WO2023161835A1 - Adjustable dual action cervical ring with pharmaco-mechanical effect - Google Patents

Adjustable dual action cervical ring with pharmaco-mechanical effect Download PDF

Info

Publication number
WO2023161835A1
WO2023161835A1 PCT/IB2023/051659 IB2023051659W WO2023161835A1 WO 2023161835 A1 WO2023161835 A1 WO 2023161835A1 IB 2023051659 W IB2023051659 W IB 2023051659W WO 2023161835 A1 WO2023161835 A1 WO 2023161835A1
Authority
WO
WIPO (PCT)
Prior art keywords
cervix
medicinal materials
hollow
hollow chambers
periphery
Prior art date
Application number
PCT/IB2023/051659
Other languages
French (fr)
Inventor
Minakshi Rohilla
Girija Shankar Mohanty
Original Assignee
Minakshi Rohilla
Girija Shankar Mohanty
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Minakshi Rohilla, Girija Shankar Mohanty filed Critical Minakshi Rohilla
Publication of WO2023161835A1 publication Critical patent/WO2023161835A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A61K9/0036—Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms

Definitions

  • the present disclosure relates to the field of wearable drug delivery device.
  • the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials (eg progesterone) into cervix of a patient.
  • medicinal materials eg progesterone
  • 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.
  • existing vaginal progesterone delivering capsules have been found to change vaginal PH levels leading to infection.
  • 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.
  • 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.
  • 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.
  • the present disclosure relates to the field of wearable drug delivery device.
  • the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials into cervix of a patient.
  • An aspect of the present disclosure is to provide a hollow, annular, wearable device (100) that may be configured to store medicinal materials.
  • the hollow, annular, wearable device (100) may be placed securely around cervix of a patient by a user.
  • 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.
  • 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.
  • the device (100) may include one or more hollow chambers (106) that may be configured to accommodate the medicinal materials.
  • the one or more hollow chambers (106) may be covered by the outer surface (102) and the inner surface (104).
  • 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.
  • 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.
  • the one or more hollow chambers (106) may be configured to have predetermined geometry and dimensions.
  • 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.
  • 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.
  • the device (100) may include a locking unit (112) that may be coupled to the outer surface (102).
  • 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.
  • 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.
  • 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.
  • 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.
  • the present disclosure relates to the field of wearable controlled drug delivery device.
  • the present disclosure provides an adjustable, wearable cervical device for storage and controlled release of medicinal materials into cervix of a patient.
  • 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.
  • the wearable cervical device for storing and releasing medicinal materials (100) 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).
  • the hollow annular structure of the device (100) may be covered by the inner surface (104).
  • the annular structure of the device (100) may have largest diameter of 2.5 cm and thickness of 8 mm.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • medicinal materials from a first one or more hollow chamber (106) may be released in month 1 and may be continued for 30 days.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the present disclosure provides for a hollow, annular, wearable device that enables storage of medicinal materials.
  • 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.
  • the present disclosure provides for a hollow, annular, wearable device that enables controlled release of the medicinal materials into the cervix of the patient.
  • 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.
  • 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.
  • 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.
  • the present disclosure provides for a hollow, annular, wearable device that enables storage of the medicinal materials inside the one or more hollow chambers.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The present disclosure provides an annular, hollow, wearable device (100) for storing and releasing medicinal materials such as progesterone into cervix of a patient to maintain uterine quiescence by maintaining optimal uterine progesterone level, the device being configured to be placed around the cervical canal of the patient. Non-permeable and elastic outer surface (102) of the device (100) is coated with antibacterial materials. An inner surface (104) of the device is coupled with one or more openings (108) configured to release the medicinal materials from one or more hollow chambers (106) into the patient's cervix. The one or more hollow chambers (106) is covered by the outer surface (102) and the inner surface (104). One or more different thickness inner membranes are enabled to control the flow of the medicinal materials in a predetermined sequence and at a predetermined rate. The device (100) is enabled to fit snugly and is adjustable to a predetermined position using a locking unit (112), configured to close the cervix in case of cervical insufficiency.

Description

ADJUSTABLE DUAL ACTION CERVICAL RING WITH PHARMACO-
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.

Claims

I Claim:
1. A hollow, annular, wearable device for storing and releasing medicinal materials (100) inside vagina around cervix of patient, wherein the device (100) is facilitated to be placed around cervix at the level of internal os, the device (100) having a first and a second periphery and comprising: an outer surface (102) configured to remain inertly inside the vaginal canal, wherein said outer surface pertains to a curvature, wherein length of said outer surface pertains to the first periphery of the device, the first periphery being larger in length than the second periphery; an inner surface (104) configured to be in contact with outer surface of the cervix, wherein said inner surface is non-detachably coupled to the outer surface to form the hollow, annular structure, wherein the inner surface pertains to the curvature, wherein length of the inner surface pertains to the second periphery of the device, the second periphery being parallel to the first periphery; one or more hollow chambers (106) coupled to the outer surface (102) and the inner surface (104), wherein the one or more hollow chambers (106) is configured to accommodate the medicinal materials, wherein the one or more hollow chambers is enclosed by the outer surface (102) and the inner surface (104), wherein the coupling of the outer surface (102) and the inner surface (104) completely conceals the medicinal materials inside the one or more hollow chambers (106) without leakage through outer surface; one or more openings (108) coupled to the inner surface (104) and the one or more hollow chambers (106), wherein the one or more openings (108) are configured to release the medicinalmaterials into cervix of the patient from the one or more hollow chambers (106), flow of the medicinal materials beinguni directional in nature; a locking unit with strap (112) coupled to the outer surface (102), wherein the locking unit (112) is configured to adjust tightness of the device (100) into the cervix of the patient, the positioning facilitating slippage-free snug fitting the device to the cervix.
2. The device (100) as claimed in claim 1, wherein the first periphery pertains to a first circle and the second periphery pertains to a second circle, wherein the first and the second circles pertain to radii and wherein the first and the second circles are coaxial when the locking unit (112) is not operated.
3. The device (100) as claimed in claim 2, wherein the outer surface (102) and the inner surface (104) are made of deformable material of thickness and texture, wherein the inner surface (104) is configured to have one or more elastic rims facilitating snug fitting of the device (100) into the cervix and wherein the position of the device (100) around the cervix is done by an applicator and tightness of device around the cervix is adjusted by operating the locking unit (112) by a user.
4. The device (100) as claimed in claim 3, wherein the locking unit (112) is configured to be operated unidirectionally, wherein operation of the locking unit by the user pertains to one or more levels of tightness, wherein the one or more levels of tightness pertain to deformation of the outer surface (102) and the inner surface (104) and wherein the one or more levels of tightness pertains to complete closure of the cervical opening if cervical insufficiency is associated.
5. The device (100) as claimed in claim 2, wherein the outer surface (102) is non- permeable and the inner surface (104) is permeable and wherein the outer surface (102) is configured to be coated by one or more layers of antibacterial material, wherein the antibacterial is configured to prevent vaginal infection.
6. The device (100) as claimed in claim 1, wherein the one or more hollow chambers (106) pertain to the cross-sectional geometry andcapacity, wherein volume, concentration, and therapeutic dosage of the medicinal materials a r e accommodated inside the one or more hollow chambers (106).
7. The device (100) as claimed in claim 1, wherein the one or more openings (108) pertain to one or more dimensions, wherein the one or more dimensions facilitate release of the medicinal materials into the cervix at one or more rates, sequence and for one or more durations of time.
8. The device (100) as claimed in claim 1, wherein the one or more openings (108) pertain to the dimensions, numbers, spacing of the one or more openings (108) and material of the device (100), wherein the dimensions, numbers and spacing of the one or more openings (108) pertain to flow rate and uniformity of distribution of the medicinal materials into the cervix of the patient.
PCT/IB2023/051659 2022-02-23 2023-02-23 Adjustable dual action cervical ring with pharmaco-mechanical effect WO2023161835A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202211009650 2022-02-23
IN202211009650 2022-02-23

Publications (1)

Publication Number Publication Date
WO2023161835A1 true WO2023161835A1 (en) 2023-08-31

Family

ID=87764947

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2023/051659 WO2023161835A1 (en) 2022-02-23 2023-02-23 Adjustable dual action cervical ring with pharmaco-mechanical effect

Country Status (1)

Country Link
WO (1) WO2023161835A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006125159A2 (en) * 2005-05-19 2006-11-23 Reprotect, Inc. Intravaginal device with improved rim designs and methods of making same
CN208809048U (en) * 2018-07-17 2019-05-03 左正敏 A kind of wearable cervical vertebra adjuvant therapy device for Pain Management
CN113599059A (en) * 2021-09-01 2021-11-05 浙江省嘉善县第一人民医院 Wearable cervical vertebra treatment device with protection function and used for pain department

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006125159A2 (en) * 2005-05-19 2006-11-23 Reprotect, Inc. Intravaginal device with improved rim designs and methods of making same
CN208809048U (en) * 2018-07-17 2019-05-03 左正敏 A kind of wearable cervical vertebra adjuvant therapy device for Pain Management
CN113599059A (en) * 2021-09-01 2021-11-05 浙江省嘉善县第一人民医院 Wearable cervical vertebra treatment device with protection function and used for pain department

Similar Documents

Publication Publication Date Title
US6758840B2 (en) Drug delivery device
US3995631A (en) Osmotic dispenser with means for dispensing active agent responsive to osmotic gradient
US3732865A (en) Osmotic dispenser
AU2014214537B2 (en) Therapeutic substance transfer catheter and method
US3760805A (en) Osmotic dispenser with collapsible supply container
US4308867A (en) Two-member medicated device for rate-controlled administration of lipophilic pharmaceuticals
JP2020075083A (en) Vaginal drug delivery and/or diagnostic system
CN105209012B (en) Drug delivery device and method for drug delivery
CN101327197A (en) Sustained release drug delivery devices
JP7396557B2 (en) Pharmaceutical formulations for application to mucous membranes and methods for their production
JP7082621B2 (en) How to administer drugs suitable for the treatment of migraine or cluster headache
KR20150058271A (en) Drug delivery systems and methods for treatment of bladder voiding dysfunction and other lower urinary tract disorders by using trospium
ES2939890T3 (en) Partially coated controlled release solid preparation
WO2023161835A1 (en) Adjustable dual action cervical ring with pharmaco-mechanical effect
US20200069459A1 (en) Mouthpiece for cooling of oral tissue of a patient
US20140330185A1 (en) Orthopedic Device For Use With An Orthopedic Cast
CN111939443A (en) Nasal cavity sustained-release drug delivery device
Mahajan et al. Overview on pulsatile drug delivery system
CN212235597U (en) Novel gynecological medicine feeder
CN217593392U (en) Film container for controlled release of a dose of a substance
Hussein et al. Pulsatile Drug Delivery System Utilizing Innovative Technology
CN215875192U (en) Accurate device of dosing of eye
CN218338809U (en) Drug delivery device for treating acute radiation proctoptositis
CN114159682A (en) Convenient in clinical device of dosing of gynaecology
CN210542847U (en) Vagina drug delivery device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23759411

Country of ref document: EP

Kind code of ref document: A1