Surgery – Sexual appliance
Reexamination Certificate
2002-04-17
2004-03-16
Gilbert, Samuel G. (Department: 3736)
Surgery
Sexual appliance
Reexamination Certificate
active
06705987
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The invention relates to vacuum constriction devices, and more particularly to a combined penile seal and constriction ring for use with a vacuum constriction device.
2. Related Art
In recent years, non-invasive devices have been designed and used for the external management of erectile dysfunction, in part because of the cost and risk involved with surgical implantation of penile prostheses. External constriction devices commonly contract around the base of the flaccid penis and prevent the outflow of blood once the penis has risen into an erect state. Several different styles of constriction devices exist that obtain this same result.
The first category of constriction devices is a constricting ring that may be used alone or in combination with an external erection device. The constriction ring is placed on an erected penis to impede the flow of blood to maintain an erect state. These devices are typically made of an elastomeric material such as rubber. A constriction ring generally consists of O-rings with shaped handles attached to the ring to assist in applying and removing the ring. By grasping the handles, the central O-ring is stretched and placed over the base of the penis where it constricts the retraction vessels to prevent outflow of blood.
When used alone, the constriction ring is placed around the base of a flaccid or semi-flaccid penis, constricting the blood vessels of the penis before it is brought to an erect state. The penis is then manipulated to encourage blood flow into the penis and the constriction ring prevents the outflow of blood to enable the user to achieve and maintain an erection.
A second category of constriction devices is designed for use with suction or vacuum erection devices. Vacuum erection devices typically include an elongated vacuum cylinder, sometimes with tapered walls, that is usually made of a clear polymeric material with a length and diameter sufficiently large to accommodate either a flaccid or an erect penis. At a first end of the cylinder, a vacuum device is secured to the cylinder to remove air either with a manually operated or electronic vacuum pump. At a second end of the cylinder, a constriction device such as a constriction ring or sleeve is secured to or slipped over the end of the cylinder. Once the constriction ring or the like is placed around the second end of the cylinder, the cylinder is positioned over the flaccid penis and pressed against the user's abdomen. While pressing the cylinder firmly against the user's abdomen around the base of the penis, the vacuum pump is operated to evacuate air from the cylinder. The resulting reduction of air pressure around the penis causes blood to engorge the penis, bringing it to an erect state. Once erection is achieved, the constriction ring is removed from the second end of the cylinder and contracts around the base of the erect penis. Placement of the ring around the erect penis significantly restricts the flow of blood back out of the penis, thereby maintaining the penis in an erect state until such time as the ring is removed.
Several problems have been identified using the above-mentioned systems. First, the vacuum cylinder used to mount the constriction device and create an airtight seal between an open end of the cylinder and the user's abdomen is often ineffective for creating an airtight seal. Furthermore, creating a vacuum tight seal against the abdomen often permits abdominal or scrotal tissue and pubic hair to be painfully pulled into the vacuum chamber. Second, constriction devices are often used by older men who may have arthritis, muscle weakness, and vascular or nervous degeneration that inhibits their ability to stretch the constriction ring over the vacuum chamber or penis and provide the necessary force required to maintain a tight vacuum seal between the cylinder and the abdomen of the user. A third disadvantage of known constriction devices is that the constriction devices are difficult to mount to an exterior of the vacuum cylinder. Constriction ring stretchers and loaders are sometime provided with vacuum erection devices and constriction rings to expand and load the constriction ring to the cylinder. These stretchers and loaders, however, are often complicated to use, often break the constriction rings, and are expensive to manufacture and purchase. Lastly, the constriction rings typically snap off the vacuum cylinder onto the penis with great force, like a rubber band, which often surprises and hurts the user.
A combination constriction ring and abdominal sealing pad has been described by Wallsdorf, U.S. Pat. No. 5,344,389. This device is expanded with a ring stretcher, placed over the penis, and released to constrict the penis. A vacuum chamber is then placed around the penis, contacting the sealing pad, and a vacuum is generated between the abdominal sealing pad and an end surface of the vacuum cylinder. The vacuum condition causes blood to be drawn past the ring and into the penis. The abdominal sealing pad prevents abdominal or scrotal tissue and pubic hair from being pulled into the vacuum chamber. However, this device suffers from some of the disadvantages described above for known vacuum systems.
A vacuum seal on the penis, rather than the abdomen, has been described by Altshuler, U.S. Pat. No. 6,036,635. Altshuler describes a sleeve that is stretched over the opening of the vacuum chamber to create a vacuum seal between the sleeve and the outer surface of the vacuum cylinder, and between the sleeve and the penis. The system of Altshuler also includes a ribbon-shaped constriction device that is wound over itself to form a cylindrical ring that is secured to the cylinder on top of the sleeve with a belt. This device minimizes discomfort due to abdominal tissue entrapment, but maintains several disadvantages. For example, this penile seal limits the achievable vacuum pressure and the quality of the erection because both a penile seal and a ribbon shaped constriction device are used. Further, stretching the seal over the vacuum cylinder may be difficult. In addition, the penile constriction ring required to hold the blood within the penis after engorgement and the sleeve are separate members, thus increasing the cost and complexity of the system. Also, removal of the separate constriction ring from the vacuum cylinder is intended to simultaneously remove the penile seal from the cylinder and break the vacuum seal. Placement of the constriction ring is therefore technique-dependent and does not provide consistent results. Lastly, the penile seal must be removed before sexual intercourse.
A combination penile seal and constriction ring is disclosed by Bonthuys, WO99/44550. This device provides a penile seal and sealing ring that is mountable on a vacuum cylinder. The device is mounted to an end of the vacuum cylinder, the penis is placed against a ring opening of the device, and the penis is drawn into the vacuum cylinder under vacuum pressure. Once seated at the base of the penis, the ring constricts and prevents venous outflow from the penis while blood is drawn into the penis under vacuum pressure. The ring is then removed from the vacuum cylinder and remains on the penis until removed by the user. To remove the ring, the opening of the ring is manually stretched to allow removal of the ring thereby permitting blood to exit the penis. The sealing ring includes a ring-shaped portion with an inward facing surface or wall that engages the outside and end surfaces of the cylinder to form a vacuum seal. The diameter of the inward facing surface of the ring-shaped portion is slightly smaller than the outside diameter of the vacuum cylinder so that the device is sealingly engaged to the outside surface of the vacuum cylinder.
SUMMARY OF THE INVENTION
The present invention generally relates to penile constriction rings for treatment of erectile dysfunction. One embodiment of the invention is a penile seal and constriction ring device with a webbing member that acts as a base for the device
Anderson David W.
Biewald Karl F.
Pedersen Allen R.
Timm Gerald W.
Endocare, Inc.
Gilbert Samuel G.
Merchant & Gould P.C.
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