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Clip cutting device to cut body tissue and place staple on at least one side of cut line; has clamp head with staples and pressure plate part, with collagen and fibrin fleece underlay covering staples

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Publication number
DE19924311A1
DE19924311A1 DE1999124311 DE19924311A DE19924311A1 DE 19924311 A1 DE19924311 A1 DE 19924311A1 DE 1999124311 DE1999124311 DE 1999124311 DE 19924311 A DE19924311 A DE 19924311A DE 19924311 A1 DE19924311 A1 DE 19924311A1
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Prior art keywords
clamp
staples
tissue
device
part
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DE1999124311
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German (de)
Inventor
Walter A Rau
Emmanuil Berstein
Michail Perelman
Andrej Zikow
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Walter A Rau
Emmanuil Berstein
Michail Perelman
Andrej Zikow
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0684Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
    • A61B17/1155Circular staplers comprising a plurality of staples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292Reinforcements for staple line, e.g. pledgets

Abstract

The device has two moving parts (15), which clamp the body tissue. One part has a clamp head (15) with a number of staples. The other part has a clamp pressure plate to secure the staples to the tissue. At least one of the moving parts has an underlay of collagen and fibrin fleece (15.1) or a similar air- and fluid-tight material, which extends along the staple arrangement. An Independent claim is included for an additional component for a clamp cutting device.

Description

Die Erfindung betrifft ein Klammerschneidegerät nach dem Ober begriff des Anspruchs 1 sowie eine Zusatzkomponente für ein solches. The invention relates to a staple-cutting apparatus according to the preamble of claim 1 and an additional component of such.

Zur Durchtrennung von Körpergewebe bei gleichzeitiger Gewähr leistung der Blutstillung im durchtrennten Gewebe sind ver schiedene Nähapparate vorgeschlagen worden, von denen einer der ersten der chirurgische Nähapparat nach Petz ist. For cutting through body tissue while warranty hemostasis in the severed tissue ver different Nähapparate have been proposed, one of which is the first of the surgical suturing apparatus as Petz. Modifika tionen dieses Nähapparates werden heute - insbesondere als sogenannte "Einmalgeräte" (zur Verwendung in nur einer Operation) - von verschiedenen Firmen angeboten, sind im alltäglichen chirurgischen Einsatz und haben dort einen weiten Anwendungsbereich gefunden. Modifika functions this Nähapparates today - especially as so-called "one-off devices" (for use in only one operation) - offered by different companies, are in everyday surgical use there and have found a wide range of applications. Sie erleichtern in vielfältigen Anwendungsfällen das Mobilisieren, Resezieren, Anastomosieren sowie den Verschluß von Haut und Faszie auf sehr flexible Weise und erfordern gegenüber früher praktizierten Techniken vielfach nur minimale Änderungen der chirurgischen Vorgehensweise. They facilitate in a variety of applications, mobilizing, resecting, anastomosing and the closure of skin and fascia in a very flexible manner and require over previously practiced techniques often only minimal changes to the surgical procedure. Sie bieten wesentliche Vorteile hinsichtlich einer signifikanten Verkürzung der Operationszeit und der Anästhesiedauer sowie einer Verringerung des Blutverlustes und einer Erleichterung der postoperativen Wundheilung. They offer significant advantages in terms of a significant reduction of the surgical time and anesthesia time and a reduction in blood loss and facilitate postoperative wound healing. Die bekannten Klammernaht- bzw. Klammerschneidegeräte sorgen insbesondere für einen ausgezeich neten Wundverschluß vor der Resektion, wodurch intra-perito neale Verunreinigungen vermieden werden. The known Klammernaht- or clip cutters ensure particularly for a magnificent P Neten wound closure prior to resection, making intra-perito neale spoilage. Durch spezielle Klammerformen wird zum einen eine Blutstillung gewährleistet, andererseits jedoch eine weitere Blutversorgung der Schnitt ränder durch die Klammerreihe gewährleistet, wodurch die Wundheilung gefördert wird und Nekrosen verhindert werden. By special bracket forms a hemostasis is firstly ensured, but on the other hand guarantees a more blood supply to the cutting edges through the row of staples, whereby wound healing is promoted, and necrosis can be prevented.

Diese Geräte waren ursprünglich für die Durchtrennung von Hohlorganen, speziell im Bereich des Magen-Darm-Traktes, entwickelt worden, werden jedoch mittlerweile auch zur Durch trennung von parenchymatösen Organen und für Resektionen im Bereich der Lunge angewandt. These devices were originally developed for the severing of hollow organs, especially in the area of ​​the gastrointestinal tract, however, be applied now also for through separation of parenchymal organs and resections in the lung. Bei diesem Einsatz der genannten Geräte, also auf dem Gebiet der Thorax-Chirurgie, hat sich gezeigt, daß die Klammernahtreihe auf dem im Organismus ver bleibenden Organabschnitt durchlässig für Blutbestandteile und - was im Falle einer Lungenresektion besonders kritisch ist - für Luft ist. In this use of the mentioned equipment, so in the field of thoracic surgery, has been shown that the staple line for blood components and in the published in the organism permanent organ section permeable - which in the case of a lung resection is especially critical - for air. Eine mit den bekannten Geräten erzeugte Klammer nahtreihe ist also unmittelbar nach der Operation nicht primär dicht, so daß bei Operationen im Bereich der Lunge die Einlage einer Thoraxdrainage erforderlich wird und sich der stationäre Verlauf verlängern kann. A bracket produced with the known devices suture line is thus not directly primary sealing after the operation, so that the insertion of a chest tube is required for operations in the region of the lung and the steady course may be longer.

Aus diesem Grunde kann in der offenen Chirurgie seit längerem die Wundfläche zusätzlich mit aus körpereigenen Materialien gewonnenen Substanzen, wie Fibrin und/oder Kollagen, versiegelt werden. For this reason, the wound surface can also be sealed with recovered from endogenous materials substances such as fibrin and / or collagen in open surgery for some time. In der entsprechenden Praxis hat sich gezeigt, daß zwar die Schnittfläche selbst in der Regel durch die Klammernaht reihe blut- und luftdicht verschlossen wird, aber die Klammer nahtreihe selbst, also die Eintrittsstelle der Klammern in das Gewebe, einen besonders kritischen Bereich bildet, der einer zusätzlichen Sicherung bedarf. In the corresponding Practice has shown that although the cut surface itself is usually row by the stapling is blood and hermetically sealed, but the staple line itself, that is the entry point of the staples in the tissue, forms a particularly critical area of ​​a additional security needs. In der offenen Chirurgie läßt sich diese Sicherung durch Auflegen eines Fibrin- bzw. Kollagenschwammes (kommerziell erhältlich zum Beispiel unter der Produktbezeichnung TachoComb®) noch relativ leicht aus führen, jedoch sind die erwähnten Probleme in der minimal invasiven Chirurgie nicht ohne weiteres zu lösen. In open surgery, these securing can still be relatively easy to carry out (commercially available, for example under the product TachoComb®) by applying a fibrin or collagen sponge, however, the problems mentioned in the minimally invasive surgery can not be solved easily.

Zur Applikation von Kollagen-, Fibrin- oder kombinierten bzw. ähnlichen Materialien nach Anlegen einer Klammernahtreihe bei der minimal invasiven Chirurgie wird daher in R. Carbon et al: "Aktuelle Aspekte thorakoskopischer Fibrinklebung in der Kinderchirurgie", Minimal Invasive Medizin 7 (2), S. 55-64 (1996), sowie in R. Carbon: "Minimal invasives Gewebemanagement in der Kinderchirurgie", Medical Tribune 35(1/2), S. 8-10 (1998) ein spezieller Applikator beschrieben. For application of collagen, fibrin or combined or similar materials by applying a staple line in minimally invasive surgery is therefore in R. Carbon et al: "Current aspects thoracoscopic fibrin in pediatric surgery," Minimally Invasive Medicine 7 (2) S. 55-64 (1996) and in R. carbon: "minimal invasive tissue management in pediatric surgery," Medical Tribune 35 (1/2), pp 8-10 (1998), a special applicator described. Dieser Applikator wird nach dem Anlegen einer Klammernahtreihe mittels eines herkömmlichen Klammerschneidegerätes (auch bezeichnet als "Linear Cutter" oder "Stapler") eingesetzt, wobei ein fibrin ogen-imprägniertes Kollagenvlies zu der zu versiegelnden Stelle geführt und über dieser abgerollt wird. This applicator is made by the application of a staple line by means of a conventional staple cutting apparatus (also referred to as "Linear Cutter" or "stacker"), where a fibrin ogen-impregnated collagen fleece is guided to the to be sealed position and rolled over it. Dieser Applikator und das mit ihm mögliche Vorgehen haben gegenüber ersten Ansätzen, bei denen ein Stück mit Kleber beschichtetes Kollagenvlies zunächst mittels eines ersten Applikators zur Applikationstelle gebracht und dort anschließend mittels zweier Faßzangen abgerollt wurde, eine deutliche Vereinfachung gebracht und die nachträgliche Versiegelung von Klammernähten in der minimal invasiven Chirurgie praktikabel gemacht. This applicator and the possible with him procedure have opposite first approaches was where placed a piece of adhesive-coated collagen fleece first by means of a first applicator for the application site and then unrolled there by means of two grasping forceps, brought a significant simplification and subsequent sealing of staple seams in the made minimally invasive surgery feasible.

Gleichwohl ist die nachträgliche Versiegelung von Klammer nahtreihen von Hand in der offenen Chirurgie, aber insbesondere unter Anwendung eines zusätzlichen, speziellen Applikators in der minimal invasiven Chirurgie, noch relativ umständlich, da sie jedenfalls zusätzliche Handhabungen während der Operation und in der minimal invasiven Chirurgie zu dem ein zusätzliches Gerät erfordert. Nevertheless, the subsequent sealing clamp is approaching rows by hand in open surgery, especially using an additional special applicator used in minimally invasive surgery, is still relatively cumbersome, at least additional handling during surgery and in minimally invasive surgery as they the requires an additional device.

Bei den bekannten Verfahren wird zudem das Fibrin- oder Kollagenvlies nicht oder nur relativ unvollkommen fixiert, weshalb sekundäre Dislokationen des Vlieses nicht sicher auszuschließen sind. In the known method, the fibrin or collagen fleece is also not or only imperfectly relatively fixed, and therefore secondary dislocations of the web are not securely excluded.

Der Erfindung liegt daher die Aufgabe zugrunde, eine Vor richtung anzugeben, mit der eine Versiegelung einer mit einem Klammerschneidegerät erzeugten Nahtreihe auf einfachere Weise erfolgen kann. The invention is therefore the object of a specified ago direction, with a sealing a seam series produced with a clamp cutter can be made more easily.

Diese Aufgabe wird durch ein Klammerschneidegerät mit den Merkmalen des Anspruchs 1 bzw. durch eine Zusatzkomponente mit den Merkmalen des Anspruchs 10 gelöst. This object is achieved by a clamp cutter with the features of claim 1 and by an additional component with the features of claim 10.

Die Erfindung schließt den wesentlichen Gedanken ein, eine zuverlässige Versiegelung einer Klammernahtreihe zugleich mit deren Anlegen, statt wie bisher in einem nachträglichen Ver siegelungsschritt, vorzunehmen. The invention includes the essential idea of ​​a, a reliable sealing of a staple line simultaneously with the application, instead of sealing step as before in a subsequent Ver to make. Sie schließt weiterhin den Gedanken ein, zu diesem Zweck die bekannten Klammerschneide geräte so weiterzuentwickeln, daß sie diese gleichzeitige Versiegelung leisten können. You still includes the idea, device to further develop the known clamp cutter for this purpose that they can afford these simultaneous sealing. Die vorgeschlagene Weiterbildung der Konstruktion der bekannten Klammerschneidegeräte kann zum einen die Form eines verbesserten Klammerschneidegerätes und zum anderen die Form einer Zusatzkomponente zu einem bekannten Gerät dieser Art haben. The proposed development of the construction of the known clip clippers can on the one hand take the form of an improved clamp cutting device and on the other the form of an additional component to a known device of this kind.

Die konstruktive Fortbildung sieht vor, eine Lage eines flüssigkeits- und luftdichten sowie insbesondere blutstillenden Materials, speziell ein Fibrin- oder Kollagenylies oder ein funktionell gleichwertiges synthetisches oder biodegradierbares Material, unmittelbar am Klammerkopf und/oder der Klammeran druckplatte anzubringen, so daß dieses beim Ausstoßen der Klammern aus dem Klammerkopf und beim Umlegen an der Klammer andruckplatte zusammen mit dem Gewebe von den Klammern durch stoßen und durch diese am Gewebe fixiert wird. The constructive training provides a layer of liquid-tight and airtight and in particular hemostatic material, especially a fibrin or Kollagenylies or a functionally equivalent synthetic or biodegradable material, directly on the stapling head and / or the Klammeran to attach the printing plate, so that this is the during the ejection staples from the staple head and the folding of the clamp pressure plate with the fabric of the brackets pierced and it is fixed to the tissue.

Bevorzugt werden sowohl der Klammerkopf (das Klammermagazin) als auch die Klammerandruckplatte mit der genannten Zwischen lage versehen. Preference is given to both of the stapling head (the staple cartridge) and the clamp edge pressure plate provided with said intermediate layer. Die Klammern treten durch die am Klammerkopf befindliche erste Zwischenlage, erfassen dann das Gewebe und treten beim Austritt aus demselben durch die zweite Zwischen lage, die sich an der Klammerandruckplatte befindet. The staples pass through the stapling head located at the first intermediate position, then enter the tissue and emerge at the outlet of the same through the second intermediate position, which is located at the edge clamp pressure plate. Es wird also beim Schließen des Klammerschneidegerätes auf beide Seiten des zu klammernden und zu durchtrennenden Gewebes in der bevor zugten Ausführung je eine Lage des flüssigkeits- und luftdich tenden Materials aufgebracht und zuverlässig fixiert. It is therefore upon closing the clamp cutting device on both sides of the to be stapled and to be severed tissue in the prior ferred design depending applied a layer of liquid and air you Tenden material and reliably fixed. Indem die Klammern an ein und denselben Punkten durch die Zwischenlagen und das Gewebe hindurch treten, werden die Durchtrittspunkte allseitig primär blut- und luftdicht versiegelt, wodurch die Hämostase und Pneumostase am Durchtrennungsbereich entscheidend gefördert wird. By making the brackets occur at one and the same points by the intermediate layers and the fabric therethrough, the passage points are sealed on all sides primarily blood and airtight, whereby the hemostasis and pneumostasis the transection area is significantly promoted. Hiermit wird letztlich die Komplikationswahr scheinlichkeit deutlich gesenkt und eine wesentliche Verkürzung der Nachoperations-Periode erreicht. This complication perception will ultimately probability significantly reduced and reaches a significant shortening of the post-operation period Auditions.

Bei der bevorzugten Ausführung mit je einer Lage des Kollagen- bzw. Fibrinvlieses oder ähnlichen Materials am Klammermagazin und der Klammerandruckplatte sind die beiden Lagen insbesondere V-förmig miteinander verbunden oder einstückig gefertigt und V-förmig gefaltet und werden in dieser Form in die geöffneten Schenkel des Klammerschneidegerätes eingesetzt. In the preferred embodiment, each with a layer of the collagen or fibrin, or similar material to the staple cartridge and the staple edge thrust plate, the two layers are in particular V-shaped interconnected, or manufactured in one piece and V-folded and are in this form in the open limb of the clip clipping device used. Hierzu haben die beiden Schenkel des V-förmigen Materials zweckmäßigerweise jeweils ein Halte- oder Tragelement, die auf die freien Enden des Klammerkopfes bzw. der Klammerandruckplatte aufsetz- bzw. aufsteckbar ist. To this end, the two legs of the V-shaped material expediently in each case a holding or supporting member, the landing on the free ends of the staple head or the staple edge jerk plate and reassembled.

Speziell bei einem von Anfang an entsprechend der vorge schlagenen Lösung konstruierten Klammerschneidegerät kann der eine Schenkel der V-förmigen Zwischenlage auch fest am Klammer magazin angebracht sein, während nur der andere Schenkel einen Halter zum Fixieren an der Klammerandruckplatte aufweist. Specifically, in a constructed from the beginning according to the-proposed solution clamp cutter of the one leg of the V-shaped liner can be attached to the staple cartridge also fixed while only the other leg has a holder for fixing to the clamp rim pressure plate.

Die vorgeschlagene Lösung ist in bevorzugten Ausführungen an bekannte Klammerschneidegeräte für die offene sowie die minimal invasive Chirurgie angepaßt. The proposed solution is adjusted in preferred embodiments of known clamp cutters for open and minimally invasive surgery. In einer ersten, besonders viel fältig einsetzbaren Ausführung sind die aufeinander zu bewegba ren Teile des Gerätes um einen gemeinsamen Drehpunkt schwenk bare Schenkel, von denen einer ein langgestrecktes Klammer magazin trägt und der andere eine an dessen Form angepaßte Klammerandruckplatte bildet bzw. trägt, und die Lage des flüssigkeits- und luftdichtenden Materials hat eine der Form des Klammermagazins entsprechende Streifenform. are in a first, particularly much TION CAREFULLY insertable embodiment the mutually bewegba ren parts of the device about a common pivot point pivotally bare legs, one of which carries an elongate staple magazine and the other is adapted to the shape clamp rim pressure plate forms or carries, and position of the liquid- and air-sealing material has a shape of the staple cartridge corresponding stripe shape. In einer seltener eingesetzten, aber gleichwohl für bestimmte Eingriffe unverzichtbaren Ausführung sind die aufeinander zu bewegbaren Teile rotationssymmetrisch und längs einer gemeinsamen Mitten achse verschieblich und das Klammermagazin sowie - daran angepaßt - die Lage des flüssigkeits- und luftdichtenden Materials haben im wesentlichen eine Ringform. In a rare used, but nevertheless indispensable for certain interventions embodiment the mutually movable parts are rotationally symmetrical and along a common middle axis displaceable and the staple cartridge, and - adapted to - the position of the liquid- and air-tight material having substantially a ring shape.

Die Erfindung schließt auch die Bereitstellung einer Zusatz komponente zur Ausrüstung vorhandener Klammerschneidegeräte mit der erwähnten Zwischenlage bzw. den Zwischenlagen ein. The invention also includes the provision of an additional component to equip existing clip cutting device with said intermediate layer or the intermediate layers. Für die erwähnte weit verbreitete Ausführung eines Klammerschneide gerätes mit zwei langgestreckten Schenkeln hat diese Zusatz komponente zweckmäßigerweise die bereits erwähnte Form einer V-förmig gefalteten oder verbundenen Materiallage mit je einer Haltekappe bzw. -klammer an jedem der Schenkel des "V". For the widespread embodiment of a staple cutting apparatus mentioned with two elongated legs has this additional component advantageously the above-mentioned form of a V-shaped folded or related sheet of material, each with a retaining cap or -Bracket at each of the legs of the "V". Für ein Klammerschneidegerät mit ringförmigen Klammerkopf wird die Materiallage (wie oben bereits erwähnt) ebenfalls Ringform haben und zweckmäßigerweise auch einen mindestens ringsegment förmigen Halter aufweisen, mit dem sie an dem Klammerkopf bzw. der Klammerandruckplatte fixiert wird. For a staple-cutting apparatus with annular stapling head, the material layer is (as above mentioned), also have annular shape, and suitably also comprise a least ring segment-shaped holder with which it is fixed to the stapling head and the staple edge pressure plate.

Diese Zusatzkomponenten sind sowohl für Klammerschneidegeräte für die offene als auch für die minimal invasive Chirurgie ausführbar, und zwar insbesondere in Anpassung an bekannte und bewährte Konstruktionen und Abmessungen. These additional components can be executed both clip-slicers for the open as well as minimally invasive surgery, particularly in adapting to known and proven designs and dimensions. Die erwähnten Kappen bzw. Halter - die in der Ausführung zum Aufschieben auf die Schenkel eines V-artig öffnenden Klammerschneidegerätes auch als "Schlitten" bezeichnet werden können - bestehen bevorzugt aus Kunststoff oder Metall und sind mit der Zwischenlage (dem Vlies) derart verbunden, daß sie sich nach dem Legen der Klammernaht von der Zwischenlage trennen und am Klammer schneidegerät verbleiben, so daß sie mit diesem wieder aus dem Körper entfernt werden. The caps mentioned or holder - which can be also referred to as "slide" in the embodiment for pushing onto the legs of a V-like opening parenthesis cutting device - preferably consist of plastic or metal and are connected to the intermediate layer (the nonwoven) such that they separate after laying the staple of the intermediate layer and on the bracket remain cutting device, so that they are removed with this from the body.

Als Material für die flüssigkeits- und luftdichtende und ins besondere blutstillende Zwischenlage werden für diesen Zweck an sich bekannte Materialien verwendet, speziell Kollagen oder Fibrin bzw. Fibrinderivate und insbesondere Kombinationen aus diesen, wie sie in dem oben erwähnten Produkt TachoComb® (im wesentlichen bestehend aus Pferdesehnen-Kollagen und Fibrinogen vom Menschen) bzw. ähnlichen Produkten realisiert sind. As material for the liquid and air-sealing, and in particular hemostatic liner materials known for this purpose to be used, particularly collagen or fibrin or fibrin derivatives and particularly combinations of these, as (in the above-mentioned product TachoComb® consisting essentially of horse tendon collagen and fibrinogen are realized by man) or similar products. Es versteht sich, daß das Material mit geeigneten, insbesondere blutstillenden Wirkstoffen versehen sein kann, zudem kann auf der dem Körpergewebe zugewandten Oberfläche zusätzlich ein Fibrin-Kleber, beispielsweise im wesentlichen aus Human fibrinogen und Humanthrombin bestehend, vorgesehen sein. It is understood that the material can be provided with suitable, in particular hemostatic agents also can on the side facing the body tissue surface additionally a fibrin glue, fibrinogen, for example, substantially from human and human thrombin consisting be provided. Neben den genannten natürlichen sind auch funktionsgleiche syntheti sche Materialien einsetzbar. In addition to the mentioned natural and functionally identical syntheti specific materials are suitable.

Vorteile und Zweckmäßigkeiten der Erfindung ergeben sich im übrigen aus den Unteransprüchen sowie der nachfolgenden Beschreibung bevorzugter Ausführungsbeispiele anhand der Figuren. Benefits and advantages of the invention will appear from the subordinate claims and the following description of preferred embodiments using the figures.

Von diesen zeigen: Of these:

Fig. 1a-d Skizzen zur Erläuterung von Aufbau und Funktionsweise einer ersten Ausführungsform, Fig. 1a-d show diagrams illustrating the design and function of a first embodiment,

Fig. 2 eine Darstellung zur Erläuterung einer zweiten Ausführungsform und Fig. 2 is a diagram for explaining a second embodiment and

Fig. 3 eine Darstellung zur Verdeutlichung einer dritten Ausführungsform der Erfindung. Fig. 3 is a diagram for illustrating a third embodiment of the invention.

In Fig. 1a-1d sind Aufbau und Funktionsweise eines mit einem Zusatzteil zur Ausführung der Erfindung nachgerüsteten endoskopischen Klammerschneidegerätes 1 skizziert. In Fig. 1a-1d structure and operation are outlined one with a supplementary part of the implementation of the invention retrofitted endoscopic clip cutting device 1. Fig. 1a zeigt den vorderen Teil des Klammerschneidegerätes 1 mit einem Schaft 3 , aus dem ein Klammerkopf (Klammermagazin) 5 , das dort auswechselbar befestigt ist, zusammen mit einer Klammerandruck platte 7 ausfahrbar ist. FIG. 1a shows the front part of the staple-cutting apparatus 1 having a shaft 3, from which a stapler head (staple magazine) 5, which is fastened there interchangeable plate together with a staple cutting force is extendable. 7 Beim Ausfahren des Klammerkopfes 5 und der Klammerandruckplatte 7 aus dem Schaft 3 wird die Klammer andruckplatte gegenüber dem Klammerkopf nach oben in die in Fig. 1a gezeigte Öffnungsstellung ausgeschwenkt. Upon extension of the clip head 5 and the clamp edge pressure plate 7 of the shaft 3, the clip is pressing plate relative to the stapling head upwardly to the position shown in Fig. 1a open position pivoted. In dieser Stellung kann mit dem Klammerschneidegerät 1 ein Körpergewebe abschnitt zwischen Klammerkopf 5 und Klammerandruckplatte 7 ergriffen und durch Zurückziehen beider Schenkel in den Schaft 3 erfaßt werden. In this position, a body tissue can with the staple cutter portion 1 gripped between stapling head 5, and clamp the edge of pressure plate 7 and are detected by retracting both legs to the shaft. 3 Durch Auslösen des - insoweit bekannten und dem Chirurgen in seiner Handhabung vertrauten - Gerätes wird anschließend durch ein im Klammerkopf 5 angeordnetes Messer das Gewebe durchtrennt und durch Ausdrücken der Klammern aus dem Klammermagazin gegen die Klammerandruckplatte beidseits des Schnittes eine Klammernaht gelegt. By triggering the - so far known and familiar to the surgeon in its handling - equipment is then cut through the tissue by a valve disposed in the stapling head 5 knives and set a staple by expressing the staples from the staple cartridge against the staple edge pressure plate on either side of the cut.

Fig. 1b zeigt ein Klammernaht-Zusatzteil 9 für das Klammer schneidegerät 1 aus Fig. 1a. FIG. 1b shows a stapling-attachment bracket 9 for the cutting device 1 of Fig. 1a. Das Zusatzteil 9 umfaßt ein V-förmig gefaltetes Kollagen-/Fibrin-Vlies 13 , an dessen freien Enden jeweils eine Halteklammer 11 a, 11 b angebracht ist, die zum Aufstecken auf den Klammerkopf 5 bzw. die Klammerandruck platte 7 des Klammerschneidegerätes 1 nach Fig. 1 ausgebildet sind und das Kollagen-/Fibrin-Vlies 13 dort beim Einführen des Schaftes 3 in den Körper eines Patienten sicher halten. The additional part 9 includes a V-shaped folded collagen / fibrin fleece 13, on whose free ends in each case a support bracket 11a, 11b is attached to b, which for attachment to the stapling head 5 and the clamp edge pressure plate 7 of the staple-cutting apparatus 1 shown in Figure are formed. 1 and hold the collagen / fibrin fleece 13 there during insertion of the shaft 3 in the body of a patient safely. Die Verbindung zwischen dem Kollagen-/Fibrin-Vlies 13 und den Halteklammern 11 a, 11 b einerseits sowie zwischen den Halte klammern und dem Klammerkopf 5 bzw. der Klammerandruckplatte 7 andererseites ist derart ausgebildet, daß sich nach dem Legen einer Klammernaht unter Einsatz des Zusatzteiles 9 das Vlies 13 von den Halteklammern 11 a, 11 b löst, während diese am Klammer schneidegerät 1 verbleiben und mit diesem zusammen wieder aus dem Körper des Patienten herausgeführt werden. The connection between the collagen / fibrin fleece 13 and the retaining clips 11 a, 11 b on the one hand and cling between the support and the staple head 5 and the clamp edge pressure plate 7 on the other seites is formed such that after laying of a staple using the additional portion 9, the web 13 of the retaining clips 11a, b triggers 11, while this cutting device to the clamp remain 1 and be taken out together from the body of the patient with this.

In Fig. 1c ist skizziert, wie das Zusatzteil 9 in die V-förmige Öffnung zwischen dem Klammerkopf 5 und der Klammerandruckplatte 7 des Klammerschneidegerätes 1 eingesetzt wird. In Fig. 1c is outlined how the additional part is inserted into the V-shaped opening between the staple head 5 and the clamp edge pressure plate 7 of the staple-cutting apparatus 1 9.

In Fig. 1d ist schematisch dargestellt, wie das Fibrinvlies 13 durch eine Nahtklammer 5 a aus dem Klammermagazin 5 beidseits eines Körpergewebsabschnittes T fixiert wird und dabei die - in der Figur mit Pfeilen bezeichneten - Ein- bzw. Durchtritts stellen der Klammer 5 a im Körpergewebe T flüssigkeits- und luftdicht versiegelt. In Fig. 1d is illustrated schematically how the fibrin web 13 is fixed by a suture clip 5a of the staple magazine 5 on both sides of a Körpergewebsabschnittes T and thereby the - denoted in the figure with arrows - input or passage provide the bracket 5a in the body tissue T liquid- and air-tight sealed.

Fig. 2 zeigt ein modifiziertes Klammermagazin zum Einsetzen in ein Klammerschneidegerät 1 , wie es in Fig. 1a dargestellt ist. Fig. 2 shows a modified staple cartridge for insertion into a staple cutter 1, as shown in Fig. 1a. Es ist zu erkennen, daß hier eine zu Fig. 1b ähnliche V-förmige Ausbildung eines Kollagen-/Fibrinvlieses 15.1 vorgesehen ist, wobei der eine Schenkel des "V" ohne zusätzliches Halteelement unmittelbar mit einem Grundkörper 15.2 des Klammermagazins verbunden ist, während der freie Schenkel eine ringförmige Halteklammer 15.3 trägt, die zum Aufschieben auf die Klammer andruckplatte 7 ( Fig. 1a) ausgebildet ist. It will be appreciated that a is provided to Fig. 1b similar V-shaped formation of a collagen / fibrin 15.1 here, wherein the one leg of the "V" is connected directly without additional support member having a base body 15.2 of the staple cartridge, while the free leg an annular retaining clamp 15.3 wears, the pressure plate for pushing onto the bracket 7 (Fig. 1a) is formed. Auch bei dieser Ausführung ist das flüssigkeits- und luftdichtende Vlies 15.1 so am Klammermagazin 15 bzw. der Halteklammer 15.3 fixiert, daß es nach dem Legen der Klammernaht durch die Klammern am Körpergewebe fixiert ist und sich beim Entfernen des Klammer schneidegerätes 1 vom Klammermagazin-Grundkörper 15.2 bzw. von dem (an der Klammerandruckplatte verbleibenden) Haltering 15.3 löst. Also in this embodiment that is liquid- and air-tight nonwoven 15.1 so fixed to the staple cartridge 15 and the support bracket 15.3 that it is fixed by the exposure of the staple by the clips to body tissue and removal of the staple is cutting apparatus 1 from the staple cartridge body 15.2 or dissolving of the (remaining at the edge clamp pressure plate) retainer ring 15.3.

In Fig. 3 ist skizzenartig ein anderes, an sich bekanntes Klammernaht- bzw. Klammerschneidegerät 21 dargestellt, bei dem die Erfindung in einer anderen Ausführung angewandt wird. In Fig. 3 is a sketch another, illustrated per se known Klammernaht- or clamp cutter 21, in which the invention is applied in another embodiment. Dieses Klammerschneidegerät 21 zur Herstellung kreisförmiger Schnitte und Klammernähte umfaßt - grundsätzlich ähnlich wie das Klammerschneidegerät 1 nach Fig. 1a - einen Schaft 23 , in dem ein zweiteiliger zentraler Führungsstab 24 a, 24 b angeordnet ist, über den ein Klammerkopf (Klammermagazin) 25 gegenüber am distalen Ende des Schaftes 23 angebrachten Klammerandruckplatte 27 verschieblich geführt ist. This clamp cutter 21 comprises for the manufacture of circular sections and staple seams - generally similar to the clamping-cutting apparatus 1 shown in Fig. 1a - a shank 23 in which a two-part central guide rod 24 a, is arranged 24 b, through which a stapling head (staple magazine) 25 with respect to the distal end of the shaft 23 attached to staple the edge of pressure plate is displaceably guided 27th Die Funktion dieses Klammer schneidegerätes ist grundsätzlich ähnlich wie beim oben be schriebenen Klammerschneidegerät 1 , wobei beim hier gezeigten Gerät 21 die ringförmige Gestalt des Klammerkopfes 25 und der Klammerandruckplatte 27 (und eine entsprechende Ausbildung des hier nicht dargestellten Trennmessers) die erwähnte Ausbildung kreisförmiger Schnitte und Klammernähte ermöglicht. The function of this bracket is cutting apparatus basically similar to the above, be written clamp cutter 1, wherein the annular shape of the clip head 25 and the clamp edge pressure plate 27 in the illustrated here device 21 (and a corresponding configuration of the separating knife not shown here) the above-mentioned formation of circular sections and staple seams allows.

In der Figur ist gezeigt, wie zwei Kollagen- bzw. Fibrin-Ringe 29 a, 29 b, die auf jeweils einem elastischen Kunststoff- Haltering 28 a bzw. 28 b angebracht sind, in das geöffnete Klammerschneidegerät 21 eingesetzt werden. In the figure it is shown how two collagen or fibrin-rings 29 a, 29 b, which are mounted on a respective elastic plastic retaining ring 28 a and 28 b are inserted into the opened clamp cutter 21st Die Halteringe 28 a, 28 b sind so ausgebildet und mit den Vliesringen 29 a, 29 b verbunden, daß sie über die Umfangsränder des Klammerkopfes 25 bzw. der Andruckplatte 27 geschoben werden können und sich dort aufgrund ihrer Elastizität, insbesondere im Zusammenwirken mit einer entsprechenden Ausformung der Umfangsränder (die jedoch keine notwendige Voraussetzung einer korrekten Funktion ist), festhalten und nach dem Legen der Klammernaht von den Vlies ringen 29 a und 29 b lösen, so daß letztere auf der Klammernaht verbleiben, die Halteringe 28 a, 28 b jedoch mit dem Klammer schneidegerät 21 wieder aus dem Körper entfernt werden. The retaining rings 28 a, 28 b and formed the nonwoven rings 29 a, 29 b, in that they can be pushed over the peripheral edges of the clip head 25 and the platen 27 and there because of its elasticity, in particular in cooperation with a corresponding shaping the peripheral edges (but not a necessary prerequisite of a correct function is), hold and after laying the staple of the fabric rings 29 a and trigger 29 b, so that the latter remain on the stapler, the retaining rings 28 a, 28 b but with the staple cutter to be removed from the body 21 again.

Die Ausführung der Erfindung ist nicht auf die beschriebenen Ausführungsbeispiele beschränkt, sondern auch in einer Vielzahl von Abwandlungen, insbesondere hinsichtlich der konkreten Ge stalt des Klammerschneidegerätes - insbesondere von dessen Klammermagazin und Klammerandruckplatte - möglich. The embodiment of the invention is not limited to the embodiments described, but also in a variety of modifications, in particular with regard to the concrete Ge Stalt of the staple cutting device - in particular its staple cartridge and staple the edge of pressure plate - possible. Auch bei einem Klammerschneidegerät mit ringförmigen oder andersartig gestaltetem Klammerkopf kann die Zwischenlage bzw. eine der Zwischenlagen fest am Klammermagazin angebracht sein und zusammen mit diesem ausgeliefert werden. Even with a staple-cutting apparatus with annular or otherwise framed stapling head, the intermediate layer or one of the intermediate layers may be fixedly attached to the staple cartridge and are delivered together with this.

Bezugszeichenliste LIST OF REFERENCE NUMBERS

1 1

; ;

21 21

Klammerschneidegerät Clamp cutter

3 3

; ;

23 23

Schaft shaft

5 5

; ;

25 25

Klammerkopf (Klammermagazin) Stapling head (staple magazine)

5 5

a Nahtklammer a suture clip

7 7

; ;

27 27

Klammerandruckplatte Clammy edge pressure plate

9 9

Klammernaht-Zusatzteil Stapling-accessory

11 11

a, a,

11 11

b Halteklammer b retaining clip

13 13

Kollagen-/Fibrin-Vlies Collagen / fibrin fleece

15 15

Klammermagazin staple magazine

15.1 15.1

Kollagen-/Fibrin-Vlies Collagen / fibrin fleece

15.2 15.2

Klammermagazin-Grundkörper Staple cartridge body

15.3 15.3

Haltering retaining ring

24 24

a, a,

24 24

b geteilter zentraler Führungsstab b split central corporate office

28 28

a, a,

28 28

b Haltering b retaining ring

29 29

a, a,

29 29

b Vliesring b fleece ring
T Körpergewebsabschnitt T Körpergewebsabschnitt

Claims (13)

1. Klammerschneidegerät ( 1 ; 21 ) zum Durchtrennen von Körper gewebe (T) und zum Legen einer Klammernaht mindestens auf einer Seite der Trennlinie, welches zwei aufeinander zu bewegbare Teile ( 5 , 7 ; 15 ; 25 , 27 ) aufweist, zwischen denen das Körpergewebe ergriffen wird und von denen das eine einen Klammerkopf ( 5 ; 15 ; 25 ) mit einer Mehrzahl von Naht klammern ( 5 a) und das andere eine Klammerandruckplatte ( 7 ; 27 ) zum Umlegen der Nahtklammern am Körpergewebe aufweist, dadurch gekennzeichnet , daß mindestens der Klammerkopf oder die Klammerandruck platte eine sich über die Anordnung der Mehrzahl von Naht klammern erstreckende Lage ( 13 ; 15.1 ; 29 a, 29 b) eines flüssigkeits- und luftdichtenden Materials, insbesondere eines Fibrin- und/oder Kollagenvlieses oder funktionell einem solchen entsprechenden Materials, trägt. 1. staple-cutting apparatus (1; 21) for severing of body tissue (T) and for placing a staple on at least one side of the parting line comprising two towards each other movable parts (5, 7; 15; 25, 27) between which the body tissue is gripped, and one of which is a stapling head (5; 15; 25) having a plurality of suture clips (5 a) and the other is a staple edge thrust plate (7; 27), for turning over the suture clips to body tissue characterized in that at least the staple head or staple edge jerk plate a about the arrangement of the plurality of suture clips extending location (13; 15.1; 29 a, 29 b) of a liquid- and air-tight material, in particular a fibrin and / or collagen fleece or functionally such corresponding material , wearing.
2. Klammerschneidegerät nach Anspruch 1, dadurch gekennzeichnet, daß die aufeinander zu bewegbaren Teile ( 5 , 7 ; 15 ) als um einen gemeinsamen Drehpunkt schwenkbare Schenkel ausge bildet sind, die einen langgestreckten Klammerkopf ( 5 ; 15 ) bzw. eine an diese angepaßte Klammerandruckplatte ( 7 ) auf weisen, und daß die Lage ( 13 ; 15.1 ) des flüssigkeits- und luftdichtenden Materials Streifenform hat. 2. clamp cutter of claim 1, characterized in that the mutually movable parts (5, 7; 15) being a pivotable about a common pivot point legs are formed which an elongated clamp head (5; 15) or one of these matched staple edge pressure plate point (7), and in that the layer (13; 15.1) of the liquid- and air-tight material has a strip shape.
3. Klammerschneidegerät nach Anspruch 1, dadurch gekennzeichnet, daß die aufeinander zu bewegbaren Teile einen rotations symmetrischen Klammerkopf ( 25 ) und eine längs einer gemeinsamen Mittenachse diesem gegenüber verschiebliche Andruckplatte ( 27 ) aufweisen und die Lage ( 29 a, 29 b) flüssigkeits- und luftdichtenden Materials im wesentlichen Ringform hat. 3. clamp cutter of claim 1, characterized in that the mutually movable parts have a rotationally symmetrical clip head (25) and along a common center axis of this opposite displaceable pressure plate (27) and the position (29 a, 29 b) liquid and has airtight material substantially ring shape.
4. Klammerschneidegerät nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß an dem Klammerkopf ( 5 ; 15 ; 25 ) und der Klammerandruck platte ( 7 ; 27 ) jeweils eine Lage ( 13 ; 15.1 ; 29 a, 29 b) des flüssigkeits- und luftdichtenden Materials fixiert ist. 4. clip cutting device according to any one of the preceding claims, characterized in that on the stapling head (7; 27) (5; 15; 25) and the clamp edge pressure plate in each case one layer (13; 15.1; 29 a, 29 b) of the liquid and airtight material is fixed.
5. Klammerschneidegerät nach Anspruch 2 und 4, dadurch gekennzeichnet, daß die an Klammerkopf ( 5 ; 15 ) und Klammerandruckplatte ( 7 ) fixierten Lagen ( 13 ; 15.1 ) des flüssigkeits- und luftdich tenden Materials V-förmig zusammenhängen, insbesondere mit einander einstückig ausgebildet sind. 5. clip cutting device according to claim 2 and 4, characterized in that the at stapler head (5; 15) and clamp the edge of pressure plate (7) fixed layers (13; 15.1) are connected the liquid and air up Tenden material is V-shaped, in particular with each other integrally formed are.
6. Klammerschneidegerät nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß die Lage oder Lagen ( 13 ; 15.1 ) des flüssigkeits- und luftdichtenden Materials an einem auf den Klammerkopf ( 5 ) und/oder die Klammerandruckplatte ( 7 ) aufsetzbaren Träger ( 11 a, 11 b; 15.3 ) befestigt ist/sind. 6. clip cutting device according to any one of the preceding claims, characterized in that the layer or layers (13; 15.1) of the liquid- and air-tight material on one of the stapler head (5) and / or the staple edge thrust plate (7) attachable support (11 a, 11 b; 15.3) is / are fastened.
7. Klammerschneidegerät nach Anspruch 5 und 6, dadurch gekennzeichnet, daß an den freien Enden der V-förmigen Lage ( 13 ) je ein Träger ( 11 a, 11 b) vorgesehen ist, der auf den Klammerkopf ( 5 ) bzw. die Klammerandruckplatte ( 7 ) aufsetzbar, insbeson dere in Richtung ihrer Längserstreckung aufschiebbar, ist. 7. clip cutting device according to claim 5 and 6, characterized in that at the free ends of the V-shaped member (13) depending on a support (11 a, 11 b) is provided (on the stapling head (5) and the clamp edge pressure plate is placed 7), in particular pushed in the direction of its longitudinal extent.
8. Klammerschneidegerät nach einem der Ansprüche 1-6, dadurch gekennzeichnet, daß die Lage ( 15.1 ) des flüssigkeits- und luftdichtenden Materials mit einem auswechselbaren Klammermagazin ( 15 ) derart fest verbunden ist, daß sie sich beim Legen der Klammernaht zusammen mit den Klammern von diesem löst. 8. clip cutting device according to any one of claims 1-6, characterized in that the position (15.1) of the liquid- and air-tight material with a replaceable staple cartridge (15) is so securely connected that they while laying staple together with the brackets of this triggers.
9. Klammerschneidegerät nach Anspruch 3 und Anspruch 6, dadurch gekennzeichnet, daß die ringförmige Lage ( 29 a, 29 b) des flüssigkeits- und luftdichtenden Materials einen mindestens ringsegment förmigen Träger ( 28 a, 28 b) zum Fixieren am rotations symmetrischen Klammerkopf ( 25 ) und/oder der rotations symmetrischen Klammerandruckplatte ( 27 ) aufweist. 9. staple cutter of claim 3 and claim 6, characterized in that the annular layer (29 a, 29 b) of the liquid- and air-tight material an at least ring segment-shaped support (28 a, 28 b) for fixing the rotationally symmetrical clip head (25 ) and / or the rotationally symmetrical edge staple pressure plate (27).
10. Zusatzkomponente ( 9 ; 29 a, 29 b) für ein Klammerschneidegerät ( 1 ; 21 ) zum Durchtrennen von Körpergewebe (T) und zum Legen einer Klammernaht mindestens auf einer Seite der Trennlinie, welches zwei aufeinander zu bewegbare Teile ( 5 , 7 ; 25 , 29 ) aufweist, zwischen denen das Körpergewebe er griffen wird und von denen das eine einen Klammerkopf ( 5 ; 25 ) mit einer Mehrzahl von Nahtklammern und das andere eine Klammerandruckplatte ( 7 ; 27 ) zum Umlegen der Nahtklammern ( 5 a) am Körpergewebe aufweist, gekennzeichnet durch eine mindestens mit dem Klammerkopf oder der Klammer andruckplatte verbindbare, sich über die Anordnung der Mehrzahl von Nahtklammern erstreckende Lage ( 13 ; 29 a, 29 b) eines flüssigkeits- und luftdichtenden Materials, insbesondere eines Fibrin- und/oder Kollagenylieses oder funktionell einem solchen entsprechenden Materials, und einen mit der Lage verbundenen und an die Form des Klammerkopfes bzw. der Klammerandruckplatte angepaßten, auf diesen bzw 10. Additional component (9; 29 a, 29 b) for a staple-cutting apparatus (1; 21) for severing of body tissue (T) and for placing a staple on at least one side of the parting line comprising two towards each other movable parts (5, 7; 25, 29), between which the body tissue being attacked and one of which is a stapling head (5; 25) having a plurality of suture clips, and the other is a staple edge thrust plate (7; 27) for folding the suture clips (5 a) on the body tissue , characterized by a pressure plate at least with the staple head or the clip can be connected, over the arrangement of the plurality extending from suture clips layer (13; 29 a, 29 b) of a liquid- and air-tight material, in particular a fibrin and / or Kollagenylieses or functionally corresponding to such material and associated with a location and adapted to the shape of the staple head or the staple pressure plate edge, on these or . diese aufsetzbaren Träger ( 11 a, 11 b; . Attachable this support (11 a, 11 b; 28 a, 28 b). 28 a, 28 b).
11. Zusatzkomponente nach Anspruch 10, gekennzeichnet durch durch eine streifenförmige, V-förmig gefaltete oder aus zwei Streifen V-förmig verbundene Lage ( 13 ) des flüssigkeits- und luftdichtenden Materials und jeweils einen an den freien Enden der Lage angebrachten Träger ( 11 a, 11 b). 11. Additional component according to claim 10, characterized by, connected by a strip-shaped, V-shaped folded or from two strips of V-shaped layer (13) of the liquid- and air-tight material and each having a mounted at the free ends of the sheet support (11 a, 11 b).
12. Zusatzkomponente nach Anspruch 11, dadurch gekennzeichnet, daß die Träger ( 11 a, 11 b) zum Aufschieben auf den Klammerkopf ( 5 ) bzw. Klammerandruckplatte ( 7 ) eines Klammerschneidegerätes ( 1 ) ausgebildet sind, bei dem Klammerkopf und Klammerandruckplatte als um einen gemein samen Drehpunkt schwenkbare Schenkel ausgeführt sind. 12. Additional component according to claim 11, characterized in that the support (11 a, 11 b) for sliding onto the stapling head (5) and clamp the edge of pressure plate (7) of a clamping-cutting apparatus are formed (1), wherein the stapling head and clamp edge pressure plate as a seed common pivot pivotable legs are executed.
13. Zusatzkomponente nach Anspruch 10, dadurch gekennzeichnet, daß der Träger ( 28 a, 28 b) einer ringförmigen Lage ( 29 a, 29 b) aus flüssigkeits- und luftdichtendem Material ring- oder ringsegmentförmig ausgebildet ist. 13. ring- additional component according to claim 10, characterized in that the support (28 a, 28 b) an annular base (29 a, 29 b) of liquid- and luftdichtendem material or is formed of a ring segment.
DE1999124311 1999-05-27 1999-05-27 Clip cutting device to cut body tissue and place staple on at least one side of cut line; has clamp head with staples and pressure plate part, with collagen and fibrin fleece underlay covering staples Withdrawn DE19924311A1 (en)

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