Drug delivery and administration device

Abstract

To provide a device for the delivery and / or application of a therapeutic composition into the rectal and / or vaginal cavity.SOLUTION: A device 1 for the delivery and / or application of a therapeutic composition in a delivery form into the rectal and / or vaginal cavity comprises: an externally worn pad 2; a non-absorbent platform 3 for receiving a delivery form of the therapeutic composition; and a sheath 4 joining the platform to a pad such that a user's finger can be received within the sheath 4. The platform 3 has a region with higher rigidity than the sheath.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present invention relates to devices for the delivery and / or administration of therapeutic compositions in the rectal or vaginal cavity.

[0002] Delivery of drugs via the vaginal or rectal cavity is known to be advantageous in that it can achieve both local and systemic administration of drugs, providing an alternative to traditional delivery routes. In some cases, oral delivery is not recommended due to gastro-intestinal side effects or reduced bioavailability, or simply because the patient is uncooperative or unable to swallow the drug. Injections (e.g., intravenous injections) may not be appropriate, as they usually must be administered by trained medical personnel.

[0003] Vaginal and rectal medications (e.g., creams) may also be applied with a gloved finger. However, when the finger is inserted into the vaginal or rectal cavity, a portion of the medication that is retained by the vaginal or rectal wall as the finger advances through the vaginal cavity is not applied to the target area. Thus, it is difficult to administer a precise amount of medication to the target area.

[0004] Suppositories can be inserted, drugs can be injected using a syringe, or drugs can be administered by spray. However, due to their physical functions, both the vaginal and rectal cavities tend to reject foreign bodies. The drug reaches the target area but is not retained within the cavity to achieve adequate contact and absorption. This is especially the case when the suppository must dissolve to allow penetration and absorption of the drug into the cavity walls. Elastic vaginal rings have been developed to retain the drug that leaks out, but these devices are often uncomfortable for the patient.

[0005] Many medicated tampons and sponges are known for delivery of drugs to the vaginal or rectal cavity. These devices are typically inserted using an applicator or inserter, which can be uncomfortable and it is often difficult to properly position the tampon.

[0006] European Patent Publication EP 3 027 155 relates to a drug delivery device comprising a medicated tampon attached to a sanitary napkin by a sheath. A user can insert a finger into the sheath to push the tampon precisely and atraumatically into the vaginal or rectal cavity. However, there may be medicines that require substantial modification and cost to be incorporated into the tampon, or that simply cannot be incorporated into the tampon at all. Summary of the Invention

[0007] It is an object of the present invention to at least mitigate the above mentioned drawbacks or to provide an alternative to existing products.

[0008] According to a first aspect of the present invention, there is provided an apparatus for delivery and / or application of a therapeutic composition in a delivery form into the rectal and / or vaginal cavity, the apparatus comprising an externally worn pad, a non-absorbent platform for receiving the delivery form of the therapeutic composition, and a sheath connecting the platform to the pad such that a user's finger can be received within the sheath.

[0009] In the context of the present invention, the delivery form may be any commercially available delivery form, including, but not limited to, suppositories, pessaries, capsules, tablets, liquids, solutions, suspensions, lotions, dispersions, creams, gels, powders and granules. The present invention does not relate to the delivery and administration of therapeutic compositions delivered in the form of a gas.

[0010] Known rectal or vaginal delivery devices require absorption or combination of the drug with the delivery device. This facilitates control of the release of the drug, but there is still a risk that the entire dose is retained by the delivery device and not delivered to the target area. The present invention allows the entire therapeutic composition (i.e., its delivery form) to be delivered to the target area, in that there is no associated absorption. The device of the present invention can be said to act as an applicator rather than a delivery device, in that there is no interaction between the device and the therapeutic composition. The therapeutic composition can also be said to be supported by a platform.

[0011] Preferably, a sheath comprises said platform. The sheath has a first end joined to the pad and a second end comprising a platform, the platform being capable of being pushed into the rectal or vaginal cavity by the tip of a user's finger.

[0012] In a preferred embodiment, the therapeutic composition is in a shaped delivery form and the platform includes a receiving portion, the shape of which corresponds in part to the shape of the delivery form of the therapeutic composition.

[0013] In the context of the present invention, we refer to the shape of a delivery form of a therapeutic composition, where the delivery form consists of one component (e.g., one suppository, one pessary, one capsule, one tablet), but the delivery form does not have a specific shape, and is not a liquid, solution, suspension, lotion, dispersion, cream, gel, powder, or granule.

[0014] The shape of the delivery form may be spherical, ovoid, cylindrical, diamond-shaped, or any other commercially available shape. The shape of the receiving part preferably corresponds partially to the shape of the delivery form so that the therapeutic composition can fit snugly into the receiving part and be released at the target area. Preferably, the shape of the receiving part corresponds to up to half of the shape of the delivery form of the therapeutic composition to allow easy release at the target site.

[0015] If the shape of the delivery form is a spherical or ovoid capsule, the platform can include a hemispherical or ovoid cup-shaped receiving portion. If the shape of the delivery form is a diamond, the platform can include a tapered receiving portion.

[0016] The receiving portion may be integrally formed within the sheath. For example, the sheath may include a receiving portion (pocket or recess) formed from the same material as the sheath. Alternatively, the receiving portion may include additional or alternative material connected to the sheath.

[0017] This particular configuration of the receiving portion is advantageous in improving the delivery of the therapeutic composition. The sheath is adapted to receive a user's finger therein. This can be accomplished by using a sheath of sufficient diameter or a sheath material that can expand to accommodate the finger. As a result, the diameter of the sheath is likely to be wider than the dimensions of the delivery form, as tablets, capsules, suppositories, etc., will become loose if not held by the shaped receiving portion, and the user will experience difficulty in pushing the therapeutic composition into the rectum or vaginal cavity.

[0018] Preferably, the platform includes a receiving portion configured to receive a predetermined amount of the therapeutic composition.

[0019] In a preferred embodiment, the receiving portion may be a receptacle such as a cup or bowl. Preferably, the receiving portion has a rounded base to prevent the therapeutic composition from getting trapped in corners and being prevented from being delivered.

[0020] This is particularly advantageous when the delivery form of the therapeutic composition is unclear, for example, when the therapeutic composition is in a delivery form that is difficult to quantify (e.g., when the delivery form is a liquid, solution, suspension, lotion, dispersion, cream, gel, powder, and granules.) When the receiving portion is adapted and configured to receive a predetermined amount of the therapeutic composition, the user can simply load the receiving portion with the exact amount of the therapeutic composition required for treatment.

[0021] In another embodiment, the receiving portion can include visual scales or markers to allow the user to adjust the amount of therapeutic composition required for treatment. The amount required can depend, for example, on the condition to be treated, the severity of the condition, and patient characteristics such as age, weight, sex, etc.

[0022] Preferably, the platform comprises a region of relatively high stiffness. The platform may comprise or be made of a material that is more stiff than the material of the sheath. Additional or alternative materials may be used to increase the stiffness of the platform and / or the receiving section. For example, the region of relatively high stiffness may have a multi-layer construction or be made of a different, stiffer material.

[0023] This allows the platform and / or receiving section to maintain its shape as it enters the rectum or vaginal cavity. If the receiving portion's shape were to collapse, the liquid therapeutic composition contained therein may spill or spread into the sheath, making delivery to the target site more difficult and / or resulting in an inaccurate amount of therapeutic composition being delivered to the target site. If the therapeutic composition is in the form of a single solid form (e.g., tablet, capsule, suppository, bougie, pessary), the composition may inadvertently become dislodged from the receiving platform before reaching the target area.

[0024] Areas of higher stiffness can also be used to increase the rigidity of the platform so that a release string can be attached to the platform.

[0025] Preferably, the receiving portion is foldable and / or invertible. In a preferred embodiment, the receiving portion is rigid enough to maintain its shape during the insertion step, i.e., when the therapeutic composition is pushed through the rectal or vaginal cavity towards the target area, but flexible enough to fold and release the therapeutic composition at the target area. Preferably, the device according to the invention does not include any completely rigid parts, so as to avoid injury or discomfort to the user during the insertion and removal process.

[0026] In a preferred embodiment, the platform comprises a means for releasing a therapeutic composition.

[0027] In the simplest embodiment, the platform is invertible so that the therapeutic composition is forced out of the receiving portion. For example, the platform comprises or is a cup or bowl shaped receptacle that can be turned upside down. Once inverted, the platform can be used to apply the therapeutic composition to the target area, e.g., in the case of a cream, lotion, liquid, granules, etc., so that the composition penetrates the cavity walls.

[0028] The platform may be collapsible or may comprise collapsible side walls so that the therapeutic composition can be released from the receiving section. The platform may comprise one or more strings constructed and arranged to be pulled towards the cavity orifice and cause the side walls to collapse. For example, the platform walls may comprise a bellows mechanism.

[0029] In preferred embodiments, the receiving portion may be closable to contain the therapeutic composition, for example, during storage, shipping, handling and insertion of the device. The sheath may be releasably closed, for example, by ultrasonic welding, impulse heat or heat welding. These techniques are particularly advantageous in that the strength of the seal can be adjusted so that it is strong enough to contain the therapeutic composition prior to use, but can also be opened by forcing the sheath into the patient's cavity. The receiving portion is pressed against the target area and the user further presses the distal end of the sheath to open the seal and release the therapeutic composition from the receiving portion.

[0030] Preferably, the length of the sheath is substantially the same as the distance between the rectum or vaginal opening and the target area within the rectal or vaginal cavity. If the sheath includes a releasable closure, it is preferred that the length of the sheath between the pad and the closure is substantially the same as the distance between the rectum or vaginal opening and the target area within the rectal or vaginal cavity.

[0031] In a preferred embodiment, the device further comprises a removal string. Preferably, the device comprises a string for releasing the therapeutic composition from the receiving portion and / or for removing the device from the rectum or vaginal cavity. Preferably, the string is connected to the end of the platform or a sheath that comprises the platform. In another embodiment, the string comprises or forms a loop, allowing for easy gripping by the user. The loop may be connected to multiple points on or adjacent to the platform to uniformly manipulate and / or pull the device, platform, or receiving portion.

[0032] In a preferred embodiment, the pad comprises an absorbent layer which, in use, faces the rectal or vaginal cavity, and an impermeable layer which, in use, faces away from the rectal or vaginal cavity.

[0033] The externally worn pad may include an absorbent layer to absorb excess therapeutic composition or bodily fluids that leak from the cavity. This is particularly advantageous when applying delivery forms such as liquids, creams or gels that tend to leak from the cavity. The externally worn pad may include an impermeable layer to prevent leaking fluids from soiling the user's undergarments. The pad is preferably positioned outside the vaginal opening as an interlabial pad, or outside the rectal opening between the user's buttocks. In a preferred embodiment, the pad includes one or more lines of weakness to facilitate holding the pad between the labia or buttocks of the user. The lines of weakness also allow for hygienic disposal of the drug delivery device, as the pad can be folded around the lines of weakness, thereby allowing the sheath to be closed so that the user does not touch the soiled surface of the pad or the sheath.

[0034] According to a second aspect of the present invention there is provided a kit comprising a therapeutic composition in a delivery form and a device according to any one of claims 1 to 9 for delivering and / or applying the delivery form of the therapeutic composition to a target area within the rectal or vaginal cavity.

[0035] Preferably, the therapeutic composition comprises an anti-fungal agent, an anti-bacterial agent, an anti-inflammatory agent, an analgesic agent, a steroid (NSAID) compound, a non-steroidal compound, and / or a hormone.

[0036] According to a further aspect of the invention, the device may be used for the delivery and / or application of a therapeutic composition for the treatment of menorrhagia.

[0037] According to a further aspect of the invention, the device may be used for the delivery and / or application of a therapeutic composition for infertility treatment. [Brief description of the drawings]

[0038] The invention will now be further explained with reference to the drawings and figures. [Figure 1A] FIG. 1A is a schematic diagram of a first device according to the present invention. [Figure 1B] FIG. 1B is a schematic diagram of a first device according to the present invention. [Figure 1C] FIG. 1C is a schematic diagram of a first device according to the present invention. [Figure 1D] FIG. 1D is a schematic diagram of a first device according to the present invention. [Figure 2A] FIG. 2A is a schematic diagram of a second device according to the present invention. [Figure 2B] FIG. 2B is a schematic diagram of a second device according to the present invention. [Figure 2C] FIG. 2C is a schematic diagram of a second device according to the present invention. [Figure 2D] FIG. 2D is a schematic diagram of a second device according to the present invention. [Figure 3A] FIG. 3A is a schematic diagram of a third device according to the present invention. [Figure 3B] FIG. 3B is a schematic diagram of a third device according to the present invention. [Figure 3C] FIG. 3C is a schematic diagram of a third device according to the present invention. [Figure 3D] FIG. 3D is a schematic diagram of a third device according to the present invention. [Figure 4]FIG. 4 is a schematic diagram of a fourth device according to the invention. [Diagram 5] FIG. 5 is a schematic diagram of a fifth apparatus according to the present invention. [Figure 6] FIG. 6 is a schematic diagram of a sixth apparatus according to the present invention. [Figure 7A] FIG. 7A is a schematic diagram of a seventh apparatus according to the present invention. [Figure 7B] FIG. 7B is a schematic diagram of a seventh apparatus according to the present invention. [Figure 7C] FIG. 7C is a schematic diagram of a seventh apparatus according to the present invention. [Figure 7D] FIG. 7D is a schematic diagram of a seventh apparatus according to the present invention. [Figure 8] FIG. 8 is a schematic diagram of an eighth apparatus according to the present invention. [Figure 9] FIG. 9 is a schematic diagram of a ninth apparatus according to the present invention. [Figure 10] FIG. 10 is a schematic diagram of a tenth apparatus according to the present invention. [Figure 11A] FIG. 11A is a schematic diagram illustrating the delivery of a therapeutic composition to the rectal cavity of a female patient using an apparatus according to the present invention. [Figure 11B] FIG. 11B is a schematic diagram illustrating the delivery of a therapeutic composition to the rectal cavity of a female patient using an apparatus according to the present invention. [Figure 11C] FIG. 11C is a schematic diagram illustrating the delivery of a therapeutic composition to the rectal cavity of a female patient using an apparatus according to the present invention. [Figure 12A] FIG. 12A is a schematic diagram illustrating the delivery of a therapeutic composition to the rectal cavity of a male patient using a device according to the present invention. [Figure 12B] FIG. 12B is a schematic diagram illustrating the delivery of a therapeutic composition to the rectal cavity of a male patient using a device according to the present invention. Detailed Description of the Invention

[0039] Referring to FIG. 1, there is shown an apparatus 1 for delivering and / or applying a therapeutic composition C in a delivery form into the rectal and / or vaginal cavity, the apparatus 1 comprising an externally worn pad 2, a non-absorbent platform 3 for receiving the delivery form of the therapeutic composition C, and a sheath 4 connecting the platform 3 to the pad 2, the sheath 4 through which a user's finger is received.

[0040] The non-absorbable platform 3 is placed at the distal end of the sheath 4. In the context of the present invention, the distal end is the end that, in use, is closest to the target area in the vaginal or rectal cavity, and the proximal end is the end of the sheath 4 that is closest to the cavity opening.

[0041] The primary function of platform 3 is to provide a support surface for therapeutic composition C, allowing the user to push therapeutic composition C along the vaginal or rectal cavity. If the user were to use latex gloves without platform 3, therapeutic composition C would leave the user's fingertips and efficient and accurate delivery would not be possible. Platform 3 can also allow the user to maintain therapeutic composition C in the targeted area of ​​the vaginal or rectal cavity and act as an internal barrier to prevent therapeutic composition C from dislodging or leaking out of the cavity.

[0042] Preferably, the platform 3 comprises a material that is more rigid than the material of the sheath 4. The platform 3 may be formed from a single or multi-layer sheet structure. The material of the platform 3 may be the same material as the material of the sheath 4, but may be of a thickness greater than the thickness of the material of the sheath 4 to provide relative rigidity. The platform 3 may comprise a multi-layer structure with structural layers that provide relative rigidity. Additionally, the relatively greater structural rigidity of the platform 3 facilitates attachment of the string or cord 6.

[0043] The platform 3 comprises or can form a receiving portion 5. The platform 3 can be disposed in a first configuration in which the receiving portion 5 is not present (e.g., in a retrieval configuration and / or delivery configuration, when inverted at a target area within the cavity) and a second configuration in which the receiving portion 5 is present (e.g., in an insertion configuration, when the therapeutic composition C is pushed along the vaginal or rectal cavity). In a preferred embodiment, the receiving portion 5 can be disposed in a receiving configuration that can contain the therapeutic composition C, and in a delivery configuration in which the therapeutic composition C is released from the receiving portion 5.

[0044] The platform 3 and the receiving portion 5 can be made of the same non-absorbent material or different absorbent materials. In a preferred embodiment, the receiving portion 5 is integrally formed within and / or with the platform 3.

[0045] Preferably, the platform 3 and / or the receiving portion 5 are made of a material that is rigid enough to allow a user to push the therapeutic composition C within the receiving portion 5, and flexible enough to allow a user to push the therapeutic composition C out of the receiving portion 5. The platform 3 and the receiving portion 5 are preferably not so rigid that they would injure the patient during the insertion and / or removal process. Preferably, the platform 3 and / or the receiving portion 5 are made from a semi-flexible sheet of a plastic material.

[0046] If the therapeutic composition is in fluid, liquid, granular or powder form, the shape and dimensions of the receiving portion 5 may be adjusted to receive the required amount / dose of the therapeutic composition C.

[0047] 2A-2D, the receiving portion 5 may be cup or bowl shaped to receive the therapeutic composition in a solid or fluid delivery form. A detachment string 6 may be connected to the platform 3 to withdraw the instrument 1 from the cavity after delivery of the therapeutic composition C.

[0048] 3A-3D and 5, the receiving portion 5 may include a flat base 7 (eg, a cylindrical receiving portion 5) to provide a surface against which a user presses.

[0049] With reference to Figure 4, the receiving portion 5 may be a recess or reservoir 8. With reference to Figure 6, the receiving portion 5 may be provided with a visual indication of the amount of therapeutic composition C contained therein.

[0050] The receiving portion 5 may be invertible (inside out) to release the therapeutic composition C from the receiving portion 5 (as shown in Figures 3A-3D), or the walls of the receiving portion 5 may be collapsible as shown in Figures 7A-7D. For example, the walls of the receiving portion 5 may include a remotely collapsible bellows mechanism 9.

[0051] A string or cord 6 may be attached to the platform 3 to allow the instrument 1 to be pulled out of the cavity after use. The string 6 may also be used to collapse the walls of the receiving portion 5. The string 6 may be attached to the platform 3 at a single point or there may be multiple attachment points which facilitate manipulation of the instrument 1 and / or the receiving portion 5.

[0052] The therapeutic composition C may also be a single solid delivery form, such as a tablet, capsule, pessary, suppository, etc. This solid form has a specific shape and dimensions. With reference to Figures 8 to 10, the shape of the receptacle portion 5 has a shape that partially corresponds to the shape of the delivery form of the therapeutic composition C.

[0053] The sheath 4 is substantially cylindrical and extends from the non-absorbent platform 3 to the pad 2. Preferably, the sheath 4 is made from or comprises a sheet of polymeric biocompatible material. The sheath 4 is arranged and configured to receive a finger. However, a wider sheath 4 may be provided, which may make insertion difficult if the sheath 4 is loose around the user's finger. The sheath 4 is preferably stretchable in at least the radial direction. A stretchable sheath 4 may be provided to fit snugly and comfortably around the user's finger.

[0054] The length of the sheath 4 between the pad 2 (which remains outside the cavity) and the platform 3 may be adjusted depending on the target area to which the therapeutic composition and / or drug is to be delivered.

[0055] The pad 2 is joined to the sheath 4, particularly at the second end of the sheath 4. The pad 2 includes an aperture 10 that allows the user to insert their finger into the sheath 4. The pad 2 may be substantially circular, oval, rectangular, or any other suitable shape. The pad 2 may be a standard rectangular napkin or a small interlabial pad. In a preferred embodiment, the pad 2 is flat-oval shaped.

[0056] The pad 2 comprises a first surface 2A comprising a layer or sheet of absorbent material. The first surface 2A faces, in use, the patient's cavity to which the therapeutic composition C is delivered. The pad 2 comprises a second surface 2B comprising a layer or sheet of impermeable material. The second surface 2B faces, in use, towards the patient's cavity. The impermeable material of the pad 2 may be the same material as that of the sheath 4. The sheath 4 may extend along the absorbent layer 2A through the aperture 10 to form the impermeable layer 2B.

[0057] The use of the device according to the invention will now be described with reference to the figures, and in particular to FIGS.

[0058] In use, the device 1 is positioned such that the absorbent surface 2A of the pad 2 faces upwards and the impermeable surface 2B faces downwards. The sheath 4 extends from the impermeable surface 2B of the pad 2, with the platform 3 and its receiving portion 5 located at its bottom. Alternatively, the device 1 is positioned such that the absorbent surface 2A of the pad 2 faces upwards and the impermeable surface 2B faces downwards. The sheath 4 extends from the absorbent surface 2A of the pad 2, with the platform 3 and its receiving portion 5 located at its top. In both starting configurations, the receiving portion 5 is in its delivery configuration and positioned to receive the therapeutic composition C therein.

[0059] The shape of the receiving portion 5 of the device 1 is selected based on the delivery form and shape of the therapeutic composition C. If the composition C is a delivery form having a particular shape, the shape and dimensions of the receiving portion 5 at least partially correspond to the shape and dimensions of the delivery form, e.g., cylindrical in the case of a suppository. The receiving portion 5 is preferably made of an extensible material to fix the therapeutic composition C therein. If the composition C is an amorphous form, e.g., granules, creams, lotions, dispersions, gels, etc., the receiving portion 5 forms a container for receiving the composition C therein, e.g., a cup- or bowl-shaped receptacle. The receiving portion 5 is preferably made of a material that is sufficiently rigid to contain the composition while maintaining its shape and to push the platform 3 through the vaginal or rectal cavity. The receiving volume of the receiving portion 5 can be adjusted to contain the amount of composition C required for one application. The sheath 4 or the receiving portion 5 can be provided with a visual indication of the amount of composition C in the receiving portion 5, e.g., one or more lines or graduated lines.

[0060] The therapeutic composition C is positioned and secured within the receiving portion 5 within the sheath 4. The user inserts a finger inside the sheath 4 so that the sheath 4 extends from the absorbent surface 2A of the pad 2. The user pushes the platform 3 so that the instrument 1 is inserted through the cavity hole. The platform 3 advances through the cavity until it reaches the target area where the composition C is to be delivered and applied. The length of the sheath 4 can be adjusted so that the platform 3 is located at the target area within the cavity when the sheath 4 is fully extended. Because the therapeutic composition C is nested within the receiving portion 5, the user can easily and precisely guide the composition through the cavity.

[0061] At the target area, the therapeutic composition is released from the receiving portion 5. This can be done, for example, by inverting the receiving portion 5 inside out, allowing the therapeutic composition to be expelled from the receiving portion 5. Alternatively, the receiving portion 5 (or its walls) can be collapsed by pushing the platform 3 against the distal end of the sheath 4, or by using alternative means of collapsing the receiving portion 5 (or its walls). For example, one or more strings 6 may be coupled to the receiving portion 3 to remotely collapse the walls of the receiving portion 3 (e.g., by pulling the strings 6 from outside the cavity).

[0062] If the instrument 1 includes a therapeutic composition C pre-positioned within the sealed receiving portion 5, the user inserts the sheath 4 and wrapped finger into the cavity until the distal end of the sheath 4 reaches the target area, and applies pressure with the finger to the sealed composition C to break the seal, invert the receiving portion, and release the therapeutic composition C.

[0063] Once delivered, the therapeutic composition C can be applied to the target area. The present invention is particularly advantageous in that the composition can be rubbed onto the cavity walls to improve application of the drug to and absorption of the drug through the cavity walls. This can be done without staining fingers.

[0064] The device 1 may be left in place such that the therapeutic composition C remains in the target area. The platform 3 acts as an anchor and / or plug, for example, until the composition dissolves and is absorbed.

[0065] Any excess fluid leaking out of the cavity is absorbed by the absorbent surface 2A of the pad 2 placed in the cavity hole. The user's fingers are protected from said fluid by the impermeable surface 2B of the pad 2.

[0066] The device 1 is removed by pulling on the pad 2 or the string 6. Pulling on the string 6 inverts the sheath 4 so that the soiled outer surface of the sheath 4 is now inward. The user can hold the device 1 by the unsoiled surface of the sheath 4 or the impermeable surface 2B of the pad 2 and dispose of the device 1.

[0067] The present invention is particularly useful in the delivery and application of therapeutic compositions to relieve the symptoms of menorrhagia. Menorrhagia is a condition in which a woman experiences excessive bleeding during her period. This is due to heavy menstrual bleeding (greater than 80 ml) and / or prolonged menstrual periods (more than 7 days). There are many causes of menorrhagia, including hormonal imbalance, use of intrauterine devices, and complications during pregnancy. There are many treatments available to relieve the symptoms of menorrhagia, including:

[0068] Nonsteroidal and / or non-hormonal medications such as NSAIDs and painkillers can reduce bleeding.

[0069] -There are hormonal medications, such as birth control pills and hormone coils for contraception, but some women with menorrhagia want to have children.

[0070] Surgery if non-invasive procedures fail (e.g. endometrial ablation)

[0071] For those patients who do not wish to use contraceptive procedures or who refuse surgery, the present invention provides a non-invasive procedure involving the delivery of a non-hormonal drug (e.g., a painkiller) to treat the condition in situ. The present invention is particularly advantageous in that it provides treatment during heavy bleeding when application of medication into the vaginal cavity is particularly difficult and messy due to the presence of large amounts of bodily fluids. Once the drug is delivered and applied, the sheath protects the patient's fingers and allows for application and rubbing of the drug against the cavity walls. The external pad soaks any bodily fluids that exit the cavity during drug delivery and application.

[0072] The present invention is particularly useful in the context of infertility treatments, particularly procedures such as in vitro fertilization (IVF), which involve the administration of various drugs such as hormones and anticoagulants, often as pessaries, tablets or injections (subcutaneous or intramuscular). The majority of IVF medications are self-administered, and there is a need for easier, more patient-friendly methods of administration without compromising the delivery of the therapeutic composition.

[0073] IVF procedures require taking progesterone around three times a day. Progesterone cannot be taken orally due to bioavailability issues. To efficiently deliver the required amount of progesterone to the uterus, the dose must be large enough to cause undesirable side effects. Another option is to inject progesterone in situ. However, injecting progesterone into the vagina is impractical, painful, and expensive. The most common route of administration is a vaginal suppository that is inserted with a finger or an applicator. To be effective, the suppository must be held in place so that it dissolves and is absorbed. However, in practice, a precise amount cannot be administered, as most of the progesterone leaks out. A tampon cannot be worn to prevent leakage, otherwise the progesterone will be absorbed into the tampon.

[0074] The present invention allows for an alternative to traditional hard applicators and allows for comfortable, clean delivery and application of suppositories. The suppository can be maintained on the target area until completely dissolved, protecting the fingers so that the dissolved composition can be rubbed into the vaginal cavity for optimal drug delivery.

[0075] The present invention provides a device for delivering and / or applying a therapeutic composition to the rectal or vaginal cavity. From the above description, it can be seen that the device is used as a drug inserter that allows for painless and hygienic delivery and application of a precise amount of a therapeutic composition to a target area.

Claims

1. 1. An apparatus for delivery and / or application of a therapeutic composition in a delivery form into the rectal and / or vaginal cavity, comprising: An externally worn pad; a non-absorbable platform for receiving the delivery form of the therapeutic composition; a sheath joining the platform to the pad, the sheath being capable of receiving a user's finger within the sheath; An apparatus comprising:

2. The device of claim 1 , wherein the therapeutic composition is in a delivery form having a shape, and the platform comprises a receiving portion whose shape corresponds in part to the shape of the delivery form of the therapeutic composition.

3. The device of claim 1 or 2, wherein the platform comprises a receiving portion configured to receive a predetermined amount of a therapeutic composition.

4. The apparatus of any one of claims 1 to 3, wherein the platform comprises a relatively stiff region.

5. The device according to any one of claims 2 to 4, wherein the receiving portion is foldable and / or reversible.

6. The device of any one of claims 1 to 5, wherein the platform comprises means for releasing the therapeutic composition.

7. The device of any one of claims 1 to 6, further comprising a removable string.

8. 8. A device according to any preceding claim, wherein the pad comprises an absorbent layer which, in use, faces the rectal or vaginal cavity and an impermeable layer which, in use, faces away from the rectal or vaginal cavity.

9. The apparatus of any one of claims 1 to 8, wherein the length of the sheath is substantially the same as the distance between the rectum or vaginal opening and the target area within the rectum or vaginal cavity.

10. 10. A kit comprising a therapeutic composition in a delivery form and a device according to any one of claims 1 to 9 for delivering and / or applying the delivery form of said therapeutic composition to a target area within the rectal or vaginal cavity.

11. 11. The kit of claim 10, wherein the therapeutic composition comprises an anti-fungal agent, an anti-bacterial agent, an anti-inflammatory agent, an analgesic agent, a steroid (NSAID) compound, a non-steroidal compound, and / or a hormone.

12. Use of a device according to any one of claims 1 to 9 for the delivery and / or application of a therapeutic composition for the treatment of menorrhagia.

13. Use of a device according to any one of claims 1 to 9 for the delivery and / or application of a therapeutic composition for infertility treatment.

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