Apparatus, systems, and methods for achieving intravascular, thermally-induced renal neuromodulation
First Claim
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1. A catheter apparatus, comprising:
- an elongated shaft extending along an axis, the elongated shaft comprising a proximal end region and a distal end region, the distal region including a first flexure zone and a second flexure zone adjacent to and extending distally beyond the first flexure zone;
a handle coupled to the proximal end region;
a thermal element carried by and extending distally beyond the second flexure zone, wherein the thermal element comprises a single distal tip electrode having an atraumatic tip;
a flexure control element coupled to the first flexure zone and configured to apply a first force to the first flexure zone to move the first flexure zone of the distal region of the elongated shaft in a radial direction away from the axis;
a flexible structure within the second flexure zone that is coupled to the thermal element and configured to allow passive flexure in any plane about the axis in response to a second force applied to the thermal element via contact with a tissue surface;
a flexure controller carried by the handle and coupled to the flexure control element, wherein the flexure controller is configured to cause the flexure control element to apply the first force to move the first flexure zone; and
a connector carried by the handle and configured to connect the thermal element to a thermal energy source;
wherein the thermal element is configured to apply treatment to a tissue region adjacent to the tissue surface.
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Abstract
Apparatus, systems, and methods for achieving thermally-induced renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a thermal element to a renal artery via an intravascular path. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.
324 Citations
31 Claims
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1. A catheter apparatus, comprising:
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an elongated shaft extending along an axis, the elongated shaft comprising a proximal end region and a distal end region, the distal region including a first flexure zone and a second flexure zone adjacent to and extending distally beyond the first flexure zone; a handle coupled to the proximal end region; a thermal element carried by and extending distally beyond the second flexure zone, wherein the thermal element comprises a single distal tip electrode having an atraumatic tip; a flexure control element coupled to the first flexure zone and configured to apply a first force to the first flexure zone to move the first flexure zone of the distal region of the elongated shaft in a radial direction away from the axis; a flexible structure within the second flexure zone that is coupled to the thermal element and configured to allow passive flexure in any plane about the axis in response to a second force applied to the thermal element via contact with a tissue surface; a flexure controller carried by the handle and coupled to the flexure control element, wherein the flexure controller is configured to cause the flexure control element to apply the first force to move the first flexure zone; and a connector carried by the handle and configured to connect the thermal element to a thermal energy source; wherein the thermal element is configured to apply treatment to a tissue region adjacent to the tissue surface. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A medical treatment kit, comprising:
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an intravascular treatment device including— an elongated shaft extending along an axis, the elongated shaft comprising a proximal end region and a distal end region, the distal end region including a first flexure zone and a second flexure zone adjacent to and extending distally beyond the first flexure zone; a handle coupled to the proximal end region; a treatment element carried by and extending distally beyond the second flexure zone, wherein the thermal element comprises a single distal tip electrode having an atraumatic tip; a flexure control element coupled to the first flexure zone and configured to apply a first force to the first flexure zone to move the first flexure zone of the distal region of the elongated shaft in a radial direction away from the axis; a flexible structure within the second flexure zone that is coupled to the treatment element and configured to allow passive flexure in any plane about the axis in response to a second force applied to the treatment element via contact with a tissue surface; and a flexure controller carried by the handle and coupled to the flexure control element, wherein the flexure controller is configured to cause the flexure control element to apply the first force to move the first flexure zone; a cable configured to electrically connect the treatment device to an energy generator; a guide catheter configured to facilitate intravascular delivery of the treatment device into a patient; and instructions for delivering the treatment device into a renal artery of the patient and at least partially denervating a kidney of the patient corresponding to the renal artery to treat the patient for a condition associated with at least one of hypertension, heart failure, kidney disease, chronic renal failure, sympathetic hyperactivity, diabetes, metabolic disorder, insulin resistance, arrhythmia, acute myocardial infarction and cardio-renal syndrome. - View Dependent Claims (29, 30, 31)
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Specification