Note: Descriptions are shown in the official language in which they were submitted.
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BACKGROUND OF THE INVENTION
1) Field of the Invention:
This invention generally appertains to new and
useful improvement in clamping devices, especially those designed
for closing or shutting off flexible tubular conduits, and is
particularly directed to a new and useful clamping instrument for
use for occluding Fallopian tubes and other ducts in an animal or
a human body.
2) State of the Art:
Devices currently available and used for occluding
~ Fallopian tubes are U-shaped clips or clamps. Applied by being
!, lnserted over the tubes and then compressed or flattened mechanic-
': ally to achieve occlusion, they are often difficult and cumbersome
i to handle and position correctly. If the compression pressure is
so 8trong that the clips are completely flattened, one or both of
two possible application failures may occur. First, the tubes
may be severed and hemorrhaging occur. Second, since the clips
are generally only lmm wide, if any part of a tube is severed, it
can readily bypass the narrow clip, re-anastomose and render the
patient fertile oncè again.
On the other hand, if the mechanical compression -~
pre8sure on such clips is not strong enough, they will not be
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:`~ completely flattened, thus leaving small openings for the Fallopian
tube, sufficient to allow passage of the microscopic-sized ova.
` SUMMARY OF THE INVENTION
An important object of the present invention is to
provide a hinged jaw type clip or clamp designed such that the
upper and lower jaws of the clip are closed down on the Fallopian
tube to an open height of lmm at the forward end of the clip, at
which point a light compressive force is applied through a U-shaped
spring. This force causes gradual necrosis and dissipation of the
tissue between the jaws so that the clip effects a complete closure,
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`~pon completion of the necrosis of the tube, both without
hemorrhaging and without any open spaces through which live tissue
and/or ova could pass.
A further object is to provide such a Fallopian tube
clip or clamp having a width of, for example, 3mm and height of
about 4mm to reduce to a minimum the possibility that the clamped
Fallopian tube will re-anastomose around the clip.
Another object is to provide such a clip and applic-
ator therefor which can be used to perform sterilization on women
under local anesthesia and with minimum interference with the
patient's occupation or home duties.
In general the clamp of the present invention com-
prises a pair of cooperating jaw members hinged adjacent one end,
a generally U-shaped spring, and means on the remote faces of each
. jaw member to slidably receive the U-shaped spring in jaws open
, and jaws closed positions. More specifically, the clip or clamp
consists of two Lexan~ plastic or other body compatible jaws hinged
around a stainless steel pin. The clip is held open by a stainless
steel U-shaped spring which is gold plated, and i9 held closed by
the same spring when the spring is pushed over the jaws and exerts
pressure on the end of the jaws distal to the hinge. A Silastic~
filler is attached to the metal spring to fill up all remaining
dead space so as to minimize the possibility of infection.
In general the clip applicator comprises a laparo-
scope adapted to receive the clip at its extended end and a pair
of jaw and spring actuating rams. The laparoscope may also include
a surgical microscope and a source of light which may comprise a
light transmitting fiber optical bundle.
In one particular aspect the parent application,
30 Canadian Application No. 207,602 filed August 22, 1974, is con-
cerned with the provision of a surgical clip and actuator for
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_cluding tubes in a living animal the clip comprising first and
second jaw members; means adjacent one end of each jaw member
- pivotally mounting the other ends of the jaw members for movement
toward and away from each other; a generally U-shaped spring
member engaging remote surfaces of each jaw member and slidable
from a first position on one side of the said pivotal mounting, to
urge the jaw members into the open arrangement, to a second position
on the other side of the said pivotal mounting, to urge the jaw
. members into a closed position; and the actuator including a cradle
. 10 for the clip and first and second manually operable rods; the first
. rod adapted to contact a top surface of the first jaw member and
to urge the jaw member toward the second jaw member against the
urging of the U-shaped spring when the spring is in the first
position; and the second rod positiGned to urge the U-shaped spring
into the second position.
In another particular aspect the parent application,
. Canadian Application No. 207,602 filed August 22, 1974, is con-
' cerned with the provision of a surgical clip for occluding tubes
in a living animal comprising first and second jaw members; means
ad;acent one end of each jaw member pivotally mounting the other
ends of the jaw members for movement toward and away from each
other; a generally U-shaped spring member engaging remote surfaces
: of each jaw member and slidable from a first position on one side
of the said pivotal mounting, to urge the jaw members into the
open arrangement, and a second position on the other side of the -
sald pivotal mounting to urge the jaw members into the closed
position.
The present application, a division of aforementioned
Canadian Patent Application No. 207,602 filed August 22, 1974, is
: 30 principally concerned with the provision of an actuator for a
hinged jawed, spring-closed clip for occluding tubes in a living
animal comprising an applicator, the applicator including a cradle
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adapted to receive the hinged clip, and first and second manually
operable rods, the first rod mounted for reciprocation and adapted
; to contact the top surface of a clip mounted in said cradle to urge
the jaws thereof into a closed relation, and the second rod mounted
for reciprocation and adapted to move the clip spring into jaw
closing position.
DESCRIPTION OF THE DRAWING
, The invention will be more particularly described
~ in reference to the accompanying drawing wherein:
; 10 Figure 1 is an enlarged partial sectional view of an
; embodiment of a tube clip of the invention with the clip jaws in
the open position and being retained therein by generally U-shaped
`~ spring; -~
Figure 2 is a view of the clip shown in Figure 1 with
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the jaws in the closed position and being retained therein by the
U-shaped spring;
Figure 3 is a top plan view of the structure shown
in Figure l;
Figure 4 is a top plan view of the structure shown
in Figure 2;
Figure 5 is an illustration of an improved laparo-
~` scope for use with the clip shown in Figures 1 thro~gh 4;
Figure 6 is an enlarged end view of the instrumentshown in Figure 5; and
Figures 7, 8, 9, 10 and 11 are diagrammatic fragment-
ary views of the use of a clip of the invention and modified -
lararoscope during the application of a clip to a Fallopian tube.
; Referring to the drawings and in particular Figures
1 through 4, 10 generally designates the improved Fallopian tube
,~ 30 clip or clamp. The clip 10 includes an upper jaw member 12, a
lower jaw member 14 and a U-shaped spring assembly 16. The upper
and lower jaws 12 and 14 of the clip are hinged together by a hinge
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~in 18 which pin may be made of stainless steel, gold, plastic or
other biocompatible material while the jaws 12 and 14 are also
formed of a biocompatible material. Lexan~ plastic has been found
to be very suitable, and comprises a thermoplastic polycarbonate
resin manufactured by General Electric Company.
The upper jaw 12 is molded or formed with a plurality
' of depending conical spikes 20a, b, c and d arranged in two rows
with spikes 20a and c aligned in one row and 20b and d in opposite
row. Further, the surface 22 of upper jaw 12 is provided with four
, 10 conical bores 24a, 24b, 24c and 24d with bores 24a and 24c being in
same row with conical spikes 20b and 20d and conical bores 24b and
24d being in the same row as conical spikes 20a and 20c as more
clearly shown in Figure 4 of the drawings. The spikes prevent the
clip from slipping off the slippery Fallopian tube as the jaws of
the clip are closed by the closure tool, and prevent extrusion of
the Fallopian tube from the forward end of the clip.
The lower jaw 14 is also provided with alternate
~` spikes and bores spaced and arranged such that when the jaws are
; closed as shown in Figures 2 and 3 spikes in the top jaw engage
bores in the lower jaw and vice versa. In the bottom jaw the spikes
are tesignated 26a, 26b, 26c and 26d and the conical bores in the
bottom jaw are designated 28a, 28b, 28c and 28d.
: The upper jaw 12 is provided with a groove 30 in its
top surface 32 which extends from adjacent to the rear end 34 to a
transverse slot 36. The groove 30 and the transverse slot 36 are
sized to receive the U-shaped spring 16 to be more fully described
hereinafter. A similar groove 38 and slot 40 are formed in the
bottom wall 42 of the lower jaw 14 of the clip. Further, the lower
jaw 14 is provided with an upstanding end element 43 which as more
clearly shown in Figure 2 assists in providing the closed clip with
a relatively smooth contour and assists in retention of a Fallopian
: tube within the jaws when the jaws are in the closed position.
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The U-shaped spring assembly 16 includes a metallic
ribbon-like spring 44 having the ends of its legs turned in as at
46 and 48. The width of the spring 44 is such that it is slidably
receivable in the grooves 30 and 38 in the respective jaws 12 and -
14 and the spring has a thickness so that the turned in ends 46
and 48 may be received in their respective slots 36 and 40 in jaws
12 and 14.
The bridge portion of the U-shaped spring assembly 16
; is provided with a fillet or filler element 50 shaped such that
when the clamps are closed as shown in Figures 2 and 4 the fillet
50 fills in the open space of the hinge arrangement of the pair of ~ .
jaws to thereby reduce to a minimum zones for the collection of
matter which might be the locus of infections. The fillet 50 :.
: generally includes a back piece 52 and a pair of generally triangular :
shaped wings 54 and 56. The fillet may be formed of the same
material as used in the formation of the jaws or a dissimilar
material. :
Referring now to Figures 5, 6 and 7, 100 generally
designates a laparoscopic clip applicator which includes a tubular
body portion 102 fitted at its extended end 104 with a headpiece
106 provided with a cradle 108 shaped to receive one of the clips
10 with the hinge end thereof positioned outwardly and the forward -
end of the clip nested against the curved recess 110 of the cradle
108. The laparoscope includes a pair of rams or applicators 112
and 114 with the ram 112 adapted to retain the clip 10 in its
:
nested position in the cradle 108 and to permib opening and closing
of the top jaw 12 thereof while the lower ram 114 is adapted to
actuate the U-shaped spring 50 from its retracted psotion shown in
Figures 1 and 3 to its closed position shown in Figures 2 and 4. ~-`
The ram 112 is connected to a slide member 116 at the
opposite end of the instrument 100 while ram 114 is connected to its
slide member 118. Upper and lower finger engaging stabilizing rings
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19a and ll9b are provided by the instrument.
In Figure 5 it will be noted that a latch member 120
for ram 112 actuating member 116 is provided. The latch member 120
cooperates with edge 122 of actuator 116 to prevent accidental
withdrawal of ram 112 beyond the position shown in Figure 8 until
the clip has been positively attached to the Fallopian tube to
thereby minimize accidental displacement of the clip from its cradle
during use of the device. When the clip is fully attached release
~ of the latch member 120 permits withdrawal of the ram 112 so that
- 10 the clip can be separated from the laparoscope as to be more fully
described hereinafter.
The laparoscope also includes a surgical microscope
having an eyepiece 128, Fig. 5, and an objective lens 130, Fig. 6. ~ -
Surrounding the objective lens of the surgical scope is a bundle 132
of ligbt transmitting fibers. The fiber optical bundle 132, as
; more clearly shown in Figure 6, is arranged in an elliptical con-
figuration so that adequate light can be conveyed to the subject
` without interferring with the clip and clip cradle and without the
.~ necessity of using a trocar sleeve for the lapàroscope of greater
diameter than lOmm as to be more fully described hereinafter.
The laparoscope is also provided with a tap 130' which
receives the external fiber optic bundle 132 which is connected to
a source of controlled light not shown. The laparoscope also
includes the conventional means 134 for directing air or other -
; gases to and from the operation zone.
The length, width and height of the clip would vary
depending on the intended use of the clip; however, it has been
found where the clip is to be used to occlude Fallopian tubes in
i adult women, a clip 3mm wide, 4mm high, and having a length of about
16mm and internal jaw lengths of about lcm has provided very satis-
factory results.
Use of the clip and applicator will be described in
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~ `~ference to Figures 7 through 11. One of the clips 10 with its
- spring assembly 16 in the rearward position is placed in the cradle
108 of the laparoscope 100 and after insertion ram or actuator 112
is moved to a forward position so that the clip and forward end of
the laparoscope are in the mode shown in Figure 7. After the
instrument is inserted into a trocar, placed in an incision in the
patient's abdomen, the ram or actuator 112 is moved rearwardly to
the position illustrated in Figure 8 whereby the jaws 12 and 14 of
the clip 10 are in their fully opened position; however, the clip
10 is still retained in the cradle 106 by the presence of the tip 112a
of ram 112.
With the clip in this position the surgeon locates
the Fallopian tube A with the aid of the microscope and fiber optic
lighting system and positions the open-jawed clip about the selected
zone of the Fallopian tube having the opening B therein. This
aspect of the operation of the device is illustrated in Figure 9.
After the Fallopian tube is properly located between the jaws of
l the clip 10, ram 112 is urged forwardly to the position shown in
.. Fig. 7 and the Fallopian tube is urged into a collapsed position
as shown in Fig. 10. While the tube is in the collapsed postion ram actùator
114 shoves the spring assembly 16 forwardly to seat the inwardly curved tips
:~ 46 and 48 thereof into engagement in their respective slots 36 and 40 and the - -
fillet member 50 into the Space rearwardly of the hinge pivot 18 of the clip.
This is how~ in Figure 10.
;~; With the spring securely in place the spring exerts ` -
` a continuing closing force upon the jaws further constricting the
' Fallopian tube. Next the latch member 120, Fig. 5 of the drawings,
; is released and ram 112 is withdrawn from the tip of the laparoscope
freeing the clip from its saddle 106 as shown in Figure 11 so that
~, 30 the surgeon may carefully manipulate the device and proceed to
insert a second clip on the other tube of the female patient.
Since the entire instrument is contained within a
lOmm trocar it has been found possible to perform the operation
while the patient is only under a local anesthetic.
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From the foregoing description of the improved
Pallopian tube clip and applicator, it will be seen by those skilled
in the art that the aims and objects of the present invention are
fully accomplished. It will be further recognized that various
motificatlons may be made in the form of the clip and its applicator
without departing from the scope of the appended claims.
This application is a division of co-pending
Canadian Patent Application No. 207,602, filed August 22, 1974.
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