MECHANICAL EFFECT

TECHNICAL FIELD

[0001] The present disclosure relates to the field of wearable drug delivery device. In particular, the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials (eg progesterone) into cervix of a patient.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present disclosure. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed disclosure, or that any publication specifically or implicitly referenced is prior art.

[0003] Preterm births, complications during delivery and birth defects due to hormonal deficiency of the mother are common issues that have not been adequately addressed so far. Oral progesterone pills have low absorption efficiency, long term side effects on LFT, cardiac remodeling due to prolonged use and complications like gestational intrahepatic cholestasis. On the other hand Hydroxy-progesterone-caproate injection has been found to have childhood malignancies. Therefore it would be beneficial to develop a device that would have pharmacological effect on uterus through cervico-uterine circulation to overcome progesterone deficiency and mechanical effects on cervix to overcome cervical insufficiency.

[0004] Existing literature describes a vaginal pessary that can store and release progesterone hormones into systemic circulatory network of the patient continuously for a predefined duration and cervical cerclage are performed for cervical insufficiency. Another adjustable vaginal pessary has been reported in the prior-art. A progesterone treatment method assisted by vaginal gel, vaginal suppository, vaginal cream, and vaginal tablet has been described by another literature. However, existing vaginal progesterone delivering capsules have been found to change vaginal PH levels leading to infection. On the other hand, vaginal progesterone tablets have been observed to introduce additional issues and discomfort by causing unusual vaginal discharge and non-compliance with a large population of female patients. Vaginal progesterone spray has been often reported to cause burning sensation and uncomfortable to use. However, none of the disclosures describe locally administered progesterone rich drug into cervical- uterine system that also performs functionalities of a cerclage if indicated the device can be tightened around cervix at the level of internal os of cervix and releases the progesterone in a predetermined sequence, duration and timing. Therefore there is need in the art to develop a device with pharmacological and mechanical effects on the cervico -uterine system.

[0005] The proposed device is enabled to be removably placed inside the vaginal canal snugly fitted around the cervix, the device having antibacterial coating to prevent infection. The device can be enabled to store and release progesterone at predetermined rate from one or more hollow chambers of the device, the one or more hollow chambers being configured to release the progesterone drug in predetermined sequence. Elastic nature of the device is enabled for a snug fit, the device being configured to be positioned by a applicator at predetermined location on the cervix, as ring around the cervix.

OBJECTS OF THE PRESENT DISCLOSURE

[0006] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0007] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables storage of medicinal materials.

[0008] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables being placed securely inside vaginal canal around the cervix of a patient.

[0009] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables controlled release of the medicinal materials into the cervix of the patient.

[0010] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables antibacterial material coated, non-permeable and elastic outer surface of the device to remain in contact with the outer wall of cervix.

[0011] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables a permeable and elastic inner surface of the device to be non-detachably coupled to the outer surface facilitating formation of the hollow annular structure.

[0012] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables the outer and the inner surface to cover one or more hollow chambers of predetermined geometry and dimensions.

[0013] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables storage of the medicinal materials inside the one or more hollow chambers.

[0014] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables one or more openings of predetermined dimensions and spacing to facilitate controlled release of the medicinal materials from the one or more hollow chambers into the cervix of the patient.

[0015] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables one or more actuators to activate flow of the medicinal materials through the one or more openings.

[0016] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables a locking unit to facilitate snug fit of the device around the cervix of the patient, the locking mechanism being operated by a user.

[0017] It is an object of the present disclosure to provide a hollow, annular, wearable device that enables slippage-free secure positioning of the device at the cervix at the level of internal os as a ring, depending on cervical insufficiency levels of tightness can be achieved by the locking unit.

SUMMARY

[0018] The present disclosure relates to the field of wearable drug delivery device. In particular, the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials into cervix of a patient.

[0019] An aspect of the present disclosure is to provide a hollow, annular, wearable device (100) that may be configured to store medicinal materials.

[0020] In an aspect the hollow, annular, wearable device (100) may be placed securely around cervix of a patient by a user.

[0021] In an aspect the hollow, annular, wearable device (100) may be enabled to perform release of the medicinal materials into the cervix of the patient at a predetermined rate and over predetermined time duration.

[0022] In an aspect the device (100) may include an outer surface (102) and an inner surface (104), the inner surface being non-detachably coupled to the outer surface (102) forming the annular shape.

[0023] In an aspect the device (100) may include one or more hollow chambers (106) that may be configured to accommodate the medicinal materials.

[0024] In an aspect the one or more hollow chambers (106) may be covered by the outer surface (102) and the inner surface (104).

[0025] In an aspect the outer surface (102) may be non-permeable, elastic and coated with antibacterial material coated, the outer surface (102) being configured to remain in vaginal wall without releasing any drug into vagina. [0026] In an aspect the inner surface (104) may be permeable/ contains drug releasing aperture and elastic in nature, the inner surface (104) being smaller but parallel to the outer surface (102) with predetermined curvature.

[0027] In an aspect the one or more hollow chambers (106) may be configured to have predetermined geometry and dimensions.

[0028] In an aspect the one or more hollow chambers (106) may have predetermined capacity, the one or more hollow chambers (106) being configured to contain predetermined types, concentration, dosage and quantity of medicinal materials.

[0029] In an aspect the device (100) may include one or more openings (108) coupled to the inner surface (104) and the one or more hollow chambers (106), the one or more openings (108) facilitating flow of the medicinal materials from the one or more hollow chambers (106) into the cervix of the patient.

[0030] In an aspect the device (100) may include a locking unit (112) that may be coupled to the outer surface (102).

[0031] In an aspect the locking unit (112) may be enabled to facilitate snug fitting of the device (100)around the cervix of the uterus, the locking unit (112) being unidirectionally operable by a user to achieve one or more levels of tightness.

[0032] In an aspect operating the locking unit (112) may enable slippage-free secure positioning of the device at the cervix, the one or more levels of tightness being configured depending upon cervical insufficiency.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0033] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0034] The diagrams described herein are for illustration only, which thus are not limitations of the present disclosure, and wherein:

[0035] FIG. 1 illustrates exemplary block diagram of the proposed wearable cervical device for storing and releasing medicinal materials (100), to elaborate upon its working in accordance with an embodiment of the present disclosure.

[0036] FIG. 2A-2F illustrates exemplary views (200) of the proposed wearable cervical device for storing and releasing medicinal materials (100), in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION

[0037] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details.

[0038] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0039] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0040] While embodiments of the present invention have been illustrated and described in the accompanying drawings, the embodiments are offered only in as much detail as to clearly communicate the disclosure and are not intended to limit the numerous equivalents, changes, variations, substitutions and modifications falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0041] The present disclosure relates to the field of wearable controlled drug delivery device. In particular, the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials into cervix of a patient.

[0042] FIG. 1 illustrates exemplary block diagram of the proposed wearable cervical device for storing and releasing medicinal materials (100), to elaborate upon its working in accordance with an embodiment of the present disclosure.

[0043] In an embodiment, the wearable cervical device for storing and releasing medicinal materials (100) (interchangeably known as the device (100), herewith) may be placed inside vaginal canal around the cervix as a ring. The device (100) may pertain to a hollow annular shape. The hollow annular shape may have a first and a second periphery, the first periphery or outer rim of the annular structure being larger than the second periphery or inner rim. The device may include an outer surface (102) and an inner surface (104). Along length of the first periphery, the hollow, annular structure of the device (100) may be covered by the outer surface (102). Along the length of the second periphery, the hollow annular structure of the device (100) may be covered by the inner surface (104). By way of example, the annular structure of the device (100) may have largest diameter of 2.5 cm and thickness of 8 mm. [0044] In an embodiment, the outer surface (102) and the inner surface (104) may pertain to predetermined curvature. The inner surface (104) may be parallel to the outer surface (102), the second periphery being parallel and coaxial to the first periphery, the coupling being configured to provide shape and support to the hollow, annular structure. The inner surface (104) may be non-detachably coupled to the outer surface (102). The first periphery may pertain to a first circle and the second periphery may pertain to a second circle, the first and the second circles corresponding to predetermined radii. The first and the second circles may be coaxial.

[0045] In an embodiment, the non-permeable outer surface (102) may be configured to remain in contact with the vaginal wall and the drug permeable inner surface (104) may be configured to be in touch with outer surface of the cervix. The device (100) may be positioned inside the vaginal canal of the patient snugly fitting the cervix such that the inner surface (104) may be configured to be located at a predetermined distance from the external os the cervix of the patient. The inner surface (104) and the outer surface (102) may be made up of deformable material of predetermined thickness, texture, permeability, endurance to tensile/compressive strength, opacity, elasticity and the likes. By way of example, the outer surface may be made of non-permeable medical grade silicon and the inner surface (104) may be made up of transparent, medical grade silicon. The inner surface (104) may be associated with one or more elastic rims that may enable snug fitting of the device (100) inside the patient’s vaginal canal. The outer surface (102) may be coated with one or more layers of antibacterial and antifungal materials for prevention of vaginal infection due to exposure of the device (100) within the vaginal.

[0046] In an embodiment, the device (100) may include one or more hollow chambers (106) that may be completely enclosed by the outer surface (102) and the inner surface (104). The one or more hollow chambers (106) may be configured to accommodate one or more medicinal materials that may be released into the patient’s cervix. The one or more hollow chambers (106) may be covered by the outer surface (102) and the inner surface (104) facilitating complete concealment of the medicinal materials inside the one or more hollow chambers (106) without leakage through the outer surface. The one or more hollow chambers (106) may pertain to predetermined cross-sectional geometry and capacity. The medicinal materials accommodated inside the one or more hollow chambers (106) may pertain to predetermined volume, concentration, and therapeutic dosage. By way of example, the one or more hollow chambers (106) may pertain to a tubular structure with four compartments made up of silicon, each of the four compartments being configured to store predetermined quantity of progesterone hormone. The one or more hollow chambers (106) may be circular in cross section, inner surface of each chamber has different thickness to have controlled prolonged release of the medicinal materials. The medicinal materials may pertain to progesterone rich drug.

[0047] In an embodiment, the device (100) may include one or more openings (108) that may be coupled to the inner surface (104) and the one or more hollow chambers (106). The one or more openings (108) may be configured to release the medicinal materials from the one or more hollow chambers (106) into cervix of the patient. The one or more openings (108) pertain to predetermined dimensions, number, spacing and material, the dimension, number and spacing of the one or more openings (108) pertaining to flow rate and uniformity of distribution of the medicinal materials into the cervix of the patient. The one or more openings (108) may correspond to the one or more hollow chambers (106), the one or more openings (108) being configured to allow flow of the medicinal materials in predetermined sequence from the one or more hollow chambers (106). In an embodiment, the one or more openings (108) may pertain to pores of one or more diameters, the pores being separated by predetermined spacing and the pores appearing as projections along the inner surface (104). The one or more dimensions of the one or more openings (108) may facilitate release of the medicinal materials at one or more predetermined, time, rate, duration, sequence and the likes. By way of example, medicinal materials from a first one or more hollow chamber (106) may be released in month 1 and may be continued for 30 days. In month 2 the one or more openings (108) corresponding to a second one or more hollow chambers (106) may be configured to start releasing the medicinal materials, the release of the medicinal materials being continued for next 30 days. By way of example, the one or more openings (108) may have physical appearance of hollow cylindrical projections made up of medical grade silicon, a first end of the projections being open to the one or more hollow chambers (106) and a second end of the projections being open to the outer surface of the cervix.

[0048] In an embodiment, the device (100) may include a locking unit (112) that may be coupled to the outer surface (102). The locking unit (112) may be configured to adjust tightness of the device (100) into the cervix of the patient, the positioning facilitating slippage-free snug fitting around the cervix. The locking unit (112) may be configured to be operated unidirectionally. Operation of the locking unit by a user may pertain to one or more levels of tightness, the one or more levels of tightness pertaining to deformation of the outer surface (102) and the inner surface (104). The one or more levels of tightness may pertain to cervical insufficiency. By way of example, the degree of tightness of the locking unit (112) may pertain to cerclage effect. The locking mechanism may pertain to a zip-tie method, the locking unit (112) being made up of medically approved predetermined material.

[0049] FIG. 2A-2F illustrates exemplary views (200) of the proposed wearable cervical device for storing and releasing medicinal materials (100), in accordance with an embodiment of the present disclosure.

[0050] In an illustrative embodiment of FIG. 2A and 2B, top view and bottom view of the device (100) may be shown. The device (100) may pertain to a hollow annular shape of predetermined dimensions. The device (100) may include an outer surface (102) and a inner surface (104) that may be non-detachably attached to the outer surface (102) to render shape, structure and support to the device (100). The outer surface (102) and the inner surface (104) may correspond to predetermined material, texture, opacity and permeability. The device (100) may include one or more openings (108) that may be coupled to the inner surface (104). The one or more openings (108) may be enabled to release medicinal materials accommodated in one or more hollow chambers (106) that may be shown in FIG.2C, FIG. 2E and FIG. 2F. FIG. 2C may be configured to show a perspective view of the device (100) and FIG. 2E being configured to show an axial section view of the device (100) along vertical plane. FIG. 2F may pertain to a cross sectional view of the device (100) along horizontal plane. The device (100) may include one or more hollow chambers (106) enclosed by the outer surface (102) and the inner surface (104), the one or more hollow chambers being enabled to accommodate medicinal materials. The one or more openings (108) may be enabled to release the medicinal materials from the one or more hollow chambers (106) into cervix of patient by diffusion .The one or more openings (108) may pertain to one or more dimensions that may facilitate releasing the medicinal materials in predetermined sequence, at predetermined rate, with predetermined timing and for predetermined duration.FIG. 2D may be enabled to represent a lateral view of the device (100). A locking unit (112) may be coupled to the outer surface (102) of the device (100). The locking unit (112) may be operable unidirectionally and may be configured to achieve one or more levels of tightness when operated, the one or more levels of tightness being configured to close the cervix in cervical insufficiency.

[0051] As used herein, and unless the context dictates otherwise, the term "coupled to" is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms "coupled to" and "coupled with" are used synonymously. [0052] The terms, descriptions and figures used herein are set forth by way of illustration only. Many variations are possible within the spirit and scope of the subject matter, which is intended to be defined by the following claims and their equivalents in which all terms are meant in their broadest reasonable sense unless otherwise indicated.

[0053] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

ADVANTAGES OF THE INVENTION

[0054] The present disclosure provides for a hollow, annular, wearable device that enables storage of medicinal materials.

[0055] The present disclosure provides for a hollow, annular, wearable device that enables being placed securely inside vaginal canal around the cervix preferably near internal os of cervix of a patient.

[0056] The present disclosure provides for a hollow, annular, wearable device that enables controlled release of the medicinal materials into the cervix of the patient.

[0057] The present disclosure provides for a hollow, annular, wearable device that enables antibacterial material coated, non-permeable and elastic outer surface of the device to remain in contact with the vaginal wall.

[0058] The present disclosure provides for a hollow, annular, wearable device that enables a permeable and elastic inner surface of the device to be non-detachably coupled to the outer surface facilitating formation of the hollow annular structure.

[0059] The present disclosure provides for a hollow, annular, wearable device that enables the outer and the inner surface to cover one or more hollow chambers of predetermined geometry and dimensions.

[0060] The present disclosure provides for a hollow, annular, wearable device that enables storage of the medicinal materials inside the one or more hollow chambers.

[0061] The present disclosure provides for a hollow, annular, wearable device that enables one or more openings of predetermined dimensions and spacing to facilitate flow of the medicinal materials from the one or more hollow chambers into the cervix of the patient. [0062] The present disclosure provides for a hollow, annular, wearable device that enables one or more different thickness inner membrane allowing controlled release of the medicinal materials through the one or more openings.

[0063] The present disclosure provides for a hollow, annular, wearable device that enables a locking unit to facilitate snug fit of the device around the cervix of the patient, the locking mechanism being operated by a user.

[0064] The present disclosure provides for a hollow, annular, wearable device that enables slippage-free secure positioning of the device at the internal os of cervix tightening the cervical canal, levels of tightness achieved by the locking unit and cervical insufficiency level.