Devices and Systems for Carotid Body Ablation

• US 20140018788A1
• Filed: 07/05/2013
• Published: 01/16/2014
• Est. Priority Date: 07/04/2012
• Status: Abandoned Application

• Current Assignee: Cibiem, Inc.
• Original Assignee: Marat Fudim, Zoar Jacob Engelman
• Inventors: Engelman, Zoar Jacob, Grasse, Martin M., Gelfand, Mark, Lennox, Charles, Abboud, Marwan, Leung, Mark, Levin, Howard, Fudim, Marat, Taimisto, Miriam H., Martin, Kenneth M., Brommer, Robert, West, Scott H., Markham, Michael Brick
• Application Number:
  US13/936,121
• Publication Number:
  US 20140018788A1
• Time in Patent Office: Days
• US Class Current: 606/33
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• 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 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00684 : using lookup tables
• 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 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00803 : with temperature prediction
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00863 : Fluid flow
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00904 : Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• 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 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 : Irrigation
• 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 1/36053 : adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods and endovascular catheters for assessing, and treating patients having sympathetically mediated disease, involving augmented peripheral chemoreflex and heightened sympathetic tone by reducing chemosensor input to the nervous system via transmural carotid body ablation.

Claims

1. An endovascular ablation catheter comprising a structure at a distal region, the structure comprising:

two arms configured to couple with a carotid bifurcation;

at least one ablation element on one of the arms positioned on the arm such that when the structure is coupled to a carotid bifurcation the at least one ablation element is placed on a target site for carotid body ablation.

2-10. -10. (canceled)

11. A system configured for endovascular transmural ablation of a carotid body including:

a catheter having two arms to facilitate positioning and apposition of ablation elements on an intercarotid septum.

12-19. -19. (canceled)

20. A device for ablating the function of a carotid body comprising:

an elongate tubular structure configured for endovascular access of a carotid bifurcation having a distal region and a proximal region,

a bifurcated structure at the distal region configured to abut the carotid bifurcation, the structure comprising diverging structures and at least one ablation element mounted on one of the diverging structures, and

a conveyor of energy to be applied to said ablation element from a source of ablation energy;

whereby, the bifurcated structure is configured to apply a contact force between the ablation element and a carotid artery wall.

21-24. -24. (canceled)

25. A system for ablating a function of a carotid body in a patient comprising:

a catheter configured for use in the vicinity of a carotid artery bifurcation comprising a distal region and a proximal region, a structure at the distal region configured for coupling with a carotid septum comprising at least one ablation element, a means for connecting said ablation element to a source of ablation energy;

a console comprising source of ablation energy and a means for controlling said energy, a user interface configured to provide the user with a selection of ablation parameters and to provide the user with indications of the status of the console and the status of ablation activity, and a means to activate and deactivate an ablation;

whereby, the catheter provides the means for user placement of said ablation element into an optimal position within a carotid artery for ablation, and the console provides the means for user selection of optimal ablation parameters.

26. An endovascular ablation catheter comprising:

a fixation structure configured to engage with a carotid bifurcation;

an arm configured to extend into a carotid artery when the fixation structure engages with the carotid bifurcation; and

at least one ablation element arranged on the arm such that it is spaced apart a fixed distance from a carotid bifurcation saddle when the fixation structure engages with the carotid bifurcation.

27-33. -33. (canceled)

34. An endovascular carotid septum ablation catheter comprising:

first and second diverging arms, the first arm comprising an ablation element and configured so that the ablation element is in contact with a carotid septal wall in one of an external carotid artery and an internal carotid artery when the catheter is coupled with a common carotid artery bifurcation, the second arm configured to be disposed in the other of the internal carotid artery and external carotid artery when the catheter is coupled with the bifurcation.

38. The catheter of claim 34 wherein the second arm comprises a second ablation element, the second arm being configured so that the second ablation element is in contact with a carotid septal wall in the internal carotid artery between the bifurcation and about 10-15 mm cranial to the bifurcation when the catheter is coupled with the bifurcation.

39. The catheter of claim 34 wherein the first arm is configured such that substantially all contact that occurs between the first arm and the wall of the one of the internal carotid artery or the external carotid artery occurs between the ablation element and the wall.

45. The catheter of claim 34 wherein the first arm comprises a clearance portion proximal the ablation element, the clearance portion configured to make less surface area contact with the wall of the one of the external carotid artery and internal carotid artery than the ablation element.

47. The catheter of claim 34 wherein the second arm comprises a second ablation element, the second arm configured so that the second ablation element is in contact with a carotid septal wall in the other of the external carotid artery and internal carotid artery when the catheter is coupled with a common carotid artery bifurcation, wherein the first and second arms are configured to self-align within the internal and external carotid arteries against the septum.

50. The catheter of claim 47 wherein the first and second arms are in substantially the same plane in unstressed configurations.

51. The catheter of claim 50 wherein the first and second arms are flexible so that they are configured to be deflectable out of plane, and yet are resilient to allow them to return to the plane.

53. The catheter of claim 51 wherein the first and second arms have sufficient resiliency to allow them to move from one stress state to a lower stress state when positioned in contact with the walls of the internal and external carotid arteries.

56. The catheter of claim 34 wherein the first and second arms have unstressed configurations in which the first and second ablation elements are less than about 4 mm apart measured along a line perpendicular to a longitudinal axis of a catheter axis.

35-37. -37. (canceled)

40-44. -44. (canceled)

46. (canceled)

48-49. -49. (canceled)

52. (canceled)

54-55. -55. (canceled)

57-94. -94. (canceled)

95. An endovascular carotid septum ablation catheter comprising:

first and second diverging arms, the first arm comprising a first ablation element and configured so that the first ablation element is in contact with an external carotid artery wall when the catheter is coupled with a common carotid artery bifurcation, the second arm comprising a second ablation element and configured so that the second ablation element is in contact with an internal carotid artery when the catheter is coupled with the bifurcation, wherein the first and second ablation elements are positioned on the first and second arms so that when the catheter is coupled with the bifurcation, a straight line passing through the first and second ablation elements passes through a carotid septum.

96. (canceled)

97. A method of ablating a carotid septum, comprising:

advancing a first diverging arm of an ablation catheter into an external carotid artery and a second diverging arm of the ablation catheter into an internal carotid artery so that a first ablation element on the first diverging arm is in apposition with a carotid septum wall in the external carotid artery and a second ablation element on the second diverging arm is positioned in the internal carotid artery; and

ablating carotid septal tissue by delivering ablation energy between the first and second ablation elements so that the ablation energy passes through a carotid septum.

98-131. -131. (canceled)

132. A method of ablating a carotid septum, comprising

advancing a first diverging arm of an ablation catheter into an external carotid artery and a second diverging arm of the ablation catheter into an internal carotid artery so that a first ablation element on the first diverging arm is in apposition with a carotid septum wall in the external carotid artery and a second ablation element on the second diverging arm is in apposition with a carotid septum wall in the internal carotid artery;

and

ablating carotid septal tissue by delivering ablation energy between the first and second ablation elements so that the ablation energy passes through a carotid septum.

133. A method of endovascularly ablating a carotid septum, comprising

providing an elongate device comprising first and second diverging arms, the first diverging arm comprising a first ablation element and the second bifurcating arm comprising a second ablation element;

positioning the first ablation element in contact with an external carotid artery so as to create a surface contact area between the first ablation electrode and the external carotid artery that is between about 30% to about 70% of a total surface area of the first ablation element, and

positioning the second diverging arm in an internal carotid artery; and

ablating carotid septal tissue by delivering ablation energy between the first and second ablation elements through the carotid septum.

134. (canceled)

135. A method of endovascularly ablating a carotid septum, comprising

providing an elongate device comprising first and second diverging arms, the first diverging arm comprising a first ablation element and the second bifurcating arm comprising a second ablation element;

positioning the first ablation element in contact with an external carotid artery so as to create a surface contact area between the first ablation electrode and the external carotid artery that is between about 4.5 mm2 and about 21 mm2;

positioning the second diverging arm in an internal carotid artery; and

ablating carotid septal tissue by delivering ablation energy between the first and second ablation elements through the carotid septum.

136-137. -137. (canceled)

138. A method of endovascularly ablating a carotid body, comprising:

providing an elongate device comprising first and second diverging arms, the first diverging arm comprising a first electrode and the second diverging arm comprising a second electrode;

positioning the first diverging arm in an external carotid artery and the second diverging arm in an internal carotid artery;

delivering alternating electric current between the first and second electrodes;

forming an ablation zone within a carotid septum that does not extend to the internal or external carotid arteries, wherein the ablation zone includes a location midway along a line passing through the first and second electrodes; and

continuing to deliver alternating electric current energy to extend the ablation zone towards the internal and carotid arteries.

139-141. -141. (canceled)