Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
  • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
• • 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
• • 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
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
  • A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
  • A61F13/2074—Tampons, e.g. catamenial tampons; Accessories therefor impregnated with hydrophobic, hydrophilic, skin enhancers, medicinal etc. substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/14—Female reproductive, genital organs
  • A61M2210/1475—Vagina

Definitions

• TITLE DEVICE FOR INTRA VAGINAL ADMINISTRATION OF SUBSTANCES
• the present invention relates to a device for intravaginal administration of substances.
• the device of the invention is particularly indicated in the intravaginal administration of drugs and/or other substances for therapeutic, preventive and/or cosmetic purposes.
• the means currently used to convey various types of active ingredients at the vaginal level consist of creams, vaginal douches and vaginal suppositories.
• a disadvantage of the creams is related to the difficulty of application and the insufficient safety of the correct interaction of the active substance with the corresponding parts involved in its absorption or its transmission.
• vaginal douches Similar drawbacks are presented by vaginal douches, which, moreover, provide for a period of contact and interaction that is less prolonged over time with respect to creams and, therefore, have a relatively milder action with the same active substance being conveyed.
• vaginal suppositories As far as vaginal suppositories are concerned, these can allow a longer administration, but they can be negatively influenced by the possibility of drainage to the outside of the active substance together with the excipients associated with it; in practice, the use of suppositories is usually limited to nighttime due to the possible losses determined by them.
• An aim of the present invention is to eliminate or at least greatly reduce the aforementioned drawbacks with a device for intravaginal administration of substances capable of conveying the active substance safely and that is correctly usable.
• the device releases a drug or an active substance in the times and quantities best suited to the correct therapy, prevention and/or cosmetic use thanks to the presence of a veil in biocompatible material that defines a diffusion surface of the substance to be administered, surface which interacts with the walls of the vagina, allowing a release of the substance over time with a propagation unreachable by the means of the prior art;
• the device allows the release in the vaginal environment of substances with a soothing purpose and anti-inflammatory aim to alleviate the common problems, itching and disorders that characterize the pathologies of the vaginal cavity;
• the device has an adjuvant action in the treatment of the most common diseases such as inflammation of the vaginal area, through the gradual release of biologically-tested substances containing, for example, pharmacologically active principles such as antibiotics or antifungal substances;
• FIG. 1 is a schematic side view of a possible embodiment of the invention
• FIG. 2 is a schematic perspective view of another embodiment of the invention.
• FIG. 3 shows a further example of embodiment of the invention, shown schematically in a perspective view, represented in use configuration in the left drawing and isolated in the right drawing;
• Fig. 4 is a diagram which illustrates the use of the device
• FIG. 5 shows another example of embodiment of the invention, shown schematically in perspective view, in use configuration.
• the device (1) of the invention comprises a core (2) consisting of a body preferably of ovoid or ellipsoid shape, which can be produced in semi-rigid polymeric or rubber material with good elastic properties.
• good elastic properties it is meant that the mechanical properties of the core (2) are such as not to allow permanent deformations of the core due to the stresses to which the device could be subjected during its use (transport in a casing, extraction from the casing, gripping with the fingers, insertion and permanence in the vaginal environment) with an elasticity that does not cause discomfort by adapting well to the vaginal cavity.
• the core (2) is covered with a veil (3) of biologically tested polymeric material compatible with vaginal tissues, capable of exchanging cosmetic, adjuvant or pharmaceutical substances with the vaginal environment gradually and for a prolonged period of time.
• the core (2) can be constituted by a soluble structure contained within the veil (3), also constituting a single body with the same veil (3); in other words, the two components, core (2) and veil (3), can in practice be combined into a single whole.
• the device (1) may consist only of the veil component (3).
• the core (2) is also connected to a rigid cannula or hollow rod (5), which acts as an applicator, and to a string (4) which slides inside the rod (5) itself and which is used for the removal of the device (1) from the vagina.
• Fig. 4 shows how the device (1) can be used.
• the procedure for applying the device can be summarized in the following steps: extraction of the device (1) from the casing in which it is contained; insertion of the device inside the vagina (V) using the hollow rod (5) as applicator; placement of the core (2) at the end of the cervix (C); extraction of the rod (5) with sliding of the same rod (5) along the string (4), which remains attached to the core (2).
• the other parts of the body are marked with the following references: (U) - uterus; (O) - urethral orifice; (A) - anus / rectum.
• An application method therefore comprises the steps of insertion inside the vagina (V) of a device comprising a veil (3) which allows to convey on the walls of the vagina (V) the substances with which the device is soaked and the use of the device for a pre-established period.
• the method can provide the preparatory phase to soak the core (2) and/or the veil (3) of these substances.
• the subsequent stay on site for the prescribed period of treatment for example of the order of hours, allows the continuous transmission of the drugs or other indicated substances during the medical prescription or to be administered as non-therapeutic.
• the substances that can be administered with the present device (1) may be drugs containing pharmacologically active principles such as antibiotics or antifungals or of another type indicated for a specific therapy, or soothing and/or refreshing substances, with the possibility of perfuming.
• the veil (3) is fixed to the core (2) or is in a single body with it at the end of the device (1) in which the core (2) is placed; in the remaining part of the device (1) the veil (3) is loose and can adhere to the inner walls of the vagina, copying its profile. An interaction is determined by a remarkably high contact between the veil (3) and the inner walls of the vagina.
• the reference (Ll) indicates the value of the length of the entire device (1)
• the reference (L2) indicates the part of the device (1) occupied by the core (2)
• (L3) indicates the part of the device occupied exclusively from the veil (3).
• the veil (3) is pendulous with respect to the core (2) and is that part of the device (1) that can vary its conformation precisely because it is bound to the core (2) only in a relatively small portion.
• the value of the longitudinal development (L3) of the free or loose part (33) of the veil (3) with respect to the entire length (Ll) of the device (1) is greater than half and may be equal to 2/3 or 3/4 of this value (Ll).
• the veil (3) Thanks to the relatively large surface of the veil (3) a diffusion of the drug, and/or of the other substances to be administered, is obtained inside the vagina, diffusion which was not obtainable by the means used up to now. With respect to the previously known techniques (douches, creams and vaginal suppositories), the difference in amplitude of the area directly affected by the interaction of the veil during the duration (measurable in hours) of the treatment performed is evident. The fact that the veil (3) can cover most of the walls of the vagina allows a constant and continuous administration of the drug and/or other substances.
• the device (1) is conveniently impregnated with the substance to be conveyed, a substance which, depending on the type of treatment and/or type of substance and/or the desired release times can be contained by the core (2), by the veil (3) or by both components of the device (1).
• the core (2) is stably wrapped by the veil (3) and, therefore, does not come into direct contact with the vagina; it may contain or not the active ingredients depending on the purpose of use and the type of substances that must spread in the vagina.
• the nucleus (1) contains substances to be conveyed into the vagina it will be cribrose or spongy to transmit these substances to the structure of the veil (3) of polymeric material (which constitutes the interaction surface between the device and the vaginal environment) that covers the core (2) and forms precisely the pendulous veil of the device.
• the core (2) is free of substances to be diffused, it will be ovoidal (or ellipsoidal) shaped, not cribrose and the polimeric veil will be directly impregnated to form the diffuser for the vaginal environment.
• the veil (3) determines a controlled drainage of the substances to be administered, allowing the release and the corresponding absorption to an optimal extent.
• the veil (3) will therefore be made of a polymeric material whose structure allows the substances to be administered to be conveyed gradually into the vaginal environment.
• the rod (5) can be made of plastic material of a rigid nature (similar to those used for lollipops) and will be inserted in a cavity presented by the core (2), such that once the device is positioned (1) inside the vagina (V) it can be extracted with a minimum traction from the outside, possibly accompanied by a slight rotary movement of the rod itself to facilitate its extraction from the core cavity (2).
• the rod (5) can be constrained to the core (2) thanks to the particular shape of the seat provided on the core (2), seat which can be made so as to be conformed complementarily to the rod (5) to allow stable insertion of this last with slight interference.
• the receiving seat will also be cylindrical with a diameter corresponding to that of the rod, but slightly higher to allow insertion and above all extraction with slight forcing.
• the string (4) is firmly fixed to the core (2) in such a way as to allow the device to be removed after use by simply pulling the string itself.
• the veil (3) constitutes the interaction surface between the device (1) and the vaginal environment. Its length will be such as to cover the vaginal wall portion that goes from the cervix to the vulva, with the possibility of leaking slightly to the level of the labia. It may be available in different sizes, depending on the age and the physical conformation of the user.
• the veil (3) is fixed to the core (2) (when the core is not cribrose) on its inner side with a minimum amount of biocompatible adhesive, i.e. with a fixing means that does not interact with the vaginal environment.
• a cribrose (2) core containing gels and active substances to be diffused, the substantially rigid plastic material with a cribrose conformation is pervaded and invaded by the elastic polymer which conveys the substance to be administered, so that it is the same polymer that forms the coating which is modelled according to the ovoidal cribrose skeleton that contains the active substances.
• the diffusion methods of the various substances which impregnate the polymer of the device (1) can be substantially two, with the core (2) which does not come into contact with the vagina but may contain or not the active principles depending on the purpose of use and the type of substances that must spread in the vagina.
• the veil (3) of the device (1) consists of a polymeric material of a matrix nature (for example hydrogel) capable of incorporating the molecules of the substance to be released and ensuring a gradual release over time.
• a polymeric material of a matrix nature for example hydrogel
• the core (2) contains substances to be conveyed into the vagina it will be cribrose for the veil (3) of polymeric material (which constitutes the surface of interaction between the device and the vaginal environment) that covers the core and form, as previously mentioned, the pendulous veil of the device.
• the correct positioning of the device at the extremity of the cervix (C) takes place thanks to the fact that the dimensions of the device head (formed by the coated core) offer a greater encumbrance and resistance than the pendulous veil that instead, without a rigid skeleton, leaves the vaginal cavity almost completely closed under the ovoidal head.
• transverse rings can be created slightly inclined with respect to the hypothetical longitudinal axis of the device, or orthogonal to the same, so as to form a sort of spiral or a multiple-ring conformation (31) which can be made on the rigid core (2) and then polymer coated or formed directly on the veil polymer (3).
• one or more transversal polymeric disks (31) of variable diameter can be applied, diameter that is however greater compared to that of the polymeric head so as to increase the pressure on the vaginal wall and the retaining in place.
• microvilli (32) can be produced both on the rigid core and directly on the polymer which forms the veil (3).
• the term microvilli means any small elongated formation which protrudes from the external surface of the device (1).
• the microvilli (32) can have a double function: to stabilize the positioning of the device in the vagina and to increase the diffusion of the substance conveyed by device towards the outside of the device. What is described is intended with reference to what is illustrated in the attached diagrams which constitute embodiments of the invention.

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

Applications Claiming Priority (1)

Publications (1)

Family

ID=63442722

Family Applications (1)

Country Status (2)

Family Cites Families (5)

• 2018
  • 2018-07-06 EP EP18762386.3A patent/EP3817803A1/de active Pending
  • 2018-07-06 WO PCT/IB2018/055016 patent/WO2020008245A1/en unknown

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