NEUROMODULATION CRYOTHERAPEUTIC DEVICES AND ASSOCIATED SYSTEMS AND METHODS
Neuromodulation cryotherapeutic devices and associated systems and methods are disclosed herein. A cryotherapeutic device configured in accordance with a particular embodiment of the present technology can include an elongated shaft having distal portion and a supply lumen along at least a portion of the shaft. The shaft can be configured to locate the distal portion intravascularly at a treatment site proximate a renal artery or renal ostium. The supply lumen can be configured to receive a liquid refrigerant. The cryotherapeutic device can further include a cooling assembly at the distal portion of the shaft. The cooling assembly can include an applicator in fluid communication with the supply lumen and configured to deliver cryotherapeutic cooling to nerves proximate the target site when the cooling assembly is in a deployed state.
1 . A method for treating a patient, comprising:
intravascularly positioning a cryotherapeutic device at a target site in a renal artery or a renal ostium of the patient;
deploying the cryotherapeutic device from a delivery state to a deployed state at least proximate the target site;
removing heat from tissue at the target site and thereby causing therapeutically-effective renal nerve modulation; and
retracting the cryotherapeutic device from the deployed state to the delivery state, wherein a procedure period from deployment to retraction of the cryotherapeutic device is less than five minutes.
2 . The method of claim 1 wherein the target site is a first target site in a first renal artery or first renal ostium, and wherein the method further comprises:
intravascularly positioning the cryotherapeutic device in the delivery state at least proximate a second target site in a second renal artery or a second renal ostium of the patient;
deploying the cryotherapeutic device from the delivery state to the deployed state at least proximate the second target site;
removing heat from tissue at the second target site and thereby causing therapeutically-effective renal nerve modulation; and
retracting the cryotherapeutic device from the deployed state to the delivery state, wherein a procedure period from deployment of the cryotherapeutic device at the first target site to retraction of the cryotherapeutic device at the second target is less than 12 minutes.
3 . The method for claim 1 wherein:
intravascularly positioning the cryotherapeutic device at least proximate the target site comprises locating an applicator of the cryotherapeutic device at least proximate the renal artery of the patient; and
removing heat from tissue at the target site comprises cooling at least a portion of the renal artery via the applicator at a rate of heat transfer sufficient to cause therapeutically-effective, cryogenic renal nerve modulation, wherein the cooling has at least one cooling cycle of at most 100 seconds.
4 . The method of claim 1 wherein removing heat from tissue at the target site comprises modulating the renal nerves in a single application of cryogenic cooling within the procedure period.
5 . The method of claim 1 wherein removing heat from tissue at the target site comprises removing heat from tissue at the target site sufficient to cause therapeutically-effective renal nerve modulation around a full circumference of the renal artery.
6 . The method of claim 1 wherein removing heat from tissue at the target site comprises removing heat from tissue at the target site sufficient to cause therapeutically-effective renal nerve modulation around less than a full circumference of the renal artery.
7 . The method of claim 1 wherein removing heat from tissue at the target site comprises cryogenically cooling the renal nerves in at least two cooling cycles separated by a warming period.
8 . The method of claim 7 wherein cryogenically cooling the renal nerves in at least two cooling cycles each having a duration of less than 60 seconds.
9 . A method for treating a patient, comprising:
locating an energy delivery device at least proximate post-ganglionic neural fibers that innervate a kidney of the patient;
intravascularly deploying the energy delivery device from a delivery state to a deployed state; and
delivering an energy field via the energy delivery device sufficient to modulate neural function of the post-ganglionic neural fibers, wherein deploying the energy delivery and delivering the energy field has a procedure time of less than five minutes.
10 . The method of claim 9 wherein:
locating the energy delivery device at least proximate to the post-ganglionic neural fibers comprises intravascularly positioning an applicator of a cryotherapeutic device at least proximate the post-ganglionic neural fibers; and
delivering the energy field comprises—
expanding a refrigerant in at least a portion of the applicator, and
cryogenically cooling via the applicator and modulating the post-ganglionic neural fibers that innervate a kidney such that therapeutically-effective, cryogenic cooling includes at least one cooling cycle of less than 100 seconds.
11 . The method of claim 10 wherein delivering an energy field via the energy delivery device sufficient to modulate neural function of the post-ganglionic neural fibers comprises cryogenically cooling post-ganglionic neural fibers that innervate a kidney using at least two cooling cycles separated by a warming period.
12 . A cryotherapeutic device, comprising:
an elongated shaft having a distal portion, wherein the shaft is configured to locate the distal portion intravascularly at a treatment site;
a cooling assembly at the distal portion of the shaft, the cooling assembly having a delivery state, a deployed state, and an expansion chamber in which a refrigerant expands; and
wherein the cryogenic device is configured to automatically terminate a procedure period in less than five minutes, and wherein the procedure period begins when the cooling assembly moves from the delivery state to the deployed state at the treatment site and the procedure period ends when the cooling assembly terminates delivery of the refrigerant to the expansion chamber.
13 . The cryotherapeutic device of claim 12 wherein:
the treatment site is proximate at least one of a renal artery and a renal ostium;
the cooling assembly further comprises an applicator configured to have a rate of heat transfer in the deployed state sufficient to cause therapeutically-effective, cryogenic renal-nerve modulation within 100 seconds; and
the cryotherapeutic device further comprises—
a supply lumen along at least a portion of the shaft, the supply lumen being configured to receive at least a substantially liquid refrigerant, and the supply lumen being in fluid communication with the expansion chamber, and
an exhaust lumen along at least a portion of the shaft, the exhaust lumen being in fluid communication with the expansion chamber.
14 . The cryotherapeutic device of claim 12 wherein the procedure period is less than two minutes.
15 . The cryotherapeutic device of claim 12 wherein the cooling assembly further comprises an applicator having a heat-transfer portion that extends around less than a full circumference of the applicator, and wherein the heat transfer portion is configured to deliver therapeutically-effective, cryogenic nerve modulation at the treatment site when the cooling assembly is in the deployed state.
16 . The cryotherapeutic device of claim 12 wherein the cooling assembly further includes an applicator having a heat-transfer portion that extends around a full circumference of the applicator, and wherein the heat transfer portion is configured to deliver therapeutically-effective, cryogenic nerve modulation at the treatment site when the cooling assembly is in the deployed state.
17 . The cryotherapeutic device of claim 12 wherein the cooling assembly further comprises an applicator configured to deliver therapeutically-effective, cryogenic nerve modulation at the treatment site in a single application within the procedure period.
18 . The cryotherapeutic device of claim 17 wherein the treatment site is at a peripheral vessel, and wherein the applicator is configured to deliver therapeutically-effective, cryogenic nerve modulation around a full circumference of the peripheral vessel in the single application.
19 . The cryotherapeutic device of claim 17 wherein the treatment site is at a peripheral vessel, and wherein the applicator is configured to deliver therapeutically-effective, cryogenic nerve modulation around at least two partially-circumferential portions of the peripheral vessel spaced laterally apart from one another in the single application.
20 . The cryotherapeutic device of claim 12 wherein the procedure period ends when the cooling system moves from the deployed state to the delivery state.
21 . The cryotherapeutic device of claim 12 wherein the cryogenic device is configured to automatically terminate the procedure period upon use of a preset volume of the refrigerant.
22 . The cryotherapeutic device of claim 12 , further comprising a controller including instructions that cause the controller to automatically terminate the procedure period at a preset time interval.