CH634999A5 - DEVICE FOR THE EVACUATION OF FLUIDS FROM A WOUND. - Google Patents

Description

The invention relates to suction devices, and more particularly to an improved device for the automatic removal of fluids from a wound.

The use of suction devices to remove bodily fluids from a wound is well known. Such devices are used to decrease the amount of bodily fluids or to eliminate bodily fluids that normally accumulate in the area of a wound following surgery.

In the event that body fluids or fluids accumulate and remain in a wound, especially in a closed wound, they can lead to complications in the healing process and therefore they decrease the chances of a satisfactory recovery. In addition, not only is the healing stage accelerated when a wound is dry, but wound healing is promoted.

Typical and known suction devices are described and represented in the patents of the United States of America Nos 3809086, 3845765,3889677,4058123,4085751 and 4112947.

The aforementioned patent No. 3809086 describes a suction device comprising a container which contains a diaphragm constituted by an elastic sheet and hermetically fixed to the walls of the container. A displacement of the diaphragm by means of a plate and a control element makes it possible to reduce the volume of the container, which in-i5 generates a suction force when the control element is released. The control element can be locked in a position such that the elastic diaphragm remains where it has been moved.

The device described in the aforementioned patent No. 3845765 comprises a rigid outer container containing a flexible bag, the interior of which communicates with the interior of the exterior container, so that a vacuum can be created inside the bag without this the latter collapses due to the balancing of the internal and external pressures of the bag.

The aforementioned Patent No. 3889677 describes an autonomous fluid drainage device which comprises a substantially rigid container 25 containing an inflatable element. A member, mounted on the container, makes it possible to inflate this element. A valve, sensitive to the difference between the pressure of the inflation member and that of the inflatable element, makes it possible to increase the flow rate of the fluids towards the interior of the inflatable element.

30 The aforementioned patents Nos 4058123 and 4112947 describe a combined irrigation and evacuation device, intended to bathe a wound with an irrigation solution and to remove the fluids from this wound. This apparatus comprises a rigid housing which forms a chamber, a partition element, resiliently recalled and dividing into two parts a sealing member which prevents any communication between the two parts, and a member for access to each part. When the partition element is moved against its restoring force, this results in an increase in the volume of the irrigation part. The flow of the solution from the irrigation part allows the partitioning element to return to its initial position under the restoring force. During operation, the return member discharges the liquid from the irrigation part towards the wound, so as to increase the volume of the evacuation part to create a depression which causes a flow of the liquids towards this part. A flow re-adjustment element allows an expulsion of the solution from the irrigation part, at the same time as the admission of wound fluids into the evacuation part. The partitioning element is preferably an elastic diaphragm.

The aforementioned patent No. 4085751 describes a drainage apparatus which comprises a collecting collecting chamber. This device also contains a sealed chamber arranged above the collecting chamber. An opening of the upper wall of the sealed chamber communicates the latter with the collecting chamber. The liquid coming from the wound enters the sealed chamber which contains an initial quantity of liquid, and this liquid ends up overflowing from the sealed chamber into the drainage collecting chamber.

Although all of the devices described above have varying degrees of utility, they all have certain shortcomings. Body fluids collected in typical suction devices sometimes contain a large number of viruses and other pathogenic microorganisms. People handling such drainage devices, during the collection and disposal of body fluids, are therefore exposed to a significant risk of infection. This exposure of users to infection exists in particular in the devices described 65 in the aforementioned patents Nos. 3809086 and 3889677, because the bodily fluids are emptied after being collected.

In addition, suction drainage devices, in which the suction element can communicate with the ambient air and with

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the collecting chamber, present a risk of contamination of the wound by the introduction of bacteria and others along the suction / evacuation circuit. Patents Nos. 3845765 and 4085751 describe devices in which communication between the suction element and the collecting chamber is possible, which presents a risk of contamination of the wound.

In addition, some typical and known suction devices have a complex or special structure which not only increases the manufacturing cost, but also makes their operation difficult. The aforementioned patents Nos. 3809086,4058123 and 4112947 describe several-piece return members. Each of these patents, as well as the aforementioned patent N ° 3889677, also describes a member, preferably made of elastomer, which, by resuming its initial shape, increases the volume of the collecting chamber by establishing a depression there. These elastomeric bodies end up tiring, which reduces the reliability of these devices.

The aforementioned patents Nos 3845765 and 4085751 also describe devices the use of which is generally limited to a vertical position, since the liquids which they contain are otherwise liable to flow from the interior chambers by gravity.

The invention relates to an improved device compared to the devices described above, and designed to eliminate the drawbacks. The device according to the invention is designed, in particular, so as to comprise a suction element isolated from the collected body fluids, in order to avoid any risk of contamination of the wound. The device according to the invention is also designed so as to allow the use of a remote source of suction, which can establish any necessary degree of suction. Alternatively, the device can be used with a suction source which can be connected directly, preferably a bellows pump, so as to constitute a portable device, the utility of which is not limited by the presence of an element fixed suction. The device according to the invention is inexpensive and designed so as to allow, after the separation of the suction source, a total rejection of the bodily fluids collected by drainage of the wound, which reduces the risk of infection for the user.

The device according to the invention is defined by claim 1.

In an exemplary embodiment of the invention, the passive element is hermetically fixed, by its periphery, to the edges of the other end of the housing, and a plate is fixed to this other end of the housing in order to close off the second chamber. . A remote suction device is connected to a tube made in one piece with the plate and communicating with the second chamber. When applying suction from the plate tube, the passive element folds back into the second chamber in order to increase the volume of the first chamber and create a vacuum there. A tube, made in one piece with the end wall and communicating with the first chamber, is connected to a conventional wound drainage pipe, one end of which is placed in the immediate vicinity of a wound, in order to allow liquids to be dragged into the first room.

In another embodiment indicated by way of example, an elastic bellows is connected to the plate so as to constitute a portable and hand-operated suction device. A valve allows the air contained in the bellows to be discharged into the ambient air when the bellows is compressed, while at the same time preventing the air from entering the second chamber. The expansion of the bellows then produces a suction transmitted to the second chamber. Consequently, it is possible to then recharge the bellows without affecting the amplitude of the depression then established in the second chamber.

The invention therefore relates to a wound drainage device comprising a suction element which is isolated from the collected bodily fluids, in order to allow evacuation of a wound without risk of contamination. The device according to the invention can be implemented without risk of infection for the user. It is inexpensive and can be discarded after use. It is also simple and easy to use.

The invention will be described in more detail with reference to the accompanying drawings by way of non-limiting example and in which:

fig. 1 is an elevation, with partial section, of an embodiment of the device according to the invention;

fig. 2 is a partial section, on an enlarged scale, of the detail surrounded by the circle A in FIG. 1, and fig. 3 is a vertical section of several boxes of the device of FIG. 1 nested one inside the other.

Fig. 1 shows, in vertical section, an example of the device 10 according to the invention.

The device 10 comprises a rigid housing 20, roughly cylindrical, comprising side walls 22 and a wall 24 at a first end. The side walls 22 are preferably inclined towards the end wall 24. The other end of the housing 20 is open. A passive element 40, that is to say non-elastic, is disposed inside the housing 20 so that its peripheral edge 41 (fig. 2)

either fixed, in a fluid-tight manner, to a lip 22 of the edge of the housing 20. The passive element 40 can both be inflated, to assume an almost completely expanded state, and folded up from this expanded state, thus looking like a bag. In the expanded state, the passive element 40 has dimensions which make it substantially match the shape of the inclined side walls 22 of the housing 20, so as to constitute a structure similar to a bag, as shown in FIG. 1. In this way, the passive element 40 divides the interior of the housing 20 into a first chamber 38 and a second chamber 42, the functions of which will be described below. The end wall 24 has a central truncated conical part 25 which projects towards the open end of the housing 20 and which ends in a roughly circular disc 26 having an opening 27. A tube 28, produced in one piece piece with the disc 26 and projecting from the latter so as to move away from the open end of the case 20 and to communicate with the aligned opening 27, allows the first chamber 38 to communicate with the outside of the case 20 A plug 29, which can be removably placed on the tube 28, is connected to the latter by a tab 30, one end of which is constituted by a ring 31 fitted tightly onto the tube 28. Consequently, the plug 29, when it is fitted onto the tube 28, completely closes the first chamber 38 in order to hermetically separate it from the ambient air surrounding the housing.

A plate 70 is tightly connected to the open end of the housing 20, so that the second chamber is hermetically isolated from the ambient air surrounding the housing 20. FIG. 2 shows in detail the sealed mounting of the plate 70 on the open end of the housing 20. The plate 70 has a flat surface 72 whose outer edges are extended by a flange 71 oriented approximately transversely to this surface 72. A seal circular 73 is housed as shown in figs. 1 and 2. Several threads 75, formed on the inner surface of the rim 71 of the plate, cooperate with several threads 35 formed on the outer surface of the rim 33 of the housing, so that the plate 70 can be screwed onto the open end of the housing 20, as shown in fig. 2. In this way, the seal 73 seals between the lower face of the flat part 72 and the upper edge of the rim 33 of the housing.

The plate 70 has a central opening 77; it is made in one piece with a tube 78 which enters the second chamber and which is aligned and communicates with the opening 77. The latter allows the application of suction to the second chamber 42.

If desired, the suction can be produced by a remote device (not shown) and transmitted to the opening 77 by a suitable pipe and fittings (not shown). Alternatively, the tube 78 can rise from the outer surface of the plate 70 so as to be connected to a suitable pipe (not shown) which terminates in the remote suction device.

Alternatively, the suction element may be an elastic bellows 80 having a roughly circular cross section and a diameter approximately equal to that of the plate 70. The bellows 80 has an upper surface 84 and a lower surface 86 roughly parallel to each other and to the surface 72 of the plate. The lower surface 86 comprises a central tube 82 which communicates with the interior of the bellows 80 and which projects from the lower surface 86 to penetrate the tube 78 of the plate, as shown in FIG. 1. The

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tubes 78 and 82 are suitably sized so that an airtight seal is formed between their respective contacting surfaces.

When the suction force is produced by means of a bellows 80, the plate 70 is preferably made in one piece 5 with side walls 74 of a thickness approximately equal to that of this plate 70 , and has an outer diameter approximately equal to that of the lower surface 86 of the bellows. The upper edges 76 of the side walls 74 are adjacent to the lower surface 86 of the bellows, so as to provide a space 94 for separation, the function of which will be "> described below.

The bellows tube 82 carries a vent tube 87, made in one piece with this tube 82 and projecting transversely. The vent tube 87 communicates with the interior of the tube 82 and, therefore, with the interior of the bellows 80. 15

A check valve 90 is housed in a sealed manner inside the tube 82, at the end of the latter furthest from the bellows 80, in order to allow air to pass from the second chamber into the bellows 80. Another check valve 92 is hermetically mounted on the tube 87, in order to allow air to escape from the valve 80 into the atmosphere through the separation space 94.

The device 10 described above constitutes for the user a wound drainage device by suction of a simple and easy implementation. Upon receipt of the device 10, the user removes the plug 29 and connects to the tube 28 a suitable tube (not shown) 25 for wounds. The user then compresses the bellows 80 in order to actuate the device 10. During compression, the air contained inside the bellows 80 is expelled therefrom by the tube 82, the vent tube 87, the valve 92 retainer and separation space 94, as described above. When the bellows 80 is released, its elasticity causes it to expand so as to draw the air from the second chamber 42, towards the inside of the bellows 80, passing through the check valve 90 and the tube 82 However, the check valve 92 closes during the evacuation of the air from the second chamber 42, in order to prevent the aspiration of ambient air inside the bellows 80.

The tube 82 can be made of a relatively rigid material,

in order to prevent the lower surface 86 of the bellows from coming into contact with the upper edges of the side walls 74 during compression, and thus to prevent the air contained in the bellows 80 from escaping into the atmosphere. Alternatively, the side walls 74 40 may have perforations allowing this air to escape.

The application of suction to the second chamber causes the passive element 40 to be pulled towards the plate 70, which causes the element 40 to fold back. At the same time, the volume of the first chamber increases so that a negative pressure, or depression, appears in this first chamber and produces suction drawing bodily fluids from a wound to the first chamber 38 by passing them through the conventional wound tube.

During the aspiration of wound fluids, if one wishes to recompress the bellows 80, the distribution constituted by the 50

check valves 90 and 92 allow this refilling of the bellows while maintaining the vacuum established in the second chamber 42 at a constant value.

During the folding of the passive element 40 inside the housing 20, it is possible that this element can be applied to the opening of the tube 78 and prevent the application of suction to the second chamber 42. To eliminate this risk, notches 79 can be made in the circumferential edge of the tube 78 of the plate. In this way, it is possible to maintain the circuit allowing the application of the suction to the second chamber 42 even when the passive element 60 folds back in a manner capable of blocking the tube 78.

The housing 20 is preferably made of transparent plastic and it can have engraved graduations 110, as shown in FIG. 1. The user can therefore visually check the proper functioning of the device 10. In addition, he can measure 65 the quantity of fluids collected by holding the housing 20 so that its end wall 24 faces downwards and by comparing the level liquid at graduations 110.

The housing 20, the plate 70 and the passive element 40 are preferably injection molded from suitable plastic. The bellows 80 is produced by blow molding. The seal 73 is preferably made of rubber and it is fixed inside the flat part 72, in order to ensure fluid-tightness when the plate 70 is fixed to the housing 20. The latter is advantageously rigid,

in order to avoid any risk of accidental decompression by a patient rolling on the device 10. In addition, the latter constitutes an independent and watertight device when the plug 29 is replaced, which eliminates the risk of infection for the user avoiding the latter having to empty the device 10 after use. If desired, the device 10 can be safely transported by the user, for example to a pathology laboratory in which the liquids removed from a wound must be examined, also without risk of infection.

The device 10 also avoids any contamination of the wound by bacteria or other bodies present in the ambient air. The passive element 40 isolates the suction device, preferably the bellows 80, the interior of which communicates with the ambient air at the time of loading, of the first chamber 38 and, consequently, of the wound.

The device 10 described in this patent is sensitive to orientation and it can be used in any position. If desired, a handle 88 can be attached to the upper surface 84 of the bellows 80 to allow the device 10 to be attached to the patient. In this way, the patient, to whom the device 10 is connected, can move freely.

The final assembly of the device 10 is not limited to the elements described above. The valves 90 and 92, which are fitted respectively in the tube 82 and on the tube 87 in order to form fluid-tight seals, can also be glued in the tube 82 and on the tube 87. The plate 70, instead of be screwed onto the outer surface of the rim 33 of the housing, can be made so as to avoid the use of threads 35 and 75 and to allow a pressurized and fluid-tight fitting of the flat surface 72 on the rim 33 of the housing. As a variant, the planar surface 72 can be glued, or welded by ultrasound, to the rim 63 of the housing. However, the passive element 40 is preferably welded, thermally or by ultrasound, to the lip 32 of the housing 20. The assembly of the device 10 is not limited to bonding, force fitting or ultrasonic welding , but it can be achieved by other conventional means known and appreciated by those skilled in the art, including, without limitation, mechanical means such as screws.

Fig. 3 shows a number of housings 20 stacked by nesting into each other, this nesting being facilitated by the conicity of the housings 20 and by the corresponding shape of the passive elements 40. The housings 20 can thus be conveniently stored until we need it. The stopper 29 placed on the tube 28 of the housing maintains a sterile medium inside the first chamber 38. When it is necessary to evacuate the liquids from a wound, a housing 20 is removed from the other stacked housings 20. A plate 70, preferably comprising a bellows 80, is fixed to the housing 20 in order to seal the second chamber 42. The plug 29 is then removed and a conventional wound tube (not shown) is connected to the tube 28. The device 10 is then implemented by compression of the bellows 80, and the liquids from a wound are sucked inside the first chamber 38.

In another embodiment (not shown), the disc 26 is made in a single piece of rubber and has a thickness allowing it to be pierced by one end of a hollow needle with a thin wall (not shown). The disc 26 provides a fluid-tight seal around the wall of the needle in contact with the rubber of this disc 26. The needle has a diameter suitable for the flow of body fluids into the first chamber 38. The other The end of the needle is connected to a conventional tube which communicates with the region of the wound to be drained. In this way, a sterile medium is maintained in the first chamber 38 while the device 10 is connected to the conventional wound tube.

1 drawing sheet

Claims (10)

634999 1. Device for evacuating fluids from a wound, characterized in that it comprises a housing (20) which comprises side walls (22) and at least one end wall (24), located at a first end of this housing, and a passive element (40) which can be expanded and folded, airtight and watertight, disposed inside the housing and hermetically connected, by its peripheral edge, to the side walls of the housing, so dividing the interior of the latter into first and second chambers (38,42), the first chamber (38) being contiguous with said end wall (24), the passive element (40) being substantially expanded towards said end wall and roughly matching the internal shape of the side walls of the housing, a member making it possible to pull the passive element towards the other end of the housing in order to increase the volume of the first chamber (38) and to create a depression in the latter . 2. Device according to claim 1, characterized in that the passive element (40) is hermetically connected, by its peripheral edge, to the other end of the housing. 2 3. Device according to claim 2, characterized in that it comprises elements communicating the first chamber and the wound from which fluids must be discharged. 4. Device according to claim 3, characterized in that the communication elements comprise a tube (28) of which a first end is connected to the end wall (24) of the housing so as to communicate with the first chamber (38), this tube allowing the first chamber to communicate with the outside of the housing. 5. Device according to claim 4, characterized in that it comprises a plate (70) hermetically fixed to the other end of the housing in order to close the second chamber (42) at said other end of the housing, this plate having an opening (77) which communicates with the second chamber (42) of the housing, so that this second chamber can communicate with the exterior of the housing. 6. Device according to claim 5, characterized in that the member for pulling the passive element towards the other end of the housing comprises a suction member which is connected to said opening (77) of the plate (70) , so that the application of suction to the second chamber (42) causes a pull of the passive element (40) towards the plate in order to increase the volume of the first chamber (38) and to establish in the latter a depression. 7. Device according to claim 6, characterized in that the suction member comprises a bellows (80), fixed to the plate (70), which is aligned and which communicates with said opening (77) of the plate so that compression and loosening of the bellows produce a suction force which brings the passive element towards the plate. 8. Device according to claim 7, characterized in that it comprises distribution members (90,92) allowing air to escape from the bellows during the compression of the latter, while preventing this air from entering the second chamber, so as to close the latter during the compression of the bellows. 9. Device according to claim 8, characterized in that the housing (20) is substantially rigid and substantially cylindrical. 10. Device according to claim 9, characterized in that the side walls (22) are inclined towards the end wall (24).