US 3587577 A
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United States Patent lnventors Oleg Alexandrovich Smirnov ulitso Solyanlm, H2, .20;
Viktor Petrovich Danllov, ulitsa 3 Parkovaya, $2, korpns l, kv. 23, Moscow; Vyacheslnv Ivanovich Znbkov, Rnmensky ralon, poselok llinskoe, ulitsa Vtoraya Lesnaya, 33, Moskovskaya oblast, U.S.S.R. 17,030
Mar. 9, 1970 June 28, 1971 Continuation of application Ser. No. 614,262, Feb; 6, 1967, now abandoned.
Appl. No. Filed Patented DEVICE FOR APPLYING SELECTIVE AND GENERAL HYPOTHERMY TO AND REHEATING OF HUMAN BODY THROUGH THE COMMON INTEGUMENTS THEREOF 6 Claims, 3 Drawing Figs.
US. Cl 128/254, 128/402,4/l59 Int. Cl. A61! 7/00 Field of Search. 128/254, 256, 258, 260, 248, 65, 66, 379, 380, 400, 402;
References Cited UNITED STATES PATENTS 5/1886 1.61161 998,804 7/1911 Salisbury 4/159 1,847,619 3/1932 MaSCOlO... 128/254 2,566,600 9/1951 Colon 128/65 2,726,658 12/1955 Chessey 128/400 2,854,969 10/1958 Nolan 128/65 2,914,066 11/1959 GOW 128/66 3,088,459 5/1963 Rabinotf 128/66 3,091,242 5/1963 .lohnson,Jr.etal. 128/402 3,272,201 9/1966 Burns 128/66 FOREIGN PATENTS 685,816 4/1930 France 128/66 528,292 6/1931 Germany... 4/159 1,022,767 1/1958 Germany 132/9 Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks Attorney-Waters, Roditi, Schwartz and Nissen ABSTRACT: A device is provided for applying selective and general hypothermy to and reheating of a human or animal body through the common integuments thereof, the device being provided with hollow elements made in a shape corresponding to that of the body surface to be treated. A heattransfer medium is supplied to the hollow elements which are disposed on the side facing the body surface under treatment and are provided with openings facing the body surface to allow heat-transfer medium to emerge in uniformly distributed jets at right angles onto the surface being treated.
PATENTH] JUN28 197i SHEET 1 [1F 2 DEVICE FOR APPLYING SELECTIVE AND GENERAL HYPOTHERMY TO AND REHEATING OF HUMAN BODY THROUGH THE COMMON INTEGUMENTS THEREOF This application is a continuation of prior copending application Ser. No. 614,262, filed Feb. 6, 1967, now abandoned.
This invention relates to devices used for both selective and general hypothermy applied to human or animal body through the common integuments thereof, use of such devices being preferably made in medical practice for rendering bodily tissues e.g., the brain more endurable to oxygen deficiency (anoxia), in surgical operations on an open heart without applying an artificial blood circulation apparatus, as well as in craniocerebral surgery, for local cooling of extremities affected by thrombosis of arteries, for treating complications resulting from acute anoxia of tissues, for eliminating hypothermy of the body, and in some other cases.
Known in the art are devices for performing selective and general hypothermy applied to man or animal through the common integuments thereof, wherein a heat-transfer agent while circulating inside hollow elements located nearby the surface of the patient's body, is capable of thermal interaction or interchange therewith through the walls of said hollow elements (cf. Great Medical Encyclopedia, 2nd edition, vol. 7, p. 243).
The aforementioned devices are made as blankets (thermosuits") provided with double walls where between the heattransfer agent is circulating. Having passed through the "thermosuit" the heat-transfer agent passes to the heat-exchanger of a refrigerating machine for subsequent reuse.
The device described above, however, suffers from the disadvantage that the heat exchange process between the patients body and the thermosuit" proceeds slowly which results in that the necessary level of general hypothermy is attained only in l or 2 hours whereas an isolated high hypothermy of the brain cannot be obtained at all.
By making use of apparatus for artificial blood circulation one can quickly lower or raise the temperature of the whole body or of a certain part thereof, e.g. the head.
However, a number of disadvantages are inherent in the aforesaid apparatus which reside in the fact that some 5 liters of donor's blood and blood substitutes are needed for their functioning, the blood to be used should necessarily be rendered incoagulable with heparin; moreover, the application of said apparatus oftentimes leads to some complications occurring in the patient being treated, such as haemolysis, thrombocytopenia, fibrinogenopenia, disturbance of electrolytic balance of the organism, embolism, as well as variation in the vascular tonus. Furthermore, the known apparatus for artificial blood circulation fail to be applied in emergency cases on account of great technological difficulties offered thereto.
Some other applicances made use of heretofore for reducing the temperature of the human body, such as cold baths, ice bags, and the like are bulky, difficult in use, unreliable, hard to control and need much time to attain the required level of hypothermy.
It is an object of the present invention to eliminate the above-mentioned disadvantages.
It is another object of the present invention to obtain both selective and general hypothermy not only under stationary conditions (at an inflrmary) but in a first aid service, too.
It is likewise an object of the present invention to provide such a device that would be capable not only of cooperating with a refrigerating machine but be operative from a source of heat or cold which makes use of a heat-transfer fluid possessing the necessary temperature and fed at the required pressure.
It is a further object of the present invention to obtain a high selective hypothermy e.g., of the cerebral cortex, the temperature of the rest of the body being maintained at the desired level.
It is a specific object of the present invention to provide a device for both selective and general hypothermy of man or animal applied to the common integuments of the body or of any part thereof, e.g., of the head, by means of a heatexchange device which is capable of effective thermal interaction or interchange between the surface of the living body being treated and the heat-transfer fluid, enables the surface under treatment to be kept under visual observation and be accessible freely.
Said object is accomplished due to the fact that the present device is given a shape approximating the shape of that part of the body which is to be treated with said device, whereas hollow elements thereof, on their effective side facing the body in the course of heat exchange, are provided with openings for the heat-transfer fluid to emerge in distributed jets which are capable of directly acting upon the body surface being treated, preferably at right angles thereto, whereby a forced convective heat exchange is attained.
It is advantageous that in the present device the hollow elements be spaced somewhat apart from one another so as to gain free and unobstructed access to the surface being treated and. to keep it under visual observation. Apart from this, such an arrangement contributes to a more effective heat exchange between the heat-transfer fluid and the patients body since the former is rapidly taken off the surface being treated.
Provision is also made in the proposed device for projections located on the side facing the surface being treated in the course of the heat exchange process so as to provide some gap between the device and the surface involved and, consequently, to obtain jets of a present length.
For the purpose of greater economy in operation of the proposed device as well as for reusing the heat-transfer fluid by reiterative circulating through the device, the latter comprises a receiver or header for the heat-transfer fluid, said receiver or header being located on the side opposite to the surface under treatment and being preferably made from a material possessing low thermal conductance.
Given below is a description of the present invention and exemplary embodiments thereof with due reference to the accompanying drawings, wherein:
FIG. I is a side diagrammatic view of the device for applying hypothermy to and reheating of the human brain through the common integument of the head, as made of tubes according to the invention;
FIG. 2 illustrates inside elevation an alternative design of said device featuring a space formed by two hemispheres made of a synthetic material for the heat-transfer fluid to pass;
FIG. 3 shows said device when connected to a source of cold (or heat) provided with an automatic control system of a cooling or heating process.
In the description of the particular embodiments of the invention disclosed hereinabove, specific narrow terminology has been resorted to for the sake of clarity. It should be understood, however, that the present invention is in no way limited to the specific terms so selected and that each such term covers all equivalent elements operating in a similar manner and employed for solving similar problems.
Referring to the drawings, the device for hypothermy and reheating of the human brain comprises, according to the invention, hollow elements i.e. tubes 1 (FIG. 1), a header 2, a pipe union 3 and a connecting hose 4 (FIG. 3) through which the heat-transfer fluid is fed to the device.
The tubes 1 on their side facing the surface being treated, are provided with openings 5 (FIG. 1) wherefrom the heattransfer fluid emerges, and a few projections 6 made as limiting lugs or bosses whereby a gap'between the inner surface of the device and the surface of the patient's head is obtained. The tubes 1 are spaced somewhat apart from one another.
In an alternative embodiment of the invention the present device is composed of two hemispheric elements 7 and 8 (FIG 2) which are made from a synthetic material.
Provision is likewise made on the top of said device for the pipe union 3 whereto the heat-transfer fluid feed hose is connected. A hemisphere 7 which in the course of the heat exchange process faces the patient's head, is provided with the openings 5 for the heat-transfer fluid to emerge, and with a few projections 6 by which the requisite gap between the inner surface of the device and the surface of the heat is attained. To make the surface being treated freely accessible and visually observable as well as for unobstructed removal of the heattransfer fluid, provision is made in the proposed device for slits 9.
Represented in FIG. 3 is a schematic diagram showing the connection of the device for selective hypothermy and reheating of the human brain through the common integument of the head, to a source of cold (or heat) provided with an automatic control system for the cooling or heating process. As can be seen from the FIG, the hose 4 with one of its ends communicates through the pipe union 3 with the header 2 while with the other end of said hose is connected to the source of cold or heat, vizla refrigerating unit provided with a heat-exchanger or a bank of semiconductor thermoelectric generators 10. The heat interchanger or the bank of thermogenerators 10 is connected to a centrifugal pump 11 which, in turn, communicates with a receiver 12 of the heat-transfer fluid. Said refrigerating unit or said bank of the thermoelectric generators I is likewise connected to an automatic system 13 for regulating the temperature of the heat-transfer fluid. The automatic system 13 comprises temperature pickups, driving stages, amplifiers and power units; (not shown). The system 13 is capable of maintaining the temperature of the heat-transfer fluid exactly at a prerequisite level.
The device of the present invention functions as follows (FIG. 3). To perform the hypothermy of, say, the human brain the patient's head is placed within the receiver 12 of the heattransfer fluid and onto a rest M whereupon the device is brought close to the head. A specified gap between the device and the patient's head is provided due to the presence of the projections 6 located on the inner surface of the device and a holder 15 which allows the device to be set in any position with respect to the patients head. The device is articulated to said holder 15 by means ofajoint 16.
The aforesaid pump is intended to deliver the heat-transfer fluid via the connecting hose to the source it) and further on through the hose 4 to the hollow elements, i.e. the tubes 1, wherefrom the heat-transfer fluid is distributed as jets from the openings onto the surface of the patient's body to be treated, preferably at right angles thereto, the fluid having a preset temperature and being fed at a necessary pressure. The used heat-transfer fluid is passed through a strainer 17 located in the receiver 12 of the heat-transfer fluid and passes to the centrifugal pump 11 which delivers it to the heat-exchanger or the bank of the thermoelectric generators where the heattransfer fluid is cooled (or heated), whereupon the entire working cycle is repeated.
The advantages of the device, according to the invention, are as follows.
The proposed device is capable of attaining a high rate of cooling or heating (up to 2 C. per 5 min.) of the whole body or a part thereof, e.g. the cerebral cortex, the treatment being effected through the common integument of the body, the temperature of the rest of the body being maintained within the safe limits of+32 to +35 C.
The design of the present device enables the surface under treatment to be under visual observance, gives a free access thereto and makes possible the application of hypothermy at. any position assumed by the patient's body or the part thereof being treated.
An effective heat-exchangeprocess by the proposed device results in low persistence of both the cooling and the heating procedures which makes it possible to provide a reliable automatic stepless regulation of both processes through following a preset programme, a quick transition from cooling to heating and vice versa as well as a prolonged retention of the temperature at a preset hypothermic level.
Moreover, the application of the present device for obtaining hypothermy through the tegminal tissues of the human body when performing surgical operations involving the arrest of blood circulation, needs no donor' s blood or blood substitutes, and cuts the postoperative period of a hospitalization term by 10 to 12 days.
Though this invention has been described hereinbefore with reference to the preferable embodiment thereof, it will be understood that minor changes and modifications may be made without departing from the spirit and scope of the invention, as will be readily understood by those skilled in the art.
l. A device for applying selective and general hypothermy to and reheating of a human or animal body through the common integuments thereof, said device comprising: a plurality of spaced hollow elements having a collective shape corresponding to that of the body surface to be treated, a header coupled to said hollow elements, means to supply a heattransfer medium to said header and thereby to said elements, said elements having inner openings facing the body surface to be treated and including internal projections for contact with the surface to be treated to position said openings above said surface for allowing the heat-transfer medium to emerge from said hollow elements in uniformly distributed jets directly acting on the body surface being treated at approximately right angles thereto, a receiver for receiving and collecting the medium after contact thereof with said surface, means for recirculating the collected medium to said header from said receiver, and means between the latter recirculating means and said header for varying the temperature of the medium in the course of recirculation thereof from said receiver to said header.
2. A device as claimed in claim 1 comprising filter means in said receiver for cleaning the collected medium of impurities.
3. A device as claim in claim 1 wherein said recirculating means is a pump and whereinsaid means for varying the temperature of the medium comprises a heat exchanger between said pump and header and automatic control means coupled to the heat exchanger to automatically regulate the temperature of the medium supplied to the header in accordance with the actual temperature of the body.
4. A device as claimed in claim 1 wherein said hollow elements are sufficiently spaced such that gaps are formed therebetween to provide quick and free evacuation of the spent medium therethrough as well as visual control of the surface being treated and free access thereto.
5. A device as claimed in claim 1 wherein said receiver for the heat-transfer medium includes means adapted to be arranged under the body being treated.
6. A device as claimed in claim 1 wherein said means for varying the temperature of the medium comprises semi conducting thermoelectrical generators.