Abstract:
An intravaginal inflatable member impermeable to fluids adapted to collect upon inflation, menstrual blood and also capable of [provide] providing sealable closure of the vaginal canal for the prevention of vaginal exit of menstrual blood. By being inflatable, the device is easily inserted and removed when deflated and is also capable of sealing off the blood collected avoiding the spillage of blood upon extraction and disposal. The inflation of the device can be conveniently initiated prior to insertion into vagina and completed with the device fully inserted or can be initiated and completed with the device already inserted into the vagina. Inflation of the device can be achieved without the use of an external pneumatic source, but with a self-inflating apparatus within the device. The cup shaped member can be used as a standing alone device or in combination with a vaginal tampon for the prevention of blood leakage.

Description:
RELATED CASES  
       [0001]    This application is a Continuation in Part of our copending application No. 08/907,529, filed on Aug. 8, 1997, which is a Continuation in Part of patent application No. 08/391,342 filed on Apr. 18, 1995 [and allowed.], issued as Pat. No. 5,674,239 on Oct. 7, 1997. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    This invention relates to obstetrical-gynecological devices, more specifically to intravaginal devices designed to collect menstrual blood and to prevent leaking or exit of blood or any other organic fluid from the vagina.  
         BACKGROUND-DESCRIPTION OF THE PRIOR ART  
         [0003]    The vagina is a musculomembranous tubular organ extending from the uterine cervix to the exterior of the body. The vaginal canal is about  9  or  10  cm long. Its lumen is generally quite small, and the walls that surround it are usually in contact with each other. Various are the organic fluids which pass through the vaginal canal during the female lifetime, such as blood, vaginal secretion fluids, amniotic fluid, etc.  
           [0004]    An important organic fluid passing through the vaginal canal and exiting through the vaginal orifice is blood, either as a result of physiological conditions such as the menstrual period or as a result of pathological conditions such as cervical or endometrial carcinoma. The various inconveniences to women resulting from the occurrence of physiological bleeding occurring during the menstrual period have prompted attempts to regulate or control the outflow of menstrual bleeding according to the women personal and social needs. For the purpose of controlling the outflow of menstrual blood, vaginal tampons were introduced a few decades ago. Vaginal tampons are common catamenial devices made of absorbing material and insertable into the vagina by the female user. Due to their absorbing material, tampons, once inserted into the vagina, begin to absorb upon contact the blood they meet, which outflows from the cervical canal into the vagina, and function as reservoirs aiming at delaying exit of the blood from the vaginal orifice conceivably until they become saturated with blood and, in so doing, they exert a regulatory effect on the outflow of menstrual bleeding to meet women&#39;s&#39; needs or preferences.  
           [0005]    However, regardless of their absorbency capabilities, tampons, for various reasons, are known to allow leakage of menstrual blood at rather unpredictable time or shortly after insertion, falling short of providing the regulatory effect which is the very reason for their use. No known tampon is capable of preventing leakage of blood from the vaginal orifice, regardless of shape, size, intravaginal resting site, absorbency capabilities of the material or materials of which they are made of, etc. Blood may leak from the vaginal orifice because the tampon is too early saturated with blood or because the blood flow is disproportionately heavy for the absorbency capabilities of the inserted tampon or because the tampon does not provide an adequate sealing with the vaginal walls or orifice or for all the above reasons variously combined.  
           [0006]    Despite the use of tampons, therefore, leakage of blood from the vaginal orifice is almost the rule during the days of the vaginal bleeding and its occurrence may result in a great deal of annoyance and inconvenience to the woman: leakage indeed actually defeats the main purpose for which tampons are used.  
           [0007]    Prior art deals with the problem of leakage of menstrual blood through the tampons, some inventions by providing additional blood reservoirs to the tampons, some others by increasing the tampons absorbing capabilities by the means of improved absorbing material, and others by using absorbing pads to apply in correspondence of the vaginal orifice to capture the blood escaped from the tampon. In all such cases, main object of the prior art is rather to minimize and possibly delay the outflow of blood, rather than reliably preventing the leakage of blood until it is the appropriate time for the woman, as determined by the woman rather than by her endometrium, to permit exit of the menstrual blood from the vaginal orifice.  
           [0008]    No known catamenial device has been disclosed to provide means of preventing leakage of menstrual blood by entailing the use of an intravaginal balloon.  
           [0009]    Another group of catamenial devices introduced for the purpose of avoiding leakage of menstrual blood are the menstrual cups. Indeed cup-shaped intravaginal devices for collection of menstrual blood are not new in the art of feminine hygiene. U.S. Pat. Nos. 3,845,766 by Zoller, 3,626,942 by Waldron, 2,534,900 by Chalmers and 5,295,984 by Audrey all disclose a cup shaped menstrual collector made of flexible material impervious to fluid inserted into the vaginal canal for the purpose of collecting menstrual blood and preventing leakage of blood [form] from the vaginal orifice. These devices all suffer from poor ergonomic design. They are all bulky, necessarily of large diameter, difficult to insert and remove. They all have a resilient circular rim that regardless of the material is made of is necessarily significantly larger than the diameter of the vaginal orifice they have to pass through during insertion and during removal. Regardless of the individual differences among the menstrual blood collector cups, the general design of all these devices makes their insertion into the vaginal canal an uncomfortable and difficult task. Removal of these devices is even more difficult and uncomfortable for the user than the insertion. Furthermore on their removal spillage of blood is a very frequent occurrence. Indeed none of the menstrual cups is provided with an effective simple sealable closure apparatus of the cup opening apt to prevent spillage of blood. A lot of expertise has to be learned by the user before effective insertion and removal of these devices can be achieved and no matter how expert the user can become, the use of the above mentioned menstrual cups is unavoidably associated with poor tolerance during use, discomfort on insertion and removal and in general difficult application.  
           [0010]    Zadini et al disclose in their patent application No. 08/391,342 an inflatable device for sealable closure of the vaginal canal as a standing alone device and as a device associated with an intravaginal tampon. In FIG. 5 of the above cited Zadini&#39;s patent, an inflatable cup shaped member is described associated with a tampon. While this inflatable device offers advantages with respect the priorly cited menstrual cups, being undeniably capable of being inserted into the vagina and removed from it in an easy and comfortable fashion being deflatable, still has the drawback of not being able to collect the blood escaped from tampon absorption and of allowing spillage of blood on removal as with all priorly cited menstrual cups.  
         BRIEF SUMMARY OF THE INVENTION  
         [0011]    The present invention comprises an intravaginal inflatable cup shaped member capable of providing reliable vaginal closure to outflow of organic fluids such as menstrual blood from the vaginal orifice until the woman determines to be the appropriate time for allowing exit of the menstrual blood from the vaginal orifice, and also provides reliable vaginal closure to pathological bleeding. Vaginal closure is achieved by an inflatable member, impermeable to fluids, easily self-adaptable to the variability of size and shape of the vaginal lumen and to the variability of smoothness of the vaginal walls, said inflatable member expanding to exert a gentle pressure on the vaginal mucosa, such a pressure being sufficient to prevent passage of blood between the inflatable member itself and the vaginal mucosa. The inflatable cup shaped device is inserted into the vagina and extracted from it through the vaginal orifice in a deflated status allowing an easy and discomfort free insertion and extraction. The device is provided with an automatic sealable closure of the opening of the cup to prevent spillage of blood on removal. The device may be used as a stand-alone intravaginal device, or may be used in combination with blood absorbing means such as tampons. When used in cases of pathological vaginal bleeding, the inflatable intravaginal cup-shaped member, comprising material substantially impermeable to fluids, expands to exert pressure on the vaginal mucosa to prevent passage of blood between the inflatable device and the vaginal mucosa, such prevention of passage of blood resulting in a blockage to intravaginal transit of blood.  
         OBJECT OF THE INVENTION  
         [0012]    It is an object of the present invention to propose a device that conceivably offers a solution to the problem of untimely leakage of menstrual blood. As such, i.e. if employed as a means for prevention of leakage of menstrual blood, one embodiment of the present invention could be used in combination with blood absorbing material, such as tampons.  
           [0013]    However, it may also be used alone to provide means for prevention of blood leakage, or, for that same purpose, it may be used in combination with other devices or suitable components employed in association with menstrual bleeding such as menstrual pads.  
           [0014]    It is another object of the present invention to offer a device capable of assuring prevention of blood leakage regardless of the anatomical size, shape, changing of direction and of lumen contour of the vagina, as a result of remarkable adaptability to anatomical size, shape, contour of the vagina, and adaptability to contingent changes of size, shape, lumen contour of the vagina, to maintain its outer surface in close contact with the vaginal mucosa and offer a sealing closure to blood in any condition.  
           [0015]    It is another object of this invention to propose an inflatable cup shaped device capable of reliably achieving prevention of leakage of menstrual blood while being easy to be worn, conceivably adding no discomfort to the female user, by gently applying upon the vaginal mucosa a pressure just barely sufficient to prevent passage of blood between the device and the vaginal mucosa, such a pressure being generally proportional to the pressure, notoriously negligible, exerted by menstrual blood.  
           [0016]    It is another object of this invention to propose an inflatable device capable of reliably achieving prevention of leakage of menstrual blood, while being easy to insert and likewise easy and comfortable to extract.  
           [0017]    It is [an other] another object of the present invention to provide an intravaginal device capable of preventing, when indicated, leakage or outflow, in any amount, of organic fluids in general, besides blood, from the vaginal orifice.  
           [0018]    It is an object of the present invention to provide an inflatable intravaginal device offering means of prevention of significant hemorrhage in cases for instance of pathological bleeding, by reliably preventing excessive blood loss from the vagina, by limiting the amount of blood extravasation to an amount not exceeding the maximum capacity of reservoir of a tract of the vagina proximal to the site of placement of said inflatable device, as a result of a blockage exerted by such inflatable intravaginal device on the vaginal transit of blood. A device of this kind may prevent the serious medical complications associated with massive vaginal-uterine bleeding and at times may well be a life saving device.  
           [0019]    It is another object of this invention to provide an inflatable cup shaped device capable of functioning as reservoir for the blood exiting from the cervical os. It is an object of the present invention to provide an inflatable menstrual cup capable of changing size due to its inflatability. Due to its significantly reduced size when deflated the device is easy to insert and extract from the vaginal orifice without causing any discomfort to the female user experienced by the users of the priorly cited menstrual cups.  
           [0020]    It is an object of the present invention to provide an inflatable menstrual cup capable of automatic sealable closure of its opening on extraction so as to not allow escape of blood from the collector cup at the time of extraction and disposal. 
       
    
    
     DRAWING FIGURES  
       [0021]    [0021]FIG. 1 is a side view of the device as it appears in operation, i.e. after inflation.  
         [0022]    [0022]FIG. 2 is a side view of an alternative form of the device shown after inflation.  
         [0023]    [0023]FIG. 3 is a side view of an alternative form of the device shown after inflation.  
         [0024]    [0024]FIG. 4 is a cross sectional view of the human female pelvis.  
         [0025]    [0025]FIG. 5 is a side view of an alternative form of the device shown after inflation.  
         [0026]    [0026]FIG. 6 is a side view of an alternative form of the device shown after inflation.  
         [0027]    [0027]FIG. 7 is a side view of an alternative form of the device shown after inflation.  
         [0028]    [0028]FIG. 8 is a side view of an alternative form of the device shown after inflation.  
         [0029]    [0029]FIG. 9 through  14  show a pneumatic pressure delivery device incorporated into a vaginal tampon applicator at different stages of operation.  
         [0030]    [0030]FIG. 15 shows the device of FIG. 2 shown in situ, i.e.inserted and resting inside the vaginal canal and accomplishing the function of impeding exiting of blood from the vaginal orifice.  
         [0031]    [0031]FIG. 16 is a side view of an alternative form of the device as it appears in operation, after inflation.  
         [0032]    [0032]FIG. 17 is a prospective view of a part the device of FIG. 16.  
         [0033]    [0033]FIG. 18 is a prospective view of another part the device of FIG. 16.  
         [0034]    [0034]FIG. 19 is a prospective view of another part the device of FIG. 16.  
         [0035]    [0035]FIG. 20 is a cross section view of the lower chamber of the device of FIG. 16 showing an inflating apparatus.  
         [0036]    [0036]FIG. 20A is a cross section view of the lower chamber of the device of FIG. 16 showing an alternative type of inflating apparatus similar to the inflating apparatus shown in FIG. 20.  
         [0037]    [0037]FIG. 21 is a cross section view of the lower chamber of the device of FIG. 16 showing an alternative type of inflating apparatus.  
         [0038]    [0038]FIG. 22 is side view of an alterrnative form of the device shown in operation after inflation.  
         [0039]    [0039]FIG. 23 is a side view of the device of FIG. 16 deflated, with blood collected and sealed off, ready to be extracted .  
         [0040]    [0040]FIG. 24 is a side view of an alternative form of the device associated with a tampon, shown after inflation.  
         [0041]    [0041]FIG. 25 is a side view of the device of FIG. 24 shown deflated, with blood collected and sealed off, ready to be removed.  
         [0042]    [0042]FIG. 26 is a side view of an alternative form of the device as it appears in operation after inflation. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0043]    A typical embodiment of the invention is illustrated in [fig] FIG. 1. The device generally indicated at  1  is composed of an inflatable or expandable member or means or balloon  2  and pneumatic pressure delivery system or inflating means  4 . Balloon  2  has walls  3 , unidirectional valve  6 , which can be constructed as a pivoting flap, operating [in] inlet  5  of tubular member or conduit  10  of inflating means  4 . Inflating means  4  is composed of pressure delivery source or pump  8  with air intake opening  7  provided with unidirectional pivoting flap valve  9 , and tubular member or conduit  10  connecting pump  8  to balloon  2  via valve inlet  5  through unidirectional valve  6 . Balloon  2  can be made of material substantially impermeable to fluids. Inflatable member  2  may be coated with a suitable means which by interfacing between the balloon and the vaginal walls provides reversible sealing with the vaginal walls as it will be disclosed in the description of the operations. Such interfacing means could include filtering means which selectively allows passage of air or suitable gas while preventing passage of blood or organic fluids. The inflatable member  2  can be constructed as a self-deflatable member after a predetermined time of inflation.  
         [0044]    Such a feature can be achieved with micro porous material allowing air to escape from the inflatable member after inflation at a substantially predetermined rate of a change in permeability to air of a suitable material included in said inflatable member, said change in permeability allowing air to escape from the inflatable member at a substantially predetermined time following inflation of the inflatable member.  
         [0045]    In operation balloon  2  is inserted by the operator or user in vagina in a deflated status. As shown in [fig] FIG. 4, balloon  2 , once inserted into the vaginal canal or vagina  30  beyond vaginal orifice  32 , is inflated by the operator-user by means of pumping air or other suitable gas or fluid inside balloon  2  via conduit  10  by acting on pump  8 . Balloon  2  will be expanded by the user-operator acting on pump  8  until wall  3  of balloon  2  become in contact, in an expanded status, with vaginal walls  33  of vagina  30 .  
         [0046]    Balloon  2 , when expanded, will not permit exit of any organic fluid such as blood from vagina  30  by sealing the walls  33  of vagina  30  to walls  3  of balloon  2 . Indeed expanded balloon  2  obliterates the space between balloon walls  3  of balloon  2  and, vaginal walls  33 . Balloon  2  is easily extracted from the vaginal orifice  32  by pulling on conduit  10  or alternatively by pulling on other means such as a string connected to balloon  2 . The operator or user, by pulling on conduit  8  or on the just described string, will decrease the transverse diameter of balloon  2 , facilitating its exit from vaginal orifice  31 .  
         [0047]    FIG. 2  shows another version of the device, generally indicated at  11 . In this version balloon  2  is connected to blood absorbing means or vaginal tampon  13 . The device is operated exactly as device  1 . Tampon  13  will provide absorbent action for the blood. Blood which escapes tampon  13  is impeded to exit from vaginal orifice by expanded balloon  2 .  
         [0048]    [0048]FIG. 3 shows another version of the device, generally indicated at  20 . In this version balloon  2  [is] has extension  2 ′ engaging correspondent recess  17 ′ of blood absorbing means or tampon  13 .  
         [0049]    In use, after insertion in vagina, balloon  2  is inflated as described for devices  1  and  11 . Balloon extension  2 ′ will also inflate as soon as tampon  13  will soften due to absorbency of blood providing little resistance to radial expansion of extension  2 ′ of balloon  2 . In this device, tampon  13 , being pressed against wall  33  of vagina  30  by the expanded extension  2 ′ of balloon  2 , will contribute to the sealing by obliterating any gap between tampon  13  and vaginal walls  33 .Balloon  2 , as in the two other described devices, will provide sealable closure of vaginal canal  30 .  
         [0050]    [0050]FIG. 5 shows yet an alternative form of the device, where balloon  40  is cup-shaped harboring tampon  13 . In this version blood will be forced to enter distal end  41  of tampon  13  as balloon  40  encircles tampon  13  except in correspondence of distal end  41  of tampon  13 , sealing side  42  of tampon  13 .  
         [0051]    [0051]FIG. 6 shows an embodiment where the inflatable member  43  is concentric to, and sealed to, a segment  44  of any intravaginal menstrual blood absorbing means or tampon  13 , where said segment  44  is adapted to be impermeable to fluids. In such an embodiment the inflatable member  43  expands to exert a pressure on the vaginal walls  33  of vagina  30  to seal to fluids the space between the inflatable member  43  and the vaginal walls  33 , providing, in combination with the adapted segment  44  of a tampon  13 , for a blockage to vaginal transit of menstrual blood or organic fluids.  
         [0052]    FIG. 7  shows another embodiment of the device where balloon  47  is contained in its entirety within tampon  13 . In use, once balloon  47  is inflated, it will press on corresponding overlying segment  48  of tampon  13  closing the gap between vaginal walls  33  and tampon  13  by compressing segment  48  to the extent of preventing any leakage of blood.  
         [0053]    [0053]FIG. 8 shows another embodiment, where the intravaginal inflatable member  45 , substantially impermeable to fluids, is contained in the interior of a segment  46  of a tampon  13 . The segment  46  is adapted to be substantially impermeable to fluids. The inflatable member  45  expands to exert a pressure on the vaginal walls  33  via segment  46  of tampon  13  to seal to fluids the space between segment  46  of tampon  13  and vaginal walls  33 , so as to provide, in combination with the adapted segment  46  of tampon  13 , a blockage to the vaginal transit of menstrual blood.  
         [0054]    [0054]FIG. 9 shows a pneumatic pressure delivery system or applicator-inflator  50  comprising a standard tampon applicator  51  which incorporates a syringe  52 . Operator, after inserting tampon applicator  51  into vagina  30 , press on syringe barrel  53 , which telescopically slides within applicator barrel  51  to eject tampon  13  with its connected balloon  2  into the vaginal canal  30 . FIG. 10 and  11  illustrate the insertion and delivery of tampon  13  with its connected balloon  2 . As shown in [fig] FIG. 12 the user-operator, after having fully advanced syringe barrel  53  on applicator barrel  51 , will act on syringe plunger  54 , inflating balloon  2 . As shown in [Fig] FIG. 14, upon full inflation of balloon  2 , further advancement of syringe plunger  54  will result in a disengagement of applicator-inflator  50  from tampon  13  and its connected balloon  2 . As shown in [fig] FIG. 15, tampon  13  with balloon  2 , rests firmly in vaginal canal  30 , providing sealable closure of the canal, preventing any blood leakage.  
         [0055]    [0055]FIG. 16 shows an alternative form of the cup-shaped inflatable device of FIG. 5 in use after inflation. As shown in FIG. 16, 17 , 18  and  19 , the device generally indicated at  60  is a cup-shaped or inverted dome shaped member composed of inflatable, generally concave, reservoir or inflatable body means  62  for providing a collection site of menstrual blood and inflatable donut shaped member  64  sealingly connected to reservoir  62  at rim  68  and  68 ′ of reservoir  62  as better seen in FIG. 17 and  18 . Both reservoir  62  and donut shaped member  64  are made of substantially gas and fluid impervious material. Cup shaped member  60  has, superiorly, circular opening or mouth  65  delimited by donut shaped member  64 , and has, inferiorly, pole  61  through which exits, or to which is connected, string  70 . As best seen in FIG. 17 and  19  reservoir  62  is made of two generally concave or cup shaped thin sheets parallelely arranged, respectively interior wall  74  and exterior wall  74 ′ of substantially non compliant material impervious to gas and fluids. Reservoir  62  is composed of a series of elongated chambers  63  regularly spaced and separated one from another by sealed segments  66  obtained for example by thermally fusing interior wall  74  and exterior wall  74 ′ at regular intervals. Chambers  63  are in flow communication superiorly via upper common chamber  71  with the interior of inflatable donut shaped member  64  and inferiorly they are in flow communication with lower common chamber  72 . Donut shaped member  64  is made of substantially resilient impervious compliant material such as, for instance, rubber. With device deflated at rest prior to inflation or at the time of extraction, as shown in FIG. 23, donut member  64 , retracts centripetally as a result of its resiliency, sealingly closing circular opening or mouth  65 , not allowing escape of the collected blood at time of removal as it will be described below. Inflatable cup shaped member  60  can be inflated as all the previously described devices of FIG. 1 to  15  via an external source of pneumatic means i.e.inflating means, such as for instance a syringe or a bladder, connected to the device via a tubular member or conduit, or can be inflated via internal source of pneumatic means, i.e. internally located within the device, as illustrated in FIG. 20, 20A and  21 . FIG. 20 shows a type of apparatus of [internal] pneumatic source means of [pneumatic means]of inflation housed within the inflatable member. Lower chamber  72  houses bladder  67  having wall  111  made of material substantially impermeable to fluid but not to gasses such as air or CO 2 . Bladder  67  preferably adheres to segment  77  of interior wall  74  and has internal breakable membrane or diaphragm  82  made of material less resistent to pressure than the material of wall  111 , separating upper compartment  81  from lower compartment  87 . Compartment  81  and  87  contain components chemically reacting to produce pneumatic means of inflation such as air, CO 2  or any suitable gas.For instance upper compartment  81  may contain[s] an acidic fluid solution  90 , such as a solution of citric acid or malic acid or any other suitable acidic solution and lower compartment  87  contains effervescent substrate  89  such as sodium bicarbonate or any suitable substrate mixable with the acidic solution  90  contained within upper compartment  81  of bladder  67  to generate pneumatic means of inflation or gas,such as CO 2 . As better shown in FIG. 20, string  70  is anchored via segment  70 ′ to segment  77  of interior wall  74  of reservoir  62 , slackly traverses lower chamber  72  to adhere via segment  70 ″ to internal surface of exterior wall  74 ′ of lower chamber  72  and sealingly exits through exterior wall  74 ′ in proximity of pole  61  of reservoir  62 . In use, the female user compresses bladder  67  between her finger. Since closed upper compartment  81  of bladder  67  is filled with fluids, the pressure applied upon it will result into rupture of membrane  82  which is made of less resistent material than the wall of bladder  67 . Rupture of membrane  82  allows mixing of acidic solution  90  with effervescent substrate  89 . Upon mixing of acidic solution  90  with substrate  89 , CO 2  or any other suitable gas will be generated. Being wall of bladder  67  made of material permeable to gasses, CO 2  or the generated gas will enter and diffuse within reservoir  62  and donut shaped member  64  which will inflate up to sealingly engage the wall of the vagina. The device fully inflated will appear as shown in FIG. 16. Blood flowing from the cervical os will be collected within reservoir  62  and no leakage will occur due to the fact that donut shaped member  64  and reservoir  62  sealingly engage the vaginal wall. Once the female user wants to extract cup shaped member  60  from the vagina she will pull on string  70 . The pulling of string  70  will cut through exterior wall  74 ′ creating a slit through which CO 2  or other suitable gas can escape. Due to the impermeability to fluids of wall of bladder  67 , the residual acidic solution and substrate will remain within bladder  67  and will not be spilled into the vagina. Donut shaped member  64 , due to its intrinsic resilient properties will centripetally retract closing circular opening  65  not allowing any spillage of blood upon extraction.  
         [0056]    [0056]FIG. 20A shows an alternative form of inflating apparatus for the mixing of acidic solution  90  with substrate  89 . This apparatus is in all similar to inflating apparatus of FIG. 20, except for an additional element, string  105 . String  105  is firmly attached along a diameter of membrane  82 , traverses lower chamber  72  to sealingly exit[s] through invaginated portion  107  of exterior wall  74 ′. In use, in devices supplied with string  105 , the female user ruptures membrane  82  by pulling on string  105 , which upon traction will cut through membrane  82  creating a slit which leads to mixing of acidic solution  90  with substrate  89 . Subsequent steps are identical as for the device with inflating apparatus shown in FIG.20.  
         [0057]    [0057]FIG. 21 shows yet an alternative type of apparatus of internal pneumatic source of inflation in all similar to the apparatus illustrated in FIG. 20 with the folllowing differences. Acidic solution  90  and substrate  89  are no longer present. Bladder  67  is replaced by capsule or container  67 ′ which is void of membrane  82 . Capsule  67 ′ has wall  113  and a weaker portion  112  of said wall, positioned in correspondence of puncher  86 . Wall  113  of capsule  67 ′ is made of material impermeable to gasses and contains compressed pneumatic means or gas  110 , such as CO 2  or air. Perforating puncher  86  is attached via flexible arm  87  to the wall  113  of capsule  67 ′, as clearly shown if FIG. 21.  
         [0058]    In use, the female user prior to inserting the device into the vagina will press on pole  61  of wall  74  to puncture membrane  112  of capsule  67 ′ and permit passage of gas  110  or other suitable gas from capsule  67 ′ into reservoir  62  and donut shaped member  64  which will inflate up to sealingly engage the wall of the vagina. Alternatively, as shown for the device of FIG. 5, inflatable cup shaped member  40  is inflated by an external source of pneumatic means i.e.inflating means such as for instance a syringe or a bladder via tubular member or conduit  29 . Alternatively an external source of pneumatic means applicable to all disclosed devices comprises a capsule containing compressed air or CO 2  or any suitable gas or a bladder containig components chemically reacting to produce the pneumatic means such as CO 2  or any suitable gas, said gasses delivered to the inflatable member via a conduit such as conduit  29  of FIG. 5.  
         [0059]    [0059]FIG. 24 and  25  show an alternative form of the device of FIG. 16 through  21  and FIG. 23. The device generally indicated at  100  is composed of the same cup shaped member  60  and of tampon or absorbent member  102 . Tampon  102  is connected to cup shaped member  60 . The device is used exactly as device  60  of FIG. 16. Absorbent member  102  will absorb blood while cup shaped member  60  will collect the blood escaped from absorbent member  102 . As shown in FIG. 25, at time of extraction donut shaped member  64  will circularly retract around tampon  102  not allowing escape of blood collected within reservoir  62 .  
         [0060]    [0060]FIG. 22 shows an alternative form of the device of FIG. 16 through  21  and FIG. 23. The device generally indicated at  150  is composed of a generally donut shaped inflatable member  64 ′ to which is connected reservoir or pouch or bag or body means  62 ′ for the collection of menstrual blood. In this device,reservoir or body means  62 ′ is no longer inflatable being made of a thin sheet of flexible substantially impermeable material attached ,as above disclosed, to donuut shaped member  64 . Device  150  is provided with striing  152  attached to pole  154  of reservoir  62 ′ for removal of the device. Donut shaped member  64  can house any of the inflating apparatuses described in FIG. 20, 20A and  21  with annexed strings or can be inflated by an external pneumatic source as for the device of FIG. 5. Inflation and deflation [and] of donut shaped member  64  is accomplished as for the devices of FIG. 16 to FIG. 23. An absorbent member can be harbored within the device as for the devices of FIG. 5 and FIG. 24 and  25 .  
         [0061]    FIG. 26  shows an alternative form of the device of FIG. 16 through  21  and FIG. 23. In this device generally indicated at  160 , cup shaped inflatable member or reservoir or body means  162  is composed of inflatable substantially impermeable tube  164  made either of resilient material such as rubber or polyurethane or of a not compliant material, arranged in a coils where spires  166  are sealingly connected to each other or are connected via an impermeable connecting membrane. Spires  166  of tube  164 , as arranged, form a wall delimiting cavity  168  for the collection of menstrual blood. Proximal end  165  of tube  164  can house the pneumatic source means of inflation such as the ones described in FIG. 16 through  21 . Distal end  167  of tube  164  is sealed to avoid escape of gas. Cup shaped member  162  can house absorbent member  102 . As for the previously described devices, device  162  is inflated either by the pneumatic source means of inflation housed within the inflatable coiled tube  164  or by a connected external pneumatic source. The device is inserted into the vagina and extracted as the previuosly described devices.