WO2017064349A1 - Endoluminal device for rectal transection - Google Patents

Endoluminal device for rectal transection Download PDF

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Publication number
WO2017064349A1
WO2017064349A1 PCT/ES2016/070727 ES2016070727W WO2017064349A1 WO 2017064349 A1 WO2017064349 A1 WO 2017064349A1 ES 2016070727 W ES2016070727 W ES 2016070727W WO 2017064349 A1 WO2017064349 A1 WO 2017064349A1
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Prior art keywords
cannula
rectum
discs
clamping discs
clamping
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PCT/ES2016/070727
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Spanish (es)
French (fr)
Inventor
Francisco Javier PÉREZ LARA
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Servicio Andaluz De Salud
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Publication of WO2017064349A1 publication Critical patent/WO2017064349A1/en

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  • the present invention belongs in general to the field of medicine, and more particularly to the devices used for the removal of a portion of the rectum.
  • the object of the present invention is a new device specially designed for its introduction through the patient's anus with the aim of transecting a patient's rectum.
  • Transection refers to a cross-section, or perpendicular to the longitudinal axis, of a particular organ or biological sample. In this context, it is a cross section to the patient's rectum.
  • Anastomosis refers to the surgical connection between two biological structures of the same type, usually tubular. In this context, it refers to the union of the two free ends created as a result of the transection of the rectum.
  • Removal refers to the complete removal of an organ or the portion of an organ from the patient.
  • the removal of a rectum portion includes the realization on both sides of the rectum portion of a distal transection and a proximal transection, the removal of said rectum portion, and the anastomosis of the remaining rectum free ends. .
  • Distal rectus transection In this context, it refers to the cut made farther from the patient's heart, that is, closer to the patient's anus.
  • Proximal transection of the rectum In this context, it refers to the cut made near the patient's heart, that is, farther from the patient's anus.
  • Treatment of rectal cancer sometimes requires the removal of the portion of the rectum affected by the tumor. For this, it is necessary to perform a distal transection and a proximal transection of the rectum on both sides of the rectum portion affected by the tumor, remove said rectum portion, and perform the anastomosis of the two remaining free ends.
  • the performance of both transections should be carried out with extreme care that the contents of the rectum does not come out, as this could contaminate the surgical field. Because of this, usually the transection of the rectum is performed simultaneously with the closure of the free ends created by said transection, for example by stapling or suturing.
  • Monassevich describes the introduction of a special cannula through the patient's anus that allows the rectus to be clamped transversely in two locations located on each side of the lesion to be removed. Then, a retraction of the distal portion of the cannula into the proximal portion allows to achieve invagination of the rectum portion that has been pinched. Finally, the transection is performed to remove the portion of the rectum in question.
  • the present invention describes a device specially designed for its introduction through the patient's anus for the purpose of performing at least distal transection of the rectum.
  • This device allows distal transection to be performed quickly and easily, saving the problems of spaces inherent in this intervention.
  • the device of the present invention is defined by the attached claim 1.
  • the features of the preamble of claim 1 correspond to the known elements of the Monassevitch document, which is the document with the structure most similar to the present invention.
  • the endoluminal device for the transection of a portion of the rectum basically comprises a cannula, a pair of clamping discs and, optionally, also a blade. Each of these elements is described in more detail below: a) Cannula
  • the cannula is a cannula configured for introduction into a patient's rectum through the anus.
  • the cannula is normally cylindrical with a diameter of approximately 1 cm or less.
  • Its distal end may have an anatomical shape, for example essentially conical, rounded, or the like, which facilitates its introduction and movement through the inside of the patient's rectum.
  • It can be made of any material with sufficient rigidity and that is hypoallergenic, such as metal (titanium, stainless steel) or plastic materials.
  • the cannula can be divided into proximal and distal portions.
  • the distal portion essentially corresponds to the cannula section which, during the use of the device, is introduced into the area of the patient's rectum where the transection is to be performed.
  • the proximal portion corresponds to the rest of the cannula, essentially comprising a section of cannula that, during the use of the device, is outside the patient's rectum, plus a section located inside the patient but that is outside the area of the patient's rectum where the transection is to be performed. grip cos
  • clamping discs that are coupled to the distal portion of the cannula, the cannula being detachable from the clamping discs.
  • the clamping discs that form each pair are longitudinally movable along the cannula between an open position, in which they are separated, and a closed position, in which they are fitted to transversely clamp the rectum.
  • an open position in which they are separated
  • a closed position in which they are fitted to transversely clamp the rectum.
  • the reason is to minimize the length of the rectum that remains between the two couples so that, when the transection is performed at an intermediate point between both discs, the rectum content poured into the surgical field is as low as possible.
  • the clamping discs of each pair comprise means for engaging each other when they are in the closed position.
  • the use of these means will allow, as will be described below, to extract the cannula and leave the two pairs of clamping discs permanently in a closed position by transversely clamping the rectum at two points.
  • This clamping constitutes a closure or blockage of the rectum that will allow the transection of the rectum to be performed at a point between both pairs of discs.
  • Said coupling means between discs can be implemented in different ways, such as using pressure joints, auxiliary elements such as screws or nails, hook elements, etc.
  • the facing surfaces of each pair of clamping discs comprise complementary reliefs that fit together when in the closed position, so that the clamping discs are coupled to each other when they are in the closed position.
  • the cannula is also separable from the clamping discs.
  • the clamping discs may comprise a central hole through which said cannula is disposed in a removable manner.
  • the clamping discs further comprise a cover element configured to automatically close the central hole when the cannula is removed to prevent the contents of the rectum from exiting through said central hole.
  • This cover element can be configured in any way as long as it automatically closes the hole at the moment when the cannula stops covering it when it is removed.
  • it may be a diaphragm type mechanism formed by a plurality of tabs housed inside the disc, so that the tabs are permanently driven by a spring or the like towards their closed position.
  • the cover element may be a sheet requested by a spring that continuously drives it towards a position where it blocks the central hole of the pinch disk.
  • the sheet cannot move to the closed position of said hole.
  • the spring automatically forces the sheet to occupy the central position where the central hole closes.
  • the diameter of the clamping discs will preferably be smaller than the diameter of the circular staplers usually used to carry out the anastomosis of the free ends of the rectum once the corresponding portion is removed.
  • the diameter of these staplers is usually approximately 25 mm to just over 30 mm. Therefore, the diameter of the clamping discs will preferably be between 20 mm and 30 mm, so that there will always be a larger diameter stapler with which to perform the anastomosis.
  • the distal face of the impingement disc located in the most distal position may have an anatomical shape. It can be, for example, essentially conical, rounded, or similar.
  • the device of the invention further comprises a transverse blade fixed to the cannula between the two pairs of clamping discs, which is configured to cross-section the rectum.
  • the transverse blade can be configured in different ways as long as it is capable of cross-cutting the rectum in its entire circumference, although preferably it is a circular and rotary transverse blade.
  • this new device for performing a distal transection of the rectum would be essentially as follows. First, with the pairs of clamping discs in their open position, the device is introduced through the patient's anus until the distal portion of the cannula reaches the rectum area where the distal transection is to be performed. Because the distal end of the cannula, or the distal face of the more distal impingement disc, has a rounded, conical or similar anatomical position, the introduction through the patient's anus can be done in a smooth and progressive way. Next, it is necessary to introduce the walls of the rectum between each pair of clamping discs so that they can clamp them when they move from the open position to the closed position. This can be done in different ways.
  • a thread can be introduced laparoscopically through the patient's abdomen and cause it to surround the cannula just midway between each pair of discs. By tightening the thread, the walls of the rectum are introduced into the space between the pairs of discs, allowing them to clamp when they are closed. You could also use a pliers type instrument or similar introduced laparoscopically. This pliers could automatically place a closing thread, such as a wire made of wire or the like, knotting the rectum between each pair of clamping discs. In either of these two cases, it can be complicated from the outside of the rectum to locate exactly the point corresponding to the space between the pairs of discs.
  • the cannula comprises a magnetized portion located between each pair of clamping discs in their open position.
  • This magnetic feature will allow medical personnel to easily locate the position of the discs from outside the rectum and then introduce the walls of the rectum between said discs with the help of a thread, a pincer, or any other suitable instrument that can be introduced via laparoscopic
  • the distal portion of the cannula may comprise a plurality of vacuum holes to suction the walls of the rectum.
  • the cannula provided with the vacuum holes may be hollow and connected through a tube to a vacuum compressor located outside the patient.
  • the blade located in the cannula can be used in the intermediate space located between each pair of clamping discs to perform transection of the rectum.
  • the presence of vacuum holes is also useful in this step of the intervention, since it not only causes the walls of the rectum to "stick" to the cannula in the area between each pair of discs, but also causes them to " stick "in the area of the cannula located between a couple and the other, which is the place where the blade is located. This facilitates the completion of the cut and allows the use of shorter blades.
  • the medical staff can remove the cannula. Thanks to the special configuration of the clamping discs, the central hole through which the cannula is removed is automatically closed, so that the free ends of the rectum are kept sealed. Assuming that the transection that has been performed is the distal transection, the surgeon can now "pull" the portion of the rectum to be removed to extract it from the pelvic area into the abdomen cavity, where there is enough space to perform with greater comfort proximal transection.
  • the surgeon must perform the anastomosis of the two free ends that have remained. Of these, at least the distal end is sealed by the two clamping discs coupled together.
  • the stapler is then inserted into the rectum anally, and then the central stapler of the stapler is threaded into the central hole of the clamping discs that plug the distal free end. Therefore, the central hole of the clamping discs has a double function, since it not only allows the removal of the cannula, but also serves to introduce the central skewer stapler that constitutes the center of the stapling circumference. .
  • the diameter of the clamping discs will be smaller than the diameter of the stapling circumference of the stapler.
  • the anastomosis can be easily performed by stapling along a circumference outside the perimeter of the discs.
  • Figs. 1a and 1b respectively show a perspective view and a side view of a device according to the invention where the cannula has vacuum holes.
  • Figs. 2a and 2b show a pair of clamping discs respectively in the open position and in the closed position.
  • Figs. 3a and 3b show a front view respectively of a first and a second clamping disc of the same pair that fit together.
  • Fig. 4 shows a detailed schematic view of the closing mechanism of the central hole of a pinch disk according to the invention.
  • Figs. 5a-5f show the main steps of a rectum transection procedure using the device provided with vacuum holes shown in Figs. 1st and 1st b.
  • Figs. 6a and 6b respectively show a perspective view and a side view of a device according to the invention where the cannula has magnetized portions.
  • Figs. 7a-7f show the main steps of a rectum transection procedure using the device provided with magnetized portions shown in Figs. 6a and 6b.
  • Figs. 8a-8c schematically show a rectum sealing process using pliers that are not part of the present invention.
  • Figs. 1 and 2 show two views of an example of the device (1) according to the present invention which is provided with vacuum holes (9).
  • the device (1) is formed by a hollow cylindrical cannula (2) having a proximal portion (2p) and a distal portion (2d).
  • the cannula (2) can be made of any suitable surgical material, such as a metallic material such as stainless steel or titanium, or a plastic or polymeric material.
  • the distal portion (2d) corresponds to the cannula section (2) which, during the use of the device (1), will be introduced into the rectum area (100) where the transection is to be performed.
  • Two pairs of clamping discs (3a, 3b) are located in adjacent positions in the distal portion (2d) of the cannula (2).
  • Each clamping disc (3a, 3b) has an essentially circular flat shape, and can be made of any suitable surgical material, such as a metallic material such as stainless steel or titanium, or a plastic or polymeric material.
  • the clamping discs (3a, 3b) of each pair are longitudinally movable along the cannula (2) between an open position and a closed position.
  • the open position which is represented in Figs. 1 and 2
  • the proximal clamping discs (3a) of each pair are separated from the respective corresponding distal clamping discs (3b) of said pair.
  • the closed position the proximal clamp discs (3a) of each pair are coupled to the respective distal clamp discs (3b) of each pair.
  • Figs. 2 and 3 where different views of the pair of clamping discs (3a, 3b) located in the most distal position of the cannula (2) are presented. It can be seen how the facing faces of the clamping discs (3a, 3b) have complementary reliefs (7a, 7b) that allow their coupling.
  • the relief (7a) of the distal face of the clamping disc (3a) is of the female type with an essentially circular shape
  • the relief (7b) of the proximal face of the clamping disc (3b) It is of the male type with an essentially circular shape corresponding to the previous one. It is easy to see, as shown in Fig.
  • each disc (3a, 3b) also has a lid element configured to automatically close the central hole (5) when the cannula (2) is removed.
  • This cover element takes the form of a circular sheet (6) that is articulated at a point of the edge of the hole (5) of the disc (3a, 3b) in question in such a way that it can pass from an opening position in which the hole (5) does not cover to a closed position in which the hole (5) covers.
  • a spring for example a coil-type spring, continuously drives the sheet (6) towards the closed position.
  • the disc (3a, 3b) While the disc (3a, 3b) is coupled to the cannula (2), it passes through the hole (5) and therefore the sheet (6) is forced to remain in the open position. However, when the cannula (2) is removed during a rectum transection procedure, the sheet (6) automatically goes into the closed position thanks to the action of the spring.
  • the cannula (2) further comprises a blade (4) located in the distal portion (2d) between the pairs of clamping discs (3a, 3b).
  • This blade (4) can, for example, have a circular shape and function thanks to a rotary movement.
  • the cannula (2) of this example also has a plurality of vacuum holes (9) distributed throughout its distal portion (2d). In order to create the vacuum in such holes (9), the cannula (2) is hollow and its proximal end is connected to a tube (10) connected to a compressor (not shown).
  • Figs. 5a-5f an example of a distal rectal transection procedure using this example of a device (1).
  • the device (1) is introduced through the patient's anus to accommodate the distal portion (2d) of the cannula (2) in the rectum area (100) where it is You will perform the distal transection.
  • the proximal portion (2p) of the cannula (2) partially protrudes through the patient's anus and is connected to the vacuum compressor, which is currently deactivated, through the tube (10).
  • the pairs of clamping discs (3a, 3b) are in their open position.
  • the vacuum compressor connected to the tube (10) is activated.
  • the suction effect created by the vacuum holes (9) causes the walls of the rectum to stick to the distal portion (2d) of the cannula (2) in general, and in particular to the section of said cannula (2) located between each pair of clamping discs (3a, 3b), which continue in their open position, as well as between one pair and the other.
  • each pair of clamping discs (3a, 3b) is passed to its closed position.
  • the clamping discs (3a, 3b) of each pair are connected to each other autonomously and permanently thanks to the complementary reliefs (7a, 7b), the rectum being pinched between them as shown in Fig. 5c.
  • Fig. 5d The next step is shown in Fig. 5d, which consists of activating the blade (4) to perform the cross-section along the entire circumference of the rectum.
  • the action of the vacuum holes (9) that causes the walls of the rectum to "stick" to the distal portion (2d) of the cannula (2) facilitates this step and allows the use of a small blade (4) .
  • Fig. 5e shows a view from the outside of the rectum of the state in which the distal free end is left. The surgeon can now pull the other free end that has been created with the transection distal, that is, the most proximal end, to remove it from the pelvis and take it to the abdomen, where the operation can continue.
  • the device (1) of the invention may not have vacuum holes (9) that allow the walls of the rectum to be introduced between each pair of clamping discs (3a, 3b). In this case, it is necessary to do so with the help of instruments inserted into the patient's abdomen by laparoscopic or open route. Under these conditions, it is sometimes difficult to locate the position of said clamping discs (3a, 3b) from outside the rectum.
  • Figs. 6a and 6b show a second example of device (1) according to the present invention that facilitates this step thanks to magnetized portions (8) located in the cannula (2) between each pair of clamping discs (3a, 3b) in position. open
  • This example of device (1) does not include vacuum holes (9), although as described hereinbefore these would be compatible with the use of magnetized portions (8).
  • Figs. 7a-7f show the steps of a distal transection of the rectum performed using this second example of device (1).
  • the positions corresponding to the space between each pair of clamping discs (3a, 3b) are located in their open position from the outside of the rectum with aid of a magnetically sensitive instrument (200).
  • This instrument (200) detects, from outside the rectum, the place where the magnetized portions (8) of the cannula (2) located inside it are located. Once this is done, as shown in Fig.
  • a thread (201) is used to surround the rectum and knotted so that a pinch of rectum is inserted into the space between each pair of discs (3a, 3b) clamping in its open position.
  • the result of this operation is shown in Fig. 7b.
  • the clamping discs (3a, 3b) are then moved from their open position to their closed position, so that they clamp the rectum portion located between them, as seen in Fig. 7c.
  • distal transection of the rectum is performed.
  • the device (1) does not have a cutting blade (4), so that it is carried out from the outside with the aid of an auxiliary instrument (300) introduced laparoscopically, as seen in Fig. 4.
  • the final result of this procedure which is shown in Figs.
  • FIGs. 8a-8c schematically show an alternative process of introducing the walls of the rectum between each pair of clamping discs (3a, 3b) using pliers that are not part of the present invention.
  • the use of these pliers (300) constitutes an alternative to the use of the vacuum holes (9) or the wire (201) described above.
  • the pliers (300) are specially designed for the placement and closing of a section of wire (301) around the rectum, in a manner equivalent to the wire (201) described in the previous example.
  • the point where the clamping between a pair of clamping discs (3a) must first be located. This can be done, as described above, using a magnetically sensitive instrument (200) to detect the magnetized portions (8).
  • the pliers (300) are located at that point (Fig. 8a) and pressed (Fig. 8b).
  • the special configuration of the pliers (300) causes a section of wire (301) housed in one of its arms to wrap around the rectum and, when tightened, is firmly closed around it. The result of this process is shown in Fig. 8c. The rest of the procedure would be performed as described in the previous examples.

Abstract

The invention relates to a new device specially designed for the introduction thereof via the anus of the patient for the purpose of carrying out a rectal transection. The device comprises a cannula (2) configured for the introduction thereof into the rectum of a patient via the anus, and at least two pairs of clamping discs (3a, 3b) coupled to a distal portion (2d) of said cannula (2), wherein the clamping discs (3a, 3b) forming each pair can be moved longitudinally along the cannula (2) between an open position in which they are separated, and a closed position in which they remain joined together in order to transversely clamp the rectum, wherein the cannula (2) can be separated from the clamping discs (3a, 3b).

Description

DISPOSITIVO ENDOLUMINAL PARA TRANSECCIÓN DE RECTO OBJETO DE LA INVENCIÓN  ENDOLUMINAL DEVICE FOR TRANSLATION OF STRAIGHT OBJECT OF THE INVENTION
La presente invención pertenece en general al campo de la medicina, y más particularmente a los dispositivos empleados para la extirpación de una porción de recto. El objeto de la presente invención es un nuevo dispositivo especialmente diseñado para su introducción a través del ano del paciente con el objetivo de realizar la transección del recto de un paciente. The present invention belongs in general to the field of medicine, and more particularly to the devices used for the removal of a portion of the rectum. The object of the present invention is a new device specially designed for its introduction through the patient's anus with the aim of transecting a patient's rectum.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
En primer lugar, se describen brevemente algunos términos técnicos específicos que se emplean a lo largo del presente documento. First, some specific technical terms that are used throughout this document are briefly described.
Transección: Hace referencia a una sección transversal, o perpendicular al eje longitudinal, de un determinado órgano o muestra biológica. En este contexto, se trata de un corte transversal al recto del paciente. Transection: Refers to a cross-section, or perpendicular to the longitudinal axis, of a particular organ or biological sample. In this context, it is a cross section to the patient's rectum.
Anastomosis: Hace referencia a la conexión quirúrgica entre dos estructuras biológicas del mismo tipo, normalmente tubulares. En este contexto, se refiere a la unión de los dos extremos libres creados como consecuencia de la transección del recto. Anastomosis: Refers to the surgical connection between two biological structures of the same type, usually tubular. In this context, it refers to the union of the two free ends created as a result of the transection of the rectum.
Extirpación: Hace referencia a la extracción completa de un órgano o la porción de un órgano del paciente. En este contexto, la extirpación de una porción de recto incluye la realización a ambos lados de la porción de recto de una transección distal y de una transección proximal, la extracción de dicha porción de recto, y la anastomosis de los extremos libres de recto restantes. Removal: Refers to the complete removal of an organ or the portion of an organ from the patient. In this context, the removal of a rectum portion includes the realization on both sides of the rectum portion of a distal transection and a proximal transection, the removal of said rectum portion, and the anastomosis of the remaining rectum free ends. .
Transección distal del recto: En este contexto, hace referencia al corte realizado más lejos del corazón del paciente, es decir, más cerca del ano del paciente. Transección proximal del recto: En este contexto, hace referencia al corte realizado cerca del corazón del paciente, es decir, más lejos del ano del paciente. Distal rectus transection: In this context, it refers to the cut made farther from the patient's heart, that is, closer to the patient's anus. Proximal transection of the rectum: In this context, it refers to the cut made near the patient's heart, that is, farther from the patient's anus.
El tratamiento del cáncer de recto exige en ocasiones la extirpación de la porción de recto afectada por el tumor. Para ello, es necesario realizar una transección distal y una transección proximal del recto a ambos lados de la porción de recto afectada por el tumor, extraer dicha porción de recto, y realizar la anastomosis de los dos extremos libres restantes. La realización de ambas transecciones debe realizarse con extremo cuidado de que el contenido del recto no se salga, ya que ello podría contaminar el campo quirúrgico. Debido a ello, habitualmente la transección del recto se realiza simultáneamente con el cierre de los extremos libres que crea dicha transección, por ejemplo mediante grapado o sutura. Treatment of rectal cancer sometimes requires the removal of the portion of the rectum affected by the tumor. For this, it is necessary to perform a distal transection and a proximal transection of the rectum on both sides of the rectum portion affected by the tumor, remove said rectum portion, and perform the anastomosis of the two remaining free ends. The performance of both transections should be carried out with extreme care that the contents of the rectum does not come out, as this could contaminate the surgical field. Because of this, usually the transection of the rectum is performed simultaneously with the closure of the free ends created by said transection, for example by stapling or suturing.
Actualmente, este procedimiento se realiza con ayuda de diversos instrumentos que se introducen en el abdomen del paciente, bien por vía laparoscópica o bien mediante cirugía abierta. Primero se realiza la transección distal y el cierre de los extremos libres creados y, a continuación, se saca la porción de recto que se va a extirpar desde la pelvis hacia la cavidad del abdomen para realizar la transección proximal. Un inconveniente de este procedimiento está relacionado con el escaso espacio existente en la pelvis, que dificulta enormemente la realización de la transección distal y el posterior cierre de los extremos libres. El documento de patente US2004/0015179 de Monassevitch et al describe un dispositivo específicamente diseñado para la transección transanal de una porción de recto. Esencialmente, Monassevich describe la introducción una cánula especial a través del ano del paciente que permite pinzar el recto transversalmente en dos ubicaciones situadas a cada lado de la lesión a extirpar. A continuación, una retracción de la porción distal de la cánula hacia el interior de la porción proximal permite conseguir una invaginación de la porción de recto que se ha pinzado. Por último, se realiza la transección para extirpar la porción de recto en cuestión. Currently, this procedure is performed with the help of various instruments that are inserted into the patient's abdomen, either by laparoscopic route or by open surgery. First, the distal transection and the closure of the created free ends are performed, and then the rectum portion that is to be removed from the pelvis to the abdomen cavity is removed to perform the proximal transection. A drawback of this procedure is related to the limited space in the pelvis, which greatly hinders the performance of the distal transection and the subsequent closure of the free ends. Patent document US2004 / 0015179 of Monassevitch et al describes a device specifically designed for transanal transection of a portion of the rectum. Essentially, Monassevich describes the introduction of a special cannula through the patient's anus that allows the rectus to be clamped transversely in two locations located on each side of the lesion to be removed. Then, a retraction of the distal portion of the cannula into the proximal portion allows to achieve invagination of the rectum portion that has been pinched. Finally, the transection is performed to remove the portion of the rectum in question.
Este dispositivo resuelve el problema de la falta de espacio en la pelvis para la realización de la transección distal. Sin embargo, esta técnica presenta el inconveniente de que no es aplicable a casos en los que la lesión, por su tipología, conlleva una rigidización de un tramo de recto que impide llevar a cabo la invaginación, como por ejemplo en el caso de tumor de recto. DESCRIPCIÓN DE LA INVENCIÓN This device solves the problem of the lack of space in the pelvis to perform the distal transection. However, this technique presents the disadvantage that it is not applicable to cases in which the lesion, due to its typology, entails a stiffening of a stretch of rectum that prevents invagination, such as in the case of a rectal tumor. DESCRIPTION OF THE INVENTION
La presente invención describe un dispositivo especialmente diseñado para su introducción a través del ano del paciente con el propósito de realizar al menos la transección distal del recto. Este dispositivo permite realizar la transección distal de una manera rápida y sencilla, salvando los problemas de espacios inherentes a esta intervención. El dispositivo de la presente invención está definido por la reivindicación 1 adjunta. Las características del preámbulo de la reivindicación 1 corresponden a los elementos conocidos del documento de Monassevitch, que es el documento con la estructura más parecida a la presente invención. The present invention describes a device specially designed for its introduction through the patient's anus for the purpose of performing at least distal transection of the rectum. This device allows distal transection to be performed quickly and easily, saving the problems of spaces inherent in this intervention. The device of the present invention is defined by the attached claim 1. The features of the preamble of claim 1 correspond to the known elements of the Monassevitch document, which is the document with the structure most similar to the present invention.
El dispositivo endoluminal para la transección de una porción de recto de acuerdo con la presente invención comprende fundamentalmente una cánula, un par de discos de pinzamiento y, opcionalmente, además una cuchilla. A continuación, se describe cada uno de estos elementos con mayor detalle: a) Cánula The endoluminal device for the transection of a portion of the rectum according to the present invention basically comprises a cannula, a pair of clamping discs and, optionally, also a blade. Each of these elements is described in more detail below: a) Cannula
Se trata de una cánula configurada para su introducción en el recto de un paciente a través del ano. La cánula es normalmente cilindrica de un diámetro de aproximadamente 1 cm o menor. Su extremo distal puede tener una forma anatómica, por ejemplo esencialmente cónica, redondeada, o similar, que facilite su introducción y desplazamiento por el interior del recto del paciente. Puede estar hecha de cualquier material con la suficiente rigidez y que sea hipoalergénico, como por ejemplo metal (titanio, acero inoxidable) o materiales plásticos. It is a cannula configured for introduction into a patient's rectum through the anus. The cannula is normally cylindrical with a diameter of approximately 1 cm or less. Its distal end may have an anatomical shape, for example essentially conical, rounded, or the like, which facilitates its introduction and movement through the inside of the patient's rectum. It can be made of any material with sufficient rigidity and that is hypoallergenic, such as metal (titanium, stainless steel) or plastic materials.
La cánula puede dividirse en porción proximal y porción distal. La porción distal corresponde esencialmente al tramo de cánula que, durante el uso del dispositivo, está introducida en la zona del recto del paciente donde se va a realizar la transección. La porción proximal corresponde al resto de la cánula, abarcando esencialmente un tramo de cánula que, durante el uso del dispositivo, queda fuera del recto del paciente, más un tramo situado dentro del paciente pero que está fuera la zona del recto del paciente donde se va a realizar la transección. cos de pinzamiento The cannula can be divided into proximal and distal portions. The distal portion essentially corresponds to the cannula section which, during the use of the device, is introduced into the area of the patient's rectum where the transection is to be performed. The proximal portion corresponds to the rest of the cannula, essentially comprising a section of cannula that, during the use of the device, is outside the patient's rectum, plus a section located inside the patient but that is outside the area of the patient's rectum where the transection is to be performed. grip cos
Se trata de dos parejas de discos de pinzamiento que están acoplados a la porción distal de la cánula, siendo la cánula separable de los discos de pinzamiento. These are two pairs of clamping discs that are coupled to the distal portion of the cannula, the cannula being detachable from the clamping discs.
Los discos de pinzamiento que forman cada pareja son desplazables longitudinalmente a lo largo de la cánula entre una posición abierta, en que están separados, y una posición cerrada, en que quedan encajados para pinzar transversalmente el recto. De ese modo, una vez la porción distal de la cánula está alojada en el interior del recto del paciente, es posible accionar los discos de pinzamiento para que cada pareja de discos se acerque uno a otro hasta pinzar transversalmente el recto entre ambos discos. El pinzamiento se produce a lo largo de toda la circunferencia del recto, ya que los discos son normalmente circulares. Preferentemente, las dos parejas de discos de pinzamiento, cuando están cerradas, son adyacentes una a la otra. En este contexto, ello significa que están separadas una distancia de aproximadamente entre 1-2 cm, en cualquier caso pequeña con relación a su propio diámetro (que se describirá más adelante). El motivo es minimizar la longitud de recto que queda entre ambas parejas con el propósito de que, cuando se realice la transección en un punto intermedio entre ambos discos, el contenido de recto vertido al campo quirúrgico sea el mínimo posible. The clamping discs that form each pair are longitudinally movable along the cannula between an open position, in which they are separated, and a closed position, in which they are fitted to transversely clamp the rectum. Thus, once the distal portion of the cannula is housed inside the patient's rectum, it is possible to operate the clamping discs so that each pair of discs approaches each other until the rectum is clamped transversely between both discs. The impingement occurs along the entire circumference of the rectum, since the discs are normally circular. Preferably, the two pairs of clamping discs, when closed, are adjacent to each other. In this context, this means that they are separated by a distance of approximately 1-2 cm, in any case small in relation to their own diameter (which will be described later). The reason is to minimize the length of the rectum that remains between the two couples so that, when the transection is performed at an intermediate point between both discs, the rectum content poured into the surgical field is as low as possible.
Preferentemente, los discos de pinzamiento de cada pareja comprenden medios para acoplarse uno a otro cuando están en la posición cerrada. El uso de estos medios permitirá, como se describirá a continuación, extraer la cánula y dejar las dos parejas de discos de pinzamiento permanentemente en posición cerrada pinzando transversalmente el recto en dos puntos. Este pinzamiento constituye un cierre o bloqueo del recto que permitirá realizar la transección del recto en un punto situado entre ambas parejas de discos. Los citados medios de acoplamiento entre discos pueden implementarse de diferentes modos, como por ejemplo usando uniones a presión, elementos auxiliares como tornillos o clavos, elementos de gancho, etc. Concretamente, en una realización particularmente preferida de la invención, las superficies enfrentadas de cada pareja de discos de pinzamiento comprenden sendos relieves complementarios que encajan entre sí cuando están en la posición cerrada, de modo que los discos de pinzamiento quedan acoplados uno a otro cuando están en la posición cerrada. Preferably, the clamping discs of each pair comprise means for engaging each other when they are in the closed position. The use of these means will allow, as will be described below, to extract the cannula and leave the two pairs of clamping discs permanently in a closed position by transversely clamping the rectum at two points. This clamping constitutes a closure or blockage of the rectum that will allow the transection of the rectum to be performed at a point between both pairs of discs. Said coupling means between discs can be implemented in different ways, such as using pressure joints, auxiliary elements such as screws or nails, hook elements, etc. Specifically, in a particularly preferred embodiment of the invention, the facing surfaces of each pair of clamping discs comprise complementary reliefs that fit together when in the closed position, so that the clamping discs are coupled to each other when they are in the closed position.
Como se ha comentado, la cánula es además separable de los discos de pinzamiento. Para permitir la extracción de la cánula, los discos de pinzamiento pueden comprender un orificio central a través del cual dicha cánula está dispuesta de manera extraíble. Preferentemente, los discos de pinzamiento comprenden además un elemento de tapa configurado para cerrar automáticamente el orificio central cuando se extrae la cánula para evitar que el contenido del recto salga a través de dicho orificio central. Este elemento de tapa puede estar configurado de cualquier modo siempre que cierre de manera automática el orificio en el momento en que la cánula deja de taparlo cuando se extrae. Por ejemplo, puede tratarse de un mecanismo de tipo diafragma formado por una pluralidad de pestañas alojadas en el interior del disco, de modo que las pestañas están permanentemente impulsadas por un resorte o similar hacia su posición de cierre. Sin embargo, de acuerdo con una realización preferida de la invención, el elemento de tapa puede ser una lámina solicitada por un resorte que la impulsa continuamente hacia una posición en que bloquea el orificio central del disco de pinzamiento. Cuando el orificio central de los discos de pinzamiento está ocupado por la cánula, la lámina no puede pasar a la posición de cierre de dicho orificio. Sin embargo, cuando la cánula se extrae, automáticamente el resorte fuerza a la lámina a ocupar la posición central donde cierra el orificio central. Una vez extraída completamente la cánula, en el interior del recto quedan las dos parejas de discos acopladas una a la otra en su posición cerrada, pinzando el recto en dos puntos adyacentes. As mentioned, the cannula is also separable from the clamping discs. In order to allow the cannula to be removed, the clamping discs may comprise a central hole through which said cannula is disposed in a removable manner. Preferably, the clamping discs further comprise a cover element configured to automatically close the central hole when the cannula is removed to prevent the contents of the rectum from exiting through said central hole. This cover element can be configured in any way as long as it automatically closes the hole at the moment when the cannula stops covering it when it is removed. For example, it may be a diaphragm type mechanism formed by a plurality of tabs housed inside the disc, so that the tabs are permanently driven by a spring or the like towards their closed position. However, according to a preferred embodiment of the invention, the cover element may be a sheet requested by a spring that continuously drives it towards a position where it blocks the central hole of the pinch disk. When the central hole of the clamping discs is occupied by the cannula, the sheet cannot move to the closed position of said hole. However, when the cannula is removed, the spring automatically forces the sheet to occupy the central position where the central hole closes. Once the cannula is completely removed, inside the rectum the two pairs of discs are attached to each other in their closed position, pinching the rectum at two adjacent points.
En cuanto a las medidas, el diámetro de los discos de pinzamiento preferentemente será menor que el diámetro de las grapadoras circulares habitualmente utilizadas para llevar a cabo la anastomosis de los extremos libres del recto una vez extirpada la porción correspondiente. El diámetro de estas grapadoras suele estar aproximadamente entre 25 mm hasta algo más de 30 mm. Por tanto, el diámetro de los discos de pinzamiento será preferentemente de entre 20 mm y 30 mm, de modo que siempre existirá una grapadora de mayor diámetro con la que realizar la anastomosis. As for the measurements, the diameter of the clamping discs will preferably be smaller than the diameter of the circular staplers usually used to carry out the anastomosis of the free ends of the rectum once the corresponding portion is removed. The diameter of these staplers is usually approximately 25 mm to just over 30 mm. Therefore, the diameter of the clamping discs will preferably be between 20 mm and 30 mm, so that there will always be a larger diameter stapler with which to perform the anastomosis.
Adicionalmente, y con el objeto de facilitar la introducción de este dispositivo a través del recto del paciente, la cara distal del disco de pinzamiento ubicado en la posición más distal puede tener una forma anatómica. Puede tratarse, por ejemplo, de una forma esencialmente cónica, redondeada, o similar. c) Cuchilla Preferentemente, el dispositivo de la invención comprende además una cuchilla transversal fijada a la cánula entre las dos parejas de discos de pinzamiento, que está configurada para seccionar transversalmente el recto. Así, como se ha mencionado anteriormente, una vez las parejas de discos están en su posición cerrada con el recto pinzado en dos puntos adyacentes, la cuchilla realiza la transección del recto. Additionally, and in order to facilitate the introduction of this device through the patient's rectum, the distal face of the impingement disc located in the most distal position may have an anatomical shape. It can be, for example, essentially conical, rounded, or similar. c) Blade Preferably, the device of the invention further comprises a transverse blade fixed to the cannula between the two pairs of clamping discs, which is configured to cross-section the rectum. Thus, as mentioned above, once the pairs of discs are in their closed position with the rectum pinched at two adjacent points, the blade transects the rectum.
La cuchilla transversal puede configurarse de diferentes modos siempre que sea capaz de realizar el corte transversal del recto en toda su circunferencia, aunque preferentemente se trata de una cuchilla transversal circular y rotatoria. The transverse blade can be configured in different ways as long as it is capable of cross-cutting the rectum in its entire circumference, although preferably it is a circular and rotary transverse blade.
El funcionamiento de este nuevo dispositivo para la realización de una transección distal de recto sería esencialmente el siguiente. En primer lugar, estando las parejas de discos de pinzamiento en su posición abierta, se introduce el dispositivo a través del ano del paciente hasta que la porción distal de la cánula alcanza la zona de recto donde se va a realizar la transección distal. Gracias a que el extremo distal de la cánula, o bien la cara distal del disco de pinzamiento más distal, tiene una posición anatómica redondeada, cónica o similar, la introducción a través del ano del paciente puede realizarse de un modo suave y progresivo. A continuación, es necesario introducir las paredes del recto entre cada pareja de discos de pinzamiento con el propósito de que éstos puedan pinzarlas cuando pasan de la posición abierta a la posición cerrada. Esto se puede hacer de diferentes modos. The operation of this new device for performing a distal transection of the rectum would be essentially as follows. First, with the pairs of clamping discs in their open position, the device is introduced through the patient's anus until the distal portion of the cannula reaches the rectum area where the distal transection is to be performed. Because the distal end of the cannula, or the distal face of the more distal impingement disc, has a rounded, conical or similar anatomical position, the introduction through the patient's anus can be done in a smooth and progressive way. Next, it is necessary to introduce the walls of the rectum between each pair of clamping discs so that they can clamp them when they move from the open position to the closed position. This can be done in different ways.
Por ejemplo, puede introducirse por vía laparoscópica un hilo a través del abdomen del paciente y hacer que rodee la cánula justamente en un punto intermedio entre cada pareja de discos. Apretando el hilo, las paredes del recto se introducen en el espacio entre las parejas de discos, permitiendo que cuando éstos pasan a la posición cerrada puedan pinzarlas. También se podría utilizar un instrumento de tipo tenaza o similar introducido por vía laparoscópica. Esta tenaza podría colocar de manera automática un hilo de cierre, como por ejemplo un hilo hecho de alambre o similar, anudando el recto entre cada pareja de discos de pinzamiento. En cualquiera de estos dos casos, puede resultar complicado desde el exterior del recto localizar exactamente el punto correspondiente al espacio entre las parejas de discos. Para resolver este problema, en una realización preferida de la invención la cánula comprende una porción imantada situada entre cada pareja de discos de pinzamiento en su posición abierta. Esta característica magnética permitirá al personal médico ubicar fácilmente la posición de los discos desde el exterior del recto para luego introducir las paredes del recto entre dichos discos con la ayuda de un hilo, una tenaza, o cualquier otro instrumento adecuado que se pueda introducir por vía laparoscópica. En otra realización preferida, para introducir las paredes del recto entre cada pareja de discos de pinzamiento la porción distal de la cánula puede comprender una pluralidad de orificios de vacío para succionar las paredes del recto. Por ejemplo, la cánula dotada de los orificios de vacío puede ser hueca y estar conectada a través de un tubo a un compresor de vacío ubicado en el exterior del paciente. En este caso, una vez el dispositivo está introducido en el recto del paciente, sólo es necesario activar el compresor de vacío. Los orificios de vacío de la porción distal de la cánula "tiran" de las paredes del recto, que se adhieren a la cánula. Como consecuencia, las paredes del recto quedan también introducidas entre cada pareja de discos de pinzamiento. Esta realización puede utilizarse en combinación con las porciones imantadas. En cualquiera de los casos, una vez se ha conseguido introducir las paredes del recto en el espacio intermedio entre cada pareja de discos de pinzamiento, se accionan los discos de pinzamiento para que pasen desde la posición abierta a la posición cerrada hasta que se acoplan uno al otro. Las paredes del recto quedan pinzadas entre cada pareja de discos de pinzamiento, y los discos de cada pareja de discos de pinzamiento quedan acoplados entre sí de manera permanente. For example, a thread can be introduced laparoscopically through the patient's abdomen and cause it to surround the cannula just midway between each pair of discs. By tightening the thread, the walls of the rectum are introduced into the space between the pairs of discs, allowing them to clamp when they are closed. You could also use a pliers type instrument or similar introduced laparoscopically. This pliers could automatically place a closing thread, such as a wire made of wire or the like, knotting the rectum between each pair of clamping discs. In either of these two cases, it can be complicated from the outside of the rectum to locate exactly the point corresponding to the space between the pairs of discs. To solve this problem, in a preferred embodiment of the invention the cannula comprises a magnetized portion located between each pair of clamping discs in their open position. This magnetic feature will allow medical personnel to easily locate the position of the discs from outside the rectum and then introduce the walls of the rectum between said discs with the help of a thread, a pincer, or any other suitable instrument that can be introduced via laparoscopic In another preferred embodiment, to introduce the walls of the rectum between each pair of pinch discs the distal portion of the cannula may comprise a plurality of vacuum holes to suction the walls of the rectum. For example, the cannula provided with the vacuum holes may be hollow and connected through a tube to a vacuum compressor located outside the patient. In this case, once the device is inserted into the patient's rectum, it is only necessary to activate the vacuum compressor. The vacuum holes in the distal portion of the cannula "pull" the walls of the rectum, which adhere to the cannula. As a consequence, the walls of the rectum are also inserted between each pair of clamping discs. This embodiment can be used in combination with the magnetized portions. In either case, once the walls of the rectum have been introduced into the intermediate space between each pair of clamping discs, the clamping discs are operated so that they pass from the open position to the closed position until one is coupled. the other. The walls of the rectum are pinched between each pair of clamping discs, and the discs of each pair of clamping discs are permanently coupled to each other.
A continuación, puede utilizarse la cuchilla ubicada en la cánula en el espacio intermedio situado entre cada pareja de discos de pinzamiento para realizar la transección del recto. La presencia de orificios de vacío es también útil en este paso de la intervención, ya que no sólo provoca que las paredes del recto se "peguen" a la cánula en la zona situada entre cada pareja de discos, sino que también hace que se "peguen" en la zona de la cánula situada entre una pareja y la otra, que es el lugar donde está ubicada la cuchilla. Ello facilita la realización del corte y permite el uso de cuchillas más cortas. Next, the blade located in the cannula can be used in the intermediate space located between each pair of clamping discs to perform transection of the rectum. The presence of vacuum holes is also useful in this step of the intervention, since it not only causes the walls of the rectum to "stick" to the cannula in the area between each pair of discs, but also causes them to " stick "in the area of the cannula located between a couple and the other, which is the place where the blade is located. This facilitates the completion of the cut and allows the use of shorter blades.
Una vez se ha realizado la transección del recto, el personal médico puede extraer la cánula. Gracias a la especial configuración de los discos de pinzamiento, el orificio central a través del cual se extrae la cánula se cierra automáticamente, con lo que los extremos libres del recto se mantienen sellados. Suponiendo que la transección que se ha realizado es la transección distal, el cirujano puede ahora "tirar" de la porción de recto que se va a extirpar para extraerla de la zona pélvica hacia la cavidad del abdomen, donde hay espacio suficiente para realizar con mayor comodidad la transección proximal. Once the transection of the rectum has been performed, the medical staff can remove the cannula. Thanks to the special configuration of the clamping discs, the central hole through which the cannula is removed is automatically closed, so that the free ends of the rectum are kept sealed. Assuming that the transection that has been performed is the distal transection, the surgeon can now "pull" the portion of the rectum to be removed to extract it from the pelvic area into the abdomen cavity, where there is enough space to perform with greater comfort proximal transection.
Una vez se ha practicado la transección proximal, el cirujano deberá llevar a cabo la anastomosis de los dos extremos libres que han quedado. De ellos, al menos el extremo distal está sellado mediante los dos discos de pinzamiento acoplados entre sí. Se introduce entonces la grapadora en el recto por vía anal para, a continuación, ensartar el pincho central de la grapadora en el orificio central de los discos de pinzamiento que taponan el extremo libre distal. Por lo tanto, el orificio central de los discos de pinzamiento cumple una doble función, ya que no sólo permite la extracción de la cánula, sino que también sirve para la introducción del pincho central de la grapadora que constituye el centro de la circunferencia de grapado. Además, como se ha comentado anteriormente en este documento, el diámetro de los discos de pinzamiento será menor que el diámetro de la circunferencia de grapado de la grapadora. De ese modo, la anastomosis puede realizarse fácilmente mediante un grapado a lo largo de una circunferencia exterior al perímetro de los discos. Once the proximal transection has been performed, the surgeon must perform the anastomosis of the two free ends that have remained. Of these, at least the distal end is sealed by the two clamping discs coupled together. The stapler is then inserted into the rectum anally, and then the central stapler of the stapler is threaded into the central hole of the clamping discs that plug the distal free end. Therefore, the central hole of the clamping discs has a double function, since it not only allows the removal of the cannula, but also serves to introduce the central skewer stapler that constitutes the center of the stapling circumference. . In addition, as discussed earlier in this document, the diameter of the clamping discs will be smaller than the diameter of the stapling circumference of the stapler. Thus, the anastomosis can be easily performed by stapling along a circumference outside the perimeter of the discs.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
La Figs. 1a y 1 b muestran respectivamente una vista en perspectiva y una vista lateral de un dispositivo de acuerdo con la invención donde la cánula tiene orificios de vacío. Figs. 1a and 1b respectively show a perspective view and a side view of a device according to the invention where the cannula has vacuum holes.
Las Figs. 2a y 2b muestran una pareja de discos de pinzamiento respectivamente en la posición abierta y en la posición cerrada. Figs. 2a and 2b show a pair of clamping discs respectively in the open position and in the closed position.
Las Figs. 3a y 3b muestran una vista frontal respectivamente de un primer y de un segundo disco de pinzamiento de la misma pareja que encajan entre sí. Figs. 3a and 3b show a front view respectively of a first and a second clamping disc of the same pair that fit together.
La Fig. 4 muestra una vista esquemática detallada del mecanismo de cierre del orificio central de un disco de pinzamiento de acuerdo con la invención. Las Figs. 5a-5f muestran los pasos principales de un procedimiento de transección de recto usando el dispositivo dotado de orificios de vacío mostrado en las Figs. 1a y 1 b. Fig. 4 shows a detailed schematic view of the closing mechanism of the central hole of a pinch disk according to the invention. Figs. 5a-5f show the main steps of a rectum transection procedure using the device provided with vacuum holes shown in Figs. 1st and 1st b.
Las Figs. 6a y 6b muestran respectivamente una vista en perspectiva y una vista lateral de un dispositivo de acuerdo con la invención donde la cánula tiene porciones imantadas. Figs. 6a and 6b respectively show a perspective view and a side view of a device according to the invention where the cannula has magnetized portions.
Las Figs. 7a-7f muestran los pasos principales de un procedimiento de transección de recto usando el dispositivo dotado de porciones imantadas mostrado en las Figs. 6a y 6b. Figs. 7a-7f show the main steps of a rectum transection procedure using the device provided with magnetized portions shown in Figs. 6a and 6b.
Las Figs. 8a-8c muestran esquemáticamente un proceso de sellado de recto utilizando unas tenazas que no forman parte de la presente invención. Figs. 8a-8c schematically show a rectum sealing process using pliers that are not part of the present invention.
REALIZACIONES PREFERENTES DE LA INVENCIÓN Las Figs. 1 y 2 muestran dos vistas de un ejemplo del dispositivo (1) de acuerdo con la presente invención que está dotado de orificios (9) de vacío. El dispositivo (1) está formado por una cánula (2) cilindrica hueca que tiene una porción proximal (2p) y una porción distal (2d). La cánula (2) puede estar hecha de cualquier material quirúrgico adecuado, como por ejemplo un material metálico tal como el acero inoxidable o el titanio, o bien un material plástico o polimérico. PREFERRED EMBODIMENTS OF THE INVENTION Figs. 1 and 2 show two views of an example of the device (1) according to the present invention which is provided with vacuum holes (9). The device (1) is formed by a hollow cylindrical cannula (2) having a proximal portion (2p) and a distal portion (2d). The cannula (2) can be made of any suitable surgical material, such as a metallic material such as stainless steel or titanium, or a plastic or polymeric material.
La porción (2d) distal corresponde al tramo de cánula (2) que, durante el uso del dispositivo (1), quedará introducido en la zona de recto (100) donde se va a realizar la transección. Dos parejas de discos (3a, 3b) de pinzamiento están ubicadas en posiciones adyacentes en la porción (2d) distal de la cánula (2). Cada disco (3a, 3b) de pinzamiento tiene una forma plana esencialmente circular, pudiendo estar hechos de cualquier material quirúrgico adecuado, como por ejemplo un material metálico tal como el acero inoxidable o el titanio, o bien un material plástico o polimérico. The distal portion (2d) corresponds to the cannula section (2) which, during the use of the device (1), will be introduced into the rectum area (100) where the transection is to be performed. Two pairs of clamping discs (3a, 3b) are located in adjacent positions in the distal portion (2d) of the cannula (2). Each clamping disc (3a, 3b) has an essentially circular flat shape, and can be made of any suitable surgical material, such as a metallic material such as stainless steel or titanium, or a plastic or polymeric material.
Los discos (3a, 3b) de pinzamiento de cada pareja son desplazables longitudinalmente a lo largo de la cánula (2) entre una posición abierta y una posición cerrada. En la posición abierta, que es la representada en las Figs. 1 y 2, los discos (3a) de pinzamiento proximales de cada pareja están separados de los respectivos discos (3b) de pinzamiento distales correspondientes de dicha pareja. En la posición cerrada, los discos (3a) de pinzamiento proximales de cada pareja están acoplados a los respectivos discos (3b) de pinzamiento distales de cada pareja. The clamping discs (3a, 3b) of each pair are longitudinally movable along the cannula (2) between an open position and a closed position. In the open position, which is represented in Figs. 1 and 2, the proximal clamping discs (3a) of each pair are separated from the respective corresponding distal clamping discs (3b) of said pair. In the closed position, the proximal clamp discs (3a) of each pair are coupled to the respective distal clamp discs (3b) of each pair.
Esto se aprecia con mayor detalle en las Figs. 2 y 3, donde se presentan diferentes vistas de la pareja de discos (3a, 3b) de pinzamiento ubicada en la posición más distal de la cánula (2). Se aprecia cómo las caras enfrentadas de los discos (3a, 3b) de pinzamiento presentan unos relieves (7a, 7b) complementarios que permiten su acoplamiento. En concreto, en este ejemplo el relieve (7a) de la cara distal del disco (3a) de pinzamiento es de tipo hembra con una forma esencialmente circular, mientras que el relieve (7b) de la cara proximal del disco (3b) de pinzamiento es de tipo macho con una forma esencialmente circular correspondiente a la anterior. Es fácil apreciar, como se representa en la Fig. 2b, cómo el relieve (7b) macho se introduce en el relieve (7ab) hembra de manera que encajan entre sí. Por otra parte, en este ejemplo concreto de dispositivo (1) el acoplamiento deslizante entre las parejas de discos (3a, 3b) de pinzamiento y la cánula (2) se realiza gracias a que los discos (3a, 3b) tienen un orificio (5) central a través del cual pasa dicha cánula (2). Esta configuración permite extraer de una manera sencilla la cánula (2) de los discos (3a, 3b) de pinzamiento durante el procedimiento de transección del recto, como se verá más adelante en este documento. This is seen in greater detail in Figs. 2 and 3, where different views of the pair of clamping discs (3a, 3b) located in the most distal position of the cannula (2) are presented. It can be seen how the facing faces of the clamping discs (3a, 3b) have complementary reliefs (7a, 7b) that allow their coupling. Specifically, in this example the relief (7a) of the distal face of the clamping disc (3a) is of the female type with an essentially circular shape, while the relief (7b) of the proximal face of the clamping disc (3b) It is of the male type with an essentially circular shape corresponding to the previous one. It is easy to see, as shown in Fig. 2b, how the male relief (7b) is inserted into the female relief (7ab) so that they fit together. Moreover, in this particular example of device (1) the sliding coupling between the pairs of clamping discs (3a, 3b) and the cannula (2) is realized thanks to the fact that the discs (3a, 3b) have a central hole (5) through which said cannula (2) passes. This configuration allows the cannula (2) of the clamp discs (3a, 3b) to be removed in a simple manner during the rectum transection procedure, as will be seen later in this document.
Además, con el objeto de cerrar el orificio (5) central cuando la cánula (2) se extrae de los discos (3a, 3b) de pinzamiento, cada disco (3a, 3b) presenta además un elemento de tapa configurado para cerrar automáticamente el orificio (5) central cuando se extrae la cánula (2). Este elemento de tapa, como se aprecia en la Fig. 4, adopta la forma de una lámina (6) circular que está articulada a un punto del borde del orificio (5) del disco (3a, 3b) en cuestión de tal modo que puede pasar desde una posición de apertura en la que no tapa el orificio (5) a una posición de cierre en la que tapa el orificio (5). Un resorte, por ejemplo un resorte de tipo helicoidal, impulsa de manera continua la lámina (6) hacia la posición de cierre. Mientras el disco (3a, 3b) está acoplado a la cánula (2), ésta atraviesa el orificio (5) y por lo tanto la lámina (6) está forzada a permanecer en la posición de apertura. Sin embargo, cuando se extrae la cánula (2) durante un procedimiento de transección de recto, la lámina (6) pasa automáticamente a la posición de cierre gracias a la acción del resorte. In addition, in order to close the central hole (5) when the cannula (2) is removed from the clamping discs (3a, 3b), each disc (3a, 3b) also has a lid element configured to automatically close the central hole (5) when the cannula (2) is removed. This cover element, as seen in Fig. 4, takes the form of a circular sheet (6) that is articulated at a point of the edge of the hole (5) of the disc (3a, 3b) in question in such a way that it can pass from an opening position in which the hole (5) does not cover to a closed position in which the hole (5) covers. A spring, for example a coil-type spring, continuously drives the sheet (6) towards the closed position. While the disc (3a, 3b) is coupled to the cannula (2), it passes through the hole (5) and therefore the sheet (6) is forced to remain in the open position. However, when the cannula (2) is removed during a rectum transection procedure, the sheet (6) automatically goes into the closed position thanks to the action of the spring.
La cánula (2) comprende además una cuchilla (4) ubicada en la porción distal (2d) entre las parejas de discos (3a, 3b) de pinzamiento. Esta cuchilla (4) puede tener, por ejemplo, forma circular y funcionar gracias a un movimiento rotativo. Por último, la cánula (2) de este ejemplo presenta además una pluralidad de orificios (9) de vacío distribuidos por toda su porción distal (2d). Con el objeto de poder crear el vacío en tales orificios (9), la cánula (2) es hueca y su extremo proximal está conectado a un tubo (10) conectado a un compresor (no mostrado). A continuación, se describe con ayuda de las Figs. 5a-5f un ejemplo de procedimiento de transección distal de recto empleando este ejemplo de dispositivo (1). Nótese que, aunque por motivos de claridad las parejas de discos (3a, 3b) de pinzamiento aparecen en estas y otras figuras bastante separadas una de otra, en realidad estarán lo más cerca que sea posible para minimizar la longitud de recto que queda entre ambas. En primer lugar, como se muestra en la Fig. 5a, se introduce el dispositivo (1) a través del ano del paciente hasta alojar la porción distal (2d) de la cánula (2) en la zona de recto (100) donde se va a realizar la transección distal. La porción proximal (2p) de la cánula (2) sobresale parcialmente a través del ano del paciente y queda conectada al compresor de vacío, que de momento está desactivado, a través del tubo (10). Las parejas de discos (3a, 3b) de pinzamiento se encuentran en su posición abierta. The cannula (2) further comprises a blade (4) located in the distal portion (2d) between the pairs of clamping discs (3a, 3b). This blade (4) can, for example, have a circular shape and function thanks to a rotary movement. Finally, the cannula (2) of this example also has a plurality of vacuum holes (9) distributed throughout its distal portion (2d). In order to create the vacuum in such holes (9), the cannula (2) is hollow and its proximal end is connected to a tube (10) connected to a compressor (not shown). Next, it is described with the help of Figs. 5a-5f an example of a distal rectal transection procedure using this example of a device (1). Note that, although for reasons of clarity the pairs of clamping discs (3a, 3b) appear in these and other figures quite separate from each other, in reality they will be as close as possible to minimize the length of the rectum that remains between the two. . First, as shown in Fig. 5a, the device (1) is introduced through the patient's anus to accommodate the distal portion (2d) of the cannula (2) in the rectum area (100) where it is You will perform the distal transection. The proximal portion (2p) of the cannula (2) partially protrudes through the patient's anus and is connected to the vacuum compressor, which is currently deactivated, through the tube (10). The pairs of clamping discs (3a, 3b) are in their open position.
A continuación, como se muestra en la Fig. 5b, se activa el compresor de vacío conectado al tubo (10). El efecto de succión creado gracias a los orificios (9) de vacío provoca que las paredes del recto se peguen a la porción distal (2d) de la cánula (2) en general, y en particular al tramo de dicha cánula (2) ubicado entre cada pareja de discos (3a, 3b) de pinzamiento, que continúan en su posición abierta, así como entre una pareja y la otra. Then, as shown in Fig. 5b, the vacuum compressor connected to the tube (10) is activated. The suction effect created by the vacuum holes (9) causes the walls of the rectum to stick to the distal portion (2d) of the cannula (2) in general, and in particular to the section of said cannula (2) located between each pair of clamping discs (3a, 3b), which continue in their open position, as well as between one pair and the other.
Una vez las paredes del recto están introducidas entre cada pareja de discos (3a, 3b) de pinzamiento, se hace pasar cada pareja de discos (3a, 3b) de pinzamiento hacia su posición cerrada. Los discos (3a, 3b) de pinzamiento de cada pareja quedan acoplados entre sí de manera autónoma y permanente gracias a los relieves (7a, 7b) complementarios, quedando el recto pinzado entre ellos tal como se muestra en la Fig. 5c. Once the walls of the rectum are inserted between each pair of clamping discs (3a, 3b), each pair of clamping discs (3a, 3b) is passed to its closed position. The clamping discs (3a, 3b) of each pair are connected to each other autonomously and permanently thanks to the complementary reliefs (7a, 7b), the rectum being pinched between them as shown in Fig. 5c.
En la Fig. 5d se muestra el siguiente paso, que consiste en activar la cuchilla (4) para realizar el corte transversal a lo largo de toda la circunferencia del recto. La acción de los orificios (9) de vacío que provoca que las paredes del recto se "peguen" a la porción distal (2d) de la cánula (2) facilita este paso y permite el uso de una cuchilla (4) de pequeño tamaño. The next step is shown in Fig. 5d, which consists of activating the blade (4) to perform the cross-section along the entire circumference of the rectum. The action of the vacuum holes (9) that causes the walls of the rectum to "stick" to the distal portion (2d) of the cannula (2) facilitates this step and allows the use of a small blade (4) .
Seguidamente, se extrae la cánula (2), separándola de las dos parejas de discos (3a, 3b) de pinzamiento. Cuando la cánula (2) deja de tapar los respectivos orificios (5) de los discos (3a, 3b) de pinzamiento, las respectivas láminas (6) son impulsadas por el resorte y cierran dichos orificios (5), asegurando la estanqueidad del cierre. El resultado final de este procedimiento se muestra en la Fig. 5e. La Fig. 5f muestra una vista desde el exterior del recto del estado en que queda el extremo libre distal. El cirujano puede ahora tirar del otro extremo libre que se ha creado con la transección distal, es decir, el extremo más proximal, para sacarlo de la pelvis y llevarlo hacia el abdomen, donde puede continuar la operación. Next, the cannula (2) is removed, separating it from the two pairs of clamping discs (3a, 3b). When the cannula (2) stops covering the respective holes (5) of the clamping discs (3a, 3b), the respective plates (6) are driven by the spring and close said holes (5), ensuring the seal tightness . The final result of this procedure is shown in Fig. 5e. Fig. 5f shows a view from the outside of the rectum of the state in which the distal free end is left. The surgeon can now pull the other free end that has been created with the transection distal, that is, the most proximal end, to remove it from the pelvis and take it to the abdomen, where the operation can continue.
Como se ha mencionado anteriormente en este documento, el dispositivo (1) de la invención puede no disponer de orificios (9) de vacío que permitan introducir las paredes del recto entre cada pareja de discos (3a, 3b) de pinzamiento. En este caso, resulta necesario hacerlo con ayuda de instrumentos introducidos en el abdomen del paciente por vía laparoscópica o abierta. En estas condiciones, en ocasiones resulta difícil ubicar la posición de dichos discos (3a, 3b) de pinzamiento desde el exterior del recto. Las Figs. 6a y 6b muestran un segundo ejemplo de dispositivo (1) según la presente invención que facilita este paso gracias a unas porciones (8) imantadas ubicadas en la cánula (2) entre cada pareja de discos (3a, 3b) de pinzamiento en su posición abierta. Este ejemplo de dispositivo (1) no incluye orificios (9) de vacío, aunque como se ha descrito con anterioridad en este documento éstos serían compatibles con el uso de porciones (8) imantadas. As mentioned earlier in this document, the device (1) of the invention may not have vacuum holes (9) that allow the walls of the rectum to be introduced between each pair of clamping discs (3a, 3b). In this case, it is necessary to do so with the help of instruments inserted into the patient's abdomen by laparoscopic or open route. Under these conditions, it is sometimes difficult to locate the position of said clamping discs (3a, 3b) from outside the rectum. Figs. 6a and 6b show a second example of device (1) according to the present invention that facilitates this step thanks to magnetized portions (8) located in the cannula (2) between each pair of clamping discs (3a, 3b) in position. open This example of device (1) does not include vacuum holes (9), although as described hereinbefore these would be compatible with the use of magnetized portions (8).
Las Figs. 7a-7f muestran los pasos de una transección distal de recto realizada utilizando este segundo ejemplo de dispositivo (1). En primer lugar, una vez se ha introducido el dispositivo (1) en el recto del paciente, se ubican las posiciones correspondientes a al espacio entre cada pareja de discos (3a, 3b) de pinzamiento en su posición abierta desde el exterior del recto con ayuda de un instrumento (200) magnéticamente sensible. Este instrumento (200) detecta, desde el exterior del recto, el lugar en que se encuentran las porciones (8) imantadas de la cánula (2) ubicada en su interior. Una vez hecho esto, como se muestra en la Fig. 7a, se utiliza un hilo (201) para rodear el recto y se anuda de manera que un pellizco de recto queda introducido en el espacio entre cada pareja de discos (3a, 3b) de pinzamiento en su posición abierta. El resultado de esta operación se muestra en la Fig. 7b. Se desplazan entonces los discos (3a, 3b) de pinzamiento desde su posición abierta a su posición cerrada, de modo que pinzan la porción de recto ubicada entre ambos, como se aprecia en la Fig. 7c. A continuación, se realiza la transección distal del recto. En este ejemplo, el dispositivo (1) no tiene cuchilla (4) de corte, por lo que éste se lleva a cabo desde el exterior con ayuda de un instrumento auxiliar (300) introducido por vía laparoscópica, como se observa en la Fig. 4. El resultado final de este procedimiento, que se muestra en las Figs. 7e y 7f, es el mismo que antes cuando el dispositivo (1) tenía orificios (9) de vacío. Por último, las Figs. 8a-8c muestran esquemáticamente un proceso alternativo de introducción de las paredes del recto entre cada par de discos (3a, 3b) de pinzamiento utilizando unas tenazas que no forman parte de la presente invención. El uso de estas tenazas (300) constituye una alternativa al uso de los orificios (9) de vacío o el hilo (201) que se han descrito anteriormente. Figs. 7a-7f show the steps of a distal transection of the rectum performed using this second example of device (1). First, once the device (1) has been introduced into the patient's rectum, the positions corresponding to the space between each pair of clamping discs (3a, 3b) are located in their open position from the outside of the rectum with aid of a magnetically sensitive instrument (200). This instrument (200) detects, from outside the rectum, the place where the magnetized portions (8) of the cannula (2) located inside it are located. Once this is done, as shown in Fig. 7a, a thread (201) is used to surround the rectum and knotted so that a pinch of rectum is inserted into the space between each pair of discs (3a, 3b) clamping in its open position. The result of this operation is shown in Fig. 7b. The clamping discs (3a, 3b) are then moved from their open position to their closed position, so that they clamp the rectum portion located between them, as seen in Fig. 7c. Next, distal transection of the rectum is performed. In this example, the device (1) does not have a cutting blade (4), so that it is carried out from the outside with the aid of an auxiliary instrument (300) introduced laparoscopically, as seen in Fig. 4. The final result of this procedure, which is shown in Figs. 7e and 7f, is the same as before when the device (1) had vacuum holes (9). Finally, Figs. 8a-8c schematically show an alternative process of introducing the walls of the rectum between each pair of clamping discs (3a, 3b) using pliers that are not part of the present invention. The use of these pliers (300) constitutes an alternative to the use of the vacuum holes (9) or the wire (201) described above.
Las tenazas (300) están especialmente diseñadas para la colocación y cierre de un tramo de alambre (301) alrededor del recto, de un modo equivalente al hilo (201) descrito en el ejemplo anterior. De ese modo, en primer lugar se localiza el punto donde se debe llevar a cabo el pinzamiento entre una pareja de discos (3a) de pinzamiento. Esto se puede hacer, como se describió antes, utilizando un instrumento (200) magnéticamente sensible para detectar las porciones (8) imantadas. A continuación, se ubican las tenazas (300) en ese punto (Fig. 8a) y se presionan (Fig. 8b). La especial configuración de las tenazas (300) provoca que un tramo de alambre (301) alojado en uno de sus brazos se enrolle alrededor del recto y, al apretar, quede firmemente cerrado alrededor del mismo. El resultado de este proceso se muestra en la Fig. 8c. El resto del procedimiento se realizaría según se ha descrito en los ejemplos anteriores. The pliers (300) are specially designed for the placement and closing of a section of wire (301) around the rectum, in a manner equivalent to the wire (201) described in the previous example. Thus, the point where the clamping between a pair of clamping discs (3a) must first be located. This can be done, as described above, using a magnetically sensitive instrument (200) to detect the magnetized portions (8). Next, the pliers (300) are located at that point (Fig. 8a) and pressed (Fig. 8b). The special configuration of the pliers (300) causes a section of wire (301) housed in one of its arms to wrap around the rectum and, when tightened, is firmly closed around it. The result of this process is shown in Fig. 8c. The rest of the procedure would be performed as described in the previous examples.

Claims

REIVINDICACIONES
1. Dispositivo (1) endoluminal para transección de recto, que comprende: 1. Endoluminal device (1) for transection of the rectum, comprising:
una cánula (2) configurada para su introducción en el recto de un paciente a través del ano; y  a cannula (2) configured for introduction into a patient's rectum through the anus; Y
dos parejas de discos (3a, 3b) de pinzamiento acoplados a una porción (2d) distal de dicha cánula (2), donde los discos (3a, 3b) de pinzamiento que forman cada pareja son desplazables longitudinalmente a lo largo de la cánula (2) entre una posición abierta, en que están separados, y una posición cerrada, en que quedan encajados para pinzar transversalmente el recto,  two pairs of clamp discs (3a, 3b) coupled to a distal portion (2d) of said cannula (2), where the clamp discs (3a, 3b) that form each pair are longitudinally movable along the cannula ( 2) between an open position, in which they are separated, and a closed position, in which they are fitted to transversely clamp the rectum,
caracterizado por que la cánula (2) es separable de los discos (3a, 3b) de pinzamiento.  characterized in that the cannula (2) is separable from the clamping discs (3a, 3b).
2. Dispositivo (1) de acuerdo con la reivindicación 1 , donde los discos (3a, 3b) de pinzamiento comprenden un orificio (5) central a través del cual está dispuesta de manera extraíble la cánula (2). 2. Device (1) according to claim 1, wherein the clamping discs (3a, 3b) comprise a central hole (5) through which the cannula (2) is removably disposed.
3. Dispositivo (1) de acuerdo con la reivindicación 2, donde los discos (3a, 3b) de pinzamiento comprenden un elemento de tapa configurado para cerrar automáticamente el orificio (5) central cuando se extrae la cánula (2). 3. Device (1) according to claim 2, wherein the clamping discs (3a, 3b) comprise a cover element configured to automatically close the central hole (5) when the cannula (2) is removed.
4. Dispositivo (1) de acuerdo con la reivindicación 3, donde el elemento de tapa es una lámina (6) solicitada por un resorte que la impulsa continuamente hacia una posición en que bloquea el orificio (5) central del disco (3a, 3b) de pinzamiento. Device (1) according to claim 3, wherein the cover element is a sheet (6) requested by a spring that continuously drives it towards a position where it blocks the central hole (5) of the disc (3a, 3b ) grip.
5. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde las dos parejas de discos (3a, 3b) de pinzamiento, cuando están cerradas, son adyacentes una a la otra. 5. Device (1) according to any of the preceding claims, wherein the two pairs of clamping discs (3a, 3b), when closed, are adjacent to each other.
6. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde los discos (3a, 3b) de pinzamiento de cada pareja comprenden medios para acoplarse uno a otro cuando están en la posición cerrada. 6. Device (1) according to any of the preceding claims, wherein the clamping discs (3a, 3b) of each pair comprise means for engaging each other when they are in the closed position.
7. Dispositivo (1) de acuerdo con la reivindicación 6, donde las superficies enfrentadas de cada pareja de discos (3a, 3b) de pinzamiento comprenden sendos relieves (7a, 7b) complementarios que encajan entre sí cuando están en la posición cerrada. 7. Device (1) according to claim 6, wherein the facing surfaces of each pair of clamping discs (3a, 3b) comprise two reliefs (7a, 7b) complementary that fit together when they are in the closed position.
8. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la cara distal del disco (3b) de pinzamiento ubicado en la posición más distal tiene una forma anatómica. 8. Device (1) according to any of the preceding claims, wherein the distal face of the clamping disc (3b) located in the most distal position has an anatomical shape.
9. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde los discos (3a, 3b) de pinzamiento tienen un diámetro de entre 20 mm y 30 mm. 9. Device (1) according to any of the preceding claims, wherein the clamping discs (3a, 3b) have a diameter between 20 mm and 30 mm.
10. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la cánula (2) comprende sendas porciones (8) imantadas situadas entre cada pareja de discos (3a, 3b) de pinzamiento en su posición abierta. 10. Device (1) according to any of the preceding claims, wherein the cannula (2) comprises two magnetized portions (8) located between each pair of clamping discs (3a, 3b) in their open position.
1 1. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la porción (2d) distal de la cánula (2) comprende una pluralidad de orificios (9) de vacío para succionar las paredes del recto. 1 Device (1) according to any of the preceding claims, wherein the distal portion (2d) of the cannula (2) comprises a plurality of vacuum holes (9) for suctioning the walls of the rectum.
12. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, caracterizado por que además comprende una cuchilla (4) transversal fijada a la cánula (2) entre las dos parejas de discos (3a, 3b) de pinzamiento que está configurada para seccionar transversal mente el recto. 12. Device (1) according to any of the preceding claims, characterized in that it further comprises a transverse blade (4) fixed to the cannula (2) between the two pairs of clamping discs (3a, 3b) that is configured to cross section the rectum mind.
13. Dispositivo (1) de acuerdo con cualquiera la reivindicación 12, donde la cuchilla (4) transversal es circular y rotatoria. 13. Device (1) according to any one of claim 12, wherein the transverse blade (4) is circular and rotary.
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US20040015179A1 (en) * 2002-07-22 2004-01-22 Leonid Monassevitch Intussusception and anastomosis apparatus
EP2272442A1 (en) * 2009-07-11 2011-01-12 Tyco Healthcare Group, LP Surgical instrument with double cartridge and anvil assemblies
US20130060258A1 (en) * 2011-08-26 2013-03-07 Carman Giacomantonio Endoluminal Surgical Instrument for Stapling, Cutting and Dividing

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ES2618252A1 (en) 2017-06-21

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