U.S. patent number 3,774,600 [Application Number 05/193,064] was granted by the patent office on 1973-11-27 for gynaecological surgical device.
This patent grant is currently assigned to Rhone-Poulenc S.A.. Invention is credited to Michel Cognat.
United States Patent |
3,774,600 |
Cognat |
November 27, 1973 |
GYNAECOLOGICAL SURGICAL DEVICE
Abstract
A gynaecological surgical device to avoid Fallopian tubes
becoming blocked again during cicatrisation following a tuboplasty
operation, such device comprising a hollow cone of flexible sheet
material and a cord firmly fixed to the apex of the cone. In use
after performing a salpingostomy of the blocked portion of a
patient's Fallopian tube, the device is placed with the apex
extending into the cut end of the tube with the cord extending to
the abdominal wall. The base edge of the cone is folded around the
end of the tube and secured to the tube exterior to prevent
blockage during cicatrisation of the tube. When this is completed,
the device can be removed simply by pulling the cord.
Inventors: |
Cognat; Michel (Lyon,
FR) |
Assignee: |
Rhone-Poulenc S.A. (Paris,
FR)
|
Family
ID: |
9063341 |
Appl.
No.: |
05/193,064 |
Filed: |
October 27, 1971 |
Foreign Application Priority Data
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|
|
|
|
Oct 27, 1970 [FR] |
|
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7038735 |
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Current U.S.
Class: |
600/33;
128/831 |
Current CPC
Class: |
A61B
17/42 (20130101); A61F 2/04 (20130101) |
Current International
Class: |
A61B
17/42 (20060101); A61F 2/04 (20060101); A61f
005/46 (); A61m 029/00 (); A61m 027/00 () |
Field of
Search: |
;128/130,132,131,341,350,127,1,349 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Medbery; Aldrich F.
Claims
I claim:
1. A gynaecological surgical device to avoid Fallopian tubes
becoming blocked during cicatrisation following a tuboplasty
operation, said device comprising a single hollow cone of flexible
sheet material having an apex and a base edge and closed at its
apex, ane a cord-like member fixed firmly to the apex of the
cone.
2. A device as claimed in claim 1, and further comprising a drain
tube sheathing the cord and means defining lateral orifices in the
tube located near the apex of the cone.
3. A device as claimed in claim 2, wherein said drain tube is
formed of organosilicon elastomer.
4. A device as claimed in claim 1, wherein said cord is hollow
effective to form a drain tube and further comprising means
defining lateral orifices in the tube located near the apex of the
cone.
5. A device as claimed in claim 1, wherein said cord comprises a
first portion extending externally beyond the apex of the cone and
a second portion extending through the interior of the cone.
6. A device as claimed in claim 5, wherein the first portion is of
larger diameter than the second portion, the cross-section of the
first portion corresponding substantially to that of the cone
folded upon itself.
7. A device as claimed in claim 5, and further comprising a drain
tube sheathing the first portion of the cord and means defining
lateral orifices in the tube located near the apex of the cone.
8. A device as claimed in claim 5, wherein the apex angle of the
cone is between 5.degree. and 80.degree., wherein the height of the
cone is between 20 and 200 mm, wherein the wall thickness of the
cone is between 0.1 and 0.8 mm and wherein the first and second
portions are of substantially equal length of between 200 and 600
mm.
9. A device as claimed in claim 1, wherein the cone consists of
organosilicon elastomer and the cord of polyamide.
10. A device as claimed in claim 1, wherein the apex angle of the
cone is between 5.degree. and 80.degree., wherein the height of the
cone is between 20 and 200 m.m. and wherein the wall thickness of
the cone is between 0-1 and 0-8 m.m.
11. A method of surgically treating female sterility of tubal
origin said method comprising the steps of performing a
salpingostomy of the blocked portion of the patient's fallopian
tube, providing a surgical device comprising a single hollow cone
of flexible sheet material having an apex and a base edge and
closed at its apex with a cord-like member fixed firmly to the apex
of the cone, placing said device with the apex of the cone
extending into the end of the fallopian tube and extending the cord
- like member from the inside of said cone to the abdominal wall,
folding the base edge of the cone around the end of said tube and
securing it to the exterior of the tube to hold it in place to
prevent blockage during cicatrisation of the tube, and when
cicatrisation has occurred, pulling said cord-like member through
the abdominal wall to withdraw the device.
12. A method as claimed in claim 11, wherein the cord-like member
extends through the cone apex and has portions projecting both
inwardly and outwardly of the apex, and wherein the cone is placed
in position over the end of the fallopian tube with one of said
portions extending along the fallopian tube into the uterine cavity
and the other of said portions extending outwardly to the abdominal
wall.
Description
The present invention relates to a gynaecological surgical device
intended to facilitate the surgical treatment of female sterility
of tubal origin. It relates, more especially, to a surgical device
which makes it possible to avoid the ends of the Fallopian tubes
becoming blocked again after a tuboplasty operation (in particular,
a salpingostomy) as a result of rapid and correct cicatrisation in
the open position of the tubes.
If the blockage is an internal tubal blockage, the surgical devices
described in U.S. Pat. Nos. 3,182,662 and 3,349,770 allow
tubo-uterine anastomosis to be carried out.
If the blockage is external tubal blockage, the end of the tubes is
opened and a surgical device is placed in position which protects
the open end until cicatrisation is complete and which prevents the
tube from becoming blocked again. In order to place such a surgical
device in position, it is necessary to carry out a laparotomy.
MULLIGAN W. J., ROCK J. and EASTERDAY C. L. (Use of polyethylene in
tuboplasty -- Fertility and Sterility 4 : 428, 1953) have in this
case proposed a rigid surgical device in the form of a cone which
covers the end of the tubes and which is withdrawn after
cicatrisation, after a period of 2 to 3 months, by carrying out a
second laparotomy.
CLYMAN M. J. (Silastic hoods in tuboplasty: A new approach to their
removal. Fertility and Sterility vol. 19, No. 4, 1968) has proposed
replacing the second laparotomy by a colpotomy. However, this
latter technique is very delicate to carry out and requires the use
of special forceps which are introduced through the natural
passages in order to withdraw the surgical devices 2 to 5 months
after it is placed in position. Furthermore, this technique cannot
be practised successfully, especially if the surgical device is
covered by adhesions or if it has shifted; it is then necessary to
resort to a second laparotomy.
According to the invention there is provided a surgical device to
avoid Fallopian tubes becoming blocked again during cicatrisation
following a tuboplasty operation, such device comprising a hollow
cone of flexible sheet material and a cord-like member firmly fixed
to the apex of the cone.
Such a surgical device only requires a single operation (when it is
placed in position), it is easily held in position in the patient,
it can be withdrawn very easily and it ensures rapid cicatrisation
(within a period of 1 to 3 weeks) of the end of the tubes in the
open position.
The invention also provides a method of surgically treating female
sterility of tubal origin comprising performing a salpingostomy on
the blocked portion of a patient's Fallopian tube, placing a
surgical device according to the invention with the apex of the
cone extending into the end of the tube and the cord extending to
the abdominal wall, folding the edge of the cone around the end of
the tube and securing it to the exterior of the tube to prevent
blockage during cicatrisation of the tube.
The invention will be better understood from the following
description, which is given by way of example, reference being made
to the accompanying drawings, in which:
FIGS. 1, 3 5, 7, 8 and 9 are schematic perspective views of three
embodiments of the device according to the invention; and
FIGS. 2, 4 and 6 are similar views showing the devices of FIGS. 1,
3 and 5 respectively after being placed in position in the
patient.
The surgical device shown in FIG. 1 consists of a flexible sheet
rolled up in the shape of a cone 1, the angle .alpha. at the apex
being between 5.degree. and 80.degree. and preferably between
10.degree. and 50.degree.. A cord 2 is firmly fixed to the apex 3
of the cone 1, the length of this cord being between 200 and 600
mm, and its diameter being generally between 0.2 and 6 mm. This
cord 2 for example consists of polyamide, which gives it a certain
flexibility as well as sufficient tensile strength during removal
of the device.
The cone 1 consists of a sterilisable plastic tolerated by the
organism, which is sufficiently flexible that it can easily be
folded over on itself and remain in this position when it has been
brought thereto when placing the device in position.
Organopolysiloxane elastomers, in particular, are suitable for this
application. Generally, the thickness of the wall of the cone 1 is
between 0.1 and 0.8 mm, whilst its height is between 20 and 200
mm.
The cone 1 can, for example, be obtained by the so-called
"slush-coating" technique, that is to say, by depositing successive
thin layers of material on a shaping device of the desired shape.
It is also possible to obtain the cone from a sheet which is cut
and of which the edges are joined by welding or gluing.
The apex 3 of the cone can be attached to the cord 2 by, for
example, passing the cord 2 through the apex 3 of the cone and
knotting the cord two or three times onto itself at its end which
is near the apex of the cone. Then some silicone elastomer, for
example, is deposited on the excess thickness formed by the knots
and the part of the cord which is outside the cone is pulled gently
so that the knotted end comes to lie against the apex of the cone
and to stick thereto, either under hot or under cold conditions,
depending on the type of elastomer used. A "knob" is thus obtained
at the apex of the cone.
It is also possible, after knotting the end of the cord, to
pre-mould the knob on the knotted thread and to fix it thereafter
to the end of the cone by wedging and gluing. It is thus possible
to impart the desired shape to the knob and to proceed in such a
way that when the device is placed in the partially invaginated
position in the patient (FIG. 2) is practically has a first, solid
cone (forming the knob) of which the angle at the apex is less than
that of the cone 1.
FIG. 2 shows the device of FIG. 1 after being placed in position.
To achieve this, the surgeon carries out a laparotomy and then a
salpingostomy (he cuts the end of the blocked tube). He places the
device, which has previously been sterilised (by heat or by
.gamma.-rays) and entirely invaginated, in position by introducing
the apex 3 of the cone into the open tube for a distance of 10 to
40 mm. He then turns the base edge of the cone 1 over around the
end of the tube (shown in broken lines) so that the tube end is
entirely enveloped by the cone. The surgeon is able to adapt the
cone to the size which he considers necessary by cutting it near
its base edge 4 and, if necessary, along a generatrix in order that
it shall cover the tube better. He then attaches the cone 1 to the
end of the tube by making a few stitches (not shown in FIG. 2)
using a resorbable material, for example catgut, the resorption
time of this material corresponding substantially to the time
required for cicatrisation. The cord 2 is thereafter anchored to
the abdominal wall 5. The surgeon places an identical surgical
device in position in the same manner on the other tube if the
blockage is bilateral.
When sufficient cicatrisation has occurred, which merely requires
from about 1 to 3 weeks (thanks to the flexible cone, which
completely covers the end of the tube), the surgical device is
withdrawn by simply pulling the cord 2 through the abdominal wall 5
in the manner of a simple drain, without anaesthetic.
FIG. 3 represents a preferred embodiment of the surgical device.
This comprises all the elements described in the preceding device
of FIG. 1, that is to say a cone 6 with a cord fixed firmly to its
apex 7. However, the cord of this embodiment passes through the
cone practically along its axis and has substantially equal
portions (marked 8 and 9), of between 200 and 600 mm, extending on
either side of the apex. The sizes and the materials of which this
device is made up are the same as those mentioned for the device of
FIG. 1.
In order to place the device in position (see FIG. 4), if only the
end (10) of the tube (shown in broken lines) is blocked, the
surgeon follows substantially the same procedure as when placing
the device of FIG. 1 in position. He first of all carries out a
laparotomy and then cuts the end of the tube. He now leaves the
cord 9 to be the length required so that after it has been
introduced through the end 10 of the open tube, it can reach into
the uterine cavity 11 if the cone 6 is in position on the end of
the tube. The cone 6 is folded over onto the tube, the surgeon
being able to cut its base 12 to the desired length. The surgeon
now attaches the cone to the end of the tube by a few stitches (not
shown in FIG. 4) using a resorbable material, for example catgut,
and anchors the other end of the cord 8 to the abdominal wall 13.
To withdraw this surgical device, the surgeon follows exactly the
same procedure, and with equal ease, as for withdrawing the device
previously described.
The device of FIG. 3, whilst it can be withdrawn as easily as that
of FIG. 1, has the advantage of allowing the cone 6 to be
positioned better during the period of cicatrisation and of
resorption of the stitches. The part 9 of the cord which is in the
tube in effect assists better stability of the device during
cicatrisation.
This device can be used with advantage in the case where the
external and internal portions of one and the same tube are
blocked. In effect the cord 9 acts as a cicatrisation tutor for the
duct 14 whilst the cone 6 ensures rapid cicatrisation in the open
position of the tube. In order to place the prosthesis in position,
the surgeon can operate as follows: he carries out a laparotomy and
then a salpingostomy, he adjusts the part 9 of the cord to the
desired length for it to reach the uterine cavity 11, he introduces
the part 9 of the cord through the open tube until it can slide no
further in the duct, he cuts the duct in two places so as to remove
the obstructed part, effects a termino-terminal anastomosis and
continues to slide the cord 9 until the cone 6 is in position on
the end of the tube. The continuation of the operation is then
identical to that previously carried out.
It is also possible to use this surgical device if only the duct is
blocked.
Another embodiment of the invention is shown in FIGS. 5 and 6. The
cord 17 extending from externally beyond the apex 16 of the cone 15
to the abdominal wall 19 is surrounded by a sheath 20, for example
consisting of an organosilicon elastomer. This sheath forms a drain
as a result of transverse orifices 21 and 22 located near the apex
of the cone 15.
This latter device, in addition to having the advantages quoted for
the device shown in FIGS. 3 and 4, additionally makes it possible
to inject, from the abdominal wall 19, any liquid which can, for
example, activate cicatrisation or arrest a possible infection.
This latter embodiment furthermore has the advantage of making it
even easier to withdraw the device because the external diameter of
the sheath 20 forming the drain is substantially the same as the
cross-section which th cone assumes if it is folded up on itself
during its removal.
As materials for making these devices it is possible to use
plastics of medical quality, which can be sterilised and which do
not allow adhesions of human tissues to their surface, whilst being
well tolerated by the organism. The cone must have sufficient
flexibility that it can easily be folded onto itself and can
maintain this position after it has assumed it. The cord must have
sufficient tensile strenth after sterilisation to allow the
surgical device to be withdrawn; it must also have sufficient
flexibility to match the shape of the duct of the tube all the way
into the uterine cavity (in the case of the devices shown in FIGS.
3 and 5) and to remain as far as possible in the position in which
it has been placed.
For example, organopolysiloxane elastomers are used for the
manufacture of the cone and of the drain. The cone can also be
produced from a textile material, for example a polyethylene
terephthalate fabric, which is coated with organopolysiloxane
elastomer.
The cord can for example be made of polyamide or of polyester.
Numerous embodiments will suggest themselves to those skilled in
the art. It is for example possible to make up a surgical device,
such as that shown in FIG. 7 in which the cord 2 is sheathed with a
drain 20 provided with lateral orifices 21 and 22 in the zone
located near the apex of the cone. A further embodiment of the
device (FIG. 8) replaces the solid cord by a hollow cord 30 forming
a drain and provided with lateral orifices 31 and 32 in the zone
located near the apex of the cone 6.
A modification of the device of FIG. 3 is shown in FIG. 9 in which
a cord 38 extends from the apex of the cone to the abdominal wall,
of greater diameter than the part of the cord 39 which extends from
the tube into the uterine cavity. This favours the withdrawal of
the surgical device, the cross-section of the cord 38 being of
greater diameter, for example corresponding substantially to the
cross-section which the cone assumes when it is folded up on itself
during its withdrawal.
It is also possible to provide all these devices with a mark which
is opaque to X-rays, for example in the position of the knob or on
the wall of the cone, longitudinally or transversely.
EXAMPLE 1
A device corresponding to that shown in FIG. 3, was produced, the
cone having an angle of 20.degree. at the apex, being 150 mm high
and having a wall thickness of 0.16 mm.
The cord was passed through the cone 6 at its apex 7 along its axis
and then extended on either side of the apex 7 to equal lengths of
500 mm. The cord was 0.5 mm in diameter and consisted of polyamide
6,6, its tensile strength being 45.3 kg/mm.sup.2 before
sterilisation and its elongation being 40 percent.
The cone was obtained by the slush-moulding technique, that is to
say by successively steeping a shaping device into a liquid
elastomer until the desired thickness was obtained. For this, a
diluted hot-vulcanisable organopolysiloxane elastomer, of the same
composition as that described in the example of French Patent No.
1,499,305, was used.
The shaping device used was of polished stainless steel.
It was steeped in the elastomer and then left to drain for 20
seconds, and the shaping device was rotated so as to distribute the
material well and allow the solvent to evaporate. The operation was
repeated six times so as to obtain a thickness of 0.16 mm. The
article was vulcanised in a ventilated oven at 140.degree.C for 30
minutes and was then reheated for 18 hours at between 180.degree.
and 200.degree.C.
In order to attach the cone to the cord, the cord was first of all
passed through the end of the cone and was knotted substantially in
its middle, on the inside of the cone. A ball of undiluted silicone
elastomer was placed around the knot and was shaped into an
olive-shaped knob. The part of the cord which was outside the cone
was then pulled until the knob obtained pressed against the apex of
the cone. The whole was vulcanised at 180.degree. - 200.degree.C
for 4 hours.
This prosthesis was heat-sterilised at 180.degree.C for 4 hours.
The tension required to break the cord was then 16.6 kg/mm.sup.2
and the elongation of the cord was 17 percent.
The same device can be sterilised with .gamma. rays. The tension to
break the cord was then 41 kg/mm.sup.2, its elongation being 36
percent, after an irradiation under 2.5 Megarads.
EXAMPLE 2
A device as shown in FIG. 5, was made starting from a device
identical to that described in Example 1, of the same dimensions
and made of the same materials.
A drain of heat-vulcanisable organopolysiloxane elastomer of 3 mm
internal diameter, 5 mm external diameter and 300 mm length was
added. The distal end of the drain was provided with two pairs of
lateral orifices (as shown in FIG. 5), the first pair being located
20 mm from the end and the second 30 mm from the end.
The drain was attached to the cone by gluing by means of undiluted
silicon elastomer. For this gluing, the material was vulcanised for
4 hours at 180.degree. - 200.degree.C.
* * * * *