METHODS AND APPARATUS FOR INCREASING BLOOD CIRCULATION

• US 20080021531A1
• Filed: 07/30/2007
• Published: 01/24/2008
• Est. Priority Date: 09/24/2003
• Status: Active Grant

• Current Assignee: AVAcore Technologies, Inc.
• Original Assignee: Carefusion 2200 Corporation (Becton, Dickinson & Co)
• Inventors: Williams, Stephen, KANE, John, Hamilton, Nathan, Christensen, Scott
• Granted Patent: US 8,182,521 B2
• Time in Patent Office: Days
• US Class Current: 607/111
• CPC Class Codes: A61F 2007/0039 Leg or parts thereof
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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 2201/0214 cooled
• CPC Class Codes: A61H 2201/0228 heated by an electric resistance element
• CPC Class Codes: A61H 2201/0242 by a fluid circulating in the apparatus
• CPC Class Codes: A61H 2201/025 by direct air flow on the patient's body
• CPC Class Codes: A61H 2205/12 Feet
• CPC Class Codes: A61H 2209/00 Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• CPC Class Codes: A61H 9/005 Pneumatic massage
• CPC Class Codes: A61H 9/0057 Suction suction kneading A61H7/008
• 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

Abstract

A method and apparatus for the prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), lower extremity edema, and other associated medical conditions by adjusting the temperature of the muscles of a foot or a leg, and/or applying vacuum or negative pressure to increase blood flow. A human extremity such as a leg is exposed to a negative pressure environment and/or a thermally controlled environment within a medical device. In one aspect, the device is portable. A thermal exchange unit and, optionally, a vacuum or negative pressure unit, are provided to increase blood flow and vasodilation. The device can be programmed by a controller in a manner to stimulate the muscles of the extremity to reduce pooling of blood therein.

Claims

1. An apparatus for increasing blood flow and preventing deep vein thrombosis (DVT), comprising:

a chamber body defining a chamber therein;

a vacu-seal comprising;

a vacu-sealing portion attached to an opening on the chamber body and adapted to provide a vacuum seal for the chamber body; and

a vacu-seal body portion adapted to contact with a portion of a human extremity therein and provide a space between the vacu-seal and the chamber body;

one or more thermal exchange units attached to the chamber body;

one or more thermal exchange supply lines and one or more thermal exchange return lines attached to the one or more thermal exchange units;

one or more apertures in the chamber body, the thermal exchange units are connected to the chamber body and one or more thermal sources via the one or more thermal exchange supply lines and the one or more thermal exchange return lines through at least one of the one or more apertures in the chamber body; and

2. The apparatus of claim 1, wherein the chamber body comprises a materials selected from the group consisting of elastomers, polycarbonates, polypropylenes, acrylic materials, polystyrenes, high density polyethylenes (HDPE), low density polyethylenes (LDPE), poly(vinyl chloride), urethanes, polyurethanes, graphites, fiberglass, glass, rubbers, stainless steels, glass, aluminum, polymeric materials, composite materials, titanium, light weight metal alloys, aluminum alloys, titanium alloys, and combinations thereof.

3. The apparatus of claim 2, wherein the chamber body is selected from the group consisting of a hard chamber body, a soft chamber body, and combinations thereof.

4. The apparatus of claim 1, further comprising one or more vacuum ports attached to at least one of the one or more apertures on the chamber body and adapted to be connected to at least one vacuum pump on one end and the space between the vacu-seal and the chamber body on the other end.

5. The apparatus of claim 1, wherein the pressure of the space between the vacu-seal and the chamber body is maintained between about zero and about −

120 mm-Hg.

6. The apparatus of claim 5, further comprising a vacuum sensor port connected to at least one of the one or more openings.

7. The apparatus of claim 1, wherein the vacu-seal is disposable.

8. The apparatus of claim 1, wherein the vacu-seal is detachably attached to the chamber body.

9. The apparatus of claim 1, wherein the one or more thermal exchange units are adapted to provide therein a fluid medium selected from the group consisting of heated fluids, heated air, cooled fluids, cooled air, and combinations thereof.

10. The apparatus of claim 1, wherein the one or more thermal exchange units are electric pads.

11. The apparatus of claim 1, wherein the one or more thermal exchange units are placed permanently near one or more portions of the chamber body.

12. The apparatus of claim 1, wherein the one or more thermal exchange units are detachably placed inside the chamber.

13. The apparatus of claim 1, further comprising one or more backing sheets adapted to surround the one or more thermal exchange units and provide ease of thermal exchange.

14. The apparatus of claim 1, wherein the chamber body is adapted to flex and further comprises one or more compression pads for applying a compression pressure intermitted on one or more portions of the human extremity.

15. The apparatus of claim 1, further comprising one or more flexible membranes positioned between the one or more thermal exchange units and the chamber body.

16. The apparatus of claim 1, wherein the vacu-seal further comprises a temperature sensor adapted to monitor the temperature of the portion of the human extremity.

17. The apparatus of claim 1, wherein the portion of a mammal'"'"'s lower extremity is selected from the group consisting of a foot, a leg, a calf, an ankle, and any combinations thereof.

18. An apparatus for increasing blood flow and preventing deep vein thrombosis (DVT), comprising:

a chamber body defining a chamber therein;

a vacu-seal comprising;

a vacu-sealing portion attached to an opening on the chamber body and adapted to provide a vacuum seal for the chamber body; and

a vacu-seal body portion adapted to contact with a portion of a human extremity therein and provide a space between the vacu-seal and the chamber body;

one or more thermal exchange units attached to the chamber body;

one or more thermal exchange supply lines and one or more thermal exchange return lines attached to the one or more thermal exchange units;

one or more apertures in the chamber body, the thermal exchange units are connected to the chamber body and one or more thermal sources via the one or more thermal exchange supply lines and the one or more thermal exchange return lines through at least one of the one or more apertures in the chamber body; and

a controller unit connected to the vacu-seal, the thermal exchange units, the thermal exchange supply lines, and the one or more thermal exchange return lines.

19. A method of preventing DVT, comprising:

providing to one or more extremities of a mammal one or more devices, each device comprising;

a chamber body;

a vacu-seal having a vacu-sealing portion attached to an opening on the chamber body and a seal liner body for contacting with the leg therein and providing a space between the vacu-seal and the chamber body; and

one or more thermal exchange units;

regulating the temperature of the one or more extremities of the mammal using the one or more devices;

vasodilating an arteriovenous anastomoses (AVAs) blood vessel of the one or more extremities of the mammal; and

reducing the constriction of the AVA blood vessel using the one or more devices, thereby increasing blood flow of the one or more extremities and decreasing clotted veins in the one or more extremities.

20. The method of claim 19, further comprising applying pressurized compression forces to the one or more extremities of the mammal.

21. The method of claim 20, wherein the pressurized compression is applied by one or more pressurized compression pads inside the one or more devices.

22. The method of claim 20, wherein the pressurized compression is applied by a separate pressurized compression device.

23. The method of claim 19, further comprising reducing the pressure of the chamber of the one or more devices.

24. The method of claim 23, wherein the pressure reduced to between zero and about −

120 mm-Hg.

25. The method of claim 19, wherein the temperature of the one or more extremities are maintained by the one or more devices to between about 10°

C. and about 42°

C.

26. The method of claim 23, wherein the one or more extremities are one or more legs.