Surgery – Devices transferring fluids from within one area of body to...
Reexamination Certificate
1998-03-02
2001-09-18
Sykes, Angela D. (Department: 3762)
Surgery
Devices transferring fluids from within one area of body to...
C604S540000, C604S544000, C623S001100, C623S001160, C623S017120
Reexamination Certificate
active
06290666
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the treatment of natural lumina or tracts of the human or animal body through which a transit or flow of a fluid is effected, in particular a body fluid, either liquid or gaseous, on either side of a sphincter. The urinary, respiratory, digestive, and gynecological tracts constitute natural lumina within the meaning of the present invention.
“Treatment” is understood to mean both an intervention of a mechanical type, aiming to re-establish a flow which has previously been disturbed or prevented on account of an obstruction or a stenosis of the natural lumen, and also a treatment or intervention with a therapeutic objective, for example, to control the cicatrization of the wall of the natural lumen after surgical intervention, or to reduce hyperplasia of an organ or gland surrounding this same lumen.
The present invention will be introduced, defined and described, by way of a non-limiting example, with reference to the endo-urethral prostheses which are used in the urethra in connection with the striated muscular sphincter.
In accordance with the document FR-A-2 667 783, an endo-urethral prosthesis has been described which consists of a tubular element, of general cylindrical shape, whose wall comprises a relatively smooth and soft biocompatible material, for example a silicone rubber, at least in its outer part. This tubular element is sufficiently flexible to conform to the anatomical profile of the urethra and to its movements, but sufficiently rigid, particularly in the radial or diametral direction, to maintain an artificial passage in the urethra. This tubular element is intended to be placed in the urethra, without passing through the striated muscular sphincter, in the prostatic segment and/or in any one of the membranous, bulbar, perineal, and penile segments.
“Tubular element” is understood to mean any element whose outer surface is described by a generatrix corresponding to a straight or curved line, or other line, about an axis.
According to the document FR-A-2 667 783, the tubular element is supported in the urethra principally by the elastics bearing of the wall of said element, in radial extension, against the urethral wall, and secondarily by various notches formed in the wall of the same tubular element, freeing catches which fasten on the urethral wall, somewhat in the manner of scales.
In practice, such a prosthesis is not self-stabilizing, for various reasons:
the elastic bearing of the tubular element is insufficient to support it in position in the urethra, except by providing or obtaining a very substantial bearing which is likely to damage the urethral wall, leading to the patient experiencing pain, and in any case rendering the withdrawal of the implanted prosthesis difficult or impossible,
the fastening catches, or scales, cooperate with the urethral wall, in its longitudinal direction, only in the sense of precluding or limiting the descent of the prosthesis; these fastening catches cannot therefore prevent the prosthesis from ascending,
the externally smooth nature of the tubular element encourages its natural sliding against the urethral wall, in particular during the various movements of the urethra,
and, finally, the various notches constitute as many punctiform bearing surfaces, or zones of turbulence, on which both the static pressure and the dynamic pressure of the urinary flow act during miction; this has the result of encouraging the descent of the urethral prosthesis.
In accordance with the document WO91/16005, metal prostheses are furthermore known which consist of two elements, each consisting of metal coils, either contiguous or non-contiguous, which are intended to be arranged in the urethra on either side, respectively, of the striated muscular sphincter. For each element, these coils, which are compressible in a centripetal manner and are expansible in a centrifugal manner, define, in their expanded position, an enveloping surface with a cross section varying from one end to the other.
Prostheses are also known which consist of a metallic or non-metallic tube which is perforated and is expansible at the moment of its implantation in the urethra.
At present, the various urethral prostheses proposed and described have been unable to reconcile:
on the one hand, the self-stabilization which presupposes in one way or another, in the previous solutions, a certain anchoring of the prosthesis on the mucosa of the urethral wall,
and, on the other hand, ease of introduction and especially of withdrawal of the prosthesis, that is to say its reversibility.
SUMMARY OF THE INVENTION
The present invention relates to a prosthesis, and in particular an endo-urethral prosthesis, which is self-stabilizing and which can be introduced and withdrawn in a non-traumatic manner from the natural lumen or tract in which it is implanted.
A prosthesis according to the invention comprises two tubular elements which are made from a relatively smooth and soft biocompatible material, such as a silicone rubber, and which are intended to be arranged in the lumen on either side, respectively, of the sphincter, and to be attached to each other by a flexible and deformable connection means which is intended to be held in the orifice of the sphincter. Each element has an external cross section which is substantially constant from one end to the other of said element.
The connection means preferably consists of a flexible sleeve, the two ends of which are connected, in continuity of flow, to the two tubular elements respectively; this connection means can also be a single connecting thread or several connecting threads which are attached individually at their two ends to the two tubular elements, respectively.
A prosthesis which comprises the technical characteristics defined hereinabove moreover affords the following decisive advantages.
The flexible sleeve or connection means constitutes a predetermined zone of bending of the prosthesis, which is capable of absorbing without stiffness all the movements of the natural lumen. This predetermined zone of bending permits harmonious functioning of the sphincter. The length of this flexible sleeve is moreover adapted to that of the sphincter.
Such a prosthesis has a uniform external profile, which fact renders it non-traumatic, both during its insertion and its removal, which maneuvers can be carried out without general anesthesia, and which fact makes it easy to position. This also makes it biocompatible in the sense that it does not irritate the inner mucosa of the natural lumen or tract.
Such a prosthesis also has an inner surface which is continuous and uniform, in particular as regards its internal cross section, which fact confers upon it very good hydraulic properties, that is to say without obstacle, for example, vis-à-vis urinary flow. As far as miction is concerned, a urethral prosthesis according to the invention is not moved by the urinary flow.
Such a prosthesis is self-stabilizing with respect to the sphincter: at rest, the sphincter immobilizes it, and during miction its sliding is prevented by the two tubular elements which are in abutment, respectively, on either side of the sphincter.
Such a prosthesis is also particularly easy to put into place, using simple instruments, in particular without necessarily having recourse to endoscopic or radiological checks. In particular, as is explained hereinafter, by simply sliding the endo-urethral prosthesis along the urethra, it is immobilized automatically in the correct position at the moment when the flexible sleeve arrives at the level of the sphincter which closes over it.
Essentially, such a prosthesis does not impede or disturb the functions of the sphincter; it opens and closes, and thus functions in a symmetrical and fluid-tight manner, under the action of the sphincter.
REFERENCES:
patent: 3527226 (1970-09-01), Hakin
patent: 3657744 (1972-04-01), Ersek
patent: 3938529 (1976-02-01), Gibbons
patent: 4240434 (1980-12-01), Newkirk
patent: 4350161 (1982-09-01), Davis, Jr.
patent: 4423725 (1984-01-01), Ba
Bianco Patricia M.
Oliff & Berridg,e PLC
Sykes Angela D.
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