Morpho-Anatomic Flexible Web

Abstract

The present invention relates to a morpho-anatomic flexible web (1) intended to be introduced into a vaginal or rectal cavity (40,50) of a human or animal, being provided with means of removal (4) from said vaginal or rectal cavity (40,50), said web (1) having a proximal end which corresponds to the part of the web (1) that first contacts said cavity (40,50) and a distal end which corresponds to the part of the web (1) that last enters said cavity (40,50) and said web (1) comprising two sheets (16,17) that at least partly overlap, defining an overlapping area, wherein said first and second sheets (16,17) are fixed to one another by means of at least two stopping elements (11,12,13), defining at least one pouch (10) in the interior of the overlapping area for holding a substance (60), and wherein said web (1) further comprises at least one blocking element (20) for retaining an applicator (30) in a substantially fixed position relative to the web (1), said blocking element (20) having at least one blocking side (22) which is perpendicular to the direction of insertion of the web (1) into the vaginal or rectal cavity (40,50), preferably said blocking side (22) being situated below the mouth of the pouch (10) such that part of the web may fold over said mouth of the pouch to completely close it. The present invention also relates to the use of the web (1) for retention of bodily fluids from said cavities or for delivery of a substance such as a microbicide gel (for example anti-HIV microbicide), or a probiotic or both.

Claims

1.-81. (canceled)

82. Morpho-anatomic flexible web (1) intended to be introduced into a vaginal or rectal cavity (40,50) of a human or animal by means of an applicator, said web being provided with means of removal (4) from said vaginal or rectal cavity (40,50), said web (1) having a proximal end which corresponds to the part of the web (1) that first contacts said cavity (40,50) and a distal end which corresponds to the part of the web (1) that last enters said cavity (40,50) and said web (1) comprising two sheets (16,17) that at least partly overlap, defining an overlapping area, each of said sheets (16,17) being made of the same or different non-expandable or minimally expandable atraumatic material having a thickness of less than 2 mm, preferably less than 1 mm, wherein said first and second sheets (16,17) are fixed to one another by means of at least two stopping elements (11,12,13), defining at least one closed pouch (10) in the interior of the overlapping area for holding a substance (60), wherein at least one of the first and second sheets is permeable to said substance; said pouch (10) comprising a mouth (15) for receiving said substance (60), which is continued on each side with one of the at least two stopping elements (11,12) which extend downwards, considering the direction of insertion of the web (1) into said cavity (40,50), forming the edges and the bottom of said pouch (10), and wherein said web (1) further comprises at least one blocking element (20) for retaining the applicator (30) in a substantially fixed position relative to the web (1), said blocking element (20) having at least one blocking side (22) which is perpendicular to the direction of insertion of the web (1) into the vaginal or rectal cavity (40,50).

83. The web (1) according to claim 82 wherein the stopping elements (11,12,13) form a pouch (10) having a V shape, U-shape, a rectangular or trapezoidal shape with the mouth (15) corresponding to one of the sides of the rectangle or trapezoid respectively.

84. The web (1) according to claim 82 comprising two pouches (10a, 10b).

85. The web (1) of claim 82 wherein the atraumatic material is a woven or non-woven textile comprising synthetic fibers, semi-synthetic fibers, plant fibers, animal fibers or combinations thereof and is preferably hydrophilic.

86. The web (1) according to claim 85 wherein the atraumatic material comprises polyester, polypropylene, polyethylene, polyamide, polylacetate, polyvinyl acetate, viscose, modal, lyocell, cotton, silk, or combinations thereof.

87. The web (1) according to claim 86, wherein the atraumatic material is a nonwoven fabric with a soft carded smooth surface, comprising polyethylene and polyester.

88. The web (1) according to claim 82 wherein the atraumatic material, having dimensions suitable to be completely housed inside the vaginal cavity (40) of a woman, has an absorption and/or retention capacity of less than 6 g.

89. The web (1) according to claim 82 wherein the atraumatic material has an absorption capacity of less than 0.3 g/cm2, preferably less than 0.21 g/cm2.

90. The web (1) according to claim 82 having dimensions which are designed in such a way as to allow the web (1) to be completely housed inside the vaginal or rectal cavity (40,50) of said human or animal.

91. The web (1) of claim 82 having dimensions which are designed in such a way that, after insertion, part of the web (1) protrudes outside of the bodily cavity, for use as a pantiliner.

92. The web (1) according to claim 82 wherein the means of removal (4) are attached to the web (1) on the outer side of the first sheet (16) of the web (1), preferably on the lower outer side of said sheet (16), in one or a plurality of points situated outside the area of the pouch (10).

93. The web (1) according to claim 92 wherein the means of removal (4) are also releasably attached on the outer side of the second sheet (17) of the web (1) in one or a plurality of points situated outside the area of the pouch (10).

94. The web (1) according to claim 82 wherein the at least one blocking element (20) is in the form of a line or a double line situated one on top of the other, for example a welded line or a welded double line, obtained by fixing together said first and second sheets (16,17).

95. The web (1) according to claim 94 wherein the at least one blocking element (20) contains guiding sides (23) for guiding and/or housing an applicator (30).

96. The web (1) according to claim 95 wherein the at least one blocking element (20) has the shape of a pocket to receive said applicator (30).

97. The web (1) according to claim 94 wherein the blocking side (22) of the blocking element (20) is situated at least 5 mm below the lowest extremity (151,152) of the mouth (15) relative to the direction of insertion of the web (1) inside the cavity (40,50), more preferably 1 cm below said extremity (151,152).

98. The web (1) according to claim 82 comprising an opening (21) for inserting an applicator (30) into the blocking element (20) arranged such that an axis connecting any point of said opening (21) with any point of the blocking side (22) of the blocking element (20) will not intersect the mouth (15) of the pouch, in particular the mouth line (M).

99. Morpho-anatomic flexible web (1) intended to be introduced into a vaginal or rectal cavity (40,50) of a human or animal by means of an applicator, said web being provided with means of removal (4) from said vaginal or rectal cavity (40,50), said web (1) having a proximal end which corresponds to the part of the web (1) that first contacts said cavity (40,50) and a distal end which corresponds to the part of the web (1) that last enters said cavity (40,50) and said web (1) comprising two sheets (16,17) that at least partly overlap, defining an overlapping area, each of said sheets (16,17) being made of the same or different non-expandable or minimally expandable atraumatic material having a thickness of less than 2 mm, preferably less than 1 mm, wherein said first and second sheets (16,17) are fixed to one another by means of at least two stopping elements (11,12,13), defining at least one partially open pouch (10) in the interior of the overlapping area for holding a substance (60), said pouch (10) comprising a mouth (15) for receiving said substance (60), which is continued on each side with one of the at least two stopping elements (11,12) which extend downwards, considering the direction of insertion of the web (1) into said cavity (40,50), forming the edges of said pouch (10), such that a further opening (18) of the pouch (10) is formed, situated opposite to the mouth (15) of the pouch (10) relative to the stopping elements (11, 12, 13) or on a lateral side of the pouch (10) and wherein said web (1) further comprises at least one blocking element (20) for retaining the applicator (30) in a substantially fixed position relative to the web (1), said blocking element (20) having at least one blocking side (22) which is perpendicular to the direction of insertion of the web (1) into the vaginal or rectal cavity (40,50)

100. The web (1) according to claim 99 wherein the blocking side (22) of the blocking element (20) is represented by the folding line (L) of the web (1).

101. A system comprising a web (1) according to claim 82 and an applicator (30).

102. The system according to claim 101, wherein the applicator (30) is a dispensing device, such as a syringe.

103. Method for administering a substance (60) into the vaginal or rectal cavity (40,50) of a human or animal comprising: introducing the substance (60) into the pouch (10) of the web (1) according to claim 82; inserting said web (1) into the vaginal or rectal cavity (40,50) of the human or animal with an applicator (30); extracting the applicator (30) from the vaginal or rectal cavity (40,50), without removing also the web (1).

104. Method for administering a fluid substance (60) into the vaginal or rectal cavity (40,50) of a human or animal, comprising: introducing a fluid substance (60) into an applicator (30); inserting the applicator (30) filled with said substance (60) into the web (1) according to claim 82; inserting the web (1) into the vaginal or rectal cavity (40,50) of the human or animal with the applicator (30); releasing the substance (60) from the applicator (30); extracting the applicator (30) from the vaginal or rectal cavity, without removing also the web (1).

105. System for delivering, distributing and retaining a liquid, a gel or a cream substance into a vaginal or an anal cavity of a human or animal, comprising an applicator (30) comprising at least one orifice at one end for delivering said substance and a flexible web (1) provided with means of removal (4) from said vaginal or anal cavity, wherein a first portion (1) of the web (1) is folded over a remaining second portion (1) of the web (1) along a folding line (L), the first (1) and second (1) portions of the web (1) are maintained in a folded position by a plurality of welding regions (23), thereby: i) defining a retaining pouch (2) having lateral edges corresponding to said welding regions (23) and a top opening and a bottom opening (0) for receiving the applicator (30), wherein the top is the side of the pouch closest to the folding line and the bottom is the side of the pouch furthest away from the folding line (L), ii) also defining a zone (Z) which is delimited by the folding line (L) and by said top opening of the pouch and on the lateral sides by two further openings (O1, O2), situated at the extremities of the folding line (L), wherein the top opening is delimited by two extremities of the welding regions (23) and is configured to receive said applicator (30) and to keep said applicator (30) in a releasably fixed position when its end comprising the at least one orifice is in the zone (Z).

106. The system according to claim 105, wherein the welding zones (23) are welding lines symmetrically placed in respect to the longitudinal axis of the first portion (1) of the web (1).

107. The system according to claim 105, wherein the pouch (2) and/or zone (Z) is/are initially in a bloated state.

108. The system according to claim 105, wherein a third portion (1) of the web (1) is folded over the second portion (1) of the web (1) along a second folding line (L) opposite to the first folding line (L), such that the first portion (1) and the third portion (1) are identical in terms of area and means for maintaining the respective portions in folded position.

109. The system according to claim 105 wherein the means of removal consist of one string (4) attached to the second portion (1) of the web (1), such that: i) the attachment region of the string (4) is situated in the central zone or near either of the end regions of the second portion (1) ii) the width of the second portion (1) in the attachment region is significantly smaller than the width of the second portion (1) in either end region.

110. The system according to claim 105, wherein the first portion (1) of the web (1) overlaps the second portion (1) of the web (1) over a length of at least 4.5 cm, preferably between 6-10 cm.

111. The system according to claim 105, wherein for each welding line (23), the welding line extremity that is closer to the folding line (L) is at a distance of 8-12 mm from the folding line (L), preferably at a distance of 10 mm.

112. The system according to claim 105, wherein the distance between the welding line extremities that are the closest to the longitudinal line (L) is between 0.5-15 mm greater than the diameter of the dispensing device (D), preferably between 1-3 mm.

113. The system according to claim 105 wherein the web (1) area in the vicinity of the folding line (L) is made of a hydrophobic material while the remaining area of the web (1) is made of hydrophilic material.

114. The system according to claim 113 wherein the web (1) area made of a hydrophobic material is impregnated with an active or non-active substance.

115. Kit for delivering a substance (60) into a vaginal or a rectal cavity (40,50) of a human or animal, comprising: the web (1) according to claim 82; an applicator (30); and at least one substance (60) to be administered inside the vaginal or rectal cavity of a human or animal.

116. Kit according to claim 115 comprising a web (1) according to any of claims 1 to 19, wherein the substance (60) is housed inside the pouch (10).

117. Kit according to claim 116 wherein the substance (60) is a liquid, a cream, a gel, a tablet, capsule or suppository.

118. Kit according to claim 116 wherein said substance (60) is placed inside the pouch (10) before or after the insertion of the web (1) in the vaginal or rectal cavity (40,50).

119. Method of manufacturing the web (1) according to claim 82, comprising the steps of: a) applying the means of removal (4) on the material of the web (1); b) cutting the web (1) to the desired dimension; c) placing two sheets (16, 17) of the web (1) one above the other to form an overlapping area; d) fixing said two sheets (16, 17) together with stopping elements (11, 12, 13) for example by welding; e) optionally adding at least one blocking element (20) in the desired position.

120. Method of manufacturing the web (1) according to claim 119, comprising the steps of: a) delivering a roll of material to a conveyor; b) attaching the means of removal (4) on the web (1) such that areas of strong attachment alternate with areas of releasable attachment; c) cutting the roll of material together with the means of removal (4) at regular intervals to obtain rectangular shaped fabrics each having one area of strong attachment and one area of releasable attachment; d) folding each rectangular fabric of the preceding step by lifting it along a folding line that represents its middle width, thus obtaining two overlapping sheets (16, 17) of the web (1); e) welding together said two sheets of the web (1) along desired lines or areas defining a closed pouch (10) and next to it a blocking element (20).

121. Method of manufacturing the web (1) according to claim 120, comprising a further step before step d) to partially cut the roll of material along the line that represents the middle width of said rectangular fabric.

Description

[0107] FIGS. 1a, 1b, and 1c represent front views of different embodiments of the web according to the invention having a closed pouch;

[0108] FIGS. 2a, 2b, and 2c represent front views of different embodiments of the web according to the invention having a partially open pouch;

[0109] FIG. 3 represents a front view of an embodiment of the web according to the invention having two pouches;

[0110] FIG. 4 represents a front view of an applicator according to some embodiments of the invention;

[0111] FIGS. 5a, 5b, 5c, and 5d represent sectional views of different embodiments of a web according to the invention together with an applicator;

[0112] FIGS. 6a, 6b, 6c, and 6d represent sectional views of one of the embodiments according to the invention, with the web taking different shapes before and after insertion in a vaginal cavity;

[0113] FIG. 7 represents a sectional view of a rectal cavity with a web according to one of the embodiments of the invention;

[0114] FIG. 8 represents a front view of another embodiment of the web according to the invention having guiding sides for the applicator and removal means;

[0115] FIG. 9 represents a front view of another embodiment of the web according to the invention having guiding sides for the applicator and removal means, together with an applicator;

[0116] FIG. 10 represents a front view of another embodiment of the web according to the invention, having guiding sides for the applicator and removal means applied on the web;

[0117] FIGS. 11, 12, and 13 represent the fluid substance flow directions when using the web according to another embodiment of the invention.

[0118] FIGS. 1 and 2 depict several embodiments of a web 1 according to the invention to be introduced into the vaginal or rectal cavity of a human or animal, comprising a first sheet 16 and second sheet 17, each having a substantially rectangular shape. In a preferred embodiment, the web 1 has a length of less than 100 mm, preferably less than 100 mm, and a width of less than 60 mm, the first and second sheets 16,17 being substantially equal and fully overlapped, the proximal end 5 of the web 1 being situated on a first short side of the rectangle and the distal end 6 of the web being situated on the second short side of the rectangle.

[0119] In the overlapping area of the web 1 which is created by overlapping the first and second sheets 16, 17, a pouch 10 is defined, having a mouth 15 which is open, to allow a substance to be introduced into said pouch, said mouth 15 being oriented upwards, considering the direction of insertion R of the web into said cavity. In a preferred embodiment according to FIG. 1, said mouth 15 is situated at the upper edge of the web, such that it remains in contact with the exterior and can therefore receive into the pouch 10 bodily fluids from said cavity.

[0120] In an alternative embodiment according to FIG. 2, the mouth 15 of the pouch 10 is housed inside the overlapping area of the web 1 and the upper edge of the web 1 is closed. For example, the first and second sheets 16,17 of atraumatic material are integrally formed and folded one over the other upon a folding line, which defines the upper edge of the web 1.

[0121] The mouth 15 is continued on each side with a stopping element 11,12 which extend downwards, considering the direction of insertion R of the web 1 into said cavity. In a preferred embodiment (FIG. 1a, 1b, 1c) such stopping elements 11, 12 are parallel to each other and are connected by means of a third stopping element 13, such that the pouch 10 is completely closed, meaning that the only opening of the pouch 10 is the mouth 15. The pouch 10 can have the same length as the web (FIG. 1a) or lower (FIG. 1b, 1c).

[0122] According to an alternative embodiment (FIG. 2a, 2b, 2c) the pouch 10 is partially open, this meaning that at least a further opening 18 is provided in said pouch 10.

[0123] The stopping elements 11,12 keep together the first and second sheets 16,17 of the web 1, defining the edges of the pouch 10.

[0124] The intersection between the mouth 15 and the stopping elements 11, 12 define the extremities of the mouth 151 and 152 respectively, that form together an imaginary mouth line M.

[0125] In yet another preferred embodiment (FIG. 3), the web 1 comprises two pouches 10a and 10b, for holding advantageously two different substances.

[0126] As can be seen from FIGS. 1, 2 and 5, the web 1 according to the invention further comprises a blocking element 20 for retaining an applicator 30 (FIG. 5) in a substantially fixed position relative to the web 1. The blocking element 20 has at least one side 22 which is perpendicular to the direction R of insertion of the web 1 into said cavity.

[0127] According to a preferred embodiment, said blocking element 20 is situated laterally from the pouch 10 (FIG. 1, 5a, 5c). Preferably, the side 22 is in the form of one straight line that fixes the first and second sheets 16,17 together, for example by welding, more preferably in the form of two such straight lines, one on top of the other, considering the direction of insertion R, to improve the strength of the blocking element 20. More preferably, the side 22 of the blocking element 20 is situated at least 5 mm below the lowest extremity 151, 152 of the mouth line M, considering the direction of insertion R. In an alternative embodiment, a pre-cut is made between the mouth 15 and the side 22 of the blocking element 20, having a length corresponding to the distance from the upper edge of the web 1 to said side 22.

[0128] In yet a more preferred embodiment, the blocking element 20 has sides 23 for guiding and housing an applicator 30 (FIG. 5a, 5c). Preferably, the blocking element 20 and the pouch 10 have one edge in common which serves both as a stopping element 12 of the pouch 10 and at least partly as a side 23 of the blocking element 20 for guiding and housing an applicator 30 (FIG. 1, 5a, 5c).

[0129] Alternatively, as can be seen from FIG. 2 and FIG. 5b, the first and second sheets 16,17 of the web 1 are integrally formed and folded one over the other upon a folding line L, which defines the upper edge of the web 1 and which preferably corresponds to the side 22 of the blocking element 20. Further sides 23 may be provided on the web 1 to guide the applicator 30 towards the side 22.

[0130] An applicator 30 according to a preferred embodiment is depicted in FIG. 4 and has the shape of a rod, having two ends 31, 32 with rounded protuberance, such as spherical or ovoid protuberances. Said ends 31, 32 may have the same or different shape and dimension. More preferably, there are provided on said rod a plurality of protrusions 33, advantageously smaller than said protuberances at the ends 31, 32. FIGS. 5 and 6 represent different ways of using a system according to the invention comprising a web 1 and an applicator 30. When an applicator 30 is inserted into the blocking element 20 via an opening 21, it advances, preferably guided by the guiding elements 23, until the applicator 30 contacts the side 22 of the blocking element 20. The applicator 30 is blocked by the side 22 from moving forward, considering the direction of insertion R, such that said applicator is retained in a substantially fixed position relative to the web 1.

[0131] When the applicator contacts the side 22 of the blocking element, the system is ready to be inserted into the desired cavity, for example the vaginal cavity 40 (FIG. 6c, 6d) or rectal cavity 50 (FIG. 7).

[0132] According to a preferred embodiment as can be seen in FIG. 6, a system is provided comprising a web 1 according to the invention and an applicator 30. The web 1 comprises a pouch 10 with a mouth 15 situated on the upper edge of the web 1 such that it has direct contact with the exterior of the web 1 and a blocking element 20 arranged laterally and in contact with one edge 12 of said pouch, with the side 22 situated below the mouth line L, preferably more than 5 mm below said mouth line L. A substance 60 is introduced into the pouch 10 of the web 1 before insertion of the web 1 into the desired cavity. The applicator 30 is introduced through the opening 21 and advances, guided by the guiding sides 23, toward the side 22 of the blocking element 20. When the applicator 30 contacts the side 22 of the blocking element 20, it cannot move forward, and remains substantially fixed relative to the web 1. When the system is to be inserted into the cavity, for example the vaginal cavity 40 (FIG. 6c), the web 1 first contacts the cavity 40 at the proximal end 5, corresponding in this case to the part of the upper edge of the web 1 that is above the side 22 of the blocking element 20. Due to the flexibility of the web 1 at the proximal end 5, part of the web 1 comprising its upper edge will fold over the rest of the web 1, at a site corresponding to the side 22 of the blocking element 20, thus covering also the mouth 15 of the pouch 10 (FIG. 6b). According to this embodiment, the pouch 15 becomes completely closed when it enters the vaginal cavity 40 and remains completely closed inside said cavity also after removal of the applicator 30 (FIG. 6c, 6d). In such a situation, the substance 60 will not leak even if the user, for example a woman, stands up, lays down or changes her position by 360. In such a situation, the substance 60 will be released through the at least one of the first and second sheets 16, 17 forming the walls of the pouch 10, thus reaching the desired administration spots.

[0133] The web 1 is further provided with removal means 4 (FIGS. 1, 2, 3, 5 and 6) which are attached to the web 1 in a conventional manner, preferably on an outer side of the web 1, more preferably attached such that the web is not creased, for example by welding the removal means 4 on the web 1 over a welding area 3. The removal means 4 may be attached in any part of the web, for example in the lower outer side of the web 1 (see FIG. 1a, 1b, 2a, 2b) or in the upper outer side of the web (FIG. 1c). At the same time, the removal means may be attached in an area corresponding to the pouch 10 (FIG. 1a, 2b) or alternatively in an area which does not overlap with the pouch 10, either below said pouch (FIG. 1b, 2a), above said pouch (FIG. 2c) or laterally at the same level with said pouch 10 (FIG. 1c). Alternatively, the web 1 comprises two pouches 10a and 10b and the removal means 4 are situated between the pouches 9 (FIG. 3).

[0134] The pouch 10 can have the same length as the web (FIG. 1a) or lower (FIG. 1b, 1c).

[0135] By means of a system according to the invention, comprising a web 1 and an applicator 30, either a substantially fluid or a substantially solid substance 60 is delivered into the vagina 40 or rectal ampulla 50 by placing said substance 60 inside the pouch 10 of the web 1 according to the invention. Preferably, a substantially solid substance 60 such as a capsule or a suppository will be placed inside said pouch 10 before the insertion of the web 1 into the bodily cavity 40, 50; a substantially fluid substance such as a liquid, gel or cream may be placed inside the pouch 10 either before the insertion of the web 1, and then the web 1 together with the substance 60 may be inserted into the bodily cavity 40, 50 by means of the applicator 30, or during/after the insertion of the web 1, by using a applicator 30 such as a syringe (not shown) as described above. For example, a plastic syringe filled with the substance 60 can be used as the applicator 30, by inserting the syringe in the blocking element 20. According to this embodiment, the blocking element 20 has the side 22 substantially above the mouth 15 of the pouch 10, considering the direction of insertion R, such that when the applicator 30 is inside said cavity, by releasing the substance 60 from said applicator 30, said substance will flow and will be collected inside the pouch 10 via the mouth 15.

[0136] According to a preferred embodiment, the width of the mouth 15 of the pouch 10 is 2-6 mm higher than the diameter of the applicator 30. Preferably, the mouth 15 of the pouch 10 is placed below and sufficiently close to the blocking element 20 (for instance less than 3 cm below, preferably less than 2 cm), so that when introduced into vaginal or rectal cavity, the fluid substance 60 being delivered under a relatively high pressure, the flush of substance will be guided laterally by the side 22 and preferably by the sides 23 of the blocking element 20, thus avoiding the penetration in undesired places, for example into the uterus. The applicator 30 will then be retracted from the web 1, and the remaining substance 60 will be then housed into said pouch 10, which will allow for its release into the bodily cavity 40, 50 and will slow its flowing out of the bodily cavity. Because of the web's fluid retaining capability and its anatomical flexible shape, the fluid substance 60 may be delivered also when the person is in a standing position, as after delivery and distribution, the fluid substance will not immediately leak out of the bodily cavity 40, 50.

[0137] According to another embodiment of FIG. 8-13, the morpho-anatomic web 1 has preferably a substantially rectangular shape, being folded along one folding lines L, at one end. Said web 1 is maintained in folded position by a plurality of welding regions 23 which correspond to the guiding sides of the blocking element 20, while the folding line L corresponds to the blocking side 22 of the blocking element 20. The welding regions may be welding lines, welding points or welding ellipses.

[0138] A first portion 1 of the web 1 is folded over a remaining second portion 1 of the web 1 along a folding line L, the first 1 and second 1 portions of the web 1 are maintained in a folded position by a plurality of welding regions 23, thereby defining a retaining pouch 2 having an opening O in the region opposite to the folding line L, and also defining together with the folding line L a zone Z with two further openings O1, O2 at the extremities of the folding line L, the extremities of the welding regions 23 in the proximity of the folding line L are disposed such that the pouch 2 and zone Z can receive a applicator 30 or applicator 30 (FIG. 9) for the delivery of a substance which may be any of a liquid, gel or cream, into the zone Z. The web 1 is also provided with means of removal 4. The extremities of the welding regions 23 in the proximity of the folding line L are disposed such that at least a fraction of the liquid, gel or cream delivered into the zone Z by the applicator 30 is guided through the two further openings O1, O2.

[0139] This arrangement allows the delivery of the desired substance in more than one spot inside the vaginal or anal cavity. As can be seen from FIG. 12, when released from the dispensing device, the substance to be delivered will be guided through the openings O1 and O2 and also through the pouch 2, once the applicator 30 is removed. Because of the pressure, the two regions of the web are pressed together, keeping the substance inside the pouch 2 and limiting the leakage. Moreover, the web's material may become impregnated with said substance allowing the delivery of the substance through the web 1, when in contact with the cavity walls.

[0140] Preferably, the welding zones 23 are symmetrically placed in respect to the longitudinal axis of the first portion 1 of the web 1.

[0141] The web 1 further comprises means of removal 4 which may consist of one string attached to the second portion 1 of the web 1, such that the attachment region of the string 4 is situated in the central zone or near either of the end regions of the second portion 1, the width of the second portion 1 in the attachment region is significantly smaller than the width of the second portion 1 in either end region.

[0142] According to a preferred embodiment, as can be seen from FIGS. 8-10, the welding lines 23 are inclined. Preferably, the first portion 1 of the web 1 overlaps the second portion 1 of the web 1 over a length of at least 4.5 cm, preferably between 6-10 cm. These dimensions ensure a very good retention of the substance inside the pouch 2 and also an effective area of the web is impregnated with the fluid substance that is further delivered to an effective area of the bodily cavity walls. It is also preferred that for each welding line 23, the welding line extremity that is closer to the folding line L is at a distance of 8-12 mm from the folding line L, preferably at a distance of 10 mm. These dimensions ensure an adequate flow of the fluid substance through the openings O1 and O2.

[0143] Preferably, the web 1 is folded along a folding line L situated such that the two resulting web portions 1, 1 are substantially equal. When the two portions 1 and 1 are substantially equal, the distribution of the fluid substance to the bodily cavity walls is more effective due to the increased area of the web 1.

[0144] In another preferred embodiment, at least one notch (not shown), preferably two notches are provided, said notches being situated in the central zone of the folding line L and having a length of preferably 1-5 mm. The notches allow a limited quantity of the fluid substance to exit the zone Z in a direction perpendicular to the folding line L.

[0145] FIGS. 12 and 13 show the flow directions of the fluid substance delivered by the applicator 30, when using the web 1 according to FIGS. 8-10. The fluid substance under pressure will be guided towards the web, thus avoiding the fluid substance to directly contact or enter the uterus.

[0146] The applicator 30 movement and fluid substance flow directions when using the web 1 according to an embodiment of the invention is shown in FIGS. 11-13. The applicator 30 is pushed into the pouch 2 towards the folding line L and towards the zone Z (FIG. 11). The applicator 30 reaches the zone Z and delivers the fluid substance under pressure. Due to the pressure and to the welding lines emplacement, part of the fluid substance is guided through the openings O1 and O2, in the directions indicated by the arrows (FIG. 12). After delivery of all the quantity of fluid substance the applicator 30 is retracted. The amount of fluid substance that was not guided through the openings O1 and O2 remains in the pouch 2 and in time will impregnate the whole area of the web 1 and from there it will be transferred to the bodily cavity walls.

[0147] As can be seen from FIGS. 11-13, upon receiving the fluid substance, the web 1 changes its shape, from a substantial flat one to a bloated shape, having a T shape section. Said bloated shape is advantageous in the sense of increasing the contact area between the web 1 and the bodily cavity walls. More precisely, the web in bloated state will mold on the bodily cavity walls.

[0148] The permeability of the web according to the invention to different substances was tested. The web 1 according to the invention was made from a nonwoven fabric with a soft carded smooth surface, comprising polyethylene and polyester. Tests were performed in order to assess the permeability of this material to substances in both solid and liquid form, using dipropylphthalate as solid substance and dicyclohexylphthalate as liquid substance. The rate of dissolving of these substances in colza oil was calculated when the substances were placed directly in the colza oil and compared to the rates of dissolving when the substances were placed first in the web according to the invention and then the web with the substance was put in colza oil. Also, a blank (web without substance) was tested to verify that the web 1 itself did not contain any of the substances. The recovery rates of the two substances in the colza oil after 2 h, 4 h, and 8 h are depicted in the following table, showing that the material is highly permeable to these substances, (for the solid substance the dissolving rate was even greater when the substance is placed in the web than if it is put directly in the oil) and therefore it can be used for the delivery of substances placed inside a pouch made of such a material to the outside of such a pouch, for example into a bodily cavity.

TABLE-US-00001 Content of Content of dipropyl- dipropyl- phthalate phthalate recalculated theoretical Recovery (g/mL) (g/mL) rate (%) RN16-23531 21.5 18.09 118.8 sample after 2 h RN16-23531 20.0 110.5 sample after 4 h RN16-23531 21.0 115.9 sample after 8 h Content of Content of dicyclohexyl- dicyclohexyl- phthalate phthalate recalculated theoretical Recovery (g/mL) (g/mL) rate (%) RN16-23531 16.7 17.23 92.0 sample after 2 h RN16-23531 16.3 89.9 sample after 4 h RN16-23531 15.1 83.7 sample after 8 h