WO2023004090A1

WO2023004090A1 - Wearable devices to augment penile rigidity in men with erectile disfunction

Info

Publication number: WO2023004090A1
Application number: PCT/US2022/037949
Authority: WO
Inventors: Michael EISENBERG; Wei Zhang
Original assignee: The Board Of Trustees Of The Leland Stanford Junior University
Priority date: 2021-07-22
Filing date: 2022-07-22
Publication date: 2023-01-26

Abstract

Devices are provided device for augmenting penile rigidity that include first and second annular bands spaced apart from one another, and a plurality of longitudinal strips extending between the first and second annular bands. The bands and the longitudinal strips may be integrally formed from elastomeric material and an exterior surface of the bands and, optionally, the longitudinal strips may include hydrophilic material to reduce friction during use. During use, a penis is inserted through the device such that the first band is positioned at the base of the penis, the second band is positioned adjacent the tip of the penis, and the one or more strips are positioned adjacent the penis, e.g., to support the penis while largely exposing the skin, e.g., to enhance skin contact during sexual intercourse to increase the user's and partner's sexual arousal.

Description

WEARABLE DEVICES TO AUGMENT PENILE RIGIDITY IN MEN WITH

ERECTILE DISFUNCTION

RELATED APPLICATION DATA

[0001] The present application is related to co-pending U.S. provisional application

Serial No. 63/224,682, filed July 22, 2021, the entire disclosure of which is expressly incorporated by reference herein.

TECHNICAL FIELD

[0002] The present invention relates to devices and methods for treating erectile disfunction and, more particularly, to wearable devices for augmenting penile rigidity, e.g., in men with erectile disfunction, and to methods for using such devices.

BACKGROUND

[0003] Erectile disfunction (“ED”) or impotency is very common in the United

States and around the world with over 50% of men over the age of forty affected. For people with certain medical conditions, such as complications of diabetes, impotency is even more prevalent. Although ED is not fatal, it may cause significant emotional suffering and thus effective cures and/or treatments are needed.

[0004] Current treatments include oral therapy, urethral suppositories, penile injections, vacuum erectile devices, and surgical implants. While existing therapies are effective for some men, failure rates range from 10-40% and dropout rates climb over 80% for some treatments (e.g. penile injections).

[0005] As such, additional therapies are desired to allow penetrative sex for men with erectile dysfunction, particularly for those who do not tolerate existing options.

SUMMARY

[0006] The present invention is directed to devices and methods for treating erectile disfunction and, more particularly, to wearable external devices for augmenting penile rigidity in men with erectile disfunction, and to methods for using such devices.

[0007] The devices and methods herein may provide effective, comfortable, easy to use, and/or low cost noninvasive solutions for treating ED with no substantial side effects. Such external devices may be easy to wear, comfortable to the skin, adjustable, effective, extremely low cost for consumers to use, and/or may cause no side effects. In addition, the devices may also help males who have a small or thin penis. More importantly, compared to existing devices, the devices herein may increase physical contact between male and female skins and thus enhance natural feelings in users.

[0008] Generally, wearable external devices are described herein that include longitudinal supports between annular bands or rings, which may maximize strength, prevent rotation during use, allow low profile for patient/partner comfort, and/or maximize skin exposure. For example, the devices may include a biocompatible core, e.g., formed from one or more of plastic, silicone, and metal and an outer coating, e.g., formed from one or more of silicone, latex, or hydrophilic material to facilitate use. The devices may be washable and/or reusable with an optional compressive ring base to facilitate penile engorgement.

[0009] In one example, the device may have a soft exterior, e.g., similar to human skin so that it is not uncomfortable for the female partner. In one particular embodiment, the device only covers a small portion of the male penis so that the male’s penis is largely exposed to the inner wall of the female partner’s vagina during sexual intercourse to increase both the male user’s and female partner’s sexual arousal. Optionally, the exterior of the device may include hydrophilic or other lubricious material, e.g., by coating the device or utilizing hydrophilic material as part or all of the device body. Thus, the friction of the exterior may decrease significantly when the device is wet and thus significantly improve user experience.

[00010] In accordance with one example, a device is provided for augmenting penile rigidity that includes first and second annular bands spaced apart from one another, and one or more longitudinal strips extending between the first and second annular bands.

Optionally, one or both of the annular bands and/or the longitudinal strips may be adjustable to change the size of the device, e.g., the girth, base circumference, and/or length.

Optionally, one or more features may be provided at the base or tip of the device, e.g., for comfort and/or stimulation of the user and/or their partner. For example, one or more smooth or rough protuberances may be provided and/or one or more heating, cooling, and/or vibrating elements may be provided on the device.

[00011] In accordance with another example, a device is provided for augmenting penile rigidity that includes first and second annular bands spaced apart from one another; and one or more longitudinal strips extending between the first and second annular bands to define an interior region sized to receive a penis between the bands.

[00012] In accordance with still another example, a device is provided for augmenting penile rigidity that includes first and second annular bands spaced apart from one another; and a plurality of longitudinal strips extending between the first and second annular bands, wherein the first and second annular bands and the longitudinal strips are integrally formed from elastomeric material, and wherein an exterior surface of the first and second annular bands and the longitudinal strips comprises hydrophilic material.

[00013] In accordance with yet another example, a device is provided for augmenting penile rigidity that includes a “C” shaped body comprising a base end and a tip end, the body comprising a sidewall defining a passage extending between the ends for receiving a penis and one or more openings in the sidewall to expose skin of the penis. For example, the body may include side edges defining a longitudinal slot extending between the ends and the body may be formed from elastic material such that the side edges may be separated to facilitate positioning a penis within the passage and released to resiliently engage the penis.

[00014] In accordance with another example, a method is provided for augmenting penile rigidity that includes providing a device comprising first and second annular bands spaced apart from one another and one or more longitudinal strips extending between the first and second annular bands; and inserting a penis through the first and second annular bands such that the one or more strips are positioned adjacent the penis.

[00015] In accordance with still another example, a method is provided for augmenting penile rigidity that includes providing a device comprising a “C” shaped body including a base end and a tip end, the body comprising a sidewall defining a passage extending between the ends; and positioning a penis within the passage such that a base of the penis is positioned adjacent the base end and a tip of the penis extends beyond the tip end, the body comprising one or more openings in the sidewall to expose skin of the penis . [00016] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[00017] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[00018] FIG. 1 A shows an example of a wearable external device for augmenting penile rigidity that includes a pair of annular bands connected by longitudinal strips.

[00019] FIG. IB shows the device of FIG. 1A positioned on a model penis.

[00020] FIGS. 2A-2D show alternative examples of wearable devices that include multiple annular connected bands connected by longitudinal strips.

[00021] FIGS. 3 A and 3B show another example of a wearable external device.

[00022] FIG. 3C is a cross-section view of the device of FIGS. 3A and 3B showing internal corrugations within a wall of the device.

[00023] FIGS. 4A-4D show additional examples of wearable devices custom made by 3D printing.

[00024] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[00025] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. [00026] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. [00027] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[00028] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[00029] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[00030] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[00031] Turning to the drawings, FIGS. 1A and IB show an example of a device 10 for augmenting penile rigidity that generally includes a plurality of annular bands or rings 20, 60 spaced apart from one another along a longitudinal axis 40 of the device 10 and connected together by one or more longitudinal strips 30. In the example shown, the device 10 includes a first or proximal band 20 at one end of the device 10 and a second or distal band 60 at an opposite end of the device 10, and a pair of longitudinal strips 30 extending between the first and second annular bands 20, 60. In the example shown, the strips 30 extend substantially parallel to the axis 40 on opposite sides of the device 10, e.g., offset about one hundred eighty degrees (180°) around the circumference of the bands 20, 60. [00032] Optionally, the strips 30 may extend non-parallel to the longitudinal axis 40 and/or the strips 40 may be offset at other angles than one hundred eighty degrees around the perimeter of the bands 20, 60, as desired, e.g., as shown in FIGS. 2A-2D. In addition or alternatively, more than two bands, e.g., three, four, five, or more bands, and/or more than two strips, e.g., three, four, or more strips, may be provided on the device, e.g., depending on the amount of support and/or open skin area desired. In another alternative, rather than enclosed bands or rings, one or more “C” shaped members may be provided on the device, e.g., that can at least partially surround a portion of the penis to secure the device.

[00033] With continued reference to FIG. 1 A, the bands 20, 60 and strips 30 are integrally formed from the same material, e.g., from silicone or other elastomeric and/or biocompatible material, e.g., by one or more of molding, casting, 3D printing, and the like. Alternatively, the bands 20, 60 and strips 30 may be formed separately and attached together, e.g., by one or more of bonding with adhesive, sonic welding, fusing, and the like. In an exemplary method, the device 10 may be formed by 3D printing, e.g., which may enable the dimensions of the device 10 to be customized to an individual subject’s penis. [00034] Optionally, one or more wires, struts, or other internal supports (not shown) may be provided within the strips 30, e.g., formed from metal, plastic, or composite materials, to enhance support of the strips 30 during use, if desired. Optionally, the one or more wires, struts, or supports may be dipped in biocompatible material and/or material may be deposited around the wires, struts, or supports to provide the finished strips 30 of the device 10, e.g., formed integrally with or attached to the bands 20, 60.

[00035] In addition or alternatively, if desired, one or more dyes or pigments may be included in the material of the device 10 (or any of the other devices herein), e.g., pigment corresponding to the skin tone of the user or a visually appealing and/or stimulating color, if desired to make the device 10 relatively inobtrusive in appearance.

[00036] The strips 30 may have a predetermined length, e.g., between about seven and sixteen centimeters (7.0-16 cm), such that, when a penis 90 is inserted through the bands 20, 60, e.g., as shown in FIG. IB, the first band 20 may be positioned adjacent the base 92 of the penis 90, the second band 60 is positioned adjacent a tip 94 of the penis 90.

In addition, the inner diameter or other cross-section of the bands 20, 60 may be set to correspond to the size of the subject’s penis, e.g., between about three and five centimeters (3.0-5.0 cm). The axial length of the bands 20, 60 may be substantially shorter than the length of the strips 30, e.g., between about five and twenty millimeters (5.0-20 mm). The bands 20, 60 and/or strips 30 may have a relatively low profile, e.g., having a substantially uniform thickness between about half and three millimeters (0.5-3.0 mm), and/or may have variable thickness and/or exterior and/or interior textures or features, e.g., longitudinal internal grooves (not shown), as desired.

[00037] In one example, the first and second bands 20, 60 may have the same dimensions. Alternatively, the first band 20 may have a smaller diameter than the second band 60. For example, at least the first band 20 may be formed from elastic material such that the first band 20 may be radially expanded to facilitate placement at the base 92 of the penis 90 and then released, whereupon the first band 20 may resiliently radially compress the base 92 of the penis 90 when the device 10 is worn, e.g., to enhance engorgement of the penis 90.

[00038] In addition, the bands 20, 60 may have a uniform inner diameter or cross- section along their lengths. Alternatively, one or both bands 20, 60 may be tapered to accommodate the subject’s anatomy. For example, the first band 20 may include tapered inner surface, e.g., tapering from a proximal-most location of the device 10 inwardly towards the distal end, to accommodate the shape of the base 92 of the penis 90, which may increase comfort for the user.

[00039] Optionally, the device 10 (or any of the other devices herein) may include hydrophilic or other lubricious material, e.g., coating one or more surfaces of the device 10. For example, exterior surfaces of the bands 20, 60 and strips 30 may be coated with a lubricious coating or may include lubricious material embedded in or formed with the base material, e.g., such that the friction of the exterior surfaces may decrease significantly when the device 10 is wet and thus significantly improves user experience and/or comfort. Exemplary hydrophilic coatings may include polyurethane resin dried with heat or UV, PVP cured by heat or UV, hyaluronic acid or polyacrylate cured with heat, UV, and/or other materials and curing methods.

[00040] Optionally, the device 10 (or any of the other devices herein) may include one or more elements, e.g., carried on one or more of the first and second annular bands 20, 60 and/or the longitudinal strips eO, that may be powered and/or activated during use, e.g., to stimulate the penis. For example, one or more vibrating elements, heating elements, and the like may be provided adjacent the inner surfaces of the device 10, e.g., attached to or embedded within the material of the bands 20, 60 and/or the strips 30. A controller (not shown) may be provided that may be coupled to the elements, e.g., by one or more cables or leads(also not shown) connected to the device 10, e.g., at the first band 20, that may be used to selectively activate the one or more elements, as desired. Alternatively, the controller may include settings that provide a preset mode of activation of the elements, e.g., to provide continuous, intermittent, or set time of operation.

[00041] During use, the user’s penis is inserted through the device 10, e.g., such that the first band 20 is positioned at the base 92 of the penis 90, the second band 60 is positioned adjacent the tip 94 of the penis 90, and the strips 30 are positioned adjacent the penis 90, e.g., as shown in FIG. IB. The device 10 may then support the penis 90 while largely exposing the user’s skin, which may enhance skin contact during sexual intercourse to increase the user’s and partner’s sexual arousal. If the device 10 includes an elastic first band 20 that is smaller than the user’s penis, the first band 20 may be pulled to expand it to facilitate placement at the base of the penis. Once properly positioned, the first band 20 may be released such that the elastic material compresses the base of the penis, which may enhance engorgement.

[00042] The material of the device 10, e.g., silicone, may provide elasticity and/or softness similar to that of a human organ, e.g., providing a smooth and fine texture. In addition, the device 10 may be stretchable yet provide a strong pulling force to enhance penile rigidity during intercourse. The material may be non-toxic without causing any allergic reaction and/or may be made discrete and/or appealing to the eye, e.g., by including pigment to match skin color to accommodate various racial and/or individual preferences. [00043] If the device 10 includes a hydrophilic material on the exterior surfaces, the material may generate low friction when wet, which may enhance interaction with the user’s partner, e.g., providing a natural lubricant during use to enhance comfort and/or stimulation of the user and/or partner. In addition, hydrophilic material may wet evenly with water, which may reduce any unevenness in the exterior surfaces. In addition or alternatively, commercially available lubricants may be used, e.g., to facilitate placement of the device on the penis and/or to reduce friction during use.

[00044] After use, the device may be removed and cleaned for subsequent reuse. Alternatively, the device may be disposable and simply discarded after use. [00045] It will be appreciated that the devices here may be made in a variety of shapes and/or sizes such that an individual user may select a device appropriate for their individual anatomy. Alternatively, a customized device may be formed after analyzing the individual’s anatomy, e.g., using an algorithm to determine appropriate dimensions and/or angles, whereupon the customized device may be formed, e.g., by 3D printing.

[00046] Turning to FIGS. 2A-2D, additional examples of devices 10A-10D for augmenting penile rigidity are shown, which may be constructed similar to and/or include any of the features described above with respect to the device 10. The devices 10A-10D generally include a first or proximal band 20 (e.g., configured to placement at the base of the penis) and a second or distal band 60 and two near-parallel side walls or strips 30, each connecting the proximal and distal bands 20, 60, generally similar to the device 10. In addition, the device 10B shown in FIG. 2B includes an additional intermediate partial band 80.

[00047] As shown, in these devices 10A-10D, the strips 30 are provided on opposite sides of the bands 20, 60 but may be provided below a midpoint of the bands 20, 60. The width of the strips 30 may be less than a third of the cylindrical perimeter of the bands 20, 60, e.g., one sixth of the perimeter, e.g., to expose more of the penis skin yet maintaining the overall shape of the devices 10A-10D.

[00048] In these devices 10A-10D, the proximal band 20 may have the same or different diameter and/or width as that of the distal band 60. In one example, the proximal band 20 may have a diameter of about four centimeters (4 cm) and width of about one centimeter (1 cm), while the distal band 60 may have a diameter of about five centimeters (5 cm) and a width of about one centimeter (1 cm). The thickness of the strips 30 may be substantially uniform along the perimeter of the bands 20, 60. Alternatively, the side wall thickness may decrease gradually when moving closer to the end of the side wall in a tapered fashion like a wedge. This may allow the side wall of the strips 30 to conform better to the penis shape.

[00049] As shown in FIGS. 2 A and 2B, the proximal band 20 has a top portion (dorsal side) 22, a bottom portion (ventral side) 24, while the distal band 60 has a top portion (dorsal side) 62, and a bottom portion (ventral side) 64, and the strips 30 may extend substantially parallel to one another closer to the bottom portions 24, 64. Alternatively, as shown in FIG. 2C, connecting points 20a, 20b of the struts 30a, 30b to the proximal band 20 are spaced apart from one another near the bottom portion 24, while connecting points 60a, 60b to the distal band ring 60 are closer to the middle or upper portion 62 of the distal band 60. In a further alternative, shown in FIG. 2D, the connecting points 20a, 20b may located together at the bottom of the proximal band 20.

[00050] The proximal band 20 may be positioned with its circular plane substantially parallel to that of the distal band 60. Alternatively, as shown in FIGS. 2A and 2B, the distal band 60 may be oriented leaning backward such that the top portion 62 is closer to the proximal band 20 than the bottom portion 64, e.g., in order to mirror the natural contours of the penile head to maximize comfort. Similarly, the other devices herein may include a distal end that is tapered and/or angled to conform to the natural anatomy of the penis. [00051] Optionally, as shown in FIG. 2B, the device 10B may include a partial band 80, e.g., located between the proximal and distal bands 20, 60. The partial band 80 may be formed from the same material as the other bands or may be formed from different material. The partial band 80 may provide additional support of the penis when the device 10B is worn. Optionally, one or more additional partial bands (not shown) may be provided between the proximal and distal bands 20, 60, e.g., that extend only between the strips 30 around the upper or lower region of the device, if desired.

[00052] Turning to FIGS. 3A-3C, another example of a device 110 for augmenting penile rigidity is shown that includes a sleeve 120 including a proximal end 122 and a distal end 124 and a passage 126 extending there between sized for receiving the penis of a user (not shown). Rather than enclosed bands, the sleeve 120 includes a “C” shaped or other partial or semi-circular cross-section along all or a portion of the length of the device 110. For example, the device 110 may include a longitudinal slot 112 extending the entire length of the device 110 defined by opposite side edges 128 of the sleeve 120.

[00053] In addition, the body 120 includes one or more openings 130 therein, i.e., between inner and outer surfaces 140, 142 of the body 120, such that the skin of the penis may be exposed through the openings 130. For example, as shown, the bodyl20 includes a pair of elongate openings 130, e.g., opposite one other adjacent the respective longitudinal edges 128, that extend partially between the proximal and distal ends 122, 124 of the body 120. The proximal and distal ends 122, 124 may extend continuously around the perimeter of the body 120 between the edges 128 to substantially engage the penis, e.g., at the base and adjacent the tip, when the device 10 is worn. The openings 130 may provide substantially open area for skin contact, while providing longitudinal struts 160 to support the body 120, e.g., adjacent the longitudinal edges 128 and between adjacent openings 130. For example, the width of the resulting slots around the perimeter may be smaller than the width of the openings 130 to maximize skin exposure while still supporting the penis. [00054] It will be appreciated that any number of openings 130 may be provided, e.g. two, three, four, or more. As shown, the openings 130 have a substantially uniform width along their length, e.g., an elongated oval shape. Alternatively, the openings 130 may have other shapes, as desired. For example, FIGS. 4A-4D show additional examples of a variety of custom-printed devices that may be provided, e.g., including various openings to expose skin when worn on a user’s penis.

[00055] The body 120 may be formed from elastic material, e.g., silicon or other elastomeric material, similar to other devices herein, such that the edges 128 of the slot 112 may be separated to open the device 110 and facilitate placement on the user’s penis. Once properly positioned, the edges 128 may be released and the device 110 may resiliently close to secure the device 110 in position and, optionally, constrict or apply pressure to the penis. [00056] For example, the body 120 may be sized such that the edges 128 abut one another when the device 110 is worn or may be spaced apart to provide a desired gap to expose additional skin and/or enhance constriction.

[00057] With particular reference to FIG. 3C, the wall of the body 120 may have a corrugated construction, e.g., including a plurality of corrugations 144 extending between the inner and outer walls 142, 144 of the body 120. As shown, the corrugations may extend axially, i.e., between the proximal and distal ends 122, 124, which may prevent collapse and/or enhance the compressive strength of the device 110. In one method of construction, the device 110 may be 3D-printed with the corrugations integrally formed in the wall of the body 120. Alternatively, the inner and outer walls 142, 144 and the corrugations may be formed separately and laminated attached together, e.g., by one or more of bonding with adhesive, fusing, sonic welding, and the like. The openings 130 and/or other features may be formed in the wall, e.g., during or after 3D printing, or formed in the laminated wall, e.g., by one or more of machining, laser cutting, stamping, and the like. Optionally, the proximal and/or distal ends 122, 124 may be finished to conceal the corrugations and/or to provide desired finishes to the end surfaces of the device 110.

[00058] In another alternative, the device may include a clamshell configuration, e.g., including two halves or portions that open at the top or bottom (not shown). For example, one more hinge elements may be provided between the portions, e.g., opposite longitudinal edges, such that the device may be opened to allow a penis to be received within the device. In this alternative, the device may be formed from elastic material again to secure the device in position and, optionally, constrict or apply pressure to the penis. Alternatively, a separate elastic band may be used to hold the clamshell device (or a “C” shaped device) in its closed position and/or to secure the device on the penis. Optionally, the device may include one or more ridges, e.g., a plurality of longitudinal and/or circumferential to enhance holding the elastic band in place on the device.

[00059] Optionally, in any of these examples, the base of the device may be thicker than the length and/or tip of the device, may be padded, and/or may be smoothed to ease pressure on the user’s pelvis and/or improve support and/or comfort. [00060] Optionally, any of the devices herein may be used in conjunction with other erectile aids, such as oral PDE5i, urethral suppositories, penile injections, vacuum erection devices, penile implants, and the like, or may simply be used alone.

[00061] Optionally, any of the devices may include a string or other elongate flexible filament or band (not shown), e.g., attached to one end of the device, to facilitate extraction if the device slips off during use.

[00062] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

We claim:

1. A device for augmenting penile rigidity, comprising: first and second annular bands spaced apart from one another; and one or more longitudinal strips extending between the first and second annular bands to define an interior region sized to receive a penis between the bands.

2. The device of claim 1, wherein the first and second annular bands and the one or more longitudinal strips are integrally formed from the same material.

3. The device of claim 1 or 2, wherein the first and second annular bands and the one or more longitudinal strips comprise elastomeric material.

4. The device of claim 1 or 2, wherein an exterior surface of the first and second annular bands and the one or more longitudinal strips comprises hydrophilic material.

5. The device of claim 1 or 2, wherein the one or more longitudinal strips have a predetermined length such that, when a penis is inserted through the first and second annular bands to position the first annular band at the base of the penis, the second annular band is positioned adjacent a tip of the penis.

6. The device of claim 1 or 2, wherein the first annular band comprises a tapered inner surface to accommodate the base of the penis.

7. The device of claim 1 or 2, wherein the first annular band comprises elastic material such that the first annular band may radially compress the base of the penis when the device is worn to enhance engorgement.

8. The device of claim 1 or 2, further comprising one or more vibrating elements carried on one or more of the first and second annular bands and the one or more longitudinal strips.

9. The device of claim 8, further comprising a controller coupled to the one or more vibrating elements for selectively activating the one or more vibrating elements.

10. The device of claim 1 or 2, further comprising one or more heating or cooling or stimulatory elements carried on one or more of the first and second annular bands and the one or more longitudinal strips.

11. The device of claim 10, further comprising a controller coupled to the one or more heating or cooling or stimulatory elements for selectively activating the one or more heating elements.

12. A device for augmenting penile rigidity, comprising: first and second annular bands spaced apart from one another; and a plurality of longitudinal strips extending between the first and second annular bands, wherein the first and second annular bands and the longitudinal strips are integrally formed from elastomeric material, and wherein an exterior surface of the first and second annular bands and the longitudinal strips comprises hydrophilic material.

13. A device for augmenting penile rigidity, comprising a “C” shaped body comprising a base end and a tip end, the body comprising a sidewall defining a passage extending between the ends for receiving a penis and one or more openings in the sidewall to expose skin of the penis.

14. The device of claim 13, wherein the body comprises side edges defining a longitudinal slot extending between the ends and wherein the body is formed from elastic material such that the side edges may be separated to facilitate positioning a penis within the passage and released to resiliently engage the penis.

15. The device of claim 13, wherein the body comprises a clamshell configured to be opened to position a penis within the passage and closed to secure the device.

16. The device of claim 15, further comprising an elastic band configured to be positioned around the body to hold the clamshell closed.

17. The device of claim 13, wherein the body comprises side edges defining a longitudinal slot extending between the ends, the slot having a uniform width between the ends.

18. The device of claim 13, wherein the body comprises side edges defining a longitudinal slot extending between the ends, the slot having a narrower width at the ends.

19. The device of any one of claims 13-18, further comprising one or more one or more heating or cooling elements carried on the body.

20. The device of claim 19, further comprising a controller coupled to the one or more heating or cooling elements for selectively activating the one or more heating or cooling elements.

21. The device of any one of claims 13-18, further comprising one or more one or more vibratory elements carried on the body.

22. The device of claim 21, further comprising a controller coupled to the one or more vibrating elements for selectively activating the one or more vibrating elements.

23. The device of any one of claims 13-18, wherein a wall of the body comprises a plurality of corrugations therein.

24. The device of claim 23, wherein the corrugations extend between inner and outer surfaces of the wall.

25. The device of claim 23, wherein the corrugations extend axially at least partially between the base and tip ends.

26. The device of claim 23, wherein the corrugations are integrally formed in the wall.

27. The device of claim 1 or 13, further comprising an elongate string attached to the device to facilitate extraction.

28. A method for augmenting penile rigidity, comprising: providing a device comprising first and second annular bands spaced apart from one another and one or more longitudinal strips extending between the first and second annular bands; and inserting a penis through the first and second annular bands such that the one or more strips are positioned adjacent the penis.

29. The method of claim 28, wherein inserting the penis comprises positioning the first annular band at the base of the penis such that the second annular band is positioned adjacent a tip of the penis.

30. The method of claim 29, wherein the first annular band comprises a tapered inner surface that is positioned around the base of the penis.

31. The method of any one of claims 28-30, wherein the first annular band comprises elastic material such that the first annular band radially compresses the base of the penis when the device is worn to enhance engorgement.

32. The method of any one of claims 28-30, wherein the device comprises a plurality of longitudinal strips extending between the first and second annular bands, the longitudinal strips spaced apart from one another such that skin of the penis is exposed between adjacent longitudinal strips to enhance contact with the user’s partners skin during intercourse.

33. A method for augmenting penile rigidity, comprising: providing a device comprising a “C” shaped body including a base end and a tip end, the body comprising a sidewall defining a passage extending between the ends; and positioning a penis within the passage such that a base of the penis is positioned adjacent the base end and a tip of the penis extends beyond the tip end, the body comprising one or more openings in the sidewall to expose skin of the penis.

34. The method of claim 33, wherein the body comprises side edges defining a longitudinal slot extending between the ends and wherein the body is formed from elastic material, and wherein positioning the penis comprises: separating the side edges to facilitate positioning a penis within the passage; and releasing the side edges such that the body resiliently engages the penis.

35. The method of claim 33, wherein the body comprises a clamshell, and wherein positioning the penis comprises: opening the clamshell ed to position the penis within the passage; and closing the clamshell to secure the device around the penis.

36. The method of claim 35, further comprising positioning an elastic band around the body to hold the clamshell closed.

37. The method of any one of claims 28-30 and 33-36, wherein the device comprises elastomeric material.

38. The method of any one of claims 28-30 and 33-36, wherein the device comprises hydrophilic material.

39. The method of any one of claims 28-30 and 33-36, wherein the device carries one or more vibrating elements, the method further comprising activating the one or more vibrating elements to stimulate the penis.

40. The method of any one of claims 28-30 and 33-36, wherein the device carries one or more heating elements, the method further comprising activating the one or more heating elements to stimulate the penis.

41. The method of any one of claims 28-30 and 33-36, further comprising consuming an oral aid to enhance penile rigidity before inserting the penis.

42. The method of any one of claims 28-30 and 33-36, wherein providing the device comprises 3D printing the device.

43. The method of claim 42, wherein the dimensions of the device are customized for an individual subject’s penis before 3D printing the device.

44. A method for making a device for augmenting penile rigidity, comprising: forming first and second annular bands spaced apart from one another and one or more longitudinal strips extending between the first and second annular bands to define an interior region sized to receive a penis between the bands.

45. The method of claim 44, wherein the bands and strips are integrally formed by 3D printing.

46. A method for making a device for augmenting penile rigidity, comprising: forming a “C” shaped body comprising a base end and a tip end, the body comprising a sidewall defining a passage extending between the ends for receiving a penis and one or more openings in the sidewall to expose skin of the penis.

47. The method of claim 46, wherein the body comprises side edges defining a longitudinal slot extending between the ends and wherein the body is formed from elastic material such that the side edges may be separated to facilitate positioning a penis within the passage and released to resiliently engage the penis.

48. The method of claim 46, wherein the body is formed by 3D printing.

49. The method of claim 45 or 48, wherein the dimensions of the device are customized for an individual subject’s penis before 3D printing.