WO2011089294A1 - Surgical stapling device - Google Patents

Surgical stapling device Download PDF

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Publication number
WO2011089294A1
WO2011089294A1 PCT/ES2011/070016 ES2011070016W WO2011089294A1 WO 2011089294 A1 WO2011089294 A1 WO 2011089294A1 ES 2011070016 W ES2011070016 W ES 2011070016W WO 2011089294 A1 WO2011089294 A1 WO 2011089294A1
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WO
WIPO (PCT)
Prior art keywords
legs
staples
closure
substantially flat
lines
Prior art date
Application number
PCT/ES2011/070016
Other languages
Spanish (es)
French (fr)
Inventor
Luis HERRERA NOREÑA
Original Assignee
Fundación Marqués De Valdecilla
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Filing date
Publication date
Application filed by Fundación Marqués De Valdecilla filed Critical Fundación Marqués De Valdecilla
Publication of WO2011089294A1 publication Critical patent/WO2011089294A1/en

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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
    • A61B17/072Surgical 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
    • 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
    • A61B17/068Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil
    • A61B2017/07264Stapler heads characterised by its anvil characterised by its staple forming cavities, e.g. geometry or material

Definitions

  • the present invention refers to a surgical suture system that can be applied, by means of the use of a device opportunely designed for this purpose, both in open surgery procedures and in endoscopic or laparoscopic interventions.
  • the mechanical suture devices commonly used, both in open and endoscopic or laparoscopic surgery comprise the application of more than one row of staples.
  • the rows of staples are arranged symmetrically on both sides of the cutting line in the linear suture devices, and only in the region external to the cutting line, in circular suture devices.
  • the staples used in these sutures have identical sizes and shapes, similarly happening with the staple formation holes that the anvil footprint presents, using this last to fold the ends of the staples when applying the stapling, in order to produce the curvature of the staples when closing the device and performing the suture.
  • the staples usually used to practice the suture in the intervened tissues are made of various materials and have a design with a typical shape consisting of a flat crown and two legs.
  • the design of the closure of the staples used in surgery is carried out in the form of "B", so that the legs are folded or rolled over the crown of the staple, but leaving a space between said components and the sutured tissue , facilitating the vascularization of said tissue and thus preventing its necrosis.
  • the aforementioned "B" shaped closure design is, today, a constant of the manufacturers of this type of devices, which presents few variations in the designs commercially in force today.
  • the "B" shaped closure is effective in achieving the purpose that it mainly pursues, that is, allowing vascularization of the sutured tissues, it also carries with it a disadvantage, especially relevant in thick tissue suture. Said drawback consists in the tendency to bleed at the edges of the suture closest to the cut line, once the tissue has been cut. This bleeding may lead, in practice, to cauterize, resurrect or, in non-infrequent cases, to have to intervene again, due to the hidden place of the suture or the late appearance of bleeding.
  • the surfaces used in the state of the art to shape the closure of surgical staples usually made by means of staple formation gaps engraved on an anvil that is part of the stapler, have partition walls greater than the separation distances between contiguous gaps, thus providing another pathway free of vascular penetration between the winding of the staple legs.
  • This arrangement in addition to the aforementioned separation between adjacent gaps, also favors bleeding from the free edge of the suture.
  • the current state of the art comprises some approaches 5 aimed at solving this problem, by means of surgical stapling systems based on the joint use of staples of different sizes, aimed at reducing post-surgical bleeding by means of a greater compression of the sutured tissue.
  • rado. Said company, together with different applications thereof, is, for example, reflected in the patent applications WO 03094747, US 4941623, EP 1915954 or EP 1964526. They describe, through different embodiments, the use of one or more rows of staples with modified shapes and lengths, favoring that some areas of tissue exhibit greater compression and, consequently, less bleeding.
  • the present invention is aimed at providing a more effective reduction of post-surgical bleeding, increasing the level of hemostasis by an occlusive and flat closure of the nearest staple row (s) to the cut line to be sutured. , applied by means of staples and an anvil conveniently designed for this purpose.
  • An object of the present invention is the design of a surgical suture device, preferably a stapler, which allows to avoid or reduce the bleeding that occurs in the treated region after a surgical intervention, and which can be used by means of suturing devices both Ineal as circular, independently of the applicator model used for the suture.
  • Another object of the invention is, as set forth above, a system based on the application of at least two rows of staples through which, in the row or rows closest to the cut line practiced, it is sutured using a type of clip that is closed by a substantially occlusive and substantially flat fold.
  • Said type of clips has a shape that facilitates, in conjunction with an appropriate anvil design, the substantially occlusive and substantially flat closure of the ends of the clip on its crown, thereby increasing the compression force on the sutured tissue, and consequently reducing bleeding in the regions closest to the cut line.
  • Another object of the present invention is a surgical stapling device, preferably a stapler, comprising an anvil whose surface has at least two staple formation lines where at least one of said lines includes characterized staple formation gaps. Because they have a substantially flat internal surface and because, when the clips are applied against the surface of said anvil, they effect a substantially occlusive and substantially flat closure of said clips.
  • Another object of the present invention is a surgical stapling device where the closure substantially occlusive and substantially flat made corresponds to a gap between the legs of the staples, once folded, less than 0.5 mm.
  • Another object of the present invention is a surgical stapling device 5 where the substantially occlusive and substantially flat closure made corresponds to a state, after the application of the staples on the anvil, in which the legs of said staples are substantially closed. parallel to the crown of said staples.
  • Another object of the present invention is a surgical stapling device where the substantially occlusive and substantially flat closure made corresponds to a state, after the application of the clips on the anvil, in which each leg of said clips is closed forming a angle equal to or less than 6 or with the crown axis of said clips.
  • Another object of the present invention is a surgical stapling device where the staples are made at a substantially occlusive and substantially flat closure having legs whose length is preferably half the crown length of said staples.
  • Another object of the present invention is a surgical stapling device where the staples under which a substantially occlusive and substantially flat closure is made have legs whose length is preferably greater than half the crown length of said staples. .
  • Another object of the present invention is a surgical stapling device where at least one of the staple formation lines 30 includes staple formation gaps characterized in that, when the staples are applied against the surface of the anvil, they effect a non-occlusive closure. which allows vascularization of the sutured tissue along said lines of staple formation, including staple formation gaps, optionally, the presence of a partition for folding or stapling the staples.
  • Another object of the present invention is a surgical stapling device where the clips on which a non-occlusive closure is made have legs whose length is different from the length of the closed clips substantially substantially occlusively and substantially flat.
  • Another object of the present invention is a surgical stapling device in which the staple formation gaps have an open box footprint where, to obtain the substantially occlusive and substantially flat closure by folding the staple legs, either by approaching or by attaching the legs at the time of closing, said footprint includes:
  • Another object of the present invention is a surgical stapling device where the staple gaps have a diagonally divided footprint comprising:
  • Another object of the present invention is a surgical stapling device where the staple gaps have an oblique footprint comprising:
  • each of the housings substantially equal to the length of the staple legs
  • each pair of housings greater than twice the thickness of the staple wire, preferably between 2 and 2.5 times the size of said thickness, to allow the accommodation of the folded legs;
  • Another object of the present invention is a surgical stapling device where the staple formation lines are straight lines. Another object of the present invention is a surgical stapling device where the staple formation lines are circular or curved lines. Another object of the present invention is the use of a surgical stapling device in surgical interventions.
  • Another object of the present invention is the use of a surgical stapling device in open surgery procedures.
  • Another object of the present invention is the use of a surgical stapling device in endoscopic or laparoscopic interventions.
  • Another object of the present invention is a surgical stapling method comprising the application of at least two lines of staples to the sutured tissue where, at least in one of said lines, a substantially occlusive and substantially flat closure of said lines is made. staples
  • Another object of the present invention is a surgical stapling method comprising the application of at least two lines of staples to the sutured tissue where, at least in one of said lines a substantially occlusive and substantially flat closure of said staples is made by a surgical stapling device.
  • Figure 1 a represents the elements of an open clip, in the state prior to its application.
  • Figure 1b represents a side view of an embodiment of the substantially occlusive and substantially flat closure described herein. Invention and carried out by means of staples whose legs have a length equal to half the length of their crown.
  • Figure 1 c represents a side view of an embodiment of the substantially occlusive and substantially flat closure 5 described in the present invention and made by means of staples whose legs have a length greater than half the length of their crown.
  • Figure 1d represents a side view of a non-occlusive closure ("I” or "B” closure) made by the surgical staplers commonly used in the state of the art.
  • Figure 1 e represents the elements of an open clip with parallel-asymmetric bevel tips.
  • Figure 2 depicts the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with open box footprint are employed.
  • Figure 3a represents the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with diagonally divided box footprint are used.
  • Figure 3b represents a top view of a staple formation hole 25 with a diagonally divided box footprint along with the shape that a staple adopts when applying the closure.
  • Figure 4a represents the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with oblique fingerprint are employed.
  • Figure 4b represents a top view of a staple formation hole with an oblique footprint along with the shape a staple adopts when applying the closure.
  • the present invention consists of a surgical stapling device applicable to the different designs of commonly used staplers, such as surface, endoscopic or laparoscopic staplers, or through the use of staples arranged in succession forming straight or circular lines.
  • Figure 1 shows the geometry of an open clip 1, in the state prior to its application by mechanical stapling. It identifies the
  • the initial form, prior to its application, of the clips 1 used by the device of the invention preferably have a flat and straight shape in the length of its crown, suitable for the majority of
  • the surgical stapling device of the present invention preferably a stapler, comprises an anvil 5 whose surface has at least two staple formation lines 6, 8 that respectively have a succession of staple formation gaps 9 , 7.
  • FIG. 30 comprises staple formation gaps having a substantially flat internal surface, capable of effecting a substantially occlusive and substantially flat closure of the staples 1 applied on the tissue sutured ( Figures 1 b and 1 c).
  • This closure preferably made on the line or lines closest to the surgical cut line performed, provides a compression on the tissues greater than that offered by conventional "B" closures used in the prior art ( Figure 1 d) , facilitating hemostasis in these regions, avoiding bleeding and reducing the possibility of tissue tearing.
  • substantially occlusive closure' refers to a closure of the staples 1 whereby the structure of the legs 2 and the crown 3 of said staples is, after stapling, substantially closed, that is , with a clearance between the legs 2 of the clips 1, once folded, less than 0.5 mm.
  • the free separation distance between the legs of the staples, once folded after the stapling process, can be zero, in which case a 'completely occlusive closure' would occur.
  • substantially flat refers to that, after stapling, the legs 2 of the clips 1 are substantially parallel to the crown 3 or each of said legs 1 forming an angle equal to or less than 6 or with the axis of the crown 3, either with its ends facing or laterally attached, depending on the length of the legs 2 of the staples 1 used.
  • the space between the crown 3 and the legs 2 may vary depending on the type of fabric that is to be sutured, requiring, accordingly, different lengths of staples depending on the case.
  • commercial staples constructed with 0.21 mm thick wires primarily intended for sealing very thin-walled vascular structures, provide, after stapling, closures with a 1 mm "grip thickness" of separation between the crown 3 and the legs 2.
  • the device of the invention also incorporates the presence of one or more staple formation lines 6, preferably arranged in the outermost regions of the region of suture with respect to the cut line practiced.
  • Said more external lines 6 can optionally provide an open non-occlusive stapling usually used in conventional devices that allows vascularization of the sutured tissue, which prevents tissue necrosis and also provides a progressive compression of the tissue that favors hemostasis. in the region
  • the clips 1 used have a crown 3 whose length is in a defined range between 2-5 mm, with a length of preferably 3 mm.
  • said bevel can be parallel-asymmetric (Figure 1 e), instead of symmetrical ( Figure 1 a).
  • the clips 1 used can be manufactured using one or more 30 materials commonly used in the market, such as, for example, titanium.
  • the thickness of the staples 1 is preferably greater than 0.2 mm, the most frequently used value in the market, and that which provides sufficient staple resistance, in a quadrangular section.
  • Figure 1 b shows an embodiment of the hemostatic closure described 5 by the present invention, carried out by means of staples 1 whose legs 2 preferably have a length preferably equal to half the size of their crown 3. Said size allows a substantially occlusive and substantially flat closure, which compresses the sutured tissue facilitating hemostasis, where said closure is preferably performed by means of an anvil 5 for the formation of staples comprising staple formation gaps 7 whose internal surface is substantially flat.
  • the length of the legs for the embodiment according to Figure 1b, is between 1.5 - 4.5 mm, preferably 3 mm. In order to achieve a substantially occlusive closure, the length of leg 2 may need, in
  • Figure 1 c shows a preferred embodiment of the hemostatic closure described by the present invention, made by staples 1 whose legs 2 have lengths greater than half the length of its crown 3, where the closure is practiced by laterally attaching the legs, closing both legs 2 substantially occlusive and substantially flat on the crown 3.
  • the length of the legs in said embodiment is between 2.5-5.5 mm, preferably being 3 mm.
  • the staple loader employed in any of the embodiments of the present invention may take the form usually adopted in the prior art, with all its identical staples 1, or, for a better hemostasis, it can have a size of the staples 1 in the staple formation lines 8, closer to the cutting line, larger than in the rest of staple formation lines 6.
  • An oblique arrangement ( Figures 4a and 4b) could also be adopted in said lines 8 to adapt the staples 1 to the footprints of the corresponding grading forms 7 of the anvil 5
  • the stapling strategies according to the device of the present invention are equally applicable to straight and circular sutures or curves.
  • the staple formation lines 6, 8 of the anvil 5 have staple formation gaps 7, 9 arranged successively along said lines, where the gaps 7 closest to the line They have a substantially flat internal surface which, when the clips 1 are applied against the surface of the anvil 5, make a substantially occlusive and substantially flat surface of said clips.
  • the staple formation gaps 7 closest to the cutting line have an open box footprint ( Figure 2) where, to obtain the substantially occlusive and substantially flat closure by folding the legs 2 of the clip 1, either by approximation or by attaching the legs 2, at the time of its closure, said footprint comprises:
  • the staple formation gaps 7 closest to the cutting line have a diagonally divided footprint ( Figures 3a and 3b), with the same length, width and depth as in the open box embodiment described above, but which is distinguished from it by the presence of a diagonal partition 1 1 that forms triangular-shaped housings 10, which serve as a guide to the legs 2 of the clip 1 during folding.
  • This partition 1 1 has a flush height with the surface of the anvil 5.
  • the staple formation gaps 7 closest to the cutting line have oblique traces ( Figures 4a and 4b), where said traces are arranged successively by pairs of parallel housings 12, facing and oblique with respect to the staple formation lines 6 farthest from the cutting line.
  • each of the housings 12 in each pair has a length substantially equal to the size of the legs 2 of the clips 1, with a depth and width similar to the embodiments of open box and diagonally divided footprint described above. .

Abstract

The invention relates to a surgical stapling device that can be used in both open surgery procedures and endoscopic or laparoscopic operations. Said device helps to prevent or reduce bleeding occurring in the treated area, following a surgical operation, by means of a design based on the application of at least two rows of staples, by which means suturing is carried out, in the row or rows closest to the line of incision, using a type of staple that closes by folding in a substantially occlusive and substantially flat manner, which increases the compressive force on the sutured tissue, significantly reducing the bleeding in the areas closest to the line of incision.

Description

DISPOSITIVO DE GRAPADO QUIRÚRGICO  SURGICAL STAPLING DEVICE
CAMPO DE LA INVENCIÓN La presente invención hace referencia a un sistema de sutura quirúrgica que puede ser aplicado, mediante el empleo de un dispositivo oportunamente diseñado al efecto, tanto en procedimientos de cirugía abierta como en intervenciones de tipo endoscópico o laparoscópico. ANTECEDENTES DE LA INVENCIÓN FIELD OF THE INVENTION The present invention refers to a surgical suture system that can be applied, by means of the use of a device opportunely designed for this purpose, both in open surgery procedures and in endoscopic or laparoscopic interventions. BACKGROUND OF THE INVENTION
Desde su invención, las suturas mecánicas empleadas en cirugía han supuesto un gran avance en términos de seguridad, rapidez y mejora de los resultados quirúrg icos obten idos en intervenciones "convencionales", realizadas tanto mediante heridas quirúrgicas, así como en intervenciones endocavitarias o endoscópicas. En dichas suturas, la consecución de un área "biológicamente activa" que contribuya no sólo a la adecuada cicatrización del tejido, sino también a la consolidación de la propia sutura, ha resultado un factor determinante en el éxito de este tipo de dispositivos médicos, realizados en su mayoría mediante el uso de grapadoras de sutura mecánica. Since its invention, the mechanical sutures used in surgery have been a great advance in terms of safety, speed and improvement of the surgical results obtained in "conventional" interventions, performed both by surgical wounds, as well as in endocavitary or endoscopic interventions. In these sutures, the achievement of a "biologically active" area that contributes not only to the proper healing of the tissue, but also to the consolidation of the suture itself, has been a determining factor in the success of this type of medical devices, performed mostly by using mechanical suture staplers.
Normalmente, los dispositivos de sutura mecánica empleados habitualmente, tanto en cirugía abierta como endoscópica o laparoscópica, comprenden la aplicación de más de una fila de grapas. Cuando se pretende la sección tisular, o bien la anastomosis o unión de dos órganos cavitarios, las filas de grapas se disponen de forma simétrica a ambos lados de la línea de corte en los dispositivos de sutura lineal, y únicamente en la región externa a la línea de corte, en los dispositivos de sutura circular. En la mayoría de los casos, las grapas utilizadas en dichas suturas presentan tamaños y formas idénticas, sucediendo de igual modo con los huecos de formación de grapas que presenta la huella del yunque, empleándose este último para doblar los extremos de las grapas al aplicar el grapado, con el objetivo de que se produzca la curvatura de las grapas al cerrar el dispositivo y realizar la sutura. Las grapas empleadas habitualmente para practicar la sutura en los tejidos intervenidos se fabrican en diversos materiales y poseen un diseño con una forma típica compuesta por una corona plana y dos patas. En la actualidad, el diseño del cierre de las grapas empleadas en cirugía se realiza de forma de "B", de forma que las patas queden plegadas o arrolladas sobre la corona de la grapa, pero dejando un espacio entre dichos componentes y el tejido suturado, facilitando la vascularización de dicho tejido y evitando así su necrosis. El citado diseño de cierre en forma de "B" es, hoy en día, una constante de los fabricantes de este tipo de dispositivos, que presenta pocas variaciones en los diseños comercialmente vigentes en la actualidad. Normally, the mechanical suture devices commonly used, both in open and endoscopic or laparoscopic surgery, comprise the application of more than one row of staples. When the tissue section is intended, or the anastomosis or union of two cavitary organs, the rows of staples are arranged symmetrically on both sides of the cutting line in the linear suture devices, and only in the region external to the cutting line, in circular suture devices. In most cases, the staples used in these sutures have identical sizes and shapes, similarly happening with the staple formation holes that the anvil footprint presents, using this last to fold the ends of the staples when applying the stapling, in order to produce the curvature of the staples when closing the device and performing the suture. The staples usually used to practice the suture in the intervened tissues are made of various materials and have a design with a typical shape consisting of a flat crown and two legs. At present, the design of the closure of the staples used in surgery is carried out in the form of "B", so that the legs are folded or rolled over the crown of the staple, but leaving a space between said components and the sutured tissue , facilitating the vascularization of said tissue and thus preventing its necrosis. The aforementioned "B" shaped closure design is, today, a constant of the manufacturers of this type of devices, which presents few variations in the designs commercially in force today.
Si bien el cierre en forma de "B" resulta efectivo para conseguir el fin que principalmente persigue, esto es, permitir la vascularización de los tejidos suturados, también lleva consigo un inconveniente, especialmente relevante en la sutura de tejidos gruesos. Dicho inconveniente consiste en la tendencia a la aparición de sangrado en los bordes de la sutura más próximos a la línea de corte, una vez se ha cortado el tejido. Este sangrado puede llegar a obligar, en la práctica, a cauterizar, resuturar o, en casos no infrecuentes, a tener que volver a intervenir, por lo oculto del lugar de sutura o por la aparición tardía del sangrado. Although the "B" shaped closure is effective in achieving the purpose that it mainly pursues, that is, allowing vascularization of the sutured tissues, it also carries with it a disadvantage, especially relevant in thick tissue suture. Said drawback consists in the tendency to bleed at the edges of the suture closest to the cut line, once the tissue has been cut. This bleeding may lead, in practice, to cauterize, resurrect or, in non-infrequent cases, to have to intervene again, due to the hidden place of the suture or the late appearance of bleeding.
Las superficies empleadas en el estado de la técnica para dar forma al cierre de grapas quirúrgicas, realizado habitualmente por medio de huecos de formación de grapas grabados sobre un yunque que forma parte de la grapadora, poseen tabiques de separación mayor que las distancias de separación entre huecos contiguos, proporcionando así otra vía libre de penetración vascular entre el arrollamiento de las patas de la grapa. Esta disposición, además de la referida separación entre huecos contiguos, también favorece el sangrado del borde libre de la sutura. The surfaces used in the state of the art to shape the closure of surgical staples, usually made by means of staple formation gaps engraved on an anvil that is part of the stapler, have partition walls greater than the separation distances between contiguous gaps, thus providing another pathway free of vascular penetration between the winding of the staple legs. This arrangement, in addition to the aforementioned separation between adjacent gaps, also favors bleeding from the free edge of the suture.
El estado actual de la técnica comprende algunas aproximaciones 5 orientadas a solucionar este problema, mediante sistemas de grapado quirúrgico basados en el empleo conjunto de grapas de diferentes tamaños, destinadas a reducir el sangrado post-quirúrgico mediante una mayor com pres ión del tej ido sutu rado . Dicho em pl eo, junto a diferentes aplicaciones del mismo, se encuentra, por ejemplo, reflejado en las í o solicitudes de patente WO 03094747, US 4941623, EP 1915954 o EP 1964526. En ellas se describe, a través de diferentes realizaciones, el uso de una o más filas de grapas con formas y longitudes modificadas, favoreciendo que algunas zonas de tejido presenten una mayor compresión y, en consecuencia un menor sangrado. The current state of the art comprises some approaches 5 aimed at solving this problem, by means of surgical stapling systems based on the joint use of staples of different sizes, aimed at reducing post-surgical bleeding by means of a greater compression of the sutured tissue. rado. Said company, together with different applications thereof, is, for example, reflected in the patent applications WO 03094747, US 4941623, EP 1915954 or EP 1964526. They describe, through different embodiments, the use of one or more rows of staples with modified shapes and lengths, favoring that some areas of tissue exhibit greater compression and, consequently, less bleeding.
15  fifteen
A pesar de que los citados documentos suponen una mejora en la efectividad de la sutura mecánica practicada, todos ellos comparten el uso del mismo tipo de cierre que las grapadoras habituales, efectuado mediante un grapado en forma de "B". Dicho cierre se realiza mediante una huella de 20 yunque convencional que, aunque en algunos dispositivos permite dotar de diversos tamaños a las grapas utilizadas, mantiene a su vez en todas ellas una superficie de cierre idéntica.  Although the aforementioned documents imply an improvement in the effectiveness of the mechanical suture performed, they all share the use of the same type of closure as the usual staplers, made by means of a "B" stapling. Said closure is carried out by means of a conventional 20 anvil footprint that, although in some devices allows the staples used to be of various sizes, in turn maintains an identical closure surface in all of them.
La presente invención está orientada a proporcionar una reducción más 25 efectiva del sangrado post-quirúrgico, aumentando el nivel de hemostasia mediante un cierre oclusivo y plano de la/s fila/s de grapas más cercana/s a la línea de corte que se desea suturar, aplicado mediante unas grapas y un yunque convenientemente diseñados al efecto. OBJETO DE LA INVENCIÓN The present invention is aimed at providing a more effective reduction of post-surgical bleeding, increasing the level of hemostasis by an occlusive and flat closure of the nearest staple row (s) to the cut line to be sutured. , applied by means of staples and an anvil conveniently designed for this purpose. OBJECT OF THE INVENTION
Un objeto de la presente invención es el diseño de un dispositivo de sutura quirúrgica, preferentemente una grapadora, que permita evitar o reducir el sangrado que acontece en la región tratada después de una intervención quirúrgica, y que puede ser empleado mediante dispositivos de sutura tanto l ineal como circular, independ ientemente del modelo de aplicador utilizado para la sutura. An object of the present invention is the design of a surgical suture device, preferably a stapler, which allows to avoid or reduce the bleeding that occurs in the treated region after a surgical intervention, and which can be used by means of suturing devices both Ineal as circular, independently of the applicator model used for the suture.
Otro objeto de la invención es, según lo expuesto anteriormente, un sistema basado en la aplicación de, al menos, dos filas de grapas a través de las cuales, en la fila o filas más próximas a la línea de corte practicada se sutura util izando un tipo de grapa que se cierra mediante un plegado sustancialmente oclusivo y sustancialmente plano. Another object of the invention is, as set forth above, a system based on the application of at least two rows of staples through which, in the row or rows closest to the cut line practiced, it is sutured using a type of clip that is closed by a substantially occlusive and substantially flat fold.
Dicho tipo de grapas posee una forma tal que facilita, en conjunción con un diseño del yunque apropiado, el cierre sustancialmente oclusivo y sustancialmente plano de los extremos de la g rapa sobre su corona, aumentando así la fuerza de compresión sobre el tejido suturado, y reduciendo en consecuencia el sangrado en las regiones más próximas a la línea de corte. Said type of clips has a shape that facilitates, in conjunction with an appropriate anvil design, the substantially occlusive and substantially flat closure of the ends of the clip on its crown, thereby increasing the compression force on the sutured tissue, and consequently reducing bleeding in the regions closest to the cut line.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico, preferentemente una grapadora, que comprende un yunque cuya superficie presenta, al menos, dos líneas de formación de grapas donde, al menos, una de dichas líneas incluye huecos de formación de grapas caracterizados porque poseen una superficie interna sustancialmente plana y porque, al aplicarse las grapas contra la superficie de dicho yunque, efectúan un cierre sustancialmente oclusivo y sustancialmente plano de dichas grapas. Another object of the present invention is a surgical stapling device, preferably a stapler, comprising an anvil whose surface has at least two staple formation lines where at least one of said lines includes characterized staple formation gaps. because they have a substantially flat internal surface and because, when the clips are applied against the surface of said anvil, they effect a substantially occlusive and substantially flat closure of said clips.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un espacio libre de separación entre las patas de las grapas, una vez plegadas, inferior a 0,5 mm. Another object of the present invention is a surgical stapling device where the closure substantially occlusive and substantially flat made corresponds to a gap between the legs of the staples, once folded, less than 0.5 mm.
Otro objeto de la presente invención es un dispositivo de grapado 5 quirúrgico donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un estado, tras la aplicación de las grapas sobre el yunque, en el cual las patas de dichas grapas quedan cerradas de forma sustancialmente paralela a la corona de dichas grapas. í o Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un estado, tras la aplicación de las grapas sobre el yunque, en el cual cada pata de dichas grapas queda cerrada formando un ángulo igual o inferior a 6o con el eje de la corona de dichas grapas. Another object of the present invention is a surgical stapling device 5 where the substantially occlusive and substantially flat closure made corresponds to a state, after the application of the staples on the anvil, in which the legs of said staples are substantially closed. parallel to the crown of said staples. Another object of the present invention is a surgical stapling device where the substantially occlusive and substantially flat closure made corresponds to a state, after the application of the clips on the anvil, in which each leg of said clips is closed forming a angle equal to or less than 6 or with the crown axis of said clips.
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Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde las grapas so b re l a s q u e se efectú a u n cierre sustancialmente oclusivo y sustancialmente plano poseen patas cuya longitud es, preferentemente, la mitad de la longitud de la corona de dichas 20 grapas.  Another object of the present invention is a surgical stapling device where the staples are made at a substantially occlusive and substantially flat closure having legs whose length is preferably half the crown length of said staples.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde las grapas so b re l a s q u e se efectú a u n cierre sustancialmente oclusivo y sustancialmente plano poseen patas cuya 25 longitud es, preferentemente, mayor que la mitad de la longitud de la corona de dichas grapas. Another object of the present invention is a surgical stapling device where the staples under which a substantially occlusive and substantially flat closure is made have legs whose length is preferably greater than half the crown length of said staples. .
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde, al menos, una de las líneas de formación de grapas 30 incluye huecos de formación de grapas caracterizados porque, al aplicarse las grapas contra la superficie del yunque, efectúan un cierre no oclusivo que permite la vascularización del tejido suturado a lo largo de dichas líneas de formación de grapas, incluyendo los huecos de formación de grapas, opcionalmente, la presencia de un tabique para el plegamiento o arrollamiento de las grapas. Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde las grapas sobre las que se efectúa un cierre no oclusivo poseen patas cuya longitud es diferente a la longitud de las grapas cerradas de forma sustancialmente oclusiva y sustancialmente plana. Another object of the present invention is a surgical stapling device where at least one of the staple formation lines 30 includes staple formation gaps characterized in that, when the staples are applied against the surface of the anvil, they effect a non-occlusive closure. which allows vascularization of the sutured tissue along said lines of staple formation, including staple formation gaps, optionally, the presence of a partition for folding or stapling the staples. Another object of the present invention is a surgical stapling device where the clips on which a non-occlusive closure is made have legs whose length is different from the length of the closed clips substantially substantially occlusively and substantially flat.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico en el que los huecos de formación de grapas presentan una huella de caja abierta donde, para obtener el cierre sustancialmente oclusivo y sustancialmente plano mediante el plegamiento de las patas de la grapa, bien por aproximación o por adosamiento de las patas en el momento de su cierre, dicha huella comprende: Another object of the present invention is a surgical stapling device in which the staple formation gaps have an open box footprint where, to obtain the substantially occlusive and substantially flat closure by folding the staple legs, either by approaching or by attaching the legs at the time of closing, said footprint includes:
- ausencia de tabiques y separaciones;  - absence of partitions and separations;
- una superficie interior sustancialmente plana;  - a substantially flat interior surface;
- una longitud sustancialmente igual al la longitud de la corona de la grapa;  - a length substantially equal to the length of the crown of the clip;
- una anchura mayor del doble del grosor del alambre de la grapa, preferentemente, entre 2 y 2,5 veces el tamaño de d icho grosor, para permitir el adosamiento de las patas plegadas;  - a width greater than twice the thickness of the staple wire, preferably between 2 and 2.5 times the size of said thickness, to allow the bending of the folded legs;
- una profund idad inferior a la huella empleada por un yunque convencional, comprendida entre 1 y 3 veces el grosor del alambre de la grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor.  - a depth less than the footprint used by a conventional anvil, between 1 and 3 times the thickness of the staple wire, preferably being twice the size of said thickness.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde los huecos de formación de grapas presentan una huella dividida diagonalmente que comprende: Another object of the present invention is a surgical stapling device where the staple gaps have a diagonally divided footprint comprising:
- un tabique diagonal que conforma unos alojamientos de forma triangular, que sirven de guía a las patas de la grapa durante su plegado, donde dicho tabique pose una altura rasante con la superficie del yunque; - una superficie interior sustancialmente plana; - a diagonal partition that forms triangular-shaped housings, which serve as a guide to the legs of the clip during its folding, where said partition has a flush height with the surface of the anvil; - a substantially flat interior surface;
- una longitud sustancialmente igual al la longitud de la corona de la grapa;  - a length substantially equal to the length of the crown of the clip;
- una anchura mayor del doble del grosor del alambre de la grapa, preferentemente, entre 2 y 2,5 veces el tamaño de dicho grosor, para permitir el alojamiento de las patas plegadas;  - a width greater than twice the thickness of the staple wire, preferably between 2 and 2.5 times the size of said thickness, to allow the accommodation of the folded legs;
- una profund idad inferior a la huella empleada por un yunque convencional, comprendida entre 1 y 3 veces el grosor del alambre de la grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor.  - a depth less than the footprint used by a conventional anvil, between 1 and 3 times the thickness of the staple wire, preferably being twice the size of said thickness.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde los huecos de formación de grapas presentan una huella oblicua que comprende: Another object of the present invention is a surgical stapling device where the staple gaps have an oblique footprint comprising:
- una disposición sucesiva de parejas de alojamientos paralelos enfrentados y oblicuos respecto a las líneas de formación de grapas más alejadas de la línea de corte practicada;  - a successive arrangement of pairs of parallel and oblique parallel accommodation with respect to the staple formation lines furthest from the cut line practiced;
- una superficie interior sustancialmente plana;  - a substantially flat interior surface;
- una longitud de cada uno de los alojamientos sustancialmente igual al la longitud de las patas de la grapa;  - a length of each of the housings substantially equal to the length of the staple legs;
- una anchura total de cada pareja de alojamientos mayor del doble del grosor del alambre de la grapa, preferentemente, entre 2 y 2,5 veces el tamaño de dicho grosor, para permitir el alojamiento de las patas plegadas;  - a total width of each pair of housings greater than twice the thickness of the staple wire, preferably between 2 and 2.5 times the size of said thickness, to allow the accommodation of the folded legs;
- una profu nd idad inferior a l a h uel la empleada por u n yunque convencional, comprendida entre 1 y 3 veces el grosor del alambre de la grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor.  - a depth of less than that used by a conventional anvil, between 1 and 3 times the thickness of the staple wire, preferably being twice the size of said thickness.
Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde las líneas de formación de grapas son líneas rectas. Otro objeto de la presente invención es un dispositivo de grapado quirúrgico donde las líneas de formación de grapas son líneas circulares o curvas. Otro objeto de la presente invención es el uso de un dispositivo de grapado quirúrgico en intervenciones quirúrgicas. Another object of the present invention is a surgical stapling device where the staple formation lines are straight lines. Another object of the present invention is a surgical stapling device where the staple formation lines are circular or curved lines. Another object of the present invention is the use of a surgical stapling device in surgical interventions.
Otro objeto de la presente invención es el uso de un dispositivo de 5 grapado quirúrgico en procedimientos de cirugía abierta. Another object of the present invention is the use of a surgical stapling device in open surgery procedures.
Otro objeto de la presente invención es el uso de un dispositivo de grapado quirúrgico en intervenciones de tipo endoscópico o laparoscópico. í o Otro objeto de la presente invención es un método de grapado quirúrgico que comprende la aplicación de al menos, dos líneas de grapas al tejido suturado donde, al menos, en una de dichas líneas se efectúa un cierre sustancialmente oclusivo y sustancialmente plano de dichas grapas. Another object of the present invention is the use of a surgical stapling device in endoscopic or laparoscopic interventions. Another object of the present invention is a surgical stapling method comprising the application of at least two lines of staples to the sutured tissue where, at least in one of said lines, a substantially occlusive and substantially flat closure of said lines is made. staples
15 Otro objeto de la presente invención es un método de grapado quirúrgico que comprende la aplicación de al menos, dos líneas de grapas al tejido suturado donde, al menos, en una de dichas líneas se efectúa un cierre sustancialmente oclusivo y sustancialmente plano de dichas grapas mediante un dispositivo de grapado quirúrgico. Another object of the present invention is a surgical stapling method comprising the application of at least two lines of staples to the sutured tissue where, at least in one of said lines a substantially occlusive and substantially flat closure of said staples is made by a surgical stapling device.
20  twenty
Otras características y ventajas de la presente invención se desprenderán de la descripción de la invención que sigue, así como de la realización ilustrativa de las figuras que la acompañan.  Other features and advantages of the present invention will be apparent from the description of the invention that follows, as well as from the illustrative embodiment of the accompanying figures.
25 DESCRIPCIÓN DE LAS FIGURAS 25 DESCRIPTION OF THE FIGURES
La Figura 1 a representa los elementos de una grapa abierta, en el estado previo a su aplicación. Figure 1 a represents the elements of an open clip, in the state prior to its application.
30 La Figura 1 b representa una vista lateral de una realización del cierre sustancialmente oclusivo y sustancialmente plano descrito en la presente invención y efectuado por medio de grapas cuyas patas poseen una longitud igual a la mitad de la longitud de su corona. Figure 1b represents a side view of an embodiment of the substantially occlusive and substantially flat closure described herein. Invention and carried out by means of staples whose legs have a length equal to half the length of their crown.
La Figura 1 c representa una vista lateral de una realización del cierre 5 sustancialmente oclusivo y sustancialmente plano descrito en la presente invención y efectuado por medio de grapas cuyas patas poseen una longitud superior a la mitad de la longitud de su corona. Figure 1 c represents a side view of an embodiment of the substantially occlusive and substantially flat closure 5 described in the present invention and made by means of staples whose legs have a length greater than half the length of their crown.
La Figura 1d representa una vista lateral de un cierre no oclusivo (cierre í o en "B") realizado por las grapadoras quirúrgicas utilizadas habitualmente en el estado de la técnica. Figure 1d represents a side view of a non-occlusive closure ("I" or "B" closure) made by the surgical staplers commonly used in the state of the art.
La Figura 1 e representa los elementos de una grapa abierta con puntas de biselado paralelo-asimétrico. Figure 1 e represents the elements of an open clip with parallel-asymmetric bevel tips.
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La Figura 2 representa el yunque de grapadora empleado en una realización preferente de la invención, en la que se emplean huecos de formación de grapas con huella de caja abierta.  Figure 2 depicts the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with open box footprint are employed.
20 La Figura 3a representa el yunque de grapadora empleado en una realización preferente de la invención, en la que se emplean huecos de formación de grapas con huella de caja dividida en diagonal. Figure 3a represents the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with diagonally divided box footprint are used.
La Figura 3b representa una vista superior de un hueco de formación 25 de grapas con huella de caja dividida en diagonal junto con la forma que adopta una grapa al aplicar el cierre. Figure 3b represents a top view of a staple formation hole 25 with a diagonally divided box footprint along with the shape that a staple adopts when applying the closure.
La Figura 4a representa el yunque de grapadora empleado en una realización preferente de la invención, en la que se emplean huecos de 30 formación de grapas con huella oblicua. La Figura 4b representa una vista superior de un hueco de formación de grapas con huella oblicua junto con la forma que adopta una grapa al aplicar el cierre. Figure 4a represents the stapler anvil used in a preferred embodiment of the invention, in which staple formation gaps with oblique fingerprint are employed. Figure 4b represents a top view of a staple formation hole with an oblique footprint along with the shape a staple adopts when applying the closure.
5 DESCRIPCIÓN DETALLADA DE LA INVENCIÓN 5 DETAILED DESCRIPTION OF THE INVENTION
La presente invención consiste en un dispositivo de grapado quirúrgico aplicable a los diferentes diseños de grapadoras utilizadas habitualmente, tales como grapadoras superficiales, endoscópicas o laparoscópicas, í o mediante el empleo de grapas dispuestas en sucesión formando líneas rectas o circulares. The present invention consists of a surgical stapling device applicable to the different designs of commonly used staplers, such as surface, endoscopic or laparoscopic staplers, or through the use of staples arranged in succession forming straight or circular lines.
La Figura 1 a muestra la geometría de una grapa 1 abierta, en el estado previo a su aplicación mediante grapado mecánico. En ella se identifican lasFigure 1 shows the geometry of an open clip 1, in the state prior to its application by mechanical stapling. It identifies the
15 patas 2, una corona 3 y unas regiones de curvatura 4 que se cierran bajo presión mediante la aplicación de la grapa. Tal como se muestra en la citada figura, la forma inicial, previa a su aplicación, de las grapas 1 empleadas por el dispositivo de la invención poseen, preferentemente, una forma plana y recta en la longitud de su corona, apta para la mayoría de15 legs 2, a crown 3 and regions of curvature 4 that are closed under pressure by applying the clip. As shown in the aforementioned figure, the initial form, prior to its application, of the clips 1 used by the device of the invention preferably have a flat and straight shape in the length of its crown, suitable for the majority of
20 cargadores empleados habitualmente en grapadoras quirúrgicas, y sus patas se disponen paralelas entre sí partiendo de los extremos de sus regiones de curvatura 4, formando, preferentemente, un ángulo de 90° con el eje de la corona 3. 20 loaders usually used in surgical staplers, and their legs are arranged parallel to each other starting from the ends of their regions of curvature 4, preferably forming an angle of 90 ° with the axis of the crown 3.
25 El d ispositivo de grapado quirúrgico de la presente invención, preferentemente una grapadora, comprende un yunque 5 cuya superficie presenta, al menos, dos líneas de formación de grapas 6, 8 que presentan, respectivamente, una sucesión de huecos de formación de grapas 9, 7. En las distintas realizaciones de la invención, al menos una de dichas líneas 7The surgical stapling device of the present invention, preferably a stapler, comprises an anvil 5 whose surface has at least two staple formation lines 6, 8 that respectively have a succession of staple formation gaps 9 , 7. In the different embodiments of the invention, at least one of said lines 7
30 comprende huecos de formación de grapas que poseen una superficie interna sustancialmente plana, capaz de efectuar un cierre sustancialmente oclusivo y sustancialmente plano de las grapas 1 aplicadas sobre el tejido suturado (Figuras 1 b y 1 c). Este cierre, realizado preferentemente sobre la línea o líneas más próximas a la línea de corte quirúrgica practicada, proporcionan una compresión sobre los tejidos mayor que la que ofrecen los cierres convencionales en "B" utilizados en el estado de la técnica (Figura 1 d), facilitando la hemostasia en dichas regiones, evitando el sangrado y reduciendo la posibilidad de desgarro del tejido. 30 comprises staple formation gaps having a substantially flat internal surface, capable of effecting a substantially occlusive and substantially flat closure of the staples 1 applied on the tissue sutured (Figures 1 b and 1 c). This closure, preferably made on the line or lines closest to the surgical cut line performed, provides a compression on the tissues greater than that offered by conventional "B" closures used in the prior art (Figure 1 d) , facilitating hemostasis in these regions, avoiding bleeding and reducing the possibility of tissue tearing.
A lo largo del presente documento, el término 'cierre sustancialmente oclusivo' se refiere a un cierre de las grapas 1 mediante el cual la estructura de las patas 2 y la corona 3 de dichas grapas queda, después del grapado, sustancialmente cerrada, esto es, con un espacio libre de separación entre las patas 2 de las grapas 1 , una vez plegadas, inferior a 0,5 mm. La distancia libre de separación entre las patas de las grapas, una vez plegadas tras el proceso de grapado, puede ser cero, en cuyo caso se daría un 'cierre completamente oclusivo'. El término 'sustancialmente plano' se refiere a que, después del grapado, las patas 2 de las grapas 1 quedan sustancialmente paralelas a la corona 3 o formando cada una de dichas patas 1 un ángulo igual o inferior a 6o con el eje de la corona 3, ya sea con sus puntas enfrentadas o bien adosadas lateralmente, en función de la longitud de las patas 2 de las grapas 1 empleadas. Throughout this document, the term 'substantially occlusive closure' refers to a closure of the staples 1 whereby the structure of the legs 2 and the crown 3 of said staples is, after stapling, substantially closed, that is , with a clearance between the legs 2 of the clips 1, once folded, less than 0.5 mm. The free separation distance between the legs of the staples, once folded after the stapling process, can be zero, in which case a 'completely occlusive closure' would occur. The term "substantially flat" refers to that, after stapling, the legs 2 of the clips 1 are substantially parallel to the crown 3 or each of said legs 1 forming an angle equal to or less than 6 or with the axis of the crown 3, either with its ends facing or laterally attached, depending on the length of the legs 2 of the staples 1 used.
Una vez realizado el grapado según la presente invención, el espacio comprendido entre la corona 3 y las patas 2 puede variar en función del tipo de tejido que se desea suturar, requiriendo, en consecuencia, distintas longitudes de grapas según el caso. De este modo, por ejemplo, las grapas comerciales construidas con alambres de 0,21 mm de grosor, destinadas fundamentalmente al sellado de estructuras vasculares de paredes muy finas, proporcionan, tras el grapado, cierres con un "grosor de agarre" de 1 mm de separación entre la corona 3 y las patas 2. Para los casos en los que la sutura se realiza sobre tejidos gruesos, por ejemplo, en anastomosis del tracto digestivo, e s habitual utilizar grapas de 3-4 mm de corona 3, construidas con alambre de 0,23 mm de grosor y patas 2 de hasta 4 mm de longitud para, una vez plegadas, abarcar todos los tejidos sin cortarlos y dejando un espacio o grosor de agarre entre la corona 3 y las patas 2 de la grapa de 1 ,5 mm, que permita realizar una unión tisular eficaz y mantenida. Once the stapling according to the present invention has been carried out, the space between the crown 3 and the legs 2 may vary depending on the type of fabric that is to be sutured, requiring, accordingly, different lengths of staples depending on the case. Thus, for example, commercial staples constructed with 0.21 mm thick wires, primarily intended for sealing very thin-walled vascular structures, provide, after stapling, closures with a 1 mm "grip thickness" of separation between the crown 3 and the legs 2. For cases in which the suture is made on thick tissues, for example, in anastomosis of the digestive tract, it is usual to use 3-4 mm clips of crown 3, constructed with wire 0.23 mm thick and 2 feet up to 4 mm thick length for, once folded, to cover all the tissues without cutting them and leaving a space or thickness of grip between the crown 3 and the legs 2 of the 1.5 mm staple, which allows for an effective and maintained tissue union.
5 Adicionalmente a la línea o líneas de formación de grapas 8 que proporcionan el cierre sustancialmente oclusivo y sustancialmente plano, el dispositivo de la invención incorpora también la presencia de una o más líneas de formación de grapas 6, preferentemente dispuestas en las regiones más externas de la región de sutura respecto a la línea de corte í o practicada. Dichas líneas 6 más externas pueden proporcionar, opcionalmente, un grapado abierto no oclusivo empleado habitualmente en los dispositivos convencionales que permite la vascularización del tejido suturado, lo que evita la necrosis del tejido y proporciona, además, una compresión progresiva del tejido que favorece la hemostasia en la región5 In addition to the line or staple formation lines 8 which provide the substantially occlusive and substantially flat closure, the device of the invention also incorporates the presence of one or more staple formation lines 6, preferably arranged in the outermost regions of the region of suture with respect to the cut line practiced. Said more external lines 6 can optionally provide an open non-occlusive stapling usually used in conventional devices that allows vascularization of the sutured tissue, which prevents tissue necrosis and also provides a progressive compression of the tissue that favors hemostasis. in the region
15 más cercana a la línea de corte practicada. El efecto de la presión ejercida por el empleo de diferentes modos de cierre de las grapas 1 descritos según la presente invención llega a su punto máximo en la región próxima a la línea de corte efectuada. 15 closest to the cut line practiced. The effect of the pressure exerted by the use of different ways of closing the clips 1 described according to the present invention reaches its maximum point in the region close to the cut line made.
20 En las distintas realizaciones de la presente invención, las grapas 1 utilizadas poseen una corona 3 cuya longitud está comprendida en un rango definido entre 2-5 mm, con una longitud de, preferentemente, 3mm. In the different embodiments of the present invention, the clips 1 used have a crown 3 whose length is in a defined range between 2-5 mm, with a length of preferably 3 mm.
Los extremos de las patas 2, preferentemente, están cortados en punta, de manera simétrica, con el bisel hacia dentro. Opcionalmente, para The ends of the legs 2, preferably, are pointedly cut, symmetrically, with the bevel inward. Optionally, for
25 evitar un hipotético choque de puntas al enfrentarse por el efecto del plegado en la huella receptáculo del yunque 5, dicho biselado puede ser paralelo- asimétrico (Figura 1 e), en vez de simétrico (Figura 1 a). 25 to avoid a hypothetical tip collision when faced by the effect of folding on the anvil receptacle footprint 5, said bevel can be parallel-asymmetric (Figure 1 e), instead of symmetrical (Figure 1 a).
Las grapas 1 utilizadas pueden fabricarse empleando uno o más 30 materiales de los habitualmente utilizados en el mercado, tales como, por ejemplo, el titanio. El grosor de las grapas 1 es, preferentemente, mayor de 0,2 mm, valor más frecuentemente empleado en el mercado, y el que proporciona suficiente resistencia a la grapa, en sección cuadrangular. The clips 1 used can be manufactured using one or more 30 materials commonly used in the market, such as, for example, titanium. The thickness of the staples 1 is preferably greater than 0.2 mm, the most frequently used value in the market, and that which provides sufficient staple resistance, in a quadrangular section.
La Figura 1 b muestra una realización del cierre hemostático descrito 5 por la presente invención, efectuado mediante grapas 1 cuyas patas 2 poseen una longitud preferentemente igual a la mitad del tamaño de su corona 3. Dicho tamaño permite un cierre sustancialmente oclusivo y sustancialmente plano, q u e comprime el tejido suturado facilitando la hemostasia, donde dicho cierre se practica, preferentemente, mediante un í o yunque 5 para la formación de grapas que comprende huecos de formación de grapas 7 cuya superficie interna es sustancialmente plana. La longitud de las patas, para la realización según la Figura 1 b, está comprendida entre 1 ,5 - 4,5 mm, siendo preferentemente de 3 mm. Con el objetivo de conseguir un cierre sustancialmente oclusivo, la longitud de la pata 2 puede necesitar, enFigure 1 b shows an embodiment of the hemostatic closure described 5 by the present invention, carried out by means of staples 1 whose legs 2 preferably have a length preferably equal to half the size of their crown 3. Said size allows a substantially occlusive and substantially flat closure, which compresses the sutured tissue facilitating hemostasis, where said closure is preferably performed by means of an anvil 5 for the formation of staples comprising staple formation gaps 7 whose internal surface is substantially flat. The length of the legs, for the embodiment according to Figure 1b, is between 1.5 - 4.5 mm, preferably 3 mm. In order to achieve a substantially occlusive closure, the length of leg 2 may need, in
15 distintas realizaciones de la invención, comprender unas regiones de curvatura 4 de diferentes longitudes en función del tejido suturado, de forma que dicha región abarque el grosor del tejido a tratar. Dichas variaciones han de ser también tenidas en cuenta convenientemente en el diseño del yunque 5 utilizado para practicar el cierre de las grapas 1 y la profundidad de los15 different embodiments of the invention, comprise regions of curvature 4 of different lengths depending on the sutured tissue, such that said region covers the thickness of the tissue to be treated. Said variations must also be conveniently taken into account in the design of the anvil 5 used to practice the closure of the clips 1 and the depth of the
2 o huecos de formación de grapas 7. 2 or staple formation holes 7.
La Figura 1 c muestra una realización preferente del cierre hemostático descrito por la presente invención, efectuado mediante grapas 1 cuyas patas 2 poseen longitudes mayores que la mitad de la longitud de su 25 corona 3, donde el cierre se practica adosando las patas lateralmente, cerrando ambas patas 2 de forma sustancialmente oclusiva y sustancialmente plana sobre la corona 3. La longitud de las patas en dicha realización está comprendida entre 2,5 - 5,5 mm, siendo, preferentemente, de 3 mm. Figure 1 c shows a preferred embodiment of the hemostatic closure described by the present invention, made by staples 1 whose legs 2 have lengths greater than half the length of its crown 3, where the closure is practiced by laterally attaching the legs, closing both legs 2 substantially occlusive and substantially flat on the crown 3. The length of the legs in said embodiment is between 2.5-5.5 mm, preferably being 3 mm.
30  30
El cargador de grapas empleado en cualquiera de las realizaciones de la presente invención puede adoptar la forma habitualmente adoptada en el estado de la técnica, con todas sus grapas 1 idénticas, o bien, para una mejor hemostasia, puede poseer un tamaño de las grapas 1 en las líneas de formación de grapas 8, más próximas a la línea de corte, mayor que en el resto de líneas de formación de grapas 6. También podría adoptarse, en dichas líneas 8, una disposición oblicua (Figuras 4a y 4b) para adaptar las grapas 1 a las huellas d e los h u ecos de form ación de g ra pas 7 correspondientes del yunque 5. Las estrategias de grapado según el dispositivo de la presente invención, son igualmente aplicables a las suturas rectas y a las circulares o curvas. The staple loader employed in any of the embodiments of the present invention may take the form usually adopted in the prior art, with all its identical staples 1, or, for a better hemostasis, it can have a size of the staples 1 in the staple formation lines 8, closer to the cutting line, larger than in the rest of staple formation lines 6. An oblique arrangement (Figures 4a and 4b) could also be adopted in said lines 8 to adapt the staples 1 to the footprints of the corresponding grading forms 7 of the anvil 5 The stapling strategies according to the device of the present invention are equally applicable to straight and circular sutures or curves.
En diferentes realizaciones del dispositivo de sutura de la invención, las líneas de formación de grapas 6, 8 del yunque 5 poseen huecos de formación de grapas 7, 9 dispuestos sucesivamente a lo largo de dichas líneas, donde los huecos 7 más cercanos a la línea de corte practicada poseen una superficie interna sustancialmente plana que, al aplicarse las grapas 1 contra la superficie del yunque 5, efectú a n u n ci erre sustancialmente oclusivo y sustancialmente plano de dichas grapas. In different embodiments of the suture device of the invention, the staple formation lines 6, 8 of the anvil 5 have staple formation gaps 7, 9 arranged successively along said lines, where the gaps 7 closest to the line They have a substantially flat internal surface which, when the clips 1 are applied against the surface of the anvil 5, make a substantially occlusive and substantially flat surface of said clips.
En una realización preferente de la invención, los huecos de formación de grapas 7 más cercanos a la línea de corte poseen una huella de caja abierta (Figura 2) donde, para obtener el cierre sustancialmente oclusivo y sustancialmente plano mediante el plegamiento de las patas 2 de la grapa 1 , bien por aproximación o por adosamiento de las patas 2, en el momento de su cierre, dicha huella comprende: In a preferred embodiment of the invention, the staple formation gaps 7 closest to the cutting line have an open box footprint (Figure 2) where, to obtain the substantially occlusive and substantially flat closure by folding the legs 2 of the clip 1, either by approximation or by attaching the legs 2, at the time of its closure, said footprint comprises:
- Ausencia de tabiques y separaciones.  - Absence of partitions and separations.
- Una superficie interior sustancialmente plana.  - A substantially flat interior surface.
- Una longitud sustancialmente igual al la longitud de la corona 3 de la grapa 1 .  - A length substantially equal to the length of the crown 3 of the clip 1.
- Una anchura mayor del doble del grosor del alambre de la grapa 1 , preferentemente, entre 2 y 2,5 veces el tamaño de dicho grosor, para permitir el alojamiento, mediante adosamiento, de las patas 2 plegadas. - Una profundidad inferior a la huella empleada por un yunque convencional, comprendida entre 1 -3 veces el grosor del alambre de la grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor. En otra realización preferente de la invención, los huecos de formación de grapas 7 más cercanos a la línea de corte poseen una huella dividida en diagonal (Figuras 3a y 3b), con la misma longitud, anchura y profundidad que en la realización de caja abierta anteriormente descrita, pero que se distingue de ella por la presencia de un tabique diagonal 1 1 que conforma unos alojamientos de forma triangular 10, que sirven de guía a las patas 2 de la grapa 1 durante su plegado. Este tabique 1 1 posee una altura rasante con la superficie del yunque 5. - A width greater than twice the thickness of the wire of the clip 1, preferably, between 2 and 2.5 times the size of said thickness, to allow the accommodation, by means of a tie, of the folded legs 2. - A depth less than the footprint used by a conventional anvil, between 1-3 times the thickness of the staple wire, preferably being twice the size of said thickness. In another preferred embodiment of the invention, the staple formation gaps 7 closest to the cutting line have a diagonally divided footprint (Figures 3a and 3b), with the same length, width and depth as in the open box embodiment described above, but which is distinguished from it by the presence of a diagonal partition 1 1 that forms triangular-shaped housings 10, which serve as a guide to the legs 2 of the clip 1 during folding. This partition 1 1 has a flush height with the surface of the anvil 5.
En otra realización preferente de la invención, los huecos de formación de grapas 7 más cercanos a la línea de corte poseen huellas oblicuas (Figuras 4a y 4b), donde dichas huellas se disponen sucesivamente mediante parejas de alojamientos paralelos 12, enfrentados y oblicuos respecto a las líneas de formación de grapas 6 más lejanas a la línea de corte. En esta realización, cada uno de los alojamientos 12 en cada pareja posee una longitud sustancialmente igual al tamaño de las patas 2 de las grapas 1 , con una profundidad y una anchura similares a las realizaciones de caja abierta y de huella dividida en diagonal anteriormente descritas. In another preferred embodiment of the invention, the staple formation gaps 7 closest to the cutting line have oblique traces (Figures 4a and 4b), where said traces are arranged successively by pairs of parallel housings 12, facing and oblique with respect to the staple formation lines 6 farthest from the cutting line. In this embodiment, each of the housings 12 in each pair has a length substantially equal to the size of the legs 2 of the clips 1, with a depth and width similar to the embodiments of open box and diagonally divided footprint described above. .
Las realizaciones preferentes de la presente invención antes expuestas no han de ser consideradas como limitativas frente variaciones de su diseño o de los elementos empleados para su fabricación, siempre que dichas variaciones no alteren la esencia de la invención, así como el objeto de la misma. The preferred embodiments of the present invention set forth above should not be considered as limiting against variations of its design or of the elements used for its manufacture, provided that said variations do not alter the essence of the invention, as well as the object thereof.

Claims

REIVINDICACIONES
1 . - Dispositivo de grapado quirúrgico, preferentemente una grapadora, que comprende un yunque (5) cuya superficie presenta, al menos, dos líneas de formación de grapas (6), (8) donde, al menos, una de dichas líneas (8) incluye huecos de formación de grapas (7) caracterizados porque poseen una superficie interna sustancialmente plana y porque, al aplicarse las grapas (1 ) contra la superficie de dicho yunque (5), efectúan un cierre sustancialmente oclusivo y sustancialmente plano de dichas grapas. one . - Surgical stapling device, preferably a stapler, comprising an anvil (5) whose surface has at least two staple formation lines (6), (8) where at least one of said lines (8) includes Staple formation gaps (7) characterized in that they have a substantially flat internal surface and because, when the staples (1) are applied against the surface of said anvil (5), they effect a substantially occlusive and substantially flat closure of said staples.
2. - Dispositivo según la reivindicación 1 donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un espacio libre de separación entre las patas (2) de las grapas (1 ), una vez plegadas, inferior a 0,5 mm. 2. - Device according to claim 1 wherein the substantially occlusive and substantially flat closure made corresponds to a gap free of separation between the legs (2) of the clips (1), once folded, less than 0.5 mm.
3. - Dispositivo según cualquiera de las reivindicaciones 1 -2 donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un estado, tras la aplicación de las grapas (1 ) sobre el yunque (5), en el cual las patas (2) de dichas grapas quedan cerradas de forma sustancialmente paralela a la corona (3) de dichas grapas. 3. - Device according to any of claims 1 -2 wherein the substantially occlusive and substantially flat closure made corresponds to a state, after application of the clips (1) on the anvil (5), in which the legs (2) of said clips are closed substantially parallel to the crown (3) of said clips.
4. - Dispositivo según cualquiera de las reivindicaciones 1 -2 donde el cierre sustancialmente oclusivo y sustancialmente plano efectuado corresponde a un estado, tras la aplicación de las grapas (1 ) sobre el yunque (5), en el cual las patas (2) de dichas grapas quedan cerradas formando un ángulo igual o inferior a 6o con la corona (3) de dichas grapas. 4. - Device according to any of claims 1 -2 wherein the substantially occlusive and substantially flat closure made corresponds to a state, after application of the clips (1) on the anvil (5), in which the legs (2) of said clips are closed at an angle equal to or less than 6 or with the crown (3) of said clips.
5. - Dispositivo según cualquiera de las reivindicaciones 1 -4 donde las grapas (1 ) sobre las que se efectúa un cierre sustancialmente oclusivo y sustancialmente plano poseen patas (2) cuya longitud es, preferentemente, la mitad de la longitud de la corona (3) de dichas grapas. 5. - Device according to any of claims 1-4 wherein the clips (1) on which a substantially occlusive and substantially flat closure is made have legs (2) whose length is preferably half the length of the crown ( 3) of said staples.
6. - Dispositivo según cualquiera de las reivindicaciones 1 -4 donde las grapas (1 ) sobre las que se efectúa un cierre sustancialmente oclusivo y sustancialmente plano poseen patas (2) cuya longitud es, preferentemente, mayor que la mitad de la longitud de la corona (3) de dichas grapas. 6. - Device according to any of claims 1-4 wherein the clips (1) on which a substantially occlusive and substantially flat closure is made have legs (2) whose length is preferably greater than half the length of the crown (3) of said staples.
5  5
7. - Dispositivo según cualquiera de las reivindicaciones 1 -6 donde, al menos, una de las líneas de formación de grapas (6) incluye huecos de formación de grapas (9) caracterizados porque, al aplicarse las grapas contra la superficie del yunque, efectúan un cierre no oclusivo que permite la í o vascularización del tejido suturado a lo largo de dichas líneas de formación de grapas (6), incl uyendo los h uecos de formación de grapas (9), opcionalmente, la presencia de un tabique para el plegamiento o arrollamiento de las grapas (1 ).  7. - Device according to any one of claims 1-6 wherein at least one of the staple formation lines (6) includes staple formation gaps (9) characterized in that, when the staples are applied against the surface of the anvil, they make a non-occlusive closure that allows the vascularization of the sutured tissue along said staple formation lines (6), including staple formation holes (9), optionally, the presence of a partition wall for the folding or winding of the clips (1).
15 8.- Dispositivo según la reivindicación 7 donde las grapas (1 ) sobre las que se efectúa un cierre no oclusivo poseen patas (2) cuya longitud es diferente a la longitud de las grapas cerradas de forma sustancialmente oclusiva y sustancialmente plana. Device according to claim 7 wherein the staples (1) on which a non-occlusive closure is made have legs (2) whose length is different from the length of the closed staples in a substantially occlusive and substantially flat manner.
20 9.- Dispositivo según cualquiera de las reivindicaciones 1 -8 donde los huecos de formación de grapas (7) presentan una huella de caja abierta donde, para obtener el cierre sustancialmente oclusivo y sustancialmente plano mediante el plegamiento de las patas (2) de la grapa (1 ), bien por aproximación o por adosamiento de las patas (2) en el momento de suDevice according to any one of claims 1-8, wherein the staple formation holes (7) have an open box footprint where, to obtain the substantially occlusive and substantially flat closure by folding the legs (2) of the clip (1), either by approximation or by attaching the legs (2) at the time of its
25 cierre, dicha huella comprende: 25 closure, said footprint comprises:
- ausencia de tabiques y separaciones;  - absence of partitions and separations;
- una superficie interior sustancialmente plana;  - a substantially flat interior surface;
- una longitud sustancialmente igual al la longitud de la corona (3) de la grapa (1 );  - a length substantially equal to the length of the crown (3) of the clip (1);
30 - una anchura mayor del doble del grosor del alambre de la grapa (1 ), preferentemente, entre 2 y 2,5 veces el tamaño de dicho grosor, para permitir el adosamiento de las patas (2) plegadas; - una profund idad inferior a la huella empleada por un yunque convencional, comprendida entre 1 y 3 veces el grosor del alambre de la grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor. 30 - a width greater than twice the thickness of the staple wire (1), preferably, between 2 and 2.5 times the size of said thickness, to allow the bending of the folded legs (2); - a depth less than the footprint used by a conventional anvil, between 1 and 3 times the thickness of the staple wire, preferably being twice the size of said thickness.
5 10.- Dispositivo según cualquiera de las reivindicaciones 1 -8 donde los h uecos d e formación d e g ra pas (7) presentan una huella dividida diagonalmente que comprende: 5. Device according to any one of claims 1-8 wherein the cups of the formation of the country (7) have a diagonally divided footprint comprising:
- un tabique diagonal (1 1 ) que conforma unos alojamientos de forma triangular (10), que sirven de guía a las patas (2) de la grapa (1 ) durante su í o plegado, donde dicho tabique (1 1 ) pose una altura rasante con la superficie del yunque.  - a diagonal partition (1 1) that forms triangular-shaped housings (10), which serve as a guide to the legs (2) of the clip (1) during its folding, where said partition (1 1) has a flush height with the surface of the anvil.
- una superficie interior sustancialmente plana;  - a substantially flat interior surface;
- una longitud sustancialmente igual al la longitud de la corona (3) de la grapa (1 );  - a length substantially equal to the length of the crown (3) of the clip (1);
15 - una anchura mayor del doble del grosor del alambre de la grapa (1 ), preferentemente, entre 2 y 2,5 veces el tamaño de d icho grosor, para permitir el adosamiento de las patas (2) plegadas;  15 - a width greater than twice the thickness of the staple wire (1), preferably, between 2 and 2.5 times the size of said thickness, to allow the bending of the folded legs (2);
- una profund idad inferior a la huella empleada por un yunque convencional, comprendida entre 1 y 3 veces el grosor del alambre de la - a depth less than the footprint used by a conventional anvil, between 1 and 3 times the thickness of the wire of the
20 grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor. 20 staple, preferably being twice the size of said thickness.
1 1 .- Dispositivo según cualquiera de las reivindicaciones 1 -8 donde los huecos de formación de grapas (7) presentan una huella oblicua que comprende: 1 .- Device according to any of claims 1-8 wherein the staple formation gaps (7) have an oblique footprint comprising:
25 - una disposición sucesiva de parejas de alojamientos paralelos (12) enfrentados y oblicuos respecto a las líneas de formación de grapas (6) más alejadas de la línea de corte practicada;  25 - a successive arrangement of pairs of parallel accommodations (12) facing and oblique with respect to the staple formation lines (6) furthest from the cut line practiced;
- una superficie interior sustancialmente plana;  - a substantially flat interior surface;
- una longitud de cada uno de los alojamientos (12) en cada pareja 30 sustancialmente igual al la longitud de las patas (2) de la grapa (1 );  - a length of each of the housings (12) in each pair 30 substantially equal to the length of the legs (2) of the clip (1);
- una anchura total de cada pareja de alojamientos (12) mayor del doble del grosor del alambre de la grapa (1 ), preferentemente, entre 2 y 2,5 veces el tamaño de dicho grosor, para permitir el adosamiento de las patas (2) plegadas; - a total width of each housing pair (12) greater than twice the thickness of the staple wire (1), preferably between 2 and 2.5 times the size of said thickness, to allow the bending of the folded legs (2);
- una profund idad inferior a la huel la empleada por un yu nq ue convencional, comprendida entre 1 y 3 veces el grosor del alambre de la 5 grapa, siendo preferentemente de 2 veces el tamaño de dicho grosor.  - a depth less than the one used by a conventional yu nq ue, between 1 and 3 times the thickness of the wire of the staple, preferably being twice the size of said thickness.
12.- Dispositivo según cualquiera de las reivindicaciones 1 -1 1 , donde las líneas de formación de grapas (6), (8) son líneas rectas. í o12. Device according to any of claims 1 -1 1, wherein the staple formation lines (6), (8) are straight lines. í o
13.- Dispositivo según cualquiera de las reivindicaciones 1 -1 1 , donde las líneas de formación de grapas (6), (8) son líneas circulares o curvas. 13. Device according to any of claims 1 -1 1, wherein the staple formation lines (6), (8) are circular or curved lines.
14. - Uso de un dispositivo según cualquiera de las reivindicaciones 1 - 13 en intervenciones quirúrgicas. 14. - Use of a device according to any of claims 1-13 in surgical interventions.
15  fifteen
15. - Uso de un dispositivo según la reivindicación 14 en procedimientos de cirugía abierta.  15. - Use of a device according to claim 14 in open surgery procedures.
16. - Uso de un dispositivo según la reivindicación 14 en intervenciones 20 de tipo endoscópico o laparoscópico. 16. - Use of a device according to claim 14 in interventions 20 of the endoscopic or laparoscopic type.
17. - Método de grapado quirúrgico que comprende la aplicación de al menos, dos líneas de grapas al tejido suturado donde, al menos, en una de dichas líneas se efectú a un cierre sustancialmente oclusivo y17. - Surgical stapling method comprising the application of at least two lines of staples to the sutured tissue where at least one of said lines is made to a substantially occlusive closure and
25 sustancialmente plano de dichas grapas. 25 substantially flat of said staples.
18. - Método de grapado quirúrgico según la reivindicación 17 que comprende la aplicación de al menos, dos líneas de grapas al tejido suturado donde, al menos, en una de dichas líneas se efectúa un cierre18. - Surgical stapling method according to claim 17 comprising the application of at least two lines of staples to the sutured tissue where, at least, in one of said lines a closure is made
30 sustancialmente oclusivo y sustancialmente plano de dichas grapas, que emplea un dispositivo de grapado según cualquiera de las reivindicaciones 1 -13. Substantially occlusive and substantially flat of said staples, which employs a stapling device according to any of claims 1-13.
PCT/ES2011/070016 2010-01-20 2011-01-14 Surgical stapling device WO2011089294A1 (en)

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