Topical hypothermia apparatus and method for treating the human body and the like

• US 4,111,209 A
• Filed: 04/18/1977
• Issued: 09/05/1978
• Est. Priority Date: 04/18/1977
• Status: Expired due to Term

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Hanson, Bruce L., Wolvek, Sidney, Bregman, David
• Primary Examiner(s): Trapp, Lawrence W.
• Application Number:
  US05/788,228
• Time in Patent Office: 505 Days
• Field of Search: 128/400, 128/401, 128/399, 128/344, 128/303.11, 128/303.12
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

Apparatus and method for providing hypothermia or effecting hemostasis to prevent hemorrhaging in organs or regions of the human body and the like. In one application described herein, the apparatus provides hypothermia to the heart during, for example, cardio-pulmonary bypass. The apparatus comprises a unitary preferably disposable coolant fluid circuit, including a length of flexible tubing having a heat exchange portion and a flexible, inflatable bag through which a sterile coolant fluid passes. The inflatable bag is connected to the flexible tubing by a double lumen. The tubing is provided with appropriate fittings proximate to its juncture with the double lumen to allow introduction of coolant fluid. The heat exchanger portion of the coolant fluid circuit is located within a preferably disposable container which contains refrigeration means for reducing the temperature of the coolant fluid. A pump is provided which operates externally to the coolant fluid circuit in order to cause the coolant fluid to circulate therethrough.

Just prior to locating the bag into proximity with the organ to be treated, the fluid circuit is filled with coolant fluid by parting the tubing at the fitting (which may comprise a three-way petcock) and introducing the coolant fluid with the bag maintained in a deflated condition. The bag is then appropriately located proximate to or within the organ, the tubing joined and the bag distended by introducing additional coolant fluid through the fitting using a syringe of the like.

Claims

1. A method of cooling a region of the human body comprising the steps of:

providing a coolant circuit assembly including a length of flexible tubing and a flexible, inflatable bag fluidly coupled to said tubing by a lumen having at least two parallel passages formed therethrough;

while maintaining the bag in a deflated condition, introducing coolant fluid into the entire coolant circuit except for the bag;

introducing said deflated flexible bag into the region to be treated;

introducing additional coolant fluid into the coolant circuit thereby inflating the bag, the additional coolant fluid being introduced in an amount based upon the volume of the region of the body to be coated;

cooling said coolant liquid; and

circulating said coolant fluid through said coolant circuit.

2. A method as recited in claim 1 for cardiac hypothermia wherein said introducing step comprises introducing said flexible bag into a ventricle of the heart through a pulmonary vein.

3. A method as recited in claim 1 further including the step of prior to circulating said coolant fluid, positioning a substantially thin bladder between the organ containing the region to be treated and the contiguous region of the body.

4. A method as recited in claim 1 further including the step of prior to circulating said coolant fluid, positioning an insulating layer member between the organ containing the region to be treated and the contiguous region of the body.

5. A method of using apparatus for cooling an organ or body cavity, which apparatus includes;

a coolant circuit assembly including a length of flexible tubing, said length of flexible tubing including a heat exchange portion and a flexible, inflatable bag fluidly coupled to said flexible tubing by a lumen having at least two parallel passages formed therethrough, said coolant circuit being adapted to contain a sterile coolant fluid;

means for circulating the coolant fluid through the coolant circuit, said circulating means being entirely external to the path of said coolant fluid through said coolant circuit;

means in thermal exchange relationship with said heat exchange section of said length of flexible tubing for cooling said coolant fluid; and

valve means provided within the coolant circuit assembly, including a first fluid conduit portion forming a part of the coolant circuit assembly and a second fluid conduit portion fluidly communicating between said first conduit portion and the external environment including an inlet extending into said external environment adapted to receive a supply of coolant fluid from a reservoir thereof, and gating means for sealing said first conduit portion from said second conduit portion, said valve means being for selectively alternately providing external fluid communication to the interior of said coolant circuit and for fluidly sealing said coolant circuit;

said method comprising the steps of;

adjusting said gating means to provide fluid communication between said first and second fluid conduit portions;

maintaining said inflatable bag in a deflated condition;

connecting a reservoir of coolant fluid to said inlet of said second fluid conduit portion thereby introducing coolant fluid into the entire coolant circuit assembly except for the bag;

locating the bag in a deflated condition into a region of the body to be cooled while removing all constraints from the bag so that it can be inflated;

introducing additional coolant fluid into the coolant circuit assembly through said second fluid conduit portion thereby inflating said bag, said additional coolant fluid being introduced in an amount corresponding to the volume of the region to be cooled;

adjusting said gating means to seal said first conduit portion from said second conduit portion; and

circulating said coolant fluid through said coolant circuit.