US2022409059A1PendingUtilityA1

Systems and methods for monitoring and evaluating neuromodulation therapy

Assignee: TRUDEL JULIEPriority: Feb 1, 2016Filed: Sep 7, 2022Published: Dec 29, 2022
Est. expiryFeb 1, 2036(~9.5 yrs left)· nominal 20-yr term from priority
A61B 5/021A61B 5/0538A61B 5/201A61B 2018/00577G16H 50/20A61B 5/4833A61B 5/01A61N 1/36A61M 25/0026A61B 5/4848A61B 5/053A61N 2007/0026A61B 5/7232A61N 1/3606A61B 18/1492G16H 20/30A61B 5/026A61N 5/045A61B 5/6851A61B 5/0285G16H 40/63A61N 1/36114A61N 7/02A61B 5/0215A61B 5/0084A61N 5/0622G16H 20/40
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Claims

Abstract

Systems and methods for informing and evaluating neuromodulation therapy are disclosed herein. A system configured in accordance with embodiments of the present technology can include, for example, a guidewire having a proximal portion, a distal portion configured to be positioned at a target site in a blood vessel of a human patient, and a sensing element positioned along the distal portion. The sensing element can be a pressure sensing element, a flow sensing element, an impedance sensing element, and/or a temperature sensing element. The system can further include a controller configured to obtain one or more measurements related to a physiological parameter of the patient via the sensing element. Based on the measurements, the controller can determine the physiological parameter and compare the parameter to a predetermined threshold. Based on the comparison, the controller and/or the operator can assess the likelihood of the patient benefitting from neuromodulation therapy.

Claims

exact text as granted — not AI-modified
1 - 25 . (canceled) 
     
     
         26 . A method comprising:
 obtaining, by a sensing element at a target site within a blood vessel of a patient, a measurement related to a hemodynamic parameter of the patient;   determining, by a controller, a physiological parameter indicative of patient responsiveness to neuromodulation therapy at the target site based on the measurement;   determining, by the controller and based on the physiological parameter, a likelihood of the patient benefitting from the neuromodulation therapy; and   indicating, by the controller, the likelihood of the patient benefitting from the neuromodulation therapy.   
     
     
         27 . The method of  claim 26 , wherein the blood vessel comprises a renal blood vessel, and wherein physiological parameter comprises a renal wave speed. 
     
     
         28 . The method of  claim 26 , wherein the blood vessel comprises a renal blood vessel, and wherein the physiological parameter comprises a renal resistance. 
     
     
         29 . The method of  claim 26 , wherein determining the likelihood of the patient benefitting from the neuromodulation therapy comprises comparing the physiological parameter to a predetermined threshold. 
     
     
         30 . The method of  claim 26 , wherein the sensing element comprises at least one of an electrocardiogram sensor, a pressure sensor, a temperature sensor, a flow sensor, an impedance sensor, a flow rate sensor, a chemical sensor, a bio-sensing element, an electrochemical sensor, a hemodynamic sensor, or an optical sensor. 
     
     
         31 . The method of  claim 26 , wherein a guidewire comprises the sensing element. 
     
     
         32 . The method of  claim 26 , wherein a catheter assembly comprises the sensing element, wherein the catheter assembly is configured to deliver the neuromodulation therapy to the target site. 
     
     
         33 . The method of  claim 32 , wherein the catheter assembly is configured to deliver the neuromodulation therapy by at least delivering energy, a chemical, or cryogenic cooling to the target site. 
     
     
         34 . The method of  claim 26 , wherein determining the likelihood of the patient benefitting from the neuromodulation therapy comprises determining the patient will likely benefit from the neuromodulation therapy, the method further comprising causing a medical device to apply the neuromodulation therapy to the target site to at least partially ablate nerves proximate to a wall of the blood vessel based on determining the patient will likely benefit from the neuromodulation therapy. 
     
     
         35 . A system comprising:
 a sensing element configured to sense a hemodynamic parameter at a target site within a blood vessel of a patient; and   a controller configured to:
 receive, from the sensing element, a measurement related to the hemodynamic parameter, 
 determine a physiological parameter indicative of patient responsiveness to neuromodulation therapy at the target site based on the measurement, 
 determine, based on the physiological parameter, a likelihood of the patient benefitting from the neuromodulation therapy, and 
 indicate the likelihood of the patient benefitting from the neuromodulation therapy. 
   
     
     
         36 . The system of  claim 35 , wherein the blood vessel comprises a renal blood vessel, and wherein the physiological parameter comprises a renal wave speed. 
     
     
         37 . The system of  claim 35 , wherein the blood vessel comprises a renal blood vessel, and wherein the physiological parameter comprises a renal resistance. 
     
     
         38 . The system of  claim 35 , wherein the controller is configured to determine the likelihood of the patient benefitting from the neuromodulation therapy by at least comparing the physiological parameter to a predetermined threshold. 
     
     
         39 . The system of  claim 35 , wherein the sensing element comprises at least one of an electrocardiogram sensor, a pressure sensor, a temperature sensor, a flow sensor, an impedance sensor, a flow rate sensor, a chemical sensor, a bio-sensing element, an electrochemical sensor, a hemodynamic sensor, or an optical sensor. 
     
     
         40 . The system of  claim 35 , further comprising a guidewire, wherein the guidewire comprises the sensing element. 
     
     
         41 . The system of  claim 35 , further comprising a catheter assembly configured to deliver the neuromodulation therapy to the target site, wherein the catheter assembly comprises the sensing element. 
     
     
         42 . The system of  claim 41 , wherein the catheter assembly is configured to deliver the neuromodulation therapy by at least delivering energy to the target site. 
     
     
         43 . The system of  claim 42 , wherein the energy comprises at least one of radiofrequency energy, pulsed electrical energy, microwave energy, optical energy, ultrasound energy, direct heat energy, or radiation. 
     
     
         44 . The system of  claim 41 , wherein the catheter assembly is configured to deliver the neuromodulation therapy by at least delivering a chemical to the target site. 
     
     
         45 . The system of  claim 41 , wherein the catheter assembly is configured to deliver the neuromodulation therapy by at least applying cryogenic cooling to the target site. 
     
     
         46 . The system of  claim 35 , further comprising a catheter assembly configured to deliver neuromodulation therapy to the target site, wherein the controller is configured to determine the patient will likely benefit from the neuromodulation therapy and, based on determining the patient will likely benefit from the neuromodulation therapy, cause the delivery of the neuromodulation therapy via the catheter assembly to at least partially ablate nerves proximate to a wall of the blood vessel. 
     
     
         47 . A system comprising:
 a catheter assembly configured to be positioned at a target site within a renal blood vessel of a patient, wherein the catheter assembly is configured to deliver neuromodulation therapy to the target site;   a sensing element; and   a controller configured to:
 receive, from the sensing element, a measurement related to the hemodynamic parameter, 
 determine a physiological parameter indicative of patient responsiveness to renal neuromodulation therapy at the target site based on the measurement, 
 determine, based on the physiological parameter, the patient will likely benefit from the renal neuromodulation therapy, and 
 based on determining the patient will likely benefit from renal neuromodulation therapy, cause the delivery of the neuromodulation therapy via the catheter assembly to at least partially ablate nerves proximate to a wall of the renal blood vessel. 
   
     
     
         48 . The method of  claim 47 , wherein the physiological parameter comprises a renal wave speed.

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