WO2023073724A1

WO2023073724A1 - Device for treatment of erectile dysfunction

Info

Publication number: WO2023073724A1
Application number: PCT/IN2021/051151
Authority: WO
Inventors: Rajeev Sood
Original assignee: Rajeev Sood
Priority date: 2021-10-26
Filing date: 2021-12-09
Publication date: 2023-05-04

Abstract

The present invention relates to a device (1) for use in erectile dysfunction disorders. More particularly, the device (1) of the present invention is an external penile support device comprising at least a bolster (2) and at least a band (3) attached to at least a part of said at least a bolster (2). The bolster (2) has a lumen (4) structure, which can be filed via at least a one-way valve with at least a gas or a liquid to afford rigidity to the device (1).

Description

DEVICE FOR TREATMENT OF ERECTILE DYSFUNCTION

FIELD OF INVENTION

The present invention relates to the field of bio-medical devices. Particularly, the present invention provides a passive device for supporting male sexual performance.

BACKGROUND OF THE INVENTION

External support penile devices are a treatment option for men with erectile dysfunction, who do not want or cannot afford an internal penile implant or are not suitable candidates due to medical reasons. Internal penile support devices are surgically placed inside the penis. These implants provide adequate rigidity and some flexibility for comfort and concealment. However, like with any implant surgery, if there is any infection, the implant has to be removed. This often renders the patient in a worse condition than prior to the surgery.

Oral or injectable medications are also available; however, they may not be suitable for a given individual, because of risks and side effects or lack of efficacy. The external support penile devices that are currently available are of two types. The first type comprises a penile sleeve with or without a harness to keep it n place, and the second types comprises a rod and ring support mechanism.

The first type of sleeve like devices completely sheath the penis, thus depriving the user of any sensation which would emanate from stimulation of the glans and skin on the shaft of the penis. The second type of devices having the rod and ring support allows the penis minimal entrapment, however, the ring design restricts the natural increase of the girth of the penis. The ring design may also restrict flow of blood to an extent that may cause tissue damage or abrasion. In some cases, it also takes considerable time to mount the ring, which acts as a psychological barrier for users. Further, the rigidity of the rod does not allow for natural flexibility of the penis and can eb uncomfortable for the user as well as the partner.

US patent 8394011B2 describes a rod and ring type expandable external penile support device (EEPSD). US 4776325A describes another rod and ring type external penile support device. Currently available external penile support devices are re-usable, however, are expensive and suffer the limitations as mentioned. Therefore, there is a need for effective device(s) for treating erectile dysfunction in males.

SUMMARY OF THE INVENTION

In an aspect of the present invention, there is provided an external male appendage support device (1) comprising: (a) at least one bolster (2); and at least one band (3) attached to at least a part of said at least one bolster (2).

In another aspect of the present invention, there is provided an an external male appendage support device (1) comprising: (a) at least one bolster (2); and at least one band (3) attached to at least a part of said at least one bolster (2) for use in erectile dysfunction disorder.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Fig la-c shows top-view of bolster (2) of various shapes, in accordance with an embodiment of the present invention.

Fig. 2 shows longitudinal view of bolster (2) with 2 compartments (5a, 5b) and one-way valve, in accordance with an embodiment of the present invention.

Fig. 3a-b depicts top-view of the device (1) comprising multiple bolsters (2), in accordance with an embodiment of the present invention.

Fig. 4 depicts the side-view of the device (1) with multiple bands (3), in accordance with an embodiment of the present invention.

Fig. 5a-b depicts longitudinal cross-section of a bolster (2) depicting lumen (4) of uniform and varying cross-section, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Erectile dysfunction is often assumed to be a natural concomitant of the aging process, to be tolerated along with other conditions associated with aging. This assumption may not be entirely correct. For the elderly and for others, erectile dysfunction may occur as a consequence of specific illnesses or of medical treatment, resulting in fear, loss of image, self-confidence, and depression.

Particularly in older men, erectile dysfunction often has a physical cause, such as disease, injury, or side effects of drugs. Any disorder that causes injury to the nerves or impairs blood flow in the penis has the potential to result in erectile dysfunction. Incidence of erectile dysfunction increases with age. About 5% of 40-year-old men and between 15-25% of 65-year-old men experience erectile dysfunction. Erectile dysfunction is treatable at any age, and awareness of this has been growing.

Thus, there is a need for novel devices for promoting or enhancing male erectile function and for treating erectile dysfunction, particularly need for comparatively simple, inexpensive and non-invasive devices which are easily and readily be accessed and used by a person suffering from erectile dysfunction without the stigma attached to it.

The present invention provides an external male appendage support device (1) comprising: (a) at least one bolster (2); and (b) at least one band (3) attached to at least a part of said at least one bolster (2). The device (1) is configured such that in a deployed form, the device (1) conforms to a cylindrical shape with a hollow interior that can accept the male appendage. The at least a bolster (2) and at least one band (3) of the device (1) in deployed form are arranged about the outside of the cylindrical hollow interior. The device (1) in undeployed form in an embodiment is partially collapsible such that the cylindrical shaped hollow interior is substantially reduced. In another embodiment, the device (1) in undeployed form is completely collapsible such that the cylindrical hollow interior is eliminated.

In an embodiment, the device (1) comprises 2 bolsters (2a, 2b). In another embodiment, the device (1) comprises 3 bolsters (2a, 2b, 2c). In yet another embodiment, the device (1) comprises 4 bolsters (2a, 2b, 2c, 2d). It is understood that the scope of the presently claimed device (1) is not to be construed as limited to any of 2-4 bolsters (2). The number of bolsters (2) can be more than 4 as per requirement, but has to be necessarily more than 1. While more than 4 bolsters (2) are contemplated and deemed covered and disclosed herein, 3 or 4 bolsters are sufficient for majority of practical considerations. The device (1) of the present invention comprising 3 or 4 bolsters (2), when in deployed state, in an embodiment, the bolsters (2) are equidistant from each other when arranged on the imaginary surface of the hollow cylindrical shape formed upon deployment. In another embodiment, the bolsters (2) are not equidistant from each other. In yet another embodiment, at least 2 bolsters are equidistant from each other.

Each bolster (2) has a lumen (4) structure, i.e., each bolster has a hollow sealable interior. In an embodiment, the hollow interior can be filled with at least a gas. In an embodiment, the gas can be any one of, but not limited to, nitrogen, carbon-di-oxide, or an inert gas. In an embodiment, the gas can be purified nitrogen gas. In another embodiment, the gas can be a mixture. In an alternate embodiment, the hollow interior can be filled with at least a fluid. The fluid can be any one of, but not limited to, water, or saline. The fluid can liquid silicone. In an embodiment, the liquid may have the property of being able to solidify upon change in temperature, pressure, or time-delayed reaction with another component. The gas or fluid can be introduced into the bolster(s) (2) through the one-way valve through an external injection, pump or any suitable device. It is understood that the mode of injection does not form part of the present invention, nor limit the scope of the present invention.

Each bolster (2) of the device (1) of the present invention comprises at least a one-way valve for injection of at least a gas or a liquid. Once injected with at least a gas or a liquid the said bolster (2) is a rigid structure. The amount of gas or liquid that can be injected in a bolster (1) can be a pre-determined fixed amount or can be customizable as per user requirement. In an embodiment, the lumen (4) of the bolsters (2) of the device (1) are continuous and each of the bolsters (2) can be filled with liquid or gas via a single on-way valve. In another embodiment, there may be multiple one-way valves and lumen (4) of a sub-set of bolsters (2) may be interconnected.

The bolster (2) of the device (1) of the present invention comprises at least one or more compartments (5). In an embodiment, the bolster (2) is a single compartment (5). In another embodiment, the bolster (2) comprises 2 compartments (5a, 5b). In yet another embodiment, the bolster (2) comprises 3 compartments (5a, 5b, 5c). It is to be understood that the scope of the present invention is not limited to 3 compartments. More than 3 compartments are envisioned as part and parcel of this disclosure. It is also understood herein that each compartment (5) of the bolster will have a lumen (4) which can be filled with at least a gas or a liquid.

In an embodiment, at least a bolster (2) is a single compartment (5) structure with a oneway valve via which at least a gas or a liquid can be introduced into the lumen (4) of the bolster (2) such that the bolster (2) is a rigid structure. In another embodiment, at least a bolster (2) has two compartments (5a, 5b), wherein a first compartment is connected with the second compartment via at least a one-way valve, and wherein the first or second compartment is provisioned with a one-way valve for injection of at least a gas or a liquid. In another embodiment, the compartments are sealed from each other.

The bolster (2) of the device (1) of the present invention is made of a material selected from the group consisting of latex, silicone, polyethylene, polyurethane, AT-10 resin, and neoprene. In a preferred embodiment, the material is medical grade. In another preferred embodiment, the material is hypoallergenic material.

The bolster (2) has a proximal end (6) and a distal end (7). The proximal end (6) refers to the bolster (2) region closer to the base of the male appendage and the distal end (7) refers to the bolster (2) region further away from the base of the male appendage when in deployed state.

The device (1) of the present invention comprises at least a first (3a) and a second band (3b), said first band (3a) positioned at the proximal end (6) or in the region of the proximal end (6) of the at least a bolster (2) and said second band (3b) positioned at the distal end (7) or in the region of the distal end (7) of the at least a bolster (2). The first band (3a) or the second band (3b) is of a particular width as per requirement. It is understood that the width of the band (3) is nonlimiting. In an embodiment, the width of the first band (3a) is lesser than that of the second band (3b). In an alternate embodiment, the width of the first band (3a) is greater than that of the second band (3b). In an embodiment, the width of the first band (3a) and the second band (3b) are same. The device (1) further comprises a third band (3c) positioned generally in the bolster region between the proximal end (6) and the distal end (7) of the bolster (2). The width of the third band (3c) can be same, less or more than any one of first band (3a) or the second band (3b). In an embodiment, there may be additional bands, which is deemed covered and disclosed as part of the present invention. The at least one band (3) of the device (1) are elastic and can stretch. In an embodiment, the elasticity of the bands (first, second, or third) are same. In another embodiment, the elasticity of the bands (first, second, or third) are different. In another embodiment, the elasticity of at least two bands (first, second, or third) are same.

In an embodiment, the elasticity of the first band (3a) located at the proximal end (6) or proximal end (60 region of the bolster (2) has less elasticity relative to the second band (3b) located at the distal end (7) or distal end (7) region of the bolster (2) or the third band (3c) located between the proximal end (6) and the distal end (7).

In an embodiment, the elasticity of the first band (3a) located at the proximal end (6) or proximal end (60 region of the bolster (2) has more elasticity relative to the second band (3b) located at the distal end (7) or distal end (7) region of the bolster (2) or the third band (3c) located between the proximal end (6) and the distal end (7).

The at least a bolster (2) of the device (1) of the present invention has an inner surface (8) and an outer surface (9), wherein said inner surface (8) and outer surface (9) are continuous with each other and said inner surface (8) or part thereof can be in contact with the male appendage.

The said at least a band (3) is attached to the outer surface (9) or part thereof of at least a bolster (2). In an embodiment, at least a part of the band (3) is attached to the outer surface (9) or part thereof of at least a bolster (2).

The bolster (2) shape, in an embodiment, can be circular. In another embodiment, the bolster (2) shape can be semi-circular. In yet another embodiment, the bolster (2) can be crescent shaped. Other shapes are also possible and do not limit the scope of the present invention.

In an embodiment, the cross-section of the lumen (4) of the bolster (2) along the length of the bolster (2) is constant. In another embodiment, the cross-section is variable. In an embodiment, where the cross-section of the lumen along the length is variable, the cross-section at the proximal end (6) region is greater than that at the distal end (7) region. In another embodiment, where the cross-section of the lumen along the length is variable, the cross-section at the proximal end (6) region is lesser than that at the distal end (7) region. In an embodiment, the variation may be gradual or in a step-wise manner. The at least a bolster (2) material elasticity can be constant. In an alternate embodiment, the at least a bolster (2) material elasticity can be variable. In an embodiment, where the at least a bolster (2) material elasticity is variable, the elasticity at the proximal end (6) or proximal end (6) region is greater than that of the distal end (7) or distal end (7) region. Alternatively, the elasticity at the proximal end (6) or proximal end (6) region is lesser that of the distal end (7) or distal end (7) region.

The device (1) as substantially described herein further comprises a removable sheath (10) covering the at least a bolster (2) and at least a band (3). The sheath (10) is made of latex material is optionally retractable.

It is to be appreciated that the structural features of the device (1) of the present invention, including materials used ensures that the device is sufficiently elastic and bendable so as to conform to the requirements of a particular user, provides all-around support, does not inconvenience the user or partner(s), while at the same time providing sufficient external support/rigidity to the male appendage. The unique feature of injecting a gas or liquid into the lumen (4) of the bolster(s) (2) further allows a user to customize the extent of support/rigidity required. This is contrasted to devices known in the art where one size/feature fits all and is therefore inconvenient to use.

The device (1) as substantially described herein, is for use in erectile dysfunction disorder. While it is understood that erectile dysfunction can be due to various physical and/or psychological conditions, a common feature is the inability of a person to get an erection or sustain an erection firm enough for sexual intercourse. The device (1) of the present invention can assist a person who is unable to sustain an erection firm enough for sexual intercourse.

Use of the device (1) of the present invention is not exclusively limited to in instances of erectile dysfunction, but can also be used otherwise without any deleterious side effects.

The device (1) of the present invention as described substantially herein may be a singleuse or multiple use device (1).

The invention is now going to be described by way of particular exemplary non-limiting embodiments. The reference to numerals is not to be construed as limiting the scope or features of the device (1) in any form whatsoever. As seen in Fig. la, the bolster (2) is circular in shape (top-view) with a lumen (4) which can be filled with a gas or a liquid to give rigidity to the bolster (2). The bolster (2) comprises a oneway valve, via which the bolster (2) can be filled with the gas or the liquid.

As seen in Fig lb, the bolster (2) is semi circular in shape (top-view) with a lumen (4) which can be filled with a gas or a liquid to give rigidity to the bolster (2). The bolster (2) comprises a one-way valve, via which the bolster (2) can be filled with the gas or the liquid.

As seen in Fig. lc, the bolster (2) is crescent shaped (top-view) with a lumen (4) which can be filled with a gas or a liquid to give rigidity to the bolster (2). The bolster (2) comprises a oneway valve, via which the bolster (2) can be filled with the gas or the liquid.

Fig. 2 depicts the bolster (2) (longitudinal view) with 2 compartments (5a, 5b), whereby the compartments are connected by a one-way valve and the first compartment (5a) comprises a one-way valve for filling of bolster (2) with gas or liquid.

Fig. 3a depicts the device (1) comprising 3 bolsters (2a, 2b, 2c) (top-view) whereby the bolsters are arranged on the outside of cylindrical hollow structure (to receive the male appendage) formed when the device (1) is deployed. It is to be noted that only for representative purpose, the 3 bolsters appear equidistant from each other.

Fig. 3b depicts the device (1) comprising 4 bolsters (2a, 2b, 2c, 2d) (top-view) whereby the bolsters are arranged on the outside of cylindrical hollow structure (to receive the male appendage) formed when the device (1) is deployed. It is to be noted that only for representative purpose, the 4 bolsters appear equidistant from each other.

Fig. 4 depicts a side-view of the device (1) whereby a first bolster (2a) front view is visible and side view of second bolster (2b) and third bolster (2c) are visible. There may be a fourth bolster (2d), which is not visible as it is directly behind the first bolster (2a). The proximal end (6) or proximal end region and distal end (7) or distal end region of the device (1) are also visible. The one-way valve on the first bolster (2a) is also depicted via which, a gas or liquid can be injected into the bolster (2a). The bolsters (2a, 2b, 2c) may be connected such that each of the bolsters can be filled via a single one-way valve. Also depicted is a first band (3a) located in the proximal end (6)/ region of the device (1), a second band (3b) located in the distal end (7)/region of the device (1), and a third band (3c) located between the proximal end (6)/region and the distal end (7)/region. At least a part of each band is attached to the inside surface of each bolster to provide support to the device (1).

Fig. 5a shows a longitudinal cross-section of a bolster (2) depicting lumen (4) of uniform cross-section.

Fig. 5b shows a longitudinal cross-section of a bolster (2) depicting lumen (4) of varying cross-section, whereby the lumen is cross-section is broader at the proximal end (6)/region of the bolster (2) and is narrower at the distal end (7)/region of the bolster (2). As support requirement of the male appendage at the appendage base by the device (1) may be more than at the tip region of the male appendage, the cross-section of the lumen (4) in the bolster (2) at the base may be more than that at the tip region of the male appendage (distal end (7)/region of the device (1)). It is understood by any person of ordinary person skilled in the art that the difference in cross-section of the lumen at the proximal end (6) relative to the distal end (7) may be continuous gradient or step-wise gradient.

Due to the elasticity and expandability of the bands (3), the device (1) when in deployed configuration assumes a cylindrical shape whereby the bolsters are arranged in a circular manner with a hollow region formed in the middle, which can receive the male appendage and can conform to variety of girth of the male appendage.

The device (1) of the present invention is compatible with condoms and can be worn over a condom for protection against Sexually Transmitted Diseases (STDs) and to practice safe sex.

Without any limitation to the features of the device (1) disclosed in the present specification, the bolster (2) and band (3) dimensions can be of different lengths and/or widths as per particular demographic requirements.

Claims

l/We claim:

1. An external male appendage support device (1) comprising: a. at least one bolster (2); and b. at least one band (3) attached to at least a part of said at least one bolster (2).

2. The device (1) as claimed in claim 1, wherein said device comprises any one of 2 (2a, 2b), 3 (2a, 2b, 2c) or 4 (2a, 2b, 2c, 2d) bolsters.

3. The device (1) as claimed in claim 1, wherein said at least one bolster (2) has a lumen structure (4).

4. The device (1) as claimed in claim 3, wherein said lumen (4) can be filled with at least a gas, or at least a liquid.

5. The device (1) as claimed in claim 1, wherein said at least a bolster (2) comprises at least one or more compartments (5).

6. The device (1) as claimed in claim 5, wherein a first compartment (5a) is connected with at least a second compartment (5b) via at least a one-way valve.

7. The device (1) as claimed in claim 1, wherein said at least one bolster (2) comprises at least a one-way valve for injection of at least a gas or a liquid.

8. The device (1) as claimed in claim 1, wherein said at least a bolster (2) is made of a material selected from the group consisting of latex, silicone, polyethylene, polyurethane, AT-10 resin, and neoprene.

9. The device (1) as claimed in claim 1, wherein said at least one bolster (2) has a proximal end (6) and a distal end (7), the said proximal end (6) refers to the bolster region closer to the base of the male appendage and the distal end (7) refers to the end further from the base of the male appendage.

10. The device (1) as claimed in claim 9, wherein said device comprises at least a first (3a) and a second band (3b), said first band (3a) positioned at the proximal end (6) or in the region of the proximal end of the at least a bolster and said second band (3b) positioned at the distal end (7) or in the region of the distal end of the at least a bolster. The device (1) as claimed in claim 10, comprising at least a third band (3c), wherein said third band (3c) is positioned generally in the bolster region between the proximal end (6) and the distal end (7). The device (1) as claimed in claim 10, wherein said at least a band (3) is elastic of same or varying elasticity. The device (1) as claimed in claim 1, wherein said at least one bolster (2) has an inner (8) and an outer surface (9), wherein said inner surface (8) and outer surface (9) are continuous with each other and said inner surface (8) or part thereof can be in contact with the male appendage. The device (1) as claimed in claim 13, wherein said at least one band (3) is attached to the outer surface (9) or part thereof of the at least a bolster (2). The device (1) as claimed in claim 3, wherein said lumen (4) cross-section along the length of at least a bolster (2) is constant or variable. The device (1) as claimed in claim 15, wherein said lumen (4) cross-section at the proximal end (6) or proximal end (6) region is greater or lesser than the lumen cross-section at the distal end (7) or distal end (7) region. The device (1) as claimed in claim 8, wherein said bolster (2) material elasticity of at least a bolster (2) is constant or variable. The device (1) as claimed in claim 17, wherein said bolster (2) material elasticity at the proximal end (7) or proximal end (7) region is greater or lesser than the elasticity at the distal end (6) or distal end (6) region. The device (1) as claimed in claim 1, further comprising a removable sheath (10) covering the at least one bolster (2) and at least a band (3), and wherein the sheath (10) is made of latex material and is optionally retractable. The device (1) as claimed in claim 1 for use in erectile dysfunction disorder.