Granted Patent B2

US 12,268,631 · App. 18/183,308 · Granted Apr 8, 2025

Inventors: Erik Kulstad (Dallas, TX); Hugh Patrick Caherty (Canton, MI)

Assignee: Advanced Cooling Therapy, Inc.

A61F7/12A61F7/123A61B2017/00084A61B2090/064A61F2007/0054A61F2007/0095A61F2007/126

Abstract

Claims (37)

1. A method for protecting an esophagus of a patient from thermal injury during a thermal ablation procedure, the method comprising:

nasally or orally inserting a heat transfer device into the patient, wherein the heat transfer device comprises

a distal end configured for insertion into a nostril or mouth of the patient;

a heat transfer medium supply tube that defines an inflow lumen and forms a heat transfer region, wherein the heat transfer region is configured to transfer heat to or extract heat from the esophagus when a heat transfer medium flows through the inflow lumen;

a heat transfer medium return tube that defines an outflow lumen;

an input port for receiving the heat transfer medium from a source, wherein said input port is connected to the heat transfer medium supply tube; and

an output port connected to the heat transfer medium return tube;

wherein the heat transfer region is not inflatable;

wherein the heat transfer medium return tube is not positioned within the heat transfer medium supply tube; and

wherein the heat transfer medium supply tube and the heat transfer medium return tube have substantially equal cross-sectional areas; and

initiating flow of the heat transfer medium through the inflow lumen.

2. The method of claim 1 , wherein the heat transfer region has a diameter of about 1.0 to about 2.0 centimeters.

3. The method of claim 1 , wherein the heat transfer region has a surface area of at least about 100 cm 2 .

4. The method of claim 1 , wherein the heat transfer device further comprises a sensor for detecting a parameter and generating a signal representative of the parameter.

5. The method of claim 1 , wherein the heat transfer medium return tube and the heat transfer medium supply tube are arranged in parallel.

6. The method of claim 5 , wherein the heat transfer medium return tube and the heat transfer medium supply tube share a common inner wall.

7. The method of claim 1 , wherein the heat transfer medium is a coolant and the method further comprises continuing flow of the coolant through the inflow lumen for a time sufficient to cool esophageal tissue in the patient.

8. The method of claim 1 , wherein flow of the heat transfer medium through the inflow lumen is initiated prior to inserting the heat transfer device into the patient.

9. A heat transfer device for protecting an esophagus of a patient from thermal injury during a thermal ablation procedure, the device comprising:

a heat transfer medium supply tube that defines an inflow lumen;

a heat transfer medium return tube that defines an outflow lumen;

wherein the heat transfer medium supply tube and the heat transfer medium return tube are configured such that at least a portion of an exterior wall of the heat transfer medium supply tube is in contact with esophageal tissue upon placement of the device in a patient;

wherein the portion of the exterior wall constitutes a heat transfer region configured to transfer heat to or extract heat from the esophageal tissue when a heat transfer medium flows through the inflow lumen;

wherein the heat transfer region is not inflatable;

wherein the heat transfer medium return tube is not positioned within the heat transfer medium supply tube; and

wherein the heat transfer medium is a coolant.

10. A heat transfer device for protecting an esophagus of a patient from thermal injury during a thermal ablation procedure, the device comprising:

a distal end configured for insertion into a nostril or mouth of a patient;

a proximal end comprising an input port for receiving a heat transfer medium from a source and an output port;

a length of tubing that defines a multi-lumen cavity, the length of tubing comprising an inner divider wall disposed longitudinally therein, the inner divider wall dividing the cavity into at least a first lumen and a second lumen, wherein the first lumen and the second lumen are arranged in parallel to each other, and wherein the first lumen and the second lumen are in fluid communication with each other, thereby defining a fluid path for flow of the heat transfer medium;

wherein the first lumen is defined by a first circumferential portion of an interior wall of the length of tubing and the inner divider wall and the second lumen is defined by a second circumferential portion of an interior wall of the length of tubing and the inner divider wall; and

wherein at least a portion of an exterior wall of the length of tubing is in contact with esophageal tissue upon placement of the device in a patient and the portion of the exterior wall constitutes a non-inflatable heat transfer region configured to transfer heat to or extract heat from the esophageal tissue when the heat transfer medium flows through the first and/or second lumen.

11. The device of claim 10 , wherein the inner divider wall is connected to or coextensive with the interior wall of the length of tubing.

12. The device of claim 10 , wherein a first end of the inner divider wall is connected to or coextensive with a first site on the interior wall of the length of tubing and a second end of the inner divider wall is connected to or coextensive with a second site on the interior wall of the length of tubing.

13. The device of claim 10 , wherein the first site on the interior wall of the length of tubing and the second site on the interior wall of the length of tubing are about 180 degrees apart.

14. The device of claim 10 , further comprising a sensor for detecting a parameter and generating a signal representative of the parameter.

15. The device of claim 10 , wherein the heat transfer medium is a coolant.

Assignments (1)

Continuity (13)

References Cited (400)