WO1981001651A1

WO1981001651A1 - Device for treating cutaneous lesions

Info

Publication number: WO1981001651A1
Application number: PCT/FR1980/000179
Authority: WO
Inventors: D Wassermann
Original assignee: Coquilleau R; D Wassermann
Priority date: 1979-12-11
Filing date: 1980-12-10
Publication date: 1981-06-25
Also published as: EP0041973A1; FR2485920A1

Abstract

The device for intensive treatment of cutaneous lesions, such as burns, comprises an outer housing (2) having in the inside a treatment capacity (3) arranged for receiving the body of the patient (1) suffering from lesions, and means (5, 6, 7) for introducing in said capacity and evacuating therefrom a treating liquid (4). The device comprises means (18, 20, 21, 28) for continuously filtering and sterilizing the treatment liquid discharged from said capacity before being reintroduced in the latter, the means (7) for evacuating the treatment liquid comprising a discharge orifice (11) arranged at the vicinity of the lower part of the capacity.

Description

"Device for the treatment of skin lesions"

The present invention relates to a device allowing an intensive treatment of skin lesions, in particular those having an appreciable extent, these lesions being able to result from various traumas and in particular from burns.

Skin cells, like all cells in the body, are surrounded by a liquid, the interstitial fluid made up of water and various electrolytes. The surface layers of the skin and in particular the stratum corneum represent a barrier between the interior medium (cells and interstitial liquid) and the exterior aerial medium. Extensive skin lesions such as burns partially break this barrier and unprotected the interior environment in direct contact with the exterior environment. It follows a series of disturbances and complications all the more important as the lesions are more extensive. Among these disturbances and complications, the following may be mentioned in particular: - pain due to exposure of sensitive endings; - hydroelectrolytic losses which can lead to hypovolemic shock, - increase in thermal losses, responsible for weight loss decreasing the resistance of the organism, - infections finally by colonization of lesions by the bacterial agents responsible for the majority of deaths in burn victims. The treatment of severely burned people is currently carried out in specialized hospital centers with highly sanitized premises and extremely expensive means of treatment.

The treatments currently applied to burn victims are often ineffective in very serious cases.

In British Patent No. 1316430 there has been described an apparatus comprising a bathtub containing a liquid in which the patient is intended to be immersed. However, the device described in this patent can only be suitable for very short treatment times and / or for minor burns. Indeed, the holder of this patent did not take into consideration the filtration and sterilization problems of the treatment liquid which arise in the event of long-term treatments.

The aim of the present invention is to create a device which makes it possible to treat in an effective, intensive and continuous manner extensive skin lesions and in particular those caused by burns.

The device targeted by the invention, for the intensive treatment of skin lesions, such as burns, comprises an external enclosure comprising inside its treatment capacity arranged to receive at least a substantial part of the body of the patient presenting lesions and means to introduce into this capacity and to evacuate from the latter a treating liquid. According to the invention, this device is characterized in that it comprises means for continuously filtering and sterilizing the treating liquid discharged from said capacity before its reintroduction into the latter, and in that the means for discharging the treating liquid include a discharge opening disposed in the vicinity of the lowest part of the capacity.

The treatment fluid used is identical to the interstitial fluid. The processing capacity enclosing the patient's body which is substantially in hydrostatic balance in the aforementioned liquid makes it possible to restore around this patient an impermeable barrier which replaces the damaged skin. The original interstitial fluid is thus reconstituted between the lesions and the wall of this capacity by returning the exposed tissues by the destruction of the skin covering, in an optimal physiological environment. Injured skin is therefore protected against bacterial infections. Furthermore, the fact that the patient is substantially in hydrostatic equilibrium in the treatment capacity, avoids permanent contact between the skin and the wall of the treatment capacity, so that the injured tissues are almost constantly in contact with the liquid. dealing with. In addition, it avoids pain caused by contact of injured tissue with a solid surface. Finally, circulating rapidly around the patient, the treating liquid can have a detersive effect which then allows rapid elimination of necrotic tissue.

In addition, the continuous filtration and sterilization of the treating liquid makes it possible to avoid any bacterial infection. The fact that the discharge orifice is disposed in the vicinity of the lowest part of the treatment capacity ensures rapid and efficient evacuation of the patient's faeces and avoids any risk of bacterial infection. All of these provisions thus make it possible to keep the patient immersed in the treating liquid for several weeks without risk of infection.

According to an advantageous version of the invention, the evacuation orifice is arranged near the anal region of the patient.

This arrangement ensures immediate evacuation. of the patient's faeces and thus helps to avoid any risk of bacterial infection due to these faeces.

According to a preferred version of the invention, the treatment capacity consists of a wall of preformed plastic material so as to marry with substantial play the patient's body.

Thus the volume of the treatment capacity is reduced to the maximum, while allowing the patient sufficient movement in particular for the members. The dead volume of the treating liquid being thus reduced, the recycling of the latter can be carried out very quickly and it is avoided that certain zones of the treatment capacity by remaining stationary escape filtration and sterilization and cause infection.

Preferably, the treatment capacity is adapted to allow complete immersion of the patient's body, with the exception of his head, in the treating liquid, the patient's body being in the lying, semi-lying or other position.

Other features and advantages of the invention will appear in the description below.

In the accompanying drawings given by way of nonlimiting examples: - Figure 1 is a perspective view of an embodiment of a device according to the invention, - Figure 2 is a sectional view along the plane II-II of Figure 1, - Figure 3 is another perspective view with cutaway of the device according to Figure 1, - Figure 4 is a diagram of an apparatus for recycling, filtration, sterilization and heating, or cooling of the liquid treating device according to the invention. In the embodiment of FIGS. 1 to 3, the device for the treatment of a patient 1 suffering from major burns mainly comprises: an outer enclosure 2 substantially parallelepipedic, a treatment capacity 3 arranged in this enclosure 2 to receive the body of the patient 1 , means for maintaining in this capacity 3 a volume of liquid treating 4 in an amount such that the body of the patient 1 is there substantially in a state of hydrostatic equilibrium, and supply pipes 5, 6 and discharge 7 treating liquid communicating with the processing capacity 3 and connected to recycling, thermoregulation and filtration apparatus which will be detailed below.

In the embodiment shown by way of example, the processing capacity 3 is constituted by a wall 8 made of plastic material such as polyvinyl chloride or of a thermoformable or thermosetting material formed so as to marry the body of the body with substantial play. patient 1. This play is determined so as to allow a certain freedom of movement in particular of the limbs of patient 1. In the example shown, the treatment capacity 3 is adapted to allow complete immersion of the body of patient 1 with the exception of its head 1a, this body being in the fully extended position. Of course, the processing capacity can also be adapted to receive the patient's body in a semi-lying position as on a chaise-longue.

It can be seen in FIGS. 1 to 3 that the wall 8 of plastic material is placed on vertical side walls 9 which constitute the base of the device. The supply pipes 5, 6 ensuring the introduction of the treating liquid 4 into the capacity 3 open into the latter at the feet 1b and the hands 1c of the patient 1. The ends of the pipes 5, 6 are provided for this purpose. orientable outlet nozzles 5a, 6a, for example mounted on ball joints which make it possible to orient the direction of introduction of the treating liquid 4 along the legs and arms of the patient 1.

The introduction of the treating liquid 4 into the treatment capacity 3 is also carried out by means of supply pipes 10 which can be moved along the side walls 9 to allow the introduction of the treatment liquid at any point of the capacity 3 The pipe 7 for discharging the used treating liquid has an inlet orifice 11 formed on the preformed wall 8 in the lowest part of the treatment capacity 3, near the anal region of the patient 1. This orifice the discharge 11 is covered by a plate 12 (see FIG. 2) placed at a certain distance from the orifice 11 and intended to support the buttocks of the patient 1 in order to separate them from the orifice 11.

This plate 12 is advantageously made of a flexible and non-slip material.

At the periphery of the processing capacity 3 are provided substantially horizontal areas 13. These areas 13 have orifices 14 allowing the treatment liquid to overflow 4. These orifices 14 communicate with the evacuation pipe 7 by conduits 15, 16 (see FIG. 3) which are connected to a treatment liquid recovery tank 17 placed along the side wall 9 of the enclosure 2, adjacent to the head 1a of the patient 1.

Lines 15 and 16 can also lead to a recovery tank located under the treatment capacity 3, and the bottom of which opens onto a pipe connecting this tank to the discharge pipe 7.

These overflow orifices 14 can advantageously be replaced by an overflow chute formed on the pads 13 all around the treatment capacity 3.

The inner surface of the wall 8 advantageously comprises loops 8a or similar members making it possible to attach the patient 1 by means of straps or the like.

The supply pipes 5, 6, 10 and discharge 7 of the treating liquid 4 communicate with an apparatus shown by way of example in FIG. 4 ensuring recycling, filtration, sterilization and adjusting the temperature of the treating liquid 4.

This apparatus successively comprises, following the discharge pipe 7 for the treating liquid 4: two coarse prefilters 18, 19 arranged in parallel to decant and filter the faeces of patient 1 and which communicate with a pump 20, the outlet of which is connected to two bacterial filters 21, 22 arranged in series.

18 _Λ The coarse filters / 19 have a mesh screen with dimensions of the order of a millimeter. The bacterial filter 22 is connected by pipes 23, 24 to the supply pipes 5, 6, 10. The inlet of the pump 20 is connected to the outlet of the bacteria filter 22 by bypass pipes 25, 26 which are themselves -same connected respectively to the inlet and outlet of a storage tank 27 for treating liquid 4. This latter circuit controlled by valves is used when it is desired to add or withdraw liquid to the treatment capacity.

The first bacterial filter 21 is constituted by an exchangeable filter cartridge containing a material whose porosity is approximately 5 microns. The second bacterial filter 22 has a finer porosity of the order of 0.2 to 0.3 microns. These filters 21, 22 are associated with pressure gauges, not shown, the pressure of which indicates their clogging state to allow replacement of their cartridges at the appropriate time. Filters 21, 22 can advantageously be combined with a filter aid such as cellulose or silica to absorb the proteins and a device for sterilization by ultraviolet rays to prevent rapid clogging of these filters. The pump 20 is adapted to ensure a circulation of treating liquid at a flow rate at least equal to 10 m ³ / h.

The pipe 23 connected to the outlet of the bacterial filter 22 is connected to the return pipe 24 of the filtered and sterilized liquid by means of a heat exchanger 28. This heat exchanger 28 contains a coil 28a in contact with the treating liquid, in which circulates a heat transfer fluid such as water brought to the appropriate temperature. The temperature of this water is regulated by a circuit comprising a cold water inlet 29 and a hot water inlet 30 coming from a tank 31 comprising an immersion heater 32. This tank 31 is itself supplied with water by a pipe. 33. The hot water inlet 30 and the cold water inlet 29 are connected to the inlet 34 of the exchanger 28 by bypass circuits 35, 36, 37 comprising electromagnetic valves not shown which allow control the supply of hot, cold water or a mixture of hot and cold water according to the desired temperature. The control of the water circulation can be automatic or manual according to the necessities, and in all cases, a security system prohibits any arrival of hot water when the treatment liquid is at a higher temperature. at a pre-determined high threshold, or any cold water arrival in the opposite case.

The arrivals of hot and cold water into the heat exchanger 28 are controlled as will be seen in more detail in the description of operation of the device according to the invention by means of a thermal probe in contact with the patient. 1 and a thermal probe in contact with the treating liquid.

The use and operation of the device is as follows:

Before introducing the patient 1 into the treatment capacity 3, the latter and the entire installation are filled with treating liquid 4. The composition of this liquid corresponds to that of the extracellular liquid of normal humans. This composition is normally as follows: sodium ions (Na ⁺ ): 140 mi11. equivalent / 1 chloride ions (Cl-): 103 "potassium ions (K ⁺ ): 4.5" bicarbonate ions (CO ₃ H-): 27 "calcium ions (Ca ⁺⁺ ): 5" sulfate ions (SO ₄ ^{- -} ): 3 "magnesium ions (Mg ⁺⁺ ): 1" The treating liquid 4 is then circulated at a flow rate greater than 10 m ³ / h by means of the pump 20 and the initial temperature of this liquid is regulated at 30 -35 ° C depending on the patient's condition and temperature by means of the heat exchanger supply circuit 27. The patient 1 is then lengthened in the treatment capacity 3 so as to immerse it entirely except of his head in the treating liquid 4. The patient 1 is attached to the loops 8a and is placed, for example, in the bladder of the latter and by via a urine probe, a temperature probe.

Thanks to the density of the treating liquid which is close to that of the human body, the patient 1 is substantially in a state of hydrostatic equilibrium with the liquid, which prevents any painful contact of the patient's body with the wall 8 of the ability to treatment. This prevents the formation of pressure sores. Substantially all the patient's body and is surrounded by a treating liquid layer 4. The damaged areas of the patient's body 1 are thus separated from 1. ^ambient atmosphere by a treating liquid layer, identical to the extracellular fluid of the human body, which protects patient 1 against any risk of infection. The necrotic tissue and the faeces of the patient are eliminated quickly and effectively by the evacuation pipe 7, the inlet orifice 11 of which is placed in the vicinity of the anal region of the patient 1. The various impurities which float on the surface of the treated liquid 4 are also quickly eliminated by the overflow orifices 14. Furthermore, the introduction of liquid 4 into the treatment capacity 3 at the level of the patient's hands and feet makes it possible to avoid any risk of the formation of stationary zones of treating liquid favorable to bacterial proliferation.

Thus, the burned parts of the patient's body are not likely to come into contact with impurities which can cause infection.

The impurities discharged through the pipe 7 first pass through a coarse filter 18 making it possible to retain the coarsest impurities such as the faeces.

The treating liquid 4 then passes through the filters 21 and 22 which retain the microscopic impurities and in particular the bacteria. The purified and sterilized treating liquid 4 then returns to treatment capacity 3 via lines 23 and 24.

Patient 1 is thus immersed in a treating liquid 4 which is continuously filtered and sterilized. Patient 1 can therefore remain in this state for long periods of time, for example several weeks, while being totally protected against any risk of infection which is essential for his recovery. The fact that the injured cells of the patient's body are placed in a normal physiological medium allows rapid healing of wounds. In addition, the presence of the treating liquid considerably reduces the pain felt by the patient and avoids the use of dressings. In addition, the erosion effect exerted by the treating liquid allows rapid excision of the necrotic parts, in the case of third degree burns.

The temperature of the treating liquid 4 is permanently adjusted, by means of the exchanger 28 as a function of the reactions of the patient's organism, that is to say the central temperature of the latter.

This regulation of the temperature of the treating liquid 4 is effected as follows: A temperature comparator simultaneously records the temperature of the treating liquid and that of the patient. The difference between these two temperatures is compared to a predetermined and adjustable difference. When the actual difference is greater than the predetermined difference, the treating liquid is heated by introduction into the exchanger 28 of heated water in the tank 31. In the opposite case, the treating liquid is cooled by introduction into the exchanger 28 cold water 29.

We can thus obtain a constant difference between the temperature of the patient and that of the treating liquid. However, when the patient's temperature rises (in case of fever), it is advantageous to limit the rise in the temperature of the treating liquid to increase the difference between the temperature of the patient and that of the treating liquid in order to compensate for the increase in heat production of the patient and thus avoid causing hyperthermia. Thus, thanks to a judicious thermal regulation of the treating liquid, it is possible to control the patient's metabolism and avoid weight loss which may reduce the resistance of his body. This automatic regulation of the temperature can be replaced, by means of a switch, by a thermostatic regulation with fixed set point of the temperature of the treating liquid.

Of course, the invention is not limited to the example which has just been described and many modifications can be made to it without departing from the scope of the invention. Thus, the outer enclosure 2 and the processing capacity 3 can be made of steel or any polymerizable, inert and therapeutically acceptable plastic.

The patient, within the treatment capacity can be supported by a mobilizable stretcher, and with variable geometry, thanks to a hydraulic jack or any other device of a comparable effect. This system also allows the patient to be easily placed in or out of the treatment capacity. The wall 8 in which the treatment capacity 3 is formed can also be removable so as to allow its easy replacement.

It is thus possible to have several walls 8 comprising processing capacities of different dimensions adapted to patients of different sizes.

The filtration of the treating liquid by means of bacterial filters can be replaced or supplemented by means of sterilization by ultraviolet rays. The filtration apparatus can be supplemented by a device making it possible to eliminate large waste and faeces from the circuit in order to avoid an excessive proliferation of bacteria which could cause rapid clogging of the bacterial filters 21 and 22. The device can operate discontinuously like that shown in FIG. 4. In the case of this figure, it is an additional circuit implemented periodically and intended to eliminate by de-current the debris and faeces accumulated in the coarse prefilter 19. A set of pneumatic valves not shown and controlled through solenoid valves by a pressurized gas allows cyclically to divert the circulation from the discharge pipe 7 to the coarse pre-filter 18, then to the pump 20 and from there to the outlet of the latter, towards the pipe 44. The treating liquid 4 is thus sent against the current in the prefilter 19 and drives via the t uyau 39 large waste and faeces in a settling tank 38. When this settling tank 38 is full, the liquid is again diverted into the main circuit, and the settling tank 38 is gradually purged through an annex pump 40 at low flow rate, the output of which is connected to the main circuit through bacterial filters 41 and 42, of small dimensions and whose porosities are respectively 5 and 0.3 microns.

In another version of the invention, the additional device shown in FIG. 4 - and which has just been described - can be replaced by a device operating continuously using centrifugal inertial force to separate the suspended particles from the treating liquid 4. This device is then located in place of the coarse prefilters 18 and 19, between the exhaust pipe 7 and the inlet of the pump 20.

Of course, the apparatus shown in FIG. 4 could be connected to several treatment capacities 3 provided that for each treatment capacity there is provided a heat exchanger and the associated probes to enable the temperature of the liquid treating in each capacity to be adjusted.

Claims

CLAIMS 1. Device for the intensive treatment of skin lesions, such as burns, comprising an external enclosure (2) having inside a treatment capacity (3) arranged to receive at least a substantial part of the body of the patient with legions and means (5), (6), (7) for introducing into this capacity and for evacuating therefrom a treating liquid (4), the device being characterized in that it comprises means (18, 20,

21, 28) for continuously filtering and sterilizing the treating liquid discharged from said capacity before its reintroduction into the latter, and in that the means for discharging the treating liquid comprise a discharge orifice (11) disposed in the vicinity of the lowest part of the capacity.

2. Device according to claim 1, characterized in that the evacuation orifice (11) is arranged near the anal region of the patient.

3. Device according to any one of claims 1 or 2, characterized in that the treatment capacity (3) consists of a wall (8) of plastic preformed so as to marry with substantial play the patient's body (1).

4. Device according to any one of claims 1 to 3, characterized in that the treatment capacity (3) is adapted to allow complete immersion of the patient's body (1) with the exception of his head (1a) in the treating liquid (4), the patient's body being in the lying or semi-lying position.

5. Device according to any one of claims 3 to 4, characterized in that said wall (8) of preformed plastic is molded in one piece with sensitive side walls (9) vertical mounts constituting the base of the device.

6. Device according to any one of claims 1 to 5, characterized in that the means for introducing the treating liquid into the capacity comprise supply pipes (5, 6) ensuring the introduction of the treating liquid ( 4) in the capacity and opening into the latter at the hands (1c) and / or feet (1b) of the patient (1).

7. Device according to any one of claims 1 to 6, characterized in that the means for introducing the treating liquid (4) into the capacity (3) comprise one or more supply supply hoses (10) allowing the introduction of the treating liquid at any point of this capacity.

8. Device according to any one of claims 2 to 7, characterized in that the discharge orifice (11) of the treating liquid (3) is covered by a plate (12) spaced from this orifice and intended to receive the patient's buttocks (1).

9. Device according to any one of claims 1 to 8, characterized in that on the periphery (13) of the treatment capacity (3) are formed one or more overflow orifices (14) of the treating liquid (4) , these orifices communicating with the discharge pipe (7) of the treating liquid.

10. Device according to any one of claims 1 to 9, characterized in that the means for continuously sterilizing and filtering the treating liquid (4) comprise at least one pump (20), a prefilter (19) for retaining faeces and other coarse particles, and at least one bacterial filter (21, 22).

11. Device according to claim 10, characterized in that it comprises a porosity filter (21) equal to about 5 microns in series with a bacterial filter (22) of porosity equal to 0.2 - 0.3 micron.

12. Device according to any one of claims 1 to 11, characterized in that the means for continuously filtering and sterilizing the treating liquid (4) comprise at least one pump (20), a prefilter (19) for retaining the faeces and other coarse particles and means of sterilization by ultraviolet rays.

13. Device according to any one of claims 1 to 12, characterized in that the means for continuously filtering and sterilizing the treating liquid (4), comprising at least one pump (20), a bacterial filter (21, 22 ) and means for evacuating outside the circuits taken by the treating liquid

(4) coarse particles and faeces.

14. Device according to any one of claims 10 to 13, characterized in that the pump (20) is adapted to ensure a flow rate of treating liquid (4) greater than 10 m ³ per hour.

15. Device according to any one of claims 10 to 14, characterized in that the circuit comprising the pump (20) and the bacterial filter (s) (21, 22) is connected in parallel with a storage tank (27) treating liquid (4).

16. Device according to any one of claims 1 to 14 and comprising an apparatus for adjusting the temperature of the treating liquid, characterized in that this apparatus comprises at least one temperature probe in contact with the patient (1) and means now a predetermined difference between the temperature measured by this probe and the temperature of the treating liquid.