IP Verse

Devices For Thermally-Induced Renal Neuromodulation

Patent No. US11801085 (titled "Devices For Thermally-Induced Renal Neuromodulation") was filed by Medtronic Ireland Manufacturing Unlimited Co on Jul 24, 2020.

What is this patent about?

’085 is related to the field of renal neuromodulation , specifically methods and systems for reducing sympathetic nerve activity in the kidneys. The background of the invention lies in addressing conditions like congestive heart failure, chronic renal failure, and hypertension, where excessive sympathetic activation of the kidneys exacerbates these conditions. Prior approaches involved electrical stimulation for renal denervation, but improvements were needed to enhance the implementation and effectiveness of these methods.

The underlying idea behind ’085 is to use thermally-induced neuromodulation to alter or damage renal neural fibers, thereby reducing sympathetic nerve activity. This is achieved by either heating or cooling the neural fibers or the vascular structures that supply them. The thermal energy can be applied directly or indirectly, and the process can be controlled by monitoring parameters of the neural fibers, surrounding tissue, or the energy delivery element itself.

The claims of ’085 focus on a system for renal neuromodulation that includes a catheter with a neuromodulation element and an expandable positioning element. The generator delivers energy sufficient to ablate renal neural fibers, and the expandable positioning element receives a cooling fluid to remove heat. The neuromodulation element is spaced radially inward from the outer diameter of the expandable positioning element when in the expanded configuration.

In practice, the catheter is inserted into the renal blood vessel, and the expandable positioning element is deployed. Cooling fluid is circulated within the positioning element to protect the vessel wall from excessive heat. The generator then delivers energy via the neuromodulation element to ablate the renal neural fibers. The cooling fluid acts as a heat sink , preventing thermal damage to non-target tissues while allowing sufficient energy to reach the target nerves.

’085 differentiates itself from prior approaches by incorporating a cooling mechanism within the expandable positioning element. This allows for higher energy delivery to the target neural fibers without causing excessive thermal damage to the vessel wall. The radial spacing of the neuromodulation element from the positioning element's outer diameter further contributes to the controlled energy delivery and targeted ablation of the renal neural fibers.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’085 was filed, renal neuromodulation via catheter-based techniques was an emerging field, at a time when systems commonly relied on radiofrequency ablation or electrical stimulation to achieve nerve modulation. Intravascular access was a standard approach for reaching target tissues, but controlling the thermal effects on surrounding non-target tissues, particularly within the vessel wall, was non-trivial. Pulsed energy delivery was being explored as a means to improve control and minimize damage, but continuous energy delivery was also common.

Novelty and Inventive Step

The examiner approved the claims because the prior art did not disclose a renal neuromodulation system or method that includes a catheter with at least one neuromodulation element, an expandable positioning element at its distal end, and a generator configured to deliver energy to ablate neural fibers and reduce sympathetic nerve activity. Furthermore, the neuromodulation element is spaced radially inward from the outer diameter of the expandable positioning element in an expanded configuration, and a cooling fluid is delivered to the expandable positioning element to remove heat.

Claims

There are 19 claims in total, with independent claims 1 and 12. Independent claim 1 focuses on a system for renal neuromodulation using a catheter with a neuromodulation element and an expandable positioning element that receives cooling fluid. Independent claim 12 focuses on a method of renal neuromodulation involving positioning a catheter with a neuromodulation element and expandable positioning element, expanding the positioning element, introducing cooling fluid, and delivering energy to ablate renal neural fibers. The dependent claims generally specify details and features of the system and method described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Cooling fluid
(Claim 1, Claim 12)		“When utilizing thermal heating mechanisms for thermal neuromodulation, protective cooling elements, such as conductive or convective cooling elements, optionally may be utilized to protect smooth muscle cells or other non-target tissue from undesired thermal effects during the thermally-induced renal neuromodulation.”A fluid used to remove heat from within the expandable positioning element.
Expandable positioning element
(Claim 1, Claim 12)		“When utilizing thermal heating mechanisms for thermal neuromodulation, protective cooling elements, such as conductive or convective cooling elements, optionally may be utilized to protect smooth muscle cells or other non-target tissue from undesired thermal effects during the thermally-induced renal neuromodulation. Likewise, when utilizing thermal cooling mechanisms, protective heating elements, such as conductive or convective heating elements, may be utilized to protect the non-target tissue.”A component of the catheter that can change shape to contact the vessel wall and position the neuromodulation element.
Expanded configuration
(Claim 1, Claim 12)		“When utilizing thermal heating mechanisms for thermal neuromodulation, protective cooling elements, such as conductive or convective cooling elements, optionally may be utilized to protect smooth muscle cells or other non-target tissue from undesired thermal effects during the thermally-induced renal neuromodulation. Likewise, when utilizing thermal cooling mechanisms, protective heating elements, such as conductive or convective heating elements, may be utilized to protect the non-target tissue.”A state of the expandable positioning element where it contacts the vessel wall, positioning the neuromodulation element at a specific distance from the wall.
Low profile delivery configuration
(Claim 1, Claim 12)		“To better understand the structures of several embodiments of devices described below, as well as the methods of using such devices for thermally-induced renal neuromodulation, a description of the renal anatomy in humans is provided.”A state of the expandable positioning element that allows for easier insertion and navigation within the renal vessel.
Renal neural fibers
(Claim 1, Claim 12)		“Reduction of sympathetic renal nerve activity (e.g., via denervation), can reverse these processes. An electric field can initiate renal neuromodulation via denervation caused by irreversible electroporation, electrofusion, apoptosis, necrosis, ablation, thermal alteration, alteration of gene expression or another suitable modality. The electric field can be delivered from an apparatus positioned intravascularly, extravascularly, intra-to-extravascularly, or a combination thereof.”Nerve fibers associated with renal function that are targeted for ablation to reduce sympathetic nerve activity.

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US11801085

MEDTRONIC IRELAND MANUFACTURING UNLIMITED CO
Application Number
US16938404
Filing Date
Jul 24, 2020
Status
Granted
Expiry Date
Aug 14, 2026
External Links
Slate, USPTO, Google Patents