Medical device, kit, method and anti-inflammatory substance

Abstract

The present invention relates to a medical device (10) configured to be at least partially placed in a patient's body through the patient's vagina for treating dysmenorrhea and / or endometriosis. The medical device (10) comprises at least one carrier (12); at least one release element (14) at least partially attached to the carrier (12) and made of at least one biodegradable material; and at least one anti-inflammatory substance (16) embedded in the release element (14) such that the anti-inflammatory substance (16) can be released in a patient when the medical device (10) is placed in the patient. The invention also relates to a kit, a method and an anti-inflammatory substance.

Description

[0001] There are a variety of known disorders related to the female reproductive system, many of which can cause discomfort, particularly, at least in some cases, severe discomfort. For example, dysmenorrhea and endometriosis are known disorders of the female reproductive system, with symptoms ranging from mild to severe.

[0002] Dysmenorrhea, also known as perimenstrual pain or period pain, is a condition estimated by the World Health Organization (WHO) to affect up to 81% of women during their reproductive years. Clinically, dysmenorrhea can be divided into primary and secondary dysmenorrhea. Primary dysmenorrhea, the most common form of dysmenorrhea, has no obvious cause, such as an underlying anatomical abnormality. Instead, primary dysmenorrhea appears to be based on interacting genetic, epigenetic, and environmental factors. Secondary dysmenorrhea, on the other hand, is caused by an identifiable underlying condition, the most common of which is endometriosis. Therefore, endometriosis may exacerbate dysmenorrhea and worsen symptoms in affected women.

[0003] The detailed mechanisms of dysmenorrhea remain incompletely understood (see Ferries-Rowe et al. (2020): Primary Dysmenorrhea: Diagnosis and Therapy). However, it is clear that abnormal prostaglandin synthesis and prostaglandin signaling are central to the disorder. In affected women, hormonal changes—the normal drop in progesterone shortly before menstruation—lead to increased production of inflammatory mediators, such as prostaglandins. Prostaglandins may cause constriction of small uterine blood vessels, leading to tissue ischemia and discomfort, such as pain. Furthermore, prostaglandins are directly involved in pain signaling. While some external factors, such as reproductive history, nutrition, and physical activity, may influence uterine prostaglandin signaling and, therefore, pain generation, the development of primary dysmenorrhea is likely determined by innate and genetic factors.

[0004] Endometriosis is the most common cause of secondary dysmenorrhea, affecting approximately 6-10% of women. The hallmark of endometriosis is the presence of the endometrium (the lining of the uterine cavity) in locations outside the uterine cavity in affected women. However, most importantly, endometriosis is characterized by chronic, cyclical exacerbations of inflammation in the uterus and other pelvic tissues. This inflammation is more pronounced than in primary dysmenorrhea. Chronic, recurring episodes of inflammation during each menstrual period can lead to progressive tissue destruction and fibrosis.

[0005] The severity of dysmenorrhea, whether primary or secondary, can range from mild pelvic discomfort to disabling pain, with up to 29% of women experiencing this symptom. In a recent large survey of 42,879 women, 85% of participants reported experiencing abdominal pain during menstruation (see Schoep et al., “The impact of menstrual symptoms on everyday life: a survey among 42,879 women,” Am J Obstet Gynecol, 220(6):569, doi: 10.1016 / j.ajog.2019.02.048). In the United States, it is estimated that 10–30% of working or school women with dysmenorrhea lose one to two workdays / schooldays each month due to dysmenorrhea, which equates to approximately 600 million work hours lost annually and an economic cost of approximately $2 billion annually (see Ferries-Rowe et al., Primary Dysmenorrhea: Diagnosis and Therapy, Obstet Gynecol, 136(5):1047–1058, doi:10.1097 / AOG.0000000000004096). Thus, the burden of dysmenorrhea on the individual woman and the economy is considerable. Furthermore, there is currently no cure for dysmenorrhea. Therefore, improving care for affected women should be a major public health priority.

[0006] While treatments for dysmenorrhea and / or endometriosis exist, existing treatments suffer from several drawbacks. Specifically, the effectiveness of existing treatments may be insufficient to alleviate the discomfort caused by dysmenorrhea and / or endometriosis. The consequences of inadequate treatment can be severe, as it can lead to chronic pain. Furthermore, many existing treatments are prescribed and / or used on an "as needed" basis—that is, when dysmenorrhea symptoms are acute or imminent. This forces patients to frequently and proactively seek treatment, or at least proactively implement one or more countermeasures, when dysmenorrhea symptoms are acute or imminent, making treatment more cumbersome for affected women. This can also limit the effectiveness of treatment. Furthermore, many existing treatments may cause one or more side effects, particularly one or more relatively severe side effects. Existing treatments for dysmenorrhea include hormonal therapies, which can severely interfere with numerous organ systems and often cause unacceptable side effects. Another major existing treatment for dysmenorrhea is the systemic administration of anti-inflammatory drugs (e.g., oral pills). Systemic administration of these drugs also often results in adverse effects on non-reproductive organs, such as the gastrointestinal tract and / or kidneys. During systemic drug administration, these organs are exposed to high concentrations of active anti-inflammatory drugs, while only a small fraction of the active drug affects target organs in the reproductive tract.

[0007] The prior art has not addressed these shortcomings, or at least has not addressed them adequately.

[0008] US10064815B2 discloses a method for treating various progesterone-related diseases by vaginally administering pullulan capsules and filler formulations comprising one or more antiprogestins dispersed in a mixture of isopropyl palmitate or isopropyl myristate and polyethylene glycol.

[0009] US2014 / 030313A1 discloses a method for relieving menstrual pain and reducing menstrual blood loss in women, comprising administering a first therapeutically effective amount of a nonsteroidal anti-inflammatory drug for relieving dysmenorrhea and a second therapeutically effective amount of an active agent for reducing menstrual blood loss into the female vagina.

[0010] WO2019 / 119059A1 discloses a method for treating dysmenorrhea-related pain in a subject, the method comprising administering to the subject an effective amount of an agent that reduces spinal glial cell activation, thereby treating the subject's pain and / or pain-related symptoms.

[0011] It is therefore an object of the present invention to provide an improved means for treating dysmenorrhea and / or endometriosis, in particular a means for treating dysmenorrhea that addresses one or more of the above-mentioned disadvantages.

[0012] This object is achieved by a medical device according to a first aspect of the present disclosure, as defined by the features in claim 1. Preferred embodiments are defined by the features of the respective dependent claims.

[0013] The medical device may be configured to be at least partially inserted into a patient through the patient's vagina to treat dysmenorrhea and / or endometriosis.

[0014] The medical device may include at least one carrier and at least one release element. The release element may be made of at least one biodegradable material, preferably at least one biodegradable biopolymer. The medical device may also include at least one anti-inflammatory substance. The anti-inflammatory substance may be embedded and / or trapped in the release element. Alternatively, the anti-inflammatory substance may be incorporated into the medical device in a variety of alternative ways. For example, the anti-inflammatory substance may be directly attached to the carrier, in which case the release element, which serves as an intermediate structure connecting the carrier and the anti-inflammatory substance, may be omitted. Alternatively or additionally, the anti-inflammatory substance may be coated on a surface (preferably an outer surface) of the release element and / or on a surface (preferably an outer surface) of the carrier.

[0015] The release element can be at least partially attached (preferably securely attached) to the carrier so that the anti-inflammatory substance can be released in the patient's body when the medical device is placed in the patient's body. Alternatively or additionally, the release element and the carrier can be configured so that the release element can be attached (preferably securely attached) to the carrier so that the release element remains attached to the carrier after the medical device has been placed in the patient's body (preferably in the patient's uterus). In other words, after the medical device is placed in the patient's body and throughout the duration (i.e., the treatment period), the release element and the carrier can be configured to remain in the patient's body, preferably as a single coherent unit, wherein the anti-inflammatory substance is released in the patient's body. After the treatment is completed, the carrier and possibly some remnants of the release element (in the event that the anti-inflammatory substance has not been completely released from the release element) can be removed from the patient's body and can be replaced with another medical device (e.g., the medical device described herein).

[0016] The anti-inflammatory substance can prevent or at least reduce the production of inflammatory agents (e.g., prostaglandins) and / or can prevent or at least reduce pain signaling caused by inflammatory agents (e.g., prostaglandins). This can reduce pain and / or discomfort in patients suffering from dysmenorrhea and / or endometriosis.

[0017] A medical device comprising an anti-inflammatory substance and deployable through the patient's vagina into the patient's body (e.g., into the patient's uterus, more specifically, the patient's uterine cavity) is provided, wherein the anti-inflammatory substance is released and applied primarily locally to one or more female reproductive organs, particularly within the patient's uterus, and particularly at or at least near one or more areas of the patient's body affected by a disease.

[0018] The localized delivery and application of such anti-inflammatory substances can reduce systemic adverse effects of the anti-inflammatory substances, for example, compared to oral and / or injectable therapeutic substances. This can also increase the effectiveness and / or efficiency of the anti-inflammatory substances in relieving dysmenorrhea and / or endometriosis symptoms, for example, compared to oral and / or injectable therapeutic substances.

[0019] Furthermore, because sustained release of anti-inflammatory substances can initially prevent or at least limit the production of inflammatory mediators (e.g., prostaglandins) locally (i.e., at the site of discomfort and / or pain), the dosage of the anti-inflammatory substance can be reduced, for example, when inflammatory mediators have already accumulated and caused symptoms, compared to oral and / or injected therapeutic substances. This may reduce, or at least mitigate the risk of, adverse reactions caused by the anti-inflammatory substance. Furthermore, because known anti-inflammatory therapies that are prescribed and / or used regularly (e.g., on an "as needed" basis) are often taken after pain and / or discomfort has already occurred, such therapies may be less effective (at least based on similar or identical dosages) than the therapies provided by the medical devices described herein.

[0020] Furthermore, the medical device can release the anti-inflammatory substance into the patient's body continuously, or at least over a certain period of time, while the medical device remains in the patient's body. Thus, the patient does not need to reapply the medical device, at least for an extended period of time, such as at least 6 or 12 months, preferably at least 24 months. Thus, the medical device described herein can provide a more reliable, convenient, patient-friendly, and / or effective treatment for dysmenorrhea and / or endometriosis, particularly compared to known treatments that are prescribed and / or used on a regular basis, such as for "on-demand" use. In particular, it has been found that pain control, particularly pain control for dysmenorrhea and / or endometriosis, particularly when using an anti-inflammatory substance, can be more effective and / or efficient if taken in advance, i.e., before the pain and / or discomfort develops.

[0021] Hormonal contraceptive methods, such as oral contraceptives or hormone-releasing intrauterine devices (IUDs), are commonly used to treat dysmenorrhea. However, these methods can cause one or more side effects, sometimes severe. For example, the primary hormones estrogen and progestogen used can cause side effects, including but not limited to mood changes (including depression), weight gain, and blood clots. Consequently, certain treatments are contraindicated for many women, such as those who are overweight, smokers, or have a history of thrombosis, arterial hypertension, liver disease, or migraines. Therefore, providing medical devices containing anti-inflammatory substances could reduce the side effects of treatment, or at least minimize the risk of side effects, compared to, for example, hormonal contraceptive methods.

[0022] The release element and the carrier can be attached to each other by any suitable means to provide the desired degree of attachment between the release element and the carrier. The release element and the carrier can be attached to each other in a fixed manner, i.e., such that the release element and the carrier are immovable relative to each other. In particular, the carrier and the release element can be securely fused together, at least once the carrier and the release element are assembled. Alternatively, the attachment between the release element and the carrier can allow for some movement between the release element and the carrier.

[0023] The release element and the carrier may be permanently connected to each other, ie such that the release element cannot be removed from the carrier without compromising the structural integrity of the carrier and the release element.

[0024] Alternatively, the release element and the carrier can be detachably attached to each other. For example, this allows the carrier and the release element to be assembled and disassembled, preferably multiple times. This allows, for example, the release element and the carrier to be provided as a kit, which is assembled by, for example, the user and / or medical personnel. For example, this allows the carrier to be configured as a reusable component that can be reloaded with one or more replacement release elements, for example, once the anti-inflammatory substance of the original release element has been completely consumed. In addition, this allows the carrier to be more easily combined with a variety of different release elements, and vice versa, for example, to accommodate different patient anatomies, for example by providing a variety of different release elements and / or a variety of different carriers having different shapes, sizes, materials, etc. In addition, this allows a variety of release elements having different anti-inflammatory substances to be combined with one or more carriers, each of which differs in one or more characteristics, such as the amount and / or weight of the anti-inflammatory substance, the type of anti-inflammatory substance, the rate of release of the anti-inflammatory substance, etc.

[0025] The medical device can be configured to remain securely positioned within the patient's body, preferably within the patient's uterus, and more specifically within the patient's uterine cavity, for an extended period of time, including during daily activities (e.g., exercise). To securely retain the medical device within the patient's body, the medical device (e.g., the carrier and / or the release element) can include one or more securing mechanisms (e.g., one or more engagement arms) configured to engage at least a portion of an anatomical structure within the patient's body to secure the medical device within the patient's body.

[0026] The carrier may be made of a material that is non-resorbable and / or non-absorbable and / or non-degradable by the patient's body. Preferably, the carrier is made of plastic, such as low-density polyethylene (LDPE).

[0027] Preferably, the at least one anti-inflammatory substance comprises at least one non-hormonal and / or non-steroidal anti-inflammatory substance, preferably celecoxib and / or diclofenac. However, a variety of alternative anti-inflammatory substances may also be used. For example, alternative anti-inflammatory substances may include one or more of ibuprofen, ketoprofen, mefenamic acid, naproxen, piroxicam, and indomethacin. Alternative non-hormonal anti-inflammatory substances may include nitroglycerin, which may require lower concentrations than other anti-inflammatory substances (particularly non-hormonal anti-inflammatory substances).

[0028] Preferably, the medical device is configured to be inserted into at least a portion of a patient's uterus, more specifically, into the patient's uterine cavity. In other words, the medical device can be configured as an intrauterine device. This allows for a more targeted and localized release and application of the anti-inflammatory substance, i.e., within the patient's uterus, to more precisely target the source of discomfort and / or pain caused by dysmenorrhea and / or endometriosis.

[0029] Preferably, the medical device does not contain hormonal substances. As mentioned above, this can prevent side effects caused by hormonal substances, for example, compared to hormonal-based contraceptive methods such as oral contraceptives or hormone-releasing intrauterine devices (IUDs).

[0030] Preferably, when the medical device is placed in a patient, the medical device is configured to continuously release the anti-inflammatory substance within the patient at a rate greater than zero. This allows the medical device to continuously release the anti-inflammatory substance within the patient while the medical device remains in the patient, which, as described above, can provide more effective and / or efficient relief of discomfort and / or pain to the patient.

[0031] Preferably, the release element is configured to interact with the patient's internal environment to trigger the release of the anti-inflammatory substance. Preferably, the release element is configured to continuously release the anti-inflammatory substance thereafter. For example, the release of the anti-inflammatory substance can be activated by the aqueous and / or warm environment in the patient's body.

[0032] Preferably, the release element is configured to at least partially disintegrate within the patient's body when the release element is attached to the carrier and / or when the medical device is placed in the patient's body. The anti-inflammatory substance may be at least partially embedded in the release element, such that when the medical device is placed in the patient's body, the anti-inflammatory substance is released into the patient's body as the release element disintegrates. Alternatively, the release element may not disintegrate, at least not to release the anti-inflammatory substance. Instead, the anti-inflammatory substance may be applied to a portion of the carrier and / or the release element, for example as at least one coating, and the anti-inflammatory substance may be released / expelled from the release element.

[0033] Preferably, the anti-inflammatory substance is dispersed within the release element, which is preferably firmly attached to the carrier.

[0034] Preferably, the release element is configured to at least partially degrade within the patient at a preferably constant rate when the medical device is placed within the patient, such that the anti-inflammatory substance is released into the patient as the release element degrades.

[0035] Preferably, the release element comprising the anti-inflammatory substance is configured as a solid component. The release element may be at least partially hollow. The release element may be configured as a tube that is configured to at least partially surround at least a portion of the carrier to which the release element is attached. The term "solid" refers to the aggregated state of the release element comprising the anti-inflammatory substance. Providing the release element comprising the anti-inflammatory substance in a solid aggregated state may facilitate administration of the medical device into the patient, for example, by providing the medical device with a more robust structure. Furthermore, this may enable more precise control of the release of the anti-inflammatory substance, for example, which may allow the dose and / or release rate of the anti-inflammatory substance to be reduced.

[0036] Preferably, the carrier comprises at least one receiving portion configured to securely receive the release element. The receiving portion may be configured as an elongated member configured to be at least partially received within the release element, or vice versa. Preferably, the release element comprises at least one cavity configured to at least partially receive the receiving portion of the carrier, or vice versa.

[0037] Preferably, the diameter of the receiving portion does not exceed 2.4 mm, more preferably does not exceed 2.2 mm, more preferably does not exceed 2 mm, more preferably does not exceed 1.8 mm, more preferably does not exceed 1.6 mm, more preferably does not exceed 1.4 mm, more preferably does not exceed 1.2 mm, and more preferably does not exceed 1 mm. This can limit the size of the carrier, and thus the size of the medical device, which can reduce the discomfort that the medical device may cause to the patient. The diameter (i.e., width) of the receiving portion can be configured to be relatively small, for example, according to the values ​​determined above, because the release element can be configured to provide stability to the carrier within the receiving portion, for example, by extending around and / or along at least a portion of the receiving portion. In fact, the release element can partially or completely replace the receiving portion.

[0038] Preferably, the medical device includes at least one securing mechanism configured to secure the medical device within at least a portion of the patient's uterus, more specifically within the patient's uterine cavity. The securing mechanism may be configured in any manner suitable for engaging with at least a portion of the patient's uterus to secure the medical device within at least a portion of the patient's uterus. The securing mechanism may be provided by a carrier. Preferably, the carrier including the securing mechanism may be integrally formed; alternatively, the carrier may comprise a plurality of assembled components. Alternatively, or in addition, the securing mechanism may be provided by a release element and / or one or more further components of the medical device.

[0039] Preferably, the securing mechanism comprises at least one arm configured to engage with the patient's uterine wall to secure the medical device within the patient's uterus. The arm may be provided by the carrier. For example, the arm may extend from at least one main portion of the carrier, such as from the receiving portion. Preferably, the receiving portion and the arm may be integrally formed. Alternatively, the receiving portion and the arm may be configured as separate components that are assembled together. The arm may be flexible, such as bendable and / or stretchable, preferably elastically deformable, such as to facilitate deployment of the medical device into the patient's body and / or to facilitate securing the medical device within the patient's body.

[0040] Preferably, the securing mechanism includes at least two arms configured to engage substantially opposite sides of the patient's uterus to secure the medical device within the patient's uterus. This can further reduce the risk of the medical device shifting and / or dislodging from its intended position within the patient's uterus. The arms can be flexible, e.g., bendable and / or stretchable, and are preferably elastically deformable.

[0041] Preferably, the arm is attached to the receiving portion such that the arm and the receiving portion are configured substantially in the shape of a Y or T. This may provide a shape that corresponds to or at least fits the general shape of a female uterine cavity, facilitating secure placement of the medical device within the patient's cavity.

[0042] Preferably, the release element comprising the embedded anti-inflammatory substance is at least partially attached to at least one arm, preferably to both arms. This allows the area of ​​the release surface of the medical device (from which the anti-inflammatory substance can be released) to be tailored to desired needs, for example by increasing the area of ​​the release surface of the medical device to provide, for example, a more effective and / or efficient treatment.

[0043] Preferably, the medical device is configured to release the anti-inflammatory substance in the patient's body, more preferably for a sustained release of at least 10 months, more preferably at least 11 months, more preferably at least 12 months, more preferably at least 13 months, more preferably at least 14 months, more preferably at least 15 months, more preferably at least 16 months, more preferably at least 17 months, more preferably at least 18 months, more preferably at least 19 months, more preferably at least 20 months, more preferably at least 21 months, more preferably at least 22 months, more preferably at least 23 months, and more preferably at least 24 months. This period of time allows a patient to use a single medical device for an extended period of time (i.e., the period described above) without having to reapply another medical device within the corresponding period of time. This may provide a more reliable, convenient, patient-friendly, and / or effective treatment for dysmenorrhea and / or endometriosis.

[0044] Preferably, the medical device is configured to release the anti-inflammatory substance, more preferably a sustained release, at a daily release rate of less than 3 mg / day, more preferably less than 2.8 mg / day, more preferably less than 2.6 mg / day, more preferably less than 2.4 mg / day, more preferably less than 2.2 mg / day, more preferably less than 2 mg / day, more preferably less than 1.8 mg / day, more preferably less than 1.6 mg / day, more preferably less than 1.4 mg / day, more preferably less than 1.2 mg / day, more preferably less than 1 mg / day. Limiting the daily release rate to the above values ​​may allow for more precise control of the release of the anti-inflammatory substance and / or reduce the patient's exposure to the anti-inflammatory substance per unit time, for example, compared to known treatments where the anti-inflammatory substance is prescribed and / or used on a regular "as needed" basis. This may reduce potential side effects and / or toxicity of the anti-inflammatory substance.

[0045] Preferably, the medical device is configured to release the anti-inflammatory substance at a daily release rate in the range of 0.2 mg / day to 1 mg / day, more preferably 0.4 mg / day to 1 mg / day, more preferably 0.6 mg / day to 1 mg / day, more preferably 0.8 mg / day to 1 mg / day.

[0046] Preferably, the medical device is configured to release the anti-inflammatory substance with a daily variation in the daily release rate of no more than 0.3 mg / day, more preferably no more than 0.2 mg, and more preferably no more than 0.1 mg. This can allow for more precise control of the release of the anti-inflammatory substance, which can reduce potential side effects of the anti-inflammatory substance and / or can improve the effectiveness and / or efficiency of treatments performed by the medical devices described herein.

[0047] Preferably, the medical device is provided with at least 100 mg, more preferably at least 150 mg, more preferably at least 200 mg, more preferably at least 250 mg, more preferably at least 300 mg, more preferably at least 350 mg, more preferably at least 400 mg, more preferably at least 450 mg, and more preferably at least 500 mg of the anti-inflammatory substance. It may be desirable to strike a balance between the weight of the medical device (which may desirably be relatively low) and the longevity and / or effectiveness of the anti-inflammatory substance, for example, by selecting an appropriate / desired amount / weight of the anti-inflammatory substance. Thus, the weight of the anti-inflammatory substance may be selected accordingly, for example, based on the values ​​determined above.

[0048] Preferably, the medical device further includes a withdrawal device configured to enable withdrawal of the medical device from the patient's body. The withdrawal device may be configured as one or more graspable elements capable of being grasped by a human (e.g., the patient and / or medical personnel). The withdrawal device may allow for safe and secure retrieval of the medical device from the patient's body. For example, the withdrawal device may include one or more elongated elements, such as one or more wires, that extend into or into the patient's cervical canal and / or vagina when the medical device is in an operational state within the patient's body. The withdrawal device is preferably made of a material that is non-absorbable and / or non-resorbable and / or non-degradable by the patient's body.

[0049] Preferably, the medical device further comprises at least one hemostatic agent, which is preferably attached to the carrier. This can stop or at least reduce bleeding that may occur at or near the location where the medical device is deployed in the patient's body, for example due to potential interactions between the patient's anatomy and the medical device, and / or due to increased menstrual bleeding.

[0050] The object mentioned at the outset is also solved by a kit according to the second aspect of the disclosure, as defined by the features of claim 13. Features, embodiments and advantages described above with respect to the medical device according to the first aspect of the disclosure also apply correspondingly to the kit.

[0051] The kit may include at least one carrier configured to be at least partially inserted into a patient's body through the patient's vagina and at least one release element. The release element may be made of at least one biodegradable material.

[0052] The kit may further comprise at least one anti-inflammatory substance. The anti-inflammatory substance may be embedded in the release element.

[0053] The release element may be configured to be at least partially attachable to the carrier such that when the release element is attached to the carrier and the carrier including the release element is placed in a patient, the anti-inflammatory substance may be released in the patient.

[0054] The object mentioned at the outset can also be achieved by a method for treating at least one disorder of the female reproductive system of a patient, preferably by means of a medical device, preferably by means of the aforementioned medical device for treating dysmenorrhea and / or endometriosis. The features, embodiments, and advantages described above with respect to the medical device according to the first aspect of the present disclosure also apply to the method accordingly.

[0055] The method is configured to treat at least one disorder of the female reproductive system of a patient, preferably dysmenorrhea and / or endometriosis, preferably by means of a medical device according to any of the embodiments described herein.

[0056] The method may include at least partially inserting a medical device into a patient's body via the patient's vagina, the medical device comprising at least one carrier, at least one release element made of at least one biodegradable material, and at least one anti-inflammatory substance embedded in the release element. The release element may be attached to the carrier, preferably securely attached to the carrier. The release element may remain attached to the carrier after the medical device is inserted into the patient's body, preferably within the patient's uterus.

[0057] The method may further include releasing an anti-inflammatory substance in the patient's body while the medical device is positioned within the patient's body.

[0058] The object mentioned at the outset is also solved by an anti-inflammatory substance according to a fourth aspect of the disclosure, as defined by the features of claim 14. The features, embodiments and advantages described above with respect to the medical device according to the first aspect of the disclosure also apply correspondingly to the anti-inflammatory substance.

[0059] The anti-inflammatory substance is preferably a non-steroidal anti-inflammatory substance and / or a non-hormonal anti-inflammatory substance. The anti-inflammatory substance may be diclofenac and / or celecoxib. However, a variety of alternative anti-inflammatory substances may also be used. For example, alternative anti-inflammatory substances may include one or more of ibuprofen, ketoprofen, mefenamic acid, naproxen, piroxicam, and indomethacin. Alternative (non-hormonal) anti-inflammatory substances may include nitroglycerin, which may require even lower concentrations than other anti-inflammatory substances (particularly non-hormonal anti-inflammatory substances). Anti-inflammatory substances can be used to treat dysmenorrhea and / or endometriosis, preferably using a medical device according to any embodiment described herein.

[0060] The anti-inflammatory substance may be embedded in at least one release element made of at least one biodegradable material. The release element may be at least partially attached to at least one carrier. The carrier including the release element and the embedded anti-inflammatory substance may be at least partially placed into the patient's body through the patient's vagina. When the carrier including the release element is placed into the patient's body, the anti-inflammatory substance may be released into the patient's body.

[0061] The following aspects provide preferred embodiments of the present disclosure:

[0062] 1. A medical device configured to be at least partially inserted into a patient's body through the patient's vagina for treating dysmenorrhea and / or endometriosis, the medical device comprising:

[0063] at least one carrier,

[0064] At least one anti-inflammatory substance is at least partially attached to the carrier, so that when the medical device is placed in the patient's body, the anti-inflammatory substance can be released in the patient's body.

[0065] 2. The medical device according to aspect 1, further comprising at least one release element, said release element being at least partially attached to said carrier, wherein said anti-inflammatory substance is attached to said release element, preferably at least partially embedded within said release element.

[0066] 3. Medical device according to aspect 2, wherein the release element is at least partially, preferably completely, made of at least one biodegradable material.

[0067] 4. The medical device according to any of the preceding aspects, wherein the at least one anti-inflammatory substance comprises at least one non-hormonal and / or non-steroidal anti-inflammatory substance, preferably celecoxib and / or diclofenac.

[0068] 5. The medical device according to any one of the preceding aspects, wherein the at least one anti-inflammatory substance comprises diclofenac and / or celecoxib.

[0069] 6. The medical device according to any of the preceding aspects, wherein the medical device is configured to be inserted into at least a portion of a patient's uterus.

[0070] 7. The medical device according to any one of the preceding aspects, wherein the medical device does not contain hormonal substances.

[0071] 8. The medical device according to any of the preceding aspects, wherein the medical device is configured to continuously release the anti-inflammatory substance in the patient's body at a rate greater than zero when the medical device is placed in the patient's body.

[0072] 9. The medical device according to any one of aspects 2 to 8, wherein the release element is configured to interact with the environment in the patient's body to trigger the release of the anti-inflammatory substance, preferably wherein the release element is configured to continuously release the anti-inflammatory substance thereafter.

[0073] 10. A medical device according to any one of aspects 2 to 9, wherein, when the medical device is placed in a patient's body, the release element is configured to at least partially disintegrate in the patient's body, wherein the anti-inflammatory substance is at least partially embedded in the release element, so that when the medical device is placed in the patient's body, the anti-inflammatory substance is released into the patient's body as the release element disintegrates.

[0074] 11. The medical device according to any one of aspects 2 to 10, wherein the anti-inflammatory substance is dispersed within the release element.

[0075] 12. A medical device according to any one of aspects 2 to 11, wherein the release element is configured to at least partially degrade in the patient's body at a preferably constant rate when the medical device is placed in the patient's body, so that the anti-inflammatory substance is released into the patient's body as the release element degrades.

[0076] 13. A medical device according to any one of aspects 2 to 12, wherein the release element containing the anti-inflammatory substance is configured as a solid component, wherein the release element is at least partially hollow, preferably wherein the release element is configured as a tube, which is configured to at least partially surround at least a portion of the carrier.

[0077] 14. The medical device according to any one of aspects 2 to 13, wherein the carrier comprises at least one receiving portion configured to securely receive the release element, preferably wherein the receiving portion is configured as an elongated member configured to be at least partially received within the release element.

[0078] 15. The medical device according to aspect 14, wherein the diameter of the receiving portion does not exceed 2.4 mm, preferably does not exceed 2.2 mm, more preferably does not exceed 2 mm, more preferably does not exceed 1.8 mm, more preferably does not exceed 1.6 mm, more preferably does not exceed 1.4 mm, more preferably does not exceed 1.2 mm, and more preferably does not exceed 1 mm.

[0079] 16. The medical device according to any of the preceding aspects, wherein the medical device comprises at least one securing mechanism configured to secure the medical device in at least a portion of the patient's uterus.

[0080] 17. The medical device of aspect 16, wherein the securing mechanism comprises at least one arm configured to engage a wall of a patient's uterus to secure the medical device within the patient's uterus.

[0081] 18. The medical device of aspect 16 or 17, wherein the securing mechanism comprises at least two arms configured to engage substantially opposite sides of the patient's uterus to secure the medical device within the patient's uterus.

[0082] 19. The medical device of aspect 18, wherein the arm is attached to the receptacle such that the arm and receptacle are configured in a substantially Y-shape or T-shape.

[0083] 20. The medical device according to any of the preceding aspects, wherein the anti-inflammatory substance is at least partially attached to at least one of the arms, preferably both arms.

[0084] 21. A medical device according to any preceding aspect, wherein the medical device is configured to release the anti-inflammatory substance in the patient's body, preferably continuously, for at least 10 months, more preferably at least 11 months, more preferably at least 12 months, more preferably at least 13 months, more preferably at least 14 months, more preferably at least 15 months, more preferably at least 16 months, more preferably at least 17 months, more preferably at least 18 months, more preferably at least 19 months, more preferably at least 20 months, more preferably at least 21 months, more preferably at least 22 months, more preferably at least 23 months, more preferably at least 24 months.

[0085] 22. A medical device according to any of the preceding aspects, wherein the medical device is configured to release the anti-inflammatory substance, preferably continuously, with a daily release rate of less than 3 mg / day, more preferably less than 2.8 mg / day, more preferably less than 2.6 mg / day, more preferably less than 2.4 mg / day, more preferably less than 2.2 mg / day, more preferably less than 2 mg / day, more preferably less than 1.8 mg / day, more preferably less than 1.6 mg / day, more preferably less than 1.4 mg / day, more preferably less than 1.2 mg / day, more preferably less than 1 mg / day.

[0086] 23. The medical device according to any of the preceding aspects, wherein the medical device is configured to release the anti-inflammatory substance at a daily release rate in the range of 0.2 mg / day to 1 mg / day, preferably 0.4 mg / day to 1 mg / day, more preferably 0.6 mg / day to 1 mg / day, more preferably 0.8 mg / day to 1 mg / day.

[0087] 24. The medical device according to any of the preceding aspects, wherein the medical device is configured to release the anti-inflammatory substance with a daily variation in the daily release rate of no more than 0.3 mg / day, preferably no more than 0.2 mg, more preferably no more than 0.1 mg.

[0088] 25. The medical device according to any of the preceding aspects, wherein the medical device is provided with at least 100 mg, preferably at least 150 mg, more preferably at least 200 mg, more preferably at least 250 mg, more preferably at least 300 mg, more preferably at least 350 mg, more preferably at least 400 mg, more preferably at least 450 mg, more preferably at least 500 mg of the anti-inflammatory substance.

[0089] 26. The medical device according to any one of the preceding aspects, further comprising a withdrawal device configured to enable the medical device to be withdrawn from the patient's body.

[0090] 27. The medical device according to any of the preceding aspects, further comprising at least one hemostatic agent, preferably attached to a carrier.

[0091] 28. A kit comprising:

[0092] at least one carrier configured to be at least partially placed into the patient's body through the patient's vagina,

[0093] at least one anti-inflammatory substance;

[0094] The anti-inflammatory substance is configured to be at least partially attachable to the carrier, so that when the anti-inflammatory substance is attached to the carrier and the carrier containing the release element is placed in a patient's body, the anti-inflammatory substance can be released in the patient's body.

[0095] 29. The kit according to aspect 28 further includes at least one release element, wherein the anti-inflammatory substance is attached to, preferably at least partially embedded in, the release element, and wherein the release element is configured to be at least partially attachable to the carrier so that when the release element is attached to the carrier and the carrier is placed in the patient's body, the anti-inflammatory substance can be released in the patient's body.

[0096] 30. Kit according to aspect 29, wherein the release element is at least partially, preferably completely, made of at least one biodegradable material.

[0097] 31. A method for treating at least one disease of the female reproductive system of a patient, preferably dysmenorrhea and / or endometriosis, preferably by means of a medical device according to any one of aspects 1 to 27, the method comprising:

[0098] placing at least partially into the patient's body through the patient's vagina a medical device comprising at least one carrier and at least one anti-inflammatory substance at least partially attached to the carrier, and

[0099] When the medical device has been placed in a patient's body, the anti-inflammatory substance is released in the patient's body.

[0100] 32. The method according to aspect 31, wherein the anti-inflammatory substance is attached to, preferably at least partially embedded in, at least one release element, wherein the release element is at least partially attached to the carrier.

[0101] 33. Method according to aspect 32, wherein the release element is at least partially, preferably completely, made of at least one biodegradable material.

[0102] 34. An anti-inflammatory substance, preferably a non-steroidal anti-inflammatory substance and / or a non-hormonal anti-inflammatory substance, preferably diclofenac and / or celecoxib, for treating dysmenorrhea and / or endometriosis, preferably by means of a medical device according to any one of aspects 1 to 27, wherein the anti-inflammatory substance is embedded in at least one release element made of at least one biodegradable material, the release element being at least partially attached to at least one carrier, wherein the carrier comprising the release element and the embedded anti-inflammatory substance is at least partially placed into the patient's body through the patient's vagina, wherein the anti-inflammatory substance is released in the patient's body when the carrier comprising the release element has been placed into the patient's body.

[0103] The preferred embodiments of the present invention will be further described below in conjunction with the accompanying drawings. The described embodiments are merely exemplary and do not limit the present invention.

[0104] Figure 1 A schematic diagram shows a medical device according to an embodiment of the present disclosure;

[0105] Figure 2 A medical device according to another embodiment of the present disclosure is schematically shown.

[0106] Figure 1A medical device 10 is schematically shown and can be configured to be at least partially inserted into a patient's body through the patient's vagina for the treatment of dysmenorrhea and / or endometriosis. The medical device 10 can include at least one carrier 12 and at least one release element 14, which can be made of at least one biodegradable material, preferably at least one biodegradable biopolymer. The medical device 10 can also include at least one anti-inflammatory substance 16, which can be at least partially embedded or bound within the release element 14. The release element 14 can be at least partially attached to the carrier 12 such that the anti-inflammatory substance 16 can be released within the patient's body when the medical device 10 is inserted into the patient's body.

[0107] The release element 14 can be configured to at least partially disintegrate / degrade within the patient's body when the medical device 10 is placed within the patient's body. When the medical device 10 is placed within the patient's body, the anti-inflammatory substance 16 can be released within the patient's body as the release element 14 disintegrates / degrades.

[0108] Preferably, the release element 14 containing the anti-inflammatory substance 16 is configured in a solid aggregate state. The release element 14 may include at least one cavity (not shown) configured to receive at least a portion of the carrier 12 to secure the release element 14 to the carrier 12. Preferably, the release element 14 may be configured as a tube configured to at least partially surround at least a portion of the carrier 12.

[0109] The at least one anti-inflammatory substance 16 comprises at least one non-hormonal and / or non-steroidal anti-inflammatory substance, preferably celecoxib and / or diclofenac. However, a variety of alternative anti-inflammatory substances 16 may also be used. For example, the alternative anti-inflammatory substance may include one or more of ibuprofen, ketoprofen, mefenamic acid, naproxen, piroxicam, and indomethacin. Alternative non-hormonal anti-inflammatory substances may include nitroglycerin, which may require even lower concentrations and / or release rates than other anti-inflammatory substances (particularly non-hormonal anti-inflammatory substances).

[0110] One advantage of the medical device 10 described herein is that the release of a therapeutic substance (i.e., an anti-inflammatory substance 16) can be relatively precisely controlled. This can, for example, allow the dosage and / or release rate of the anti-inflammatory substance to be reduced and / or maintained relatively consistent or continuous. For example, the release rate of the anti-inflammatory substance 16 can be controlled / adjusted by controlling / adjusting the decomposition / degradation rate of the release element 14.

[0111] The medical device 10 can be configured to continuously release the anti-inflammatory substance 16 into the patient's body at a rate greater than zero when the medical device 10 is placed in the patient's body. The medical device 10 can be configured to release the anti-inflammatory substance 16, preferably continuously, at a daily release rate of less than 3 mg / day, more preferably less than 2 mg / day, and even more preferably less than 1 mg / day.

[0112] The medical device 10 may include at least one fixing mechanism 30 configured to fix the medical device 10 in the patient's body, preferably in at least a portion of the patient's uterus, more specifically in the patient's uterine cavity. The fixing mechanism 30 may include at least one arm 32 configured to engage with the patient's uterine wall to fix the medical device 10 in the patient's uterus. Alternatively, the fixing mechanism 30 may include multiple arms, such as at least two arms 32, such as Figure 1 and Figure 2 The arms 32 may be configured to engage substantially opposite sides of the patient's uterus to secure the medical device 10 within the patient's uterus.

[0113] The carrier 12 may include at least one receptacle 34 configured to securely receive the release element 14. For example, the receptacle 34 may be configured as an elongated member configured to be at least partially received within the release element 14.

[0114] The arm 32 may be attached to the receiver 34 such that the arm 32 and receiver 34 are configured in a substantially Y-shape or T-shape.

[0115] The medical device 10 may also include a withdrawal device 36 configured to enable the medical device 10 to be withdrawn from the patient's body. The withdrawal device 36 may be configured as one or more graspable elements that can be grasped by a human (e.g., a patient and / or medical personnel). For example, the withdrawal device 36 may include one or more elongated elements, such as Figure 1 and Figure 2 As shown, for example, one or more wires, the elongated member extends into or into the patient's cervical canal and / or vagina when the medical device 10 is in an operative state within the patient's body.

[0116] The anti-inflammatory substance 16 may also be disposed on and optionally attached to one or more arms 32, such as Figure 2 For example, the release element 14 may extend across at least a portion of one or more arms 32. In this case, the medical device 10 may preferably include a plurality of release elements 14, for example, at least one first release element 14 may be arranged and optionally attached to one or more arms 32, and at least one second release element 14 may be arranged and optionally attached to the receiving portion 34.

Claims

1. A medical device (10) configured to be inserted into at least a portion of a patient's uterus through the patient's vagina to treat dysmenorrhea and / or endometriosis, the medical device (10) comprising: at least one carrier (12), at least one release element (14) attached to the carrier (12) and made of at least one biodegradable material; at least one anti-inflammatory substance (16) embedded in the release element (14) so ​​that the anti-inflammatory substance (16) can be released in the patient's body when the medical device (10) is placed in the patient's uterus, wherein the at least one anti-inflammatory substance (16) includes at least one non-steroidal anti-inflammatory substance; and At least one securing mechanism (30) configured to secure the medical device (10) within at least a portion of the patient's uterus.

2. The medical device (10) according to claim 1, wherein the at least one anti-inflammatory substance (16) comprises at least one non-hormonal anti-inflammatory substance.

3. The medical device (10) according to claim 1 or 2, wherein the at least one anti-inflammatory substance (16) is celecoxib and / or diclofenac.

4. The medical device (10) according to any one of the preceding claims, wherein When the medical device (10) is placed in the patient's body, the release element (14) is configured to at least partially disintegrate in the patient's body, wherein the anti-inflammatory substance (16) is at least partially embedded in the release element (14), so that when the medical device (10) is placed in the patient's body, the anti-inflammatory substance (16) is released into the patient's body as the release element (14) disintegrates.

5. The medical device (10) according to any one of the preceding claims, wherein the release element (14) is configured to at least partially degrade in the patient's body at a preferably constant rate when the medical device (10) is placed in the patient's body, so that the anti-inflammatory substance (16) is released into the patient's body as the release element (14) degrades.

6. The medical device (10) according to any one of the preceding claims, wherein the release element (14) containing the anti-inflammatory substance (16) is configured as a solid component, wherein the release element (14) is at least partially hollow, preferably wherein the release element (14) is configured as a tube, which is configured to at least partially surround at least a portion of the carrier (12).

7. The medical device (10) of any one of the preceding claims, wherein the securing mechanism (30) comprises at least two arms (32) configured to engage substantially opposite sides of the patient's uterus to secure the medical device (10) within the patient's uterus.

8. The medical device (10) according to any of the preceding claims, wherein the release element (14) containing the embedded anti-inflammatory substance (16) is at least partially attached to at least one of the arms, preferably both arms.

9. The medical device (10) according to any of the preceding claims, wherein the medical device (10) is configured to release the anti-inflammatory substance (16) in the patient's body, preferably continuously, for at least 10 months, more preferably at least 11 months, more preferably at least 12 months, more preferably at least 13 months, more preferably at least 14 months, more preferably at least 15 months, more preferably at least 16 months, more preferably at least 17 months, more preferably at least 18 months, more preferably at least 19 months, more preferably at least 20 months, more preferably at least 21 months, more preferably at least 22 months, more preferably at least 23 months, more preferably at least 24 months.

10. The medical device (10) according to any of the preceding claims, wherein the medical device (10) is configured to release the anti-inflammatory substance (16), preferably continuously, with a daily release rate of less than 3 mg / day, more preferably less than 2.8 mg / day, more preferably less than 2.6 mg / day, more preferably less than 2.4 mg / day, more preferably less than 2.2 mg / day, more preferably less than 2 mg / day, more preferably less than 1.8 mg / day, more preferably less than 1.6 mg / day, more preferably less than 1.4 mg / day, more preferably less than 1.2 mg / day, more preferably less than 1 mg / day.

11. The medical device (10) according to any one of the preceding claims, wherein the medical device (10) is configured to release the anti-inflammatory substance (16) with a daily variation in the daily release rate of not more than 0.3 mg / day, preferably not more than 0.2 mg, more preferably not more than 0.1 mg.

12. A kit comprising: at least one carrier (12) configured to be placed through the patient's vagina into at least a portion of the patient's uterus, at least one release element (14) made of at least one biodegradable material; at least one anti-inflammatory substance (16) embedded in the release element (14), wherein the at least one anti-inflammatory substance (16) comprises at least one non-steroidal anti-inflammatory substance; wherein the carrier (12) and / or the release element (14) comprises at least one fixing mechanism (30) configured to fix the carrier (12) and / or the release element (14) in at least a portion of the patient's uterus; The release element (14) is configured to be at least partially attached to the carrier (12), so that when the release element (14) is attached to the carrier (12) and the carrier (12) including the release element (14) is placed in the patient's uterus, the anti-inflammatory substance (16) can be released in the patient's body.

13. A nonsteroidal anti-inflammatory substance for treating dysmenorrhea and / or endometriosis, preferably by means of a medical device (10) according to any one of claims 1 to 11, wherein the anti-inflammatory substance (16) is embedded in at least one release element (14) made of at least one biodegradable material, the release element (14) being at least partially attached to at least one carrier (12), wherein The carrier (12) comprising the release element (14) and the embedded anti-inflammatory substance (16) is placed into at least a portion of the patient's uterus through the patient's vagina, and wherein when the carrier (12) comprising the release element (14) has been placed into the patient's uterus, the anti-inflammatory substance (16) is released in the patient's body, wherein the carrier (12) and / or the release element (14) comprises at least one fixing mechanism (30) configured to fix the carrier (12) and / or the release element (14) in at least a portion of the patient's uterus.

14. The nonsteroidal anti-inflammatory substance according to claim 13, wherein the substance is diclofenac and / or celecoxib.

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