Drug delivery and administration devices

Abstract

The present invention relates to a device for delivering and / or applying a delivery form of a therapeutic composition into the rectal and / or vaginal cavity, the device comprising an externally worn pad, a non-absorbent platform for receiving the delivery form of the therapeutic composition, and a sheath joining the platform to the pad such that a user's finger can be received within the sheath.

Description

Technical Field

[0001] The present invention relates to an instrument for the delivery and / or administration of a therapeutic composition in the rectal cavity or vaginal cavity.

[0002] Drug delivery via the vagina or rectal cavity is known to be advantageous in that it can achieve both local and systemic administration of the drug and provides an alternative to conventional 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) are often not appropriate as they usually have to be administered by trained medical personnel.

[0003] Sometimes, drugs (such as creams) for the vagina or rectum are applied with gloved fingers. However, when a finger is inserted into the vagina or rectal cavity, a portion of the drug retained by the vaginal wall or rectal wall as the finger advances through the vaginal cavity is not applied to the target area. Therefore, it is difficult to administer an accurate amount of the drug to the target area.

[0004] It is also possible to insert suppositories, inject drugs using a syringe, or administer drugs by spraying. However, due to their physical function, both the vaginal and rectal cavities tend to reject foreign objects. The drug reaches the target area but is not retained within the cavity to achieve sufficient contact and absorption. This is especially the case when the suppository has to dissolve to allow penetration and absorption of the drug into the cavity wall. Elastic vaginal rings have been developed to hold the leaking drug, but these instruments are often uncomfortable for the patient.

[0005] Many medicinal tampons and sponges are known for drug delivery to the vagina or rectal cavity. These instruments are usually inserted using an applicator or inserter, which is uncomfortable and often difficult to position the tampon properly.

[0006] European Patent Publication EP3 027 155 relates to a drug delivery device comprising a medicated tampon attached to a sanitary napkin by a sheath. The user can insert a finger into the sheath to accurately and non-traumatically push the tampon into the vaginal or rectal cavity. However, there may be medicinal products that require substantial modifications and costs to be incorporated into the tampon, or that simply cannot be incorporated into the tampon at all. [Overview of the project]

[0007] The object of the present invention is to at least mitigate the above-mentioned drawbacks or to provide a substitute for existing products.

[0008] According to a first aspect of the present invention, an instrument is provided for the delivery and / or application of a therapeutic composition in a delivery form to the rectum and / or vaginal cavity, the instrument comprising an externally attached pad, a non-absorbent platform for receiving the delivery form of the therapeutic composition, and a sheath that connects the platform to the pad so that the user's fingers can be received inside the sheath.

[0009] In the context of the present invention, the delivery form may be any commercially available delivery form and includes, but is 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 gaseous form.

[0010] Known rectal or vaginal delivery devices require absorption or combination of the drug and the delivery device. While this facilitates control of drug release, there remains a risk that the entire dose may be held by the delivery device and not delivered to the target area. The present invention enables the delivery of the entire therapeutic composition (i.e., its delivery form) to the target area without associated absorption. The device of the present invention can be said to act more as an applicator 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 the platform.

[0011] Preferably, the sheath comprises the platform. The sheath comprises a first end joined to a pad and a second end with the platform, which can be pushed into the rectum or vaginal cavity by the tip of the user's finger.

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

[0013] In the context of the present invention, the inventors refer to the form of delivery 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, oval, cylindrical, rhomboid, or any other commercially available shape. The shape of the receptor portion preferably partially corresponds to the shape of the delivery form so that the therapeutic composition fits snugly to the receptor portion and can be released at the target area. Preferably, the shape of the receptor portion corresponds to up to half the shape of the delivery form of the therapeutic composition to allow for easy release at the target site.

[0015] If the delivery form is a spherical or oval capsule, the platform may have a hemispherical or oval cup-shaped receiving portion. If the delivery form is rhomboid, the platform may have a tapered receiving portion.

[0016] The receiving portion may be integrally formed within the sheath. For example, the sheath may have a receiving portion (pocket or recess) formed of 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 designed to accommodate the user's finger. This can be achieved by using a sheath of sufficient diameter or a sheath material that can expand to accommodate a 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 molded receiving portion, and the user will experience difficulty pushing the therapeutic composition into the rectum or vaginal cavity.

[0018] Preferably, the platform comprises a receiving portion configured to receive a predetermined amount of 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 failing to be delivered.

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

[0021] In another embodiment, the receiving portion may be equipped with a visual scale or markers so that the user can adjust the amount of therapeutic composition required for treatment. The required amount may depend, for example, on the condition to be treated, the severity of the condition, and patient characteristics such as age, weight, and sex.

[0022] Preferably, the platform includes regions of relatively high rigidity. The platform may be made of a material more rigid than the sheath material, or may be made of a material more rigid than the sheath material. Additional or alternative materials can be used to increase the rigidity of the platform and / or the receiving section. For example, the regions of relatively high rigidity may have a multilayer structure or may be made of different, more rigid materials.

[0023] This allows the platform and / or receptive section to maintain its shape as it enters the rectal or vaginal cavity. If the shape of the receptive section folds, the liquid therapeutic composition contained within it may spill or spread within the sheath, making delivery to the target site more difficult and / or resulting in an inaccurate amount of therapeutic composition delivered to the target site. If the therapeutic composition is in the form of a single solid (e.g., tablet, capsule, suppository, bougie, pessary), the composition may accidentally detach from the receptive platform before reaching the target area.

[0024] The platform's robustness can also be increased by using a higher rigidity region, allowing the detachable string to be attached to the platform.

[0025] Preferably, the receiving portion is foldable and / or reversible. 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 toward the target area, but flexible enough to fold and release the therapeutic composition in the target area. It is preferable that the device according to the present invention does not contain any completely rigid parts so as not to cause injury or discomfort to the user during the insertion and removal process.

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

[0027] In the simplest embodiment, the platform is invertible such that the therapeutic composition is extruded from the receiving portion. For example, the platform comprises a cup or bowl-shaped receptacle that can be turned inside out, or is such a receptacle. Once inverted, the platform can be used to apply the therapeutic composition to the target area, such as in the case of creams, lotions, liquids, granules, etc., such that the composition penetrates the cavity wall.

[0028] The platform may be foldable such that the therapeutic composition is released from the receiving section, or the platform may comprise foldable sidewalls. The platform can comprise one or more strings configured and arranged to be pulled towards the cavity orifice to fold the sidewalls. For example, the platform wall can comprise a bellows mechanism.

[0029] In a preferred embodiment, the receiving portion may be closable, for example, to contain the therapeutic composition during storage, transport, handling and insertion of the instrument. The sheath can be releasably closed, for example, by ultrasonic welding, impulse heat or thermal welding. These techniques are particularly advantageous in that the strength of the seal can be adjusted such that it is strong enough to contain the therapeutic composition prior to use, but can also be opened by pushing the sheath into the patient's cavity. Push the receiving portion into the target area and the user further pushes 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 rectal or vaginal opening and the target area within the rectum or vagina. If the sheath comprises a releasable closure, the length of the sheath between the pad and the closure is preferably substantially the same as the distance between the rectal or vaginal opening and the target area within the rectum or vagina.

[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 rectal or vaginal cavity. Preferably, the string is connected to the platform or to the end of the sheath that constitutes the platform. In another embodiment, the string comprises or forms a loop to enable easy gripping by the user. The loop may be connected to a plurality of points on or adjacent to the platform so as to uniformly manipulate and / or pull the device, the platform, or the receiving portion.

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

[0033] The externally worn pad can comprise an absorbent layer for absorbing excess therapeutic composition or body fluid leaking from the cavity. This is particularly advantageous when applying delivery forms such as liquids, creams or gels that are prone to leakage from the cavity. The externally worn pad can comprise an impermeable layer to prevent the leaking fluid from soiling the user's underwear. 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 comprises one or more weak lines to facilitate holding the pad between the labia or the user's buttocks. Also, the weak lines enable the hygienic disposal of the drug delivery device as the pad can be folded around the weak lines, thereby closing the sheath so that the user does not touch the soiled surface or sheath of the pad.

[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. ​​Preferably, the therapeutic composition comprises an antifungal agent, an antibacterial agent, an anti-inflammatory agent, an analgesic, a steroid (NSAID) compound, a nonsteroidal compound, and / or a hormone.

[0036] According to a further aspect of the present invention, the instrument 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 present invention, the instrument may be used for the delivery and / or application of a therapeutic composition for infertility treatment. [Brief explanation of the drawing]

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

[0039] Referring to Figure 1, an instrument 1 is shown for delivering and / or applying therapeutic composition C in a delivery form into the rectum and / or vaginal cavity, the instrument 1 comprising an externally attached pad 2, a non-absorbent platform 3 for receiving the delivery form of therapeutic composition C, and a sheath 4 that connects the platform 3 to the pad 2, the sheath for receiving the user's finger.

[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 closest to the target area in the vaginal or rectal lumen when in use, and the proximal end is the end of the sheath 4 closest to the cavity opening.

[0041] The primary function of platform 3 is to provide a support surface for the therapeutic composition C, allowing the user to press the therapeutic composition C along the vaginal or rectal cavity. If the user were using latex gloves without platform 3, the therapeutic composition C would separate from the user's fingertips, making efficient and accurate delivery impossible. Platform 3 also allows the user to maintain the therapeutic composition C in the target area of ​​the vaginal or rectal cavity and can act as an internal barrier to prevent the therapeutic composition C from detaching or leaking out of the cavity.

[0042] Preferably, platform 3 is made of a material that is more rigid than the material of sheath 4. Platform 3 may be formed from a single-layer or multi-layer sheet structure. The material of platform 3 may be the same as the material of sheath 4, but may be thicker than the material of sheath 4 to provide relative rigidity. Platform 3 may have a multi-layer structure with structural layers that provide relative rigidity. Also, platform 3 with relatively high structural rigidity facilitates the attachment of strings or cords 6.

[0043] Platform 3 may be configured in a first configuration in which the receptive portion 5 is absent (e.g., in a retrieval configuration and / or delivery configuration, when inverted in a target region within a cavity) and in a second configuration in which the receptive 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 receptive portion 5 may be configured in a receptive configuration that can contain the therapeutic composition C and in a delivery configuration from which the therapeutic composition C is released from the receptive 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 formed integrally within and / or together with the platform 3.

[0045] Preferably, the platform 3 and / or receptacle 5 are made of a material that is rigid enough for the user to press the therapeutic composition C within the receptacle 5, and flexible enough for the user to press the therapeutic composition C out of the receptacle 5. Preferably, the platform 3 and / or receptacle 5 are not rigid enough to injure the patient during the insertion and / or removal process. Preferably, the platform 3 and / or receptacle 5 are made from a semi-flexible sheet of plastic material.

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

[0047] Referring to Figures 2A to 2D, the receiving portion 5 may be cup or bowl-shaped to receive the therapeutic composition in solid or fluid delivery form. The removal string 6 may be connected to the platform 3 to pull the instrument 1 out of the cavity after delivery of the therapeutic composition C.

[0048] Referring to Figures 3A to 3D and Figure 5, the receiving portion 5 may comprise a flat base 7 (e.g., a cylindrical receiving portion 5) and provide a surface to be pressed by the user.

[0049] Referring to Figure 4, the receiving portion 5 may be a recess or a reservoir 8. Referring to Figure 6, the receiving portion 5 may have a visual indicator of the amount of therapeutic composition C contained therein.

[0050] The receiving portion 5 may be reversible (inside out) to release the therapeutic composition C from the receiving portion 5 (as shown in Figures 3A to 3D), or the wall of the receiving portion 5 may be foldable as shown in Figures 7A to 7D. For example, the wall of the receiving portion 5 may be equipped with a remotely foldable bellows mechanism 9.

[0051] A string or cord 6 can 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 fold the wall of the receiving section 5. The string 6 may be attached to the platform 3 at a single point, or there may be multiple attachment points to facilitate the operation of the instrument 1 and / or the receiving section 5.

[0052] Therapeutic composition C may also be in a single solid delivery form, such as a tablet, capsule, pessary, or suppository. This solid form has a specific shape and dimensions. Referring to Figures 8 to 10, the shape of the receiving portion 5 has a shape that partially corresponds to the shape of the delivery form of 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 a polymer biocompatible material. The sheath 4 is positioned and configured to receive a finger. However, it is also possible to provide a wide sheath 4, as looseness around the user's finger can make insertion difficult. Preferably, the sheath 4 is stretchable at least radially. The stretchable sheath 4 may be provided to fit snugly and comfortably to 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 delivered.

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

[0056] Pad 2 comprises a first surface 2A having a layer or sheet of absorbent material. The first surface 2A faces the patient cavity to which the therapeutic composition C is delivered during use. Pad 2 comprises a second surface 2B having a layer or sheet of impermeable material. The second surface 2B faces the patient cavity during use. The impermeable material of Pad 2 may be the same material as that of Sheath 4. Sheath 4 can extend through the aperture 10 along the absorbent layer 2A to form the impermeable layer 2B.

[0057] The use of the apparatus according to the present invention will be described with reference to the figures, particularly Figures 1, 2, 3, 7, 11, and 12.

[0058] When in use, the device 1 is positioned so that the absorbent surface 2A of the pad 2 faces upward and the impermeable surface 2B faces downward. The sheath 4 extends from the impermeable surface 2B of the pad 2, and the platform 3 and its receiving portion 5 are placed at its bottom. Alternatively, the device 1 is positioned so that the absorbent surface 2A of the pad 2 faces upward and the impermeable surface 2B faces downward. The sheath 4 extends from the absorbent surface 2A of the pad 2, and the platform 3 and its receiving portion 5 are placed at its top. In both initial configurations, the receiving portion 5 is in its delivery configuration and is arranged to receive the therapeutic composition C therein.

[0059] The shape of the receptacle 5 of the device 1 is selected based on the delivery form and shape of the therapeutic composition C. If the composition C is in a delivery form with a specific shape, the shape and dimensions of the receptacle 5 correspond at least partially to the shape and dimensions of the delivery form, for example, in the case of a suppository, it is cylindrical. The receptacle 5 is preferably made of an extensible material to hold the therapeutic composition C in it. If the composition C is amorphous, for example, granules, cream, lotion, dispersion, gel, etc., the receptacle 5 forms a container for receiving the composition C in it, for example, a cup or bowl-shaped receptacle. The receptacle 5 is preferably made of a material that is rigid enough to contain the composition while maintaining its shape and to press the platform 3 through the vaginal or rectal cavity. The receptive volume of the receptacle 5 can be adjusted to contain the amount of composition C required for one application. The sheath 4 or receptacle 5 may have a visual indicator of the amount of composition C in the receptacle 5, for example, one or more lines or graduated lines.

[0060] The therapeutic composition C is positioned and secured inside the receiving portion 5 within the sheath 4. The user inserts their finger into the inside of 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 to which the composition C is delivered and applied. The length of the sheath 4 can be adjusted so that the platform 3 is positioned in 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 accurately guide the composition through the cavity.

[0061] In the target region, the therapeutic composition is released from the receptor 5. This can be done, for example, by inverting the receptor 5 inward so that the therapeutic composition is discharged from the receptor 5. Alternatively, the receptor 5 (or its wall) can be folded by pushing the platform 3 against the distal end of the sheath 4, or by using alternative means to fold the receptor 5 (or its wall). For example, one or more strings 6 may be attached to the receptor 3 to remotely fold the wall of the receptor 3 (for example, by pulling the strings 6 from the outside of the cavity).

[0062] If the instrument 1 includes a therapeutic composition C pre-positioned within a 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. Pressure is applied 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, 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 wall to improve the application of the drug to the cavity wall and the absorption of the drug through the cavity wall. This can be done without getting your fingers dirty.

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

[0065] Excess fluid leaking from 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 the fluid by the impermeable surface 2B of the pad 2.

[0066] The device 1 is removed by pulling either the pad 2 or the string 6. By pulling the string 6, the sheath 4 is inverted, with the soiled outer surface of the sheath 4 facing inward. The user can then dispose of the device 1 by holding it with the clean surface of the sheath 4 or the impermeable surface 2B of the pad 2.

[0067] The present invention is particularly useful in the delivery and application of therapeutic compositions for alleviating the symptoms of menorrhagia. Menorrhagia is a condition in which women experience excessive bleeding during menstruation. This is due to heavy menstrual bleeding (more than 80 ml) and / or prolonged menstruation (more than 7 days). The causes of menorrhagia are varied, including hormonal imbalances, the use of intrauterine devices, and complications during pregnancy. Many treatments available to alleviate the symptoms of menorrhagia include:

[0068] Nonsteroidal and / or nonhormonal drugs, such as NSAIDs and analgesics, can reduce bleeding.

[0069] There are hormonal treatments, such as birth control pills and hormonal coils, but some patients with heavy menstrual bleeding still want to have children.

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

[0071] For patients who do not wish to use contraceptives or refuse surgery, the present invention provides a non-invasive procedure involving the delivery of a non-hormonal drug (e.g., an analgesic) to treat symptoms in situ. The present invention is particularly advantageous in performing the procedure during heavy bleeding when the application of the drug into the vaginal cavity is particularly difficult and cumbersome due to the presence of a large amount of bodily fluids. Once the drug is delivered and applied, the sheath protects the patient's fingers and allows for the application and rubbing of the drug against the cavity walls. An external pad is immersed in any bodily fluids leaving the cavity during the delivery and application of the drug.

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

[0073] IVF treatment requires taking progesterone approximately 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 dosage must be sufficient to avoid undesirable side effects. Another option is injecting progesterone in situ. However, injecting progesterone into the vagina is impractical, painful, and costly. The most common route of administration is vaginal suppositories inserted with a finger or applicator. For effectiveness, the suppository must be held in place to dissolve and be absorbed. However, in practice, a significant portion of the progesterone leaks out, making it impossible to administer the exact amount. Wearing a tampon to prevent leakage is also not feasible, as the progesterone would be absorbed by the tampon.

[0074] This invention provides an alternative to conventional rigid applicators, enabling comfortable and clean delivery and application of suppositories. The suppository can be retained in the target area until completely dissolved, and the fingers are protected, allowing the dissolved composition to be rubbed into the vaginal cavity to optimize drug delivery.

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

Claims

1. In a device for the delivery and / or application of therapeutic compositions in a delivery form to the rectum and / or vaginal cavity, Externally mounted pad (2), A non-absorbable platform (3) for receiving the delivery form of the therapeutic composition, A sheath (4) for joining the platform to the pad, the sheath (4) capable of receiving the user's fingers inside the sheath, The apparatus (1) is provided with the platform (3) having a region that is more rigid than the sheath (4).

2. The device (1) according to claim 1, wherein the therapeutic composition is a delivery form having a shape, and the platform (3) comprises a receiving portion (5) whose shape partially corresponds to the shape of the delivery form of the therapeutic composition.

3. The device (1) according to claim 1 or 2, wherein the platform (3) comprises a receiving portion (5) configured to receive a predetermined amount of therapeutic composition.

4. The device (1) according to any one of claims 2 to 3, wherein the receiving portion (5) is foldable and / or reversible.

5. The device (1) according to any one of claims 1 to 4, wherein the platform (3) comprises means for releasing the therapeutic composition.

6. The apparatus (1) according to any one of claims 1 to 5, further comprising a detachable string (6).

7. The device (1) according to any one of claims 1 to 6, wherein the pad (2) comprises an absorbent layer that faces the rectum or vaginal cavity when in use and an impermeable layer that faces away from the rectum or vaginal cavity when in use.

8. The instrument (1) according to any one of claims 1 to 7, wherein the length of the sheath (4) is substantially the same as the distance between the rectum or vaginal opening and the target region within the rectal or vaginal cavity.

9. A kit comprising a therapeutic composition in a delivery form, and an instrument (1) according to any one of claims 1 to 8 for delivering and / or applying the therapeutic composition in its delivery form to a target area in the rectum or vaginal cavity.

10. The kit according to claim 9, wherein the therapeutic composition comprises an antifungal agent, an antibacterial agent, an anti-inflammatory agent, an analgesic, a steroid (NSAID) compound, a nonsteroidal compound, and / or a hormone.

11. The apparatus (1) according to any one of claims 1 to 8, wherein the apparatus comprises a composition that improves infertility.

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