Abstract:
A disposable device for transferring an active liquid into a body cavity has sufficient intrinsic consistency for being inserted by being thrust into the cavity. The device includes a central element, that is the source of at least part of the active liquid. The central element is preferably formed from a capsule having a wall that forms a detachable appendage. A peripheral element is arranged around the central element. The peripheral element may be a pad arranged to collect and absorb active liquid delivered into the body cavity by expanding and thereby being urged to press sealingly against mucous membrane of the body cavity.

Description:
[0001]    This application is a continuation of U.S. patent application Ser. No. 09/830,426, which is the National Stage of International Application No. PCT/FR00/00245, filed Feb. 2, 2000. The entire disclosure of the prior application is hereby incorporated by reference herein in its entirety. 
     
    
     
       SUMMARY OF THE INVENTION  
         [0002]    The present invention relates to the transfer or circulation of an active liquid into or in a body cavity of the human body or of an animal, particularly in contact with the mucous membrane of said cavity.  
           [0003]    The term “body cavity” is to be understood as meaning any bodily cavity, particularly an elongate one, which can be accessed externally for various purposes, particularly clinical, therapeutic, prophylactic or diagnostic, but also for cosmetic or personal hygiene purposes. By way of an example of such a cavity, mention may be made of the woman&#39;s vagina extending from the vulva to the neck of the uterus, into which an active liquid is to be transferred or in which an active liquid is to be circulated, in contact with the mucous membranes or tissues of said cavity.  
           [0004]    In consequence, the term “active liquid” is to be understood as meaning any liquid or fluid for treatment, either locally via a topical route, or systemically and in general comprising a liquid or fluid phase in which a treatment agent is distributed in solution or in suspension. This treatment agent is chosen from the group consisting of wetting agents, agents for solubilizing and fluidizing particularly a bodily fluid or liquid present in the body cavity, therapeutic, prophylactic and diagnostic agents, cosmetic or personal hygiene agents, antiseptics, bactericides, fungicides and spermicides (in the case of the woman&#39;s vagina cavity for example).  
           [0005]    A subject of the present invention is a disposable device allowing better availability of the active principle or principles in contact with the mucous membrane of the wall of the body cavity, particularly when the treatment agent is therapeutic agent.  
           [0006]    Another object of the invention is a device which ensures an almost total absence of external flow of the active liquid and/or of the bodily fluid or of any liquid present in the body cavity in question, throughout the time that said device is present or held in this cavity, simply by constriction thereof.  
           [0007]    To this end, according to the invention, the disposable device has sufficient intrinsic consistency that it can be inserted into the body cavity by pushing, and comprises:  
           [0008]    a central element at the source of at least part of the active liquid, in that it comprises a substrate which is relatively solid at ambient temperature and outside the body cavity, and becomes relatively liquid or fluid inside this same cavity and at body temperature so that within this cavity the central element liquefies at least partially to generate at least part of the liquid phase of the active liquid,  
           [0009]    a peripheral element arranged around the central element, in the solid state, comprising a pad designed to collect and absorb the active liquid which has circulated into the body cavity by expanding and thus coming to press in a sealed manner against the mucous membrane of the body cavity. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    The present invention is now described by way of nonlimiting example with reference to the schematic appended drawing in which:  
         [0011]    [0011]FIG. 1 depicts a disposable device according to the invention, in position in a body cavity, and just after it has been inserted into the latter by pushing, this being according to a first embodiment of the invention; FIG. 1 is an axial section through a device according to the invention, the latter having symmetry of revolution about an axis;  
         [0012]    FIGS.  2  to  4  respectively depict three other embodiments of the present invention, still in axial section;  
         [0013]    [0013]FIG. 5 depicts another embodiment of the present invention, still in axial section. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0014]    According to FIG. 1, a disposable device according to the invention is referenced by the numerical reference  1 . In general, it allows an active liquid as previously defined to be dispensed or released into a body cavity denoted by the numerical reference  2 . This device has an intrinsic and overall consistency which is relatively firm but soft and stiff or strong enough to allow it to be inserted into the cavity by pushing, without altering the structure of said device, particularly without dissociating its various components and/or rupturing any liquid-containing capsule that may be contained inside said device (cf. embodiment according to FIG. 4).  
         [0015]    The device according to the invention essentially comprises two components assembled together permanently, namely:  
         [0016]    a central element  3  at the source of at least part of the active liquid as previously defined;  
         [0017]    and a peripheral element  4  arranged around the central element  3 , comprising a pad  5  designed to absorb the active liquid which has circulated or been dispensed into the body cavity, by expanding and thus coming to press in a relatively sealed manner against the mucous membrane of the body cavity (cf. shape depicted in dotted line in FIG. 1).  
         [0018]    The central element  3  comprises a substrate, for example based on gelatin, which is relatively solid at ambient temperature and outside the body cavity and which becomes relatively liquid inside the body cavity and at body temperature so that within this cavity the central element liquefies at least partially to generate at least part of the liquid phase of the active liquid.  
         [0019]    The gelatin may be replaced by any other substrate with the same properties, for example a lipid.  
         [0020]    In consequence, according to one essential feature of the present invention, it is therefore the substrate of the central element which, by liquefaction within the body cavity, and therefore within the human body or the body of the animal, makes it possible to obtain all or part of the liquid phase of the active liquid.  
         [0021]    As a preference, an agent for treating the body cavity as previously described is distributed discretely in the solid substrate of the central element, this being so regardless of the physical form or nature of said treatment agent outside the substrate, for example an oily, solid or liquid physical form, or whether it is hydrophobic or hydrophilic by nature. This discrete distribution of the treatment agent may be achieved by incorporating this agent into the previously defined substrate in the liquid phase when the disposable device according to the invention is being manufactured.  
         [0022]    As clearly shown in FIG. 1, the central element  3  is a kind of molded part, molded by the solidification of the liquid substrate, for example the gelatin. And the pad  5  is a sleeve also molded or shaped from a material capable of absorbing a liquid or a fluid as it expands. This material is, for example, a foam of a biocompatible plastic material or alternatively a fibrous material (for example of the cellulose type), opened (for example folded) around the central element  3 . The central element  3  and the peripheral element  4  are thus tailored to one another so that they fit together by simple axial pushing of the central element toward the peripheral element or vice versa.  
         [0023]    The peripheral element  4  has a hole  4   a , or bore, particularly a blind hole as shown in FIG. 1, the shape and size of which are tailored correspondingly to receive the body  3   a  of the central element  3 . The head  3   b  of the central element  3 , of convex external shape, for example spherical, has a collar  6  while the peripheral element  4  has a neck  7 , the shape and size of which are tailored to definitively retain the collar  6 , by axially pushing the central element  3  and peripheral element  4  together. As shown in FIG. 1, the neck  7  has an undercut accommodating the collar  6  directed inward, and also of convex external shape, for example spherical. The foot  3   c  of the central element  3  has a bulging shape, while the peripheral element  4  has a correspondingly flared part  4   d , the shape and size of which are tailored to retain the foot  3   c  of the central element  3 .  
         [0024]    The absorbent material of the pad  5  can expand and/or is spongy and consists, for example, of filaments, capillary fibers, or natural fibers (cellulose or viscose for example), etc. As mentioned earlier, it is the liquefaction or melting of the substrate of the central element  3  which, generating at least part of the liquid phase of the active liquid within the body cavity  2 , then allows the pad  5  to expand by collecting said liquid therein, this being the case at body temperature and inside the body cavity  2 .  
         [0025]    In order possibly to recycle the active liquid in contact with the body cavity  2 , the pad  5  is bored for example with four radial passages  11  in a cross configuration, located below the hole  4   a , opening onto the exterior face of the pad  5  and possibly communicating with the bottom of the hole  4   a.    
         [0026]    According to FIG. 2, the collar  6  extends toward the foot  3   c  of the central element  3  in the form of a skirt  6   a  capping the part  4   b  of the peripheral element  4  away from the neck  7 .  
         [0027]    Moreover, still according to FIG. 2, a string  12  attached to the peripheral element  4  allows the disposable device  1  to be extracted from the body cavity  2  after it has treated the latter, that is to say after the substrate of the central element  3  has liquefied.  
         [0028]    According to FIG. 3, a closed temporary protective case  10  encases the central element  3  and peripheral element  4  when these elements are assembled, as described earlier. This casing consists, for example, of a substrate with the properties described above, for example based on gelatin. What this means is that the casing is made of a material which is relatively solid at ambient temperature and outside the body cavity so that within this cavity and at the body temperature, this material melts and thus constitutes another part of the liquid phase of the active liquid previously defined. However, this casing  10  may consist of a hard and solid excipient, for example sucrose, as used in a galenic form to obtain sugar-coated pills, and capable of dissolving or breaking up in contact with any bodily liquid present in the cavity  2 .  
         [0029]    According to FIG. 4, the central element  3  is a capsule, the wall  8  of which consists of the previously defined substrate and the interior of which contains another liquid  15 , active or otherwise, the wall  8  being closed and sealed at ambient temperature and outside the body. The liquid thus contained in the capsule makes it possible to increase the amount of liquid phase of the active liquid. This liquid  15  may have any appropriate form, for example oily, and may contain all or part of a treatment agent as previously described, in solution or in suspension in said liquid.  
         [0030]    As depicted in FIG. 5, the casing  10  depicted in FIG. 4 may be omitted, while the wall  8  forms an appendage  13  that can be broken off at its opposite end of the pad  5 , which allows the user to open the capsule just before inserting the device into the body cavity and to benefit from a small amount of the liquid  15  to moisten the exterior of said device at the time of inserting it into said cavity.  
         [0031]    According to FIGS.  1  to  4 , a device according to the invention, prior to its insertion into the body cavity  2 , comprises a distal part  1   a , via which it is inserted into the body cavity  2 , and a proximal part  1   b , the largest transverse diameter of which is smaller than the largest transverse diameter of the distal part  1   a . This allows the device to be held temporarily in the cavity before the active liquid takes over by swelling the pad  5 .  
         [0032]    This configuration also makes it possible to limit or eliminate any contact between the mucous membrane of the body cavity  2  and the absorbent material when the pad  5  is in the dry state at the time of insertion of the device  1 ; as such contact could not only give rise to a not insignificant amount of friction but may also be a source of discomfort or pain to the user. On the other hand, by virtue of the configuration adopted, it is only the distal part  1   a , covered with the relatively slippery collar  7 , which slides in contact with the mucous membrane of the body cavity as the device is being inserted.  
         [0033]    A disposable device as previously described affords the following essential advantages:  
         [0034]    the absorption of the treatment agent or agents by the mucous membrane of the body cavity is more complete and rapid;  
         [0035]    the incorporation of this treatment agent into the substrate of the central element makes it possible to have a precise and uniform amount of treatment agent which is also protected by the substrate, this keeping it away from any oxidation or hydrolysis, for example;  
         [0036]    the mucous membrane of the cavity and the active liquid are brought fully into contact with each other.