Transvenous cryoneurolysis system, devices and methods
AssigneeNervana, LLC
InventorsBhavraj Khalsa, Ali Golshan, Richard S. Williams
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Abstract
There is provided a transvenous approach for accessing and targeting neural treatment sites to relieve a variety of clinical indications, including peripheral neuropathy. A neurosome approach is described that includes one or more target nerves to receive selective cryoneurolysis via a target vein. A range of different freeze and thaw cycles are performed via the target vein to induce a desired thermal treatment temperature range for selective sensory loss without adverse impact or minimal impact to associated motor nerves. The target nerves and veins are selected to combine the treatment of the identified neurosome for pain relief in addition to the regenerative properties of cryoneurolysis.
Claims25
A method of performing a transvenous cryoneurolysis procedure to treat a symptom of peripheral neuropathy in a lower limb of a patient, comprising:
- Identifying a target neurosome in the lower limb of the patient for performing the transvenous cryoneurolysis procedure to provide relief to the symptom of peripheral neuropathy in the lower limb of the patient;
- Identifying a target nerve associated with the target neurosome of the lower limb of the patient, the target nerve selected from the group consisting of:
- the saphenous nerve, the deep peroneal nerve, the tibial nerve and the sural nerve;
- Selecting a target vein for accessing the venous vasculature in proximity to the target nerve;
- Inserting the transvenous cryoneurolysis device into the target vein in proximity to an ankle of the patient;
- Advancing the transvenous cryoneurolysis device along the target vein to a treatment position in proximity to the target nerve;
- Inflating the transvenous cryoneurolysis device to distend the target vein to a diameter from 5 mm to 9 mm;
- Performing at least one freeze-thaw cryoneurolysis cycle to maintain a temperature at the target nerve within a range of −20 C to −80 C sufficient to induce Sunderland II axonotmesis of sensory fibers of the target nerve;
- Deflating the transvenous cryoneurolysis device after a last cryoneurolysis freeze-thaw cycle;
- and
- Removing the transvenous cryoneurolysis device from the target vein.
A method of performing transvenous cryoneurolysis for temporary cryoanalgesia of a symptom of a patient, comprising:
- Selecting a vein of the patient as a target vein for a transvenous cryoneurolysis access point;
- Inserting a transvenous cryoneurolysis device into the target vein;
- Advancing the transvenous cryoneurolysis device to a location within the target vein that is 3 mm to 7 mm from a target nerve associated with the symptom of the patient;
- Inflating a balloon of the transvenous cryoneurolysis device to expand the target vein to a diameter of 5 mm to 12 mm to reduce a distance between the balloon and the target nerve;
- Cooling the balloon to a temperature below −20° C. to create a thermal zone including the motor fibers and the sensory fibers of the target nerve, wherein the thermal zone remains in a temperature in the range of −20° C. to −80° C. to induce Sunderland II axonotmesis in the sensory fibers of the target nerve;
- Performing one or more freeze-thaw cycles with the balloon for inducing temporary cryoanalgesia of a portion of the sensory fibers of the target nerve to provide the patient relief of the symptom;
- wherein after the step of selecting a vein of the patient as a target vein there is a step of using the target vein to select a target vein/nerve pair and an ankle access landmark combination selected from the group consisting of:
- (a) great saphenous vein/saphenous nerve, with an access point anterior and superior to the medial malleolus;
- (b) posterior tibial vein/tibial nerve, with an access point posterior to the medial malleolus;
- (c) anterior tibial vein/deep peroneal nerve, with an access point midway between the tibia and fibula and lateral to the extensor hallucis longus tendon;
- and
- (d) small saphenous vein/sural nerve, with an access point at or posterior to the lateral malleolus.
Dependencies are inferred from the claim text.