Patent ID: 12220344

DETAILED DESCRIPTION

Overview

In the following detailed description, numerous specific details are set forth by way of examples to provide a thorough understanding of the relevant teachings. However, it should be apparent that the present teachings may be practiced without such details. In other instances, well-known methods, procedures, components, and/or circuitry have been described at a relatively high-level, without detail, to avoid unnecessarily obscuring aspects of the present teachings. Various techniques are described in detail with reference to a few example embodiments thereof as illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of one or more aspects and/or features described or reference herein. It will be apparent, however, to one skilled in the art, that one or more aspects and/or features described or reference herein may be practiced without some or all of these specific details. In other instances, well known process steps and/or structures have not been described in detail in order to not obscure some of the aspects and/or features described or reference herein.

One or more different concepts may be described in the present application. Further, for one or more of the concepts described herein, numerous embodiments may be described in this disclosure, and are presented for illustrative purposes only. The described embodiments are not intended to be limiting in any sense. One or more of the concepts may be widely applicable to numerous embodiments, as is readily apparent from the disclosure. These embodiments are described in sufficient detail to enable those skilled in the art to practice one or more of the present concepts, and it is to be understood that other embodiments may be utilized and that structural, logical, and other changes may be made without departing from the scope of the one or more of the concepts discussed herein. Accordingly, those skilled in the art will recognize that the one or more of the concepts may be practiced with various modifications and alterations. Particular features of one or more of the concepts may be described with reference to one or more particular embodiments or figures that form a part of the present disclosure, and in which are shown, by way of illustration, specific embodiments of one or more of the concepts. It should be understood, however, that such features are not limited to usage in the one or more particular embodiments or figures with reference to which they are described. The present disclosure is neither a literal description of all embodiments of one or more of the concepts nor a listing of features of one or more of the concepts that must be present in all embodiments.

Headings of sections provided in this disclosure and the title of this disclosure are for convenience only, and are not to be taken as limiting the disclosure in any way. A description of an embodiment with several components in communication with each other does not imply that all such components are required. To the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present disclosure.

Further, although process steps, method steps, or the like may be described in a sequential order, such processes or methods may be configured to work in alternate orders. In other words, any sequence or order of steps that may be described in this application does not, in and of itself, indicate a requirement that the steps be performed in that order. The steps of described processes may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary, and does not imply that the illustrated process is preferred.

When a single device or article is described, it will be understood that more than one device/article (whether or not they cooperate) may be used in place of a single device/article. Similarly, where more than one device or article is described (whether or not they cooperate), it will be readily apparent that a single device/article may be used in place of the more than one device or article.

The functionality and/or the features of a device may be alternatively embodied by one or more other devices that are not explicitly described as having such functionality/features. Thus, other embodiments need not include the device itself.

Techniques and mechanisms described or reference herein are sometimes described herein in singular form for clarity. However, it should be noted that particular embodiments include multiple iterations of a technique or multiple instantiations of a mechanism unless noted otherwise.

Although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of example embodiments. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.

Example embodiments are described herein with reference to cross-sectional illustrations and different views that are schematic illustrations of idealized or simplified embodiments (and intermediate structures). As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, may be expected. Thus, the regions illustrated in the figures are schematic in nature and their shapes do not necessarily illustrate the actual shape of a region of a device and do not limit the scope. It should be appreciated that the figures and/or drawings accompanying this disclosure are exemplary, non-limiting, and not necessarily drawn to scale, unless a scale is specifically provided in that particular figure.

It is to be understood that other embodiments may be used and structural or logical changes may be made without departing from the spirit and scope defined by the claims. The description of the embodiments is not limiting. In particular, elements of the embodiments described hereinafter may be combined with elements of different embodiments.

Various aspects described or referenced herein are directed to different internal urethral condom devices (IUCDs) and methods of using thereof. The male contraceptive device includes an insertion tool. A urethral sleeve is inside the insertion tool, the urethral sleeve comprises a balloon on an outer surface and proximal end of the urethral sleeve. The balloon has an air lumen that extends to the distal end of the urethral sleeve. An inside reservoir at a distal end of the sleeve is configured to capture any fluid traveling from the proximal end to the distal end of the urethral sleeve. An insertion plunger is coupled to a plunger head, wherein the insertion plunger is configured to be placed inside the distal end of the insertion tool.

By virtue of the devices and methods discussed herein, in addition to preventing pregnancy, the spread of sexually transmitted diseases (STDs) can be substantially suppressed by preventing the escape of bodily fluids that may include, without limitation, human papilloma virus (HPV), Herpes simplex virus (HSV), Human immunodeficiency virus (HIV), Monkey pox, poliovirus, etc. These benefits are provided while maintaining full sensation between sexual partners.

The techniques described herein may be implemented in a number of ways. Example implementations are provided below with reference to the following figures.

Example Components of a Urethral Condom

FIG.1illustrates an example male intraurethral contraceptive system (ICS)150, consistent with an illustrative embodiment. The ICS150includes a urethral sleeve100, sometimes referred to herein as a catheter, having a first (e.g., proximal) end116and a second (e.g., distal) end118that are configured to prevent any fluids from being released from the second end118. In various embodiments, the urethral sleeve100may comprise rubber, latex, silicone, TPE, and/or any other suitable material that provides sufficient flexibility and durability to be inserted and kept in a urethra for a prolonged period of time. In one embodiment, the urethral sleeve100also comprises a distal urethral stop configured to prevent the distal end of the urethral sleeve from passing beyond the fossa navicularis when inserted. For example, the cavernous portion of the urethra may be narrow, and of uniform size in the body of the penis (e.g., measuring about 6 mm in diameter and can stretch to 8 to 9 mm in diameter.) It is dilated anteriorly within the glans penis, where it forms the fossa navicularis urethrae which may be 10-11 mm diameter.

In one embodiment, the first end116is made more rigid than the second end118. For example, the rigidity of the proximal end of the urethral sleeve100is sufficient to prevent the balloon from narrowing a diameter of an opening (e.g., tract) of the urethral sleeve below a predetermined threshold.

There is a balloon104, sometimes referred to herein as a bladder, on an outer surface of the urethral sleeve100. In one embodiment, the balloon104circumferentially covers the outer surface of at least a portion of the first end116. The balloon104includes an air lumen106that extends from the first end116to the distal end of the urethral sleeve. In one embodiment, the balloon104is pre-inflated with a fluid, such as air, nitrogen, etc., through the air lumen106to a predetermined pressure. The air lumen106is sealed108at the distal end of the sleeve, for example, by way of adhesion to the outer wall (e.g., surface) at the distal end of the urethral sleeve. The air lumen106can later also be used to deflate the balloon104, as will be discussed in more detail below.

There is an inside reservoir110configured to capture any fluid traveling from the proximal end to the distal end of the urethral sleeve100. For example, the inside reservoir110may capture the fluid by turning inside-out and expanding sufficiently to capture this fluid at the distal end of the urethral sleeve100.

By way of example only and not by way of limitation, the urethral sleeve100can have a length ranging from 3.5″ to 6.5″ and have a diameter at the first end116ranging from 2 mm to 6 mm (uninflated) to 10 mm when it is fully inflated. The second end118can remain constant in diameter ranging from 4 to 6 mm.

The urethral sleeve100is provided inside of an insertion tool120of the ICS150. The insertion tool120can be cylindrically shaped, although other shapes, such as oval, are contemplated as well. The insertion tool120provides the structural integrity that is salient to be inserted into a urethra. The insertion tool120also provides the requisite compression of the pre-inflated balloon104of the urethral sleeve100, such that the balloon104does not impede the sliding entry into a urethra. In various embodiments, the insertion tool120may comprise polyurethane or any other suitable material. In one embodiment, between the insertion tool and the urethral sleeve100there is a vasodilator, spermicidal, bactericidal, and/or virucidal lubricant.

The insertion tool120has a first (e.g., proximal) end and a second (e.g., distal) end, and configured to securely house the urethral sleeve100such that the balloon104is housed at the proximal end of the insertion tool120. In one embodiment, the insertion tool120has a first protruding member124, referred to herein as an insertion stop124, at the distal end of the insertion tool120. The insertion stop124can act as a physical barrier (i.e., stop) for the insertion of the insertion tool120into a urethra. In this regard, reference is made toFIG.2, which provides cross section views200and250of an insertion tool150placed inside a urethra of a penis204, consistent with an illustrative embodiment. Accordingly, the insertion tool120can be slidingly inserted into the urethra until the tip of the penis204abuts this insertion stop124, thereby providing a physical barrier from further insertion into the urethra.

In one embodiment, the insertion tool120has a second protruding member128, sometimes referred to herein as a plunger stop. The plunger stop128includes the function of a physical barrier from the insertion plunger130to be inserted more than a predetermined distance A.

The insertion plunger130is placed inside the insertion tool120from the distal end of the insertion tool120. For example, after the insertion tool120is slidingly placed inside a urethra, the plunger head132can be pressed towards the plunger stop128of the insertion tool120, such that the urethral sleeve is ejected inside a urethra (e.g., erect penis) by a predetermined distance A. The insertion plunger130has a first (e.g., proximal) end and a second (distal) end having a handle (i.e., plunger head132). As shown in configuration150ofFIG.1, the proximal end of the insertion plunger130abuts the distal end of the urethral sleeve100inside the insertion tool120.

As illustrated in cross section view250ofFIG.2, by pressing the plunger head132of the insertion plunger130towards the plunger stop128, a portion of the urethral sleeve100is slidingly pushed outside the proximal end of the insertion tool120by a predetermined distance A such that the balloon can expand inside the urethra of the individual wearing the contraceptive device, thereby providing an occlusion between passage of any fluid from the urethral sleeve. Such expansion of the balloon also anchors the urethral sleeve within the urethra so that the urethral sleeve remains anchored internally as the insertion device is withdrawn and/or once it is completely removed. In one embodiment, instead of pushing the plunger head132towards the plunger stop128, the plunger stop128can be pulled towards the plunger head132by the distance A. Referring back toFIG.1, in one embodiment, the insertion plunger130has a spring136, which pushes the insertion plunger130back to its original position after the deployment of the urethral sleeve100in the urethra.

Thus, the insertion plunger130allows the urethral sleeve100to be inserted into a (e.g., erect) penis. The insertion plunger130can then be slidingly removed from the urethra of the erect penis, together with the insertion tool120, by pulling the handle of the plunger stop128away from the urethra. In this regard,FIG.3Aprovides a cross-section view300of a urethral sleeve100that is inside a urethra after the insertion tool is removed, consistent with an illustrative embodiment. The balloon104anchors and prevents the urethral sleeve100from sliding out during the removal of the insertion tool120together with the insertion plunger130, thereby leaving the urethral sleeve100securely inside the urethra. In one embodiment, a stop at the distal end of the urethral sleeve can be configured to stop at the head of the glans penis and/or within the fossa navicularis (e.g., the expanded portion of the distal end of the male urethra) within the glans penis so that the stop is completely internalized and not visible externally.

FIG.3Bis a cross section view350of a urethral sleeve100after the reservoir110catching any fluids in the tract of the urethral sleeve100, consistent with an illustrative embodiment. As illustrated inFIG.3B, the reservoir110is external from the distal end of the urethral sleeve100. In one embodiment, there is a tab306at the distal end of the urethral sleeve100that is configured to open the seal108of the air lumen106, thereby deflating the balloon104. In this regard,FIG.4illustrates a urethral sleeve100having a deflated balloon, consistent with an illustrative embodiment. In one embodiment, the tab306is operative to also remove the urethral sleeve from the urethra. Stated differently, the pulling force applied to the tab306is operative to not only deflate the balloon104but also remove the urethral sleeve100from the urethra. In yet another embodiment, a tab is not required; rather by virtue of pulling the reservoir110with sufficient force allows to open the seal of the air lumen106and deflate the balloon. In this way, the entire urethral sleeve can be efficiently and quickly removed from the urethra.

For a more detailed understanding of the concepts discussed herein,FIG.5provides a top500, a cross-section520, and a side view530of an example male intraurethral contraceptive system (ICS) discussed in the context ofFIGS.1to4drawn at a scale of 3, consistent with an illustrative embodiment.FIG.6provides perspective views from a proximal end600A and a distal end600B of the ICS ofFIG.5, consistent with an illustrative embodiment.FIG.7provides an exploded view of an example intraurethral contraceptive system, consistent with an illustrative embodiment. It will be understood that theFIGS.5to7are provided as a conceptual overview of an ICS, and that many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. In one aspect, the intraurethral contraceptive devices discussed herein can be used with an external and/or internal lubricant that is bactericidal, virucidal, and/or spermicidal. The lubricant can also be associated with a vasodilator to help maintain an erection.

Example Process

With the foregoing overview of the architecture of an ICS, it may be helpful now to consider a high-level discussion of an example process related thereto. To that end,FIG.8presents a conceptual process800of administering an intraurethral contraceptive device, consistent with an illustrative embodiment. For discussion purposes, the process800is described in a series of drawings810to850using components described in the context of the discussion ofFIGS.1to6.

In drawing810, an intraurethral contraceptive device is shown having an insertion tool120, a urethral sleeve inside the insertion tool100, and an insertion plunger130at a distal end of the insertion tool. The insertion tool120is slidingly inserted into a urethra. In one embodiment, the insertion of the intraurethral device100into the urethra is stopped by an insertion stop124of the insertion tool120.

In drawing820, a proximal portion of the urethral sleeve100including a balloon104is released from a proximal end of the insertion tool120into the urethra. In one embodiment, the balloon is pre-inflated and expands upon release in the urethra, thereby anchoring the urethral sleeve100in the urethra. In various embodiments, the releasing of the proximal portion of the urethral sleeve100is by bringing a plunger head132of the insertion plunger130towards the plunger stop128of the insertion tool120, by a predetermined distance, by either bringing the plunger head132to the plunger stop128and/or the plunger stop128towards the plunger head132.

In drawing830, the insertion tool120is slidingly removed from the urethra, together with the insertion plunger132.

In drawing840, any fluid traveling from the proximal end to the distal end of the urethral sleeve100is caught by a reservoir110coupled to a distal end of the urethral sleeve. In one embodiment, the reservoir110is initially within (i.e., inside) the urethral sleeve100and turns inside-out, thereby creating an external reservoir110.

In drawing850, the balloon is deflated. In one embodiment, the deflation of the balloon is by way of pulling a tab306at a distal end of the urethral sleeve, operative to open a seal of an air lumen leading to the balloon104. In another embodiment, a separate tab is not necessary; rather, the deflation of the balloon104is facilitated by pulling the reservoir110, which is operative to, in addition to catching fluids, to open a seal of an air lumen leading to the balloon104when pulled with sufficient force.

CONCLUSION

The descriptions of the various embodiments of the present teachings have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

While the foregoing has described what are considered to be the best state and/or other examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that the teachings may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all applications, modifications and variations that fall within the true scope of the present teachings.

The components, steps, features, objects, benefits and advantages that have been discussed herein are merely illustrative. None of them, nor the discussions relating to them, are intended to limit the scope of protection. While various advantages have been discussed herein, it will be understood that not all embodiments necessarily include all advantages. Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

Numerous other embodiments are also contemplated. These include embodiments that have fewer, additional, and/or different components, steps, features, objects, benefits and advantages. These also include embodiments in which the components and/or steps are arranged and/or ordered differently.

While the foregoing has been described in conjunction with exemplary embodiments, it is understood that the term “exemplary” is merely meant as an example, rather than the best or optimal. Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.

It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.