The present invention relates generally to noninvasive penile erection aids and more specifically to vacuum-constriction erection aid devices used to induce and maintain erection in males having erectile dysfunction.
Without limiting the scope of the invention, its background is described in connection with existing treatments for erectile dysfunction. In some instances of erectile dysfunction, in which the patient does not respond to more conventional therapy, the surgical implantation of a penile prosthesis was considered the only practical means of remedying the dysfunction. In the past, several types of implanted penile prostheses have been employed. One type of penile implant prosthesis which has been used includes a pair of inflatable and distensible tubes that are implanted into the corpora cavernosae of the penis. Typically, each of the tubes is connected by tubing to a fluid filled reservoir through a pump and valve assembly. The entire system is typically surgically implanted in the body of the patient. A second type is a rod of suitable stiffness surgically implanted into the corpus cavernosus of the penis. Most males find the surgical option intimidating. The surgical prior art solutions have proven undesirable and generally do not provide a popular or reliable solution to the erectile dysfunction of most patients.
External erection control systems have also been developed that typically provide vacuum-constriction therapy to induce the erection of the human penis by creating a vacuum atmosphere around the penis that causes blood to enter and inflate the penis. Most vacuum assist devices have three essential components: a cylindrical penile vacuum chamber for receiving the penis, a diaphragm for sealing the open end of the vacuum chamber around the penis, and a vacuum pump for evacuating air from the vacuum chamber. These vacuum assist devices may be used with some form of constriction band, clip device or male truss. There have been numerous modifications and variations of these devices. Examples of such devices are shown in U.S. Pat. No. 3,820,533 to Jones, U.S. Pat. No. 4,641,638 to Perry, U.S. Pat. No. 4,741,329 to Marcune, U.S. Pat. No. 4,753,227 to Yanuk, U.S. Pat. No. 4,856,498 to Osbon, U.S. Pat. No. 5,125,890 to Merrill, U.S. Pat. No. 5,344,389 to Walsdorf, and U.S. Pat. No. 5,964,695 to Vollrath.
The Jones '533 patent describes an inflatable ring adapted to be inserted around the base of the penis and remain in place during intercourse. The ring is inflated so as to apply a radially inward force thereto sufficient to retain blood in the organ and a tubular sleeve portion is secured about the ring element and actuated to develop a low pressure within the interior of the tube and outside the penis, to aid in causing an erection. Similarly, the Perry '638 patent discloses a two part system including an expansible diaphragm that acts as a prosthesis that is left in place during intercourse. An outer tubular vacuum chamber is positioned over the penis and the prosthesis device and activation of vacuum pressure within the chamber effects vascularization of the penis.
The Merrill '890 patent describes a constriction band dislodging mechanism comprising a flexible strap which is attached to a sealing diaphragm that provides a simple method for transferring any constriction band from the chamber on the penis. The Vollrath '695 patent describes a constriction ring designed to fit against the base of the penis, and a diaphragm seal that forms a substantially air tight seal against the constriction ring. The Merrill '890 patent discloses a penile sealing diaphragm that forms an airtight seal between the tubular chamber and the penis. A constriction band dislodging mechanism comprises a flexible strap that is attached to the sealing diaphragm to provide a simple method for transferring any constriction band from the chamber onto the penis.
One shortcoming of conventional penile vacuum tubes that are designed to cooperate with various penile constriction devices, such as those described herein above, is that existing vacuum tube diaphragms or inflatable rings do not fit all users with equal comfort, and are not sufficiently adjustable.
An additional shortcoming of existing devices is that the diaphragm does not form a sufficiently tight seal to produce a desired amount of vacuum pressure inside the tube. Air tends to leak between the diaphragm and the penis even when gel lubricants are applied. Conventional penile vacuum tubes with conventional penile diaphragms achieve between 14-16 in. of mercury vacuum pressure while a satisfactory erection often requires 17-22 in. of mercury of vacuum pressure.
To achieve a partial vacuum around the penis, some prior art vacuum tubes, exemplified by the above cited Marcune '329 patent require that the open end of a vacuum chamber make an air tight seal with the abdominal wall around the penis. One shortcoming specifically with such device, as well as with most of the prior devices, is that the scrotum and testicles may be inadvertently drawn into the vacuum chamber causing pain and injury.
The present invention is provided to solve these and other problems.
In one embodiment described herein an improved penile sealing adapter is provided that overcomes the limitations of the sealing diaphragms of the prior art. Provided herein is an inflatable tubular adapter having an external diameter enabling it to fit snugly into the front end of a vacuum chamber, wherein the tubular adaptor includes an inner inflatable annular balloon member that enables effective dimensional adjustment of the internal opening of the adaptor and ultimately the organ-receiving-end of the vacuum chamber, thus accommodating differing user requirements.
Another object of the present invention is to provide an air-tight fit for more effective vacuum attainment and retention in the vacuum chamber than prior art diaphragms.
Another object of the present invention is to avoid the problems of loosely fit diaphragms of the prior art that result in scrotal tissue or testicles being inadvertently drawn into the vacuum chamber causing user pain or injury.
Another object of the present invention is to avoid the expense and inconvenience of the use of adapter inserts of differing internal diameters proposed by the prior art.
A further object is to provide an inflatable member having a continuous smooth interior surface thus presenting a comfortable yet tight fit that can improve the vacuum seal.
A yet further object, is to provide a penile sealing adapter that can be manually or electrically actuated to inflate/deflate the annular balloon member of the present adapter.
A still further object is to provide an adapter that can be separated from the vacuum tube to facilitate the cleaning of the components.
In order to prevent the blood from flowing out of the erect penis once erection is accomplished, an elastic penile strap device or inflatable external sleeve are placed about the base of the organ to compress the draining veins and maintain erection. The strap device or external penile sleeve will remain in place throughout the period of erection or intercourse.
These and other objects are achieved by the embodiments of the present invention which comprise an inflatable tubular adapter that may be manually or electrically actuated, that may be easily connected or disconnected from a conventional vacuum tube and having a central opening at one end, providing an adjustable central opening receptive of different size penises, states of flacidity, or erection.
For a more complete understanding of the present invention, including features and advantages, reference is now made to the detailed description of the invention along with the accompanying figures:
While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts which can be employed in a wide variety of specific contexts. The specific embodiment discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.
To facilitate the understanding of this invention, and for the avoidance of doubt in construing the claims herein, a number of terms are defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. The terminology used to describe specific embodiments of the invention does not delimit the invention, except as outlined in the claims.
The terms such as “a,” “an,” and “the” are not intended to refer to a singular entity unless explicitly so defined, but include the general class of which a specific example may be used for illustration. The use of the terms “a” or “an” when used in conjunction with “comprising” in the claims and/or the specification may mean “one” but may also be consistent with “one or more,” “at least one,” and/or “one or more than one.”
The terms “comprising” (and any form thereof such as “comprise” and “comprises”), “having” (and any form thereof such as “have” and “has”), “including” (and any form thereof such as “includes” and “include”) or “containing” (and any form thereof such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
As used herein the term “fluid” includes non-compressible liquids and gases such as air.
In one embodiment depicted in
An inflatable member (13) extends along the inner circumference of tubular member (11) and encloses central chamber (40) for receiving the male organ. Inflatable member (13) can be formed as a single annular balloon or as a fusion of two or more pieces. Outer layer (15) of the inflatable member (13) is bonded to tubular member (11). Inner inflation member (14), is designed to expand into lumen (40) when inflated with a gas or a fluid to form inner fluid tight annular space (16). Inflatable member (13) has a smooth interior surface, providing comfort to the user and optimal air tight seal when inflation member (14) is inflated and extended inwardly within central lumen (40).
Vacuum apparatus (20) includes a vacuum cylinder (21) of adequate dimensions to slidably accommodate tubular member (11) of adapter (10). Vacuum cylinder (21) may be made from a material similar to tubular member (11). Vacuum chamber (50) is enclosed by vacuum cylinder (21) of vacuum apparatus (20).
The dimensions of the tubular components of adapter (10) and vacuum cylinder (21), are selected to enable the adapter to be positioned quickly and easily, and nested securely within the open end (51) of vacuum cylinder (21) before or after adapter (10) is placed over the male organ. In one embodiment, an air tight connection between adapter (10) and vacuum cylinder (21) is accomplished via a gasket (96) against which vacuum cylinder rests during vacuum administration.
Fittable vacuum apparatus (30) can be provided as a kit containing a cylindrical vacuum tube (20) with adapter (10) that is receivable telescopically into vacuum cylinder (21).
Inflatable member (13) may be formed from an elastomeric material or balloon membrane that may be thermoplastic or thermoset. Inner layer (14) and an outer layer (15) may be formed form two concentric round tubular membranes. The outer layer is sized to be received along the inner margin of tubular member (11), and securely bonded thereto. In one embodiment, the annular edges of the first and second concentric round membranes are aligned and bonded together, thus creating the fluid tight annular space (16) there between. The annular edges may be joined by means such as gluing, welding, or by RF energy.
Strap device (70) in certain embodiments is applied around user's penis (100) and behind the scrotum (102) as depicted in
Adjustable strap device (70) or (72) may include an easily stretchable elastic tubing for ease of application around the user's penis or penis and scrotum, and it does not need to be tightened until a satisfactory penile erection has been achieved. Unlike prior art constriction rings, which generally are not adjustable, and which generally have predetermined diameters around 1 inch, the present strap may be easily stretched to an oval diameter of 2-3 inches; and thereafter can be tightened with the above mentioned strap when the erection has been achieved including if desired with the aid of the inflatable penile sealing adapter of the present specification.
Advantageously, the inflatable sealing adapter disclosed herein separates the air tight sealing function from the constricting band mechanism of the prior art, exemplified by the constricting band variation of the above referenced Vollrath '695 patent. Accordingly, the adjustable strap device mentioned above and the sealing adapter of the present specification are free to provide their specific functions in a specialized fashion.
With reference to
The inflatable sealing adapter (10) is configured to provide a substantially airtight seal around penile sleeve (80), to draw the penis into a vacuum chamber (50) so that a satisfactory erection is achieved. Penile sleeve (80) is then pressurized to maintain the erection after the inflatable sealing apparatus and vacuum tube are removed.
Inflatable sealing adapter (10) can be provided in a kit containing a cylindrical vacuum chamber (50) with inflatable sealing adapter (10) received telescopically in the inlet (51) of vacuum chamber (50), and with a hand or power operated pump at an outlet of vacuum chamber (50).
Inflatable sealing adapter (10) may comprise a generally cylindrical housing (11) into which penile sleeve (80) is received into internal lumen (40). Cylindrical housing (11) is composed of a rigid tubular structure that is preferably transparent, having an inner pressurizable chamber (16) that provides an annular diaphragmatic seal against penile sleeve (80).
Along the proximal outer margin of cylindrical housing (11), an inflation-deflation pump unit (58) is provided in the form of a small chamber comprising a fluid reservoir (53), at least one valve (56), and an electric or manual pumping mechanism (54) for transferring fluid to and from the fluid tight annular space (16). The volumetric capacity of the reservoir (53) is in the order of 5-10 cc.
Referring to
Those skilled in the art will appreciate the value and advantage of spatial and functional separation of the above discussed functions of an adjustable penile sealing adapter in conjunction with an adjustable penile strap device or external penile sleeve for the treatment of erectile dysfunction.
All publications, patents and patent applications cited herein are hereby incorporated by reference as if set forth in their entirety herein. While this invention has been described with reference to illustrative embodiments, this description is not intended to be construed in a limiting sense. Various modifications and combinations of illustrative embodiments, as well as other embodiments of the invention, will be apparent to persons skilled in the art upon reference to the description. It is therefore intended that the appended claims encompass such modifications and enhancements.
This application claims priority based on U.S. Provisional Application Ser. No. 62/458,120 filed Feb. 13, 2017 and incorporated herein by reference it is entirety.
Number | Date | Country | |
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62458120 | Feb 2017 | US |