Note: Descriptions are shown in the official language in which they were submitted.
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NON-METALLIC, BIO-COMPATIBLE ~IEMOSTATIC CLIP (TWO
IDENTICAL PIECE CLIP)
The present invention relates to hemostatic clips and more
~particularly to hemostatic clips fabricated from bio-
compatible, polymeric materials which may be absorbable or
non-absorbable in body tissue.
Background of the Invention
In many surgical procedures, it is often necessary to
ligate a plurali~y of vessels within the surgical site.
The vessels may be severed downstream of the ligated
portion. In some instances, the vessels may be ligated in
spaced apart areas and the portion of the vessel between
the ligations removed. The purpose of ligating vessels is
to maintain the surgical site free from an excess of blood
and reduce blood loss in the patient. Also, in certain
surgical procedures where tumors and the like are to be
removed, the tumor or organ may have to be separated rom
certain vessels. Before separation, the vessels are
ligated. Once a blood vessel is completley shut off,
hemostasis, that is, the natural closing of the end of the
vessel so as to stop blood flow, will occur in several
days depending on the vessel. The body, in the meantime,
will continue to allow blood flow around the ligated area
through appropriate capillaries and secondary vessels,
with the natural physiological functicn of the body
enlarging the bypass vessels until adequate blood flow is
obtained. Hence, when ligating the vessel, there should
be positive stoppage of the blood flow in the main vessel.
Failure to provide complete stoppage may cause blood loss
in the patient and may also disrupt the natural hemostasis
and concurrent manufacture of new passages of blood flow
in the patient.
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In the past, this closing of the vessel was usually accom
plished using ligatures, i.e. 7 filaments or thread which
the doctor tied around the vessel to be closed. This is a
time-consuming process and one wherein positive closure of
the vessel is not always accomplished. In recent years
hemostatic clips have replaced ligatures in surgical proce-
dures to close blood vessels and other fluid ducts. Very
often these hemostatic clips are narrow U or V-shaped strips
formed of tantalum or stainless steel which are capable of
lo being deformed and possess sufficient strength to retain
the deformation when clamped about a blood vessel. The
closing forces are developed by the deformation of the me-tal.
Recently, various types of clips have been made from bio-
compatible polymeric materials which are absorbable or
non-absorbable in body -tissue~ Examples of such clips are
disclosed in Canadian Patent ~o. 1,162 9 453, 1,157,335; and
1,162,454~ and Canadian patent application Ser. No. ~25,396.
In hemostatic clips, it is important to have a clip with a
positive lock or a positive closure of the vessel. The clip
should be easily handled by the nurse and surgeon during the
procedure so that it will remain sterile when taken from its
package by the nurse with a suitable instrument 7 handed to
the surgeon, and placed appropriately in the patient~ Many
clips are designed to take advantage of certain physical
properties of materials such as resiliency or deformability.
When this is done, the materials which may be used to make
the clips are limited. It is desirable to configure a clip
in such a manner that a satisfactory clip may be produced from
any of the various bio-compatible materials whether they be
absorbable or non-absorbable in body tissue. Our new clip
meets all of the above requirements in that it is simple to
manufacture and can be made from any of the various
absorbable or non-absorbable polymeric materials. Our
new clip produces a positive lock or closure of the
vessel to which it is applied and is readily manipulated
by the nurse or surgeon during the procedure.
Summary of the Present Invention
A sterile, two-piece hemostatic clip for occluding
vessels. The pieces are substantially identical in
configuration and each piece comprises a first member
having a vessel clamping surface and a second member
disposedsubstantially perpendicular from one end of said
first member from said vessel clamping surface. The
first member has disposed at its opposite end an
opening adapted to accept the second member of the other
piece. Each piece includes means for locking the second
member of the opposite piece to the first member with
the vessel clamping surfaces of the pieces facing each
other. In certain embodiments of the hemostatic clips
of the present invention, the locking means may be
adjustable to allow the clip to be used for various
size vessels. Also 7 in some embodiments of the hemostatic
clips of the present invention, the locking means may
include an interference fit between the second member of
one piece and the opening in th~ first member of the
opposite piece.
According to a broad aspect of the present invention
there is provided a sterile, two-piece hemostatic clip
for occluding vessels. The pieces are substantially
identical in configuration and each comprises a first
member having a vessel clamping surface and a second
member disposed from one end of the first member and
substantially perpendicular thereto and on the same
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side as -the vessel clamping surface. The second
member has its free end terminating in a sharp point
capable of penetrating human tissue. The first member
has disposed at its opposite end an opening adapted to
accept the second member of the other piece and means
for locking the second member of one piece to the first
member of the other piece with the vessel clamping
surface of the pieces facing each other. The means
for locking provides an interference fit between said
second member of one piece and the opening of the other
piece.
Brief Description of the Drawin~Ls
The presen-t invention will be more fully described to
conjunction with the accompanying drawings wherein:
Figure 1 is an enlarged perspective view of one
embodiment of the two-piece clip of the present inven-
tion depicting the pieces in an open position:
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Figure 2 is an enlarged perspective view of the clip of
Figure 1 disposed closing a blood vessel;
Figure 3 is an enlarged perspective view o~ another
embodiment of the clip of the present invention with the
pieces disposed from each o~her;
Figure 4 is an enlarged perspective view of another
embodiment of the new clip of the present invention with
the pieces disposed from each other;
Figure 5 is a side view showing an instrument for applying
the clips of the present invention; and
Figure 6 is an enlarged perspective view showing a clip of
the present invention in the jaws of the instrument
depicted in Figure 5.
Detailed Description of the ~rawings
Referring to the drawings, in Figure 1 there is shown a
clip 10 of the present invention. The clip comprises a
first piece 11 having a first member 12 with a vessel
clamping surface 13. Disposed from one end of this member
is a second member 14O The first and second member are
perpendicular to each other and the second member is
disposed from the vessel clamping surface of the first
member. Disposed at the opposite end of the first member
is an opening 15 through the member. The clip includes a
second piece 16 substantially identical to the first piece
in that the second piece comprises a first member 17 and
second member 18 perpendicular to each other with the
first member having a vessel clamping surface 19 and the
second member disposed from that surface. The first
member of the second piece also includes an appropriate
opening 20 disposed at the opposite end from which the
second member is disposed.
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Each of the second members includes a plurality of ears 21
or beveled extensions on one surface. As may be seen in
Figure 2, the pieces are placed on opposite sides of the
vessel 22 to be occluded with the vessel clamping surfaces
facing each other. The second member of one piece is
inserted into the opening in the first member of the other
piece and the pieces urged together allowing the ears to
lock the pieces together by engaging the opposite surface
23 from the vessel clamping surface of the first member of
the other piece.
In Figure 3 there is shown another embodiment of the clip
of the present invention. Again, the clip 25 comprises a
first piece and a second piece which are substan~ially
identical in configuration. Each piece has a first member
26 with a clamping surface 27 and disposed from one end of
the first member perpendicular to the vessel clamping
surface is a second member 28. The second member termi~
nates in an arrowhead shaped area 29. At the opposite end
of each first membe-c is a widened area 30 in which there
is an opening 31. In use, the vessel clamping surfaces
are placed on opposite sides of the vessel to be occluded
and the arrowhead shaped portion of the second member of
each piece forced through the opening in the first member
of the opposite piece to close the vessel between the
vessel clamping surfaces. In this embodiment adjustabil-
ity for use with vessels of varying size is attained
through deflection of members 26.
In Figure 4 there is shown yet another embodiment of the
hemostatic clip of the present invention. The hemostatic
clip 35 comprises two pieces of substantially identical
configurations. Each piece has a first member 36 with a
vessel clamping surface 37. Disposed from one end of the
vessel clamping surface and perpendicular thereto is a
second member 38. Disposed at the opposite end of that
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first member and through the vessel clamping surface is an
opening 39. The opening may have raised areas disposed on
its inner surface to provide an interference fit between
the opening and the second member of the opposite piece or
the second member may include protrusions 40 on its
surface to provide such an interference fit. In use, the
vessel clamping surfaces of the first members are placed
on opposite sides of the vessel ~l to be occluded and the
- second member is inserted into the opening of the opposite
piece to close the vessel between the vessel clamping
surfaces. In any embodiments of the clips, the two pieces
may be attached if desired by a suitable strip 42 or band
connecting the pieces together at any of a number of
various positions. Such a strip is shown in the
embodiment in Figure 4.
Figure 5 illustrates a forceps type ligating clip applier
43 comprising two handle members 44 and 45 crossing at a
hinge point 46 and maintained in a normally open position
by a spring 47. One handle extends beyond the hinge
forming a jaw member 48 while the extension of the other
handle also forms a corresponding jaw member 49. As is
more clearly shown in Figure 6, the jaw members 4~ and 49
are substantially mirror images and are provided with
channels 50 and 51 extending rearwardly from the tip of
the jaws to guide the clip. The two pieces 52 and 53 of
the clips are held in these channels by frictional
engagement between the sides of the channel and the sides
of the pieces. Each channel includes an appropriately
disposed opening 54 to allow the second member of the
piece held in the opposite channel to pass through that
opening when the clip is closed about a blood vessel. The
jaws of the applier are moved or positioned over the
vessel to be occluded and the jaws of the applier closed
and the clip locked on to the vessel. The friction is
insufficient to hold the locked pieces of the clip and
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when the jaws are reopened the cllp is left on the vessel
and the applier readily removed.
The clips o the present invention may be constructed in
various sizes according to their intended function.
Hemostatic clips are usually less than 6 millimeters in
length and 1 1/2 millimeters in width and have a vessel
clamping surface of about 3 millimeters in length. The
dimension of the clip may be reduced by about 50% for
certain applications in microsurgery. Larger clips for
special hemostatic applications may be about double the
size of a typical hemosta~ic clip The various sizes of
the clip may be preferably matched with individual
appliers having jaws tailored to the size of the clip for
best performance.
As can be appreciated, the configuration of our improved
ligating clips allows the clip to be made from virtually
any material. Our new clips may be made from both
resilient and non-resilient materials as well as
deformable and non-deformable materials. The final clip
made from any of these materials adequately closes a
blood vessel for a sufficient period of time to provide
hemostatis and provides a suitable hemostatic clip.
The clip of the present invention is most conveniently
molded of biologically acceptable polymeric material which
may be absorbable or non-absorbable in body tissue.
Preferred absorbable polymers and copolymers include those
of glycolide, lactide, and (p)dioxanone. Preferred non-
absorbable polymers include nylon, polyester, and
polypropylene. All of these materials have been
demonstrated to be biologically acceptable when used as
sutures or other implantable medical devices.
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The clips of the present invention are sterilized by any
of the known sterilization techniques generally depending
on the material used to make the clip. Examples of
suitable sterilization techniques which may be used with
our clips are ethylene oxide sterilization, radiation
sterilization, such as cobalt irradiation, electron beam,
heat or steam sterilization, etc., and the like.
The clips of the present invention may be easily and
economically manufactured by injection molding and other
suitable molding techniques well known in the art. As may
be appreciated, because of the identical configuration of
the two-pieces of the clip, the molding is simple and
only one mold shape is required.
Having now described the present invention and certain
specific embodiments, it will be readily apparent to those
skilled in the art that many variations and modifications
may be made to the present invention without departing
from the spirit and scope thereof.
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