U.S. patent number 3,741,216 [Application Number 05/214,541] was granted by the patent office on 1973-06-26 for cervical cuff.
This patent grant is currently assigned to Heyer-Schulte Corporation. Invention is credited to Donald K. McGhan, Edward E. Yosowitz.
United States Patent |
3,741,216 |
Yosowitz , et al. |
June 26, 1973 |
CERVICAL CUFF
Abstract
A cervical cuff for holding closed an incontinent cervix,
comprising a stiffly flexible substantially inelastic support ring
having a central axis and an inner and an outer peripheral wall.
The inner wall forms an opening to receive the neck of the cervix.
A first and second elastic impermeable membrane extends around and
is mounted to the inner and outer walls respectively so as to form
a first and second laterally expansible chamber. Inflation of the
chambers extends the membranes so that the inner membrane engages
the cervical neck inside the opening, and the outer membrane
engages body tissue surrounding and spaced from the cervical neck.
The ring is thereby retained in the body and the neck is held
closed inside the ring.
Inventors: |
Yosowitz; Edward E. (Wichita
Falls, TX), McGhan; Donald K. (Santa Barbara, CA) |
Assignee: |
Heyer-Schulte Corporation
(Santa Barbara, CA)
|
Family
ID: |
22799466 |
Appl.
No.: |
05/214,541 |
Filed: |
January 3, 1972 |
Current U.S.
Class: |
128/830; 446/224;
251/5 |
Current CPC
Class: |
A61B
17/42 (20130101); A61B 2017/4225 (20130101) |
Current International
Class: |
A61B
17/42 (20060101); A61b 017/42 () |
Field of
Search: |
;128/346,129,127,130,131,344,2.5C,325,326,DIG.20,DIG.25,327,349B,361
;29/243.56 ;269/20,328 ;277/21,38.3,58 ;251/5 ;46/87,88,90 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Hargest & Derrick, An Artificial Urethral Sphincter
1971.
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Recla; Henry J.
Claims
We claim:
1. A cervical cuff for holding closed the neck of an incontinent
cervix comprising: a stiffly flexible, substantially inelastic
support ring having a central axis and an inner and an outer
peripheral wall, the inner wall forming an opening to receive the
neck of the cervix; a first and a second elastic fluid-tight
membrane extending around and mounted to the said inner and outer
wall respectively, forming a first and a second laterally
expansible chamber, means permitting the inflation of said first
and second chambers whereby inflation of said chambers extends said
membranes laterally so that the inner membrane engages a cervical
neck inside the opening, and the outer membrane engages body
tissues surrounding and spaced from the cervical neck, whereby to
retain the ring in the body while the inner membrane holds closed
the cervical neck.
2. A cervical cuff according to claim 1 in which said means
permitting the inflation of said chambers is valve means provided
in fluid communication with each of said chambers to admit and
retain fluid under pressure therein.
3. A cervical cuff according to claim 1 in which the membranes
comprise bodies of revolution joined at parallel edges to the
ring.
4. A cervical cuff according to claim 1 in which the membranes
comprise continuous closed tubes an in which the inner and outer
walls have grooves to receive said tubes.
5. A cervical cuff according to claim 1 in which the inner one of
said membranes has protuberances on its inner surface and in which
the outer membrane has protuberances on its outer surface.
6. A cervical cuff according to claim 1 in which said means
permitting the inflation of said chamber is valve means provided in
each of said membranes comprising a check valve.
7. A cervical cuff according to claim 6 in which the valve means
comprises a deflectable diaphragm.
8. A cervical cuff according to claim 1 in which said means
permitting the inflation of said chamber is conduit means provided
to the respective chambers for filling the same.
9. A cervical cuff according to claim 1 in which said means
permitting the inflation of said chambers comprises a self-sealing
wall provided to the respective chambers.
Description
This invention relates to a cervical cuff for an incontinent
cervix.
The problem of incontinent cervices has been a nagging one in the
surgical field for a long time. Speaking generally, an incontinent
cervix is one which cannot contain the products of conception
during the second trimester. Its clinical manifestations including
bulging of the fetal membranes, absence of uterine contractions,
and absence of bleeding, leading to rapid and painless second
trimester abortion. There have been extensive attempts to manage
the incontinent cervix which have generally been centered on three
approaches. The first approach is surgical, which includes the
techniques of cerclage, trachelorrhaphy, and isthmorrhaphy. The
second approach is hormone therapy using progestational agents and
the third approach is mechanical devices such as certain kinds of
pessaries.
There are disadvantages in all of the above methods. For example,
surgical complications of cerclage include the risk of uterine
rupture due to failure to remove the restraint in the presence of
strong uterine contractions and amnionitis, endometritis, sepsis,
anesthesia risks to both mother and fetus, and cervical amputation.
Hormonal therapy has met with only moderate success. The use of a
pessary may involve problems of discharge, discomfort, erosion, and
bleeding.
In all of the foregoing three approaches, there is also involved
the significant factor of economic cost, both as to the time
required for the procedure, and the expenses surrounding it. To a
person with limited funds, however successful any of these
techniques may be, it is simply too expensive.
The inflatable cuff of this invention has been designed to provide
the obstetrician with a safe and easy method of treating cervical
incompetence. The device is simple to insert; it lacks the major
complications listed above, and it is very economical. It can be
inserted in the doctor's office and does not require
hospitalization.
A cervical cuff according to this invention comprises a stiffly
flexible substantially inelastic support ring having a central axis
and an inner and an outer peripheral wall. The inner wall forms an
opening to receive the neck of the cervix. A first and a second
elastic impermeable membrane extends around and is mounted to the
said inner and outer wall respectively, forming a first and a
second laterally expansible chamber. Inflation of the chambers
extends the membranes laterally so that the inner membrane engages
the cervical neck inside the opening and closes the neck. The outer
membrane engages body tissue surrounding and spaced from the
cervical neck whereby to retain the ring in the body.
According to a preferred but optional feature of the invention,
valve means is provided in fluid communication with each of said
chambers to admit and retain fluid under pressure therein.
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 taken at line 1--1 of FIG. 1;
FIG. 2 is a top view taken at line 2--2 of FIG. 1;
FIG. 3 is an axial cross-section of the presently preferred
embodiment of the invention;
FIGS. 4 and 5 are axial cross-sections of portions of FIG. 3;
FIG. 6 is a top view of FIG. 3 taken at lines 6--6 therein; and
FIG. 7 is a fragmentary cross-section showing another means for
supplying fluid to the chambers.
In FIG. 1 there is shown a cervical cuff 10, according to the
invention which includes a stiffly flexible, substantially
inelastic support ring 11, having an inner wall 12 an outer wall 13
and a central axis 14 with which the inner and outer walls are
coaxial. The inner wall forms an opening 15 to receive the neck of
the cervix.
A first and a second membrane 16, 17 are attached to the ring at
the inner and outer wall respectively so as to form therewith an
inner and an outer chamber 18, 19 respectively. The membranes are
flexible and elastic so that the chambers are expansible when fluid
is introduced therein. They are also impermeable.
The entire device is preferably made of silicone rubber because of
the tolerances of tissue to this material of construction. The
support ring will be substantially inelastic and stiffly flexible
because of its relatively heavy cross-section, while the membranes
are laterally expansible because of their relatively thinner
cross-section. These sections will be selected with a view to the
tensile properties of the particular formulation of silicone rubber
which is used. A suitable ring will have an inner diameter of 1 1/2
inches, an outer diameter of 2 1/2 inches and an axial thickness of
3/8 inch. The inner membrane will inflate to a 1 1/8 inch diameter
and the outer membrane will inflate to a 3 inch diameter.
In case a self-sealing structure is used, the chambers may be
inflated simply by piercing the support ring or either of the
membranes with a fine needle and then injecting a fluid such as
saline solution, relying upon tendency of the rubber to close on
itself to keep the fluid confined. Alternatively, check valves 20,
21 of any desired construction can be built into the ring and
connected by channels 22, 23 to the chambers. These are only two
examples of the many alternative means by which the chambers may be
filled with fluid under pressure. Another will be shown in
connection with the embodiment of FIGS. 3-6.
The device of FIGS. 3-6 is the presently preferred embodiment of
the invention. It is a cervical cuff 25 with a support ring 26
having an inner wall 27 an outer wall 28, and a central axis 29.
The inner wall forms a central opening 30.
Peripheral grooves 31, 32 are formed in an inner and outer walls
respectively. These are semi-circular in cross-section and receive
first and second membranes 33, 34 in the form of continuously
sealed circularly sectioned flexible peripheral tubes whose outer
dimensions are congruent to those of the groove into which they
fit. The first membrane 33 is shown in FIG. 3 seated in groove 31
with a plurality of protuberances 35 facing inwardly. The second
membrane 34 is shown in FIG. 5 with a plurality of protuberances 36
on its outside periphery, whereby the protuberances will face
outside the ring and engage and improve the contact with the
tissues against which it abuts when in use. When not filled with
fluid (either gas under pressure, or a trapped liquid), the
membranes will yield to pass adjacent objects, but when filled they
become rigid at or even beyond their illustrated size to fix the
cuff in place.
Suitable dimensions for the ring are: inner diameter, 1 1/2 inches,
outer diameter, 2 1/2 inches, axial thickness 1 inch. Relaxed outer
tubular diameter of outer membrane one-half inch, its peripheral
diameter equally 3 inches. Relaxed outer tubular diameter of inner
membrane, three-eighths inches, diametrical central opening, 1 1/8
inches. Protuberance one-sixteenth inch spherical domes on 1/4 inch
centers.
Valves 37, 38 are provided in the membranes 33, 34 respectively and
may be typical bladder type valves such as found in basketballs and
footballs. These may be vulcanized in place and typically will
include a base 39 and a overlying diaphragm 40 which can be
displaced by a needle to pass the fluid. Alternatively, the
membranes may be provided with tubings integral therewith which can
be led and connected to a source of fluid under pressure and then
the tube may be tied, fused or otherwise closed with the excess
tube cut off to size after installation.
In FIG. 7, a tubular membrane 45 is shown with a conduit 46
connected to it to pass fluid. This conduit may be closed in any
desired manner.
In the device of FIGS. 3-6, the materials of construction may again
be silicone rubber, the cross-sectional area of the support ring
being such as to render it stiffly flexible and substantially
inelastic while the wall thickness of the membranes is such as to
permit the chambers to be expanded so as to accomplish the purpose
of the invention.
The fluid for insertion may be gas or liquid, but liquid is
preferred. The term "inflation" as used herein encompassed not only
a stretching of the membrane, but also the rigidity of a membrane
in its normal configuration, its prior condition having been slack,
such as by there being air in the membranes of FIG. 3, followed by
filling them full of liquid.
The use of the devices are extremely simple. While the membranes
are uninflated, the neck of the cervix is grasped and pulled
through the central opening and the ring is thrust upwardly to its
final location. Then the chambers are inflated so as to bring the
membranes into contact with the tissue which they are to engage.
The fluid is retained either by check valves, by cutting, tying or
fusing the conduits, or simply by withdrawing the needle from a
self-sealing structure. The cuff is then in place and will remain
fixed there until it is time for it to be removed. The technique of
insertion is simple, does not require hospitalization and the
device itself is elegantly simple and inexpensive.
This invention is not to be limited by the embodiments shown in the
drawings and described in the description, which are given by way
of example and not of limitation, but only in accordance with the
scope of the appended claims.
* * * * *