U.S. patent number 3,789,828 [Application Number 05/285,637] was granted by the patent office on 1974-02-05 for urethral prosthesis.
This patent grant is currently assigned to Heyer-Schulte Corporation. Invention is credited to Rudolf R. Schulte.
United States Patent |
3,789,828 |
Schulte |
February 5, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
URETHRAL PROSTHESIS
Abstract
A prosthesis to resist the flow of urine through the urethra,
which comprises a fluid-impervious, flexible and deformable capsule
having a gel-filled, or gel and liquid-filled cavity therein. A
cover encapsulates the capsule, and two flexible sling ties extend
beyond the cover. The material of the cover and of the ties is such
as to enhance fiber ingrowth into openings formed by the material,
whereby mechanically to stabilize the prosthesis when it is
implanted in the human body.
Inventors: |
Schulte; Rudolf R. (Santa
Barbara, CA) |
Assignee: |
Heyer-Schulte Corporation
(Santa Barbara, CA)
|
Family
ID: |
23095093 |
Appl.
No.: |
05/285,637 |
Filed: |
September 1, 1972 |
Current U.S.
Class: |
600/30;
128/DIG.25; 623/23.66 |
Current CPC
Class: |
A61F
2/004 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61b 019/00 () |
Field of
Search: |
;128/1R,334R,DIG.25
;3/1,36 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: D. Gordon Angus et al.
Claims
1. A prosthesis to resist the flow of urine through the urethra,
comprising: a fluid-impervious, flexible and deformable capsule
having a cavity therein; a sling comprising a pair of flexible ties
extending therefrom; a gel or combination of a gel and a liquid
substantially filling the cavity; and a cover encapsulating the
capsule, the material of the cover and of the flexible ties having
openings to receive fiber ingrowth, whereby mechanically to
stabilize the prosthesis when implanted in the human body, and the
material of at least a part of the capsule being inherently
resilient, the flexibility and firmness of the filled capsule being
such as to exert, when suitably supported from surrouding tissues
by the sling and filled with gel or a combination of a gel and a
liquid to a suitable firmness, a lateral force against the urethra
sufficient to deform the urethra and close its lumen to passage of
urine under less than a predetermined upstream pressure in the
urethra, and to be deformable by the urethra when a greater
upstream pressure is exerted
2. A prosthesis according to claim 1 in which the sling is a
continuous ribbon attached to the outside surface of said portion
of greater thickness, the flexible ribbon passing through the cover
to form the ties.
3. A prosthesis according to claim 2 in which the capsule has a
portion of greater thickness and a portion of lesser thickness, the
portion of lesser thickness being adapted to bear against the
urethra and being the part made of material which is inherently
resilient, and the portion of greater thickness being sufficiently
thick and stiff enough to close a track made
4. A prosthesis according to claim 3 in which the portion of lesser
thickness is dome-shaped, and has an opening therein, and in which
the region of greater thickness is substantially flat, and extends
across and
5. A prosthesis according to claim 1 in which the capsule is made
entirely of silicone elastomer, the cover is made of polyurethane
open cell foam,
6. A prosthesis according to claim 5 in which the loop pile
material is
8. A prosthesis according to claim 7 in which the capsule is made
entirely of silicone elastomer, the cover is made of polyurethane
open cell foam,
9. A prosthesis according to claim 8 in which the loop pile
material is
10. A prosthesis according to claim 8 in which the capsule has a
portion of greater thickness and a portion of lesser thickness, the
portion of lesser thickness being adapted to bear against the
urethra and being the part made of material which is inherently
resilient, and the portion of greater thickness being sufficiently
thick and still enough to close a track made
11. A prosthesis according to claim 10 in which the portion of
lesser thickness is dome-shaped, and has an opening therein, and in
which the region of greater thickness is relatively flat, and
extends across and
12. A prosthesis according to claim 11 in which the sling is a
continuous ribbon attached to the outside surface of said portion
of greater thickness, the flexible ribbon passing through the cover
to form the ties.
13. A prosthesis according to claim 12 in which the sling is made
of a loop
14. A prosthesis according to claim 1 in which the ties are
ribbon-shaped.
15. A prosthesis according to claim 14 is which the ties are made
of a loop
16. A prosthesis according to claim 15 in which the loop pile
material is
17. A prosthesis according to claim 1 in which the capsule is
substantially circular in plan view, has a substantially flat base
surface from which the ties extend, and a dome-shaped pressure
surface symmetrical around an axis normal to the base surface.
Description
This invention relates to a prosthesis for resisting the flow of
urine through the urethra, thereby to give a patient, either male
or female, control over incontinence of urine.
Protheses to resist the incontinent flow of urine have been the
subject of many investigations. Reference is made here to Foley
F.E.B., An Artificial Sphincter, Journal of Urology, 50:250 (1947);
to U.S. patent No. 3,384,073, issued May 21, 1968 to Van Winkle,
Jr.; and to Girgis and Veenema, Perineal Urethro-plasty, A New
Operation for Correction of Urinary Incontinence in the Male
Patient, Journal of Urology, 93, 703-8 (1965).
It is known to implant a deformable capsule so that it bears
against the urethra to occlude its lumen and thereby resist the
flow of urine. Previously known prostheses for this purpose have
suffered from a number of problems, not the least of which is
pressure necrosis in the urethra. It appears that this necrosis
resulted from wrapping the capsule and its supporting means around
the urethra, which created multiple folds in the capsule and in the
urethra. By means of this invention, a deformable capsule can be
utilized which simply presses against the urethra without forming
such folds, and which can reliably be stabilized in the body by
means of tissue ingrowth into exterior surfaces. The force exerted
on the urethra can be adjusted by varying the amount of material
contained in the capsule, and also by varying the tension of a
supporting sling.
A prosthesis according to this invention comprises a
fluid-impervious, flexible and deformable capsule which has a
cavity therein that can be filled with a gel or with a combination
of liquid and gel. A sling is attached to the capsule. The sling
provides two flexible ties that extend therefrom. A cover
encapsulates the capsule. The material of which the cover and the
flexible ties is made is such as to provide openings for ingrowth
of fibrous tissue, whereby mechanically to stabilize the prosthesis
after it is implanted in the human body.
According to a preferred but optional feature of this invention,
the capsule has a portion of greater thickness and a portion of
lesser thickness, the portion of lesser thickness being adapted to
bear against the urethra through the cover, and being made of
material which is inherently resilient, and the portion of greater
thickness being thick and stiff enough to close a hole which is
made in it by a needle which penetrates it and then is
withdrawn.
According to still other preferred but optional features of this
invention, the capsule is made entirely of a silicone elastomer,
the cover is made of polyurethane open cell foam, and the sling is
made of a loop pile material, preferably a dacron velour.
The above and other features of this invention will be fully
understood from the following detailed description and the
accompanying drawings, in which:
FIG. 1 is an axial cross-section of the presently-preferred
embodiment of the invention, taken at line 1--1 in FIG. 2;
FIG. 2 is a top view of FIG. 1;
FIG. 3 is a side view of FIG. 2;
FIG. 4 is a cross-section taken at line 4--4 in FIG. 3;
FIG. 5 is a plan view of an intermediate step in the implantation
of this prosthesis;
FIG. 6 is a view similar to FIG. 5 with the prosthesis
implanted;
FIG. 7 is a side view partly in cutaway cross-section, showing the
lumen of the urethra closed by the prosthesis; and
FIG. 8 is a semi-schematic fragmentary showing of the construction
of one material from which the sling of the prosthesis can be
made.
A prosthesis 10 according to the invention is shown in FIG. 1. It
includes a fluid-impervious, flexible and deformable capsule 11
which is formed by portions 12 and 13. Portion 12 is in the nature
of a base. It is substantially flat and disc-like, and is
substantially thicker than portion 13. Portion 13 is dome-like,
with a turned-in lower rim 14 having a central opening 15 which is
closed by attaching portion 12 across it, with the portions
overlapped around the edge and cemented together. If desired, a
reinforcement 16 of mesh material, such as dacron cloth, may be
embedded in portion 12.
The two portions are preferably made of silicone elastomer, such as
medical grade silicone rubber. When this material is used, portion
12 will be made on the order of about 0.050 inches thick, and
portion 13 on the order of about 0.020 inches thick.
The said thickness of portion 12 provides sufficient stiffness to
close a needle track (not shown) which is made by a needle which
has penetrated the portion and then been withdrawn for purposes yet
to be described. The reinforcement 16 when used will assist the
closing of the track, because it tends to trap the elastomer
between its strands and resists the spreading of the material.
Portion 13 is made of material which is inherently resilient. Of
course, silicone elastomer is inherently resilient. Portion 13 is
intended to be readily flexible and deformable and will usually be
made thinner than portion 12. Also, because it is not intended to
be pierced by a needle, it need not be as thick, nor need it be
reinforced. When silicone elastomer is used for portion 13, its
thickness may be on the order of about 0.020 inch.
When the portions 12 and 13 are joined to each other, they form a
continuous, fluid-impervious structure enclosing a cavity 17 which
is filled by a gel 18, or by a combination of a gel and a liquid.
As will later be described in more detail, the capsule is initially
filled with a gel, and after implantation, if more material is
needed in the capsule, a saline solution is injected through a
needle. Therefore, this invention contemplates the use of gels and
gel-liquid combination.
The gel used in the capsule is a "silicone gel" sold under that
name by General Electric Corporation and by Dow Corning
Corporation. For purposes of this invention, the grade of silicone
gel which will be ordered is selected for its penetration rating,
which for use in this device will ordinarily be in the range
between about 10 and 20 mm with 191/2 gr. 1 inch dia. Lexan foot on
a precision scientific penetrometer. Such a range resists any
tendency of the capsule to deform to one side or the other, and
lends some structural integrity to the unit.
A sling 20 is cemented to portion 12 and provides two flexible ties
21, 22, which project through and extend beyond the capsule. The
ties are preferably in the form of a ribbon. The term "ribbon" is
used to connote a shape which has a greater width than thickness,
so as to have a substantial surface area, and is flexible so it can
be tied or turned back and sutured. A cover 25 encapsulates the
capsule, and also the central section of the sling. The ties are
preferably provided as shown as the two ends of a ribbon which
passes through the cover.
The material of the cover is preferably polyurethane open cell
foam. It is of uniform thickness, and is cemented to the capsule.
It may conveniently be on the order of about 0.125 inches thick,
and is readily compressible.
The material of the sling is preferably a loop-pile fabric, i.e., a
woven fabric with upstanding loops. A velour is the preferred
example, and the presently preferred material for the velour is
dacron.
It is a feature of the material used for the cover and for the
flexible ties of the sling that it will enhance fiber ingrowth into
openings formed by the material. As to the cover, the openings are
the cells which open onto the outside surface, and also the cells
which interconnect with these and with each other inside the body
of the foam. It is a feature of this foam material that encourages
the growth of fibers into these openings, and after enough of these
fibers have grown into them, the cover is attached to the
surrounding tissue.
Similarly, as to the material of the sling, it, too, should be of a
material which is compatible with human tissue. It should be
flexible so that it can be folded so as to be sutured or tied, and
should have openings which encourage the ingrowth of fibrous
tissue. A woven material meets these requirements, and a woven
cloth, such as Dacron cloth, can be used. It is advantageous to use
a loop-pile fabric such as a velour, because the loops provide
additional openings for tissue ingrowth. A fragmentary illustration
of a velour is shown in FIG. 8, wherein woven material 30 is shown
with cross-woven fibers 31 in one direction and 32 in the other,
and at their intersections, closed loops 33. Each loop forms an
opening 34. Openings 35 are also formed between the woven fibers.
Tissue can readily grow into the openings in the loops and in the
weave. Therefore, over a period of time, the surrounding tissue
will grow into and attach itself to the sling as well to the cover
of the capsule.
In its free and undistorted form as shown in FIGS. 1-4, the
prosthesis has a substantially flat base surface 40, and a
dome-shaped pressure surface 41. The pressure surface is
symmetrical around an axis 42 normal to the base surface. The
prosthesis is generally circular in plan view (FIG. 1).
The prosthesis is intended to be installed so as to be supported by
the sling by being sutured (in the male patient) into the heavy
Bucks fascia of the penis, rather than being supported by a
wrapping of a strap around the urethra. In this manner, the
undesirable pressure necrosis described above is avoided.
FIG. 5 shows the prosthesis located at the crus of the penis, in
the bulbocavernosis 43. Ties 21 and 22 are shown brought under the
ischiocavernosis 44, 45. In FIG. 6, the ties are shown brought
together and tied or sutured in a joinder 46. Obviously the tension
produced in the ties is directly reflected in the firmness of
support of the prosthesis. The more tension in the installed sling,
the more resistance there is to displacement of the prosthesis.
In FIG. 7, the prosthesis is shown bearing against urethra 47 and
pressing it against surrounding tissue 48. Its lumen 49 is closed
because upstream pressure is insufficient to deform the capsule and
deflect the pressure surface to open the lumen. Such upstream
pressure can be generated by some persons with the use of bladder
muscles. For others, a mechanical force on the bladder, such as by
pressing the hand strongly against the body in the proper area,
will open the lumen.
The described deflection occurs as a consequence of changing the
shape of the capsule. The volume of the capsule will not change,
but its surface area can be changed when its shape is altered. The
resistance to such change is partially determined by sling tension,
and partly by the amount of filling in the cavity. Obviously if
rather little gel is injected into the cavity, the pressure surface
will be slack, and exert relatively little force. If the capsule is
filled so as to stretch the capsule material, a tight pressure
surface will result. Evidently the resistance of the capsule to
change of shape can be adjusted by selectively injecting different
amounts of gel or gel and solution into the cavity.
The gel is formed by reaction and heating of its components in the
course of manufacture, and therefore will not be injected into the
capsule after implantation in the body. For this reason, an amount
of gel suitable for average implantation is formed in the capsule
during manufacture. Should this amount of gel be insufficient to
provide the propoer action, then it is an important advantage that,
without opening the body again, a needle may be pierced through the
body and through portion 12, and a liquid such as saline solution,
is added to the gel to increase the amount of material in the
capsule. Therefore the implantation can be adjusted to suit the
needs of the patient after implantation. The use of a gel for at
least a part of the filler material for the capsule provides the
capsule with the property of resisting sudden changes of shape
because of the viscosity of the material. However, the material
filling the capsule must not be too rigid, or the opening of the
lumen may be made too difficult.
This prosthesis is useful in the female patient, by implantation in
a respective location where the pressure surface can compress the
urethra between itself and a neighboring surface as a consequence
of a sling support which biases the pressure surface toward and
against the urethra.
This invention is not to be limited by the embodiment shown in the
drawings and described in the description, which is given by way of
example, and not of limitation, but only in accordance with the
scope of the appended claims.
* * * * *