U.S. patent number 3,646,616 [Application Number 04/844,071] was granted by the patent office on 1972-03-07 for prosthesis for implanting around a body duct such as the urethra and method of treating urinary incontinence.
Invention is credited to Jesse G. Keshin.
United States Patent |
3,646,616 |
Keshin |
March 7, 1972 |
PROSTHESIS FOR IMPLANTING AROUND A BODY DUCT SUCH AS THE URETHRA
AND METHOD OF TREATING URINARY INCONTINENCE
Abstract
Prosthesis consisting of a mesh material impregnated with an
antibiotic, antiseptic, antispore medication or a combination of
these which surrounds a conduit leading to the skin, such as the
urethra, and having an end portion thereof embedded in a
water-repellent substance which protrudes from the end of the
conduit and the surface of the skin and a cap therefor.
Inventors: |
Keshin; Jesse G. (Mount Vernon,
NY) |
Family
ID: |
25291724 |
Appl.
No.: |
04/844,071 |
Filed: |
July 23, 1969 |
Current U.S.
Class: |
623/23.66;
128/DIG.25; 604/175; 604/329 |
Current CPC
Class: |
A61F
2/0004 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61f 001/00 (); A61f 005/44 () |
Field of
Search: |
;3/1
;128/1,283,334,348-351,DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"The Use of an Inlying Plastic Conduit for Chronic Peritoneal
Irrigation" by J. P. Merrill et al., Transactions Amer. Society for
Artifical Internal Organs, Vol. VIII, 1962, pages 252-255.
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
What is claimed is:
1. A prosthesis for implantation in a generally circular incision
closely encircling the end portion of a duct which normally
terminates at and is joined with epidermal tissue comprising a
bodily flexible elongated open-ended tubular member fabricated of a
material which is nonreactive, nonabsorbable and compatible with
bodily tissues with one end portion of said tubular member having
an inside diameter selected to be only slightly larger than the
outside diameter of a duct to which it is to be secured so that
such duct may be closely fit therewithin, said one end portion
being provided with a plurality of circumferential wide-mesh
openings extending entirely radially therethrough of a size so as
to be sufficiently porous to permit fibrous tissue to grow easily
inwardly through said one end portion to knit together with said
duct and retain said member in position therebetween, the other end
portion of said tubular member being water-repellent and nonporous
to retain fluids from such duct therewithin.
2. Prosthesis defined in claim 1 comprising a tubular fibrous mesh
extending throughout substantially the entire longitudinal extent
of said member and defining alone said one end portion and a
water-repellent and nonporous coating extending substantially
entirely over a longitudinally extensive portion of said mesh to
define therewith said other end portion.
3. Prosthesis defined in claim 2 together with a solid waterproof
removable closure closing said other end for precluding the flow of
bodily fluids therethrough and removable to permit the passage of
bodily fluids therethrough.
4. Method of treating urinary incontinence comprising, at least the
steps of, freeing the end portion of the urethra of a patient from
the surrounding skin, positioning a prosthesis comprising a bodily
flexible tubular member, one end of which comprises a nonreactive
material into which tissue can grow and the other end of which
comprises a water-repellent, nonporous material with said one end
portion thereof disposed within the incision and surrounding the
end portion of the urethra and with the other end portion thereof
protruding generally axially of the end of the urethra and from the
surface of the surrounding skin; permitting of the tissue to grow
into said one end; and selectively plugging and unplugging said
other end portion of the prosthesis to control urination.
5. Method defined in claim 4 further comprising, at least the
additional step of, suturing said one end portion of said
prosthesis in position during implantation.
Description
This invention relates, generally, to medical prosthesis and, more
particularly, to prosthesis applied to a conduit leading to the
skin, such as a urethra.
The prosthesis of the present invention may comprise a tube, an end
portion of which comprises a material into which tissue will grow
and another end portion of which comprises a water-repellent
substance. The portion into which the tissue will grow may be
implanted around a tubal structure which protrudes to the skin,
such as a urethra which, prior to implantation, must be freed from
the surrounding tissue. The portion protruding beyond the urethra
may be water-repellent and nonporous and the protruding end of the
tub may be plugged by a solid plug or cap. The portion of the tube
surrounding the urethra may be fixed in place by sutures so that
when this tissue heals the tube will be permanently fixed and will
be watertight. Control of urination can be accomplished by plugging
or unplugging the protruding tube.
Having in mind the foregoing, it is a primary object of the present
invention to provide a prosthesis which comprises one portion into
which tissue will grow and another portion into which tissue will
not grow.
Another primary object of the present invention, in addition to the
foregoing object, is the provision of such a prosthesis in the form
of a tube having one portion non-reactive to tissue and another
portion which is water-repellent.
Yet another primary object of the present invention, in addition to
each of the foregoing objects, is the provision of such a tube for
implantation around a tubular structure, such as a urethra so that
the portion protruding beyond the urethra will be
water-repellent.
Yet still another primary object of the present invention, in
addition to each of the foregoing objects, is the provision of such
a tube which may be readily fixed in place, as by means of sutures
and which when the surrounding tissue heals will be permanently
fixed and will be watertight.
Another and yet a still further primary object of the present
invention, in addition to each of the foregoing objects, is the
provision of novel methods and apparatus for the treatment of
urinary incontinence.
Yet another and still further primary object of the present
invention, in addition to each of the foregoing objects, is the
provision of novel prosthesis having one portion which is adapted
for implantation under the skin of a patient fabricated of a porous
material into which tissue will grow and a second portion adapted
to protrude beyond the skin or a membrane surface fabricated of
material which is nonporous and water-repellent.
Still further, it is yet another primary object of the present
invention, in addition to each of the foregoing objects, is to
provide novel and improved methods and apparatus providing
permanent prosthesis around any tubal structure which has a
connection with the skin to prevent and control leakage and fluid
flow through the structure such as urethra or in connection with
colostomy, ileo-bladder procedures, and the like.
Yet still further, it is a primary object of the present invention,
in addition to each of the foregoing objects, to provide novel and
improved prosthesis comprising mesh material impregnated with
antibiotic, antiseptic, antispore medication or a combination of
these which surrounds a tubular structure, such as the urethra, and
having a portion imbedded in a water-repellent substance which
protrudes from the end of the tubal structure and the surrounding
skin or membrane, and which may be capped to preclude leakage
therethrough.
Yet another primary object of the present invention, in addition to
each of the foregoing objects, is the provision of a tubular device
which can be readily attached to any tubular bodily structure and
which is economical to manufacture and which is safe, durable and
effective in use.
The invention resides in the combination, construction, arrangement
and the disposition of the various component parts and elements
incorporated in improved prosthesis constructed in accordance with
the principles of this invention and in the methods of utilization
thereof. The preset invention will be better understood and objects
and important features other than those specifically enumerated
above will become apparent when consideration is given to the
following details and description, which when taken in conjunction
with the annexed drawing describes, discloses, illustrates and
shows a preferred embodiment or modification of the present
invention and what is presently considered and believed to be the
best mode of practicing the principles thereof. Other embodiments
or modifications may be suggested to those having the benefit of
the teachings herein, and such other embodiments or modifications
are intended to be reserved especially as they fall within the
scope and the spirit of the subjoined claims.
IN THE DRAWING
FIG. 1 is a sketch of a urethra opening prior to the performance of
any surgical procedure;
FIG. 2 is a sketch, similar to FIG. 1, of the urethra opening
illustrating the manner in which an incision may be utilized to
free the urethra from the surrounding tissue;
FIG. 3 is a sketch similar to the preceding figures showing a
prosthesis positioned extending from the end of the urethra and the
surface of the surrounding skin in accordance with the principles
of the present invention;
FIG. 4 is a cross-sectional sketch illustrating the appropriate
portion of a reclining female body having a prosthesis implanted
and extending from the urethra in accordance with the present
invention; and
FIG. 5 is an enlarged cross-sectional view taken along the line
5--5 of FIG. 4, showing the construction of the prosthesis, in
detail.
With reference now to the drawing, and particularly to FIGS. 3 and
5 thereof, there is shown and illustrated a novel prosthesis
constructed in accordance with the principles of the present
invention and designated generally by the reference character 10
which may comprise a generally tubular portion 12 adapted for the
implantation of the body of a patient and a cap portion 14 adapted
to close the tubular portion 12 to retain bodily fluids
therewithin.
The tubular portion 12 may, for example, comprise a tubular mesh
material impregnated with antibiotic, antiseptic, antispore
medication or a combination of these and may comprise a substance
which is nonreactive with the patient's tissues and into which
tissue will grow and is designated, in the drawing, by the
reference character 16. The portion of the tubular prosthesis 12
which is adapted to project outwardly of the patient's skin is
preferably water-repellent and may comprise, for example, an
extension of the tubular mesh material 16 provided with a single or
double coating 18 of water-repellent and nonporous material which,
preferably is also flexible or resilient. The cap 14 may be of
substantially any desired construction and may, for example,
comprise a shouldered plug of water-repellent, nonporous and
flexible or resilient material, similar to that utilized for the
coating 18.
The mesh material 16 may be fabricated to have a wide mesh and of
substantially any knitted, woven, crocheted or braided synthetic or
natural fibers that are nonabsorbable and compatible with the human
body. For example, and without limitation, materials that may be
suitable are silk, cotton, tantalum or precious metal gauze,
rubbers, silicones, silastic, latex, butyl rubber polymer or
plastics such as Vinyon-N (a resin manufactured by the Carbide and
Carbon Corporation by copolymerizing vinyl chloride and
acrylonitrile), nylon (a polyamide resin made by polymerization of
the hexamethylene diamine salt adipic acid), Orlon (a synthetic
fiber made by the E. I. du Pont de Nemours & Co., from
polyacrylonitrile), Dacron (a synthetic fiber made by the E. I. du
Pont de Nemours & Co., from terephthalic acid and ethylene
glycol), Teflon (a tetrafluoroethylene polymer manufactured by E.
I. du Pont de Nemours & Co.), Saran (a vinyl chloride polymer
manufactured by the Dow Chemical Company), Kel-F
(polyflurotrichloroethylene), polyolefins such as polyethylene and
polypropylene, urethanes, and the like.
The water-repellent and nonporous portion 18 may be produced by
coating with any of the above or may be produced by fusing the
fibers to form an integral article. Various adhesives may be used
for this purpose and the Versamids (proprietary name for a series
of polyamide resins produced by the condensation of poly carboxylic
acids with polyamines) are one suitable type of adhesive,
particularly for use with Dacron fibers. The fusing step, when the
foregoing polyamide resin is employed, can be accomplished by
simply curing the heat-setting adhesive. Ultrasonic technique may
also be employed to fuse the fiber and polyethylene teraphthalate,
for example, is known to be sealable by this technique.
Straightforward heat-sealing techniques, utilizing direct or
radiant heating may also be utilized to fuse the fibers.
With more particular reference now to FIG. 1, 2, 3 and 4, and as
heretofore pointed out, the prosthesis of the present invention may
be utilized in conjunction with substantially any tubular structure
at the location where the structure reaches the skin. For example,
the prosthesis of the present invention is particularly suited, for
use in controlling urinary incontinence by implanting in contrast
with the urethra of a female to treat incontinence and may be
implanted, as follows:
In FIG. 1 there is illustrated a urethra as it would normally
appear at the patient's skin. Preparatory to implanting the
prosthesis, an incision may be made as illustrated in FIG. 2
encircling the urethra and freeing the urethra from the surrounding
skin. Then, the tubular mesh portion 16 of the prosthesis may be
implanted into the incision so as to surround the end portion of
the urethra with the coated portion 18 of the prosthesis adjacent
the end portion of the urethra and projecting outwardly thereof and
outwardly of the surface of the surrounding skin or membrane.
Hence, it may be readily seen that with the present prosthesis,
there is no need to insert any objects, catheters, or the like,
into the urethra itself; the prosthesis surrounds the urethra and
is not inserted within it.
As heretofore pointed out, the prosthesis consists of a tube, part
of which is composed of a material into which tissue will grow,
such as the mesh material 16 which is inserted into the incision
and surrounding the tubular structure, such as the urethra. The
portion 16 into which the tissue will grow may be fixed in place,
as by sutures utilizing either nonabsorbable or absorbable sutures.
When the tissue surrounding the implantation heals, the tube will
be permanently fixed and will be watertight.
The projecting portion 18 of the prosthesis is, as heretofore
pointed out, nonreactive, water-repellent and nonporous, as by
being provided with the coating 18. The end of the tube may be
plugged by the cap or plug 14 and control of urination can then be
accomplished by plugging or unplugging the protruding tube.
It is to be expressly understood, however, that while the invention
has been specifically set forth as applied to a prosthesis for
urinary incontinence, particularly in women, the present invention
is equally applicable to prosthesis of substantially any tubular
structure having an outlet at or near the skin or a membrane.
Moreover, while the present prosthesis has been specifically
disclosed in conjunction with a solid plug or cap for controlling
fluid flow thereto, substantially any other desired flow control
means may be similarly utilized.
While the invention has been described, disclosed, illustrated and
shown in terms of an embodiment or modification which it has
assumed in practice, the scope of the invention should not be
deemed to be limited by the precise embodiment or modification
herein described, disclosed, illustrated or shown, such other
embodiments or modifications as may be suggested to those having
the benefit of the teachings herein being intended to be reserved
especially if they fall within the scope and breadth of the claims
here appended.
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