DROGUE-LIKE MENSES COLLECTION DEVICE

• US 20140012216A1
• Filed: 07/02/2013
• Published: 01/09/2014
• Est. Priority Date: 07/09/2012
• Status: Active Grant

• Current Assignee: Galmedics Biotech Ltd.
• Original Assignee: Galmedics Biotech Ltd.
• Inventors: SHAVIV, Hilla
• Granted Patent: US 9,827,136 B2
• Time in Patent Office: Days
• US Class Current: 604/330
• CPC Class Codes: A61F 5/4553 placed in the vagina, e.g. for catamenial use pessaries A61F6/08; absorbent cups A61F13/2045
• CPC Class Codes: A61F 6/08 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
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A disposable catamenial device for the collection of menses discharge of the female human, including: a flexible resilient menstrual cup (MC), which includes: at least two resilient ribs extending inwardly from the inner surface of the MC base; an elastic rim frame connected to the top of the ribs; a reservoir bag connected to the rim in a sealed manner for collecting the menstrual fluid; and a withdrawal string connected to the cup bottom for enabling the extraction of said MC from the vagina. The MC has a drogue like structure comprising at least two flexible ribs having arcuate vertical struts (AVS) structure connected to a flat base. The ribs are connected to the elastic rim frame with at least two flexible arcuate horizontal struts (AHS).

Claims

1. A disposable catamenial device for the collection of menses discharge of the female human, comprising:

a flexible resilient menstrual cup (MC), comprising;

i. at least two resilient ribs extending inwardly from the inner surface of the MC base;

ii. an elastic rim frame connected to the top of said ribs;

iii. a reservoir bag connected to said rim in a sealed manner for collecting the menstrual fluid; and

iv. a withdrawal string connected to the cup bottom for enabling the extraction of said MC from the vagina;

wherein said MC has a drogue like structure comprising at least two flexible ribs having arcuate vertical struts (AVS) structure connected to a flat base;

said ribs connected with elastic rim frame comprising at least two flexible arcuate horizontal struts (AHS).

3. The device according to claim 1, wherein at least one of the following is being held true (a) said AVS and AHS structure provides an additional spring-like resilience for facilitating semi-automatic deployment of the device to a sealing position within the vagina cavity;

(b) rim functions as a spring such that when ejected outside an applicator, said rim returns to its original shape and said MC is opened within the potential vaginal cavity; and

any combination thereof.

5. The device according to claim 1, wherein at least one of the following is being held true (a) said rim resilient structure and elasticity enables said MC to be positioned with in the vagina in a sealed manner such that said MC comprising the collected fluid is held inside the vaginal cavity;

(b) said rim is formed of at least one selected from a group consisting of an injection molded thermoplastic rubber, compression mold, 3D printing, and any combination thereof;

(c) said MC has a drogue-like structure such that it provides substantial resistance when dragged from the vaginal cavity and allows easier deployment;

(d) said MC may further have a funnel-like structure, a cone-like structure, an umbrella-like structure or any combination thereof; and

any combination thereof.

7. The device according to claim 1, wherein at least one of the following is being held true (a) said ribs have a panel or vertical structure;

(b) said ribs are connected in an arch shape resulting a structure of a small elastic cup shape such that said MC will collapse into the applicator easily;

(c) said withdrawal string may further have an elongated tube shape; and

any combination thereof.

8. The device according to claim 1, wherein said reservoir bag is adapted as a thin membrane which is made from elastic or non-elastic material which is connected to said rim and may also be connected to ribs in a sealed manner for collecting menstrual fluid.

9. The device according to claim 1, additionally comprising at least one absorbent element;

said at least one absorbent element is located along said bag walls preventing spill and leakage during extraction of said MC.

10. The device according to claim 9, wherein said absorbent element is made from absorbing material selected from a group consisting of:

natural fibers, synthetic fibers, fluff pulp, needle-punched engineered absorbents, fiber tows, tow webs, cellulosic sponge materials, superabsorbent materials, materials which forms a gel upon contact with moisture, and combinations thereof.

11. The device according to claim 1, wherein at least one of the following is being held true (a) said disposable catamenial device for the collection of menses discharge of the female human, complies with FDA regulation pertaining to Obstetrical and Gynecological Devices;

(b) said disposable catamenial device complies with FDA class II performance standards;

(c) said disposable catamenial device meets FDA biocompatibility standards for prevention of adverse tissue reaction; and

any combination thereof.

2. A disposable catamenial device for the collection of menses discharge of the female human, comprising:

a flexible resilient menstrual cup (MC), comprising;

i. at least two resilient ribs extending inwardly from the inner surface of the MC base;

ii. an elastic rim frame connected to the top of said ribs;

iii. a reservoir bag connected either to said rim or said ribs in a sealed manner for collecting the menstrual fluid; and

iv. a withdrawal string connected to the cup bottom for enabling the extraction of said MC from the vagina;

wherein said disposable catamenial device comprises biodegradable materials and further comprises an applicator for delivering said MC into the vaginal canal and extracting said MC;

further wherein said reservoir bag comprises an absorbent element located along said bag walls preventing spill and leakage during extraction of said MC.

4. The device according to claim 2, wherein said rim functions as a spring such that when ejected outside said applicator, said rim returns to its original shape and said MC is opened within the potential vaginal cavity.

6. The device according to claim 2, wherein said applicator comprises two tubular insertion members;

further wherein one of said tubular insertion members is reversibly inserted into the other.

12. The device according to claim 2, wherein at least one of the following is being held true (a) said rim resilient structure and elasticity enables said MC to be positioned with in the vagina in a sealed manner such that said MC comprising the collected fluid is held inside the vagina;

(b) said rim is formed of at least one selected from a group consisting of an injection molded thermoplastic rubber, compression mold, 3D printing from thermoplastic rubber or from nitinol and any combination thereof;

(c) said MC has a drogue-like structure such that it provides substantial resistance when dragged from the vaginal cavity and allows easier deployment;

(d) said MC may further have a funnel-like structure, a cone-like structure, an umbrella-like structure or any combination thereof; and

any combination thereof.

13. The device according to claim 2, wherein at least one of the following is being held true (a) said ribs have a panel or vertical structure;

(b) said ribs are connected in an arch shape resulting a structure of a small elastic cup shape such that said MC will collapse into the applicator easily;

(c) said withdrawal string may further have an elongated tube shape;

(d) said reservoir bag is adapted as a thin membrane which is adapted as a thin membrane made from elastic or non-elastic material which is connected to said rim and may also be connected to ribs in a sealed manner for collecting menstrual fluid; and

any combination thereof.

14. The device according to claim 2, wherein at least one of the following is being held true (a) said absorbent element is made from absorbing material selected from a group consisting of:

natural fibers, synthetic fibers, fluff pulp, needle-punched engineered absorbents, fiber tows, tow webs, cellulosic sponge materials, superabsorbent materials, materials which forms a gel upon contact with moisture, and combinations thereof;

(b) said disposable catamenial device for the collection of menses discharge of the female human, complies with FDA regulation pertaining to Obstetrical and Gynecological Devices;

(c) said disposable catamenial device complies with FDA class II performance standards;

(d) said disposable catamenial device meets FDA biocompatibility standards for prevention of adverse tissue reaction; and

any combination thereof.

15. A method of manufacturing a device for containing menstrual flow of a female human comprising the steps of:

a. molding at least two longitude arch-like ribs made of flexible material in a drogue configuration to a flat base;

b. connecting said ribs to at least two horizontal arcuate struts resulting a port having a resilient rim for leading menstrual flow discharged from the cervix to pass through the rim;

c. providing a reservoir bag comprising an absorbent material;

d. defining an intra vaginal reservoir by means of said drogue and said bag so as to receive and contain menstrual flow that enters the reservoir through the port;

e. attaching a withdrawal string to said flat base;

wherein said molding ribs results arcuate vertical struts (AVS) structure connected to a flat base;

said ribs connected with elastic rim frame comprising at least two flexible arcuate horizontal struts (AHS).

17. The method according to claim 15, wherein at least one of the following is being held true (a) said method of manufacturing a device for containing menstrual flow of a female human, complies with cGMP and QS;

(b) said rim functions as a spring such that when ejected outside said applicator, said rim returns to its original shape and said MC is opened within the potential vaginal cavity;

(c) said rim having a resilient structure and elasticity characters enables said MC to be positioned with in the vagina in a sealed manner such that said MC comprising the collected fluid is held inside the vagina;

(d) said device for containing menstrual flow of a female human structure provides an additional spring-like resilience for facilitating semi-automatic deployment of the device to a sealing position within the vagina cavity;

(e) said ribs have a panel or vertical structure;

(f) said ribs are connected in an arch shape resulting a structure of a small elastic cup shape such that said MC will collapse into the applicator easily; and

any combination thereof.

19. The method according to claim 15, wherein at least one of the following is being held true (a) said withdrawal string may further have an elongated tube shape;

(b) said reservoir bag is adapted as a thin membrane which is connected to said ribs in a sealed manner for collecting menstrual fluid;

(c) said an absorbent element is made from absorbing material selected from a group consisting of;

natural fibers, synthetic fibers, fluff pulp, needle-punched engineered absorbents, fiber tows, tow webs, cellulosic sponge materials, superabsorbent materials, materials which forms a gel upon contact with moisture, and combinations thereof; and

any combination thereof.

16. A method of capturing and containing the menstrual flow of a female human being comprising the steps of:

a. providing a disposable catamenial device for the collection of menses discharge of the human female comprising;

a menstrual cup (MC), comprising;

i. at least two resilient ribs extending inwardly from the inner surface of the MC base;

ii. an elastic rim frame connected to the top of said ribs;

iii. a reservoir bag connected to said rim in a sealed manner for collecting the menstrual fluid; and

iv. a withdrawal string connected to the cup bottom for enabling the extraction of said MC from the vagina;

b. providing an applicator;

c. placing in an end of an applicator said a disposable catamenial device;

d. inserting the end of the applicator into the vagina;

e. releasing the device from the end of the applicator whereby the device automatically seats itself within the vagina cavity; and

f. withdrawing the applicator from the vagina;

wherein said disposable catamenial device comprises biodegradable materials and further comprises an applicator for delivering said MC into the vaginal canal and extracting said MC;

further wherein said reservoir bag comprises an absorbent element located along said bag walls preventing spill and leakage during extraction of said MC.

18. The method according to claim 16, wherein at least one of the following is being held true (a) said method of manufacturing a device for containing menstrual flow of a female human, complies with cGMP and QS;

(b) said rim functions as a spring such that when ejected outside said applicator, said rim returns to its original shape and said MC is opened within the potential vaginal cavity;

(c) said rim having a resilient structure and elasticity characters enables said MC to be positioned with in the vagina in a sealed manner such that said MC comprising the collected fluid is held inside the vagina;

(d) said device for containing menstrual flow of a female human structure provides an additional spring-like resilience for facilitating semi-automatic deployment of the device to a sealing position within the vagina cavity;

(e) said rim is formed of an injection molded thermoplastic rubber;

(f) said MC has a drogue-like structure such that it provides substantial resistance when dragged from the vagina cavity and allows easier deployment;

(g) said MC may further have a funnel-like structure, a cone-like structure, an umbrella-like structure or any combination thereof;

(h) said applicator comprises two tubular insertion members having hollow cylinder shape while one has a diameter smaller than the other such that the smaller cylinder is inserted into the larger cylinder; and

any combination thereof.

20. The method according to claim 16, wherein at least one of the following is being held true (a) said ribs have a panel or vertical structure;

(b) said ribs are connected in an arch shape resulting a structure of a small elastic cup shape such that said MC will collapse into the applicator easily;

(c) said withdrawal string may further have an elongated tube shape;

(d) said reservoir bag is adapted as a thin membrane which is connected to said ribs in a sealed manner for collecting menstrual fluid;

(e) said an absorbent element is made from absorbing material selected from a group consisting of;

natural fibers, synthetic fibers, fluff pulp, needle-punched engineered absorbents, fiber tows, tow webs, cellulosic sponge materials, superabsorbent materials, materials which forms a gel upon contact with moisture, and combinations thereof; and

any combination thereof.