrode prior to a recording of at least one temperature measurement of the temperature sensor.

30. The method of claim 22, wherein the tissue is a left renal artery, a right renal artery, and/or a carotid body.

31. The method of claim 30, wherein an indication of an increase in the flow rate of the fluid provides an indication of the efficacy of the applying of the ablation procedure to the surface of the left renal artery, the right renal artery, and/or the carotid body.

32. The method of claim 31, wherein the applying of the ablation procedure to the surface of the renal artery causes an ablation of a nerve proximate to the surface of the renal artery.

33. A catheter device for performing a procedure on tissue of a renal artery, comprising:

an inflatable and/or expandable body disposed near a distal end of the catheter device;

an electronic circuit disposed on the inflatable and/or expandable body, the electronic circuit comprising a plurality of components that accommodate expanding of the inflatable and/or expandable body, the plurality of components comprising;

a plurality of electrodes, at least one electrode of the plurality of electrodes is a radiofrequency electrode configured to deliver a radiofrequency energy to a surface proximate to the radiofrequency electrode to perform an ablation procedure on a portion of the tissue of the renal artery; and

a plurality of stretchable interconnects disposed on the surface of the inflatable and/or expandable body, wherein the plurality of stretchable interconnects electrically couples at least one of the plurality of electrodes to an external circuit; and

at least one flow sensor disposed on the inflatable and/or expandable body, each of the at least one flow sensor comprising;

a heating element configured to heat an area proximate to the inflatable and/or expandable body; and

a temperature sensor disposed proximate to the heating element, wherein measurement of the temperature sensor provides an indication of a flow rate of blood in the renal artery proximate to the inflatable and/or expandable body.

34. The catheter device of claim 33, wherein the at least one component comprises at least one radiofrequency electrode disposed on the inflatable and/or expandable body and configured to deliver a radiofrequency energy to the portion of the tissue of the renal artery.

35. The catheter device of claim 33, wherein the at least one component comprises a cauterizing element or a cryo-ablation component.

36. The catheter device of claim 33, wherein the plurality of components further comprises a main bus, and wherein the plurality of stretchable interconnects electrically couples at least one of the plurality of electrodes to the main bus, and wherein the main bus is coupled to the external circuit.

37. The catheter device of claim 33, further comprising at least one pacing electrode disposed on the inflatable and/or expandable body and configured to deliver an electrical stimulation to a portion of the tissue of the renal artery proximate to the pacing electrode.

38. The catheter device of claim 37, wherein the electrical stimulation is applied to the portion of the renal artery prior to performing the ablation procedure on the portion of the tissue of the renal artery.

39. The catheter device of claim 37, wherein the electrical stimulation is applied to the portion of the renal artery subsequent to performing the ablation procedure on the portion of the tissue of the renal artery.

40. The catheter device of claim 33, further comprising at least one of a light-emitting device, a contact sensor, an image detector, a mapping electrode, a pressure sensor, a biological activity sensors, and a temperature sensor, disposed on the inflatable and/or expandable body.

41. The catheter device of claim 33, wherein the inflatable and/or expandable body is a balloon.

42. The catheter device of claim 33, wherein the inflatable and/or expandable body is an expandable spiral coil, an expandable mesh, or a deployable netting.