WO2004087026A1 - Method for obtaining a disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporal cavity - Google Patents

Method for obtaining a disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporal cavity Download PDF

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Publication number
WO2004087026A1
WO2004087026A1 PCT/IB2004/001174 IB2004001174W WO2004087026A1 WO 2004087026 A1 WO2004087026 A1 WO 2004087026A1 IB 2004001174 W IB2004001174 W IB 2004001174W WO 2004087026 A1 WO2004087026 A1 WO 2004087026A1
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WO
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Patent type
Prior art keywords
capsule
device
substrate
envelope
inside
Prior art date
Application number
PCT/IB2004/001174
Other languages
French (fr)
Inventor
Bernard Chaffringeon
Original Assignee
Bernard Chaffringeon
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Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/2051Tampons, e.g. catamenial tampons; Accessories therefor characterised by the material or the structure of the inner absorbing core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/2082Apparatus or processes of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/20Tampons, e.g. catamenial tampons; Accessories therefor
    • A61F13/26Means for inserting tampons, i.e. applicators
    • A61F13/28Means for inserting tampons, i.e. applicators with lubricating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84Accessories, not otherwise provided for, for absorbent pads
    • A61F13/8405Additives, e.g. for odour, disinfectant or pH control

Abstract

Method for obtaining a disposable device for transferring an active liquid into an intracorporeal cavity, said device being elongate along a reference axis, according to which method: (A) an expandable tampon is provided, (B) a substrate is provided which is relatively solid at ambient temperature, and which becomes relatively liquid inside said intracorporeal cavity, (C) the substrate is worked, for example by molding, to obtain a soft intermediate structure, comprising a sleeve, (D) at least one capsule constituting a source of liquid phase is provided, (E) the capsule is joined to the expandable tampon, (F) the sleeve of the soft intermediate structure is turned back on itself, along the outside, round the expandable tampon, so as to obtain an envelope for temporary protection.

Description

The present invention concerns the transfer and/or circulation of an active liquid into and/or inside an intracorporeal cavity of the human body or of an animal, especially in contact with the mucosa or membrane of said cavity.

Background of the invention

"Intracorporeal cavity" signifies any cavity of the body, particularly an elongate one, which can be accessed from the outside for different purposes, in particular for clinical, therapeutic, prophylactic or diagnostic purposes, but also for cosmetic or personal hygiene purposes .

"Active liquid" signifies any liquid or fluid for topical treatment or transport, and/or for systemic treatment or delivery, comprising in general a liquid or fluid phase in which an active agent is dispersed or distributed, for example in solution or suspension.

This active agent can be at least one material, compound or substance chosen from the group which comprises wetting or moisturizing agents, solubilizing or liquefying agents, in particular of a bodily liquid or fluid present in the intracorporeal cavity, therapeutic agents acting against infectious or noninfectious diseases, prophylactic agents, diagnostic agents, immunotherapeutic agents, cosmetic and personal hygiene agents, antiseptic agents, bactericidal agents, fungicidal agents, spermicidal agents (in the case of the vaginal cavity of women, for example) , agents for local treatment, agents for systemic or topical treatment, trophic agents and lubricating agents.

The liquid or fluid phase (depending on its viscosity) of said active liquid can, if appropriate, comprise, in whole or in part, any natural liquid or fluid (such as a bodily fluid) originally present, or produced or secreted naturally, in said intracorporeal cavity.

In a general manner, as described with reference to Fig. 4 of document WO-A- 00/45887, the present invention generally concerns a disposable device for the aforementioned purposes, elongate along a reference axis and having an intrinsic axial stability sufficient to allow it to be introduced into the intracorporeal cavity by being pushed in axially. This device comprises :

a) an expandable tampon made of at least one absorbent material, with a proximal part and a distal part, arranged to collect and absorb the active liquid present in the intracorporeal cavity, and to expand and bear in a relatively leaktight manner against the mucous membrane of the intracorporeal cavity,

(b) a source of liquid phase comprising at least one capsule of which at least the proximal part is at least partially, if not totally, surrounded by the aforementioned expandable tampon,

(c) an envelope for temporary protection covering the distal part of the capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the tampon; said envelope being made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside this cavity, so that this substrate liquefies inside said intracorporeal cavity.

According to this same document, the capsule has a wall made of or constituted entirely of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside this same cavity, so that said substrate liquefies and said wall bursts or tears inside this cavity; and the capsule can enclose a liquid charge, in a leaktight manner with respect to the outside, with an active agent distributed in the substrate or in the liquid charge.

"Substrate" signifies any material, substance, compound or composition existing naturally or at the outset in solid form, at ambient temperature and/or outside the intracorporeal cavity, and capable of transforming, at least in part, to liquid or fluid form, by any phenomenon, such as melting and/or dissolving, under the effect of one or more of the conditions existing in said intracorporeal cavity, such as the temperature of the human or animal body, the presence of a bodily fluid or liquid, a particular pH, etc. Possible examples of such substrates are sucrose, gelatin, and alginates .

Consequently, in accordance with the invention described below, the liquid or fluid phase of the active liquid concerned can comprise, in addition to any natural fluid or liquid originally and possibly present in the intracorporeal cavity, at least part of the liquid charge contained in the capsule of the device defined above, and, possibly, at least part of the substrate in liquid or liquefied form constituting part of the device defined above, for example the wall of the capsule.

Preferably, with regard to the active agent defined above, when it is hydrophilic, the liquid phase is hydrophilic, and when it is hydrophobic or lipophilic, the liquid phase is itself hydrophobic or lipophilic. Finally, the active liquid can be a solution, a suspension, an emulsion, a colloid, or any other fluid.

Summary of the invention

Generally, the present invention relates to a method for obtaining a device such as has been generally defined above, allowing said device to be manufactured in a simple manner and industrially.

According to the invention, the method comprises the following steps:

(A) the expandable tampon is provided which is made of at least one material absorbing the active liquid, with, as has been indicated above, a proximal part and a distal part,

(B) the substrate defined above is provided,

(C) the substrate is worked, for example by molding, to obtain a soft intermediate structure, elongate along the axis of the device to be obtained, and comprising a sleeve of which one end is closed, and of which the opposite end is open,

(D) the capsule defined above is also provided, which thus constitutes a source of liquid phase,

(E) the capsule is joined to the expandable tampon, for example by interlocking or recessing, so that at least the proximal part of this capsule is at least partially surrounded by the expandable tampon,

(F) the sleeve of the soft intermediate structure is turned back on itself, along the outside, round the expandable tampon, so as to obtain the envelope for temporary protection of the device, consequently covering the distal part of the capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of said expandable tampon.

Steps (C) and (D) defined above are preferably merged, and the soft intermediate structure obtained comprises two parts in continuity of material (in this case of substrate) via an axial bridge, namely, at the proximal end, the capsule with a closed wall made of said substrate, and, at the distal end, the sleeve, of which one end is closed by the aforementioned axial bridge.

In accordance with the present invention, the term "capsule" generically defines any solid or hollow element capable of generating a liquid phase once placed in the intracorporeal cavity, and whose solid or hollow wall, or material constituting it, is able to tear or burst under the conditions existing within the intracorporeal cavity.

Brief description of the drawings

The present invention is now described with reference to the attached drawing in which:

Fig. 1 represents an axial cross section through a disposable device which can be manufactured or obtained with the method according to the present invention,

Fig. 2 represents, in diagrammatic form, such a device placed in an intracorporeal cavity, in this case the vaginal cavity of a woman,

Figs 3 and 4 represent in axial cross section, and turned through 90° relative to one another, a soft initial structure made of said substrate and corresponding to a step in the production of the device represented in Fig. 1,

Fig. 5 represents a soft intermediate structure obtained with said substrate and corresponding to a subsequent step in the production of the device represented in Fig. 1,

Figs 6 to 8 represent, respectively, three phases of a step in the production of the device represented in Fig. 1, allowing the soft intermediate structure represented in Fig. 5 to be fitted on the expandable tampon of the device according to Fig. 1,

Fig. 9 represents an alternative embodiment of a soft intermediate structure according to the invention; Fig. 10 represents, again in axial cross section, a device obtained with the soft intermediate structure represented in Fig. 9,

Fig. 11 represents another variant of a soft intermediate structure according to the invention; Fig. 12 represents, again in axial cross section, the device obtained with the soft intermediate structure represented in Fig. 11,

Fig. 13 represents, again in diagrammatic form, another device obtained by combining the variants on the one hand according to Figures 9 and 10 and on the other hand according to Figures 11 and 12,

Fig. 14 represents, in diagrammatic form and in axial cross section, another device such as can be obtained with the method according to the present invention,

Fig. 15 represents another variant of the device represented in Fig. 14, Fig. 16 represents in axial cross section an original soft structure with which it is possible, by cutting, to obtain a soft intermediate structure, which in turn allows the device according to Fig. 14 or 15 to be obtained.

Description of preferred embodiments

According to Fig. 1, a disposable device 1, such as is obtained by the method described below, generally permits the transfer and/or circulation of a liquid into and/or inside an intracorporeal cavity 2, for example the vaginal cavity (see Fig. 2) .

This device, elongate along a reference axis 15, has an intrinsic axial or longitudinal stability which is sufficient to allow it to be introduced into the aforementioned cavity simply by being pushed in axially .

The device according to Fig. 1 comprises

a source 21 of liquid phase comprising a distal capsule 3 with a relatively thick wall 4, the latter being obtained with and constituted by the substrate defined above ,

a proximal expandable tampon 6 joined in any appropriate manner to the capsule 3 and arranged or predetermined to collect and absorb the active liquid delivered or existing in the intracorporeal cavity, and consequently to expand and bear in a leaktight manner against the mucous membrane 20 or wall of the intracorporeal cavity 2,

an envelope 7 for temporary protection covering the capsule 3 and the tampon 6, in the position in which they are joined to each other, and at least partially enveloping the distal end of the capsule 3,

a withdrawal string 9 used for extracting the device 1, this string being inserted in a free loop form in the tampon 6.

The tampon 6 and the capsule 3 complement one another in dimensions and/or other characteristics, so as to be able to be joined together by simply being pushed axially toward one another, or vice versa.

Since the wall 4 of the capsule 3 is made of the aforementioned substrate, for example an alginate, in the intracorporeal cavity, the wall 4 bursts or tears, leaving a passage for the liquid charge 5 originally contained inside this wall in a leaktight manner with respect to the outside of the capsule 3. Consequently, before use of the device 1, the capsule 3 encloses the liquid charge 5 in a leaktight manner with respect to the outside.

The wall 4 forms and delimits a hollow head 3a of relatively wide external median cross section, and a tail 3b, hollow and of uniform and relatively narrow external cross section. Correspondingly, the tampon 6 comprises an axial hole or recess βa for receiving the tail 3b of the capsule 3; and, as is shown in Figure 1, the head 3a forms a convex proximal part 3c and, correspondingly, the axial hole 6a of the tampon 3 opens out on a widened distal part 6b of concave shape, for receiving the head 3a, and more precisely its convex part 3c.

In accordance with the invention, the envelope 7 for temporary protection is made of a substrate such as has been defined above and identical to the substrate of the wall 4 of the capsule 3. Consequently, this envelope 7 is able to tear, and thus open or disappear, by melting and/or dissolving, once the device 1 is placed in the intracorporeal cavity 2. The envelope 7 extends longitudinally or axially as far as an intermediate level distinct from but situated before the proximal level or end of the tampon 6, so as to determine, in the tampon 6, a proximal plug 8 not covered by the envelope 7, and consequently able to radially expand independently of the rest of the same tampon.

By nature or construction, the tampon 6 is designed so as to expand radially, and possibly longitudinally. In the radial dimension, in view of the axial hole 6a, the tampon 6 is also designed to expand inward and/or outward. The tampon 6 is made of one or more materials or parts which are respectively different, at least one of said materials ,or at least one of said parts having a capacity for absorption or absorbent properties. Such an absorbent material is, for example, an open-pore foam of resin or plastic, for example polyurethane, or a fibrous material of the cellulose type, such as a viscose or cellulose sponge. This tampon 6 can be obtained by molding, shaping or extrusion of fibers or filaments, for example natural fibers. The expandable tampon 6 is preferably compressed, that is to say radially and/or axially, inside the envelope 7 for temporary protection.

The expansion, in the intracorporeal cavity, of all or part of the tampon 6 can be controlled by pre- absorbing, according to any desired profile or depth, a suitable liquid, distinct from the liquid phase, for example an oil in the case of a liquid/hydrophilic phase.

The tampon 6 comprises a proximal part 6c and a distal part 6d, which may or may not extend as far as the convex distal part of the head 3a of the capsule 3. The tampon 6 surrounds at least the proximal part comprising the axial tail 3b of the capsule 3, leaving a distal part or end of the same capsule directly in contact with the envelope 7. As is shown in Fig. 1, the tampon 6 has a proximal half and a distal half, and the envelope 7 covers said distal half and some but not all of the proximal half of said tampon, so as to define, as described above, the proximal plug 8.

The withdrawal string 9 is attached to the proximal part or end of the device 1, and more particularly of the capsule 3 and/or of the tampon 6. As is shown in Fig. 1, the withdrawal string 9 is attached to the proximal part la of the device, that is to say of the tampon 6 and/or of the capsule 3. The withdrawal string is a loop, with or without knot, disposed freely through the capsule 3 and/or the tampon 6. As is shown in Fig. 1, the proximal part 6c of the tampon 6 has a transverse hole 24 adapted for the free passage of at least one strand 9a or 9b of the withdrawal string 9.

To produce a device 1 such as has been described above with reference to Fig. 1, and according to the invention:

(A) the expandable tampon 6, obtained as described above, with a proximal part 6c and a distal part 6d, is provided;

(B) the substrate as defined above is provided, which is moreover biocompatible in the sense that its subsequent contact with the mucous membrane 20 of the intracorporeal cavity 2 does not induce any appreciable toxicity and/or inflammation;

(C) the aforementioned substrate is worked, for example by molding, as represented in Fig. 5, to obtain a soft intermediate structure 50, elongate along the axis 15 of the device and comprising a sleeve 51, of which one end 51a is closed, and of which the opposite end 51b is open;

(D) as is shown in Fig. 5, at least one capsule 3 is provided which constitutes the source 21 of liquid phase;

(E) as is shown in Fig. 6, the capsule 3 is joined to the expandable tampon 6, so that at least the proximal part 3b of the capsule 3 is at least partially surrounded by the expandable tampon 6;

(F) then, as is shown in Figures 7 and 8, the sleeve 51 of the soft intermediate structure 50 is turned back on itself, along the outside, round the expandable tampon 6, so as to obtain (see Fig. 8) the envelope 7 for temporary protection covering the distal part 3a of the capsule 3 and extending longitudinally, or parallel to the axis 15 of the device, at least as far as an intermediate level of the expandable tampon 6.

According to one embodiment of the method, represented diagrammatically in Figures 3 to 8, steps (C) and (D) are merged, and the soft intermediate structure 50 obtained in fact comprises two parts in continuity of material (in this case of substrate) via an axial bridge 52, namely, at the proximal end, the capsule 3 with a closed wall 4 made of substrate, and, at the distal end, the sleeve 5 of which one end 51a is closed by the axial bridge 52 (see Fig. 5) .

To obtain the soft intermediate structure 50 represented in Fig. 5, with reference to Figures 3 and

4 : the substrate is worked, for example by molding, to form a soft initial structure 49, elongate along the axis 15 of the device, and comprising two parts in continuity of material via the axial bridge 52, namely, at the proximal end, the capsule 3, which may or may not be filled at this stage of the method with the liquid charge 5, and, at the distal end, an ampule 53 which remains empty or hollow and has a wall 54 closed by a solid end part 53a made of or obtained from said substrate;

the end part 53a of the ampule 53 remote from the axial bridge 52 is separated, for example by cutting, so as to obtain the sleeve 51, and, consequently, the soft intermediate structure 50 represented in Fig. 5;

the end part 53a of the ampule 53 comprises or forms a grip member 55, for example for suspension of the soft initial structure 49.

If appropriate, in a subsequent step (G) , the proximal border 7a of the envelope 7 is crimped onto the expandable tampon 6, for example by heat or by adhesive bonding .

Finally, the disposable device 1 represented in Fig. 8 and obtained by the method described above is characterized by the fact that the substrate of the wall 4 of the capsule 3 and the substrate of the envelope 7 are identical and form a continuity of material, via the axial and distal bridge 52, which connects the capsule and the envelope, while remaining outside said capsule but inside said envelope.

According to the embodiment represented in Figures 9 and 10, in step (C) , described above, at least one other capsule 56 is obtained inside the sleeve 51 of the soft intermediate structure 50, and beside the axial bridge 52, which other capsule 56 may or may not be filled at this stage of the method with another liquid charge, and of which the wall 57 is thus constituted by the substrate defined above. Consequently, the sleeve 51 directly forms a part of the wall of this other capsule 56. As is shown in Fig. 10 in particular, the shape of the other capsule 56 complements that of the capsule 3, so that, in step (F) defined above, the capsule 3, which becomes axial or internal, joins said other capsule 56, which becomes external or peripheral .

Consequently, as is shown in particular in Fig. 10, the device 1 obtained in this variant of the method according to the invention is characterized in that the source 21 of liquid phase is multiple, and for this purpose comprises at least the capsule 3, which is axial or internal, and at least the capsule 57, which is external or peripheral, of which the wall is made of the same substrate as that of the capsule 3, that is to say the substrate of the envelope 7 and of the capsule 3. And, as has already been stated, the envelope 7 then directly forms part of the wall of the external or peripheral capsule 56.

The other capsule 56 can contain a lubricating liquid assisting in the introduction or contact between the wall of the intracorporeal cavity and the device, or a liquid which will be preabsorbed, or will saturate the absorbent material of the expandable tampon, with a view to controlling its expansion according to any suitable geometry in the vaginal cavity.

In the alternative embodiment of the method according to the invention represented in Figures 11 and 12, in step (C) the soft intermediate structure 50 obtained comprises, in continuity of material (that is to say substrate) , on the one hand a first capsule 3 and the sleeve 51 joined by the axial bridge 52, and, on the other hand, a second capsule 58 joined to that end of the first capsule 3 remote from the axial bridge 52 by another axial bridge 59. And the shape of the first capsule 3 complements that of the second capsule 58 so that, prior to step (E) defined above, the two capsules 3 and 58 are folded against one another about the other axial bridge 59 in order to obtain a multi-capsule 60 which itself can be joined to the expandable tampon 6, exactly as described above.

Consequently, as is shown in Fig. 12, the device 1 obtained in this variant of the method of the invention is characterized in that the source 21 of liquid phase is multiple and comprises at least a first capsule 3, in this case a semi-capsule, and a second capsule 58, in this case also a semi-capsule, the wall of each being made of substrate as defined above. And, as is shown in Figures 11 and 12, there is a continuity of material between the two capsules 3 and 58 by way of the other bridge 59 connecting the two aforementioned capsules at their respective proximal ends in the position or configuration represented in Fig. 12.

Fig. 13 represents a device 1 obtained by combining the two variants of the method according to the invention described with reference to Figures 9 and 10 and, respectively, Figures 11 and 12. Such a device is distinguished by the fact that it allows at least three different liquid phases to be introduced into the intracorporeal cavity being treated.

The variant of the method according to the invention which will now be described makes it possible to obtain a device 1, represented for example in Figures 14 and 15, which differs from that represented in Fig. 1 in terms of the following characteristics: the capsule 3 comprises a flexible envelope 23, for example of plastic material, enclosing in a leaktight manner the liquid charge 5, with an active agent distributed in the latter,

a distal end 25 of the capsule 3 emerges from the expandable tampon 6.

To obtain a device such as that represented in Fig. 14, the method described above is used, on condition that:

after step (E) , the distal end 25 of the capsule 3 emerges from the expandable tampon 6,

and, before step (F) , a central part 51c of the sleeve 51 is pierced for passage of the distal end 25 of the capsule 3.

To obtain the device represented in Fig. 14, the following method can alternatively be used:

(A) the expandable tampon 6 with, as has been described above, a proximal part 6c and a distal part 6d is provided;

(B) the substrate defined above is provided;

(C) the substrate is worked, for example by molding, to obtain a soft intermediate structure 50, elongate along the axis 15 of the device, and comprising a sleeve 51 of which one end 51a is closed, and of which the opposite end 51b is open; this intermediate structure 50 is itself obtained from an initial structure 49 represented in Fig. 16;

(D) at least the capsule 3 comprising the flexible envelope 23 is provided; (E) the capsule 3 and the expandable tampon 6 are joined together, so that at least the proximal part 3b of the capsule 3 is at least partially surrounded by the expandable tampon 6, and the distal end 25 of the capsule 3 emerges from the expandable tampon 6 ;

(F) a central part 51c is pierced for the passage of the distal end 25 of the capsule 3, and, from the outside, the sleeve 51 is passed round the expandable tampon 6 so as to obtain the envelope 7 for temporary protection covering the distal part 3a of the capsule 3 and extending longitudinally, or parallel to the axis 15 of the device 1, at least as far as an intermediate level of the expandable tampon 6.

The device obtained according to Fig. 14 differs from the device according to Fig. 1 in terms of the following characteristics:

the capsule 3 comprises an envelope or film of biocompatible plastic material containing the liquid charge enclosed in a leaktight manner in said envelope with respect to the outside, the active agent being distributed or dispersed, in solution or in suspension, in this liquid charge,

the capsule 3 is contained practically in its totality in the tampon 6; only a distal end remaining outside the tampon 6 is thus accessible to the user; for this purpose, the axial and blind hole 6a of the tampon 6 has a shape and dimensions adapted to the filled envelope 23 of the capsule 3;

the envelope 23 of the capsule 3 is sealed at its proximal end on an internal plastic plug 26, from which a ring 27 emerges for the passage of the withdrawal, string 9;

the envelope 23 is also sealed at its distal end on a distal element or part extending outside the envelope 23, comprising a separable part 28 permitting opening of this envelope; and an external grip element 29, outside the tampon 6 and envelope 23, permitting separation of the part 28 and opening of the capsule 3.

The device represented in Fig. 15 differs from that represented in Fig. 14 in that it comprises two capsules, namely 3 and 3', containing different liquid charges and joined together and contained jointly in the expandable tampon 6.

According to two advantageous embodiments of the method according to the invention:

the envelope 7 comprises a plurality of longitudinal ribs (not shown) parallel to the axis 15 of the device,

the envelope 7 is coated on its outer surface with an auxiliary liquid, impregnating it for example, in particular for lubrication.

Claims

1. A method for obtaining a disposable device for: transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, according to which method:
(A) an expandable tampon is provided which is made of at least one absorbent material, with a proximal part and a distal part,
(B) a substrate is provided which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said cavity,
(C) the substrate is worked, for example by molding, to obtain a soft intermediate structure, elongate along the axis of the device and comprising a sleeve of which one end is closed, and of which the opposite end is open,
(D) at least one capsule constituting a source of liquid phase is provided,
(E) the capsule is joined to the expandable tampon, so that at least the proximal part of said capsule is at least partially surrounded by said expandable tampon,
(F) the sleeve of the soft intermediate structure is turned back on itself, along the outside, round the expandable tampon, so as to obtain an envelope for temporary protection covering the distal part of the capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the expandable tampon.
2. The method as claimed in claim 1, wherein steps (C) and (D) are merged, and the soft intermediate structure obtained comprises two parts in continuity of material (or substrate) via an axial bridge, namely, at the proximal end, said capsule with a closed wall made of said substrate, and, at the distal end, said sleeve of which one end is closed by said axial bridge.
3. The method as claimed in claim 1, wherein steps (C) and (D) are separate, and, in step (D) , at least one capsule is provided comprising a flexible envelope of plastic material, enclosing in a leaktight manner a liquid charge, with an active agent distributed in said liquid charge, and wherein, subsequent to step (E) , a distal end of the capsule emerges from the expandable tampon and, prior to step (F) , a central part of the sleeve is pierced for the passage of the distal end of the capsule.
4. A method for obtaining a disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, according to which method:
(A) an expandable tampon is provided which is made of at least one absorbent material, with a proximal part and a distal part,
(B) a substrate is provided which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes; relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said cavity,
(C) the substrate is worked, for example by molding, to obtain a soft intermediate structure, elongate along the axis of the device, and comprising a sleeve of which one end is closed, and of which the opposite end is open,
(D) at least one capsule is provided which comprises a flexible envelope of plastic material, enclosing in a leaktight manner a liquid charge with an active agent distributed in said charge,
(E) the capsule is joined to the expandable tampon, so that at least the proximal part of said capsule is at least partially surrounded by said expandable tampon, and a distal end of said capsule emerges from the expandable tampon,
(F) a central part of the sleeve is pierced for the passage of the distal end of the capsule, and the sleeve is passed, along the outside, round the expandable tampon so as to obtain an envelope for temporary protection covering the distal part of the capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the expandable tampon.
The method as claimed in claim 2, wherein, for obtaining the intermediate structure: the substrate is worked, for example by molding, to form a soft initial structure (49) elongate along the axis (15) of said device, and comprising two parts in continuity of material via the axial bridge, namely, at the proximal end, said capsule, and, at the distal end, an ampule having a closed wall made of said substrate,
an end part of the ampule remote from the axial bridge is separated, for example by cutting, so as to obtain said sleeve, and, consequently, the soft intermediate structure.
6. The method as claimed in claim 5, wherein the end part of the ampule comprises a grip member, for example for suspension of the soft initial structure .
7. The method as claimed in claim 1, wherein, in one step, the proximal border of the envelope is crimped onto the expandable tampon, for example by heat, or by adhesive bonding.
8. The method as claimed in claim 2, wherein, in step (C) , another capsule is obtained inside the sleeve and beside the axial bridge, the wall of which other capsule is made of said substrate, that is to say the substrate of the soft intermediate structure, the sleeve directly forming a part of the wall of said other capsule, and wherein the shape of said other capsule complements that of said capsule, so that, in step (F) , said capsule which is axial or internal is joined to said other capsule, which is external or peripheral.
The method as claimed in claim 2, wherein, in step (C) , the soft intermediate structure obtained comprises, in continuity of material (or substrate) , on the one hand a first capsule and. said sleeve joined by said axial bridge, and, on the other hand, a second capsule joined to that end of the first capsule, remote from said axial bridge, by another axial bridge, and wherein the shape of the first capsule complements that of the second capsule so that, prior to step (E) , the two capsules and are folded against one another about the axial bridge in order to obtain a multi- capsule which can be joined to the expandable tampon.
10. A disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, and said device being able to be obtained by a method as claimed in any one of claims 1 through 9.
11. A disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, and said device having an intrinsic axial stability sufficient to allow said device to be introduced into said cavity by being pushed in axially, and said device comprising:
(a) an expandable tampon made of at least one absorbent material, with a proximal part and a distal part, arranged to collect and absorb said active liquid present in the intracorporeal cavity, and to expand and bear in a relatively leaktight manner against the mucous membrane of the intracorporeal cavity,
(b) a source of liquid phase comprising at least one capsule of which at least the proximal part is at least partially surrounded by said expandable tampon; said capsule having a wall made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies and said wall bursts inside said intracorporeal cavity; and said capsule enclosing a liquid charge in a leaktight manner with respect to the outside, with an active agent distributed in said substrate, or said liquid charge,
(c) an envelope for temporary protection covering the distal part of said capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the tampon; said envelope being made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said intracorporeal cavity,
wherein the substrate of the wall of the capsule and the substrate of the envelope are identical and form a continuity of material via an axial and distal bridge connecting the capsule and the envelope, situated outside said capsule but inside said envelope.
12. The device as claimed in claim 11, wherein the source of liquid phase comprises at least a first capsule, or semi-capsule, and a second capsule, or semi-capsule, of which the wall is made of said substrate, that is to say the substrate of the envelope and of said first capsule, and there is a continuity of material between the two capsules by way of another bridge connecting the two capsules at their proximal ends respectively.
3. A disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, said device having an intrinsic axial stability sufficient to allow said device to be introduced into said cavity by being pushed in axially, and said device comprising:
(a) an expandable tampon made of at least one absorbent material, with a proximal part and a distal part, arranged to collect and absorb said active liquid present in the intracorporeal cavity, and to expand and bear in a relatively leaktight manner against the mucous membrane of the intracorporeal cavity,
(b) a source of liquid phase comprising at least one capsule of which at least the proximal part is at least partially surrounded by said expandable tampon,
(c) an envelope for temporary protection covering the distal part of said capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the tampon; said envelope being made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said intracorporeal cavity,
wherein the source of liquid phase comprises at least one axial or internal capsule, and at least one external or peripheral capsule, of which the wall is made of said substrate, that is to say the substrate of the envelope and of said axial or internal capsule, and the envelope directly forming a part of the wall of said external or peripheral capsule.
14. A disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, said device having an intrinsic axial stability sufficient to allow said device to be introduced into said cavity by being pushed in axially, and said device comprising:
(a) an expandable tampon made of at least one absorbent material, with a proximal part and a distal part, arranged to collect and absorb said active liquid present in the intracorporeal cavity, and to expand and bear in a relatively leaktight manner against the mucous membrane of the intracorporeal cavity,
(b) a source of liquid phase comprising at least one capsule of which at least the proximal part is at least partially surrounded by said expandable tampon,
(c) an envelope for temporary protection covering the distal part of said capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the tampon; said envelope being made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said intracorporeal cavity, wherein the envelope comprises a plurality of longitudinal ribs parallel to the axis of the device .
15. A disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporeal cavity, said device being elongate along a reference axis, said device having an intrinsic axial stability sufficient to allow said device to be introduced into said cavity by being pushed in axially, and said device comprising:
(a) an expandable tampon made of at least one absorbent material, with a proximal part and a distal part, arranged to collect and absorb said active liquid present in the intracorporeal cavity, and to expand and bear in a relatively leaktight manner against the mucous membrane of the intracorporeal cavity,
(b) a source of liquid phase comprising at least one capsule of which at least the proximal part is at least partially surrounded by said expandable tampon,
(c) an envelope for temporary protection covering the distal part of said capsule and extending longitudinally, or parallel to the axis of the device, at least as far as an intermediate level of the tampon; said envelope being made of at least one substrate which is relatively solid at ambient temperature, outside the intracorporeal cavity, and which becomes relatively liquid inside said intracorporeal cavity, so that said substrate liquefies inside said intracorporeal cavity, wherein the envelope is covered on its outer surface by an auxiliary liquid, for example for lubrication.
PCT/IB2004/001174 2003-04-04 2004-04-02 Method for obtaining a disposable device for transferring and/or circulating an active liquid into and/or inside an intracorporal cavity WO2004087026A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
FR0304255A FR2853226B1 (en) 2003-04-04 2003-04-04 Method for obtaining a device for single use for transferring and / or circulating an active liquid into and / or inside an intracorporeal cavity
FR03/04255 2003-04-04
US46041903 true 2003-04-07 2003-04-07
US60/460,419 2003-04-07

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006105520A1 (en) * 2005-03-31 2006-10-05 Johnson & Johnson Consumer Companies, Inc. Novel tampon applicator

Citations (5)

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Publication number Priority date Publication date Assignee Title
US4286596A (en) * 1978-02-27 1981-09-01 Herbert Rubinstein Tampon containing a liquid medicant
US4318405A (en) * 1980-07-24 1982-03-09 Sneider Vincent R Tampon and drug delivery device
US5273521A (en) * 1992-08-26 1993-12-28 Peiler Frances K Tampon applicator for delivery of a medicament
US5299581A (en) * 1990-07-05 1994-04-05 Donnell John T Intravaginal device
US5840055A (en) * 1994-11-21 1998-11-24 Bernard Chaffringeon Disposable device for transfer of an active liquid into an intracorporeal cavity

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4286596A (en) * 1978-02-27 1981-09-01 Herbert Rubinstein Tampon containing a liquid medicant
US4318405A (en) * 1980-07-24 1982-03-09 Sneider Vincent R Tampon and drug delivery device
US5299581A (en) * 1990-07-05 1994-04-05 Donnell John T Intravaginal device
US5273521A (en) * 1992-08-26 1993-12-28 Peiler Frances K Tampon applicator for delivery of a medicament
US5840055A (en) * 1994-11-21 1998-11-24 Bernard Chaffringeon Disposable device for transfer of an active liquid into an intracorporeal cavity

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006105520A1 (en) * 2005-03-31 2006-10-05 Johnson & Johnson Consumer Companies, Inc. Novel tampon applicator

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