US 3238944 A
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March 8, 1966 M. L. HIRSCHHORN 3,238,944
TEMPERATURE CONTROLLING DEVICE FOR LIVING ORGANS Filed Oct. 8, 1962 2 Sheets-Sheet l INVENTOR MAX L. HIRSCHHORN A TORNE March 8, 1966 sc o 3,238,944
TEMPERATURE CONTROLLING DEVICE FOR LIVING ORGANS Filed Oct. 8, 1962 2 Sheets-Sheet 2 0 a 44 W3 \f 38 N i i i A, Fig.2
5b 1 Fig.5
TEMPERATURE CONTROL DEVICE 112; SC/ THERMOSTAT PELTIER 8 HOT JUNCTION '9 INVENTOR MAX L. HIRSCHHORN BY cow JUNCTION United States Patent 3,238,944 TEMPERATURE CGNTROLLING DEVICE FOR LIVING ORGANS Max L. Hirschlrorn, 5601 13th Ave, Brooklyn 19, N.Y. Filed Oct. 8, 1962, Ser. No. 228,798 3 Claims. (Cl. 128-400) The present invention relates to a flexible temperature regulating or cooling device to control the temperature of living body organs or areas of tissues.
General hypothermia is difiicult and dangerous, often accompanied by hemorrhages, heart irregularities, brain and kidney damage, death and other not well-defined malfunctions. Local cooling procedures reduce such complications considerably thus allowing safer surgical procedures upon such cooled structures for the purposes of removing diseased tissue or for the transplantation of live tissue from a donor to a recipient.
It is particularly to the latter aspect of organ or tissue transplants that the proposed invention is directed. Present methods are largely unsuccessful despite great care in surgical technique, matching, irradiation and cytotoxic drugs because of the inevitable transplant rejection reaction which takes place from days to a few weeks after transplantation by the recipient against the donor tissue.
It is known to the medical profession concerned with organ transplants called homografts, that a delayed rejection reaction by the host against the foreign graft follows in about 8 to days due to a sensitizing protein conjugate which is part of the biochemical structure of the white blood cells. This substance interacts with the implanted genetically different tissue causing the delayed rejection process leading to the degeneration of the graft in a predictable time-related fashion.
My invention of a controlled implanted device for prolonged cooling beyond the surgical shock stage and beyond the critical time of tissue graft rejection permits a safer operation upon diseased organs and facilitates the delicate art of organ transplants.
The invention is useful in promoting certain local biological effects caused by prolonged tissue cooling. The advantages arise from the hibernative and reversible conditions induced by cooling and are accompanied by a reduction of local pain and shock.
The invention is also useful to reduce specific local metabolic needs, reduce the amount of local circulation, reduce the cellular size and the extra-cellular fluid mass, reduce certain enzymatic processes and inhibit thermolabile enzymatic process, slow down infective and invasive neoplastic processes. More important, however, is the resulting reduction of function of the graft while still cooled within the donor and while transferred in the cooled state to the host permitting thereby a gradual resumption of function of the homograft in a time-controlled manner. The grafted tissue is, therefore, not called upon to resume immediate function while still shocked from the operative procedure and the homograft remains cooled within the host beyond the expected time for rejection before resuming its specific function.
The employment of my invention, both in the donor prior to the removal of the organ and in the recipient or host during and after implantation, is calculated to interfere, delay or suspend the enzymatic process of autoimmunization causing the delayed rejection reaction beyond the 10 to 14 day period or longer. The invention enables the researcher in this field to study viability and functional restoration of tissue structures, as well as the proper temperature control for overcoming the still regularly occurring graft destructions.
Patented Mar. 8, 1966 ice Similar considerations apply to cancer treatment and research. The invention is useful in lowering the biologic needs of normal tissue and deprives the malignant and highly active tissue of the necessary nutriment and retards the synthesis of abnormal nuclear material. Cancerous tissue has less resistance also to other forms of therapy, be it phyical, chemical or circulatory. If cancerinvaded tissue are subjected to radiation, they should disintegrate far more rapidly if previously and contemporaneously cooled to induce degeneration. It must be considered that cancer tissue is not only invasive but will degenerate in the center due to poor vascularization, thereby giving rise to necrosis and ulceration. This process is further enhanced by cooling beyond cellular tolerance.
The invention can also be used for implantation in the hypothalamic region. The invention can be used for carrying controlled heated fluid in its coils thus heating, e.g., the thermoregulatory center inducing a general hypothermic reaction. It could be used as a cooling device surrounding an overactive or inflamed thyroid like in Hashimotos disease. The range of temperatures to which an organ or tissue is desirably regulated is between minus 32 F. and plus F.
In accordance with a preferred form of the invention, the specific body organ or tissue is cooled in the body by means of a cooling tube placed in the immediate vicinity of the organ. The cooling of a body organ, such as the kidney, liver or lung, does not change substantially the overall body temperature. The cooling tube consists of a flexible plastic tubing having metallic heat conductive members which extend through its wall on one of its sides facing the organ to be temperature controlled. A refrigerated liquid is pumped through the tube to thermally flow against and absorb heat from the metallic members which in turn absorb heat from the organ.
By keeping the cooling device in place after surgery upon the organ or after transplant into the recipient, the constantly cooled organ can repair the damage and resume function in a temperature-controlled manner. The flexible tubes or coils can then be removed like any drain tube presently used in surgery by simply disconnecting one end from the chamber or by a second stage operative intervention.
It is an objective of the present invention to provide cooling apparatus which may be implanted around an animal organ in order to perform surgery upon or transplant the organ.
Other objectives of the invention will be apparent from the detailed description below, taken in conjunction with the accompanying drawings, in which:
FIGURE 1 is a perspective view of the cooling apparatus of the present invention placed about a body organ;
FIGURE 2 is a longitudinal section of a portion of the tubing of FIGURE 1;
FIGURE 3 is another form of a longitudinal section of a wall portion of tubing of FIGURE 1;
FIGURE 4 is a schematic view of the refrigerating system for the apparatus of FIGURE 1; and
FIGURE 5 is a circuit diagram of an electrical circuit utilized for the cooling of the fluid pumped through the device of FIGURE 4.
As seen in FIG. 1, an elongated flexible hollow tube 36 is placed in physical contact with or in the immediate vicinity of body organ 31.
Tube 30 is implanted in the body in the vicinity of the organ to be temperature controlled. The tube is arranged in a stacked or meandering fashion, more specifically, in a serpentine path whereby a series of folds are formed to form generally two walls on two opposing sides of the organ allowing a sufficient gap or opening for the surgeon to have access, if needed, for surgery to the organ. The serpentine path of the tube around the organ prevents knotting or bending of the tube during withdrawal of the tube from the body after the cooling function has been completed. However, a second operation for removal of the coils may still be necessary, if, for example, the relative position of the tube and body organ does not allow for withdrawal of the tube by merely applying a tension force.
The tube 30 includes a continuous hollow portion 32 through which a cooled fluid is pumped under low pressure. The coolant fluid, such as a saline solution, is preferably compatible with body fluids in case the tube accidentally produces a leak. As seen in FIG. 2, inner longitudinal wall 33 of the tube 30 includes heat conductive metal inserted in an insulative material such as nylon, or plastic, while the outer wall 34 is made of a strong flexible heat insulative material which is nonadherent to body organs or tissue. The heat conductive metal wall portion comprises a plurality of metal plugs 36 inserted in a liquid-tight manner in Wall 33 of the plastic tube. Each plug has a head portion 37 which protrudes from the wall 33, a heat transfer body portion 39, and an inner portion 38, preferably serrated to provide a large surface area for maximum heat transfer. Preferably, plugs 36 are silver or other non-toxic metal.
In FIGURE 3, another embodiment of the heat conductive wall portion of the tube is shown. The tube, as the embodiment of FIG. 2 is hollow and flexible, made of a strong heat insulative material such as a plastic, preferably nylon or polyfluoroethylene, such material being non-adhesive to body tissue. One or more wires 40 of silver (shown in elevation to simplify the drawing), or other like non-toxic heat conductive material, are embedded in the wall portion 44 of tube facing the organ to be cooled to retain the wire in the surface and yet be exposed sufliciently to provide a heat absorptive surface to the exterior of the tube. A plurality of longitudinally spaced metal clips 41 of a high thermal conductivity, such as silver or the like, are inserted in the wall portion 44 of tube 30 so that some of the clips are exposed to the coolant within the tube and others of clips extend outwardly of the exterior surface of the tube. At least some of the clips may advantageously be serrated as are members 36 which are illustrated in FIG. 2 at 38. The wires 40 are welded, soldered or brazed to the clips 41 to establish a thermal path from the wires, through the clips to the coolant within the tube 30.
The fluid which is pumped through tube 30 is cooled to a selected temperature preferably by the apparatus shown in FIGURES 4 and 5. In an operative system, the ends 53 and 54 of tube 30 are connected with suitable means to the tubing 55 and 56 connected to the ports 23 and 24 to provide a continuous conduit for coolant fluid 22 from the bath 21 through the tube 30. The cooling apparatus includes a plurality of Peltier cells 19, each of which has a cooling fin 1% attached to its hot junction.
In the Peltier effect, a direct current passes through a junction of two dissimilar conductors and heat is absorbed or generated at the junction, depending on the direction of the current. A number of combinations of dissimilar conductors exhibit the Peltier effect including two different metals, a semi-conductor with a metal, a p-type or n-type semi-conductor with a metal, and a p-type semi-conductor with an n-type semi-conductor. Preferably the combination of conductors has large thermoelectric power, low thermal conductivity, high electrical conductivity, and the materials should be inexpensive, readily formable and easy to solder or weld.
Electrical energy for the Peltier cells is supplied by an A.C. source which is applied to the primary of transformer 5b. The secondary of transformer 5b is connected to a full-Wave DC. rectifying bridge 5c which 4 supplies D.C. current to the Peltier cells. See FIG. 5. If desired, filtering the pulsating D.C. current produced by the bridge may be accomplished with circuitry well known in the art to develop a source of DC. for the cells which is substantially constant.
The cold junction of the Peltier cells 19 is in direct physical contact with the non-flammable cooling fluid 22, such as a saline solution, in the bath 21. The bath 21 has an exit port 23 and an entry port 24 so that the fluid 22 can be circulated. A low pressure pump 25 circulates the liquid from the bottom of the bath 21 at port 23, pumps it into the tube of the cooling blanket and returns the liquid back into the back through port 24.
A temperature control device 7 having a dial 7a is placed adjacent to the bath 21 (FIG. 4). This device functions to control the temperature at which the coolant is to be kept. The manually operated dial 7:! is operatively connected to a thermostat unit, of the usual bimetallic type such as used in refrigerating systems, housed within a thermally-conductive hermetically-sealed housing 8. The housing 8 is positioned in the coolant 21 as seen in FIG. 4 whereby the thermostat is rendered responsive to the temperature variations of the coolant. The desired temperature of operation of the thermostat is selected manually by dial 7a which is calibrated in the usual manner. The contacts of the thermostat are connected by conductors 51 and 52 to the AC. source in series relation with the source 5 and the primary of transformer 5b to function as an on-off switch for the system. The thermostat thus will render the cooling circuit inoperative when the temperature of the coolant is within the desired range and render the cooling circuit operative when the temperature of the coolant is without the desired. range.
The value of a resistor 8d may be made adjustable by the use of a rheostat or potentiometer to vary the resistance in the direct current portion of the circuit to regulate, in effect, the rate of cooling by the Peltier cells 19.
If desired, operation of pump 25 can be automatically under control of the temperature control device 7 with appropriate circuit connections whereby the circulation of the coolant is synchronized with the operation of the cooling cells.
It is to be understood that other equivalent temperature controls may be used with the invention in order to regulate the coolant temperature to prevent the temperature drops below or the temperature rises above the desired level.
The surgical technique of the present invention, i.e., implanting a cooling tubing to regulate the temperature of a living organ or tissue, is useful in the study of cryogenie physiopathology including the transplantation of or" gans, in operations upon the organs and in controlling malignant tissue.
In organ transplants, the body organ to be transplanted is cooled to a morphant condition before, during, and for some time after transplanting, in order to reduce immunity reactions. The implanted organ in the recipient is kept cold and permitted to warm over a period of weeks to improve the take.
The present invention includes a novel surgical operative method and apparatus to perform such operations.
For certain surgical procedures, it may be desirable to increase the temperature of the tissue or organ rather than to cool it. It is to be appreciated that by reversing the polarity of the DC. voltage to the Peltier cells, the hot junctions and cold junctions will be reversed in function so that the fluid 22 will be heated rather than cooled. Appropriate modifications of the circuit of FIG. 5 may be made to accomplish the purpose of the invention within the skill of the art.
1. A device for regulating the temperature of a living organ, comprising, in combination: a reservoir containing a coolant fluid, means for refrigerating the fluid, a flexible,
heat-insulated conduit carrying the fluid to and from the reservoir, said conduit having a longitudinal wall, and a pump for circulating the fluid through the conduit, said conduit including a plurality of closely spaced heat-conductive members arranged in a line along the longitudinal wall of the conduit, said members extending through the Wall to establish contact with the fluid, said conduit being arranged along a serpentine path generally in a plane whereby said members may be positioned adjoining a living organ.
2. A device according to claim 1 wherein said members are serrated on the portion thereof exposed to said fluid.
3. A device according to claim 1 wherein said members are made of metal and protrude beyond said longitudinal wall of the conduit.
References Cited by the Examiner UNITED STATES PATENTS Hassell 128-400 X Solomon 128-401 Cross 128-401 Zichlin 128-401 Sheckler 128-400 X Fuson 128-214 Foster 128-400 Antiles 128-401 Harrison 128-399 RICHARD A. GAUDET, Primary Examiner.
15 JORDAN FRANKLIN, Examiner.