WO2014049620A1

WO2014049620A1 - Device for assistive reproduction therapy

Info

Publication number: WO2014049620A1
Application number: PCT/IN2013/000594
Authority: WO
Inventors: Prasad KOMPELLA; Jay SOMAN
Original assignee: Plantus Health Supplements Private Limited
Priority date: 2012-09-30
Filing date: 2013-09-30
Publication date: 2014-04-03

Abstract

A device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprises a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which is opened at distal end thereof for facilitating/delivering of the sperms directly into the uterine cavity bypassing both vaginal and cervical canals to facilitate insemination thereby increasing chances of conception for couples facing sub fertility problems. The device is optionally provided with a piston (50) that can be plunged slowly into the device to ensure the ejaculated semen is disbursed evenly through the specially located apertures (20) at the tip of the device.

Description

DEVICE FOR ASSISTIVE REPRODUCTION THERAPY

FIELD OF THE INVENTION:

The present invention generally relates to a device used for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination". More particularly, the present disclosure relates to a device for facilitating insemination and increasing chances of conceiving by couples facing sub fertility problems.

BACKGROUND AND PRIOR ART:

Today roughly around 3 out of 6 couples have sub-fertile problems and need Assisted Reproductive Therapy (ART) such as intra Uterine Insemination (IUI), In vitro fertilization (IVF), Intra-cytoplasmic sperm injection (ICSI) etc. for assisting the sperm in reaching the ovaries, thereby increasing chances of conception. Most couples with sub- fertility problems are amendable to treatment. As each couple has a substantial chance of conceiving without treatment, relating the potential benefit of treatment to their chances of conceiving naturally is important to give a realistic appraisal of the added benefit offered by treatment options. One of many reasons for failed conception is the spread of mucus causing the sperms to die in the process before the reach of ovaries. Most of the conventionally known Assisted Reproductive Therapies (ART) assists in providing a healthy atmosphere for the sperm to survive in Uterine Cavity by neutralizing the mucus so that more number of sperms can actually survive and reach the ovaries and thus increase the chances of conception. However, most of the Assisted Reproductive Therapies (ART) are complex and expensive and face hygiene related issues. Further, most of the conventionally known Assisted Reproductive Therapies (ART) requires couples suffering with sub-fertile problems to approach medical practitioners and have to withstand professional intervention by the medical practitioners that may be disagreeable to most of the couples, thereby discouraging the couples suffering with sub-fertile problems from approaching the medical practitioners. Accordingly, there is an urgent need for a device that facilitates the sperms to survive and reach the Fallopian tubes. Also, there is a need for a device that may assist couples in conceiving while still maintaining privacy.

OBJECTIVE OF THE INVENTION:

In accordance with the above unmet need, the present invention provides a device/condom for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" that prevents sperms from coming in contact with cervical mucus, facilitates the sperms to survive and enables sperms' motility to increase the chances of conception.

Another object of the present invention is to provide a device that is hygienic, convenient to use and needs no professional intervention.

BRIEF DESCRIPTION OF DRAWINGS:

The invention will now be explained in relation to the accompanying drawings, in which: Fig 1 illustrates a schematic representation of a device for Assisted Reproductive Therapy in accordance with an embodiment of the present invention

Fig 2 illustrates schematic representation of a device for Assisted Reproductive Therapy in accordance with another embodiment of the present invention

Fig 3a depicts a Male condom Made with Soft rubber with end tip with hole

Fig 3b depicts a Male condom Made with Soft rubber with a solid tip at the end with a hole

Fig 4 shows male condom with stiffeners to give support to the solid end

Fig 5 shows female condom with a hole

Fig 6 depicts female condom with multi aperture to spread the semen with the help of piston.

Fig 7 Female Condom with a Reservoir and a Single Aperture with a Piston to help spread the semen.

Fig 8 depicts a male condom with slippery coating. SUMMARY OF THE INVENTION:

In accordance with the objectives, the invention provides a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination", which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprising a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which is opened at distal end thereof for facilitating/delivering of the sperms directly into the uterine cavity bypassing both vaginal and cervical canals to facilitate insemination thereby increasing chances of conception for couples facing sub fertility problems.

The tubular projection (10) of the device acts as a reservoir for receiving and allowing semen to flow down into the cervical cavity.

The device is optionally provided with a piston (50) that can be plunged slowly into the device to ensure the ejaculated semen is disbursed evenly through the specially located apertures (20) at the tip of the device.

The device for Assisted Reproductive Therapy (ART) for Intra Uterine Insemination according to the invention optionally comprises studs or ribs inside, outside, or both the sides of the device. The device may optionally comprise stiffeners (40) to provide support to the device.

The device for Assisted Reproductive Therapy (ART) for Intra Uterine Insemination according to the invention is made of a material consisting of natural latex rubber, synthetic rubber selected from polyurethane, polyisoprene, AT- 10 resin.

In another aspect, the device may optionally comprise solid tip at the end of the tubular projection (10) to provide additional pleasure.

In another aspect, the device is optionally coated with a layer of mucolytic substance in combination with a lubricant which does not cause irritation or damage to the sperm. Accordingly more suitable lubricants according to the invention are selected from the group consisting of anti-allergic silicone oil. The mucolytic agent is selected from the group consisting of Poly(lactic-co-glycolic acid) (PLGA-PEG) and Polysebacic acid (PSA-PEG).

The device may optionally comprise a lubricated tip for pleasure enhancement.

In a further aspect, the invention provides a method of facilitating/delivering of sperms directly into the uterine cavity bypassing both vaginal and cervical canals comprising using a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" , which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, consisting of a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof.

In yet another aspect, the invention provides use of a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination", which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprising a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof to facilitate the delivery of semen directly into the uterine cavity bypassing both vaginal and cervical canals.

DETAILED DESCRIPTION OF THE INVENTION:

The invention will now be described with reference to the accompanying drawings which do not limit the scope and ambit of the invention. The description provided is purely by way of example and illustration. The condoms in various colors, shapes and flavors are being promoted in TV, multimedia and newspapers, primarily used for prevention of unwanted pregnancy and for prevention of STD's such as HIV, Gonnorhoea, Syphlis etc. by pleasure seekers.

Unlike other scientific areas, research in the field of condoms has been sparse and variations have been either in color, fragrance, lubricants and addition of nodules along the length of the condom or at the tip for enhancing pleasure. Female condoms too are being promoted by. various companies; however the extent of usage and the numbers in terms of statistics are elusive.

The use of condoms for medical purposes other than pleasure, contraception and prevention of STD's have not been explored and put to the best of the use.

In accordance with the objectives, the invention provides a 'device/condom for Assisted Reproductive Therapy' for "Intra Uterine Insemination" that prevents semen from coming in contact with cervical mucus which facilitates the semen to survive and enables sperms' motility to increase the chances of conception. The device according to the invention can be termed as 'device for Assisted Reproductive Therapy' or alternately 'a condom for Assisted Reproductive Therapy' for "Intra Uterine Insemination" (IUI), that can be used in addition to the IUI medical procedure, which the couple are undergoing. While a condom is a barrier device commonly used during sexual intercourse to reduce the probability of pregnancy and spreading sexually transmitted diseases, the 'device for Assisted Reproductive Therapy' according to the invention increases the chances of conception by preventing the sperms from coming in contact with cervical mucus, facilitating sperm survival enabling the motile sperm to reach the fallopian tube the site of fertilization.

In a preferred embodiment, the device for Assisted Reproductive Therapy looks like a condom as shown in figures and hence the 'device' and 'condom' is used in the specification interchangeably and a person skilled in art will as such appreciate the same. The designs of the device for Assisted Reproductive Therapy (condoms for Assisted Reproductive Therapy), presented below with the art of science employed are described below, would not only add to the pleasure but also has substantial medical benefits that are enumerated herein below:

Thus the invention provides a device/condom for Assisted Reproductive Therapy that can be worn by a male/female during sexual intercourse. While the invention is broadly describing various condoms which can assist Reproductive Therapy, that can be worn by male and female, a preferred embodiment as shown in fig 1 can worn by a male to increase the chances of conception by preventing the sperms from coming in contact with cervical mucus thereby facilitating the sperms to survive and thus enable to improve the sperms' motility to reach the fallopian tubes.

The primary considerations of the invention include providing sufficient support and medical advantages for the user while maintaining an adequate level of comfort. All of the materials used in the instant invention are sterile and non-toxic to internal body parts.

Referring to Figure 1 of the accompanying drawings, Figure 1 depicts the device (100) for Assisted Reproductive Therapy in accordance with one embodiment of the present invention. The device (100) has a longitudinally extending tubular construction and can be worn just like a condom over a male reproductive organ. The device (100) further includes a tubular extension (10) extending from the distal end thereof, wherein the tubular extension/projection (10) has an aperture (20) which is opened at the distal end thereof for facilitating the delivery of the sperms directly into the uterine cavity thus bypassing both vaginal and cervical canals avoiding cervical mucus in the process. The device (100) is preferably made of latex material. The device (100) is not only cost effective substitute for "Intra Uterine Insemination" (IUI) but also needs no third person's professional intervention like doctors. The device (100) operates in "Do it Yourself (DIY) mode, thereby safeguarding the privacy of the user. In addition, the device (100) facilitates the sperms to reach the womb in a short span of time and length, thereby facilitating the survival of more number of sperms in a healthy surrounding and increasing the chances of conception naturally.

The device as shown in figure 1 can be prepared as per the standard sizes of the condom, however, the length of the condom is between 5 to 7 inches; the length of the tubular extension may be in the range of 0.5cms to 2 cms to suits the person's need and pleasure. Thickness of the condom body is maintained at 0.045 mm.

Figure 2 depicts the device (100) for Assisted Reproductive Therapy in accordance with another embodiment of the present invention, wherein the device may additionally include a coat/layer of mucolytic substance (means an agent which can be mucolytic or mucus thinning or mucus spreading or combination of any of these) in combination with oil (Silicone Oil which is used as Lubricant) applied on the outer surface of the device. Such a coating neutralises the mucus present in the vaginal canal and thus helps in assisting more number of sperms to travel and reach the womb in the shortest span of time and increases the rate of natural fertilization.

Accordingly, in a typical embodiment, the invention provides a Male Condom for ART made with Soft Rubber with an Aperture - as shown in fig 3a and 3b. According to Fig 3a the body of the condom is soft and has a projection (10), which acts as a temporary storage unit. The unique innovation, with a tubular extension/projection has an aperture (20) for allowing semen to flow into the cervix region. This contraption will help the infertile male with low healthy sperm count, that can be used at home in addition to undergoing intra -uterine - insemination [IUI] procedure under the guidance of an infertility specialist. The extra protrusion (10), acts as a reservoir for the semen before flowing into the mouth of the uterus. This device would help the healthy sperm swim without any impediment. On completion of intercourse the couple should lie down for some time to allow the complete evacuation of the semen, however some residue may remain in the device.

In another variant, this embodiment provides a Male Condom for ART Made with Soft Rubber with an Aperture and optionally with a solid tip as shown in 3b. This condom has an additional ribbing at the solid tip (30) for extra pleasure and has an aperture for allowing the semen to flow to the extra cervical region. This device is additionally provided with stiffeners (40) to give support to the solid end.

Fig 4 shows male condom with stiffeners to give support to the solid end and to give extra pleasure. Accordingly, Fig 5 depicts soft condom for females with or without ribs, primarily aimed at infertile couples undergoing IUI procedures. This device is useful for females, who have thick cervical mucus either due to a disease or consumption of contraceptives to avoid pregnancy. This rubber contraception has a projection (10) with an aperture (20), which acts as a reservoir for receiving and allowing semen to flow down into the cervical cavity. This device is useful for patients undergoing, IUI procedure and further improve the chances of pregnancy.

On completion of the intercourse, the female must lie down with the back elevated using support for complete evacuation of the reservoir at the tip of the condom.

This condom could be used in tandem with the male condom with protrusion, to avoid the feeling of monotony in either of the partners and the feeling of only one partner sharing the burden of using the device to improve fertility. If used in tandem, the issue of compliance would become a problem of the past if the assisted devices are used alternatively by either partner.

In a further embodiment, the invention provides a Female Condom with a Piston (50) with multiple Apertures as shown in fig 6.

The device depicted in this embodiment is an ideal female contraption, a ribbed condom with a piston to be used for completely ejecting the collected semen through apertures specially located at the tip of the bulb to ensure even distribution of the ejaculated semen into the uterine cavity.

This device is for females, who are undergoing assisted reproductive techniques, for infertility of varied aetiology, which could include conditions such as thick cervical mucus due to Clomiphene citrate, contraceptive pills or other pathological conditions that impede the sperm movement. This also is used for treating infertility due to low sperm count or motility disorders with normal morphology.

On completion of intercourse, the female who has worn the condom, is advised to elevate her back using the support of soft pillows, while the male partner, would gradually insert the piston (50) into the ribbed female condom, and plunge the piston slowly to ensure the ejaculated semen is disbursed evenly through the specially located multiple apertures (20) at the tip of the condom. Thus the present invention provides a home utility device for IUI in the confines of the home.

In another variant, the invention provides a Female Condom with a Reservoir and a Single Aperture with a Piston as shown in fig 7.

According to this embodiment, a female condom with a projection is provided that acts as a reservoir and aperture for inseminating the semen collected in the reservoir after intercourse. This device may be provided either in semi-hard or ribbed version along with a piston that is useful for forcing the ejaculated semen into the uterine cavity, as an additional device that could be used in addition to the IUI process for treating females with infertility of varied aetiology, which could include conditions such as thick cervical mucus due to Clomiphene citrate, contraceptive pills or other pathological conditions that impede the sperm movement or in males with poor sperm count or poor motility with normal sperm morphology.

On completion of intercourse, the female who has worn the condom, is advised to elevate her back using the support of soft pillows, while the male partner, would gradually insert the piston into the ribbed or semi-soft female condom, and plunge the piston slowly to ensure the ejaculated semen is disbursed evenly through the specially located aperture at the tip of the condom. The device according to this embodiment also can be utilized as a home utility device for IUI in the confines of the home.

According to another preferred embodiment, the invention provides a Male Condom with Lubrication/slippery coating and Aperture as shown in fig 8. Thus, a device with projection (10) with an aperture (20) with a lubricated tip (60) is provided for pleasure enhancement. In another aspect, the invention provides a device which is devoid of lubricant and the ribbed version, however, with a semi-soft tip which would be useful for infertile couples undergoing Intra-Uterine-Insemination [IUI], as process which can be performed during the normal intercourse. In yet another embodiment, the invention provides a method of facilitating/delivering of sperms directly into the uterine cavity bypassing both vaginal and cervical canals which comprises using a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination", which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, consisting of a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof.

In yet another embodiment, the invention provides use of a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination", which can be worn just like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprising a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof to facilitate the delivery of sperms directly into the uterine cavity bypassing both vaginal and cervical canals.

Technical Advancements and Economic Significance

The device for Assisted Reproductive Therapy in accordance with the present disclosure and described herein above has several technical advantages including but not limited to the realization of:

• a device that facilitates the semen to survive and reach the uterus/fallopian tube without any impediment thereto • a device that prevents semen from coming in contact with cervical mucus;

• a device that assists couples suffering from sub-fertile problems in conceiving in addition to the IUI medical procedure

• a device for Assisted Reproductive Therapy that is convenient to use;

• a device for Assisted Reproductive Therapy that is effective; and

• a device for Assisted Reproductive Therapy that is hygienic.

The numerical values given of various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher or lower than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention and the claims unless there is a statement in the specification to the contrary.

While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the invention. These and other changes in the preferred embodiment of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Claims

WE CLAIM,

1. A device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" which can be worn like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprising a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which is opened at distal end thereof for facilitating/delivering of the sperms directly into the uterine cavity bypassing both vaginal and cervical canals to facilitate insemination thereby increasing chances of conception for couples facing sub fertility problems.

2. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the tubular projection (10) which acts as a reservoir for receiving and allowing semen to flow down into the cervical cavity.

3. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device is optionally provided with a piston (50) that can be plunged slowly into the device to ensure the ejaculated semen is disbursed evenly through the specially located apertures (20) at the tip of the device.

4. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device optionally comprises studs or ribs inside, outside, or both the sides of the device.

5. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device is made of a material consisting of natural latex rubber, synthetic rubber selected from polyurethane, polyisoprene, AT- 10 resin.

6. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device optionally comprise stiffeners (40) to provide support to the device.

7. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device optionally comprise solid tip at the end of the tubular projection (10) to provide additional pleasure.

8. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device is optionally coated with a layer of mucolytic substance.

9. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device is coated with mucolytic agent in combination with a lubricant which does not cause irritation or damage to the sperm.

10. 'The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 9, wherein the mucolytic agent is selected from the group consisting of Poly(lactic-co-glycolic acid) (PLGA-PEG) and Polysebacic acid (PSA-PEG) and the lubricant selected from the group consisting of anti-allergic silicone oils.

11. The device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" according to claim 1, wherein the device optionally comprise a lubricated tip for pleasure enhancement.

12. A method of facilitating/delivering of sperms directly into the uterine cavity bypassing both vaginal and cervical canals comprising using a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" which can be worn like a condom over a male reproductive organ or to slip into female's reproductive orifice, consisting of a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof.

13. The method according to claim 12, wherein the device is optionally provided with a piston (50) that can be plunged slowly into the device to ensure the ejaculated semen is disbursed evenly through the specially located apertures (20) at the tip of the device.

14. Use of a device for Assisted Reproductive Therapy (ART) for "Intra Uterine Insemination" which can be worn like a condom over a male reproductive organ or to slip into female's reproductive orifice, comprising a longitudinally extending tubular construction (100) having a tubular projection (10) extending from distal end thereof, wherein the tubular extension/projection (10) has specially located one or more aperture(s) (20) which are opened at distal end thereof to facilitate the delivery of sperms directly into the uterine cavity bypassing both vaginal and cervical canals.

15. The use according to claim 14, wherein the device is optionally provided with a piston (50) that can be plunged slowly into the device to ensure the ejaculated semen is disbursed evenly through the specially located apertures (20) at the tip of the device.