U.S. patent number 3,604,425 [Application Number 04/815,395] was granted by the patent office on 1971-09-14 for hemostatic clip.
This patent grant is currently assigned to New Research and Development Laboratories, Inc.. Invention is credited to Pierre L. Le Roy.
United States Patent |
3,604,425 |
Le Roy |
September 14, 1971 |
HEMOSTATIC CLIP
Abstract
A hemostatic clip is in the form of a tubular body member having
a longitudinal slit extending completely across the body for
receiving a wound flap when the body is distended from its original
shape. A pair of projections are on the body member joined to the
body member along a longitudinal line disposed about 90.degree.
from the slit to act as convenient means for distending the body
from its original shape when external force is aPplied to the
projections.
Inventors: |
Le Roy; Pierre L. (Wilmington,
DE) |
Assignee: |
New Research and Development
Laboratories, Inc. (N/A)
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Family
ID: |
25217669 |
Appl.
No.: |
04/815,395 |
Filed: |
April 11, 1969 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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473055 |
Jul 19, 1965 |
3446212 |
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Current U.S.
Class: |
606/158; 24/562;
24/DIG.22 |
Current CPC
Class: |
A61B
17/1227 (20130101); Y10T 24/44915 (20150115); Y10S
24/22 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61B 17/122 (20060101); A61b
017/08 (); A61b 017/12 () |
Field of
Search: |
;128/325,334,335,337,346
;24/255 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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865,475 |
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Feb 1941 |
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FR |
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1,058,094 |
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Feb 1967 |
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GB |
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464,802 |
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Jul 1951 |
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IT |
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Primary Examiner: Truluck; Dalton L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of copending application
Ser. No. 473,055, filed July 19, 1965, now U.S. Pat. No. 3,446,212
issued May 27, 1969.
Claims
I claim:
1. A hemostatic clip comprising a body in the form of an elongated
tubular element, said tubular element having an ellipsoidal cross
section, wound-flap-engaging means on said body, said
wound-flap-engaging means being an elongated longitudinal slit
extended completely across said body whereby said body may be
distended from its original shape, a pair of outwardly extending
projections connected to said body remote from said slit for
accommodating a force-applying tool, said body being resiliently
urged to maintain its original tubular shape whereby the original
tubular shape of said body may be distended upon application of
force to said projections to cause said slit to widen and permit
the insertion of a wound flap therein and said body will return
toward its original undistended tubular shape upon cessation of the
application of force for firmly engaging the wound flap, said slit
being defined by a pair of longitudinal edges, and said edges being
shaped as sinusoidal teeth having gently merging hills and valleys
and wherein said teeth taper outwardly away from said edges, said
teeth being defined in cross section by an inner wall disposed
toward the interior of said tubular body, said inner walls of said
teeth being generally aligned, and each outer wall being inclined
from its edge where it merges with its inner wall outwardly away
from its inner wall.
2. A clip as set forth in claim 1 wherein said body is made of a
polymer material.
3. A clip as set forth in claim 2 wherein the sinusoidal curvatures
of said teeth are generally parallel.
4. A clip as set forth in claim 3 wherein each of said projections
is joined to said body along a longitudinal line disposed about
90.degree. from said longitudinal slit, each of said projections
comprising a stem portion connected to said body and a head portion
connected to said stem portion, said stem portion and said head
portion being of different cross-sectional widths with respect to a
section line taken perpendicular to the longitudinal axis of said
body to facilitate the reception of a force-applying tool thereon,
and said head portion being of generally circular cross section and
being solid with a greater width than said stem portion.
5. A hemostatic clip comprising a body in the form of an elongated
tubular element, wound-flap-engaging means on said body, said
wound-flap-engaging means being an elongated slit extending
completely across said body whereby said body may be distended from
its original shape, a plurality of parallel peripheral slots being
in said body and terminating adjacent said longitudinal slit with a
longitudinal margin on each side of said slit forming a thin
backbone to provide stability and to control the flexibility of
said body, and said body being at least 10 inches long and being
axially bendable for clamping a relatively long wound flap.
6. A clip as set forth in claim 5 wherein the edges of said slit
are serrated to provide positive traction on the wound flap.
Description
BACKGROUND OF INVENTION
This invention relates to hemostatic clips for use in clamping
wound flaps to prevent the flow of blood from severed arteries,
capillaries and the like.
Applicant's patent previously referred to describes and claims a
highly successful hemostatic clip which is inexpensive, easily
sterilized so that it can be prepackaged, disposable, adapted to be
made in a variety of dimensions and can be easily applied and
removed by a relatively unskilled worker. The clip disclosed in
that application is essentially a tubular member having a slit
completely across its body so that it can be distended from its
original shape to receive the wound flap therein. As particularly
disclosed in the parent application the tubular body can be
distended from its original shape because of the provision of a
pair of parallel slots which are disposed about 90.degree. from the
longitudinal slit whereby a plierslike applicating tool can be
inserted into the slots and upon application of force thereto the
longitudinal slit will be spread apart to receive the wound
flap.
SUMMARY OF INVENTION
An object of this invention is to provide a modified form of the
above-type clip which still retains all of its advantages.
In accordance with this invention a pair of projections are
disposed on the body instead of the parallel slots. The projections
are connected to the body along longitudinal lines which are
similarly disposed about 90.degree. from the wound flap receiving
slit. When force is applied to the projections they act as levers
to spread the longitudinal slit and facilitate the insertion of the
wound flap therein.
Advantageously, each projection includes a stem portion connected
to the clip body and an enlarged head portion on the stem. The body
may be horseshoe shaped to accommodate a greater portion of the
wound flap. Furthermore the body may terminate in flanges which are
perpendicular to the leg sections of the horseshoe and which have
parallel undulations to provide greater traction of the wound flap
while minimizing tissue damage and pain.
In another form of this invention the body is provided with a
plurality of parallel peripheral slots which terminate adjacent the
wound flap receiving slit whereby a longitudinal margin is formed
on each side of the slit to provide stability and to control
flexibility of the body. Such a clip has the advantages of greater
visibility, ventilation and drainage of the wound flap and can be
utilized for clamping relatively long wound flaps.
THE DRAWINGS
FIG. 1 is a side view in elevation and partly in section showing a
clip applied to a wound flap in accordance with one aspect of this
invention;
FIG. 2 is a top plan view of the clip shown in FIG. 1;
FIG. 3 is a side view of the clip shown in FIGS. 1-2;
FIG. 4 is a bottom plan view of the clip shown in FIGS. 1-3;
FIG. 5 is an enlarged view taken through FIG. 4 along the line 5--5
and showing the clip clamping against a wound flap;
FIG. 6 is a side view of an applicator in accordance with another
embodiment of this invention;
FIG. 7 is a front view of the applicator shown in FIG. 6;
FIG. 8 is a cross-sectional view taken through FIG. 6 along the
line 8--8;
FIG. 9 is a plan view of a portion of the applicator shown in FIGS.
6-8;
FIGS. 10-11 are side views of the applicator and its clip in
different phases of operation;
FIG. 12 is a cross-sectional view taken through FIG. 11 along the
line 12--12;
FIGS. 13-15 are front, top and side views, respectively, of the
clip shown in FIGS. 10-12; and
FIGS. 16-17 are side views of modified clips in accordance with
this invention.
DETAILED DESCRIPTION
FIGS. 1-5 show a clip in accordance with one embodiment of this
invention. As indicated therein clip 10 is generally of tubular
form in that it is in the shape of a hollow body open at both ends.
The clip can be constructed from any material possessing the
required elastic modulus and physical properties. Nylon tubing for
example as well as Delrin, Teflon polyethylene, polypropylene and
other suitable polymers and/or plastics are particularly adapted
for this invention. Additionally, thin metal tubes or other alloys
are also suitable. The tubular body can be formed into a circular,
rectangular, triangular, square, elliptical or other adaptable
cross section having the appropriate physical properties and being
clinically acceptable. As illustrated in the drawings, however, the
tubular body is advantageously of generally horseshoe shape to
increase its wound-flap-receiving capability.
Clip 10 may be of any desired length required by the specific
purpose to which it is to be used. Some advantageous lengths for
example are one-fourth, one-half, and 1 inch, with the longer
length being suitable for large wound flaps.
Clip 10 includes a longitudinal slit 12 across its entire length so
that it can be distended by for example any suitable applicator 14.
Upon being distended the slit 12 is spread apart whereby the wound
flap 16 can easily be inserted therein. Upon release of force from
the applicator the slit edges are then applied to the two sides of
wound flap 16 or other tissue to prevent the flow of blood from
severed arteries, capillaries or the like. At approximately
90.degree. to the longitudinal slit 12 are two parallel projections
18, 18 which are longitudinally centered on the clip body. Each
projection includes a stem portion 20 which, as best shown in FIG.
5, is integral with the clip body and is tangential thereto. Stem
20 actually forms an extension of the leg sections 24 of the
horseshoe-shaped clip body. Stem 20 terminates in an enlarged
arcuate head 22 to facilitate the reception of applicator tool 14
thereon. Projections 18 extend at least one-third of the length of
the clip body to provide a sufficient area for the reception of
applicator 14.
As best shown in FIG. 5 the clip body is horseshoe shaped having an
arcuate bridging section 26 between projections 18 with the
straight leg sections 24 connected to the bridging section. Leg
sections 24 terminate in substantially perpendicular flanges 28
which are spaced from each other to form the slit 12. The flanges
28, as shown in FIG. 4, terminate in parallel undulations 30
disposed generally parallel to the longitudinal axis of the clip
body with the sinusoidal teeth being generally parallel and having
gently merging hills and valleys. As shown in FIG. 5 the
undulations taper in a converging direction toward the slit with
the inner surfaces 32 of the flanges 28 being coplanar and with the
flanges terminating in blunt or rounded ends 34. This particular
configuration of slit 12 is particularly effective in providing
sufficient traction to the wound flap while minimizing any pain
thereto or undue damage to the tissue.
Clip 10 can be easily and rapidly removed either with applicator 14
or by hand. Manual removal is accomplished by squeezing projections
18 toward each other so that the projections act as levers to
spread flanges 28 away from each other. The clip 10 can then be
merely slipped off the wound flap 16 without noticeable damage to
the tissue. Additionally, no special training is necessary for the
scrub nurse, assistant, or surgeon in applying or removing clips
10.
Other advantages of clip 10 are that it can be sterilized by either
the flash or routine method employing high pressure and high
temperature. Clip 10 can also be sufficiently inexpensive to be
disposable and thus packaged in presterile units. When desired or
necessary, however, clips 10 can be reused. Even if the clips are
unduly abused by, for example, being dropped, the clips show no
structural fatigue or cracks and maintain their elastic state to a
high degree.
Correspondingly, the operative maintenance of applicator 14 is
minimal. Applicator 14 may for example be made of a metal which can
be autoclaved and handled without any unusual difficulty.
Advantageously, clip 10 may incorporate an X-ray or radiopaque
material such as barium sulfate. Accordingly, the clip can be
easily located if it should be "lost" within the operative site.
Additionally, a bacteriostatic material may be used for clip 10.
Accordingly, items such as iodonated compounds and an alpha or a
low energy beta emitter may be added.
As indicated above clip 10 has proven to be exceptionally
effective. For example, its ease of application, the lack of tissue
irritability, the ease of adjustment, and the rapid removal enable
the surgeon to move more quickly on entering the operative field.
Clip 10 is particularly effective with scalp and back wounds, and
can also be advantageously used on abdominal or long flap wounds as
may be necessary in extremity work. Moreover, the gentleness with
which the blood vessels are compressed and the lack of tissue
irritability are especially notable.
FIGS. 6-17 illustrate another clip 40 formed in accordance with
this invention. Clip 40 is for example made of a disposable plastic
material or materials previously enumerated with respect to clip
10. Clip 40 is of extended or continuous length, being at least 10
inches long, so that it can be cut to the desired size for
individual application. Additionally, clip 40 is specifically
designed to provide maximum ventilation and drainage of the wound
as well as increased visibility thereof.
As indicated most clearly in FIGS. 13-15, clip 40 is of tubular
form having a suitable wall thickness and a continuous elongated
longitudinal slit 42. Clip 40 may be of any length such as the
medium-size clip as indicated in FIGS. 14-15 or the extra-long clip
shown in FIG. 16. The border or margin on each side of slit 42
forms a pair of elongated longitudinal backbones 44 and 46.
Additionally, clip 40 includes a plurality of parallel-spaced
peripheral slots 48 which are separated by ribs 50 spanning
backbones 44 and 46. The provision of these perforations or slots
48 not only provides visibility, ventilation, and drainage of the
wound flap 52 (FIG. 11), but also permits the delicate adjustment
of a balance between the clamping strength and ease of application
of clip 40. The thickness of backbones 44 and 46 determines the
flexibility of clip 40 and its ability to conform to any wound
configurations. Thus clip 40 can be applied in a bent or curved
manner, as well as in a relatively straight line.
Although slots 48 are an exceptionally effective manner of forming
perforations in clip 40 it is also possible to form the
perforations in other ways, as long as the perforations permit
flexibility, adequate clamping force, and visibility of the
wound.
One modification of clip 40 is shown in FIG. 17 in which backbones
44 and 46 are serrated along slit 42 to provide more positive
traction on the wound flap.
FIGS. 6-12 illustrate the applicator 60 which is particularly
adapted for clips 40. As indicated therein, applicator 60 is made
of two parts. One part 62 is a relatively long support rod, one end
of which may be conveniently held and used as a handle as shown in
FIG. 15. The second member or part is guide rod 64. Guide rod 64
includes a feed end 66 and a discharge end 68. Discharge end 68 is
secured to the remote end 70 of support rod 62 to form the
dispensing end 76 of applicator 60. Members 62 and 64 are made, for
example, in the form of flattened tubular elements as best shown in
FIG. 16. Accordingly, a pair of grooves 72 and 74 are formed at the
juncture of discharge end 68 and remote end 70. As shown in FIGS. 7
and 9 dispensing end 76 of applicator 60 tapers or widens
outwardly. Thus the distance between grooves 72 and 74 also
increases.
In use the tubular clip 40 is inserted around feed end 66 of guide
member 64 as shown in FIG. 10. Since feed end 66 is spaced from
support rod 62, clip 40 can easily be loaded around guide rod 64.
Applicator 60 is then brought into the vicinity of wound flap 52.
Advantageously, dispensing end 76 of applicator 60 is concave and
tapered to act as a registry means for wound flap 52 so that wound
flap can be inserted in the concave portion 78 and maintained in
position for the application of clip 40 as most clearly shown in
FIG. 15. Additionally, this registry is facilitated by the tapered
end of applicator 60 in which guide member 64 projects slightly
beyond support member 62.
After wound flap 52 has been brought into registry in tapered
concave portion 78 clip 40 is slid down guide member 64. The end of
clip 40 is open or distended by the outwardly tapering dispensing
end 76 of applicator 60. Accordingly, clip 40 is simply
progressively slid off applicator 60 in an open position onto flap
52.
Applicator 60 which is made of a clinically acceptable material
such as steel or other metal or plastic, and can easily be held in
either hand with the clip 40 being advanced by the thumb of the
other hand. When the required length of clip 40 has been applied to
wound flap 52, the excess clip can be cut off by, for example, a
scissors. Clip 40 can thereby be easily applied in a simple
sweeping fashion. Thus for example for the first time a large area
can be clamped by employing two large continuous hemostatic clips
40 by using only two maneuvers, in contrast to the multiple
repeated maneuvers which have been required with conventional small
clamps. In addition to the above noted advantages of ease of
application and removal of clip 40, the clip also renders the
operative area free of clutter.
For removal, clip 40 can be fractionally withdrawn from wound flap
52 to allow for surgical closure by interrupted sutures for
controlling hemostasis and approximation of tissue planes. This can
be done manually, without requiring an instrument, as is ordinarily
necessary for conventional clips. Alternatively, the clip 40 can be
removed in one sweeping motion, if necessary, rather than
fractionally or with the conventional multiple actions.
* * * * *