U.S. patent application number 10/733165 was filed with the patent office on 2004-12-09 for medical clip and apparatus for the application of such a clip.
Invention is credited to Fischer, Harald, Kissel, Christian.
Application Number | 20040249414 10/733165 |
Document ID | / |
Family ID | 32336457 |
Filed Date | 2004-12-09 |
United States Patent
Application |
20040249414 |
Kind Code |
A1 |
Kissel, Christian ; et
al. |
December 9, 2004 |
Medical clip and apparatus for the application of such a clip
Abstract
In a medical clip consisting of a platelet of an elastic
bio-compatible material, the platelet is provided with a central
H-shaped cut-out so as to form a frame structure with tongues
extending from the frame structure toward each other and having
adjacent front edges forming grasping elements, and the frame
structure is curved and elastically biases the front edges toward
each other.
Inventors: |
Kissel, Christian;
(Weingarten, DE) ; Fischer, Harald; (Weingarten,
DE) |
Correspondence
Address: |
KLAUS J. BACH & ASSOCIATES
4407 Twin Oaks Drive
Murrysville
PA
15668
US
|
Family ID: |
32336457 |
Appl. No.: |
10/733165 |
Filed: |
December 11, 2003 |
Current U.S.
Class: |
606/221 |
Current CPC
Class: |
A61B 17/10 20130101;
A61B 2017/0451 20130101; A61B 17/82 20130101; A61B 17/083 20130101;
A61B 17/0487 20130101; A61B 2017/0404 20130101; A61B 2017/00867
20130101 |
Class at
Publication: |
606/221 |
International
Class: |
A61B 017/08 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 19, 2002 |
DE |
102 59 411.2 |
Claims
What is claimed is:
1. A medical clip comprising a platelet (1) of an elastic
bio-compatible material, said platelet being provided with a
central H-shaped cut-out so as to form in the platelet a frame
structure (5) with tongues (3) extending toward each other and
having adjacent front edges (4) forming grasping elements, said
tongues (3) extending from said frame structure (5) and said frame
structure (5) being curved and elastically biasing said front edges
(4) toward each other.
2. A medical clip according to claim 1, wherein said tongues (3)
are bent inwardly from said curved frame structure (5).
3. A medical clip according to claim 1, wherein said tongues (3)
are bent outwardly from said curved frame structure (5).
4. A medical clip according to claim 1, wherein said elastic
biocompatible material is a shape memory material.
5. A medical clip according to claim 1, wherein the front edges (4)
of said tongues (3) are serrated.
6. A medical clip according to claim 1, wherein the front edges (4)
of said tongues are provided with a non-slip coating.
7. A medical clip according to claim 1, wherein the front edges (4)
of said tongues are provided with a rough surface.
8. A medical clip according to claim 1, wherein the front edges (4)
of said tongues are corrugated.
9. An apparatus for the application of a medical clip consisting of
a platelet (1) of an elastic bio-compatible material, said platelet
being provided with a central H-shaped cut-out so as to form in the
platelet a frame structure (5) with tongues (3) extending toward
each other and having adjacent front edges (4) forming grasping
elements, said tongues (3) extending from said frame structure (5)
and said frame structure (5) being curved and elastically biasing
said front edges (4) toward each other, said apparatus comprising a
rod (10, 11) having a distal end forming a magazine body onto which
said clips are slipped and on which they are slidingly supported
and a sleeve (12) movably supported on said rod (10, 11) for moving
said clips (14) axially off said distal end (13) of said rod (10,
11).
10. An apparatus according to claim 9, wherein said rod (10) is
tubular.
11. An apparatus according to claim 10, wherein said sleeve 12 is
the end of a flexible conduit and said rod (10, 11) is the end of a
control cable axially movably disposed in the flexible conduit
(Bowden control cable).
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates to a medical clip comprising a curved
platelet of an elastic bio-compatible material.
[0002] In the field of surgery, various types of medical clips and
apparatus for the application of such clips are known. They are
designed particularly for pinching off vessels and for holding
together wounds, but also for fixing various implants in a human
body. In comparison with other surgical procedures available for
this purpose, particularly suturing, the use of a clip has the
advantage that it requires comparatively little time for its
application.
[0003] This is of great importance for example for the closing of a
heavily bleeding wound such that the success of such a procedure
overshadows all the disadvantages of clip procedures such as for
example high local stresses of the tissue being pinched by the clip
or the danger of additional injuries caused by the clip applied to
the tissue.
[0004] There are different medical clips such as elastically and
plastically deformable clips, single and multi-part clips and
lockable and non-lockable medical clips.
[0005] The present invention relates to a one-piece elastically
deformable clip without locking means. Such a clip includes in
principle the features of a clamp that is it consists essentially
of two grasping elements which are pre-tensioned and act against
each other and which can be elastically opened for application to a
patient.
[0006] The special advantage of such an arrangement resides in the
fact that such a clip is reversibly usable that is it can be
removed after application simply by bending the clip open.
[0007] DE 41 10 12 123 A1 discloses an elastic clip for holding
open wounds together and, also an apparatus for the application of
such a clip. The clip has essentially the form of a wire-like clamp
and is bent open elastically for application so that its two ends
then compress the tissue around the wound to be closed. Upon
application, the two edges of a wound are compressed elastically by
the force of the clamp. With teeth formed on the clamping arms, the
clamp is prevented from slipping out of the tissue. The elastic
clamp is in this way designed for firm clamping and is usable for
the reversible applications mentioned above only in a limited
way.
[0008] It is the object of the present invention to provide a
single-piece elastically deformable medical clip without locking
means as well as an apparatus for its application, which apparatus
does not have the above referred to limitations concerning a
reversible use. It is furthermore an object of the invention to
provide an apparatus for the application of medical clips, which
can store several clips for a serial application of the clips.
SUMMARY OF THE INVENTION
[0009] In a medical clip consisting of a platelet of an elastic
bio-compatible material, the platelet is provided with a central
H-shaped cut-out so as to form a frame structure with tongues
extending from the frame structure toward each other and having
adjacent front edges forming grasping elements, and the frame
structure is curved and elastically biases the front edges toward
each other.
[0010] The clip merely engages the tissue and reliably fixes the
tissues without piercing the tissue. Furthermore, the clip can be
clamped onto a thread or other object.
[0011] Preferably, the clip consists of a platelet of a memory
alloy, for example, and is cut by erosion or laser procedures. The
clip is removable by means of pliers.
[0012] The invention will become more readily apparent from the
following description of preferred embodiments thereof on the basis
of the accompanying Drawings:
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 shows a platelet with an H-shaped cut-out,
[0014] FIGS. 2a, 2b and 2c show a first embodiment of a clip formed
from the platelet of FIG. 1 in a tension-free and in a tensioned
configuration and also shows the clip engaging a thread,
[0015] FIGS. 3a, 3b and 3c show a second embodiment of a clip
formed from the platelet of FIG. 1 in a tension-free and in a
tensioned configuration and also shows the clip applied to wound
tissue,
[0016] FIGS. 4a and 4b are cross-sectional views of arrangements
for installing the clips, and
[0017] FIGS. 5a and 5b show an arrangement according to FIG. 4a
with additional equipment for the clip application and a particular
clip application holding a thread provided with a T-anchor.
DETAILED DESCRIPTION OF DIFFERENT EMBODIMENTS
[0018] As shown in FIGS. 1 to FIG. 3c, the clip consists of a
single part, that is, a platelet 1 of an elastic bio-compatible
material, which is provided with an H-shaped cut-out so as to form
two tongues 3 and which is curved. The two tongues 3 are bent out
so as to form, with their opposite front edges 4, the grasping
structure of the clip. The areas of the platelet, which are
disposed at opposite sides of the two parallel line cut-outs of the
H-shaped cut-out and which are connected at opposite ends to the
tongues 3, form a bending frame structure 5, which provides for the
elastic pre-tensioning of the grasping elements of the clip against
each other. The curvature of the bending frame structure 5 is
preferably in the form of a C or a U, wherein basically all
curvature angles between 0.degree. and 180.degree. are possible.
Preferably, all the corners of the clip are rounded in order to
minimize the chances of injuries by the chip.
[0019] An important advantage of the clip according to the
invention resides in its simple design, which permits an economical
manufacture thereof in large numbers. The platelet 1 as the bases
of the clip is technically very simple and can easily and
economically be stamped from sheets in large numbers.
[0020] Also, the cut-out 2 can be stamped out possibly when the
bending of the two tongues is impressed for which process a
temperature range should be selected where the bio-compatible
material has a ductile stretch behavior and low rigidity.
Subsequently, the clip is shaped--depending on the
material--thermomechanically or in an other way to give it its
final form.
[0021] For cutting the platelet 1 out of a sheet and for providing
the cut-out 2, erosion and laser material treatment procedures are
particularly suitable, especially with a miniaturizing of the
clip.
[0022] With the shape of such a clip, the two edges of a wound or
other subject matter can be readily engaged between the front edges
4 of the tongues 3, that is, they can be clamped by the grasping
elements and pressed together by the compression forces generated
by the bending of the frame the structure 5.
[0023] A high rigidity of the platelet 1 combined with a small
dimension of the clip provide for reliable clamping with high
forces, which are reproducibly adjustable in an accurate way by
simple design features. It is not necessary that at least one
catching element is pushed into tissue areas or that barbs are
employed to prevent a disengagement of the grasping elements from
the tissue.
[0024] The clamping effect of the clip can be improved by providing
the front edges 4 of the tongues with a serrated structure, with a
non-slip coating, with a rough surface or with corrugations. For
manufacturing reasons, the transverse section of the H-shaped
structure must be cut serrated if serrations are provided.
[0025] FIGS. 2a to 2c show a first embodiment of the clip wherein
the tongues 3 are bent inwardly from the curved (C-shaped) bending
frame structure 5. FIG. 2a shows the non-stressed clip, that is,
the clip in its closed position which is curved with a large angle
of curvature whereby the front edges 4 of the tongues 3 are in
contact or disposed closely adjacent each other. For application,
the clips must be bent open elastically against the given curvature
so that the front edges 4 move away from each other (see FIG. 2b).
As application apparatus, a pliers is preferably used which however
is not shown in the figures. It includes two pliers engagement
structures which engage the bending structures 5 synchronously and
bends them open elastically.
[0026] FIG. 2c shows a preferred application of the clip of the
first embodiment, wherein a thread is fixed. The two tongues are
not aligned. They extent from the kink locations 7 which are not
disposed on a straight line extending through the front edges 4. As
a result, the front edges 4 of the tongues 3 are pushed apart when
a thread 6 is pulled in the direction as shown in FIG. 2c toward
the left whereas the thread is more firmly engaged when it is
pulled in the opposite direction (toward the right as shown FIG.
2c). The tongue front edges then are pushed into firm engagement
with each other and with the thread thereby preventing further
movement of the thread. The clip therefrom not only fixes the
thread reliably in one direction of movement, but permits movement
of the thread in the opposite direction or tightening the
connection. Furthermore, the two bending elements 5 may serve as
stops, which for example abut the adjacent tissue upon receiving
the end of the thread by means of the clip.
[0027] A second embodiment of the clip is shown in FIGS. 3a-3c.
Here the tongues are not bent inwardly into the curved clip
structure, but extend outwardly. The tongues extend either
tangentially from the curved clip structure as shown in FIGS. 3a to
3c or they have defined kink areas. FIG. 3a shows the clip in a
non-tensioned state, that is, the closed clip, which has a
comparatively small curvature angle. In this state, the front edges
4 of the tongues 3 are disposed in close proximity. For
application, the clip must first be bent further together whereby
the front edges 4 of the tongues 3 move apart (see FIG. 3b). As
application devices common pliers are suitable by which the clip
can be compressed at its outer ends.
[0028] FIG. 3c shows the clip of the second embodiment in use as a
wound clamp. The edges 8 of the wound of an organ 9 of a patient
are compressed by the front edges 4 of the clip. An advantage of
the embodiment is that, because of the advantageous lever ratios a
relatively high clamping force is provided.
[0029] For an embodiment wherein the front edges act as knife edges
the second embodiment is particularly suitable.
[0030] In this embodiment, the clip may even be used as a
miniaturized cutting device for example for cutting tissue during
surgery.
[0031] Besides, the pliers mentioned above other simple specialized
application apparatus for the grasping and setting of individual
clips may be used as shown in FIGS. 4a and 4b. These simple devices
are magazine type structures, which receive a plurality of clips 14
for successive application.
[0032] With the two apparatus according to FIGS. 4a and 4b, the
clips are bent open and disposed on a rod-like magazine member. The
magazine member may be a tube 10 as shown in FIG. 4a onto which the
clips of the first embodiment are slipped or a solid rod as shown
in FIG. 4b onto which the clips of the second embodiment are
slipped. The clips 14 slipped onto the tube 10 or rod 11 can be
applied in a controlled manner one after the other by means of a
slidable sleeve 12 by which the clips 14 can be moved toward the
distal end 13, 13a of the tube or rod. In order to provide for a
reliable separate release of each individual clip from the tube or
rod, a minimum distance between adjacent clips is to be ensured.
This can be achieved by rotation of the clips on the tube or rod
but also by providing spacers, preferably of a resorbent material
between adjacent clips. The spacers are either separate perforated
discs disposed between the clips or structures formed or mounted on
one side of each clip preferably on the bending structure 5, so
that slipping of the clips over one another on the magazine body is
prevented.
[0033] FIG. 4a shows further a thread 6 passing through the tube
10. The sleeve 12 is preferably the end of a flexible conduit and
the tube 10 or rod 11 is the end of a control cable axially movably
disposed in the flexible conduit (Bowden control cable). FIG. 5a
shows this embodiment together with an additional device for the
application of a clip 14 and a thread 6 with a T-anchor 15. A
thread installed with this application device in the tissue 16 and
secured by the T-anchor and a clip is shown in FIG. 5b. The
T-anchor comprises a tube section with a center bore as shown in
FIGS. 5a and 5b. The thread end is inserted into the center bore
and is fixed to the tube section by local compression of the tube
section. The tube section consists of a bio-compatible material,
preferably of a material which can be resorbed.
[0034] For the application of the thread 6, a hollow needle 18 with
an inclined front edge cut is inserted into the tube 10. The hollow
needle 18 is provided at its end with an open slot 19. The T-anchor
is contained in the hollow needle 18 and the thread 6 extends in
the embodiment described from the T-anchor through the slot 19 into
the space between the hollow needle 18 and the tube 10. If the
hollow needle 18 has a sufficiently large inner diameter, the
thread may also extend through the needle. In this case, the open
slot 19 would not need to be provided. Furthermore, a guide wire 17
is disposed in the hollow needle 18 for the application of the
T-anchor. The end of the guide wire 17 extends into the bore in the
T-anchor for pushing it out of the needle in the desired position.
FIG. 5a shows the hollow needle 18 piercing the tissue 16 with the
T-anchor 15 already pushed out of the needle 18 by the guide wire
17. Subsequently, the hollow needle and the guide wire 17 with the
thread 6 are pulled back into the tube 10 whereby the thread is
tensioned and the T-anchor is pivoted into a transverse position so
as to be anchored in the tissue 16. The clip 14 is then slipped
onto the tensioned thread 6 (see FIG. 5b).
[0035] The tube 10 may also be used for the insertion of an
endoscope, which facilitates an accurate visual selection of the
application area and a direct visual control of the clip
application during the procedure of the minimally invasive
surgery.
[0036] The apparatus according to FIGS. 4a, 4b and 5a, however are
suitable only for the application of the medical clips. For the
removal of the clips, for example, the pliers referred to earlier
may be used.
* * * * *