Note: Descriptions are shown in the official language in which they were submitted.
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1 CLIP APPARATUS
Background of the Invention
This invention relates to a clip apparatus and, in
particular, to a clip apparatus utili~ed in cholangiography
and similar procedures wherein a catheter or the like is
placed in a duct or vessel and held therein by a clamp
mechanism.
Many medical procedures require that a catheter, tube
or the like be placed in a body duct or vessel and held
therein while some medical procedure is performed. For
example, plastic catheters are often placed in veins and
held therein by a stitch or by a loop of string tied around
the catheter. Similarly, a tubular structure must be held
within a vessel during a lymphangiogram or in an IV cut down
procedure. During cholangiography, a cannula must be
sealably held within the cystic duct.
In humans, the common bile duct joins the liver with
the duodenum to provide flow of bile from the liver to the
small intestine to assist in the digestion of fats. I'he
gallbladder is a sac-like structure which communicates with
the common bile duct through the cystic duct and provides
intermittent storage for excess bile produced by the liver,
especially between meals. Gallstones sometimes occur in the
bile and block or impede flow of the bile through the
various ducts. When this occurs, the gallbladder may have
to be surgically removed (cholecystectomy).
To ensure removal of all gallstones from the common
bile duct, cholangiography is normally perfomed on the
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1 ductile system of the biliary tract which comprises the
injection of a radiopaque dye into the duct followed by a
series of x-rays. The x-rays tend to image the outlines of
any stones or obstructions within the ducts, as variances in
opacity occur where the stones prevent the dye from filling
the duct.
~ ormally, the dye is injected into the common bile duct
through a relatively small catheter which is inserted into a
severed end of the cystic duct. It is important to form a
relatively tight fluid seal between the cystic duct and the
catheter. Such a seal prevents the dye from leaking out of
the cystic duct rather than passing through the common bile
duct to image the gallstones therein.
In order to produce such a tight seal, surgeons
initially utilized a suture which was tied securely around
the cystic duct to hold the catheter in place. Because it
is difficult and cumbersome to tie the suture at this
location, many surgeons have elected to utilize a
commercially available metallic hemoclip for this purpose.
The hemoclips were designed to have opposing walls which
flatten against one another to flatten a severed blood
vessel or the like to prevent leakage therefrom. As this
type of clip was designed to compress -flatly and not in a
circle, there is a tendency for the tissue of the cystic
duct to ovate when the clip is applied so that leakage
occurs between the cystic duct and the catheter on the sides
of the duct not compressed by the clip. In addition, the
clip must be pried loose to remove.
Some complex mechanical clips have also been designed
to be used for this purpose. However, such clips tend to be
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1 cumbersome as well as relatively expensive.
Hence, it was desired to produce a relatively simple
clip which could be easily and ~uickly applied to the cystic
duct which would compress the cystic duct fairly evenly
about its entire circumference and which would be fairly
easily removed after completion of the cholangiograpic
process.
In addition, it was desired to have a catheter which
would cooperate with the clip to provide a leak-proof seal.
Further, it was desired to provide a tool which would both
readily apply and remove the clip, as well as a process for
utilization of the clip during surgical procedures.
Objects of the Invention
Therefore, the objects of the present invention are:
to provide a clip apparatus which includes a medical clip
providing a relatively fluid-type seal between a vessel and
a tube within the vessel when the clip is cooperatively
placed around the vessel; to provide such a clip which
compresses the vessel relatively evenly about the entire
circumference of the vessel; to provide such a clip which is
relatively easy to apply and simple in nature; to provide
such a clip which is relatively easy to remove; to provide
such a clip which is especially well adapted for use in
compression of the cystic duct abou-t a catheter during
cholangiography; to provide such a clip which includes a
pair of opposed C-shaped jaws interconnected by arms at a
semimaleable juncture which allows selective positioning of
the jaws when pressure is applied to the arms and/or jaws;
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1 to provide such a clip wherein the arms may be partially
urged toward one another to compress the jaws and wherein
the arms can be further compressed in such a manner as to
urge the jaws apart to facilitate removal of the clips; to
provide such an apparatus including a catheter having
serrations thereon for cooperating with the clip to Eorm a
fluid-type seal between the catheter and the duct; to
provide such an apparatus including an application and
removal tool for the clip; to provide a process for
utilization of the clip during a cholangiographic process or
the like; to provide such a clip apparatus which is
relatively simple and inexpensive to make, simple to use and
particularly well adapted for the intended usage thereof.
According to the present invention there is provided
a medical clip for removably clamping a living vessel about
a tube during a medical procedure so as to hold the tube
within the vessel; said clip comprising: (a) a pair of
opposed jaws having curved opposed faces adapted to surround
the vessel when together, each of said faces generally being
C-shaped; (b) a pair of arms; each of said arms connected to
respective first ends of said jaws; (c) said arms being
joined near an end thereof opposite connection of said arms
to said jaws by a maleable and generally non-resilient
hinge; said hinge being deformable upon application of
opposed pressure to said jaws such -that the angular spacing
between said arms and jaws is varied by said application of
pressure and a resulting configuration is retained after
removal of the pressure such that when pressure is applied
to said jaws to bias said jaws together both opposed first
ends of said jaws are urged into touching relationship and
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1 said jaw surfaces de:Eine an opening therebetween adapted to
surround the vessel, while said hinge holds said jaw ends in
the touching relationship; (d) at least a first of said arms
being bent medially therealong outwardly with respect to the
second of said arms; and (e) said first arm being
sufficiently pliable whereat said first arm is bent to allow
said first arm to be at least partially unbent when pressure
is applied thereto; said jaw first ends attached to said
arms functioning as a Eulcrum when in touching relationship
such that when pressure is applied to said first a.rm whereat
said first arm is bent in a direction toward said second
arm, said jaws pivot about said fulcrum such that said jaw
ends opposite said fulcrum become spaced apart so as to
allow release of said clip from the vessel.
Also according to the present invention there is
provided a medical clip for removably clamping a living
vessel about a tube during a medical procedure comprising:
(a) a pair of jaws; each of said jaws having a generally C-
shaped cross-section and being positioned so as to be facing
one another; (b) a maleable and generally nonresilient
connection joining one end of said jaws toge-ther; said
connection being deformable upon application of pressure so
that said jaws may be selectively positioned together to
generally encircle said vessel such that opposite ends of
the jaws engage one another and said jaws may be urged apart
such that at least one opposed end of each of said jaws
separates to allow removal of said clip from the vessel.
Further according to -the present invention is provided
a medical clip for removably clamping a living vessel about
a tube during a medical procedure so as to hold the tube
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1 within the vessel; said clip comprising: (a) a pair of
opposed jaws' (b) a pair of arms; each of said arms
connected to one side of a respective jaw; and (c) said arms
being joined near an end thereof opposite said jaws by a
maleable hinge; said hinge allowing the angular spacing
between said arms to be varied by application of pressure to
said arms.
Further according to the present invention is provided
a medical clip for removably clamping a living vessel about
a tube during a medical procedure so as to hold the tube
within the vessel; said clip comprising: (a) a pair of
opposed jaws; (b) a pair of arms; each of said arms
connected to one side of a respective jaw; (c) said arms
being joined near an end thereof opposite said jaws by a
maleable hinge; said hinge allowing the angular spacing
between said arms to be varied by application of pressure to
said arms and retained after removal of the pressure; (d) at
least a firs-t of said arms being bent medially therealong
outwardly with respect to the second of said arms; and (e)
said first arm being sufficiently p].iable whereat said first
arm is bent to allow said first arm to be at least partially
unbent when pressure is applied thereto.
Further according to -the present invention is provided
a clip apparatus for conducting a medical procedure
includiny retaining a catheter within a cystic duc-t; said
apparatus comprising: (a) a clip having a pair of opposed
jaws interconnected at a first end thereof by a generally
maleable hinge and having a second distal end; said jaws
being spaced prior to use of said clip and said hinge
allowing said jaws to be abutted together at opposite ends
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1 of said jaws during use; a palr of arms interconnecting said
jaws with said hinge; and (b) a catheter including ribs
along an outer surface thereof; said catheter being shaped
to be positionable within a cystic duct and said clip being
shaped to snugly encircle a cystic duct with said catheter
therein during use about.
Other objects and advantages of this invention will
become apparent frorn the following description taken in
conjunction with the accompanying drawings wherein are set
forth, by way oE illustration and example, certain
embodiments of this invention.
rrhe drawings constitute a part of this specification
and include exemplary embodiments of the present invention
and illustrate various objects and features thereof.
Brief Description of the Drawings
Fig. 1 is a fragmentary view of internal organs of a
human including liver, gallbladder, common bile duct and
duodenum shortly prior to severing of the cystic duct
connecting the gallbladder with the common bile duct with a
surgical instrument.
Fig. 2 shows insertion of a cholangiographic process
catheter into the cystic duct aEter the gallbladder is
severed therefrom.
Fig. 3 is a side elevational view of a clip according
to the present invention.
Fig. 4 is a side elevational view of the clip in a
closed position just subsequent to applying the clip -to the
cystic duct by utilization of a clip applying -tool.
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1 Fig. 5 is an enlarged and fragmentary perspective view
of the common bile duct and cystic duct with the catheter
placed within the cystic duct and held therein by the clip.
Fig. 6 is a fragmentary and enlarged cross-sectional
view of the common ~ile duct and cystic duct with the
catheter positioned within the cystic duct and held therein
by the clip, taken along line 6-6 of Fig. 5.
Fig. 7 is a fragmentary and enlarged side elevational
view of the common bile duct and cystic duct showing the
clip in an open posi-tion after removal from the cystic duct
and showing the clip applying tool being utilized to remove
the clip.
Fig. 8 is a perspective view on a smaller scale of the
clip applying tool.
Detailed Description of the Invention
As required, detailed embodiments of the present
invention are disclosed herein; however, it is to be
understood that the disclosed embodiments are merely
exemplary of the invention which may be embodied in various
forms. ~herefore, specific structural and functional
details disclosed herein are not to be interpre-ted as
limiting, but merely as a basis for the claims and as a
representative basis for teaching one skilled in the art to
variously employ the present invention in virtually any
appropriately detailed structure.
The reference numeral 1 generally designates a clip
included in a clip apparatus 2 in accordance with the
present invention. The clip 1 comprises a pair of opposed
1 C-shaped jaws 3 and 4 interconnected by a handle 5.
Although the clip 1 is shown utilized in conjunction with a
cholangiographic process as described below, it is foreseen
that the clip 1 may be utilized in other medical procedures
requiring the sealing of a vessel or duct about a circular
tube or the like.
As seen in Fig. 3, the jaws 3 and 4 are spaced from one
another prior to use. The jaws 3 and 4 each have distal
ends 7 and 8 respectively which are spaced opposite one
10 another. The jaws 3 and 4 also have fulcrum ends 11 and 12
respectively which are also spaced opposite one another
prior to use of the clip 1. The ends 11 and 12 are directly
attached to the handle 5. The jaws 3 and 4 have facing
surfaces 14 and 15 which are generally semicircular in
cross-section and concave. In certain procedures where the
clip is to be positioned on the vessel for a relatively long
time, the jaw surace may be slightly parabolic rather than
semicircular to allow blood to flow from one side of the
clip to the other.
The handle 5 includes arms 20 and 21 joined at a
semimaleable but not springy hinge 22. The hinge 22 and,
preferably, the entire clip 1 is constructed of a generally
nonresiliant but semimaleable material which may be bent or
manipulated into a modified position when pressure or force
is applied thereto, but which substantially retains the
modified position when the force is removed. Therefore, if
force is applied to the arms 20 and 21 to swing the arms
relative to one another abou-t the hinge 22 and change the
angle thereof wi-th respect -to one ano-ther, -the arms 20 and
21 will retain the new angular relationship between each
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1 other ater the pressure i5 removed.
Each of the arms 20 and 21 include a first portion 25
and 26 and a second portion 27 and 28 respectively. The arm
first portions 25 and 26 are relatively straight and join at
the hinge 22. The arm second portions 27 and 28 are also
relativley straight and join at one end thereof with the arm
first portions 25 and 26 respectively opposite the hinge 22
and at the other end thereof with the jaw fulcrum ends 11
and 12 respectively.
Prior to use, the arms 20 and 21 are not linear
between the jaw fulcrum ends 11 and 12 respectively and the
hinge 22, but rather bow outwardly from one another. In
particular, the arm portions 25 and 27 meet at juncture 30
and the arm portions 26 and 28 meet at juncture 31 such that
junctures 30 and 31 are spaced substantially outward from
linear projections between the hinge 22 and the jaw fulcrum
ends 11 and 12 respectively.
The clip 1 has a first configuration which is shown in
Fig. 3 and corresponds to the clip 1 prior to use thereof.
The clip 1 has a second configuration shown in Fig. 4 which
corresponds to the conEiguration of the clip 1 during use
thereof. The clip 1 has a third con~iguration which is
shown in Fig. 7 and which corresponds to the configuration
of the clip 1 subsequent to removal thereof following use.
These three configurations will be discussed in greater
detail below.
Fig. 1 shows part of the internal organs of a human.
In particular, a liver 40 is shown interconnected with a
duodenum 41 by a common bile duct 42. The bile duct 42 is
further connected to a gallbladder 43 by a cystic duct 44.
01
1 The gallbladder 43 is about to be severed from the cystic
duct 44 along an imaginary cut line 45 by a surgical
instrument 47. Fiy. 2 shows the common bile duct 42 and
cystic duct 44 subsequent to severing of the gallbladder 43
from the cystic duct 44. The cystic duct has a free and
open end 50 communicating with an internal lumen 51 thereof.
The common bile duct 42 also has an internal lumen 52, as
can be seen in Fig. 6.
Also in Fig. 2, the clip apparatus includes an
instrument 55 for injecting a radiopaque dye into the common
bile duct 42. The instrument 55 comprises a catheter 56
having a tip 57, an in-ternal lumen 58 and an aperture 59
near the tip 57 opening into the lumen 58. The instrument
55 further includes a syringe 60 connected to the catheter
56 by a Luer Lock or the like and partially seen in Fig. 2.
The syringe 60 holds dye and allows an operator to urge dye
into and through the catheter 56. The catheter 56 is
corrugated so as to have a plurality of ridges or serrations
63 generally equally spaced along a substantial portion of
an outer surface 64 thereof.
As seen in Fig. 8 and partially in Figs. 4 and 7, the
clip apparatus 2 further includes a tool 70 having opposed
jaws 71 and 72, arms 73 and 74 joined with said jaws 71 and
72 respectively and a hinge or pivotal connection 75
positioned medially along the arms 73 and 74. The arms 73
and 74 are fixedly attached to the jaws 71 and 72
respectively such that the jaws 71 and 72 extend at right
angles to the arms 73 and 74. The arms 73 and 74 are joined
by the pivotal connecticn so as to form a pliers like tool
wherein movement of the distal ends of the arms 73 and 74,
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1 opposite the jaws 71 and 72, together urges the jaws 71 and
72 together whereas outward movement of the distal ends of
the arms 73 and 74 relative to one another separates or
spaces the jaws 71 and 72.
The tool jaws 72 and 73 have recesses 78 and 79
respectively positioned on facing surfaces 80 and 81
thereof. The recesses 78 and 79 are shaped to roughly
conform with outer surfaces 90 and 91 of a nonused clip 1.
In Fig. 4, the jaws 71 and 72 are spaced from -the clip
1, but positioned such that the recesses 78 and 79 are
generally aligned to mate with the outer surfaces 90 and 91
of the clip 1. The tool jaws 71 and 72, as shown in Fig. 4,
have just released the clip 1 after compressing the C-shaped
jaws 3 and 4 of the clip 1 together so that jaw distal ends
7 and 8 touch and jaw fulcrum ends 11 and 12 touch. During
such compression, the clip arm first portion 25 and second
portion 27 as well as the clip arm first portion 26 and
second portion 28 remain substantially unchanged and
generally retain the same angle therebetween. Each of the
jaws 71 and 72 have a face forward portion 85 and 86
respectively which are generally parallel and do not align
with any particular structure of the clip 1 when the clip 1
is being installed by the -tool 70.
The surfaces 85 and 86 however can be aligned to be
posi-tioned in opposed relationship to each other over the
junctures 30 and 31 of the arms 20 and 21 respectively, as
seen in Fig. 7. Upon movement of the jaws 71 and 72
together, the junctures 30 and 31, which are V-shaped, are
pressed toward each other so as to make a wider V, that is,
to change the relative angle between the first portions 25
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1 and 26 and second portions 27 and 28 of the arms 20 and 21
respectively so as to make the arms 20 and 21 closer to
being linear. Such modiications of the arms 20 and 21
rotate the clip jaws 3 and 4 about their fulcrum ends 11 and
12 so that the jaw distal ends 7 and 8 substantially
separate, as is shown in Fig. 7. The clip 1 is then in the
open configuration thereof and easily removed from the
cystic duct 44.
It i.s also foreseen that only one of the arms of the
clip could be bent in order for the clip to open as
described above; however, only one of the jaws would rotate
about the fulcrum point.
Therefore, in use, the clip 1 is illustrated in
conjunction with a cholangiography process. In particular,
the cystic duct 44 is severed and the catheter 56 is
inserted into the cystic duct lumen 51 such that the
catheter tip 57 extends into -the common bile duct lumen 52.
The clip 1 is originally in the first configuration shown in
Fig. 3 wherein the C-shaped jaws 3 and 4 are spaced on both
sides.
The clip 1 is positioned within the tool 70 such that
the outer surfaces 90 and 91 of the clip 1 mate with the
recesses 78 and 79 of the tool. The clip 1 is then
positioned such that the C-shaped jaws 3 and 4 are placed on
opposite sides of the cystic duct 44 at a location whereat
the catheter 56 is passing through the cystic duct 44 with
at least several of the ridges 63 positioned beneath the
clip surfaces 13 and 14. The distal ends of the tool arm 73
and 74 are urged together by manual pressure thereby urging
the tool jaws 71 and 72 together and subsequently urging the
13
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clip C-shaped jaws 3 and 4 together such that jaw ends 7 and
8 touch and jaw ends 11 and 12 touch as seen in Fig. 4. 'L`he
hinge 22 is maleable so that the arms 20 and 21 may be bent
about the hinge 22 and fold the portion they are bent to
without requiring additional biasing such as springs or the
like. q'he tool 70 is then removed from the clip 1 as shown
in Fig. 4. Dye is then injected through the catheter 56 to
perform a cholangiographic process. q~he clip 1 is sized
such that the surfaces 13 and 14 form tightly about the
10 cystic duct 44 and the catheter 56 to form a tight fluid
neck therebetween.
After the dye i5 injected, the tool jaws 71 and 72 are
then placed on the clip junctures 30 and 31 and again
pressure is exerted on the tool jaws 71 and 72 by
manipulation of the tool arms 73 and 74. q'he clip junctures
30 and 31 are urged together bending the arms 20 and 21 to
be more linear which rotates the clip C-shaped jaws 3 and 4
about their respective fulcrum ends 11 and 12 such that the
distal ends 7 and 8 thereof substantially separate, thereby
20 presenting a third or used-open configuration of the clip,
as seen in Fig. 7. The clip 1 is then removed from the
cystic duct 44 as i8 the catheter 56. Normally, a sealing
clip (not shown) is thereafter placed on the cystic duct 44
near the common bile duct 42 and the excess cystic duct stub
extending away from the clip is surgically removed~
It is to be understood that while certain forms of the
present invention have been illustrated and described
herein, it is not to be limited to the speciEic forms or
arrangement of parts described and shown.
14
