Surgery – Male reproductory tract shields or birth control devices
Reexamination Certificate
2000-11-14
2002-05-21
Brown, Michael A. (Department: 3764)
Surgery
Male reproductory tract shields or birth control devices
C600S039000
Reexamination Certificate
active
06390095
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to male therapeutic devices and, in particular, to a constriction collar for facilitating and sustaining an erection.
In order to achieve an erection, blood flow into the penis via the cavernosal arteries must increase and venous outflow must be drastically reduced or stopped altogether. During sexual stimulation, neurotransmitters are released that relax smooth muscle in the penile arterial system (i.e. cavernosal arteries) and the penile tissue (i.e. paired cavernosal bodies and sinusoids). Smooth muscle relaxation in the arterial system results in vasodilatation with increased blood flow into the penis with accompanying penile tumescence or swelling. Smooth muscle relaxation in the penile tissue results in relaxation of the sinusoidal spaces that engorge with blood and physically occlude the penile veins as they exit the tunical albuginea (i.e. firm layer that encloses the penile tissue and blood vessels).
Failure to occlude sufficiently the penile veins leads to poor entrapment of blood within the penile erectile bodies, commonly referred to as venous leakage. Venous leakage causes poor maintenance of erections and is a major cause of erectile dysfunction.
Presently known, fixed diameter constriction collars or rings provide a relatively small diameter to assure retention to the penis in a flaccid condition. During penile tumescence, the collar expands to place an increased tension on the penis to achieve venous occlusion. Most typically, too much tension results and the constriction collar becomes too tight and creates discomfiture. Undue tension or compression for protracted periods of time also heightens the risk of tissue damage, even though an erection is maintained.
The hardness, or durometer, of the material used to construct the collar is also a significant factor. If the material is too soft, an erection from the flaccid state may not be easily achieved. If the material is too hard and/or too much tension is placed on the penis, tissue damage may occur. As a result, the durometer of the material is critical to the function, as well as comfort, of a constriction ring.
U.S. Pat. Nos. 4,203,432; 4,224,933 and 5,085,209 disclose adjustable, discontinuous circumference constriction devices. That is, the user controls the effective device diameter to vary the constriction force exhibited by the device.
U.S. Pat. Nos. 5,246,015 and 5,628,329 disclose closed loop or continuous circumference collars of tubular or cylindrical construction. Each provides gripping flanges that facilitate mounting and removal.
In distinction to known penile restriction devices, the present collar was developed to provide a constant and comfortable compressive force or tension (i.e. 1.5 Kg (±0.5 Kg)) measured as a quasi-static load) over a wide range of flaccid and tumescent penile diameters. The collar is constructed of a medical grade silicone material that is rated between 40-50 durometer (±5) on the Shore “A” scale. The material is firm enough to cause and sustain an erection. Collars constructed with multiple regions of differing relative durometer and/or cross section shape have also been considered.
The collar provides a non-pharmacological penile constriction device that enhances venous occlusion and improves the ability to trap blood within the penis over a range of penile diameters. The collar enhances patient comfort, decreases the potential for tissue injury and enhances erectile performance (i.e. the ability for a man to achieve and maintain an erection sufficient for satisfactory sexual intercourse), sexual function, and sexual partner satisfaction.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the invention to provide an elastomer penile constriction collar.
It is a further object of the invention to provide a constriction collar formed from a medical grade silicone rubber exhibiting a durometer in the range of 40-50 (±5) on the Shore “A” scale.
It is a further object of the invention to provide a collar that exhibits a constriction load of 1.5 Kg (±0.5 Kg) over a range of increasing diameter equal to or greater than 150%.
It is a further object of the invention to provide a torroid shaped constriction collar.
It is a further object of the invention to provide a constriction collar having multiple circumferential regions or zones that exhibit differing durometers and/or cross sectional shapes.
Many of the foregoing objects, advantages and distinctions of the invention are obtained in a number of alternative collars. The collar is designed to provide a relatively constant compressive force over a range of changing penile diameters and tumescence to maintain comfort from the non-erect or flaccid state to the erect condition. The compressive force provides sufficient compression to cause an erection and to occlude blood flow sufficiently to achieve and maintain an erection satisfactory for sexual intercourse. Some men also believe penile engorgement enhances the penile sensation experienced during intercourse.
Still other objects, advantages, distinctions and alternative constructions and/or combinations of the invention will become more apparent from the following description with respect to the appended drawings. Similar components and assemblies are referred to in the various drawings with similar alphanumeric reference characters. The description should not be literally construed in limitation of the invention. Rather, the invention should be interpreted within the broad scope of the further appended claims.
REFERENCES:
patent: 4203432 (1980-05-01), Koch
patent: 4960113 (1990-10-01), Seeberg-Elverfeldt
patent: 4995381 (1991-02-01), Marmar
patent: 5246015 (1993-09-01), Baber
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