RF renal denervation catheter with multiple independent electrodes

• US 9,220,558 B2
• Filed: 10/26/2011
• Issued: 12/29/2015
• Est. Priority Date: 10/27/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Willard, Martin
• Primary Examiner(s): Evanisko, George
• Application Number:
  US13/281,962
• Publication Number:
  US 20120116392A1
• Time in Patent Office: 1,525 Days
• Field of Search: 606/38, 606/42, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00202 rotating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• 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 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00702 Power or energy
• 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 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 5/0075 : by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20

Abstract

A catheter includes a flexible shaft having a length sufficient to access a patient'"'"'s renal artery relative to a percutaneous access location. The catheter includes a multiplicity of elongated resilient members each comprising a pre-formed curve and extendable beyond the catheter. The resilient members are constrained to a low profile when encompassed by a removable sheath, and expand outwardly to assume a pre-defined shape when removed from the sheath. An electrode assembly is provided at a distal end of each resilient member, and includes an electrode element coupled to an electrical conductor and a thermal sensor in thermal communication with the electrode element. The resilient members have a stiffness sufficient to maintain contact between the electrode elements and an inner wall of the renal artery including irregularities of the inner wall of the renal artery during ablation of perivascular renal nerve tissue.

Claims

1. An apparatus, comprising:

a catheter comprising a flexible shaft having a proximal end, a distal end, and a length, the length of the shaft sufficient to access a patient'"'"'s renal artery relative to a percutaneous access location;

a plurality of elongated resilient members each comprising a pre-formed curve and extendable beyond the distal end of the catheter, the resilient members constrained to a low profile when encompassed by a wall of a removable sheath or a lumen wall of the shaft and, when removed from the removable sheath or lumen of the shaft, expanding outwardly and assuming a shape of the pre-formed curve, each of the plurality of elongated resilient members including a front side and opposite back side, and an electrical conductor extending along the elongated resilient member; and

an electrode assembly provided at a distal end of each of the resilient members, each of the electrode assemblies comprising;

a curved protruding electrode element disposed over the resilient member and only on the front side of the member, wherein the electrode element protrudes laterally from only a front side of the resilient member, its curvature defining a void, the curved electrode element coupled to the electrical conductor extending along the elongated resilient member and into the void defined by the curved electrode element; and

a thermal sensor situated within the void defined by the curved electrode element, the thermal sensor in thermal communication with the electrode element;

the resilient members having a stiffness sufficient to maintain contact between the electrode elements and an inner wall of the renal artery including irregularities of the inner wall of the renal artery.

2. The apparatus of claim 1, further comprising the removable sheath, the removable sheath having a length sufficient to access the patient'"'"'s renal artery relative to the percutaneous access location.

3. The apparatus of claim 1, wherein the catheter shaft comprises a lumen dimensioned to receive a guidewire.

4. The apparatus of claim 1, wherein the thermal sensor further comprises a conductor that extends from the thermal sensor and along the resilient member.

5. The apparatus of claim 1, wherein:

the electrical conductor is electrically coupled to an electrode conductor arrangement of the catheter shaft; and

the thermal sensor further comprises a conductor that extends from the thermal sensor, along the resilient member, and is coupled to a sensor conductor arrangement of the catheter shaft.

6. The apparatus of claim 1, further comprising a swiveling electrical connector provided at a hub end of the catheter, the swiveling electrical connector configured to facilitate catheter hub rotation relative to a non-rotatable cable of an external control unit.

7. The apparatus of claim 6, wherein the catheter shaft and the swiveling electrical connector comprise a lumen dimensioned to receive a guidewire.

8. The apparatus of claim 1, wherein individual elongated resilient members comprise longitudinal metal strips or ribbons, one of the electrode assemblies mounted at the distal end of one of the plurality of longitudinal metal strips or ribbons.

9. The apparatus of claim 1, wherein each of the resilient members comprises an electrically conductive wire constructed from a highly elastic or superelastic material.

10. The apparatus of claim 1, wherein a distal region of each of the resilient members including the respective electrode assemblies take on a longitudinally spaced configuration.

11. The apparatus of claim 1, wherein a distal region of each of the resilient members including the respective electrode assemblies take on a longitudinally spaced and circumferentially offset configuration.

12. The apparatus of claim 1, further comprising an active deflection arrangement coupled to one or more of the resilient members wherein actuation of the active deflection arrangement causes one or more of the resilient members to expand outwardly and assume the shape of the pre-formed curve.

13. An apparatus, comprising:

a catheter comprising a flexible shaft;

a plurality of elongated resilient members each comprising a pre-formed curve and extendable beyond a distal end of the catheter, the resilient members constrained to a low profile when encompassed by a wall of a removable sheath or a lumen wall of the shaft and, when removed from the removable sheath or lumen of the shaft, expanding outwardly and assuming a shape of the pre-formed curve, each of the plurality of elongated resilient members including a front side and opposite back side, and an electrical conductor extending along the elongated resilient member; and

an electrode assembly provided at a distal end of each of the resilient members, each of the electrode assemblies comprising;

a curved protruding electrode element disposed over the resilient member and only on the front side of the member, wherein the electrode element protrudes laterally from only the front side of the resilient member, its curvature defining a void, the curved electrode element coupled to the electrical conductor extending along the elongated resilient member and into the void defined by the curved electrode element; and

a thermal sensor situated within the void defined by the curved electrode element, the thermal sensor in thermal communication with the electrode element;

the resilient members having a stiffness sufficient to maintain contact between the electrode elements and an inner wall of a target vessel of the body including irregularities of the inner wall of the target vessel.

14. The apparatus of claim 13, wherein the catheter shaft comprises a lumen dimensioned to receive a guidewire.

15. The apparatus of claim 13, further comprising a swiveling electrical connector provided at a hub end of the catheter, the swiveling electrical connector configured to facilitate catheter hub rotation relative to a non-rotatable cable of an external control unit.

16. The apparatus of claim 15, wherein the catheter shaft and the swiveling electrical connector comprise a lumen dimensioned to receive a guidewire.

17. The apparatus of claim 13, wherein individual elongated resilient members comprise longitudinal metal strips or ribbons, one of the electrode assemblies mounted at the distal end of one of the plurality of longitudinal metal strips or ribbons.

18. The apparatus of claim 13, further comprising an active deflection arrangement coupled to one or more of the resilient members, wherein actuation of the active deflection arrangement causes the one or more of the resilient members to expand outwardly and assume the shape of the pre-formed curve.

19. A method, comprising:

constraining a plurality of resilient electrode assemblies each supported by one of a plurality of elongated support members to a low profile configuration within a removable sheath or a lumen of a catheter shaft, wherein each of the electrode assemblies has a front side and opposite back side and includes;

a curved protruding electrode element disposed over the elongated support member and only on the front side of the member, wherein the electrode element protrudes laterally from only the front side of the support member, its curvature defining a void, the curved electrode element coupled to an electrical conductor extending along the elongated support member and into the void defined by the curved electrode element; and

a thermal sensor situated within the void defined by the curved electrode element, the thermal sensor in thermal communication with the electrode element;

moving the electrode assemblies and elongated support members free of the sheath or catheter shaft lumen within a target vessel to allow the electrode assemblies to assume a pre-formed curved shape and expand outwardly to contact an inner wall of the target vessel;

resiliently maintaining contact between each electrode assembly and the inner wall of the target vessel including irregularities of the inner wall of the target vessel by the stiffness of the resilient members; and

ablating target tissue using the electrode assemblies.

20. The method of claim 19, further comprising measuring one or both of temperature and impedance at or proximate the electrodes, and moderating target tissue ablation in response to one or both of temperature and impedance measurements.

21. The method of claim 19, further comprising:

after completing ablation, constraining the electrode assemblies and elongated support members to the low profile configuration within the removable sheath or the lumen of the catheter shaft; and

removing the electrode assemblies and elongated support members from the target vessel while in the low profile configuration.

22. The method of claim 19, wherein the target vessel comprises a renal artery and the target tissue comprises perivascular renal nerves.