Methods and apparatus for adjusting blood circulation

• US 8,603,150 B2
• Filed: 10/11/2007
• Issued: 12/10/2013
• Est. Priority Date: 12/04/2006
• Status: Active Grant

• Current Assignee: AVAcore Technologies, Inc.
• Original Assignee: CareFusion 2200 Inc (Becton, Dickinson & Co)
• Inventors: Kane, John Roy, Christensen, Scott A., Hamilton, Nathan, Williams, Stephen J.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US11/870,780
• Publication Number:
  US 20080132976A1
• Time in Patent Office: 2,252 Days
• Field of Search: 607/99, 607/111, 607/152
• US Class Current: 607/111
• CPC Class Codes: A61F 2007/0029 Arm or parts thereof
• CPC Class Codes: A61F 2007/0036 Hand
• CPC Class Codes: A61F 2007/0039 Leg or parts thereof
• 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 2007/0071 using a resistor, e.g. near the spot to be heated
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/0228 heated by an electric resistance element
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1635 Hand or arm, e.g. handle
• CPC Class Codes: A61H 2201/164 Feet or leg, e.g. pedal
• CPC Class Codes: A61H 2205/065 Hands
• CPC Class Codes: A61H 2209/00 Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• CPC Class Codes: A61H 9/00 Pneumatic or hydraulic massage
• CPC Class Codes: A61H 9/0007 Pulsating
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: B29C 65/04 Dielectric heating, e.g. high-frequency welding , i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
• CPC Class Codes: B29K 2995/0082 : Flexural strength; Flexion stiffness
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

Embodiments of the invention include a method and a device for increasing blood flow and controlling the temperature of a mammal by applying a desired pressure to extremities of a mammal. The device generally includes one or more collapsible and pliant body elements, capable of expanding from a first volume into an expanded second volume so the device can receive a portion of an extremity of the mammal therein and then be reduced from the expanded second volume into a pressurized third volume to conformably enclose the portion of the extremity. One or more thermal exchange units can be positioned in the one or more collapsible and pliant body elements. Accordingly, the temperature of the extremity of a mammal can be regulated by providing a heated or cooled fluid medium or electric thermal energy to the one or more thermal exchange units. Next, by evacuating the region in which the extremity is enclosed the contact surface area between the extremity of a mammal and the one or more thermal exchange units is increased, due to the external atmospheric pressure acting on the pliant body elements against the skin of the extremity of the mammal. The application of pressure assures that sufficient contact and thermal heat transfer (heating or cooling) is provided to the extremity of the mammal.

Claims

1. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more flexible walls that enclose at least a portion of an internal region, wherein at least a portion of the flexible body defines an outermost surface of a portion of the device that is disposed over the portion of the extremity;

an opening formed in the flexible body 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 communication with the internal region; and

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region,

wherein the flexible body is configured to substantially conform to the shape of the portion of the extremity when the pump creates the pressure below atmospheric pressure within the internal region.

2. The device of claim 1, wherein the pump comprises a vacuum ejector or mechanical vacuum pump that is configured to create a pressure in the internal region between about −

3 mmHg and about −

80 mmHg relative to the pressure external to the flexible body.

3. The device of claim 1, further comprising:

a fluid source that is in fluid communication with a heat exchanging plenum in one of the one or more thermal exchanging units,

wherein the one or more thermal exchanging units are formed from a flexible and compliant material.

4. The device of claim 1, further comprising a controller unit connected to the pump, and a fluid source coupled to the one or more thermal exchanging units.

5. The device of claim 1, further comprising a flexible sealing member that is adapted to form a seal between the flexible body and a portion of the extremity, wherein the flexible sealing member comprises a material selected from the group consisting of hydrogel, urethane and combinations thereof.

6. The device of claim 1, wherein the extremity is selected from the group consisting of a hand, a forearm, a forearm with an elbow, a hand with a wrist, a foot, a leg, a calf, and an ankle.

7. The device of claim 1, wherein the flexible body comprises a material selected from the group consisting of urethane, polyurethane, polypropylenes, polystyrenes, high density polyethylene, low density polyethylene, and polyvinyl chloride.

8. The device of claim 1, wherein the flexible body comprises a first body element section and a second body element section that can be positioned to at least partially enclose the internal region by use of an enclosing clip.

9. The device of claim 8, wherein the enclosing clip is selected from the group consisting of a zipper, a plurality of snaps, hydrogel coated tabs, Velcro®

fasteners and buttons.

10. The device of claim 1, further comprising an inflatable cuff assembly that comprises a pump that is in fluid communication with the internal region of an inflatable cuff which is positioned over a portion of the extremity, wherein the pump is adapted to adjust the pressure in the internal region of the inflatable cuff.

11. The device of claim 1, further comprising:

a flexible sealing member that is configured to form a seal between the one or more flexible walls and the portion of the extremity when the extremity is disposed in the internal region, wherein the flexible sealing member comprises a material selected form the group consisting of hydrogel, urethane and polyurethane, and

the one or more flexible walls comprise urethane, polyurethane or poly(vinyl chloride).

12. The device 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.

13. The device of claim 12, wherein the one or more flexible walls further comprise:

one or more first flexible walls that enclose the at least a portion of the internal region; and

one or more second flexible walls that are bonded or sealed to at least a portion of the one or more first flexible walls to form a second region that forms at least a portion of the one or more thermal exchanging units.

14. The device of claim 1, further comprising a system comprising:

a fluid source configured to deliver a thermal exchanging fluid at a desired temperature through the one or more thermal exchanging units;

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

a temperature sensor that is configured to measure a temperature of the thermal exchanging fluid; and

a controller that is configured to control the temperature of the thermal exchanging fluid and the pressure of the internal region using inputs received from the temperature sensor and the pressure sensor.

15. The device of claim 14, wherein the one or more flexible walls further comprise:

one or more first flexible walls that enclose the at least a portion of the internal region; and

one or more second flexible walls bonded to at least a portion of the one or more first flexible walls to form a second region that forms at least a portion of the one or more thermal exchanging units.

16. The device of claim 1, further comprising:

a fluid supply line having a supply end, wherein the supply end is positioned to deliver a fluid to a heat exchanging plenum formed in one of the one or more thermal exchanging units;

a fluid return line having a return end, wherein the return end is positioned to receive at least a portion of the fluid from the fluid plenum; and

a separating in fluid communication with the heat exchanging plenum formed in the one or more thermal exchanging units, and is disposed between the supply end and the return end.

17. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more flexible walls that enclose at least a portion of an internal region, wherein at least a portion of the flexible body defines an outermost surface of a portion of the device that is disposed over the portion of the extremity;

an opening formed in the flexible body 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 communication with the internal region, wherein the one or more thermal exchanging units are disposed between the one or more flexible walls and the internal region, and wherein a contact area is formed between the one or more thermal exchange units and the portion of the extremity that is less than about 410 square inches (0.264 m²) when the flexible body collapses against the portion of the extremity; and

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

18. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more flexible walls that enclose at least a portion of an internal region, wherein at least a portion of the flexible body defines an outermost surface of a portion of the device that is disposed over the portion of the extremity, wherein the one or more flexible walls further comprise;

one or more first flexible walls that enclose the at least a portion of the internal region; and

one or more second flexible walls bonded or sealed to at least a portion of the one or more first flexible walls to form a second region that forms at least a portion of the one or more thermal exchanging units;

an opening formed in the flexible body 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 communication with the internal region; and

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

19. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more flexible walls wherein the one or more flexible walls further comprise;

one or more first flexible walls that enclose at least a portion of an internal region; and

one or more second flexible walls bonded or sealed to at least a portion of the one or more first flexible walls to form a second region that forms at least a portion of one or more thermal exchanging units, wherein the one or more thermal exchanging units are in thermal communication with the internal region, and wherein bonding or sealing the one or more second flexible walls to the one or more first flexible walls comprises forming a plurality of dimple type connections between the one or more second flexible walls and the one or more first flexible walls;

an opening formed in the flexible body 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 pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

20. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more flexible walls wherein the one or more flexible walls further comprise;

one or more first flexible walls that enclose at least a portion of an internal region; and

one or more second flexible walls bonded or sealed to at least a portion of the one or more first flexible walls to form a second region that forms at least a portion of one or more thermal exchanging units, wherein the one or more thermal exchanging units are in thermal communication with the internal region;

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

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region;

a fluid supply line having a supply end, wherein the supply end is positioned to deliver a fluid to a fluid plenum formed in one of the one or more thermal exchanging units;

a fluid return line having a return end, wherein the return end is positioned to receive at least a portion of the fluid from the fluid plenum; and

a separating feature formed by bonding or sealing a portion of the one or more second flexible walls to at least a portion of the one or more first flexible walls, wherein the separating feature is in fluid communication with the fluid plenum and is disposed between the supply end and the return end.

21. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having one or more first flexible walls that enclose at least a portion of an internal region, wherein a first portion of the one or more first flexible walls and a second portion of the one or more first flexible walls are bonded or sealed together to form the internal region;

an opening formed in the flexible body that is adapted to receive an extremity of the 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 communication with the internal region, wherein the one or more thermal exchanging units are formed by bonding or sealing one or more second flexible walls to at least a portion of the one or more first flexible walls; and

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

22. The device of claim 21, wherein bonding or sealing the one or more second flexible walls to the one or more first flexible walls comprises forming a plurality of dimple type connections between the one or more second flexible walls and the one or more first flexible walls.

23. The device of claim 21, wherein the one or more first flexible walls and the one or more second flexible walls comprise urethane, polyurethane or poly(vinyl chloride), and the one or more second flexible walls are sealably bonded to the at least a portion of the one or more first flexible walls by RF welding or thermal sealing.

24. The device of claim 21, further comprising:

a flexible sealing member that is configured to form a seal between the one or more walls and the portion of the patient, wherein the flexible sealing member comprises a material selected form the group consisting of hydrogel, urethane and polyurethane,

wherein the one or more first flexible walls and the one or more second flexible walls comprise urethane, polyurethane or poly(vinyl chloride).

25. The device of claim 21, further comprising:

a pressure controlling device; and

an inflatable cuff which is positioned over a portion of the extremity, wherein the pressure controlling device is adapted to adjust the pressure in an internal region of the inflatable cuff.

26. The device of claim 21, further comprising:

a fluid supply line having a supply end, wherein the supply end is positioned to deliver a fluid to a fluid plenum formed in one of the one or more thermal exchanging units;

a fluid return line having a return end, wherein the return end is positioned to receive at least a portion of the fluid from the fluid plenum; and

a separating feature formed by bonding or sealing a portion of the one or more second flexible walls to at least a portion of the one or more first flexible walls, wherein the separating feature is in fluid communication with the fluid plenum and is disposed between the supply end and the return end.

27. A device for increasing blood flow and/or controlling body temperature in a mammal, comprising:

a flexible body having a fluid plenum formed by bonding or sealing two layers of a collapsible and pliant material together, wherein the flexible body also comprises an internal region that is defined by bonding or sealing one or more portions of the two layers together, and wherein the fluid plenum forms at least a portion of one or more thermal exchanging units that are in thermal communication with the internal region;

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

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

28. The device of claim 27, further comprising:

a manifold bonded to at least one of the two layers of the flexible body and having a first fitting that is in fluid communication with the internal region and a second fitting that is in fluid communication with the fluid plenum; and

a system comprising;

a fluid source configured to deliver a thermal exchanging fluid at a desired temperature through the one or more thermal exchanging units;

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

a temperature sensor that is configured to measure a temperature of the thermal exchanging fluid; and

a controller that is configured to control the temperature of the thermal exchanging fluid and the pressure of the internal region using inputs received from the temperature sensor and the pressure sensor.

29. The device of claim 27, wherein a first portion of the two layers and a second portion of the two layers are bonded together to form the internal region.

30. The device of claim 27, wherein bonding or sealing the two layers further comprises forming a plurality of dimple type connections between the two layers.

31. The device of claim 27, further comprising:

a fluid supply line having a supply end, wherein the supply end is positioned to deliver a fluid to the fluid plenum;

a fluid return line having a return end, wherein the return end is positioned to receive at least a portion of the fluid delivered from the fluid plenum; and

a separating feature formed by bonding or sealing a portion of the two layers together, wherein the separating feature is in fluid communication with the fluid plenum and is disposed between the supply end and the return end.

32. The device of claim 27, further comprising:

a pressure controlling device; and

an inflatable cuff which is positioned over a portion of the extremity, wherein the pressure controlling device is adapted to adjust the pressure in an internal region of the inflatable cuff.

33. The device of claim 27, further comprising a flexible sealing member, wherein the flexible body is configured to substantially conform to the shape of the portion of the extremity when

the first device pump creates the pressure below atmospheric pressure within the internal region, and

the flexible sealing member forms a seal between the one or more flexible walls and the portion of the extremity.

34. A device for increasing blood flow and/or controlling body temperature in a mammal, wherein the device consists essentially of:

a flexible body that has an external surface, and is configured to enclose a portion of an extremity of a mammal, wherein the flexible body comprises;

a fluid plenum formed by bonding or sealing two layers of a collapsible and pliant material together;

an internal region that is defined by bonding or sealing one or more portions of the two layers together, wherein the fluid plenum forms at least a portion of one or more thermal exchanging units that are in thermal communication with the internal region; and

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

a control unit that comprises;

a pump fluidly coupled to the internal region and configured to create a pressure below atmospheric pressure within the internal region causing atmospheric pressure external to the flexible body to urge at least a portion of the flexible body against the portion of the extremity disposed in the internal region.

35. The device of claim 34, wherein the control unit further comprises:

a fluid source configured to deliver a thermal exchanging fluid at a desired temperature through the one or more thermal exchanging units;

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

a temperature sensor that is configured to measure a temperature of the thermal exchanging fluid; and

a controller that is configured to control the temperature of the thermal exchanging fluid and the pressure of the internal region using inputs received from the temperature sensor and the pressure sensor.

36. The device of claim 34, further comprising:

a flexible sealing member that is configured to form a seal between the one or more walls and the portion of the patient, wherein the flexible sealing member comprises a material selected form the group consisting of urethane and polyurethane,

wherein the two layers of the collapsible and pliant material comprise urethane, polyurethane or poly(vinyl chloride).