EP2691031A1

EP2691031A1 - Surgical clip applicator

Info

Publication number: EP2691031A1
Application number: EP12708316.0A
Authority: EP
Inventors: Peter Schulz; Pedro Morales; Dieter Weisshaupt
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2011-03-31
Filing date: 2012-03-09
Publication date: 2014-02-05
Also published as: US9468440B2; AU2012237307B2; JP5963782B2; AU2012237307A1; DE102011001706A1; WO2012130589A1; JP2014514001A; US20140005696A1

Abstract

The aim of the invention is to economically produce a surgical clip applicator (10) for U-shaped or V-shaped clips (66, 70), that enables the clips to be securely closed when applied to tissue structures, especially also for double-webbed or multiple clips. To this end, the applicator comprising a grip part (12), a shaft (18a, b) connected to the grip part, a clip application tool arranged on the free end of the shaft, and a clip cartridge (14). The application tool comprises a tongs-type part (20) comprising jaws for holding a clip during the application thereof, and a closing device (21) for moving the jaws from an open idle position to a closed position, the tongs-type part being produced from a plastic material and held on the clip applicator in such a way that it is separated from the closing device.

Description

Surgical clip applicator

The invention relates to a surgical clip applicator with the typically substantially U- or V-shaped clips on tissue structures of a patient, such as a blood vessel, created and then closed.

The surgical clip applicator has a grip part, a shaft adjoining the grip part, a clip application tool arranged at the free end of the shaft, and a clip magazine in which a plurality of U-shaped or V-shaped clips are stored, which are attached to the clip clip. Application tool can be supplied sporadically.

The application tool has a jaw part with tool jaws for holding a clip when applying and a closing device for transferring the tool jaws from an open rest position to a closed position in which the clips are closed and then adhere to the tissue structure or the blood vessel and close the latter.

The clip magazine is often held interchangeably on the clip applicator, as is known for example from DE 196 03 889 AI. There, a clip applicator with replaceable clip magazine is disclosed in which the handle part with the applicator shaft and the clip application tool is used several times, while the clip magazine is used only once and disposed of after consumption of the clip supply. The remainder of the applicator can be re-fitted with a fresh clip magazine after sterilization and reused.

Due to the harsh conditions of sterilization, it may sometimes come to deformations of clip guideways on which the clips are individually fed to the clip application tool, and / or the application tool, which then in the sequence, for example, a clip jam is caused or Clips fall out of the applicator before they are fed to the application tool. The clip applicator must then be repaired. The clip magazine used at this time with its clip supply can then no longer be used.

A clip applicator is described in EP 0 793 944 B1, in which not only the clip magazine but also the jaw part can be exchanged if necessary. The problem with this applicator is that the need for the replacement of the jaw part can only be detected when a clip is applied by the test, or possibly. only during an operation on the patient. In such a case, the clip applicator must be repaired, which means that the clip magazine with the remaining clips must be discarded and then the jaw part replaced, the instrument must be sterilized and equipped with a new clip magazine before it is reusable.

According to US 2005/0256529 AI, an applicator with a reprocessable handle part and an interchangeable with the handle part disposable clip magazine is proposed in which the jaw part is exchanged from steel together with the clip magazine. Here the jaw part is exchanged with the used magazine each time and with each clip magazine also a new jaw part is supplied, so that the application disturbances, which were described before, are prevented. However, the manufacturing costs of such disposable clip magazines with steel jaws are relatively high.

Another alternative is described in U.S. Pat. Patent 4,296,751, in which the complete applicator is designed as a disposable article. For cost reasons, there is also proposed to form the jaws of the jaw part of plastic or metal reinforced plastic.

A disadvantage of this embodiment is that the plastic, even if it is reinforced with metal, does not provide satisfactory results when closing the clips, since the closing forces applied by the plastic Zan baking can only be transferred insufficiently. Double bar or multiple clips can not be processed with such applicators, since the necessary closing forces can not be transferred here.

The object of the present invention is to propose a clip applicator which on the one hand can be produced economically and on the other hand permits secure closing of the clips when applied to tissue structures, in particular also in double-web or multiple clips.

This object is achieved by a surgical clip applicator with the features of claim 1.

Due to the production of the jaw part made of a plastic material, a cost-effective production of only once to be used parts of the clip applicator is possible. On the other hand, the high-quality manufactured components, in particular those made of steel, such as the grip part and the locking device, are reusable and thus further contribute to the economy of the surgical clip applicator according to the invention.

Due to the separate production of the jaw part, moreover, the plastic material for the particular requirements can be specially designed and selected, so that this then the mechanical requirements that result in particular from the closing of the clips and the necessary effort required can take into account.

In this context, the plastic materials are in particular selected from polyolefins, polycarbonate, polyamide, polyetheretherketone, polyphenylene sulfide, polyetherimide and liquid-crystalline polymers.

These polymers can then be fiber-reinforced, in particular glass fiber-reinforced, wherein the fiber content is in particular in the range of about 20 to about

60 wt .-%, more preferably about 30 to about 50 wt .-% is. Such plastic jaws can be injection molding in particular and are therefore the most cost-effective to produce. These are not only suitable for closing so-called single-leg clips, but also for double-bridge clips, where the deformation forces that must be applied to securely close the clip are almost doubled.

To be particularly favorable, it has been found to form the jaw part fork-shaped with two substantially parallel branches, which carry at the free ends tool jaws, which are in particular integrally formed on these and in particular formed by injection molding.

Fork-shaped jaw parts also have the advantage that the jaw part opens elastically again and brings the tool jaws in the open rest position, without further structural elements would support this. This reduces the number of parts for the production of the clip applicator according to the invention and thus also the Herste II cost.

A particularly preferred embodiment of the surgical clip applicator has a jaw part, in which the tool jaws are held pivotably on the jaw part industries. For this purpose, the jaw sections then have bearing elements which can be brought into abutment against one another on their regions adjacent to the tool jaws, which bearing elements adjoin one another to form a pivot bearing for the tool jaws. The bearing elements are arranged on the jaw sections on surfaces facing each other and are preferably formed self-centering.

In a further preferred embodiment of the invention, the jaw sections are provided with bulges on their outer surfaces opposite the tool jaws. These bulges stiffen the sections of the tool jaws and allow a safe application of the closing forces on the clips to be applied. In addition, these bulges allow the realization of a simple locking mechanism, in which the closing device comprises a slider which engages around the fork-shaped jaw part and which is displaceable parallel to the longitudinal direction of the jaw part from a first, proximal position to a second, distal position. The bulges of the jaw sections are then formed as scenes, which is engaged by the distal end of the slider and transferred when moving to the second position, the tool jaws in its closed position.

This feature leads, in particular in connection with the use of bearing elements at the transition region from the jaw sections to the tool jaws, to a mechanically very simple and efficient concept which, moreover, manages with low component thicknesses and thus a minimal outlay on material.

Preferred bearing elements are designed to be complementary, so that centering results when abutting one another. In particular, the bearing elements are designed as a pin and socket.

With regard to the interchangeability of the jaw part, it is preferred if this held on the clip magazine and is interchangeable with this. Thus, the clip magazine can be assembled together with the jaw part and packaged ready for use, so that the exchange of clip magazine and jaw part can take place in one operation and means no additional effort compared to the mere replacement of a clip magazine.

In such a case, then preferably also not yet discussed in detail tool for separating the clips and their supply to the jaw part of the application tool with replaced.

In a further embodiment of the invention, the clip magazine with the shaft and the locking device of the application tool as a structural Unit formed which is separable and replaceable connectable in one step with the handle part, so that only the mechanics of the handle part is reusable and the sterilization conditions must be subjected.

For a secure mounting of the clips, the tool jaws preferably have a receiving area into which the clip to be applied, after it has been supplied isolated to the application tool, is received.

The receiving area for the clip to be applied in each case has a contact surface for one of the legs of the clip, wherein the contact surface extends over at least part of the length of the legs and thus guides them.

Preferably, a clip applicator according to the invention has receiving areas in which adjoins the contact surface for the legs, in which a connection region of the legs or vertex of the clip is received in the closed position of the tool jaws.

This has the advantage that the receiving area widens at this point and thus the clips to be applied do not have to be completely pressed at the vertex to come between the legs to the required extent of the closing gap, which is typically 0.25 mm or less , in particular 0.07 mm to about 0.15 mm.

By avoiding excessive forces for pressing the vertex of the clip to be applied on the one hand reduces the force required by the surgeon who has to apply this to close a clip. On the other hand, the stress on the jaw parts made of plastic material is also reduced, so that in this case an optimization of the design or an optimization of the material selection in the plastic material can again be made here with material saving. Preferably, the contact surfaces in the region of the free ends of the legs of the clips are provided with a recess, so that the physical contact between the legs of the clip and the tool jaws is limited to the necessary area required for closing the clips. Due to the U- or V-shape of the clips, it is sufficient if these have contact with the tool jaws in the middle section of the legs, since due to the clip shape already a bias with respect to their free ends is achieved when closing.

Preferably, the contact surfaces are dimensioned so that the legs lie in the closed position of the tool jaws only with a central portion of the tool jaws, but in particular the legs over about one third of their length, in particular half their length or a little more in the closed position the tool jaws abut this.

In addition, the recesses of the receiving areas of the tool jaws have a depth perpendicular to the closing direction of the clip legs, which corresponds to approximately half the thickness of a clip leg or its diameter or more. In particular, the depth of the recess is approximately the thickness or the diameter of the leg of the clip.

The thickness of a clip leg is understood to mean its extent in the direction of the closing direction of the clip.

Preferably, for the length of the recess which receives the connecting portion of the clip legs, approximately twice the diameter or the thickness of a clip leg or more is selected parallel to the longitudinal direction of the clip leg.

More preferably, the length of the recess about four times the diameter or the thickness of a clip leg or less is selected. This ensures that the clip is securely fixed in position between the tool jaws of the clip applicator even under load.

In a further preferred embodiment of the clip applicator according to the invention, the contact surfaces are provided with a guide element which ensures the alignment of the clips to be applied in the tool jaws.

For single or single-leg clips this guide element is often designed as a groove. In so-called double-bridge clips, the guide element may comprise a projection which comes to lie on one side of the clip between the legs lying parallel, thus providing orientation and guidance of the double-bridge clips. The same applies to clips with, for example, three parallel legs.

These and other advantages of the invention will be explained in more detail below with reference to the drawing. They show in detail:

Figure 1: a clip applicator according to the invention;

FIG. 2 shows the clip magazine of the clip applicator from FIG. 1, separate from the grip part, from below in a partially disassembled state;

FIG. 3: the clip magazine of FIG. 2 completed and with the jaw part attached;

FIG. 4 shows the jaw part from FIG. 3;

FIG. 5 shows an alternative jaw part of a clip applicator according to the invention, held on a clip magazine; and Figures 6A and 6B: a schematic representation of the jaw part of Figure 4 in the rest and closed position.

Figure 1 shows a clip applicator 10 according to the invention with a handle portion 12 and a separated from the handle portion 12 clip magazine 14. The clip magazine 14 is releasably connected to the handle portion 12 releasably connectable, so that it consumes the stock in the magazine clips can simply be replaced by a new magazine.

The clip magazine 14 comprises, in addition to a mounting and holding device 16 with which the clip magazine 14 can be fastened on the handle 12, a shaft part 18a and at its free end a jaw part 20 as part of the clip application tool of the applicator.

The handle part integrally contains a part of the shaft 18b in which a closing device 21 is received as part of the application tool of the applicator 10. The closing device 21 is designed here as a slide whose distal end partially engages around the jaw part 20 in the mounted state.

FIG. 2 shows the clip magazine 14 from below in a partially disassembled state, so that the clip supply 22 arranged in the clip magazine 14 or its shaft part 18a is visible.

Furthermore, FIG. 2 shows a feed mechanism 24, with which, supported by the helical spring 25, the clips from the clip supply 22 can be individually fed to the application tool 20.

In Figure 3, the magazine 14 is still provided with a feed tongue 26 and finally the jaw member 28 is clipped from below, which is shown in detail again in Figure 4. The jaw part 28 is fork-shaped and has two parallel branches 30, 31, at the free ends of the tool jaws 32, 33 are integrally formed. At the transition region between the branches 30, 31 and the tool jaws 32 and 33 respectively, the branches 30, 31 have bearing elements 36, 37 which protrude in the form of pegs into the space between the two branches 30, 31.

The bearing elements 36, 37 are complementary, in the example of Figures 3 and 4, the bearing element 36 is concave at its free end inwardly, while the bearing member 37 is formed corresponding convex at its free end.

If the tool jaws 32, 33 approached from their open rest position shown in Figures 3 and 4 in a closed position, the bearing elements 36, 37 engage each other and center the tool jaws 32, 33 in correct alignment with each other. With an increase in the closing force on the tool jaws 32, 33, these are then approximated in a pivoting movement with their free ends until they reach the final closed position, wherein the bearing elements 36, 37, the pivot axis of

Define swivel movement.

On the upper side shown in Figure 4, the jaw part 28 in the proximal region of the tool jaws 32, 33 upwardly open guides 40, 41, which receive a supplied clip with its free legs.

The guides 40, 41 continue to the free (distal) end of the tool jaws 32, 33 as grooves 42, 43, in which a clip is held in its end position until it is applied.

The grooves 42, 43 have, as indicated in Figure 4 in a broken view, at its proximal end recesses 46, 47, in the connection areas or vertices of the clips to be applied with the there when the clip is closed, it can engage. This makes it possible to close the clips when applying, without completely compressing the area adjacent to the vertex of the clip to the required gap for the legs of the clip. As a result, the force required to close the clips is reduced, so that the stress on the jaw part made of plastic material is further minimized.

In order to realize a simple closing mechanism, the tool jaws 32, 33 are provided on their outer sides with recesses 50, 51, via which closing of the tool jaws 32, 33 can be accomplished by translatory movements of a slide (not shown in FIG. 4).

FIG. 5 shows an alternative embodiment of a jaw part 60 of a clip applicator according to the invention. The jaw member 60 is again fork-shaped with sectors 62, 63, at the free ends of the tool jaws 64, 65 are integrally formed. FIG. 5 shows the jaw part 60 with a clip supply 66 and a double-web clip 70 which is held in isolated fashion in the tool jaws 64, 65.

The embodiment of the jaw member 60 has a different construction of the bearing elements than the Mauteil 28. Here, the bearing elements are formed by simple flat contact surfaces 72, 73 and an articulated connection of the jaws 64, 65 with the industries 62, 63 is achieved in that these are formed on the inside of the fork-shaped jaw part with a recess 76, 77 are formed. For actuating the jaw part 60 or the tool jaws 64, 65 for applying and closing the clip 70, a slide 78 which engages around the branches 62, 63 with its distal end region 80 is actuated. If the slide 78 is pushed from its first position shown in FIG. 5 in the direction of the free end of the jaw parts 64, 65, the jaw parts 64, 65 are pivoted about the pivot axes formed by the recesses 76, 77. wherein the bulges 82, 83 of the jaw members 64, 65 serve as a backdrop for power transmission.

This closing mechanism is shown in more detail with reference to FIGS. 6A and 6B with reference to a schematic illustration of the jaw part 28 and a slide 90.

FIG. 6A shows the jaw part 28 in the open rest position of the tool jaws 32, 33, the slider 90 of the associated closing mechanism remaining in its first proximal position.

The distal end 92 of the slider 90 is located at the transition region of the branches 30, 31 to the jaws 32, 33 in which the bearing elements 36, 37 are arranged. In this position, a clip (not shown) on the guides 40, 41 are pushed into its end position between the tool jaws 32, 33.

For application of the clip, the slider 90 is moved from its proximal position to a distal position shown in FIG. 6B with the distal end 92 sliding along the protrusions 50, 51, thereby approaching the tool jaws 32, 33 until the bearing elements 36, 37 come into contact with each other. The force Fl exerted by the slider counteracts the force F2 resulting from the resistance caused by the clip when closing.

A further translational movement of the slider 90 to the distal position then causes a pivoting of the tool jaws 32, 33 about the pivot bearing formed by the bearing elements 36, 37. The finally reached end position of the slider 90 is shown in Figure 6B, in which the tool jaws 32, 33 remain in a closed position in which the distal ends of the tool jaws are aligned substantially parallel to each other and the clip (not shown in FIG. 6B) is applied to a tissue structure of a patient, for example a blood vessel.

Claims

claims

A surgical clip applicator for substantially U- or V-shaped clips, wherein the applicator comprises a handle portion, a handle adjoining shaft, a free end of the shaft disposed clip-applying tool and a clip magazine, wherein the application tool a jaw part with tool jaws for holding a clip when applying and a closing device for transferring the tool jaws from an open rest position into a closed position, characterized in that the jaw part is made of a plastic material and held separately from the closing device on the clip applicator.

2. clip applicator according to claim 1, characterized in that the plastic material is a fiber-reinforced, in particular a glass fiber reinforced plastic material, wherein the fiber content is in particular about 20 to about 60 wt .-%, more preferably about 30 to about

50% by weight.

3. clip applicator according to claim 1 or 2, characterized in that the plastic material is selected from polyolefin, polycarbonate, polyamide, polyetheretherketone, polyphenylene sulfide, polyetherimide, and liquid crystalline polymers.

4. clip applicator according to one of claims 1 to 3, characterized in that the jaw part is fork-shaped with two substantially parallel branches and carries at the free ends of its branches tool jaws, which are in particular integrally formed on these.

5. Clip applicator according to claim 4, characterized in that the

Tool jaws are held pivotally on the jaw sections, wherein the jaw part industries preferably comprise two bearing elements which can be brought into contact with the closed position during the transfer of the tool jaws from the open rest position, which bearing elements bear against one another a pivot bearing.

6. Clip applicator according to claim 4 or 5, characterized in that the jaw sections have on their outer surfaces opposite the tool jaws bulges.

7. clip applicator according to claim 6, characterized in that the

Closing device comprises a slider which engages around the bifurcated jaw part and which is displaceable parallel to the longitudinal direction of the jaw part from a first, proximal position to a second, distal position, and that the bulges of the jaw sections are formed as scenes, to which the distal end of the slider engages and transferred when moving to the second position, the tool jaws in their closed position.

8. clip applicator according to one of the preceding claims, characterized in that the jaw part is held on the clip magazine and is interchangeable with this.

9. clip applicator according to one of claims 1 to 7, characterized in that the clip magazine with the shaft and clip-applying tool forms a structural unit and is separable and replaceable in one step from the handle part.

10. clip applicator according to one of claims 1 to 9, characterized in that the tool jaws have a receiving area for a clip to be applied.

11. Clip applicator according to claim 10, characterized in that the receiving areas for the clip to be applied in each case have a contact surface for one of the legs, which extends over at least part of the length of the legs, and a recess in which a connection area the leg of the clip is arranged in the closed position of the tool jaws.

12. Clip applicator according to claim 11, characterized in that the contact surfaces in the region of the free ends of the legs have a return jump and are preferably dimensioned so that the legs rest in the closed position of the tool jaws with only a central portion of the tool jaws In particular, the legs abut over approximately half their length or more in the closed position of the tool jaws.

13. Clip applicator according to claim 1 or 2, characterized in that the recess has a depth perpendicular to the closing direction of the clip leg, which corresponds approximately to the diameter or the thickness of a clip leg or more.

14. Clip applicator according to claim 13, characterized in that the length of the recess parallel to the longitudinal direction of the clip leg corresponds approximately to twice the diameter or the thickness of a clip leg or more.

15. Clip applicator according to claim 14, characterized in that the length of the recess corresponds approximately to four times the diameter or the thickness of a clip leg or less.

16. Clip applicator according to one of claims 11 to 15, characterized in that the contact surfaces comprise a guide element.

17. Clip applicator according to claim 16, characterized in that the guide element comprises a groove.

18. Clip applicator according to claim 16, characterized in that the guide element comprises a projection.