Open-pored surgical vascular clip for occluding blood vessels

JP7638957B2Active Publication Date: 2025-03-04AESCULAP AG
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Patent Information

Application Number
JP2022506307
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-07-31
Filing Date
2020-07-22
Publication Date
2025-03-04
Estimated Expiration
2040-07-22

AI Technical Summary

Benefits of technology

【0064】 この点に関し、本用語、即ち、結紮クリップ又は動脈瘤クリップなどの外科用脈管クリップは、全て、具体的に有用な設計、及び/又はサイズ寸法、及び/又は材料を備えている。例えば、マイクロクリップの使用分野において、マイクロクリップは、本発明による、対応する脈管クリップの、比較的より小さな尺度を取らなければならない。例えば、これは、手動手術及び/又は顕微手術の分野における場合であってもよい。特に、小児、中でも新生児の外科的治療には、クリップ実サイズに対する気孔サイズのサイズ比率を変更したものを使用してもよい。それにより、脈管クリップの幾何学的形状の異なる態様についての異なる縮小要件の結果として、他の脈管クリップ寸法に対する気孔サイズの関係をシフトさせることができる。よって、技術的効果を維持したまま、クリッピングすべき中空器官又は血管又は身体組織のサイズに適合されるか又は一定尺度に応じて寸法決めされた一実施形態、特に、本明細書の比率係数に対して小型化されたものは、本開示により排除され得ず、むしろ本開示に含まれる。

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Abstract

The present invention relates to a surgical vascular clip (100), such as a ligation clip or an aneurysm clip, for closing hollow organs such as blood vessels; a corresponding suitable applicator, such as a clip applying forceps; and a corresponding medical product set, particularly a clip tray, including the vascular clip (100) in combination with a surgical accessory. In another aspect, a powder metallurgy molding method for manufacturing the vascular clip (100) is disclosed. The surgical vascular clip (100) includes elongated first and second retention arm portions (110, 120) that are flexibly interconnected and / or interconnectable at one end of each retention arm portion by a connecting portion (130) of the vascular clip (100), and the first and second retention arm portions (110, 120) include respective closure portions (140) at the other end of each retention arm portion, where the closure portions (140) are configured to be flexibly interconnected. Thus, the opposing clip inner surfaces of the first and second holding arm portions (110, 120) can be brought closer to each other starting from an open position at a greater distance from each other to a closed position and can be connected to each other, and at least one clip inner surface portion (111, 121, 131) of the vascular clip (100) is characterized by having an open porous design with at least one integrally formed pore (1), preferably multiple pores (1, 1, ...).
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Description

[Technical field]

[0001] The present disclosure relates to a surgical vascular clip, such as a ligation clip or an aneurysm clip, that is used to close a blood vessel for hemostasis purposes. The present disclosure also relates to a method for manufacturing the surgical vascular clip. Furthermore, a corresponding clip application forceps and a corresponding product set comprising the surgical vascular clip in combination with at least one accessory, such as an identification label, are proposed. [Background technology]

[0002] In the prior art of open and endoscopic surgery, it is known to use surgical vascular clips or vascular clamps to close hollow organs such as blood vessels. On the one hand, so-called ligation clips are used for the purpose of hemostasis by ligation, the intended purpose of which is usually a permanent closure of the vessel. On the other hand, so-called aneurysm clips are used, the intended purpose of which is a permanent and / or temporary closure of the vessel. Aneurysm clips of this type are, for example, sold by the company AESCULAP ​​AG under the trade name Yasargil® Aneurysm Clip System (catalog number C45601 0810 / 1.0 / 14, which is hereby expressly made a part of the present disclosure document by reference).

[0003] Firstly, the term hemostasis refers to all procedures that stop bleeding. In addition to the body's own or physiological hemostatic mechanisms, which result in primary or cellular hemostasis on the one hand, and secondary or plasmatic hemostasis on the other hand, there are various medical or surgical procedures. These procedures lead to the sealing of open blood vessels mechanically, thermally and / or by high voltage. "Ligation" (from the Latin "ligare": "to tie") is the sealing of blood vessels by ligating or tying them, and is a particularly important option among several surgical procedures or techniques. The advantage of ligation is its particular reliability, in which the blood vessels are mechanically and reliably closed. Ligation is therefore a surgical practice in which hollow organs such as blood vessels are ligated or tied in surgery, as well as being an alternative to suturing the vessels.

[0004] Ligation or tying often uses surgical thread or, alternatively, surgical ligation clips that can be applied more quickly to clamp, staple or "clip" hollow organs such as blood vessels. Thus, the applicant's WO 2007 / 087834, expressly incorporated herein by reference, relates to a universal vascular clip in the embodiment of a surgical ligation clip. The ligation clip disclosed therein comprises two retaining arms that are connected to each other at their respective ends by a deformable connection point and are bendable relative to each other so that the arms move from an open position, in which the arms are at a greater distance from each other, to a closed position, in which the mutually facing inner surfaces of the arms are permanently closer to each other.

[0005] In addition, it has been previously known from WO2015147440 that hemostasis by a vascular clip is additionally assisted by a separately provided hemostatic element in the form of an inner pad, which suppresses bleeding and surrounds the inner surface of the first and second legs of the vascular clip and for this purpose is pierced by at least two inwardly projecting pin members of the legs. For this purpose, the hemostatic element as a fibrous inner pad may be impregnated with a hemostatic substance, such as fibrin glue, calcium chloride, thrombin, etc. Summary of the Invention [Problem to be solved by the invention]

[0006] However, the prior art solutions have several drawbacks. First, the vascular clip needs to reliably maintain its position on the vessel to maintain the vascular ligation or occlusion. However, if the surface of the clip inner contour is very smooth or does not have positional stability, the clip may slip off the vessel due to the physiological moisture of the tissue, i.e., this moisture based on physical and / or chemical life phenomena acts like a lubricating film. A separate inner pad as proposed in WO2015147440 may further exacerbate the structural problem of slipping.

[0007] In addition, real surgical situations in the case of so-called cauterization (from the Latin "cauterisatio": "burning with cautery") present the additional complication that a larger amount of oily lubricating fluid mixture is constantly produced locally in the open tissue during the ongoing operation. Here, cauterizing surgical instruments such as electrocautery devices or electrocautery are used as a physical hemostatic method. For this purpose, high-frequency alternating current is applied to the electrocautery, and the blood in the cut tissue immediately undergoes superficial coagulation, which essentially stops the bleeding. However, a multi-phase physiological (and sometimes pathological) fluid mixture, such as blood, lymph, clotted blood cells and other components, burnt tissue or small body particles, continuously emerges from the locally advancing cut surface.

[0008] This multi-phase body fluid mixture exists as a kind of oil-in-water emulsion with aqueous suspended solids. This body fluid mixture with oily or lipophilic parts increases the problem of the already physiologically slippery vascular surface, such as a lubricating layer or physiological (or sometimes pathological) lubricating film. As a result, it becomes much more difficult for the surgeon to accurately position and clamp the vascular clip in a positionally reliable manner in the real situation of a surgical intervention.

[0009] In the case of conventional vascular clips, efforts are made to improve the static friction between the physiologically smooth, rubber-like, elastic-firm vascular surface and the inner contour of the vascular clip and to prevent slippage of the vascular clip, on the one hand, by profiling the inner contour, or, on the other hand, by correspondingly increasing the clip stiffness and the surface pressure. However, profiling has the drawback that the increased gripping force of the profile results in greater trauma to the vascular surface. Also, profiling generally requires additional processing steps or more complex molding tools in the manufacturing process. On the other hand, an increase in clip stiffness leads to increased loads and applied forces on the clip application forceps, which is also considered to be disadvantageous from the trauma point of view. Further drawbacks and limitations arise from the delicate movement aspects of manual manipulation by the surgeon and the spatially and / or kinematically limited range conditions of endoscopic interventions.

[0010] In addition, the main influencing factor causing slippage under real surgical conditions, i.e. the above-mentioned situation of low static friction further reduced due to a lubricating layer of a multi-phase body fluid mixture, still persists in known prior art solutions, which disadvantageously causes an inadequate surface contact between the blood vessel and the inner contour of the clip.

[0011] Thus, the object of the present invention is to create a surgical vascular clip, in particular a ligation clip or an aneurysm clip, as used for closing hollow organs such as blood vessels for hemostasis purposes, which overcomes the above-mentioned drawbacks of the prior art, thereby achieving a good surface contact between the vessel and the inner contour of the clip and substantially minimizing the static friction in order to minimize the effect of the vascular clip slipping against the vessel surface during ligation, or tying, or clamping. In particular, due to the adverse effect of the continuous emergence of a multi-phase fluid mixture in the opened or cauterized tissue, for example during cauterization with an electrocautery, and thus the continuous (new) formation of a lubricating layer, the surgeon should be optimally assisted in the manual manipulation of the vascular clip. An additional object is to provide the user, such as the surgeon and / or the assisting clinical staff, with a corresponding clip application forceps and a product set that is convenient, adaptable and reliable to be used for today's complex clinical procedures. Additionally, there is a need for corresponding methods for manufacturing vascular clips that conform to strict product specifications and allow for robust implementation on an industrial scale. [Means for solving the problem]

[0012] In a first aspect, this object is achieved according to the invention by the features of claim 1 which is directed to a surgical vascular clip.

[0013] In a first aspect of the present disclosure, a surgical vascular clip for use in closing hollow organs such as blood vessels comprises first and second holding arm portions, a connecting portion and a closing portion, whereby both the first and second holding arm portions are elongated (in shape). The first and second holding arm portions are flexibly connected to each other and / or can be flexibly connected to each other by the connecting portion of the vascular clip at one end of each of the first and second holding arm portions, whereby the first and second holding arm portions comprise respective closing portions at the other end, whereby the mutually facing inner clip surfaces of the first and second holding arm portions can be brought closer to each other and connected to each other starting from an open position having a greater distance from each other to a closed position. The closed position can be temporary or permanent, since temporary or permanent closure is the intended purpose, particularly in the case of aneurysm clips. In the case of ligation clips, the intended purpose is permanent vascular closure. For this purpose, the vascular clip is pressed into a permanently closed position, for example with the aid of a corresponding clip application forceps, for ligation of the vessel. According to the invention, at least one inner clip surface portion of the vascular clip has at least one integrally formed pore, preferably an open-porous design having a plurality of pores.

[0014] The concept of the technical solution underlying the present disclosure is explained in the introduction and is based on increasing the frictional forces by removing the physiological (or even pathological) lubricating film that would otherwise be located between the hollow organ or vessel and the portion of the clip's inner surface adjacent thereto. The vascular clip according to the present invention is therefore made of an open-porous material, allowing the lubricating film between the clip's inner contour and the vessel to be released into at least one pore, preferably multiple pores. This improves the surface contact and increases the static friction between the vascular clip and the hollow organ or vessel. In summary, the vascular clip according to the present invention has the advantage of increasing the positional stability on the hollow organ or vessel against slippage, which does not increase the trauma of the vessel.

[0015] According to the invention, a surgical vascular clip for closing hollow organs is provided with at least one porous surface portion on its inner contour. When this porous surface portion comes into contact with or abuts on a hollow organ to be closed or clipped in the context of a surgical intervention or operation, a wet surface film present or prevailing on the hollow organ can be absorbed by at least one pore, preferably a plurality of pores. By at least partially removing the wet surface film inherent to the hollow organ, in particular a multi-phase physiological lubricating film, from the surface of the hollow organ or blood vessel abutting the inner contour of the vascular clip into the pores, slippage of the vascular clip on the hollow organ is reduced or even eliminated. In other words, the blood vessel is no longer greasy or slippery on its surface, for example, surrounded by the vascular clip, while the vascular clip is closed. Thus, the vascular clip does not slide or slide on the wet surface film, but rather the essentially solid surfaces adhere or rub against each other. Thus, the static friction between the vascular clip and the hollow organ is significantly increased during the closure or clipping process. This makes it easier for the surgeon to reliably apply the vascular clip in the correct position without the need to apply traumatic high clamping forces to the hollow organ or vessel. The location-proven positioning of the vascular clip significantly improves its function and reliability. Healing is also significantly promoted because local trauma to the hollow organ or vessel is reduced or even eliminated.

[0016] As used herein, the term vascular clip includes a ligation clip or an aneurysm clip, as described in the introductory section of this disclosure (including the prior art).

[0017] The term ligation clip also includes so-called microclips for the purpose of temporary and / or permanent ligation of (cerebral) arteriovenous anomalies or anteriovenous malformations (AVMs). In the sense of the present invention, it is understood that in the case of microclips, correspondingly smaller dimensioned measures are included by the subject matter of the present invention. However, what must be taken into account here is that, if necessary, due to manufacturing aspects and / or liquid-solid interface physics considerations, it does not seem to make sense to miniaturize individual pores or internal pore structures in terms of their size to the same extent as the external dimensions or external dimensioning of the entire vascular clip.

[0018] The term "integrally formed" pores or pores is understood to mean that the pores are formed as voids (void volume) or holes in the material of the vascular clip. Thus, this term refers to pores that are formed in a quasi materially bonded manner with respect to or in the vascular clip.

[0019] In many cases, the vascular clip forms a U-shaped or V-shaped configuration in which the elongated holding arm portions form legs at the connection portion, which is preferably located approximately in the middle. In principle, however, the term type, i.e. vascular clip, should not be limited here to only variants in which the vascular clip is clamped or "clipped" only at the open end opposite the connection point, i.e., engaged on one side, for example, similar to the ligation clip described above in the introduction. In this case, the term "vascular clip" also includes any embodiment in which engagement occurs on both sides, i.e., clamping or "clipping" occurs at the two ends that are initially open. Furthermore, any circumferentially closed, in particular ring-shaped or polyhedral-shaped, vascular clip configuration is also included. The latter closed configuration can only be slid over a separate, e.g. cut, hollow organ or vessel, so that the free part of the vascular clip protruding from the vessel circumference can then be clamped or "clipped" later.

[0020] Also, whether different regions of the vascular clip, such as the retaining arm portions, have a particular configuration or constant cross-sectional area is not relevant within the meaning of this invention. Thus, embodiments of vascular clips having cross-sections that vary along the deployed clip length or longitudinal axis of the vascular clip are also intended to be included herein. Additionally or alternatively, in addition to the two embodiments shown in the drawings, embodiments having cross-sections with rounded rectangular cross-sections, as well as oval, square, U-shaped, T-shaped, I-shaped, convex, and / or concave configurations may be equally preferred.

[0021] The dependent claims indicate preferred further developments of the invention.

[0022] Preferably, in the surgical vascular clip, at least one open porous clip inner surface portion is provided as a first clip inner surface portion arranged on the first holding arm portion and / or a second clip inner surface portion arranged on the second holding arm portion and / or a third clip inner surface portion arranged on the connecting portion. This provides the technical advantage that depending on the medical indication, the overall design of the vascular clip can be optimized with respect to mechanical properties such as bending stiffness and / or hardness and / or flexibility and / or elasticity. Depending on the medical history or medical indication of each individual case, it may be preferred, for example, that only one of the two holding arm portions, i.e. either the first or the second holding arm portion, is designed with a porous clip inner surface portion. Thereby, it may be preferred that the distinction between the first and second holding arm portions, which have otherwise identical external dimensions, is determined only by the temporal sequence of application to the hollow organ during the actual surgical clipping procedure. This may be determined, inter alia, by how the vascular clip to be applied is positioned or inserted into the corresponding clip applying forceps, or in what insertion direction this is performed.

[0023] Any combination of open-porous first and / or second and / or third clip inner surface portions is included, since different local designs may be advantageous depending on the individual characteristics of the vascular or body tissue to be clipped. It is also contemplated that each or each open-porous or porous first and / or second and / or third clip inner surface portion is not only centrally but also off-centeredly positioned. The term "positioned" in this context means in relation to the corresponding partial area of ​​the vascular clip, i.e., in relation to the first retention arm portion, or the second retention arm portion, or the connecting portion, respectively.

[0024] Furthermore, it may be preferred that at least one partial region of the vascular clip, i.e. the first retaining arm portion and / or the second retaining arm portion and / or the connecting portion, in each case has two or more open pore regions or porous clip inner surface portions.

[0025] This leads to the added advantage that the overall mechanical resistance of the vascular clip to unintentional opening can be maintained by specific selection of open pore areas or portions of the porous clip inner surface.

[0026] Preferably, the surgical vascular clip is at least 60 volume percent, preferably at least 90 volume percent open porosity or porosity, and even more preferably (almost) completely, i.e. (almost) 100 volume percent open porosity or porosity. In this context, the limitation "almost" means that manufacturing-related edge effects, particularly areas associated with non-porous exit points or geometries, such as non-porous kinks, should not be included in the corresponding determination of porosity. In one variation of this type, the vascular clip is made particularly receptive to larger amounts of moisture or lubricating film to be removed from hollow organs or blood vessels.

[0027] An alternative preferred variant to the above-mentioned preferred embodiment of the surgical vascular clip concerns a not too high porosity or void volume fraction or gap volume portion of the vascular clip. The vascular clip is thereby designed to have an open porosity or porosity of at most 70 volume percent, preferably at most 50 volume percent, even more preferably at most 35 volume percent. In particular, capillary porosity and / or individual porosity may be preferred. In the case of a bicontinuous pore structure, for example in the presence of a sponge structure or (monomodal or multimodal) sphere packing, a low porosity may be preferred, since it corresponds to a thicker wall structure, for example a thicker network structure like a stronger beam. Such pore structures with rather low porosity are therefore particularly robust and mechanically strong.

[0028] Alternatively or additionally, the vascular clip in an alternative preferred variant comprises at least one non-opening porous clip inner surface portion, in particular for the connecting portion in the clip valley of the vascular clip. Thus, the preferred vascular clip in this variant comprises at least one open porous clip inner surface portion and at least one non-opening porous clip inner surface portion. In particular, at least the connecting portion and / or the closing portion of the first and / or second retaining arm portion are made of solid material. In one variant of this type, the vascular clip becomes particularly stable, since only one or several areas are porous and / or the pore structure is moderately open porous, i.e., there are few pores per surface unit. Depending on the manufacturing process and the clip design, there may still be particular manufacturing advantages, insofar as a porous design may mean increased manufacturing effort compared to solid materials.

[0029] To achieve the desired effect based on at least one pore, it may also be sufficient and even preferable to make only the inner region of the vascular clip, for example the inner third of the cross-sectional dimension of the retaining arm portion constituting the clip leg, with an open-porous design. This has the advantage that the bending stiffness of the vascular clip is less likely to be reduced compared to a continuous open-porous cross-section. Particularly advantageous vascular clips may not have an open-porous inner contour over the entirety, but rather the region of the connecting portion representing the clip valley (particularly the proximal 20% of the deployed clip length) and / or the region of the closing portion representing the clip tip (particularly the distal 10% of the deployed clip length) made of solid material. In particular, designing the connecting portion representing the clip valley with a solid material ensures the maximum bending stiffness of the vascular clip compared to conventional vascular clips. Alternatively or additionally, at least a section of the outer clip outer surface portion of the vascular clip may consist of a solid material and / or at least one pore may be designed as a drainage device for lateral drainage, preferably bent in an L-shape towards the clip side, i.e. preferably the outer surface of the vascular clip has a solid material and the liquid is drained laterally, which has the advantage that the porous area can be further limited in favor of the rigidity of the vascular clip without significantly reducing the desired drainage effect of the moisture or lubricating film to be removed from the hollow organ or blood vessel.

[0030] Preferably, at least one pore in the surgical vascular clip has a first pore size and / or, in case of multiple pores, an average first pore size, the average first pore size and / or the average first pore size being 0.01 mm to 0.2 mm, preferably 0.02 mm to 0.08 mm, more preferably about 0.05 mm, at the pore inlet height of the corresponding clip inner surface portion. Alternatively or additionally, the (average) pore size is 1% to 35%, preferably 2% to 20%, more preferably 3% to 14%, even more preferably 5% to 10% of the clip arm width determinable in the transverse direction of the central portion of the first and / or second clip arm portion. Thus, a customary retaining arm width or web width for a ligation clip may be 0.5 to 2 mm.

[0031] The term "average pore size" in this context includes statistically formed mean values ​​that can be averaged out of density distributions depending on pore diameter, pore surface area and / or pore volume. Common experimental measurement methods for determining the (average) pore size are based, for example, on the so-called bubble point method or also on optical measurements, for example using photoplans and / or electron micrographs. Furthermore, for the determination of pore size as well as porosity, (automated) measurement methods are known in which the individual pores or the internal pore structure are wetted by a wetting agent such as mercury. Thereby, specific conclusions about the variables to be measured can be drawn not only on the basis of hysteresis curves but also on the basis of the capillary Laplace pressure for the individual pores.

[0032] Preferably, at least one pore in the surgical vascular clip is capillary or cylindrical or alone. This has the advantage of being easy to manufacture. For example, the solid material of a conventionally manufactured vascular clip may be provided with a capillary pore. Preferably, for this purpose, at least one capillary pore is drilled by countersinking or drilling with a laser or a precision drilling tool, both through holes and closed holes being preferred.

[0033] Alternatively or additionally, the preferred pores may form a co-continuous, i.e. continuous pore structure with respect to each other. More specifically, the term "co-continuous" porosity refers to a pore structure formed in an uninterrupted or continuous manner in two respects. Thus, both the solid material, i.e. the wall or support, and the void volume or pore space are considered to be separate, continuous, or interconnected. This co-continuous pore structure may further preferably be sponge-like, and / or mesh-like, and / or fiber-woven, and / or filament-like, and / or beam-like. Furthermore, the preferred embodiment of co-continuous pores with and / or without closed pores is included.

[0034] As used herein, the term "trabecular" or "trabecula" (from the Latin "trabecula": "small beam") refers to a small beam-like pore structure or a network of small beams or a network of fine webs or sieve-like meshes. Trabecular structures are known from internal anatomical structures of organs, for example in myocardial fiber strands or the iridocorneal angle of the eye.

[0035] A particularly preferred bicontinuous porous metal is the so-called "Trabecular metal® material" sold under this trade name by ZIMMER SPINE, INC. (Edina, Minnesota, USA). It is a porous tantalum material used in the medical technology field, in particular in orthopedic implant treatments. The beam-shaped metal material is a highly biocompatible three-dimensional material. The beam-shaped metal material has a porosity of up to more than 80 volume percent. A thermal deposition process is used to deposit elemental tantalum on a substrate. This creates a sponge-like or cancellous bicontinuous pore structure in the three-dimensional material. This pore structure exhibits a uniform three-dimensional cellular architecture. The entire surface of the beam-shaped metal material exhibits a nanostructured surface topography. In compression tests, the beam-shaped metal material exhibits high ductility without mechanical fracture, which makes the design of the vascular clip according to the invention particularly advantageous.

[0036] This beam-like metal material with corresponding manufacturing processes is described in several patents, such as U.S. Patent No. 8,323,322 B2, U.S. Patent No. 5,282,61, U.S. Patent No. 5,443,515, and U.S. Patent No. 6,063,442, the disclosures of which are incorporated herein by reference, which describe the formation of a porous tantalum material with a beam-like pore structure based on chemically vapor-depositing tantalum onto a foam-like carbon structure.

[0037] More preferably, the vascular clip according to the invention can be made of porous metal, as previously known for moldings from M-PORE GmbH (Dresden, Germany). In these moldings, channels extend through the foam and connect the pores, thus forming a uniform, open and interconnected network of pores. In this respect, DE 102014118177 A1, the disclosure of which is incorporated by reference, teaches a method for producing foam-like metal moldings for use as heat exchangers on electronic components. Thereby, the metal molding is printed entirely from metallic or metal-containing raw materials by layer-by-layer 3D printing in its three-dimensional form. This makes it possible to design arbitrarily shaped moldings on a computer and to produce them as single-piece metal structures comprising solid material and foam areas. In the 3D printing process, the use of multiple feedstocks, each with a different type of metal, can result in a body being constructed from multiple metals in a single processing step, with regions of different metals having any shape and even being bonded together, providing the advantage that the structural properties of the metal foam, such as pore size, web width, pore shape, etc., can be specifically pre-determined.

[0038] Alternatively or additionally, it is preferred to design at least one pore with a pressure-stable pore structure and / or that is relatively constant between the open and closed positions. This has the added advantage that the water, or liquid phase, or physiological lubricating film absorbed by the at least one pore from the surface of the hollow organ or blood vessel remains accumulated in said pore. In other words, the amount of fluid absorbed by the at least one pore is not returned or squeezed out.

[0039] Preferably, at least one pore of the surgical vascular clip has a hydrophilic pore inner surface portion and / or a pore inner surface portion wettable by an aqueous fluid phase. Since at least one pore is wettable by an aqueous or hydrophilic fluid phase at its pore entrance and / or at a further pore inner surface portion, as a result of the wetting effect on the inside of the pore, the surrounding moisture or multi-phase lubricating film during clipping with the vascular clip is released faster, actively or spontaneously into the inside of the pore or into the internal pore structure. In other words, active mass transport into the inside of the pore, i.e. along the wettable pore inner surface portion, occurs by wetting or diffusion. In particular, for physiological lubricating films and for blood containing plasma, it may be a multiphase emulsion and / or suspension with a predominantly aqueous phase. In this respect, even in the case of a bicontinuous pore structure, the wetting model of the fluid phase into a single capillary or cylindrical pore can be used as a basis.

[0040] Preferably, the surgical vascular clip is designed in such a way that when it is applied to a hollow organ or when it is used to close a hollow organ, at least one pore, preferably a plurality of pores, receives and / or releases and / or absorbs the surrounding fluid phase, including components of body fluids such as blood (blood cells), lymph, tissue particles, body fat and / or cauterization products, inside the pore by capillary action, thereby creating a suction effect on the fluid phase or an active removal of the fluid phase in the at least one pore in addition to a pure storage function.

[0041] Preferably, the void volume fraction and / or interstitial volume fraction and / or volume porosity of at least one pore, preferably of a plurality of pores, is between 10% and 90%, preferably between 30% and 88%, more preferably between 35% and 86%, even more preferably between 50% and 75%. These relative variables are thereby determined for adjacent clip volumes at the clip inner surface portion. In other words, this means that in order to determine the volume porosity, which can be optionally local or optionally brought about, at each clip inner surface portion, it would not make sense from a metrological point of view to include adjacent areas of solid material or areas having significantly different volume porosity. In other words, in this respect, this means that for the determination of the volume porosity, the volume balance envelope should match with the adjacent clip volumes at the clip inner surface portion. For consistent application and product properties, a predefined target volume porosity is advantageous. In particular, a well-balanced, selected target volumetric porosity makes it possible to control and adjust, on the one hand, the mechanical properties of the vascular clip and, on the other hand, the absorption effect or storage function of at least one pore in an optimal manner for a specific application.

[0042] Preferably, a substructure with finer pores is provided within a pore or pores or an internal pore structure of the surgical vascular clip. For this purpose, the pore inner surface portion of at least one pore has an open porosity design with micropores of a smaller average second pore size. Thereby, the average second pore size is 1% to 20%, preferably 3% to 15%, more preferably about 10% of the first (average) pore size. Alternatively or additionally, the average second pore size of the micropores is 1 micrometer to 10 micrometers, preferably about 5 micrometers. The average second pore size can be determined at the micropore inlet height in the pore inner surface portion, for example, by bubble point measurement method. Such a substructure of micropores, i.e., second pore size, in at least a section of the pore inner surface of at least one pore of larger size, i.e., first pore size, creates a synergistic effect due to the bimodality of the pore size. This preferred embodiment thus offers the combined advantage of, on the one hand, larger pores for receiving, releasing and storing larger amounts of a fluid phase, such as a physiological lubricating film, and, on the other hand, micropores that maintain their storage effect by physical wetting, even when mechanical pressure is applied against the vascular clip.

[0043] Preferably, the vascular clip comprises the following materials or metallic materials, in particular powder metallurgy materials, namely: metallic materials of the ISO 5832 standard for manufacturing surgical implants; titanium (e.g., grade 2 Ti; grade 4 Ti; grade 5 Ti) or titanium alloys; tantalum or tantalum alloys; low alloy steels for heat treatment (e.g., FN02; 100Cr6); tool steels (e.g., M2); stainless steels (e.g., Nitronic 50; 316L; 17-4-PH; 430; 440C); and / or other alloys (e.g., FN50; Inconel 601; Cu99.9). In this context, the ISO 5832 standard is a series of ISO standards that specifies the properties and test methods for forgeable and cold-formable stainless metallic materials used to manufacture surgical implants.

[0044] As a second aspect of the present disclosure, a corresponding applicator, in particular a corresponding clip application forceps, is proposed, which is preferably set up to the vascular clip according to the invention, so that the user is provided with a perfectly shaped and designed instrument. Preferably, the applicator or clip application forceps may be and / or has been set up to the vascular clip according to the invention, such that the clamping force applied by it to the hollow organ in the closed position of the vascular clip is not below a minimum permissible first force limit, or alternatively or additionally not above a maximum permissible second force limit. This type of product set has the particular advantage that the manufacturer guarantees that the force applied by the user, such as a surgeon, when clipping or closing a hollow organ or vessel is sufficient to perform the clipping or closing without re-extrusion of the fluid phase absorbed by the at least one pore or having a traumatic effect in a manner that would result in excessive force being applied to the hollow organ. That is, the applicator or clip application forceps supports the goal that the force manually applied during clipping falls within a boundary range of half the optimal target, or a target range, or a corridor or boundary section.

[0045] As a third aspect of the present disclosure, a medical product set, in particular a clip tray, for the storage, transport and / or sterilization of vascular clips according to the invention is proposed. The medical product set or clip tray comprises a plurality of vascular clips according to the invention. Preferably, the plurality of vascular clips according to the invention are provided or arranged in a permanent or temporary combination according to different sizes and / or different shapes and / or different hardness and / or different bending stiffness and / or different materials and / or different closure configurations. Alternatively or additionally, the medical product set includes an identification label corresponding to each of the vascular clips. Such an identification label is used, for example, for documentation or information for immediate reordering of each of the clips used. Alternatively or additionally, an applicator, in particular a clip application forceps, corresponding to the vascular clips according to the invention is included. In particular, this type of product set supports targeted pre-operative preparation. Furthermore, there are advantages in terms of clinical procedures regarding storage, transport and / or sterilization aspects.

[0046] As a fourth aspect of the present disclosure, a powder metallurgy molding method for manufacturing the vascular clip according to the present invention is proposed. In this regard, the powder metallurgy molding method for the vascular clip according to the present invention as a component or product comprises the following steps performed in sequence: providing a powder metallurgy feed material or so-called feedstock, for example by mixing and / or kneading and / or extruding; molding the feed material to form a near-net-shape fine-grained and / or coarse-grained green body in the form of a vascular clip, optionally oversized depending on debinding and / or sintering shrinkage; optionally debinding the green body to form a brown body; and sintering the green body, optionally debinding in the brown body, to form a finished vascular clip.

[0047] In the first step of providing the powder metallurgy feed material, a homogenous feed material or feedstock is provided. Preferably, the feed material is a metal binder mixture that includes at least one organic binder in addition to fine metal powder. In some cases, it may be preferable to obtain a precombined metal binder mixture and / or to mix the metal binder mixture prior to the compact forming step. Premixing may be preferably carried out in a mixer or kneader capable of operating in batch and / or continuous and / or by screw-type extrusion.

[0048] The subsequent step of shaping the feed material to form a green body may thereby be carried out in a forming tool, preferably by powder injection molding and / or powder compaction. Alternatively and / or additionally, the step of shaping the feed material to form a green body may be carried out in an additive manufacturing process, preferably by metal 3D printing. Alternatively and / or additionally, the step of shaping the feed material to form a green body may be carried out in a continuous manufacturing process, preferably by extrusion, even more preferably by filament extrusion. Optionally, the finished vascular clip may then be subjected to further post-processing, such as surface finishing, in a subsequent step.

[0049] Any binder optionally present in the feed material is removed from the green body or preform of the vascular clip again in a subsequent debinding step, so as to obtain a debound green or brown body, if applicable. That is, if a thermally removable binder is used in the feed material, the debinding is carried out in a debinding oven. Thereby, thermally removable binders based on polyolefin wax mixtures may be used. If at least a part of the binder can be extracted by organic solvents, i.e. if a (partially) soluble binder is present, the debinding is carried out by using a solvent extraction instead of and / or in addition to the thermal debinding. Thus, in this case, it is preferred to use a partially soluble binder system in the feed material, for example in which a polyethylene-based polymer component is mixed with a wax. Alternatively and / or additionally, the use of a catalytically decomposable binder system in the feed material may be preferred. For the latter variant, binder systems based on the decomposition of polyoxymethylene (POM) by catalysis with strong acids are preferably used, such as the Catamold® binder system from BASF. The main advantage of the binders or binder systems mentioned above is the high green strength of the molded vascular clips.

[0050] In a subsequent sintering step, the optionally debindered green bodies are sintered at high temperatures in a sintering furnace, whereby the sintering furnace may be different from the debindering furnace or, in the case of continuously operated plants, may be located in a further downstream furnace stage or in the annealing section. Preferably, the sintering may be carried out as a laser sintering process.

[0051] The green or brown body is compacted or sintered by sintering to form the finished vascular clip according to the invention, which retains its final properties in terms of geometry, mechanical behavior, internal material structure, and / or porosity, except for the effects of possible further post-processing steps, so that the vascular clip behaves inertly inside the patient's body, since it is made of pure metal.

[0052] In an optional step, further post-processing of the vascular clip is performed. Preferably, this is a surface finishing and / or coating, preferably of the pore inner surface portion. Preferably, the wettability of at least one pore by the fluid phase absorbed by said pore may be specifically adjusted by a specific coating, for example a hydrophilic-lipophilic-balance (HLB) functional coating.

[0053] Alternatively or additionally, it is contemplated that the creation of an open pore area in a vascular clip according to the present invention may be achieved by applying a porous coating, or a coating that forms at least one pore, to a solid material.

[0054] Preferably, (metal) powder injection molding represents a preferred variant of the powder metallurgical molding method of the vascular clip according to the invention, in this case as a component or product. Powder injection molding (briefly PIM method) or metal injection molding (briefly MIM method) is a casting or one-step molding method for producing metal or even ceramic components of complex two- or three-dimensional geometric shapes. Powder injection molding is a further development in materials science and a variant of the injection molding technique for thermoplastics. In particular, because the vascular clip has a three-dimensionally complex geometric shape due to its pronounced curves and angles, powder injection molding offers particular advantages in terms of simpler molding compared to machining and / or molding manufacturing methods.

[0055] As a preferred variant of powder metallurgy molding methods, (metal) powder injection molding combines the mechanical advantages of sintered components with the great molding versatility of injection molding. Further advantages of powder injection molding include great design freedom as well as functional integration; elimination of numerous post-processing steps in terms of undercuts, cross holes, blind holes, threads, surface structures, logo reproduction, etc.; versatile material selection; and cost-effective series production.

[0056] In this context, a preferred powder injection molding, or PIM, or MIM process comprises the successive steps of: providing a powder metallurgy PIM / MIM material as a feed material or so-called feedstock, e.g. by mixing and / or kneading and / or extruding; injection molding the feed material as a compact into a forming tool to form a near-net-shape fine-grained and / or coarse-grained green body in the form of a vascular clip, preferably oversized depending on debinding and / or sintering shrinkage; debinding the green body to form a brown body; and sintering the brown body or the debound green body to form the finished vascular clip.

[0057] In the powder injection molding process as a preferred embodiment of the molding process, the green body or preform of the vascular clip is produced as an injection molded part, for which purpose the feed material is injected into a tool mold having a corresponding hollow geometric shape or cavity. In this process, the feed material is preferably injected in liquefied form into a closed tool mold, more preferably at an elevated temperature. This allows the powder injection molding to be controlled by a specific temperature control, whereby the feed material first ideally completely fills the mold and only then plasticizes. The resulting green body or preform already approximates the contour of the finished vascular clip or already exhibits the essential external geometric features of the finished vascular clip.

[0058] Preferably, powder injection molding is carried out at an injection pressure above ambient pressure, preferably above 60 bar, even more preferably above 90 bar. It is understood that the injection pressure provided on the machine side may be increased even more in the case of more complex and / or smaller geometric shapes of the vascular clip. The preferred injection pressure increases according to the disproportionately occurring flow resistance along the inner wall of the molding tool corresponding to the geometric shape of the vascular clip, especially insofar as narrowed flow cross sections and / or extended flow paths are present.

[0059] Preferably, (metal) powder compaction in this case represents, in addition to powder injection molding, a further preferred variant of the powder metallurgy molding method for producing the vascular clip according to the invention. In the powder compaction process as a preferred embodiment of the molding process, the feed material, i.e. the metal powder with or without binder, is provided to a die tool shape and consolidated by a corresponding male tool shape under high pressure in a mechanical press to form the green body or preform of the vascular clip. As in the case of powder injection molding, powder compaction is also a particularly cost-effective production method which is able to consistently meet the high quality requirements of medical products.

[0060] Preferably, a powder metallurgy feed material is provided, the filler content of which is less than 75 volume percent, preferably less than 60 volume percent, even more preferably less than 45 volume percent relative to the metal powder. The filler content determines both the internal pore structure and the shrinkage size of the finished sintered vascular clip, whereby the higher the filler content, the lower the sintering shrinkage or the lower the void volume fraction of the finished vascular clip. Moreover, if the filler content is too high, the feed material can no longer be processed in a molding process, especially injection molding, because the viscosity and / or abrasiveness of the feed material is then too high.

[0061] Preferably, in powder metallurgy molding methods, the molding step to form a green body is performed in a tool mold, preferably by powder injection molding and / or powder compaction. Alternatively or additionally, the molding is performed in an additive manufacturing process, preferably by metal 3D printing. Alternatively or additionally, the molding is performed in a continuous manufacturing process, preferably by extrusion, even more preferably by filament extrusion. These methods have the advantage of large-scale availability, despite the high quality assurance requirements of medical engineering products.

[0062] In summary, the vascular clip according to the invention, having at least one pore, has the advantage that the positional stability of the clip on a hollow organ or vessel against slipping off is increased without increasing the trauma of the vessel. Thus, the invention relates to a vascular clip which is open pore or has open porous parts throughout. As a result, the liquid film on the tissue surface, such as the hollow organ or vessel to be closed, is selectively removed, whereby the vascular clip according to the invention is better ensured against slipping. Thus, the vascular clip according to the invention exhibits increased positional stability on the vessel to be ligated. A further advantage of a preferred embodiment of the vascular clip according to the invention is that the resistance of the vascular clip against opening is maintained by selectively choosing the open pore areas.

[0063] Finally, it should be noted that the vascular clip according to the invention is not limited to use for merely closing blood vessels for hemostasis purposes. The invention is equally advantageous for similar medical indications or uses, in particular for various surgical situations and procedures. For example, lymphatic vessels may be closed by the vascular clip according to the invention. In particular, both human and animal surgical procedures are based on the same basic principles and objectives.

[0064] In this respect, all of the present term, i.e. surgical vascular clips such as ligation clips or aneurysm clips, are provided with a specifically useful design and / or size dimensions and / or materials. For example, in the field of use of microclips, the microclips must take a relatively smaller scale of the corresponding vascular clips according to the invention. This may be the case, for example, in the field of manual surgery and / or microsurgery. In particular, for surgical treatment of children, especially neonates, modified size ratios of pore size to clip actual size may be used. Thereby, the relationship of pore size to other vascular clip dimensions can be shifted as a result of different reduction requirements for different aspects of the geometry of the vascular clip. Thus, an embodiment that is adapted or scaled to the size of the hollow organ or vessel or body tissue to be clipped, in particular miniaturized with respect to the ratio factor of this specification, while maintaining the technical effect, cannot be excluded by the present disclosure, but is rather included in the present disclosure.

[0065] The scope of protection of the invention is given by the claims and is not limited by the features explained in the description or shown in the drawings. [Brief description of the drawings]

[0066] [Figure 1] 1 is a perspective front view according to a first exemplary embodiment of a vascular clip in an open position according to the present disclosure. [Diagram 2] FIG. 2 is a longitudinal view according to a first exemplary embodiment. [Diagram 3] 1 is a top view according to a first exemplary embodiment of a vascular clip in an open position. [Figure 4] 1 is a width view (side view) according to a first exemplary embodiment of a vascular clip in an open position. [Diagram 5] 4 is a cross-section along line AA of FIG. 3 according to a first exemplary embodiment of a vascular clip in an open position. [Figure 6]11 is a perspective front view according to a second exemplary embodiment of a vascular clip in an open position in accordance with the present disclosure. [Figure 7] FIG. 13 is a longitudinal view according to a second exemplary embodiment. [Figure 8] 13 is a top view according to a second exemplary embodiment of a vascular clip in an open position. FIG. [Figure 9] 13 is a width view (side view) according to a second exemplary embodiment of a vascular clip in an open position. [Figure 10] 9 is a cross-section along line AA of FIG. 8 according to a second exemplary embodiment of a vascular clip in the open position. [Figure 11] 13 is a micro-cross-section according to a third exemplary embodiment of a vascular clip having a beam-like co-interconnected pore structure. [Figure 12] 1 is a schematic flow diagram of a powder metallurgy molding method for manufacturing a vascular clip according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] A first exemplary embodiment of the present disclosure is described below based on the accompanying Figures 1 to 5. Further details, features and advantages of the present invention will become apparent therefrom.

[0068] 1 to 5 show various views according to a first exemplary embodiment of a ligation clip 100 according to the present invention as a vascular clip for closing a blood vessel. In the first exemplary embodiment, the ligation clip 100 is open-porous in a number of sections, each of which has a number of cylindrical capillaries 1, 1, ... as through-holes.

[0069] Fig. 1 shows a perspective front view of the ligation clip 100 bent into a U-shape and in an open position. Two elongated clip webs 110, 120 having the same shape and spaced apart from each other substantially parallel or at a slight angle open at their ends located at the left in Fig. 1 as first and second holding arm portions, leading to a U-shaped rounded clip valley 130 as a connecting portion of the ligation clip 100. The two clip webs 110, 120 are flexibly connected to each other via the semi-arch shaped bendable clip valley 130, so that they can be brought closer to each other starting from the open position having a larger distance from each other as shown in Fig. 1 or Fig. 3 to a closed position. For example, this can be done by a surgeon as a user first placing the open U-shaped ligation clip 100 in the correct position around and adjacent to the blood vessel to be closed by a corresponding ligation clip application forceps, and then compressing the ligation clip 100 to tie off or ligate the blood vessel (not shown). For secure and permanent ligation, the two clip webs 110, 120 have respective closure portions 140, 140 at their other ends opposite the clip valleys. This allows the mutually facing respective clip inner surfaces of both clip webs 110, 120 to be permanently connected to each other.

[0070] If ligation clip 100, having a constant, slightly rounded, quasi-square cross-sectional area (see Figures 4 and 5) along its entire length, were imaginarily unfolded (not shown) into an elongated square rod shape, the distinct clip portions would smoothly blend together as follows: closure portion 140, located in the upper right corner of Figure 1; first clip web 110 (top of Figure 1); semi-arch shaped clip valley 130; second clip web 120 (bottom of Figure 1); and closure portion 140, located in the lower right corner of Figure 1.

[0071] Along the inner contour of the U-shaped bent ligation clip 100, the inner clip inner surface portion should be associated with the above-mentioned distinct clip portions 140, 110, 130, 120, 140. Thereby, as is clear from Figures 1, 2, 4 and 5, each of the two clip webs 110 and 120 has, in their corresponding clip inner surface portions 111 and 121, respectively, two rows of cylindrical capillaries 1, 1, ... as pores, i.e., 24 x 2 capillaries per clip web 110 or 120 (hence a total of 96 capillaries in the ligation clip 100).

[0072] In contrast, as can be seen from FIGS. 1, 2, 4 and 5, the bendable clip valley 131 is made of a solid material without the capillary tube 1 .

[0073] As is evident from the cross-section in FIG. 5 (cross-section along line AA in FIG. 3), each of the individual capillaries 1, 1, ... is designed as a cylindrical through-hole. Each of the capillaries 1, 1 has a first pore diameter as a first pore size, which enters the clip inner surface portion 111 or 121 at the respective pore inlet height 50 inside the ligation clip 100. The capillaries or capillary-shaped pores 1, 1, ... of this first embodiment of the ligation clip 100 appear equally with a constant pore diameter in the outer clip outer surface portion, inasmuch as they are cylindrical through-holes. However, this is an optional feature and is not a structural feature essential to the invention. The retaining arm width or web width may be determined, for example, on a cross-section at a similar position as shown in FIG. 5, which for this purpose should be selected perpendicular to the longitudinal axis of one of the clip webs 110, 120.

[0074] 4 further shows a cylindrical pore wall envelope as the pore inner surface 11, which encloses the cylindrical interstitial or void volume of each capillary tube 1. The latter void volume is used in surgical applications (not shown) to accommodate the physiological (or pathological) lubricating film of the blood vessel to be ligated around the open-porous clip inner surface portion 111 or 121.

[0075] Figures 6 to 10 illustrate design details according to a second embodiment of a ligation clip 200 according to the present invention as a vascular clip for closing a blood vessel. In this regard, the various views of Figures 6 to 10 according to the second exemplary embodiment show representations similar to the views of Figures 1 to 5 according to the first embodiment. Therefore, to avoid repetition, the discussion of Figures 6 to 10 will be referred to the basic structure of the ligation clip 200, which is also bent in a U-shape (having a rectangular cross section).

[0076] In the second exemplary embodiment, the ligation clip 200, in contrast to the ligation clip 100 of the first exemplary embodiment, is not provided with capillary-like pores but is embodied in an open-pored manner with a transversely permeable or continuous, i.e. co-continuous, pore structure 1, 1, ... based on a plurality of pores. Due to the sponge-like pore structure, a non-circular shape is visible at the pore inlet height 50.

[0077] The porosity of the ligation clip 200 according to the second exemplary embodiment is significantly higher than that of the ligation clip 100 according to the first exemplary embodiment, and this porosity may be geometrically derived from a co-continuous open pore structure for comparable pore inlet sizes.

[0078] In an alternative or additional variant (not shown) of the first or second exemplary embodiment of the vascular clip, at least a section of the outer clip outer surface portion of the vascular clip may consist of a solid material, i.e. preferably the outside of the vascular clip comprises a solid material, and liquids are drained laterally. This has the advantage that the porous area can be further limited in favor of the rigidity of the vascular clip, without significantly reducing the desired drainage effect of the moisture or lubricating film to be removed from the hollow organ or blood vessel. In particular, at least one pore may be configured to drain fluids laterally, preferably bending in an L-shape towards the clip side. In the first exemplary embodiment according to Figs. 1 to 5, this presupposes that the pores 1, 1, ... of the ligation clip 100 are configured as holes, which can be recognized in Fig. 5 as an L-shaped connection (not shown) of the first or second clip inner surface portion 111, 112 with the clip side. In the second exemplary embodiment according to Figures 6 to 10, the outwardly facing partial volume of the cross section of the ligation clip 200, preferably one third, in the cross section according to Figure 10 along line AA in Figure 8, may be a solid material (not shown).

[0079] FIG. 11 shows a micro-section according to a third exemplary embodiment of a vascular clip with a co-continuous pore structure designed in a beam shape. The continuous mesh or open network shape of the webs or beams 2 forms a co-continuous pore structure with high open porosity. For example, the center of FIG. 11 shows how five beams 2 form a pore 1 in the manner of a scalene pentagon at the pore inlet height 50. It can further be seen that the beam-like pore walls have respective pore inner surfaces 11. The total internal pore surface area as the accessible internal solid surface area is given as the sum of the individual beam-like surfaces and can be determined experimentally, for example, via differential adhesion measurements.

[0080] The method for powder metallurgical molding of a vascular clip, as diagrammatically represented in FIG. 12 by a flow chart, comprises the steps S101, S102 and S104 (illustrated as boxes outlined with a solid line) which are essential to the invention, and the further optional steps S203 and S205 (illustrated as boxes outlined with a dotted line). In a first step S101, a powder metallurgical feed material is provided. This is preferably carried out continuously or quasi-continuously, for example by mixing in a mixer and / or by kneading in a kneader and / or by extrusion in an extruder. In a subsequent step S102, this feed material is molded to form a near-net-shape green body in the form of a vascular clip. The grain size or grain size distribution of this green body may thereby be adjusted to be fine-grained and / or coarse-grained. This allows a specific influence on the desired porosity in the finished product of the vascular clip. A three-dimensional overmolding is thereby preferably carried out according to a predetermined sintering shrinkage. Thereby, in optional step S203, the green body is debindered to form a Brown body, preferably with overforming based on a pre-determined debindering shrinkage, if necessary. In the subsequent step S104, the compact, i.e. the green body or possibly the Brown body debindered in the optional debindering step S203, is sintered to form the finished vascular clip. Preferably, a post-processing of the sintered vascular clip may also be performed in optional step S205. This is preferably a surface finishing and / or coating, especially of the pore inner surface portions. [Explanation of symbols]

[0081] 1 Stoma 2 beams 100, 200 Surgical Vascular Clips 110, 210 First holding arm portion 111, 211 First clip inner surface part 120, 220 Second holding arm part 121, 221 Second clip inner surface part 130, 230 Connection part 131, 231 Third clip inner surface part 140, 240 closed part 11 Pore inner surface 50 Pore entrance height

Claims

1. 1. A surgical vascular clip, such as a ligation clip or an aneurysm clip, for closing a hollow organ such as a blood vessel, comprising: having elongated first and second retaining arm portions; the first and second retention arm portions are or can be flexibly interconnected at one end by a connecting portion of the vascular clip; the first and second holding arm portions are provided at their other ends with respective closing portions, in which the mutually facing inner clip surfaces of the first and second holding arm portions can be brought closer to each other starting from an open position at a greater distance from each other to a closed position and can be connected to each other; said surgical vascular clip forming a rolled U-shape or V-shape; at least one clip inner surface portion of said vascular clip made of vascular clip material has an open porosity design having at least one pore integrally formed in said vascular clip material, thereby forming at least one open porous clip inner surface portion; The connecting portion is made of a solid material, The at least one pore has a pressure stable pore structure and / or is relatively constant between the open and closed positions.

2. The at least one open porous clip inner surface portion is a first clip inner surface portion disposed on the first retention arm portion; and / or a second clip inner surface portion disposed on the second retention arm portion; and / or a third clip inner surface portion disposed at the connecting portion; 2. The surgical vascular clip of claim 1, wherein said surgical vascular clip is provided as a

3. 3. The surgical vascular clip of claim 1 or 2, wherein said vascular clip is at least 60 percent open porosity or porous by volume.

4. the vascular clip is open or porous by volume up to 70 percent; and / or the vascular clip comprises at least one non-open porous inner clip surface portion of the vascular clip; and / or At least a section of the outer clip surface portion of the vascular clip is made of a solid material; and / or 3. The surgical vascular clip according to claim 1 or 2, wherein said at least one pore is designed as a lateral drainage device.

5. the at least one pore has a first pore size, and / or, if the at least one pore is a plurality of the pores, the plurality of pores has an average first pore size, and the first pore size and / or the average first pore size are at a pore inlet height of a corresponding one of the open porous clip inner surface portions, 0.01 mm to 0.2 mm, and / or 5. The surgical vascular clip according to claim 1, wherein the retention arm width is between 1% and 35% of a determinable retention arm width in a transverse direction of a central portion of the first and / or second retention arm portions.

6. the at least one pore is capillary; and / or 6. The surgical vascular clip of claim 1, wherein when said at least one pore is a plurality of said pores, said plurality of said pores form a co-continuous pore structure between one another.

7. 7. The surgical vascular clip of claim 1, wherein said at least one pore comprises a pore inner surface portion that is hydrophilic and / or wettable by an aqueous fluid phase.

8. 8. The surgical vascular clip according to claim 1, wherein said at least one pore receives and / or removes and / or absorbs an ambient fluid phase comprising components of body fluids into said pore by capillary action when said surgical vascular clip is applied to said hollow organ or when said surgical vascular clip is used to close said hollow organ.

9. 9. The surgical vascular clip of claim 1, wherein a void volume fraction and / or volume porosity of said at least one pore at said inner clip surface portion relative to an adjacent clip volume fraction is between 30% and 88%.

10. A pore inner surface portion of the at least one pore is open-porous having micropores of a smaller average second pore size, the average second pore size being at a micropore inlet height of the pore inner surface portion: between 1% and 20% of the first pore size; and / or 6. The surgical vascular clip of claim 5, wherein the diameter is from 1 micrometer to 10 micrometers.

11. The following materials or powder metallurgy materials: Metallic materials according to ISO 5832 standard for manufacturing surgical implants, and / or Titanium or titanium alloys, and / or Tantalum or a tantalum alloy, and / or low alloy steel for heat treatment, tool steel, stainless steel, and / or Other alloys, 11. The surgical vascular clip of claim 1, comprising:

12. 12. The surgical vascular clip of any one of claims 1 to 11, comprising a porous metal produced by powder metallurgy molding processes and / or a porous metal as a foam-like metal compact.

13. A medical product set for storing, transporting, and / or sterilizing vascular clips, comprising: A plurality of the vascular clips according to any one of claims 1 to 12, an identification label corresponding to each of said vascular clips; and / or 13. A medical product set, further comprising an applicator adapted to fit the vascular clip of any one of claims 1 to 12.

14. 1. A powder metallurgy molding method for manufacturing a vascular clip, comprising: Providing a powder metallurgy feed material, for example by mixing and / or kneading and / or extruding; forming a near net shape fine-grained and / or coarse-grained green body in the form of said vascular clip and shaping said feed material; and c. sintering the green body to form a finished vascular clip according to any one of claims 1 to 12.

15. The forming step comprises the steps of: By powder injection molding and / or powder compaction in a molding tool; and / or In additive manufacturing processes, and / or In a continuous manufacturing process, extrusion 15. The powder metallurgy molding method of claim 14, wherein the powder metallurgy molding method is carried out.

16. 16. The powder metallurgy molding method of claim 14 or 15, wherein the provided powder metallurgy feed material has a filler content based on metal powder of less than 60 volume percent.

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