Neuromodulation cryotherapeutic devices and associated systems and methods

Patent metadata

Field	Value
Publication number	US-10842547-B2
Application number	US-201816221174-A
Country	US
Kind code	B2
Filing date	Dec 14, 2018
Priority date	Oct 26, 2010
Publication date	Nov 24, 2020
Grant date	Nov 24, 2020

Abstract

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.

First claim

We claim:

1. A cryotherapeutic device, comprising;
an elongate shaft having a distal end portion, wherein the elongate shaft is configured to locate the distal end portion intravascularly at a treatment site within a renal artery or renal ostium;
an exhaust passage extending along a length of the elongate shaft, wherein the exhaust passage is configured to carry gaseous refrigerant proximally along the length of the shaft;
a supply lumen extending along the length of the elongate shaft, wherein the supply lumen is configured to carry liquid refrigerant distally along the length of the elongate shaft, and wherein the supply lumen includes—
a helical portion that wraps around the exhaust passage at the distal end portion of the elongate shaft, and
an orifice at the helical portion; and
a cooling assembly at the distal end portion of the elongate shaft, wherein the cooling assembly has a low-profile delivery state and an expanded deployed state, and wherein the cooling assembly includes an applicator having a balloon with a wall, and wherein the applicator further comprises—
a first heat-transfer portion configured to have a first heat-transfer rate while the cooling assembly is in the expanded deployed state and while the cooling assembly receives refrigerant via the supply lumen, wherein the orifice is configured to direct refrigerant from the supply lumen toward the first heat-transfer portion; and
a second heat-transfer portion configured to have a second heat-transfer rate while the cooling assembly is in the expanded deployed state and while the cooling assembly receives refrigerant via the supply lumen, wherein the second heat-transfer rate is less than the first heat-transfer rate,
wherein the first heat-transfer portion and second heat-transfer portion are helical, and wherein the portions of the wall of the balloon between the first heat transfer portion and the second heat-transfer portion are thermally insulated.

2. The cryotherapeutic device of claim 1 wherein the balloon comprises:
a first wall portion having a first average thickness; and
a second wall portion having a second average thickness, wherein the second average thickness is greater than the first average thickness.

3. The cryotherapeutic device of claim 1 , further comprising an occlusion member spaced apart proximally from the applicator, wherein the occlusion member has a low-profile collapsed state and an expanded deployed state, and wherein the occlusion member is configured to fully occlude the renal artery or renal ostium proximal of the treatment site when the occlusion member is in the expanded deployed state.

4. The cryotherapeutic device of claim 3 , further comprising a filler lumen extending along the length of the elongate shaft, wherein the filler lumen is fluidly connected to the occlusion member, and wherein the occlusion member is fluidly separate from the supply lumen.

5. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and

when the cooling assembly is in the expanded deployed state, a distance in the plane from the longitudinal axis to the given orifice is not less than 20% of a distance in the plane from the longitudinal axis to a given portion of the wall of the balloon toward which the given orifice directs expanding refrigerant.

6. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and
when the cooling assembly is in the expanded deployed state, a distance in the plane from the longitudinal axis to the given orifice is not less than 60% of a distance in the plane from the longitudinal axis to a given portion of the wall of the balloon toward which the given orifice directs expanding refrigerant.

7. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and
the given orifice is spaced apart more than 0.1 mm from the longitudinal axis.

8. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and
the given orifice is spaced apart more than 1 mm from the longitudinal axis.

9. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and
the given orifice is spaced apart more than 0.1 mm from the balloon when the cooling assembly is in the expanded deployed state.

10. The cryotherapeutic device of claim 1 wherein the supply lumen comprises a plurality of orifices extending along the helical portion, and wherein:
the cooling assembly has a longitudinal axis centered in a plane that transects the cooling assembly and intersects a given one of the orifices; and
the given orifice is spaced apart more than 4 mm from the balloon when the cooling assembly is in the expanded deployed state.

11. The cryotherapeutic device of claim 1 , further comprising a thermally-insulative member at the second heat-transfer portion.

12. The cryotherapeutic device of claim 1 wherein, during operation, the first and second heat-transfer portions have heat-transfer rates sufficient to cause therapeutically-effective renal nerve modulation.

13. The cryotherapeutic device of claim 1 wherein, during operation, portions of the wall of the balloon between the first heat-transfer portion and the second heat-transfer portion have heat-transfer rates insufficient to cause therapeutically-effective renal nerve modulation.

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Buckley Naomi
• Clark Benjamin J
• Cummins Michael
• Donovan Danny
• Gelfand Mark
• Hughes Luke
• Kelly Brian
• Kelly Gary
• Kelly Grace
• Kelly John
• Leung Mark S
• Francis Gwenda
• Mullins Barry
• Naga Karun D
• Nash Stephen
• Ryba Eric
• Sweeney Fiachra
• Tilotta Vincenzo
• Turovskiy Roman
• Woolley Lana
• Zarins Denise
• Turovskiy Michael

Classifications

• A61B2018/0268

  with restriction of flow · CPC title

• A61B2018/00261

  arranged in a line · CPC title

• A61B2018/0025

  Multiple balloons · CPC title

• A61B2018/00232

  having an irregular shape · CPC title

• A61B2018/00511

  Kidney · CPC title