IP Library Granted Patent US 11,832,867
Granted Patent B2
US 11,832,867 · App. 16/434,942 · Granted Dec 5, 2023

Cryoneedle

Inventors: Satish Ramadhyani (Minneapolis, MN); Andrew Kevin Zachman (St. Michael, MN); Mordechay Bleiwies (Kiryat Haim, IL); Mark Timothy Johnson (Mounds View, MN)
Assignee: BOSTON SCIENTIFIC SCIMED, INC.
A61B18/02A61B2018/00041A61B2018/0262A61B2018/0268A61B2018/0281A61B2018/0293
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Quick Facts
Patent No.
US 11,832,867
App. No.
16/434,942
Granted
Dec 5, 2023
Kind
B2
Abstract

A cryoneedle comprises an outer tube having a distal section with a generally central gas supply line placed within the outer tube. The gas supply line supplies a cryogas for forming an iceball on an outer surface of the outer tube over the distal section. The gas supply line terminates in an expansion chamber placed within the distal section. The cryoneedle comprises a heat exchange helix contacting the inner surface of the outer tube. The heat exchange helix has an increasing surface area per unit distance of the distal section such that the iceball has a generally symmetric shape.

Claims (26)

1. A cryoneedle comprising:

an outer tube having a longitudinal axis and a distal section for placing at or near a target area of a patient's anatomy;

a gas supply line positioned within the outer tube, the gas supply line configured to supply a cryogas for forming an iceball on an outer surface of the outer tube at the distal section;

an expansion chamber located within the distal section, the gas supply line terminating in the expansion chamber;

a return gas flow lumen configured to carry expanded cryogas away from the expansion chamber in the distal section and toward a proximal section of the outer tube,

an electrical heater positioned coaxially with the gas supply line and the outer tube, wherein the electrical heater comprises a metal wire wound in helical coils around and in contact with an outer surface of the gas supply line; and

a heat exchange helix disposed within the distal section and in contact with an inner surface of the outer tube, the heat exchange helix defining a portion of the return gas flow lumen annularly between the heat exchange helix and the gas supply line, wherein the cryogas is adapted to flow between helices of the heat exchange helix from the expansion chamber along a return flow path,

wherein the heat exchange helix along the heat exchange helix has a first pitch over a first portion of the distal section and a second pitch over a second portion of the distal section, wherein the first portion is distal of the second portion, and wherein the first pitch is greater than the second pitch such that a heat transfer rate between the cryogas and the outer tube is approximately constant over an entire length of the distal section, the heat exchange helix thereby providing a generally uniform rate of heat transfer in the distal section such that the iceball formed on the outer surface of the outer tube is generally symmetric in shape along the longitudinal axis of the outer tube.

2. The cryoneedle of claim 1 , further comprising an insulating sheath dividing the outer tube into a proximal insulated region and a distal non-insulated region, wherein the electrical heater is an electrical resistance heater that is both disposed about the gas supply line and within the distal non-insulated region.

3. The cryoneedle of claim 1 , wherein the heat exchange helix is positioned coaxially with an axis of the outer tube.

4. The cryoneedle of claim 1 , wherein the outer tube has an outer diameter of about 2.1 millimeters.

5. The cryoneedle of claim 1 , wherein the gas supply line terminates in a Joule-Thomson orifice within the expansion chamber, the expansion chamber being adapted to expand the cryogas exiting the Joule-Thomson orifice, and the return gas flow lumen being adapted to pass the expanded cryogas over the gas supply line thereby cooling incoming cryogas in the gas supply line.

6. The cryoneedle of claim 1 , wherein the heat exchange helix is a helical wire.

7. The cryoneedle of claim 1 , further comprising an insulating sheath substantially surrounding the gas supply line and thereby forming a barrier between the return gas flow lumen and the outer tube over a portion of a length of the outer tube.

8. The cryoneedle of claim 7 , wherein the insulating sheath comprises an inner tubular wall and an outer tubular wall.

9. The cryoneedle of claim 8 , wherein the outer tubular wall of the insulating sheath is in contact with the outer tube.

10. The cryoneedle of claim 8 , wherein an annular gap is defined between the gas supply line and the inner tubular wall of the insulating sheath the annular gap being in fluid communication with a distal portion of the return gas flow lumen such that the return gas flow lumen receives the cryogas therethrough.

11. The cryoneedle of claim 10 , wherein the annular gap defined between the outer tubular wall of the insulating sheath and the gas supply line has a diameter sufficient to minimize back pressure acting on the expanded cryogas flowing through the annular gap from the return gas flow lumen.

12. The cryoneedle of claim 7 , wherein an inner diameter of the insulating sheath is about 1.32 mm.

13. The cryoneedle of claim 7 , wherein the insulating sheath surrounds the gas supply line over a portion of the length of the outer tube such that the expanded cryogas directly contacts the outer tube over an exposed region, the exposed region having an exposed region length, the exposed region length adapted to generate the iceball having a predetermined aspect ratio.

14. The cryoneedle of claim 1 , wherein the gas supply line is coaxial with the longitudinal axis of the outer tube.

15. The cryoneedle of claim 1 , further comprising a heat exchanger positioned in a proximal section of the cryoneedle.

16. The cryoneedle of claim 15 , wherein the heat exchanger comprises a helical tube.

17. The cryoneedle of claim 1 , wherein the heat exchange helix has a heat exchange surface area at the distal section, the heat exchange surface area provides heat transfer between the cryogas and the outer tube such that the outer tube is cooled to a temperature of between about −150 degree Celsius and about −145 degree Celsius when a temperature of the cryogas is about −155 degree Celsius and about −150 degree Celsius respectively.

18. The cryoneedle of claim 1 , wherein the expansion chamber is adapted to expand the cryogas, and the expanded cryogas flowing in the return gas flow lumen is adapted to cool incoming cryogas flowing through the gas supply line.

19. The cryoneedle of claim 1 , wherein the electrical heater is positioned near the distal section.

Assignments (2)
NUNC PRO TUNC ASSIGNMENT Recorded Feb 13, 2020
From: GALIL MEDICAL INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 051807/0895 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 11, 2019
From: RAMADHYANI, SATISH; ZACHMAN, ANDREW KEVIN; BLEIWIES, MORDECHAY; JOHNSON, MARK TIMOTHY
To: GALIL MEDICAL INC.
Reel/Frame 049429/0873 →
Continuity (2)
Continuation 14627568 · Feb 20, 2015
Related Publication 20190350633A1 · Nov 21, 2019