PARTLY RESORBABLE TISSUE CLIP

Abstract

The invention relates to a partly resorbable tissue clip for stapling tissue, comprising at least one gripping tooth that grips the tissue, at least one force deflecting element that is equipped with at least one gripping tooth, and at least one spring element that is connected to the at least one force deflecting element; the at least one gripping tooth or a portion of the at least one force deflecting element or of at least one of the force deflecting elements is made of bioresorbable material.

Claims

1. A partly resorbable tissue clip, comprising: at least one gripping tooth configured to grip tissue, at least one force discharge element which is provided with the at least one gripping tooth, and at least one pretensioning element which is connected to the at least one force discharge element in order to place, via the at least one force discharge element, a biting force on the at least one gripping tooth, wherein the at least one gripping tooth is constructed from biologically resorbable material, a part-region of the at least one force discharge element is constructed from biologically resorbable material, and the at least one gripping tooth and the part-region of the at least one force discharge element are connected to each other in an integral manner by means of a connection plate which is retained in a positive-locking manner on the at least one force discharge element.

2. The partly resorbable tissue clip of claim 1, wherein the at least one tissue clip with the exception of the portions according to claim 1 is produced from a non-biologically resorbable material.

3. The partly resorbable tissue clip of claim 2, wherein the non-biologically resorbable material is nitinol.

4. The partly resorbable tissue clip of claim 1, wherein the portion of the tissue clip which is produced from a non-biologically resorbable material is produced in an integral manner, preferably with an injection-moulding, punching or laser cutting method and preferably forms a frame construction.

5. The partly resorbable tissue clip of claim 1, wherein the biologically resorbable material is a copolymer comprising, poly lactic-co-glycolic acid (PLGA), hydroxyapatite (HPA), beta tricalcium phosphate, tricalcium phosphate (TCP) or polylactide.

6. The partly resorbable tissue clip of claim 1, wherein as a result of the selection of the biologically resorbable material or the variation of the composition of the biologically resorbable material, the time course of the resorption and consequently the clamping force of the tissue clip can be determined.

7. The partly resorbable tissue clip of claim 1, wherein the biologically resorbable material contains medical active ingredients which are locally released over time by means of resorption of the material or diffusion from this material.

8. The partly resorbable tissue clip of claim 1, wherein the portion which is produced from biologically resorbable material is connected to the portion produced from non-biologically resorbable material in a positive-locking manner, frictionally engaging manner and/or by means of adhesive bonding.

9. The partly resorbable tissue clip of claim 1, wherein the portion of the at least one force discharge element which is produced from biologically resorbable material is constructed substantially as a flat plate, whose longitudinal axis preferably extends parallel with a clamping slot formed by the gripping teeth for tissue.

10. The partly resorbable tissue clip of claim 1, wherein the portion of the at least one force discharge element which is produced from biologically resorbable material is constructed as two flat plates which are arranged beside each other and whose longitudinal axes extend parallel with a clamping slot formed by the gripping teeth for tissue.

11. The partly resorbable tissue clip of claim 1, wherein the portion of the at least one force discharge element which is produced from biologically resorbable material is held in position by means of at least one clip which is produced from a non-biologically resorbable material.

12. The partly resorbable tissue clip of claim 1 , wherein the portion of the at least one force discharge element which is produced from biologically resorbable material at the side thereof facing the gripping teeth reproduces a zig-zag shape of the gripping teeth whilst, at the side thereof facing an outer edge of the force discharge element, it reproduces the shape of the nearest outer edge of the force discharge element.

13. The partly resorbable tissue clip of claim 1, wherein the portion of the at least one force discharge element which is produced from biologically resorbable material is constructed as two plates which are securely connected to each other and which are fitted from two outer sides to the portion which is produced from non-biologically resorbable material.

14. The partly resorbable tissue clip according to claim 13, wherein the two plates of the portion of the at least one force discharge element which is produced from biologically resorbable material are connected to each other via at least one pin which is produced from biologically resorbable material by means of medical adhesive, preferably cyanoacrylate.

15. The partly resorbable tissue clip according to claim 1, wherein the at least one gripping tooth is formed on a plate which is fixed to the at least one force discharge element in a planar manner.

Description

DESCRIPTION OF FIGURES

[0035] Other features and advantages of the present invention are illustrated by the following exemplary description of a particularly preferred embodiment of the invention based on the figures.

[0036] These are as follows:

[0037] FIG. 1a shows a perspective view of a partly resorbable tissue clip with gripping teeth made of bioresorbable material and FIG. 1b shows a view of the lower side of the tissue clip from FIG. 1a,

[0038] FIG. 2 shows a partly resorbable tissue clip in which a portion of each force deflecting element is configured as a flat cuboid made of bioresorbable material. FIG. 2 shows the view as a stamped part or laser-cut component made of a flat material. Further processing (embossment into a U profile) can create the functional shape, for example.

[0039] FIG. 3 shows a non-bioresorbable portion of a partly resorbable tissue clip in which a portion of each force deflecting element is configured as two flat cuboids arranged in series and made of bioresorbable material.

[0040] FIG. 4 shows a partly resorbable tissue clip in which a bioresorbable portion of a force deflecting element is configured as two dual-circle cuboids arranged in series and the bioresorbable portion of another force deflecting element is configured as two elements arranged in series which each run parallel to the clamp slit for tissue on their side facing the clamp slit for tissue and which run parallel to the outer edge of the force deflecting element on their side facing the outer edge of the force deflecting element.

[0041] FIG. 5 shows a partly resorbable tissue clip in which the bioresorbable portion of each force deflecting element is configured as a number of dual-circle cuboids, each of which is aligned with a gripping tooth, wherein the number of dual-circle cuboids is equal to the number of gripping teeth and the longitudinal axis of each dual-circle cuboid runs essentially at right angles to the clamp slit for tissue formed by the gripping teeth.

[0042] FIG. 6 shows a partly resorbable tissue clip in which a bioresorbable portion of a force deflecting element is configured in such a way that it replicates the zigzag shape of the gripping teeth on its side facing the gripping teeth, while on its side facing the outer edge of the force deflecting element it replicates the shape of the outer edge of the force deflecting element. The bioresorbable portion of another force deflecting element is configured as two plates made of bioresorbable material attached at the two outer sides to the portion made of non-resorbable material and permanently fixed to each other, wherein the two plates are connected to each other by three pins made of bioresorbable material by means of a medical adhesive, preferably cyanoacrylate, and secured on the non-bioresorbable portion.

[0043] In terms of its basic design, with the exception of the integration of clip areas made of resorbable material, a preferred tissue clip of this type is generally known. For the purpose of better understanding, this clip is described in more detail with reference to FIG. 1a, which shows a possible clip design allowing the realization of the invention.

[0044] On this basis such a clip 1 according to this preferred variant consists of a mouth-type clamp device with two toothed jaws (force deflection elements) 4 which can be opened and closed via two side hinges 3, 5, 6 or via flexible mouldings. The hinges 3, 5, 6 or the flexible mouldings are preferably made of spring-biased bands which save the spring energy when the jaws 4 are opened and which cause to the jaws 4 to snap closed with a predefined clamping force when the jaws 4 are released, i.e. when the hinges 3, 5, 6 or the flexible mouldings are triggered.

[0045] Specifically, each clip 1 is punched or lasered in a single piece from a spring steel sheet by carving a ring out of the spring steel sheet with a partially differing ring width. Two diametrically opposite ring sections with a large ring width form the two jaws 4 (force deflection elements), while the two ring sections in between with a narrow ring width form the hinges 3, 5, 6 or the flexible (elastic) mouldings (bending springs). In particular, each hinge in this case consists of a C-shaped spring section 6 which runs via angular deflections 3 into a connecting section 5, which in turn finishes at the relevant jaw 4. The jaws 4 are configured in that the ring sections with large ring width are additionally curved in arc-like fashion on their flat side so as to form a circle when in an open state. This particular shaping of the lasered spring steel sheet creates the shape of a shark's mouth with two rows of teeth moving towards each other, formed by lasering of the ring sections with large ring width.

[0046] The operating principle of the above-described medical tissue clip 1 can be described as follows:

[0047] Generally speaking, an endoscopic implantation of a medical device is a procedure which only slightly affects the patient overall. In this case, the medical device has to be fixed to a hollow organ from the latter's inner side. For this purpose, a number (at least one) of the above-described tissue clamps, clips or anchors are introduced by means of an endoscope or another, preferably shaft-like feeder tool into the hollow organ and placed at predefined places on the inside of the organ. To this end, the clip or anchor in question is introduced to the organ tissue and the preload spring is triggered for a closing of the clip or span the anchor. The latter then holds or clamps a tissue fold between its jaws or its hooks or needles with a predefined clamping or spreading force, wherein the teeth, hooks, needles or prongs of each jaw sink into the tissue and preferably penetrate it.

[0048] At this point it should be pointed out that the tissue clip to which the invention is applied does not necessarily have to take the basic form described above but can also be configured in a different way, e.g. in the shape of a ring clasp with a number of radially inwardly protruding teeth spaced apart from each other peripherally which are formed on spring elements grouped to form a closed ring. However, the invention will be described below based on the mouth-shaped tissue clip.

[0049] FIG. 1a shows a perspective view of the partly resorbable tissue clip 1, comprising, according to the invention, a portion 2 made of a bioresorbable material and a portion 3 made of a non-bioresorbable material. In this embodiment, the non-bioresorbable portion 3 is preferably made as a single piece out of nitinol and the bioresorbable portion is made of a copolymer consisting of lactic and glycolic acid (PLGA). The non-bioresorbable portion 3 relates to the two force deflecting elements/tooth racks/jaws 4 and the two spring elements 6, wherein the two force deflecting elements 4 are arranged parallel to each other and are each connected to one end of one of the two spring elements 6 at their two longitudinal ends via the connection element 5. On the side facing the other force deflecting element 4, each of the two force deflecting elements 4 exhibits a number of gripping teeth 7. In this example, the gripping teeth 7 are made of the bioresorbable material.

[0050] The portion 2 of the tissue clip 1 made of bioresorbable material consists in this case of two elements which each comprise a row of gripping teeth 7 and a plate 8 made of bioresorbable material on which the respective gripping teeth are formed. Each of the elements of the bioresorbable portion 2 is made as a single piece, preferably made of PLGA. Each plate 8 is arranged parallel to one force deflecting element 4 in each case and exhibits a recess in which the force deflecting element 4 is embedded. The gripping teeth 7, made as a single piece with the plate 8, protrude from each of the force deflecting elements 4 in such a way that between the two force deflecting elements 4, arranged parallel to each other, a clamp slit for tissue is formed into which the gripping teeth 7 protrude. For permanent connection of a plate 8 to one force deflecting element 4 respectively, the plate 8 comprises at its end facing away from the gripping teeth 7 a recess/material abrasion 8a (see FIG. 1b) in which the force deflecting element 4 is inserted. In order to attach the force deflecting element 4 in the recess, the plate 8 has on the recess surface a number of pins/pegs 9 which engage into the relevant cut-outs in the respective force deflecting element 4 and secure the plate 8 to the force deflecting element 4 by means of interlocking.

[0051] FIG. 1b shows the lower side/back of the tissue clip 1 shown in FIG. 1a. Here it can be clearly seen that the tissue clip 1 is composed of a single-section portion (clip frame) 3 made of non-resorbable material and a portion 2 made of bioresorbable material consisting of two elements, which are fixed to the non-resorbable clip portion 3. Each element of the bioresorbable portion is made as a single-section/unitary and exhibits the plate 8 and the number of gripping teeth 7 which protrude beyond the respective force deflecting element 4 and form the clamp slit 10 for tissue. In this depiction it can be seen that the plate 8 has in its section adjacent to the force deflecting element 4 a flat recess/material abrasion in which the force deflecting element 4 is embedded. The gripping teeth 7 and the plate 8 are made entirely of bioresorbable material. The recess in the plate 8 is configured such that the force deflecting element 4 embedded in the recess creates a continuous, smooth surface profile between the embedded force deflecting element 4 and each of the gripping teeth 7.

[0052] When such a tissue clip is used in practice, the teeth 7 penetrate into the patient tissue due to the spring force of the two spring elements 3, 5, 6 and become anchored there. In doing so, the gripping force extends beyond the plate 8 and the force deflection elements 4 as thrust forces, wherein the force deflecting elements 4 stabilize the plate 8 at the same time. When the absorbable material dissolves, at the end of the dissolving process only the non-absorbable clip portion is preserved whole, which can only exert a slight clamping force on the tissue. The clip can therefore easily detach itself from the tissue.

[0053] In order to improve the gripping effect of the gripping teeth 7, it can be advantageous to make the gripping teeth 7 from a non-bioresorbable material such as nitinol and instead, for the purpose of selective material weakening of at least one of the force deflecting elements, make at least one portion/area of this force deflecting element out of bioresorbable material.

[0054] Such a tissue clip 1 with gripping teeth 7 made of non-resorbable material is shown in FIG. 2. The portion 2 made of bioresorbable material is configured here as two elements which each take the form of a flat cuboid (rectangular plate) 15 and which are each embedded/inserted in one of the force deflecting elements 4. Each of the force deflecting elements 4 exhibits a cut-out/window opening which corresponds to the shape of an element of the bioresorbable portion 2 in which an element of the bioresorbable portion 2 is embedded. The cut-out in the force deflecting element 4 can be produced, for example, by selective etching or die sinking/sinker electrical discharge machining (this would preferably create a profile that is potentially still closed around a whole area here, but the profile could be very thin as compared to the material thickness of the remainder of the clip, making it significantly more flexibly deformable; the resorbable portion would then fill up/compensate for the thinness of the material) or simply be cut out of the force deflection elements 4 (this then creates an open, window-shaped through-hole). The longitudinal axis of each element of the bioresorbable portion 2 embedded in the force deflecting element 4 preferably runs parallel to the clamp slit 10 for tissue formed by the gripping teeth 7. The two longitudinal edges of each element of the bioresorbable portion 2 essentially run parallel to each other. Here, each element of the bioresorbable portion 2 is formed in such a way that between each short edge of each element and the nearest short edge of the force deflecting element in which the element is embedded there is only a thin bar 11 made of non-bioresorbable material (formation of a frame structure in the respective force deflection element).

[0055] Once the bioresorbable portion 2 of the tissue clip 1 has been resorbed, the entire clamping/gripping force is applied to the thin bars between the window openings, which are elastically deformed/buckled as a result. As a result there is a decrease in the clamping force applied by the tissue clip 1 to the tissue and the tissue clip 1 detaches itself from the tissue. In order to reinforce this effect, the thin bars 11 can be made of nitinol or a material with a particularly high nitinol content. The thin bars 11 also prevent the clip from falling apart into several pieces of the non-bioresorbable portion 3 after resorption of the bioresorbable portion 2 of the tissue clip 1, so that the remaining portion 3 of the tissue clip 1 remains in a single piece and can be eliminated in the normal, secure way by the body.

[0056] In order to improve the stability of the tissue clip 1 so that after resorption of the bioresorbable portion 2 it can exhibit improved clamping force, it is possible—as shown in FIG. 3—for the portion 3 of the tissue clip 1 made of non-bioresorbable material to comprise an additional thin bar 11a at the centre of each of the force deflecting elements 4 in addition to the thin bars 11 at the respective short edges of each force deflecting element 4. Here, each element of the bioresorbable portion 2 of the tissue clip 1 is configured as two flat cuboids (rectangular plates) 15 arranged in series and separated by the thin bar 11a arranged at the centre of the force deflecting element 4. In order to hold the plates 15 of the bioresorbable portion 2 arranged in series, each of the two force deflecting elements 4 comprises two cut-outs/window openings 12 arranged in series which correspond to the shape of the bioresorbable plates 15. The longitudinal axis of each cut-out 12 runs essentially parallel to the longitudinal axis of the clamp slit 10. For improved anchoring of each plate 15 of the bioresorbable portion 2 in one of the cut-outs 12 of a force deflecting element 4, the edge of each cut-out 12 facing the gripping teeth 4 exhibits one or more bulges 13 or position lugs which protrude into the cut-out 12 and are aligned with a channel of the zigzag shape defined by the gripping teeth 7. The plates 15 of the bioresorbable portion each exhibit one or more grooves in which one of the bulges 13 engages, thereby fixing the bioresorbable portion 2 to the non-bioresorbable portion 3.

[0057] As shown in FIG. 4, the exact shape of the elements of the bioresorbable portion 2 of the tissue clip 1 can be tailored to the needs of a specific application. It is also possible to insert differently shaped bioresorbable elements in different force deflecting elements 4. In a force deflecting element 4 in FIG. 4, for example, the cut-outs for holding the elements of the bioresorbable portion 2 are configured as two elongated holes arranged in series whose respective longitudinal axis run essentially parallel to the longitudinal axis of the clamp slit 10. Between the two elongated holes there is a thin bar 11a. Each of the bioresorbable elements is configured as a plate 16 corresponding to an elongated hole and embedded in an elongated hole. In addition, the non-bioresorbable portion 3 can exhibit clamps 12 by means of which the elements of the bioresorbable portion 2 are secured in the cut-outs of the non-bioresorbable portion 3.

[0058] Alternatively, the cut-outs in the non-bioresorbable portion 3 of the tissue clip 1 can be configured in such a way that the side of each cut-out facing the gripping teeth 7 runs essentially parallel to the longitudinal axis of the clamp slit 10. The short side facing the central thin bar 11a of each cut-out runs at right angles to the longitudinal axis of the clamp slit 10. The longitudinal side of each cut-out facing the outer edge of the force deflecting element 4 and the short side of each cut-out facing the outer thin bar 11 run essentially parallel to the nearest outer edge of the force deflecting element 4.

[0059] FIG. 5 shows a tissue clip 1 in which the bioresorbable portion 2 consists of several flat plates 16 per force deflection element, each of which is embedded in a respective elongated hole in a force deflecting element 4. Here the longitudinal axis of each plate 16 runs essentially at right angles to the longitudinal axis of the clamp slit 10. Each plate 16 is arranged in such a way that it is aligned with a gripping tooth 7. Thin bars 11a separate a plate 16 from the next plate 16 in each case.

[0060] FIG. 6 shows a tissue clip 1 in whose one force deflecting element 4 an element of a bioresorbable portion 2 is embedded, wherein this element is configured in such a way that it replicates the zigzag shape of the gripping teeth 7 on its side facing the gripping teeth 7, while on its side facing the outer edge of the force deflecting element 4 it replicates the shape of the outer edge of the force deflecting element. For improved fixing of the bioresorbable element in the force deflecting element 4, the cut-out in the force deflecting element exhibits pegs (pins) 13 at its inner edge which engage in corresponding holes in the element of the bioresorbable section 2 embedded in the cut-out. The element of the bioresorbable portion 2 embedded in the other force deflecting element 4 of the tissue clip 1 is configured as two plates 14 made of bioresorbable material attached by the two outer sides to the portion 3 made of non-resorbable material and permanently fixed to each other, wherein the two plates 14 extend beyond the periphery/circumference of the cut-out in the force deflecting element 4 (dotted line) and are connected to each other via three pins 15 made of bioresorbable material by means of a medical adhesive, preferably cyanoacrylate, and secured to the non-bioresorbable portion 3.