WO2014170512A1 - Method and device for suturing blood vessels - Google Patents

Method and device for suturing blood vessels Download PDF

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Publication number
WO2014170512A1
WO2014170512A1 PCT/ES2014/070136 ES2014070136W WO2014170512A1 WO 2014170512 A1 WO2014170512 A1 WO 2014170512A1 ES 2014070136 W ES2014070136 W ES 2014070136W WO 2014170512 A1 WO2014170512 A1 WO 2014170512A1
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Prior art keywords
suture
blood vessels
blood
vessel
diameter
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PCT/ES2014/070136
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Spanish (es)
French (fr)
Inventor
Andrés MARTÍNEZ GARRIDO
Original Assignee
Martínez Garrido Andrés
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Publication of WO2014170512A1 publication Critical patent/WO2014170512A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections

Definitions

  • the present invention describes a method and a device for suturing blood vessels.
  • the method and the device described here are an intermediate point between the mechanical suture and the traditional manual suture.
  • This novel invention guarantees that there are no transfixing points (points that take the back wall of the blood vessel), which is the main problem of the traditional manual suture and on the other hand, it can be used in all types of blood vessels, which is the limitation of mechanical suture. More specifically it refers to a method and a device for use in surgical interventions.
  • the present invention is framed in the field of biomedical engineering and biomedicine. Background
  • Vascular microsurgery is a technique recognized worldwide, consisting of the union of two vascular ends, in order to restore vascular flow through them. If blood vessels are considered (veins and arteries and lymphatic vessels), such as pipes, it would be a question of splicing two ends so that blood passes inside. This technique is known as anastomosis.
  • Anastomosis of large vessels such as renal vessels in kidney transplants, or hepatic vessels in homonymous transplants, are difficult and require a refined technique.
  • the use of optical magnification systems is also required, which adds complexity and technical difficulty to the case.
  • Examples of anastomosis of vessels of smaller caliber would be limb reimplants or maxillofacial cancer reconstruction.
  • the main problem in these cases is simply to prevent the suture of the vessels from clogging and preventing the passage of blood (thrombus). In these cases, graft loss occurs in almost all cases with the serious damage that this entails.
  • suture presents permeability problems that may appear at the time of the suture or occur in a deferred manner, almost always because the aggregation and coagulation systems make a thrombus.
  • the appearance of deferred suture thrombosis is associated with the existence of a blood flow that is not constant and laminar (abrupt changes in the blood pressure), either due to turbulence in the flow (discrepancy in vessel size), or because the technique is not sufficiently purified.
  • EP 1842495 describes the method and device currently used in the state of the art. Commercially it is known as GEM Coupler® from Synovis). It is used mostly in venous sutures, as it requires some elasticity of the vascular wall. It consists of an attachment where the vascular wall is passed inside a ring with spikes, and it is placed outwards fixing it on them and everting the endothelium. At the other end, the procedure is similar and then both rings are closed by means of a self-closing system. The problem is that it is a complex technique, especially in more consistent walls, such as those of the arteries. It also requires an instrument specifically designed for the placement of the vessel in the ring.
  • ES2346144 refers to a device for the surgical connection of two tubular structures where said device comprises two rings that are introduced into each of the tubular structures, adjusting to its perimeter, and subsequently closed by a pressure mechanism.
  • the problem associated with this type of invention is similar to that mentioned for the GEM Coupler®.
  • the invention described in WO2011042508 refers to a suture ring having a series of skewers on both sides that once inserted into the blood vessel is fixed to the two ends of the vessels joining them.
  • This type of invention shows a type of pressure fixation that is unreliable in terms of durability and also results in an obstacle to the passage of fluids which can lead to the appearance of thrombi.
  • US4055186 shows an anastomosis button which has two complementary axially coupled fasteners. Said fasteners are introduced inside the two sections of the vessel to be sutured so that they affect important way to the passage section of the vessel favoring again the appearance of thrombi.
  • a first object of the present invention is a blood vessel suture device, where there are two ends of the blood vessel to be sutured and where said device has an annular shape that conforms to the diameter of the larger diameter end. It also has at least two through holes in its lateral faces through which the corresponding stitches are passed so that they fix the lateral faces of the device to the internal face of the endothelium of the blood vessels.
  • the suture device object of the present invention facilitates vascular suturing. It is an intermediate point between mechanical and traditional sutures. It guarantees that there are no transfixing points, which is the main problem of manual suturing, and on the other hand, it can be used in all types of vessels.
  • suture device that does not need a specific tool for placement but can be perfectly manipulated by the practitioner in a simple way, which reduces the cost of it as well as surgical intervention.
  • the device is made of a material biochemically compatible with the substances with which it is in contact, for example, muscle, blood and other body fluids and tissues.
  • the device is made of stainless steel.
  • the through holes have a diameter that conforms to the thickness of the suture needles. This thickness should be slightly larger than the diameter of the needle so that it can pass through it without difficulty.
  • the suture device is manufactured in diameters that conform to the diameters of the most common blood vessels, specifically between 1 and 4 mm.
  • 6 through holes could be placed in a 2mm diameter device.
  • 3mm and 4mm devices would consist of 8 holes.
  • the thickness of the device could be between 1 and 2 microns.
  • the use of the device described here is also planned For suturing larger blood vessels such as the coronary arteries, the aorta, the vena cava or the renal arteries, they simply adapt the dimensions of the device to the diameter of the blood vessel to be sutured. Obviously, the suture of a larger diameter vessel will involve having a larger diameter suture device and having a greater number of through holes so that the suture is reliable.
  • a second object of the present invention is a blood vessel suture method, more specifically the suture is made between a first and a second end of a blood vessel, said method using the device described above.
  • the method comprises the following phases: - placing the device in proximity to the first and second end of the blood vessel to be sutured;
  • each stitch is passed from outside to inside the first end of the blood vessel, through one of the holes in the suture device and from inside to outside through the second out of the blood vessel.
  • a single suture point will usually be used for each hole in the suture device but there may be applications where some of these holes are not sutured or that more than one suture point is used for each hole in order to secure the suture;
  • the invention when talking about the suture of a first and a second blood line, the invention is not being restricted to terminal junctions, but is also intended for use in term-lateral sutures.
  • the method used is identical to the case of terminal joints, although they are technically more complex for the surgeon in charge. Therefore, the use of the present invention in terminal and lateral-lateral sutures is envisaged being the technical scenario of this second type of sutures more complex than that of the first.
  • the placement phase of the suture device in proximity to the ends of the blood vessel is performed by means of a silk loop of a caliber that allows the device to be easily operated by the practitioner such as a silk loop of four zeros.
  • the suture device described herein can be used for suturing anatomical ducts that are not exclusively blood vessels. Examples of this type of ducts are the intestinal handles or the urethra. This type of ducts can be sutured more easily than blood vessels because they do not generate thrombi and therefore the problem associated with the introduction of the endothelium into the lumen of the vessel does not exist. However, this device allows the correct suturing of any type of anatomical duct simply by adapting the dimensions of said device to those of the ducts to be sutured.
  • Figure 1. Shows a general view of the device object of the present invention just before being attached to the two ends of the vessel to be sutured.
  • Figure 2. Shows a view of the device shown in Figure 1 once it has already been attached to both ends of the vessel and therefore the suture has been performed.
  • Figure 1 shows an exemplary embodiment of the device object of the present invention at the time of suturing a first end (2) and a second end (3) of a blood vessel. Specifically, it shows a suture ring (1) with a minimum diameter of 1 mm that coincides with the diameter of the largest vessel. Note that the ring (1) must have a diameter that adjusts in each case to the diameter of the blood vessel larger than those that are to be sutured and that both blood vessels must also have a similar diameter because if they had very uneven diameters the blood when passing through the suture zone would enter in turbulence thrombi can be generated. It is therefore obvious that rings are provided whose diameters fit the diameters of the existing blood vessels in humans and animals and that the suture will be made between vessels of diameters not necessarily identical but similar.
  • the ring (1) is manufactured in the most frequent sizes of vessel light, that is, between 1 to 4 mm, at 1 mm intervals.
  • the thickness should be thin, but enough to have stiffness and accommodate the holes in the point.
  • the ring (1) shown has holes (4) through the entire perimeter, in this particular case 8, for the passage of traditional sutures (5) of 8 zeros.
  • the type of suture used in each case will depend on the surgical needs and the size of the ring (1) and therefore the present invention is not limited to a specific type of suture.
  • the two ends (2,3) of the blood vessel to be sutured have been previously manipulated to remove the adventitia (6) exposing the muscular layer next to the endothelium (7).
  • the suture method that makes use of the suture ring (1) object of the invention has provided that the adventitia (6) always remains on the outer face of the suture regardless of whether it has been previously removed or not, if some millimeters of it in the area of suture, ensures that in no way it is introduced into the lumen of the vessels causing thrombi.
  • the endothelium (7) is covering the ring (1) and the adventitia (outer layer) is not introduced into the lumen of the vessel (internal tunnel of the vessel, through which the blood circulates).
  • the ring (1) must have a minimum thickness, the current suture needle manufacturing technology allows the manufacture of needles of up to 12 zeros.
  • the holes (4) of the ring (1) must have a diameter that makes it possible to insert the suture needle (8).
  • the ring must be of an adequate diameter and never smaller than the diameter of the vascular ends, as it would induce the intrusion of the adventitia, and this would be disastrous. On the contrary, if the ring is somewhat larger, which is advisable, it would extrude and evert the endothelium giving security to the suture.
  • the manufacturing material of the ring this could be the same as the suture needles, which is none other than stainless steel.
  • FIG. 2 shows how the suture looks once the ring (1) is attached to the two ends (2,3) of the blood vessel. For this, each suture point (5) is passed from outside to inside a first end (2) of the vessel, it is subsequently passed through one of the through holes (4) of the ring (1) and finally removed from inside to outside in the second end (3) of the blood vessel. Then it is knotted in the extreme part of the glass closing the suture point.
  • the wall of the blood vessel has three layers: the intimate or endothelium (9), which is the one in contact with the blood and does not induce clots as is logical.
  • the muscular (7) that is the intermediate layer, and the outer layer or "sheath" (6) that is called adventitia. If, by bad technique, the adventitia is introduced into the lumen of the vessel, it is very thrombus-inducing, so it is usually removed in one mm of the vascular ends as shown in Figures 1 and 2.

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Abstract

The invention relates to a method and a device for suturing blood vessels, taking two ends of the blood vessel to be sutured, said device having an annular form which adjusts to the diameter of the end of the blood vessel that has a larger diameter. Said device also has at least two through-openings on the side faces thereof through which the corresponding suture points are passed in such a way that the side faces of the device are attached to the inner surface of the endothelium of the blood vessels.

Description

MÉTODO Y DISPOSITIVO PARA LA SUTURA DE VASOS SANGUÍNEOS  METHOD AND DEVICE FOR THE SUTURE OF BLOOD VESSELS
Objeto de la invención La presente invención describe un método y un dispositivo para la sutura de vasos sanguíneos. El método y el dispositivo aquí descrito son un punto intermedio entre la sutura mecánica y la sutura manual tradicional. Esta novedosa invención garantiza que no se den puntos transfixiantes (puntos que cojan la pared posterior del vaso sanguíneo), que es el principal problema de la sutura manual tradicional y por otra parte, se puede emplear en todo tipo de vasos sanguíneos, que es la limitación de la sutura mecánica. Más concretamente se refiere a un método y a un dispositivo para su uso en intervenciones quirúrgicas. Object of the invention The present invention describes a method and a device for suturing blood vessels. The method and the device described here are an intermediate point between the mechanical suture and the traditional manual suture. This novel invention guarantees that there are no transfixing points (points that take the back wall of the blood vessel), which is the main problem of the traditional manual suture and on the other hand, it can be used in all types of blood vessels, which is the limitation of mechanical suture. More specifically it refers to a method and a device for use in surgical interventions.
La presente invención se enmarca en el campo de la ingeniería biomédica y la biomedicina. Antecedentes The present invention is framed in the field of biomedical engineering and biomedicine. Background
La microcirugía vascular es una técnica reconocida en todo el mundo, que consiste en la unión, de dos cabos vasculares, con la finalidad de restablecer el flujo vascular a través de estos. Si se consideran los vasos sanguíneos (venas y arterias y vasos linfáticos), como cañerías, se trataría de empalmar dos cabos para que pase sangre por su interior. Dicha técnica se conoce como anastomosis. Vascular microsurgery is a technique recognized worldwide, consisting of the union of two vascular ends, in order to restore vascular flow through them. If blood vessels are considered (veins and arteries and lymphatic vessels), such as pipes, it would be a question of splicing two ends so that blood passes inside. This technique is known as anastomosis.
La anastomosis de vasos grandes, tal como los vasos renales en los trasplantes de riñon, o los hepáticos en los trasplantes homónimos, son difíciles y requieren una técnica depurada. En el caso de los vasos de pequeño calibre se requiere además el uso de sistemas ópticos de magnificación, lo que añade complejidad y dificultad técnica al caso. Ejemplos de anastomosis de vasos de menor calibre, serían los reimplantes de miembros o la reconstrucción oncológica maxilofacial. El principal problema en estos casos, radica simplemente en evitar que la sutura de los vasos se obstruya e impida el paso de sangre (trombo). En estos casos, se produce la pérdida del injerto en la casi totalidad de los casos con los graves perjuicios que esto acarrea. A veces la sutura presenta problemas de permeabilidad que pueden aparecer en el momento de la sutura o producirse de manera diferida, casi siempre porque los sistemas de agregación y coagulación fabrican un trombo. La aparición de trombosis diferida de la sutura se asocia a la existencia de un flujo sanguíneo que no es constante y laminar (cambios bruscos en la tensión arterial), o bien a que se producen turbulencias en el flujo (discrepancia en el tamaño de los vasos), o bien a que la técnica no es lo suficientemente depurada. Anastomosis of large vessels, such as renal vessels in kidney transplants, or hepatic vessels in homonymous transplants, are difficult and require a refined technique. In the case of small-sized vessels, the use of optical magnification systems is also required, which adds complexity and technical difficulty to the case. Examples of anastomosis of vessels of smaller caliber, would be limb reimplants or maxillofacial cancer reconstruction. The main problem in these cases is simply to prevent the suture of the vessels from clogging and preventing the passage of blood (thrombus). In these cases, graft loss occurs in almost all cases with the serious damage that this entails. Sometimes the suture presents permeability problems that may appear at the time of the suture or occur in a deferred manner, almost always because the aggregation and coagulation systems make a thrombus. The appearance of deferred suture thrombosis is associated with the existence of a blood flow that is not constant and laminar (abrupt changes in the blood pressure), either due to turbulence in the flow (discrepancy in vessel size), or because the technique is not sufficiently purified.
La sutura manual en manos expertas se ha demostrado como una técnica fiable con más del 90% de éxitos en casi todas las series de trabajos científicos. Sin embargo, adolece de una fiabilidad suficiente al inicio de la curva de aprendizaje y a veces es dificultosa cuando la calidad del vaso no es buena. Manual suturing in expert hands has been proven as a reliable technique with more than 90% success in almost all series of scientific papers. However, it suffers from sufficient reliability at the beginning of the learning curve and is sometimes difficult when the quality of the glass is not good.
Por todo ello, se ha intentado la búsqueda de la sutura mecánica ideal. El documento EP 1842495 describe el método y dispositivo más empleado actualmente en el estado de la técnica. Comercialmente se le conoce como GEM Coupler® de la casa Synovis). Se usa sobre todo en suturas venosas, pues requiere cierta elasticidad de la pared vascular. Consiste en un aditamento donde se pasa la pared vascular por dentro de un anillo con pinchos, y se coloca hacia fuera fijándola en éstos y evertiendo el endotelio. En el otro extremo se procede de manera similar y luego se cierran ambos anillos por medio de un sistema de autocierre. El problema es que se trata de una técnica compleja, sobre todo en paredes más consistentes, como las de las arterias. Además precisa de un instrumento específicamente diseñado para la colocación del vaso en el anillo. Otro tipo de aditamentos del estado de la técnica son por ejemplo los mostrados en los documentos de patente ES2346144, WO2011042508 y US4055186. Concretamente el dispositivo mostrado en ES2346144 se refiere a un dispositivo para la unión quirúrgica de dos estructuras tubulares donde dicho dispositivo comprende dos anillos que se introducen en cada una de las estructuras tubulares, ajustándose a su perímetro, y posteriormente se cierran mediante un mecanismo por presión. La problemática asociada a este tipo de invenciones es similar a la mencionada para el GEM Coupler®. For all this, the search for the ideal mechanical suture has been attempted. EP 1842495 describes the method and device currently used in the state of the art. Commercially it is known as GEM Coupler® from Synovis). It is used mostly in venous sutures, as it requires some elasticity of the vascular wall. It consists of an attachment where the vascular wall is passed inside a ring with spikes, and it is placed outwards fixing it on them and everting the endothelium. At the other end, the procedure is similar and then both rings are closed by means of a self-closing system. The problem is that it is a complex technique, especially in more consistent walls, such as those of the arteries. It also requires an instrument specifically designed for the placement of the vessel in the ring. Other types of prior art attachments are, for example, those shown in patent documents ES2346144, WO2011042508 and US4055186. Specifically, the device shown in ES2346144 refers to a device for the surgical connection of two tubular structures where said device comprises two rings that are introduced into each of the tubular structures, adjusting to its perimeter, and subsequently closed by a pressure mechanism. . The problem associated with this type of invention is similar to that mentioned for the GEM Coupler®.
La invención descrita en WO2011042508 se refiere a un anillo de sutura que presenta una serie de pinchos en ambas caras que una vez introducido en el interior del vaso sanguíneo se fija a los dos extremos de los vasos uniéndolos. Este tipo de invenciones muestran un tipo de fijación por presión que resulta poco fiable en términos de durabilidad y que además resulta en un obstáculo para el paso de los fluidos lo que puede derivar en la aparición de trombos. The invention described in WO2011042508 refers to a suture ring having a series of skewers on both sides that once inserted into the blood vessel is fixed to the two ends of the vessels joining them. This type of invention shows a type of pressure fixation that is unreliable in terms of durability and also results in an obstacle to the passage of fluids which can lead to the appearance of thrombi.
La invención mostrada en US4055186 muestra un botón de anastomosis que dispone de dos elementos de sujeción complementarios axialmente acoplados. Dichos elementos de sujeción se introducen en el interior de las dos secciones del vaso a suturar por lo que afectan de forma importante a la sección de paso del vaso favoreciendo nuevamente la aparición de trombos. The invention shown in US4055186 shows an anastomosis button which has two complementary axially coupled fasteners. Said fasteners are introduced inside the two sections of the vessel to be sutured so that they affect important way to the passage section of the vessel favoring again the appearance of thrombi.
Descripción de la invención Description of the invention
Un primer objeto de la presente invención es un dispositivo de sutura de vasos sanguíneos, donde se dispone de dos cabos del vaso sanguíneo que se va a suturar y donde dicho dispositivo tiene una forma anular que se ajusta al diámetro del cabo de mayor diámetro. Además dispone de al menos dos orificios pasantes en sus caras laterales a través de los cuales se hacen pasar los correspondientes puntos de sutura de manera que fijan las caras laterales del dispositivo a la cara interna del endotelio de los vasos sanguíneos. A first object of the present invention is a blood vessel suture device, where there are two ends of the blood vessel to be sutured and where said device has an annular shape that conforms to the diameter of the larger diameter end. It also has at least two through holes in its lateral faces through which the corresponding stitches are passed so that they fix the lateral faces of the device to the internal face of the endothelium of the blood vessels.
Sin ser una sutura mecánica, el dispositivo de sutura objeto de la presente invención facilita la sutura vascular. Es un punto intermedio entre la sutura mecánica y la tradicional. Garantiza que no se dan puntos transfixiantes, que es el principal problema de la sutura manual, y por otra parte, se puede emplear en todo tipo de vasos. Without being a mechanical suture, the suture device object of the present invention facilitates vascular suturing. It is an intermediate point between mechanical and traditional sutures. It guarantees that there are no transfixing points, which is the main problem of manual suturing, and on the other hand, it can be used in all types of vessels.
Además se trata de un dispositivo de sutura que no necesita de una herramienta específica para su colocación sino que puede ser perfectamente manipulado por el facultativo de un modo sencillo, lo que reduce el coste del mismo así como de la intervención quirúrgica. In addition it is a suture device that does not need a specific tool for placement but can be perfectly manipulated by the practitioner in a simple way, which reduces the cost of it as well as surgical intervention.
En una realización particular de la invención, el dispositivo está fabricado en un material bioquímicamente compatible con las sustancias con las que está en contacto, por ejemplo, músculo, sangre y otros fluidos y tejidos corporales. En otra realización más particular, el dispositivo está hecho de acero inoxidable. In a particular embodiment of the invention, the device is made of a material biochemically compatible with the substances with which it is in contact, for example, muscle, blood and other body fluids and tissues. In another more particular embodiment, the device is made of stainless steel.
En otra realización particular de la invención, los orificios pasantes presentan un diámetro que se ajusta al grosor de las agujas de sutura. Este grosor debe ser ligeramente mayor que el diámetro de la aguja para que ésta pueda pasar a través de él sin dificultad. In another particular embodiment of the invention, the through holes have a diameter that conforms to the thickness of the suture needles. This thickness should be slightly larger than the diameter of the needle so that it can pass through it without difficulty.
En una realización particular de la invención, el dispositivo de sutura se fabrica en diámetros que se ajustan a los diámetros de los vasos sanguíneos más habituales, concretamente entre 1 y 4 mm. En otras realizaciones particulares de la invención, en un dispositivo de 2mm de diámetro podrían colocarse 6 orificios pasantes. En dispositivos de 3mm y 4mm constarían de 8 orificios. Además en cualquiera de los casos, el espesor del dispositivo podría estar comprendido entre 1 y 2 mieras. También se ha previsto el uso del dispositivo aquí descrito para la sutura de vasos sanguíneos de mayor calibre como pueden ser las arterias coronarias, la aorta, la vena cava o las arterias renales sin más que adecuar las dimensiones del dispositivo al diámetro del vaso sanguíneo a suturar. Obviamente la sutura de un vaso de mayor diámetro implicará disponer de un dispositivo de sutura de mayor diámetro y que presente un mayor número de orificios pasantes para que la sutura sea fiable. In a particular embodiment of the invention, the suture device is manufactured in diameters that conform to the diameters of the most common blood vessels, specifically between 1 and 4 mm. In other particular embodiments of the invention, 6 through holes could be placed in a 2mm diameter device. In 3mm and 4mm devices would consist of 8 holes. Also in any of the cases, the thickness of the device could be between 1 and 2 microns. The use of the device described here is also planned For suturing larger blood vessels such as the coronary arteries, the aorta, the vena cava or the renal arteries, they simply adapt the dimensions of the device to the diameter of the blood vessel to be sutured. Obviously, the suture of a larger diameter vessel will involve having a larger diameter suture device and having a greater number of through holes so that the suture is reliable.
En una realización más general del anillo de sutura, éste presenta como mínimo dos orificios para pasar el punto tradicional de 8 ceros. Un segundo objeto de la presente invención es un método de sutura de vasos sanguíneos, más concretamente la sutura se realiza entre un primer y un segundo cabo de un vaso sanguíneo, haciendo uso dicho método del dispositivo descrito anteriormente. El método comprende las siguientes fases: - colocar el dispositivo en proximidad al primer y segundo cabo del vaso sanguíneo que se va a suturar; In a more general embodiment of the suture ring, it has at least two holes to pass the traditional 8-zero point. A second object of the present invention is a blood vessel suture method, more specifically the suture is made between a first and a second end of a blood vessel, said method using the device described above. The method comprises the following phases: - placing the device in proximity to the first and second end of the blood vessel to be sutured;
- realizar la sutura mediante una pluralidad de puntos de sutura, donde cada punto de sutura se pasa de fuera a dentro por el primer cabo del vaso sanguíneo, a través de uno de los orificios del dispositivo de sutura y de dentro a fuera por el segundo cabo del vaso sanguíneo. Nótese que habitualmente se empleará un único punto de sutura para cada orificio del dispositivo de sutura pero puede haber aplicaciones en las que alguno de dichos orificios no se suture o que se emplee más de un punto de sutura para cada orificio con el fin de asegurar la sutura; y,  - perform the suture through a plurality of stitches, where each stitch is passed from outside to inside the first end of the blood vessel, through one of the holes in the suture device and from inside to outside through the second out of the blood vessel. Note that a single suture point will usually be used for each hole in the suture device but there may be applications where some of these holes are not sutured or that more than one suture point is used for each hole in order to secure the suture; Y,
- atar cada punto de sutura fijando la unión de ambos cabos con la interposición del dispositivo de sutura. De este modo, los endotelios de ambos cabos quedan en contacto con el dispositivo de sutura evitándose así que la adventicia se introduzca en la luz del vaso provocando la aparición del trombo.  - tie each suture by fixing the junction of both ends with the interposition of the suture device. In this way, the endotheliums of both ends remain in contact with the suture device, thus preventing the adventitia from entering the vessel's lumen causing the thrombus to appear.
Nótese que cuando se habla de la sutura de un primer y un segundo cabo sanguíneo no se está restringiendo la invención a uniones terminales sino que también se ha previsto para su uso en suturas término-laterales. Para este tipo de uniones el método empleado es idéntico que para el caso de uniones terminales aunque sí que técnicamente son más complejas para el cirujano encargado. Por tanto se ha previsto el uso de la presente invención en suturas terminales y término-laterales siendo el escenario técnico de este segundo tipo de suturas más complejo que el de la primera. En una realización particular del método, la fase colocación del dispositivo de sutura en proximidad a los cabos del vaso sanguíneo se realiza mediante una lazada de seda de un calibre que permita manejar el dispositivo con facilidad por parte del facultativo como por ejemplo una lazada de seda de cuatro ceros. Note that when talking about the suture of a first and a second blood line, the invention is not being restricted to terminal junctions, but is also intended for use in term-lateral sutures. For this type of joints, the method used is identical to the case of terminal joints, although they are technically more complex for the surgeon in charge. Therefore, the use of the present invention in terminal and lateral-lateral sutures is envisaged being the technical scenario of this second type of sutures more complex than that of the first. In a particular embodiment of the method, the placement phase of the suture device in proximity to the ends of the blood vessel is performed by means of a silk loop of a caliber that allows the device to be easily operated by the practitioner such as a silk loop of four zeros.
En otra realización particular del método, como fase previa a la colocación del dispositivo de sutura en proximidad a los a los cabos del vaso sanguíneo comprende eliminar la adventicia de los extremos de los vasos sanguíneos. También se ha previsto que el dispositivo de sutura aquí descrito se pueda emplear para la sutura de conductos anatómicos que no sean exclusivamente vasos sanguíneos. Ejemplos de este tipo de conductos son las asas intestinales o la uretra. Este tipo de conductos permiten ser suturados de forma más sencilla que los vasos sanguíneos ya que no generan trombos y por tanto la problemática asociada a la introducción del endotelio dentro de la luz del vaso no existe. Sin embargo, este dispositivo permite la correcta sutura de cualquier tipo de conducto anatómico simplemente adaptando las dimensiones de citado dispositivo a las de los conductos que se vayan a suturar. In another particular embodiment of the method, as a phase prior to the placement of the suture device in proximity to the ends of the blood vessel, it comprises removing the adventitia from the ends of the blood vessels. It is also provided that the suture device described herein can be used for suturing anatomical ducts that are not exclusively blood vessels. Examples of this type of ducts are the intestinal handles or the urethra. This type of ducts can be sutured more easily than blood vessels because they do not generate thrombi and therefore the problem associated with the introduction of the endothelium into the lumen of the vessel does not exist. However, this device allows the correct suturing of any type of anatomical duct simply by adapting the dimensions of said device to those of the ducts to be sutured.
Descripción de las figuras Description of the figures
Figura 1.- Muestra una vista general del dispositivo objeto de la presente invención justo antes de ser unido a los dos cabos del vaso que se va a suturar. Figure 1.- Shows a general view of the device object of the present invention just before being attached to the two ends of the vessel to be sutured.
Figura 2.- Muestra una vista de del dispositivo mostrado en la figura 1 una vez ya se ha unido a ambos cabos del vaso y por tanto realizada la sutura. Figure 2.- Shows a view of the device shown in Figure 1 once it has already been attached to both ends of the vessel and therefore the suture has been performed.
Ejemplos de realización Examples of realization
Seguidamente se realizan, con carácter ilustrativo y no limitativo, una descripción de varios ejemplos de realización de la invención, haciendo referencia a la numeración adoptada en las figuras. Next, a description of several embodiments of the invention is made, by way of illustration and not limitation, with reference to the numbering adopted in the figures.
La figura 1 muestra un ejemplo de realización del dispositivo objeto de la presente invención en el momento en que se va a realizar la sutura de un primer cabo (2) y de un segundo cabo (3) de un vaso sanguíneo. Concretamente muestra un anillo de sutura (1) con un diámetro mínimo de 1 mm que coincide con el diámetro del vaso mayor. Nótese que el anillo (1) deberá tener un diámetro que se ajuste en cada caso al diámetro del vaso sanguíneo mayor de los que se vayan a suturar y que además ambos vasos sanguíneos deberán tener un dímetro similar ya que si presentasen diámetros muy desiguales la sangre al pasar por la zona de sutura entraría en turbulencias pudiendo generarse trombos. Es obvio por tanto que se han previsto anillos cuyos diámetros se ajusten a los diámetros de los vasos sanguíneos existentes en seres humanos y animales y que la sutura se realizará entre vasos de dímetros no necesariamente idénticos pero sí similares. Figure 1 shows an exemplary embodiment of the device object of the present invention at the time of suturing a first end (2) and a second end (3) of a blood vessel. Specifically, it shows a suture ring (1) with a minimum diameter of 1 mm that coincides with the diameter of the largest vessel. Note that the ring (1) must have a diameter that adjusts in each case to the diameter of the blood vessel larger than those that are to be sutured and that both blood vessels must also have a similar diameter because if they had very uneven diameters the blood when passing through the suture zone would enter in turbulence thrombi can be generated. It is therefore obvious that rings are provided whose diameters fit the diameters of the existing blood vessels in humans and animals and that the suture will be made between vessels of diameters not necessarily identical but similar.
El anillo (1) se fabrica en los tamaños más frecuentes de luz de los vasos, es decir, entre 1 a 4 mm, a intervalos de 1 mm. El espesor debe ser fino, pero lo suficiente para tener rigidez y albergar los orificios de paso del punto. The ring (1) is manufactured in the most frequent sizes of vessel light, that is, between 1 to 4 mm, at 1 mm intervals. The thickness should be thin, but enough to have stiffness and accommodate the holes in the point.
El anillo (1) mostrado presenta orificios (4) pasantes a lo largo de todo el perímetro, en este caso concreto 8, para el paso de puntos de sutura (5) tradicionales de 8 ceros. Téngase en cuenta que el tipo de punto de sutura empleado en cada caso dependerá de las necesidades quirúrgicas y del tamaño del anillo (1) y por tanto la presente invención no se limita a un tipo de punto de sutura concreto. The ring (1) shown has holes (4) through the entire perimeter, in this particular case 8, for the passage of traditional sutures (5) of 8 zeros. Note that the type of suture used in each case will depend on the surgical needs and the size of the ring (1) and therefore the present invention is not limited to a specific type of suture.
Los dos cabos (2,3) del vaso sanguíneo que se va a suturar han sido previamente manipulados para eliminar la adventicia (6) dejando al descubierto la capa muscular junto al endotelio (7). Aunque el método de sutura que hace uso del anillo de sutura (1) objeto de la invención ha previsto que la adventicia (6) quede siempre en la cara externa de la sutura independientemente de si se ha eliminado previamente o no, si se elimina unos milímetros de la misma en la zona de sutura, se asegura que de ningún modo ésta se introduzca en la luz de los vasos provocando trombos. The two ends (2,3) of the blood vessel to be sutured have been previously manipulated to remove the adventitia (6) exposing the muscular layer next to the endothelium (7). Although the suture method that makes use of the suture ring (1) object of the invention has provided that the adventitia (6) always remains on the outer face of the suture regardless of whether it has been previously removed or not, if some millimeters of it in the area of suture, ensures that in no way it is introduced into the lumen of the vessels causing thrombi.
Con este dispositivo se consigue que el endotelio (7) quede recubriendo el anillo (1) y la adventicia (capa externa) no se introduzca en la luz del vaso (túnel interno del vaso, por donde circula la sangre). Aunque el anillo (1) debe tener un espesor mínimo, la tecnología de fabricación de agujas de suturas actual permite la fabricación de agujas de hasta 12 ceros. Los orificios (4) del anillo (1) deben tener un diámetro que posibilite introducir la aguja de sutura (8). With this device it is possible that the endothelium (7) is covering the ring (1) and the adventitia (outer layer) is not introduced into the lumen of the vessel (internal tunnel of the vessel, through which the blood circulates). Although the ring (1) must have a minimum thickness, the current suture needle manufacturing technology allows the manufacture of needles of up to 12 zeros. The holes (4) of the ring (1) must have a diameter that makes it possible to insert the suture needle (8).
El anillo debe ser de un diámetro adecuado y nunca menor que el diámetro de los cabos vasculares, pues induciría a la intrusión de la adventicia, y ello sería desastroso. Por el contrario, si el anillo es algo mayor, lo que es recomendable, extruiría y evertería el endotelio dando seguridad a la sutura. The ring must be of an adequate diameter and never smaller than the diameter of the vascular ends, as it would induce the intrusion of the adventitia, and this would be disastrous. On the contrary, if the ring is somewhat larger, which is advisable, it would extrude and evert the endothelium giving security to the suture.
En cuanto al material de fabricación del anillo, éste podría ser el mismo que las agujas de sutura, que no es otro que el acero inoxidable. As for the manufacturing material of the ring, this could be the same as the suture needles, which is none other than stainless steel.
Para facilitar el posicionamiento en el campo quirúrgico de un dispositivo de tan pequeñas dimensiones, se debería administrar con una lazada de seda de cuatro ceros, que permitiría su manipulación previa a su posición en servicio. La figura 2 muestra cómo queda la sutura una vez fijado el anillo (1) a los dos cabos (2,3) del vaso sanguíneo. Para ello se pasa cada punto de sutura (5) de fuera a adentro de un primer cabo (2) del vaso, se pasa posteriormente por uno de los orificios pasantes (4) del anillo (1) y finalmente se saca de dentro a fuera en el segundo cabo (3) del vaso sanguíneo. Luego se anuda en la parte extrema del vaso cerrando el punto de sutura. To facilitate the positioning in the surgical field of a device of such small dimensions, it should be administered with a silk loop of four zeros, which would allow its manipulation prior to its position in service. Figure 2 shows how the suture looks once the ring (1) is attached to the two ends (2,3) of the blood vessel. For this, each suture point (5) is passed from outside to inside a first end (2) of the vessel, it is subsequently passed through one of the through holes (4) of the ring (1) and finally removed from inside to outside in the second end (3) of the blood vessel. Then it is knotted in the extreme part of the glass closing the suture point.
La pared del vaso sanguíneo tiene tres capas: la íntima o endotelio (9), que es la que está en contacto con la sangre y no induce a coágulos como es lógico. La muscular (7) que es la capa intermedia, y la capa externa o "funda" (6) que se denomina adventicia. Si por mala técnica la adventicia se introduce en la luz del vaso, es muy inductora de trombos, por lo que se suele extirpar en un mm de los cabos vasculares tal y como se muestra en las figuras 1 y 2. The wall of the blood vessel has three layers: the intimate or endothelium (9), which is the one in contact with the blood and does not induce clots as is logical. The muscular (7) that is the intermediate layer, and the outer layer or "sheath" (6) that is called adventitia. If, by bad technique, the adventitia is introduced into the lumen of the vessel, it is very thrombus-inducing, so it is usually removed in one mm of the vascular ends as shown in Figures 1 and 2.

Claims

REIVINDICACIONES
1. - Dispositivo de sutura (1) de vasos sanguíneos caracterizado por que comprende - tener una forma anular que se ajusta al diámetro de un cabo del vaso sanguíneo de mayor diámetro de los vasos sanguíneos que se van a suturar; 1. - Suture device (1) of blood vessels characterized in that it comprises - having an annular shape that conforms to the diameter of an end of the blood vessel of greater diameter of the blood vessels to be sutured;
- disponer de al menos dos orificios (4) pasantes en sus caras laterales a través de los cuales se hacen pasar puntos de sutura (5) fijando las caras laterales del dispositivo a la cara interna del endotelio (9) de los vasos sanguíneos.  - have at least two holes (4) through its lateral faces through which stitches (5) are passed by fixing the lateral faces of the device to the internal face of the endothelium (9) of the blood vessels.
2. - Dispositivo de sutura (1) de vasos sanguíneos, según la reivindicación 1 , caracterizado por que está fabricado en un material bioquímicamente compatible. 2. - Suture device (1) of blood vessels, according to claim 1, characterized in that it is made of a biochemically compatible material.
3. - Dispositivo de sutura (1) de vasos sanguíneos, según la reivindicación 2, caracterizado porque está fabricado en acero inoxidable. 3. - Suture device (1) of blood vessels, according to claim 2, characterized in that it is made of stainless steel.
4. - Dispositivo de sutura (1) de vasos sanguíneos, según la reivindicación 1 , caracterizado porque los al menos dos orificios (4) pasantes presentan un diámetro que se ajusta al grosor de las agujas de sutura (8). 4. - Suture device (1) of blood vessels, according to claim 1, characterized in that the at least two holes (4) have a diameter that adjusts to the thickness of the suture needles (8).
PCT/ES2014/070136 2013-04-16 2014-02-24 Method and device for suturing blood vessels WO2014170512A1 (en)

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Citations (6)

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US3254650A (en) * 1962-03-19 1966-06-07 Michael B Collito Surgical anastomosis methods and devices
US3974835A (en) * 1972-11-30 1976-08-17 Hardy Jr Thomas G Anastomotic apparatus and method
US4553542A (en) * 1982-02-18 1985-11-19 Schenck Robert R Methods and apparatus for joining anatomical structures
WO2000025679A1 (en) * 1998-11-04 2000-05-11 Karamuersel Sebat Rigid circular implant that is used as an external stent in vascular anastomoses
US20070185507A1 (en) * 2005-04-22 2007-08-09 Helmut Schreiber Surgical marker/connector and method of installation

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3254650A (en) * 1962-03-19 1966-06-07 Michael B Collito Surgical anastomosis methods and devices
US3254651A (en) * 1962-09-12 1966-06-07 Babies Hospital Surgical anastomosis methods and devices
US3974835A (en) * 1972-11-30 1976-08-17 Hardy Jr Thomas G Anastomotic apparatus and method
US4553542A (en) * 1982-02-18 1985-11-19 Schenck Robert R Methods and apparatus for joining anatomical structures
WO2000025679A1 (en) * 1998-11-04 2000-05-11 Karamuersel Sebat Rigid circular implant that is used as an external stent in vascular anastomoses
US20070185507A1 (en) * 2005-04-22 2007-08-09 Helmut Schreiber Surgical marker/connector and method of installation

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