DRUG DELIVERY DEVICE

Abstract

The present invention relates to a device for insertion into a human or animal cavity, the device comprising an internally wearable plug comprising a pharmaceutically active composition; an externally wearable anchor element; and a sheath joining the plug to the anchor element such that a wearer's finger can be received in the sheath to assist insertion.

Claims

1. A device for insertion into a human or animal cavity, the device comprising an internally wearable plug comprising a pharmaceutically active composition; an externally wearable anchor element; and a sheath joining the plug to the anchor element such that a wearer's finger can be received in the sheath to assist insertion

2. The device according to claim 1, wherein the human cavity is a vaginal cavity or a rectal cavity.

3. The device according to any preceding claim, wherein the composition is a topically active composition.

4. The device according to any preceding claim, wherein the composition is a systemically active composition.

5. The device according to any preceding claim, wherein the composition comprises a pharmaceutically active ingredient selected from an antifungal agent, an antibacterial agent and/or an anti-hemorrhoidal agent.

6. The device according to any preceding claim, wherein the composition is releasable in the presence of heat and/or fluid.

7. The device according to any preceding claim, wherein the composition comprises or consists of a solution, a lotion, a cream, an emulsion, a suspension, an ointment, a paste, a gel, a powder and/or a foam.

8. The device according to any preceding claim, wherein the plug comprises an absorbent material.

9. The device according to any preceding claim, wherein the plug is saturated with the pharmaceutically active composition.

10. The device according to any preceding claim, wherein the plug comprises a heat labile membrane.

11. The device according to any preceding claim, wherein the plug comprises a liquid labile membrane.

12. The device according to claim 10 or 11, wherein the membrane comprises the pharmaceutically active composition.

13. The device according to any preceding claim, wherein the device further comprises a plug cover.

14. The device according to claim 9, wherein the plug cover is removable before insertion of the plug into the cavity.

15. The device according to any preceding claim, wherein the anchor element is an externally wearable absorbent pad.

16. The device according to any preceding claim, wherein the anchor element comprises an absorbent layer.

17. The device according to any preceding claim, wherein the anchor element comprises a liquid impermeable layer.

18. The device according to any preceding claim, wherein the sheath is flexible.

19. The device according to claim 18, wherein the sheath is expandable only in a radial direction.

20. The device according to any preceding claim, wherein the sheath comprises an impermeable layer.

21. The device according to claim 20, wherein the impermeable layer is closed where it joins the plug.

22. The device according to any preceding claim, wherein the sheath comprises an absorbent layer.

23. The device according to any one of claims 20 to 22, wherein the impermeable layer is closed where it joins the plug.

24. The device according to any preceding claim, wherein the sheath comprises an internal impermeable layer and an external absorbent layer.

25. The device according to any preceding claim, wherein the device further comprises a cord attached to the plug to assist removal of the plug from the cavity.

26. A device for insertion into a human or animal cavity substantially as described herein with reference to the accompanying drawings.

27. A method of using a device according to any one of claims 1 to 26, the method comprising the step of inserting a finger into the sheath and pushing the plug into the cavity.

28. A method for the delivery of a pharmaceutically active composition into a human or animal cavity, the method comprising the use of a device according to any one of claims 1 to 26.

29. A method for the treatment of a vaginal or rectal condition, the method comprising the use of a device according to any one of claims 1 to 26.

30. A method for manufacturing a device according to any one of claims 1 to 26, the method comprising the step of joining an internally wearable plug comprising a pharmaceutically active composition to an externally wearable anchor by a sheath.

Description

[0037] The invention will be further described with reference to the drawings and figures, in which

[0038] FIG. 1 is a side view of a device according to the present invention, in which the pad is folded outwardly;

[0039] FIG. 2 is a side view of the device of FIG. 1, in which the pad is flat;

[0040] FIG. 3 is a front view of the device of FIG. 1;

[0041] FIG. 4 is a rear view of the device of FIG. 1;

[0042] FIG. 5 is a side view of the device of FIG. 1, after use and during removal of the plug; and

[0043] FIG. 6 is a side view of the device of FIG. 1, after use and after removal of the plug;

[0044] FIG. 7 is a side view of a device according to the present invention comprising a plug cover;

[0045] FIG. 8 is a side view of a device according to the present invention comprising a perforated membrane;

[0046] FIG. 9 is a side view of a device according to the present invention comprising a distal perforated drug reservoir; and

[0047] FIG. 10 is a side view of a device according to the present invention comprising a proximal perforated drug reservoir.

[0048] Referring to FIG. 1, there is illustrated a device 1 for insertion into a human or animal cavity, the device 1 comprising an internally wearable plug 2 comprising a pharmaceutically active composition; an externally wearable anchor element 3; and a sheath 4 joining the plug 2 to the anchor element 3 such that a wearer's finger can be received in the sheath 4 to assist insertion.

[0049] The plug 2 is substantially cylindrical so that it fits comfortably in a vaginal or rectal cavity. The end of the plug 2 that, in use, is inserted into the vaginal cavity first is referred to as the innermost end 5 of the plug 2. The end of the plug 2 that, in use, is inserted into the vaginal cavity last is referred to as the outermost end 6 of the plug 2. Both the innermost end 5 and outermost end 6 of the plug 2 are domed to ease insertion and removal of the plug 2 from the cavity.

[0050] The plug 2 is made from compressed cotton. For example, a sheet of compressed cotton may be cut and rolled into an appropriate shape. Other suitable materials and constructions may be used as desired.

[0051] The plug 2 comprises a pharmaceutically active composition. The composition can act locally as a topical composition and/or can diffuse through the cavity wall and have a systemic effect. If body fluids are present that might flush the composition out of the cavity, the absorbent material of the plug 2 can retain the fluid-composition mixture, thereby increasing the contact (and therefore administration) time.

[0052] The composition can be present in the plug 2 in several ways. For example, the plug 2 can be saturated with the composition so that it is slowly released to the vaginal or rectal tissue when positioned in the cavity.

[0053] The composition can also be present at either or both ends of the plug 2. For example, there may be a drug reservoir at the innermost end 5 of the plug 2 or at the outermost end 6. In a preferred embodiment, there may be a drug reservoir 15 at the innermost end 5 of the plug 2, shown with perforations 15a in FIG. 9; or a drug reservoir 16 at the outermost end 6 of the plug 2 (or the innermost end of the sheath 4), shown with perforations 16a in FIG. 9. When the drug reservoir 16 is located at the outermost end 6 of the plug 2, the sheath 4 (or its impermeable layer) may be closed where it joins the reservoir 16, and the reservoir 16 may be configured to release the drug upon insertion, i.e. upon application of pressure with the finger. For example, the perforations 16a could be made of a material such that they burst open upon application of pressure.

[0054] The plug 2 can comprise a membrane which retains the composition, when the device 1 is not in use, and releases it when the plug 2 is positioned in the cavity.

[0055] In a first example, the membrane 14 can be perforated so that the composition is released through the openings 14a from a medicated plug 2.

[0056] In a second example, the membrane can be labile (e.g. dissolved or disintegrate) in the presence of a liquid, such as body fluids, and/or when heated, for instance, at the cavity (body) temperature of the wearer so that the composition is released from a medicated plug 2.

[0057] In a third example, the membrane itself may comprise the composition and release it when the plug 2 is positioned in the cavity. In this example, the medicated membrane can be heat or liquid labile as explained above.

[0058] Heat labile membranes may be used for both vaginal and rectal drug delivery. Liquid labile membranes can also be used in both applications, but are preferred for use in vaginal drug devices, since there are more body fluids present in the vaginal cavity than the rectal cavity. The labile membranes may be perforated or not perforated.

[0059] The device 1 may comprise a plug cover 13 in order to prevent contamination of the device 1. In addition, the cover 13 can prevent the loss or alteration of the composition before use.

[0060] Thus, the device 1 of the present invention enables the delivery of a pharmaceutically active composition. In particular, with the device 1 of the present invention, an extended contact (and therefore administration) time can be achieved. In the case of the vaginal or rectal administration of a drug using a syringe or conventional suppository, the drug is released at one go and is likely to be promptly rejected by the cavity, especially if the patient is in a standing or sitting position. In addition, the present invention allows the slow release of a drug without the need for complex pharmaceutical formulation (e.g. micro-encapsulated drugs) and is versatile in that it can be used in combination with a large variety of pharmaceutical compounds.

[0061] The amount of drug delivered can be easily controlled. A substantial amount of the drug is retained adjacent the plug 2 and there is therefore no need to “overload” the device 1 to compensate for losses due to natural rejection from the cavity.

[0062] The concentration and amount of drug may be adjusted depending on the drug(s) to be administered, the components of the composition, the form of the composition (e.g. solution, a lotion, a cream, an emulsion, a suspension, an ointment, a paste, a gel, a powder and/or a foam), the condition to be treated and the like. Another factor that may be taken into consideration is that the wearer will tend to replace the device 1 after bowel movement and/or urination. Thus, the amount of drug in each device 1 can be adjusted in consequence, and for example, devices 1 for use in the daytime may comprise less composition, than devices 1 for use in the night when the device is worn for a longer period of time.

[0063] The sheath 4 is tubular and extends from the outward end 6 of the plug 2 to the pad 3.

[0064] More specifically, the sheath 4 comprises a tube of absorbent material with a layer of liquid impermeable material on its inside surface. In other words, there is a tube of liquid impermeable material inside the tube of absorbent material. The tube of absorbent material extends to the inward surface 7 of the pad 3. Indeed, the absorbent material of the sheath 4 can be integral with the absorbent layer of the pad 3. The tube of liquid impermeable material extends through the pad 3 to the outward surface 8 of the pad 3. Indeed, the tube of liquid impermeable material can be integral with the liquid impermeable backing of the pad 3.

[0065] The tube of liquid impermeable material and hence the sheath 4 is open on the outward surface 8 of the pad 3. An opening 10 formed by the sheath 6 on the outward surface 8 of the pad 3 can be seen in FIG. 4. In this embodiment, the tube of liquid impermeable material is closed where it joins the plug 2. This prevents liquid absorbed by the plug 2 passing into the inside of the sheath 4 and soiling the inserting finger.

[0066] A small diameter is required to improve the comfort of the device 1 in the region of the cavity orifice and the diameter of the sheath 4 is preferably smaller than that of the plug 2. However, the diameter must be sufficient to allow a finger to be accommodated inside the sheath 4. The sheath 4 is therefore expandable in a radial direction. This is accomplished by the sheath 4 being elastic in the radial direction so that the unexpanded diameter of the sheath 4 is smaller than that of the plug and the expanded diameter is sufficient to accommodate a finger. In one embodiment, an elastic tube (not shown) is provided between the absorbent tube and the liquid impermeable tube of the sheath 4. In other embodiments, either or both of the absorbent and liquid impermeable tubes of the sheath 4 are themselves elastic.

[0067] As explained above, the plug 2 can be easily guided and positioned within the cavity due to the insertion procedure. In order to further assist the positioning, the length of the sheath 4 can be chosen so that the plug 2 is inserted not too close to the cavity orifice and not too deep into the cavity. Furthermore, the sheath 4 can be substantially not expandable in the longitudinal direction in order to prevent movement of the plug 2 within the cavity.

[0068] The pad 3 is substantially circular, oval, rectangular or any other suitable shape. The pad 3 can be a standard rectangular napkin or a small interlabial pad. In a preferred embodiment as shown in the figures, the pad 3 is a flat-egg shaped that has a smaller back portion 11 and a larger front portion 12 when used as a vaginal device, and a larger back portion 11 and a smaller front portion 12 when used as a rectal device. Of course, the shape could be the same for either vaginal or rectal use, with the wearer suitably positioning the shorter and longer portions.

[0069] The side of the pad 3 in contact with the cavity in use is referred to as the inward side 7 (shown as the front of the device 1 in FIG. 3) and the side of the pad 3 in contact with clothing in use is referred to as the outward side 8 (shown as the rear of the device 1 in FIG. 4).

[0070] The pad 3 has an absorbent layer on the inward side 7 and a liquid impermeable layer on the outward side 8. In this embodiment, the absorbent layer is made from compressed cotton and the liquid impermeable layer is made from a polymeric material. Other suitable materials may be used as desired.

[0071] A cord 9 is provided to aid removal of the device. In this embodiment, the cord 9 extends inside the sheath 4 from the outward end of the plug 2 and out through the opening 10. When the wearer pulls on the cord 9 to remove the plug 2, the plug 2 is pulled outwardly from the cavity. The pad 3 tends to begin to fold around the plug 2 and the sheath 4 can invert to accommodate the plug 2. Thus, the cord 9 can be used to pull the plug 2 into the sheath 4, which can turn inside out to accommodate the plug 2. The wearer therefore retrieves the plug 2 inside the sheath 4 and with the pad 3 folded around the plug 2 and sheath 4 combination. There is therefore a very low chance of the wearer touching a soiled part of the device.

[0072] The term cord is not intended to be limiting to any particular type of twine or thread. Rather, it is a general term referring to any usable string or tail which the wearer can pull to extract the plug.

[0073] In use, the device 1 is removed from its packaging and one of the wearer's finger is inserted in the sheath 4 through the opening 12 to the outward end 6 of the plug 2. The elasticity of the sheath 4 allows it to expand radially and accommodate the finger. The protective cover 13 is removed from the plug 2. Thus, the user does not need to directly touch the plug 2 with his/her hands during the insertion procedure.

[0074] The wearer orients the device 1 so that the plug 2 extends longitudinally toward the vaginal or rectal cavity. The smaller back portion 11 of the pad 3 is positioned approximately at the rear of the vagina, i.e. toward the anus, and the larger front portion 12 of the pad 3 is positioned approximately at the front of the vagina, i.e. toward the pubic bone, when the device is used for vaginal delivery. When the device is used for rectal delivery, the pad 3 is positioned in the opposite direction.

[0075] The plug 2 is aligned with the orifice and inserted through the orifice and into the cavity. The plug 2 is pushed into the cavity until the inward surface 7 of the pad 3 comes to rest against the surface of the vagina or, more specifically, the vulva, between the labia majora. The finger is then withdrawn from the sheath 4, leaving the device 1 in place.

[0076] The composition is released from the device 1 into the cavity and more particularly in the area adjacent the plug 2.

[0077] If the device 1 comprises a perforated membrane, then the composition is released from the plug 2 through the openings. If the device 1 comprises a labile membrane, then the membrane dissolves or disintegrate, to release the composition from the plug 2. If the labile membrane comprises the pharmaceutically active composition, then the membrane dissolves or disintegrate to release the composition from the membrane.

[0078] Once released, the composition will contact the cavity walls and treat the condition locally in the case of a topical drug composition, or will diffuse through the walls, in the case of a systemic drug composition.

[0079] The absorbent plug 2 can recover any surrounding body fluids, which in excess might drag the composition out of the cavity. A further advantage is that any drug mixed with body fluid can also be recovered and retained adjacent the plug 2 from prolonged contact and administration. Excess body fluid can also be drawn along the absorbent layer of the sheath 4 and absorbed by the pad 3.

[0080] To remove the device 1, the wearer can grasp the cord 9 and pull it to remove the plug 2 from the cavity. As the plug 2 is pulled out of the cavity, the pad 3 can be folded, as shown in FIG. 5. The outward surface 11 of the pad 3 is pushed or grasped by the wearer to fold the pad 3 over the plug 2 and sheath 4 and the inward surface 7 effectively becomes enclosed by the outward surface 8. This folding of the pad 3 can reduce the likelihood of the wearer touching the soiled inner surface 7 of the pad 3. As this inward surface 7 is typically soiled during use and the outward surface 8 is generally relatively clean, hygiene can therefore be maintained.

[0081] Furthermore, as the internally worn plug 2 is removed from the cavity, it can be accommodated by the folded pad 3. The grasping of the pad 3 as the plug 2 is pulled out of the cavity can cause the pad 3 to fold over the plug 2. Indeed, the plug 2 can be enclosed by the pad 3. Again, as the plug 2 is generally soiled, but the surface 8 of the pad 3 grasped by the wearer is generally relatively clean, the likelihood of the wearer touching the plug 2 during removal of the device is reduced and hygiene is maintained.

[0082] In addition, the sheath 4 can expand radially to accommodate the plug 2. More specifically, pulling the cord 9 causes the plug 2 to invert the sheath 4. The inverted sheath 4 expands in a similar way to when accommodating the wearer's finger during insertion and allows the plug 2 to be drawn into the inverted sheath 4, as shown in FIG. 6. So, with the plug 2 accommodated, at least partially, in the inverted sheath 4 and the pad 3 folded over the plug 2, the entire device 1 is enclosed by the liquid impermeable layer of the outward surface 8 of the pad 3 and the sheath 4. This liquid impermeable layer does not come into contact with the cavity opening at any time and is therefore relatively clean. The wearer need only touch the cord 9 and this liquid impermeable layer during removal and disposal of the device 1. So, the device 1 can be hygienically removed and disposed of after use.

[0083] Thus, from the above description, it can be seen that the present invention provides a device for the vaginal or rectal delivery of a drug, so that the drug is efficiently and hygienically administered to the target area. The device is user friendly and the drug can be self administered without the need for an experienced practitioner.

[0084] The combination of the internally wearable plug, the sheath and the absorbent pad is particularly advantageous in that it provides and all-in-one drug delivery device. The plug can easily and hygienically be inserted in the correct position. The drug can be delivered over a prolonged period of time, without the need for complex formulations or constructions. Any excess fluid and/or medication can be recovered by the absorbent pad.