Methods and apparatus for enhancing vascular access in an appendage to enhance therapeutic and interventional procedures

• US 8,771,329 B2
• Filed: 01/07/2011
• Issued: 07/08/2014
• Est. Priority Date: 01/08/2010
• Status: Active Grant

• Current Assignee: AVAcore Technologies, Inc.
• Original Assignee: Carefusion 2200 Corporation (Becton, Dickinson & Co)
• Inventors: Christensen, Scott A., Kane, John Roy, Hamilton, Nathan
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US12/987,015
• Publication Number:
  US 20110172749A1
• Time in Patent Office: 1,278 Days
• Field of Search: 607/96, 607/104
• US Class Current: 607/96
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2007/0034 Lower arm
• CPC Class Codes: A61F 2007/0035 Wrist
• CPC Class Codes: A61F 2007/0036 Hand
• CPC Class Codes: A61F 2007/0043 Lower leg, calf
• CPC Class Codes: A61F 2007/0045 Foot
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0239 using vacuum
• CPC Class Codes: A61F 2007/0273 with openings in the walls between the compartments serving as passageways for the filler flowing in circuits A61F2007/0054, A61F2007/0059
• CPC Class Codes: A61F 2007/0274 the walls being reduced to spot connections, e.g. spot welds
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling

Abstract

Embodiments of the invention disclosed herein generally include methods and/or devices for increasing blood flow, controlling the vasodilatation of a patient'"'"'s vascular structure, regulating the temperature of a portion of a mammal, and for improving various interventional procedures and/or therapeutic techniques. The device may also include one or more access ports, or apertures, that allow access to portions of the mammal'"'"'s extremity to allow interventional type medical devices, therapeutic devices, surgical support equipment or patient monitoring devices to have access to the extremity on which a body element is disposed. The device may also be configured to allow other supporting components, which may include IV or other catheters, a means of accessing to a portion of the extremity positioned inside the temperature regulating device. In one configuration the device comprises flexible materials that are adapted to conform to the surface of the extremity disposed in the device when a vacuum pressure is applied to an internal region of the device.

Claims

1. An apparatus for exchanging heat with an extremity of a mammal, comprising:

a body element having one or more walls that enclose an internal region;

an opening formed in the body element that is adapted to receive an extremity of a mammal and allow a portion of the extremity to be positioned within the internal region;

one or more thermal exchanging units that are in thermal contact with the internal region;

an aperture formed in the body element, wherein the aperture provides access to the portion of the extremity positioned within the internal region; and

IV tubing disposed in proximity to at least one of the one or more thermal exchanging units, such that the IV tubing is in thermal contact with the one or more thermal exchanging units.

2. The apparatus of claim 1, further comprising a bonding material disposed around the aperture.

3. The apparatus of claim 1, further comprising:

a bonding material disposed in the internal region and around the aperture formed in the body element; and

a release liner disposed over a portion of the bonding material.

4. The apparatus of claim 1, wherein the aperture is adapted to receive an IV tube, catheter or sensor cable.

5. The apparatus of claim 1, wherein the aperture is adapted to receive an IV tube, catheter or sensor cable, and further comprises:

an extremity sealing member that is adapted to form a seal between the body element and a portion of the extremity; and

a sealing member that is adapted to form a seal over the aperture.

6. The apparatus of claim 1, further comprising a pump that is adapted to control the pressure within the internal region.

7. The apparatus of claim 1, wherein the one or more thermal exchanging units and the body element are both formed from a flexible and compliant material.

8. The apparatus of claim 1, wherein the one or more thermal exchanging units and the body element are an integral element that comprises:

a first sheet of compliant material; and

a second sheet of compliant material, wherein the first sheet of compliant material and the second sheet of compliant material are bonded together to enclose at least a portion of the internal region, and form a fluid plenum that is isolated from the internal region.

9. The apparatus of claim 1, further comprising a fluid source that is in fluid communication with a heat exchanging plenum in the one of the one or more thermal exchanging units.

10. The apparatus of claim 1, further comprising:

a manifold having a first fitting that is in fluid communication with the internal region and a second fitting that is in fluid communication with a fluid plenum formed in one of the one or more thermal exchanging units; and

a system controller comprising;

a first pump that is adapted to control the pressure within the internal region when it is in fluid communication with the first fitting;

a fluid heat exchanger having a thermal exchanging fluid that is adapted to control the temperature of the one or more thermal exchanging units when it is in fluid communication with the one or more thermal exchanging units;

a pressure sensor that is in fluid communication with the internal region;

a temperature sensor that is adapted to measure a temperature of the mammal; and

a controller that is adapted to control the temperature of the fluid heat exchanging fluid and the pressure of the internal region using inputs received from the temperature sensor and the pressure sensor, and control the first pump.

11. The method of claim 1, wherein the body element is formed from a flexible material, and wherein at least a portion of the body element defines an outermost surface of a portion of the apparatus that is disposed over the portion of the extremity.

12. An apparatus for exchanging heat with an extremity of a mammal, comprising:

a first sheet of compliant material; and

a second sheet of compliant material, wherein the first sheet of compliant material and the second sheet of compliant material are coupled together to form;

at least a portion of an internal region;

an opening that is adapted to receive an extremity of a mammal and allow a portion of the extremity to be positioned within the internal region; and

a fluid plenum that is isolated from the internal region;

an aperture in the first sheet of compliant material, wherein the aperture provides access to the portion of the extremity positioned within the internal region;

a bonding material disposed on a surface of the first sheet of compliant material and around the aperture, wherein the surface defines at least a portion of the internal region; and

IV tubing disposed in proximity to at least one of the one or more thermal exchanging units, such that the IV tubing is in thermal contact with the one or more thermal exchanging units.

13. The apparatus of claim 12, further comprising a release liner disposed over a portion of the bonding material.

14. The apparatus of claim 13, wherein the bonding material comprises hydrogel.

15. The apparatus of claim 12, wherein the first sheet of compliant material and the second sheet of compliant material each comprise a material selected from a group consisting of urethane, polyurethane, polypropylenes, polystyrenes, high density polyethylene'"'"'s (HDPE), low density polyethylene'"'"'s (LDPE), and poly(vinyl chloride).

16. The apparatus of claim 12, further comprising a pump that is adapted to control the pressure within the internal region.

17. A method of exchanging heat with an extremity of a mammal to aid in the placement or advancement of a device into a vascular structure of the mammal, comprising:

positioning a portion of an extremity of a mammal in an internal region of a body element, wherein the extremity is disposed in the internal region through an opening in the body element;

transferring heat between the portion of the extremity disposed in the body element and a thermal exchange unit;

bonding a first portion of the body element to a contact region which surrounds a first region of the surface of the extremity, wherein the first portion of the body element comprises an aperture that exposes the first region of the surface; and

inserting a catheter into the first region through the aperture and into an artery or a vein found in the extremity.

18. The method of claim 17, wherein the artery is the radial artery or the ulnar artery.

19. The method of claim 17, wherein transferring heat between the portion of the extremity and the thermal exchange unit further comprises controlling the temperature of the portion of the extremity before inserting the catheter through the aperture of the body element.

20. The method of claim 19, further comprising:

lowering the pressure in the internal region after bonding the portion of the body element to a surface of the extremity.