EP2693955A1

EP2693955A1 - Surgical clip

Info

Publication number: EP2693955A1
Application number: EP12710258.0A
Authority: EP
Inventors: Theodor Lutze
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2011-04-05
Filing date: 2012-03-21
Publication date: 2014-02-12
Also published as: WO2012136480A1; DE102011001798A1; US20140114332A1; JP2014521371A

Abstract

The invention relates to a surgical clip comprising two clip segments, which each consist of a (beam-shaped) clamping section preferably extending in a linear manner and an actuating section, and further comprising a flexible spring assembly, by means of which the two clip segments are integrally coupled to each other. According to the invention, the flexible spring assembly is arranged and shaped such that it bulges between the clip segments along the actuating sections toward the clamping sections. The flexible spring assembly is composed of a number of series-coupled individual spring arms.

Description

description

Surgical clip

The present invention relates to a surgical clip according to the preamble of patent claim 1.

Surgical clips (or also called tissue clip) are medical implants, which are mostly used temporarily for sealing, for example, tissue perforations or for the therapy of aneurysms as vascular clamps. For this purpose, a variety of clip shapes are suitable starting with mouth-like clips in which the Klemmoder clip industries are shaped similar to an upper and lower jaw as two opposing, longitudinally curved rows of teeth, which are coupled at their respective two longitudinal ends hinges together, up to row-like (straight) clips that have comparable to a conventional pliers two opposing essentially straight clamping rails that are possibly occupied by teeth or a corrugation and are hinged together only at one longitudinal end.

However, common to all known clip shapes is at least one spring arrangement which applies a clamping force to the clip branches. This at least one spring arrangement can be embodied as a separate component which is inserted into the clip in order to bias the clip branches against one another or it is integrated into the clip (in one piece). In the latter case, the spring arrangement essentially forms the hinge or hinges with which (n) the two clip branches are pivotably coupled.

From the prior art is a surgical clip of the genus with straight

Clip industries and one-sided spring arrangement known, as published for example in DE 20 2010 008 512 111.

The clamping or closing force is generated here by a leg spring, which is designed either as a round or rectangular spring. In concrete terms, such a clip consists of two clip branches that are loose in their respective center sections (ie without mechanical connection such as a hinge pin) to cross two in

Closing position parallel adjacent clamping portions and two spaced apart in this position actuating leg or actuating portions to form. The free ends of the actuating portions are connected to each other via the above-mentioned leg spring, which is formed integrally (from a single part) with the clip industries or as a separate component and then connected to the clip industries to a part (soldered, welded, put together, etc.). is. The leg spring can have either a half, a 1 .5-fold or even a 2.5-fold winding.

To operate the surgical clip is at its operating sections

compressed, whereby the clamping portions due to the

Spacing crosswise alignment of the clip industries from each other. At the same time the leg spring is biased stronger. If the operating sections are released, the leg spring causes a disengagement of the

Operating portions until the clamping portions are pressed against each other.

Although the above construction ensures a sufficiently high contact force between the two clamping portions and the leg spring is little loaded due to a low degree of elastic deformation and therefore very durable, but there are some disadvantages.

Thus, the use of the leg spring requires a comparatively complex and difficult production process for the winding of the spring, which must be done without cracking of the spring material. There is also the possibility of one

Overwinding of the leg spring, whereby the contact force between the

Clamping sections reduced. Overall, therefore, the production of the leg spring requires a high degree of precision to produce instruments whose properties (contact pressure, durability, reliability, etc) within a tight

Tolerance range are. The reject rate is therefore correspondingly high. All mentioned and other disadvantages of the known surgical clip ultimately result in a comparatively high price for the surgical clip. A further prior art according to DE 20 2010 008 714 U1 discloses a surgical clip having two clip branches which extend parallel to one another without crossing each other and which are connected to one another in their respective center regions by a web-shaped bending spring. The clip industries are

Consequently, extended beyond the spiral spring in the longitudinal direction and thus form two clamping sections on one side of the spiral spring and two

Actuating leg / sections on the other side of the spiral spring, about the principle of a well-known clothespin. Accordingly, if the two actuating sections are pressed against one another on one side of the web-shaped bending spring, the two clamping sections move on the other side of the

Bending spring away from each other and vice versa.

This surgical clip is made of a single part, for example as a stamped or laser part and is thus relatively inexpensive in terms of its production. By punching or laser cutting process, in contrast to the clip described above, the production is essentially carried out by machine and thus extremely precise. The bending and spring force curves are reproducible even in large quantities without any effort within a relatively tight tolerance. This can easily be achieved a high quality standard. But even this solution has disadvantages.

Although the spiral spring has an open ring shape bulging toward the operating portions, the deformation path / degree of the spiral spring is comparatively large in normal use, so that the spring can fatigue quickly. In addition, the bending stress against the leg spring is much higher, which also spring breaks are possible more often. This ultimately results in a lower operating safety and operating life compared to the leg spring.

Finally, there have been efforts in the prior art to arrange the ring or U-shaped bending spring at the respective one outer ends of the clip branches, so that clamping and operating sections of each clip branch come to lie on one and the same side of the spring and thus have the same direction of movement in the operation of the clip (and not opposite to the

the aforementioned prior art). In this case, a spreading of the Clips by pulling the operating sections and not by their compression, as in the aforementioned prior art. As a result, the clip becomes unwieldy / unergonomic, significantly reducing its range of use. Alternatively, it is basically possible to intersect the branches, so that compression of the actuating sections causes the clamping sections to open. But even in this case, at least the

Preload force of the spring proved to be relatively low, so that the material thickness of the spring had to be increased. The clip therefore receives a total of such a large size that it is suitable only for special purposes.

In view of this problem, it is the object of the present invention to provide an inexpensive surgical clip with improved properties. One goal here is that the clip has a high level of operational reliability and is as versatile as possible. Another / other goal is that the clip at

In addition, the clip should preferably have an (integrated) protection mechanism against mechanical overload, for example, as a result of improper handling.

This object is achieved by a surgical clip having the features of claim 1. Advantageous embodiments of the invention are the subject of

Dependent claims.

A basic idea of the invention consists in principle in a bending spring or

Biegefederanordnung to use, the total spring length largest possible

for example, by plastic / permanent folding or bending (plastic

Deformation during the manufacturing process) of the spiral spring or by

(preferably fold-like) serial arrangement of single springs one

Expand bending spring arrangement. Another or additional basic idea of the invention provides that the bending spring or the spiral spring arrangement extends at least partially from the operating sections of the clip branches inwards, ie in the direction towards the clamping sections. In this way, the degree of bending of the spiral spring / spiral spring arrangement or the individual springs can be reduced and thus the reliability can be increased. Also, due to the use of bending springs a sufficiently high biasing force can be achieved without the surgical clip must be structurally enlarged / extended.

The surgical clip according to a particular aspect of the invention consequently has two clip branches, each consisting at least of a clamping section and an actuating section, as well as a spiral spring arrangement, via which the two clip branches, in particular their actuating sections, are integrally coupled to one another. The spiral spring arrangement forms at least functionally and / or constructively two spring limbs or arms which are serially connected to each other so that the spiral spring arrangement (in a middle section) forms a kind of (pointed) sweeping form (near 180 °). These at least two spring arms are further aligned / arranged on the clip so that the turn points towards the clamping portions. In other words, according to the invention results in a spiral spring or spiral spring arrangement, which forms at least one along the clip branches in the direction of the clamping sections extending (pointed) turn or indentation.

By this technical measure, the bending distance of the spring (i.e., the effective Gesamtfederarm length) is increased and thus their degree of deformation or the

Deformation degree of the individual spring arms reduced. However, the overall dimension of the clip is not or only slightly increased (extended), since the (pointed) turn does not extend in the direction away from the clamping portions, as in the prior art, the case, but in the opposite direction. In this way, a high biasing force at low risk of breakage and compact design can be achieved, so that the application of the clip is extended due to this compact design. Because the clip also has a spiral spring (essentially two-dimensional) and no spiral or leg spring with complicated

(Three-dimensional) geometry used, its production can be done easily and therefore inexpensively.

It is advantageous if the functional and / or constructive at least two serially arranged spring arms of the spiral spring or spiral spring arrangement (in their

Plan view) form a U, C, W or V-shaped floor plan, which consequently the Basic form of the (Spitz-) turn represents. Such a simple geometric basic shape is easy and precise to manufacture and thus contributes further to the cost reduction. It should be noted at this point that other (pointed) Kehrformen such as a TT or Ω-shape are possible or the above basic forms by more

Subforms such as corrugated or formed in zig-zag form spring arms are superimposed, whereby the effective spring length per spring arm can be further increased.

According to another or additional aspect of the invention is the

Biegefeder / spiral spring arrangement of the surgical clip via their spring legs / - arms integrally connected to the axial free ends of the operating sections of the two industries. This achieves a particularly favorable introduction of bending force into the spiral spring (without additional leverage).

It should be noted here that the actuating portion of each clip industry can be rigid or at least over a partial stretch (or completely) resilient and thus form part of the spiral spring arrangement. In other words

expressed there is the possibility of bending spring / spiral spring arrangement

functional / constructive with two spring arms (as described above), such that the free ends of the spring arms in a direction away from the

Extend clamping portions of the clip industries. In this case, the free ends of these two spring arms with the rear end portions / ends of

Operating sections connected. Now, when the operating portions are manually compressed, these two spring arms undergo elastic bending deformation along their arm length, i. the (pointed) turn is spread elastically. Of the

Deformation degree of the spiral spring arrangement results accordingly exclusively from the total length of these two spring arms in the case of relatively rigid

Operating portions.

But it is also possible to make the operating sections at least over a partial length or completely elastic, i. aware of an elastic

Assign deformation in the normal operation case. In this case, a bending spring or a spiral spring arrangement results with the two above-mentioned spring arms, to each end of which another bending spring arm connects in series, so that a W-shaped spiral spring arrangement (with 4 individual springs) is formed in the plan view. The orientation of the spiral spring arrangement remains unchanged. That is, the two outer spring arms now form at the same time the operating sections or at least a part thereof, wherein the free (rear) ends are serially coupled to the (pointed) turn defining spring arms. In this way, the degree of deformation of each spring arm can be further reduced.

Another or additional aspect of the invention provides that the spiral spring at the outermost region of the (pointed) turn forms a connecting web, which connects the at least two spring arms at their respective one, the clamping portions facing each other, wherein the connecting web via the connection points with the spring arms out in the direction of the two operating sections of the

Clip branches protrudes. This results in the spring outline in about a ττ-shape, as already mentioned above by way of example. This structural measure can reduce voltage spikes in the transition areas of the spring legs / arms and thus further reduce the risk of breakage. This measure can be supported optionally by the formation of a rounding on the connecting web in the transition region between the two spring arms, which prevents or reduces a notch effect.

According to another or additional aspect of the invention, the clip of the straight sector type is preferably an aneurysm clip whose two opposing clamping sections at least partially each have a straight extending beam preferably with tooth or Riffelungsbesatz.

It is advantageous here if the two rear, the operating sections respectively facing ends of the two (straight) beam are extended to two intermediate pieces, which move in an angle or in an arc to the respective (straight) beam to each other and thereby loose (without swivel joint). In this way, as known from the prior art, a kinematic reversal of the movement sequences between the actuating portion and the clamping portion can be achieved. That is, the two actuating portions are compressed, spread the clip industries in the region of the clamping sections and vice versa. It is also advantageous if the two opposing intermediate pieces each pass at an obtuse angle or in a reversal of the arc in the two operating sections of the clip industries, which now in

Direction to the rear free ends approach each other. As a result, an ergonomic shape is achieved in which the operating sections can be gripped more easily with one hand. In addition, this is between the

Actuation sections created a distance into which the at least one (pointed) turn or indentation of the spiral spring arrangement can extend.

Another or additional aspect of the invention provides that the connecting web forming at the end of the (pointed) turn and, in particular, its end extensions extending toward the two actuating sections, each form or have a stop which, when the clip is fully open, i. when pressed together actuation sections abut against these and thus prevent further opening of the clip. This is a structurally simple measure against overstretching of the spiral spring and thus protection against

Material fatigue or spring break is.

The surgical clip according to the invention according to another or additional aspect is a sheet metal component, which is preferably processed by punching or laser cutting. The spiral spring can also be made of a separate spring steel and be integrally connected to the two clip industries preferably by soldering or welding. Alternatively, the surgical clip may be made in one piece from a single material, e.g. be heat treated in sections according to its function.

Finally, according to another or additional aspect of the invention, it is provided that the clip industries intersect loosely, with the Kiemmund actuating sections functionally arranged on one and the same side of the spiral spring, so that an agitation (compression) of the actuating sections moves away from each other ( Open) causes the clamping portions. This construction is simple and thus inexpensive to produce, since only a few additional

Forming of the punched, cut, lasered or water jet cut sheet are required. The invention will be explained below with reference to a preferred embodiment with reference to the accompanying figures.

1 shows a surgical clip (or tissue clip) of the straight sector type according to the invention, for example, for use as an aneurysm clip in construction position and thus tension-free,

Fig. 2 shows the surgical clip of FIG. 1 in (cocked) clamping position (hereinafter referred to as rest state) and

3 shows the surgical clip according to FIG. 2 in (further tensioned)

Open position (hereafter referred to as enrichment state)

The surgical clip according to a preferred embodiment of the invention has two clip industries 1 each consisting at least of a clamping section 2 and an actuating portion 4 and with a clip branches connecting

Biegefeder or spiral spring assembly 6, which bends or bulges at least over a portion along the operating portions 4 in the direction of the clamping portion 2 is preferably U- or V-shaped.

The clamping portion 2 of each clip industry 1 according to FIG. 1 comprises a in

Substantially straight, elongated clamping beam 2a, which is occupied at one, the other clamping beam 2a facing side with a toothing or provided with a corrugation (not shown). But it can also be designed with a rough surface or just plain (unprocessed surface). The front free ends of each clamping bar 2a are rounded or provided with a protective cap to prevent injuries. In addition, each clamping bar 2a may be provided or formed with a reinforcing strip preferably on a side facing away from the other clamping bar 2a side, which has a higher flexural rigidity each

Clamping bar 2a ensured at least in clamping or effective direction

The rear end of each clamping bar 2a is an extension or

Intermediate piece 2b of the clamping portion 2 extends, which is shown in FIG. 1 under a (obtuse) angle or under an arc away from the opposite clip industry 1, resulting in a continuously widening gap or distance between the two clip industries 1 in the axial region of the intermediate pieces 2b. At the rear end of each intermediate piece 2b joins axially to form an (obtuse) angle or continuation of the arc of the actuating portion 4 present in the form of an actuating beam 4a, such that the two opposite actuating beam 4a gradually approach in the direction of extent and thus the gap / Decrease distance.

In the embodiment shown, the actuating beam 4a are formed substantially straight and unprofiled. However, they may also have a longitudinal shape (e.g., slightly waved / curved) adapted to the human hand (fingers), or an actuating button (not shown) may be placed (soldered) on the actuating beams 4a.

According to the invention, the actuating beam 4a are designed to be flexible in bending. That is, the operation bars 4a are designed to elastically deform (bend) upon operation of the surgical clip. You are thus a part or

Alternatively, however, they may also be rigid over their entire length (that is to say not belonging to the spiral spring arrangement) or only over a partial length, preferably the rear beam area elastically and thus partially forming part of the spiral spring arrangement.

The free rear ends of the actuating beam 4 a go in each case to form a rounded fold 6 a in the bending spring or a further component (portion) of the spiral spring assembly over.

At this point, it should be noted that the surgical clip according to the

Invention in Fig. 1 is shown in construction position, i. in a position at the time of its manufacture in an untensioned condition. In this state, the two clip branches 1 extend substantially parallel to each other (without crossing), wherein the spiral spring arrangement 6 is located at the end of the operating sections 4. That Kiemmund operating sections 2, 4 are located functionally on one side of the

Biegefederanordnung 6. According to FIG. 1, each rounded fold 6a is followed by a (further) spring arm / spring leg 6b of the spiral spring arrangement 6 (in one piece) which, in the construction position shown, is substantially parallel to one another within that of the opposite intermediate pieces 2b and actuating beams 4a of both clip branches 1 defined gap / distance along or axially back toward the clamping portions 2a extend. In the present case, the two spring arms 6b extend up to the level of the transitions from the two intermediate pieces 2b to the actuating beams 4a and are connected to one another there by a connecting or transverse web 6c. The bending spring 6 thus receives in this subsection in principle the floor plan form of a (inwardly directed) hairpin preferably in a U-shape, although other forms are conceivable, as the beginning of the

Description were briefly named.

In the present embodiment, the crosspiece 6c beyond the connection points with the spring arms 6b out in the direction of the clip industries or the

Operating sections 4 extended. In addition, the crossbar 6c on its the struts 6b facing longitudinal side a rounding or part-circular

Notch between the joints with the struts 6b on. Both design measures are used to reduce notch effects and to avoid a spring break at least in the context of the intended deformation movements. In addition, the crosspiece 6c can thereby obtain a resilient property, which is then added to the spring arms 6b in serial sage. It should be mentioned here that the spiral spring or its spring arms 6b forming the hairspring are, in principle, also extended further in the direction of the clamping bars 2a

can / as long as between the clip industries 1 a sufficient distance for the bending spring 6, i. the hairpin is made. It is crucial that the recovered length of the spring arms a spring break is counteracted in normal use, without extending the clip in its outer dimensions excessively and while maintaining a sufficient clamping force.

But the crosspiece 6c also has another function. As stated above, the crosspiece 6c is extended beyond the connection points with the spring arms 6b in the direction of the two operating portions 4, thus forming two abutment projections or pins. The length of the crossbar 6c is dimensioned so that upon actuation of the clip, ie at (elastic) compression of the operating portions 4 for opening / spreading of the clamping portions 2, the actuating beam 4a at a predetermined opening degree abut against the cross bar 6c, thus a blocked further compression movement. In this way it is prevented that the spiral spring arrangement is overstretched and damaged.

The pivoting movement of the two clip branches (in the opening and closing direction) is also determined by the shape and material thickness of at least the two spring arms 6b and the cross bar 6c and preferably also the two actuating bar 4a in particular if they are provided resiliently over the whole or only partial beam length are and thus belong to the spiral spring assembly 6 accordingly. Are the spring arms 6b and the actuating beam 4a comparatively elastic and the transverse web 6c rigidly formed (as provided in the present example), results in a substantially orbital pivotal movement of the two clip industries 1 along a pivoting backdrop. That is, in this case, the clip has not only one fulcrum but a plurality of corresponding ones

Pivots, resulting in an individual movement mechanics.

If, on the other hand, the spring arms 6b forming the hairspring are relatively elastic and the actuating beams 4a are made more rigid for this purpose, the pivot point shifts into the region of the transverse web 6c. The pivoting movement of the two clip industries 1 is in this case rather hinged around a pivot point.

2 and 3, the clip according to the invention is shown fully assembled in the closed and open position. Consequently, the clip is provided according to Scherenart so that the two intermediate pieces 2b cross over loosely, so that a

Compressing the actuating beam 4a causes a spreading of the clamping bar 2a. The spring assembly 1 closes almost seamlessly ie in extension of the actuating beam 4a to the clip industries 1 at. This results in a continuous line which is particularly suitable for one-piece production of the clip. Therefore, the clip according to the invention as a sheet metal part of a single material For example, prepared by punching or lasering in the form shown in Fig. 1 and then cured at least in the intended as bending springs areas to obtain a certain spring elasticity. Alternatively, it is also possible to make the spring assembly at least consisting of the hairspring forming the hairspring 6b (including the cross bar 6c) or together with the actuating bar 4a separately to the clamping portions 2 made of a spring steel (through

Cutting, punching or lasers) and then to connect with the clamping portions 2, for example by brazing.

We summarize a surgical clip with two clip industries 1 each consisting of a preferably straight extending (beam-shaped) clamping portion 2 and an actuating portion 4 and with a

Biegefederanordnung 6, via which the two clip industries are integrally coupled together. According to the invention, the spiral spring arrangement 6 is at least

partially arranged (in the middle) so arranged and shaped that they are between the clip industries 1 along the operating sections 4 in the direction of the

Clamping sections 2 bulges. The spiral spring assembly 6 is independently constructed by a number of serially coupled single spring arms. The clamping portion is preferably defined as that axial portion of an industry, which in a movement of the associated (adjoining) actuating portion toward the opposite operating portion from the opposite

Clamp section removed. The pivot point of the two branches is defined by the spring arms of the spiral spring arrangement, which are the two

Connect clip industries and preferably in addition by the operating sections that are at least over a partial length or completely elastic.

Claims

claims

1 . Surgical clip with two clip branches (1) each consisting of one

Clamping section (2) and an actuating portion (4) and with a

Biegefederanordnung (6), via which the two clip industries (1) are integrally coupled together, characterized in that the

Biegefederanordnung (6) at least partially between the

Clip branches (1) along the operating sections (4) towards the

Flared clamping sections (2).

2. A surgical clip according to claim 1, characterized in that the

Biegefederanordnung (6) of a plurality of serially coupled

Spring arms is constructed.

3. Surgical clip according to claim 1 or 2, characterized in that the spiral spring arrangement (6) forms in its bulging portion of a hairpin with preferably a U-, C-, V- or W-shaped floor plan.

4. Surgical clip according to one of claims 1 to 3, characterized in that the spiral spring arrangement (6) in the region of the bulge at least two spring arms (6b) which integrally with the axial free ends of the

Operating sections (4) of the two clip industries (1) are connected.

5. A surgical clip according to claim 4, characterized in that the

Biegefederanordnung (6) has a connecting web (6c) which connects the at least two spring arms (6b) at one, the clamping portions (2) facing each other, wherein the connecting web (6c) a stop for the actuating portions (4) for limiting their

Operating path forms.

6. A surgical clip according to claim 5, characterized in that the

Connecting web (6c) beyond the connection points with the spring arms (6b) out in the direction of the two operating portions (4a) of the clip branches (1) protrudes to form an actuation limit stop.

7. Surgical clip according to one of the preceding claims, characterized in that the clip is of the straight branch type, the two opposing clamping portions (2) each having a straight extending clamping bar (2a) preferably with toothed or Riffelungsbesatz.

8. A surgical clip according to claim 7, characterized in that the two rear, the operating portions (4) respectively facing ends of the two clamping bars (2 a) are extended to two intermediate pieces (2 b), which in the design position of the clip at an obtuse angle the respective

Clamping bar (2a) extend away from each other.

9. Surgical clip according to claim 8, characterized in that the two opposing intermediate pieces (2b) each pass at an obtuse angle in the two actuating portions (4) which approach each other in the direction of the rear free ends.

10. Surgical clip according to one of the preceding claims, characterized

characterized in that the two actuating portions (4) each form an actuating beam (4a), which is resilient over its entire length or part length, as further serially arranged spring arms of the

Biegefederanordnung (6) to serve.

1 1. Surgical clip according to one of the preceding claims, characterized

in that the clip is a sheet metal component, which is preferably produced by punching or laser cutting.

12. Surgical clip according to one of the preceding claims, characterized

in that the spiral spring arrangement (6) is made of a spring steel separately from the clip branches (1) and connected to the two clip branches (1) in one piece, preferably by soldering or welding.

13. Surgical clip according to one of claims 1 to 1 1, characterized in that the clip is made in one piece from a single material.

14. Surgical clip according to one of the preceding claims, characterized

characterized in that the clip branches (1) extend in a loosely crossed manner, such that the clamping sections (2) and the functional parts are functionally connected

Operating sections (4) on the one side of the common

Arrange bending spring assembly (6), wherein a move toward each other of the actuating portions (4) causes a movement of the clamping sections (2) from each other.