US 2023/0389852 A1Published application

Methods, devices and systems that use one or more transducers to heat nerves to evoke neural response without denervating nerves, as well as to denervate nerves

AssigneeOtsuka Medical Devices Co., Ltd.

InventorLiang Zhai

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Abstract

Certain methods and systems described herein use a transducer used to produce ablation energy (aka denervation energy) to also evoke a neural response before and/or after denervation energy is delivered. Rather than the neural response being invoked in response to electrical stimulus, it is invoked in response to the transducer (e.g., RF, microwave, or ultrasound transducer) being used to sufficiently heat the nerves in tissue surrounding a biological lumen to an extent that a neural response is evoked without denervating the nerves. That is, the transducer used for performing ablation (aka denervation) is also used to evoke a neural response prior to (and/or after) ablation is performed, by using the transducer to sufficiently heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves. This can reduce the catheter production complexity and costs. Other embodiments are also disclosed.

Claims37

Dependent claims

A method for use with a catheter including one or more electrodes and also including a transducer that can be controlled to emit a selective amount of energy, wherein the method is for use while at least a distal portion of the catheter is inserted into a biological lumen that is surrounded by tissue including nerves that are to be denervated using the transducer of the catheter, the method comprising:

(a) energizing the transducer of the catheter to emit a first instance of a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves;
(b) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and storing first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy;
(c) energizing the transducer of the catheter to emit a first instance of a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen;
(d) after energizing the transducer of the catheter to emit the first instance of the second amount of energy, energizing the transducer of the catheter to emit a second instance of the first amount of energy;
(e) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and storing second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy;
and
(f) comparing the second information to the first information and using results of the comparing to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy.

4 more elements

A system, comprising:

a catheter including one or more electrodes and also including a transducer that can be controlled to emit a selective amount of energy, wherein the catheter is configured such that at least a distal portion of the catheter is insertable into a biological lumen that is surrounded by tissue including nerves that are to be denervated using the transducer of the catheter;
memory;
an excitation source configured to selectively provide energy to the transducer of the catheter;
a sensing subsystem electrically coupled to at least one of the one or more electrodes of the catheter;
and
a controller communicatively coupled to the excitation source, the sensing subsystem, and the memory, the controller configured to:
cause the excitation source to energize the transducer of the catheter to emit a first instance of a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves;
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and store in the memory first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy;
cause the excitation source to energize the transducer of the catheter to emit a first instance of a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen;
cause the excitation source to energize the transducer of the catheter to emit a second instance of the first amount of energy, after the first instance of the second amount of energy has been emitted;
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and store in the memory second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy;
and
compare the second information to the first information and use results of the comparison to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy.

10 more elements

energizing the transducer of the catheter to emit a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves;
using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first amount of energy;
determining one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter;
and
selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.

2 more elements

A system, comprising:

a catheter including one or more electrodes and also including a transducer that can be controlled to emit a selective amount of energy, wherein the catheter is configured such that at least a distal portion of the catheter is insertable into a biological lumen that is surrounded by tissue including nerves that are to be denervated using the transducer of the catheter;
memory;
an excitation source configured to selectively provide energy to the transducer of the catheter;
and
a sensing subsystem electrically coupled to at least one of the one or more sensing electrodes of the catheter;
and
a controller communicatively coupled to the excitation source, the sensing subsystem, and the memory, the controller configured to:
cause the excitation source to energize the transducer of the catheter to emit a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves;
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the first amount of energy;
determine one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter;
and
select, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.

9 more elements

Dependencies are inferred from the claim text.

Facts

Application: 18/327,280Filed 1 Jun 2023
Priority: 2 Jun 2022
Published: 7 Dec 2023
Term ends: Not estimatedThe source records don’t support an estimate.

Classification32 codes

A61B 5/388
Modalities, i.e. specific diagnostic methods: nerve conduction study, e.g. detecting action potential of peripheral nerves
A61B 18/1492
Probes or electrodes therefor: having a flexible, catheter-like structure, e.g. for heart ablation
A61B 18/1815
By applying electromagnetic radiation, e.g. microwaves: using microwaves
A61N 1/36017
External stimulators, e.g. with patch electrodes: with leads or electrodes penetrating the skin

Family

Application63/365,771Us provisional application · filed 2 Jun 2022
US 2023/0389852 A1This patent

From the US filing history. Foreign family members aren’t listed.

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