DISPOSABLE DEVICE FOR THE TRANSFER OF AN ACTIVE LIQUID TO AN INTRACORPORAL CAVITY BACKGROUND OF THE INVENTION The present invention relates to the transfer or circulation of an active liquid in or into an intracorporeal cavity of the human body or of an animal, in particular in contact with the mucous membrane of the cavity. It is understood that intracorporeal cavity means any cavity of the body, in particular an elongated cavity to which it is possible to have access from the outside for different purposes, in particular for clinical, therapeutic, prophylactic or diagnostic purposes, but also for cosmetic purposes or for personal hygiene purposes. An example that can be mentioned of one of such cavities is the vagina, which extends from the vulva to the cervix and to which / in which it is desired to transfer / circulate an active liquid mixed with the cervical mucosa for example. Consequently, the active liquids taken into consideration in the present invention are in general liquids or treatment fluids, in which a liquid agent for wetting, solubilization or fluidization is included, in particular of a body fluid or fluid present in the intracorporeal cavity. in question and also a therapeutic, prophylactic or diagnostic agent or even a cosmetic agent or agent for personal hygiene or
Ref. . 24695 finally an antiseptic, bactericidal, fungicidal or spermicidal agent in the case of the vaginal cavity for example. According to WO 80/01353, a single use device has been described and proposed for the transfer of an active liquid in an intracorporeal cavity, for example bronchial cavity, which has sufficient intrinsic rigidity to allow its introduction by pushing. This device comprises: a central element having means for contact with the mucous membrane or the interior of the intracorporeal cavity, for example a brush or brush; - a tubular peripheral element, arranged around the central element, in particular concentric to the latter, comprising a tampon designed to absorb all the liquid or fluid by expansion and by virtue of coming into contact against the membrane or mucous wall of the intracorporeal cavity; - support means with airtightness of the peripheral element, against the mucosa of the intracorporeal cavity; these support means comprise a duct disposed outside the peripheral element, capable of moving relative to the latter in translation and a hermetic membrane that joins the free edge of the duct and that of the peripheral element; Two relative positions are thus defined between the peripheral element and the conduit, ie a first position in which the peripheral element is retracted into the conduit and the membrane can play the closed diaphragm role by insufflation of an appropriate gas between the element peripheral and duct and a second position in which the peripheral element protrudes in relation to the duct and in which the membrane can be inflated to lean against the mucosa of the intracorporeal cavity: - a temporary means of protection, sealed with respect to the liquids or fluids present in the cavity, this temporary means of protection is confused with the aforementioned support means, when the peripheral element is placed inside the duct, with the inflation of the membrane that plays the diaphragm paper, - a source of active liquid that can be arranged to communicate with the interior of the peripheral element; According to US-A-3519364 a device is described that uses an active liquid to obtain a sample in an intracorporeal cavity. The present invention relates to a single use device, as defined above, which ensures the almost total absence of leaks to the outside or of active liquid and / or liquids or body fluids or of any liquid present in the intracorporeal cavity considered, during the entire time that the device is present or kept in the cavity, by simple construction of the latter; for this purpose according to the invention, in combination: the peripheral element comprises a buffer provided to absorb all liquid in the expansion, by leaning hermetically against the mucosa of the intracorporeal cavity, the temporary protection means is airtight liquid of the peripheral element against the liquids and in relation to the central element, the elements are arranged to communicate with each other in the intracorporeal cavity once the temporary means is removed, and the source of the active liquid is comprised in the central element or the peripheral element, while in correspondence a means of recovering the active liquid, which has been circulated by the intracorporeal cavity consists of the peripheral element or the central element. This single-use device can be supplemented by an application element inside the intracorporeal cavity, mounted on the central element and / or the peripheral element, integrally in the direction of introduction into the cavity and separable in the direction reverse. For the purposes of sampling and / or analysis of the body fluid or fluid present in the intracorporeal cavity considered, the device may further comprise: a transport element of the active liquid that is circulated in the intracorporeal cavity, possibly mixed with the liquid or body fluid, the element is in elongated form, for example a small cord, in continuity of flow at one end with the central element or the peripheral element respectively;
- an external element for the extemporaneous analysis of a constituent of the body fluid or liquid, mixed with the active liquid or a chemical biochemical agent or biological state of the body fluid; This analysis element is arranged at the free end of the transport element. "Constituent" of the body fluid or fluid means not only a chemical or biological constituent, but also a biological or living constituent, for example a cellular constituent. By way of example, taking the cervical mucosa into consideration as a body fluid and for the purpose of detecting periods of female fertility, the biochemical or biological constituent to be analyzed is a peroxidase or a compound having a peroxidase activity and the external element for the extemporaneous analysis comprises or forms a reagent or system of reagents, in particular colored, for example an oxidation-reduction compound, of which at least the oxidized form is colored, for example guaiacol. "Analysis" means any method or device by which it is possible to identify, separate, enrich or quantify the constituent or analyte to be tested in the body fluid, or any state of the latter, for example its acidity or pH.
BRIEF DESCRIPTION OF THE DRAWINGS The present invention is now described with reference to the following accompanying drawings in which:
Figure 1 represents an exploded view of a device according to a first embodiment of the invention; Figure 2 represents a perspective view of the device shown in Figure 1, ready for use; Figure 3 represents an axial cross-sectional view of the device shown in Figures 1 and 2; Figure 4 represents a cross-sectional view of the central and peripheral elements of the device shown in Figures 1 to 3, once inserted and retained in an intracorporeal cavity, after the temporary means for protecting the peripheral element have been removed; Figure 5 represents a cross-sectional view of a detail of the device shown in Figures 1 to 3; Figure 6 represents an axial cross-sectional view of a device according to a second embodiment of the invention; Figure 7 represents an axial cross-sectional view of the peripheral and axial elements of the device shown in Figure 6, once inserted and retained in an intracorporeal cavity, after the temporary protection means of the peripheral element has been removed; Figure 8 represents an axial cross-sectional view of a device according to a third embodiment of the invention; Figure 9 represents an axial cross-sectional view of the peripheral and axial elements of the device shown in Figure 8, once inserted and in position in an intracorporeal cavity;
Figures 10 and 11 are perspective and sectional views in perspective and sectional respectively of a device according to a fourth embodiment of the invention; Figures 12 and 13 represent the device shown in Figures 10 and 11 connected to an application element and disconnected from the latter respectively, in order to allow their separation; Figure 14 is a perspective representation of a device according to a fifth embodiment of the invention, more particularly proposed and adapted for the treatment of pathological lesions of the vaginal cavity: Figure 15 represents the device shown in Figure 14 in a seen in schematic cross section and in position in the vaginal cavity; Figure 16 represents a device according to a sixth embodiment of the invention, again proposed and adapted for the treatment of the vaginal cavity; Figure 17 represents a seventh embodiment of the invention and more particularly a device for the treatment of the vaginal cavity; Figure 18 represents in a schematic manner an eighth embodiment of the invention, which also consists of a device for the treatment of the vaginal cavity;
Figure 19 represents a device according to a ninth embodiment of the invention, in cross section and without its temporary means of protecting the spherical element.
DESCRIPTION OF THE PREFERRED EMBODIMENTS According to figures 1 to 5, a disposable device according to the invention for the transfer of an active liquid to an intracorporeal cavity, which is represented in a schematic manner in figure 4 by the number of reference 10, has a general shape and possesses an inherent rigidity which is sufficient to allow its introduction by thrust and to hold it in place in the cavity 10 by simply narrowing the latter. In a general manner, the device comprises: a central element 1 having means for contacting or communicating with a mucous membrane or the interior of the intracorporeal cavity 10; a peripheral element 4 arranged around and more precisely concentrically around the central element; this element comprises a buffer 11 designed or chosen to absorb all liquid or fluid by expansion and by virtue of being seated in a sealing manner against the mucous membrane of the intracorporeal cavity 10; temporary protective means 5, sealed with respect to the liquids, for protection of the peripheral element 4 in relation to the central element 1; the central element 1 and the peripheral element 4 are arranged, as shown in figure 4, to communicate with each other in the intracorporeal cavity 10, once the temporary means of protection have been removed; a source 12 of active liquid contained in the peripheral element; means 13 for recovering the active liquid, which has been circulated in the intracorporeal cavity and which can optionally transport a body fluid or liquid, these means are contained in the central element 1; an element 6 for application to the interior of the intracorporeal cavity 10, mounted on the central element 1 and / or the peripheral element 4, in such a way that it is integral in the direction of introduction to the cavity 10 and in such a way that it is separable in the opposite direction; a transport element 2, for example a wick, for the transport of the active liquid which has been circulated in the intracorporeal cavity 10 and which is of elongated shape, for example a small cord in continuity at one end with the central element 1 and more precisely the means of recovery 13; and an external element 3 for the extemporaneous analysis of a constituent of the body fluid present in the intracorporeal cavity 10, mixed with the active liquid or for the extemporaneous analysis of a biochemical, chemical or biological state of this same body fluid; this analysis element is arranged at the free end of transport element 2.
The central element 1 comprises a core 14 provided with filiform means 15, in particular capillary filaments, for contact with the mucous membrane of the intracorporeal cavity. These filiform means are maintained in shape by the temporary means of protection 5 described hereinafter. The capillary filaments 15 can be manufactured from any synthetic or natural material, in particular biocompatible material, for example absorbent natural fibers (cotton, flax, etc.). The peripheral material 4 comprises a sleeve 21 made of a material which is capable of absorbing a liquid or fluid by expansion and surrounding the core 14 of the central element 1 provided with filiform elements 15. The absorbent material of the sleeve 21 is expandable and / or spongy and consists for example of filaments, hair fibers or synthetic fibers, etc. This sleeve has a cylindrical shape when it is retained by the temporary means 5 of protection described hereinafter and evolves into a corolla shape once the temporary protection means 5 have been separated and the device according to the invention has been introduced and retained blocked in the intracorporeal cavity (see figure 4). The absorbent material of the sleeve 21 is impregnated until saturation with the active liquid, for example a physiological salt solution and / or a moderate fluidizing agent and / or a therapeutic agent with local diffusion. It is maintained in a non-expanded configuration by the temporary protection means 5 described hereinafter. It is in the cylindrical central hole of the sleeve 21 that the central element 1 described above is arranged. The lower part 31 of the sleeve 21 is impermeable, either by impregnation of the absorbent material with an appropriate product or by the addition of a waterproof sheet. The temporary protective means 5 comprises a sheath or enclosure 25 surrounding or enclosing at least partially in a sealing manner, the peripheral element 4 around the central element 1. This enclosure has or is integral with one end of an accessory 26, example a loop or pull ring, by means of which it is possible to remove the shell 25 in order to leave the peripheral element 4 exposed in the intracorporeal cavity 10. With the exception of the part of the ring or accessory 26, this shell has the shape General of a receptacle or plug partially turned back on itself and around the sleeve 21. The inner free edge of the shell 25 is retained in sealing contact in a circular groove 14a of the core 14, by means of an O-ring seal 32 or an easily tear weld joint. In the same way, the annular transition zone between the part of the receptacle and the part of the ring 26 of the casing 25 is hermetically retained in sealing contact in a groove or notch 29a of the support or contact element 29 described later herein. , of the application element 6 by means of an O-ring seal 33 or by an easily tear weld joint, but one of which is strong enough to maintain the seal inside the receptacle part of the shell 25. If it is In this case, the envelope 25 can be retained in a sufficiently sealed manner on the peripheral element 4 or more precisely on the impermeable base 31 of the sleeve 21 again in a sealing manner. The envelope 25 is made of a waterproof material, in particular a biocompatible material, for example a plastic that shrinks by heat. It is very thin but strong enough to make it possible, by pulling on the ring 26, as described hereinafter, to break the sealing connections at the level of the notches or grooves 14a, 39a and if appropriate the base 31, then unwinding the envelope part in the form of a receptacle and separating or withdrawing it from the device, to release the peripheral element 4 and exposing it inside the intracorporeal cavity 10. Furthermore, the envelope 25, of a general cylindrical shape, is sufficiently flexible and thin, also as smooth and slidable on its external surface to facilitate the introduction of the device into the intracorporeal cavity. The transport element 2 serves at the same time to direct the active liquid and if appropriate the fluid or bodily fluids separated by means of the latter as far as the analysis element. It also serves to remove the entire device according to the invention after use. The transport element 2 has a diameter which is sufficiently thin to ensure that it does not cause any inconvenience or discomfort in the body cavity. This element can be individual or twin and can be in the form of a coarse cord or small cord for example. The analysis element 3 is in continuity of flow with the transport element 2. This element 3 supports appropriate reagents, deposited for this purpose. This analysis element 3 advantageously has a spherical shape. However, in the case where this element does not form a small sphere or cylinder, the reagents are deposited on the free end of the small cord or on the outside of a twin cord. The application element 6 comprises a support element 29, for example a disk, fixed to the end of an axial rod 30, for example a diametrically hollowed tube. The central element 1 is mounted in a sealing manner at one end, against and within an adapted hole of the disc 29, both aligned with the axial rod 30. As shown more particularly in FIG. transport 6 in the hole formed on the disc 29 is secured by means of an elastic seal 34. The axial rod or rod 30, which has the shape of a slotted tube, is adapted for the passage of the transport element 2. The axial rod 30 ends in a bulged portion 35 in order to facilitate handling and removal of the application element 6. The device described above is used or implemented in the following manner, starting with the configuration shown in Figure 2: by pushing the application element 6, the device is introduced into the intracorporeal cavity 10, which retains it in its position by simple narrowing; by pulling the ring 26, the shell 25 or the temporary protective means 5, is released from the central element 1 and the peripheral element 4, the shell 25 is unrolled or deployed and removed from the intracorporeal cavity by sliding along the element peripheral 4; the peripheral element 4 is released and thus expands, in relatively sealing contact with the intracorporeal cavity 10, as shown in Figure 4; from this moment, the active liquid is released into the cavity 10 and carries with it the body fluid which is present in the cavity
, moving it towards the central element 1 by means of filiform means 15 and the recovery means 13, towards the analysis element 3 which can be observed or visualized by the user, outside the cavity 10; once the reaction or absence of reaction has been demonstrated, it is possible, by pulling on the transport element 2, to remove the device and then discard it. The device described above also provides the following important advantages: - its use is particularly simple, reliable and effective; - since the chemical and / or biological products necessary for the analysis are located outside the intracorporeal cavity, or there may be irritation or even burning, in contact with the living tissue and more particularly at the level of the mucous membranes of the intracorporeal cavity; - the analysis results can be read directly without any manipulation of, or direct contact with, the chemical or biological reaction products. The device shown in FIGS. 6 and 7 differs from the device shown in FIGS. 1 to 5 in terms of the following characteristics: in contrast to the device described above, the source 12 of active liquid is contained in the central element 1 and the means of recovery 13 for the active liquid, which has been circulated in the body cavity 10, is contained in the peripheral element 4, correspondingly, the transport element is in continuity at one end with the peripheral element 4; - the central element 1 comprises or consists of a cavity 16 containing the active liquid, this cavity is divided or defined by the enclosure 26, closed on itself by a seal or welding 36. The device shown in figures 8 and 9 differs of that shown in Figures 6 and 7 by the fact that a sealing partition 22 is formed between the central element 1 and the peripheral element 4. The device shown with reference to Figures 10 to 13 differs from the device shown with reference to Figures 1 to 5 in terms of the following technical characteristics. The peripheral element 4 at least partially surrounds the central element 1, which has the shape of a cavity 16, which itself consists of an elastic and flexible material 23, for example rubber. The peripheral element 4 for this part consists of a material 24 capable of absorbing a liquid by expansion, for example a fiber-based material as described above. The temporary protective means 5 consist of a capsule 27 which temporarily isolates the holes 28, for the passage of the active liquid in relation to the peripheral element. The application element 6 comprises a flange 37 which is fixed on the end of the axial rod 30 in such a way as to allow the accommodation of the transport element 2, which extends between the peripheral element 4 maintained against the flange and the element of analysis 3 maintained at the other end of the axial rod 30, consisting as indicated above, of a tube of open longitudinal section. The capsule 27 is easily detachable in order to release the holes 28 at the time of use, i.e., once the device has been put in place in the intracorporeal cavity. From this moment, any pressure exerted on the cavity 26 allows it to be emptied, in such a way that the active liquid impregnates the peripheral element 4 which, by rinsing the liquid, in turn compresses the cavity 16 in order to discharge finally the content of it. When the cavity 16 has finally been emptied, the analysis element 3 is pushed in front of the tube 30 in order to separate the transport element 2 and allow the separation and removal of the application element 6 from the intracorporeal activity. It is then sufficient, as in the case of the previous devices, to pull on the transport element 2 in order to remove the assembly consisting of the central element 1 or cavity 16 and the peripheral element 4 of spherical shape. According to figures 14 to 18, different devices according to the invention for the treatment of pathological lesions of the vaginal cavity are now described. For this purpose, the active liquid is a therapeutic liquid which may contain antibiotic or antiseptic products, hormone derivatives, corticosteroids, various emollients, local nutrients, etc. According to Figures 14 and 15 and in contrast to the embodiments shown and described above with reference to Figures 10 to 13, the peripheral element 4 comprises two bulging or prominent portions 41 and 43, either on one side or the other of a central core 42 of narrow cross section and thus has in general a "thread spool" shape. The cavity 16 containing the active liquid is arranged mainly in the upper bulged portion 41, but also partly in the interior and in the center of the central core 42. The bulged portion 41 in which the cavity 16 is arranged has several channels 41a for the flow of the active liquid towards the central nucleus, in contact with the vaginal wall, when the device is in place in the vaginal cavity 10 and is spliced against the cervix 40. And this active liquid, if properly mixed with the vaginal discharge, it is finally recovered in the other bulged portion 43 of the peripheral element 4. The device comprises a line 47 for the separation of the vaginal cavity 10, the line is integral, at one end of the peripheral element 4 and more precisely the other portion bulge 43 and comprises at the other end a fastening means 44. The device described above proves to be appropriate for preferential contact with the cervix, as described above. It is shown in Figure 15. The central core 42, which may or may not be of narrow cross section, makes it possible, by virtue of the channels 41a, for the active liquid to reach the vaginal walls. This liquid is finally absorbed in the other bulged portion 43 of the peripheral element 4, if appropriate flow into the vaginal cavity, to originate for example a pathological flow or a biological reaction triggered by the active medicinal liquid. In addition, the other bulked portion can be impregnated with any appropriate colored reagent, which makes it possible for example to detect toxins from the "microbes" destroyed by the active liquid. It is more precisely the other bulged portion 43 which makes it possible to avoid any substantial flow into the vaginal cavity during the treatment of the latter with a device according to the invention. The device shown in Figure 16 differs from that shown in Figures 14 and 15 in that: - the central core 42 has approximately the same cross section as the bulged portions 41 and 43 and includes a plurality of wedges or sections 421 or 423 which separate and reinforce each other; - the sections 421 to 423 have notches, for example 421a, in line with each other and with a rib 41a for the flow of the active liquid. The device shown in FIG. 17 differs from that shown with reference to FIGS. 14 and 15 in that, on the one hand, the central core 42 of the peripheral element 4 comprises orifices 42b for the passage of the active liquid towards the outside and the vaginal wall and, on the other hand, the temporary protective means 5 comprise separable sealing means 48 between, on the one hand, the interior of the cavity 16 and on the other hand, the aforementioned orifices 42b. These separable means preferably consist of an insulating shell 48 which can be removed separately by pulling on a string 46, from the outside of the vaginal cavity. The device shown in FIG. 18 differs from that shown in FIG. 17 by the fact that the separable sealing means between the interior of the cavity 16 and the orifices 42a for the passage of the active liquid comprise an enclosure 49 delimiting the cavity 16 and means 45 designed to break the envelope 46 in particular when pulling on the separation line 47. The device shown in Figure 19 differs from that shown in Figures 1 to 5 by the fact that the central element 1 comprises a means 17 for the controlled introduction of the active liquid from the outside of the device. This means 17 has a flexible and squeezable reservoir 18 arranged towards the end 35 of the axial rod 30, a flexible valve 19 arranged at the entrance of the central element 1 in the form of a cavity delimited by the sealing partition 22 and a conduit arranged between the container or tank 18 and the valve 19. The valve is designed in such a way to open in the direction of introduction of the active liquid and to close in the other direction.
It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects referred to therein.
Having described the invention as above, property is claimed as contained in the following