WO2019122487A1 - Device for haemostasis of an intraperitoneal trocar orifice - Google Patents

Device for haemostasis of an intraperitoneal trocar orifice Download PDF

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Publication number
WO2019122487A1
WO2019122487A1 PCT/ES2018/070821 ES2018070821W WO2019122487A1 WO 2019122487 A1 WO2019122487 A1 WO 2019122487A1 ES 2018070821 W ES2018070821 W ES 2018070821W WO 2019122487 A1 WO2019122487 A1 WO 2019122487A1
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WO
WIPO (PCT)
Prior art keywords
probe
instrument
balloons
aponeurosis
balloon
Prior art date
Application number
PCT/ES2018/070821
Other languages
Spanish (es)
French (fr)
Inventor
Francisco Javier PÉREZ LARA
Original Assignee
Servicio Andaluz De Salud
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Filing date
Publication date
Priority claimed from ES201731557U external-priority patent/ES1203693Y/en
Priority claimed from ES201731610U external-priority patent/ES1204712Y/en
Application filed by Servicio Andaluz De Salud filed Critical Servicio Andaluz De Salud
Publication of WO2019122487A1 publication Critical patent/WO2019122487A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention belongs in general to the field of laparoscopic surgery, and more particularly to the application of hemostasis in a trocar orifice practiced during an intraperitoneal laparoscopic surgical operation.
  • the object of the present is a new device of type double balloon probe particularly designed for the closure and compression of the aponeurosis in a trocar orifice practiced during an intraperitoneal laparoscopic surgical operation.
  • the current interventions for laparoscopic surgery require the realization of one or several holes through the abdominal wall and the peritoneum for the placement of one or more trocars, through which the instruments for surgical intervention are introduced. Once the operation is completed, the instruments used and the corresponding trocars are removed, leaving one or several holes that go through the patient's abdominal wall. These orifices traverse a plurality of tissues of the patient's abdomen, including the skin, subcutaneous tissue, aponeurosis, muscle tissue, and peritoneum. Occasionally, after the end of the surgical intervention, persistent bleeding may occur that must be contained, requiring the continuous attention of a medical professional.
  • the present invention solves the above problems thanks to a new device for the control of bleeding of an intraperitoneal trocar orifice which is essentially formed by a probe, called a double balloon, which is provided with two inflatable balloons.
  • a double balloon probe for the control of intraperitoneal laparoscopic surgery trocar orifice bleed.
  • the inventor of the present application describes a new double balloon probe design that allows to carry out an innovative procedure for the control of hemostasis in trocar orifices in an intraperitoneal laparoscopic operation.
  • This new procedure basically comprises the introduction of the double balloon probe of the invention through a trocar orifice that presents a persistent bleeding so that the two balloons are respectively located on one side and the other of the aponeurosis. Once the balloons have been inflated, they compress the aponeurosis and thus promote hemostasis.
  • the double balloon probe of the invention differs from the double balloon probes known in that presents features and dimensions particularly designed for the described use.
  • next G and distar are interpreted in relation to a medical professional who handles the device of the invention. That is, the term “proximal refers to a device position close to the medical professional and the term” distar refers to a position of the device remote from the medical professional.
  • the present invention describes a device for intraperitoneal trocar hole hemostasis comprising a probe having two inflatable balloons located in a distal portion.
  • the probe comprises two conduits, each of which has an open proximal end and a distal end connected to a respective inflatable balloon.
  • a medical professional can inflate or deflate the inflatable balloons by injecting or withdrawing a fluid through the open proximal end of the conduit corresponding to the desired inflatable balloon.
  • a harmless fluid such as saline or the like is used.
  • the proposed device differs from similar devices currently known in that the probe has an outer diameter of between 1.5 mm and 2.5 mm and a spacing between the two inflatable balloons of between 2.5 mm and 3.5 mm. These dimensions are particularly designed to allow the use of this device in the described hemostasis procedure.
  • the small diameter of the probe of the invention allows it to be introduced into a very small diameter trocar orifice that is partially closed by a suture. This is important because, as described below, the procedure for achieving hemostasis involves the permanence of the probe in the trocar orifice for a period of time between 24 and 48 hours. The narrower the probe, the narrower the hole in the skin through which it passes, and therefore the less likely that infections will occur.
  • the separation between the two inflatable balloons is particularly configured as a function of the thickness of the aponeurosis so that, when the device is installed, the aponeurosis is compressed between the two balloons a Once they have bloated.
  • the thickness of the aponeurosis in the area where the holes are usually made for placement of the trocars in intraperitoneal laparoscopic surgery is within the order of 2-3 mm, so the distance between the inflatable balloons of the device of the invention is particularly dimensioned so that these are just on each side of the aponeurosis, compressing it and thus stopping the bleeding.
  • the procedure for achieving hemostasis with the described device is fundamentally the following. Once the laparoscopic surgery is finished and after the trocars are removed, it is detected that some of the orifices present an incoercible bleeding. The skin is then stitched around the hole in question but the stitches are left untied. With the balloons in a deflated state, the probe is inserted through the hole until the inflatable balloons are placed one on each side of the aponeurosis. The stitches are then knotted to close the skin around the probe, and then a fluid is introduced through the respective conduits of the probe to inflate the balloons.
  • the device is held in this position with the balloons compressed compressing the aponeurosis for a period of between 24 and 48 hours.
  • the inflation pressure of the balloons causes haemostasis of both the aponeurosis itself and the adjacent layers.
  • the medical professional deflates the balloons by removing the fluid that fills the balloons through the tubes of the probe, and then pulls the proximal end of the probe to remove the device. Given the small diameter of the probe, both the skin and the aponeurosis are practically closed. It is a quick and simple procedure that can be carried out with the simple device of the invention.
  • the inflatable balloons have a flattened shape. That is, the inflatable balloons have a larger diameter within a plane perpendicular to the general direction of the probe. This helps the pressure exerted on the aponeurosis cover a greater area of the aponeurosis in the area surrounding the orifice, thus improving the hemostatic effect. In addition, it diminishes the deformation suffered by the layers where the balloons lodge, specifically the skin and subcutaneous tissue, on the outside of the aponeurosis, and the muscular and pre-peritoneal area, inside the aponeurosis.
  • the balloons and / or the distal portion of the probe are impregnated with an anti-hemorrhagic substance.
  • an anti-hemorrhagic substance comes into contact with the tissues of the patient's abdomen, thus promoting hemostasis.
  • any anti-haemorrhagic substance that can be applied to the outer surface of the balloons and / or the distal portion of the probe could be used, although according to a particularly preferred embodiment of the invention the anti-haemorrhagic substance is oxidized cellulose.
  • Fig. 1 shows a schematic view of an example of a device according to the present invention with the balloons in the deflated state.
  • Fig. 2 shows a schematic view of the example device of the invention of Fig. 1 with the balloons in the inflated state.
  • Fig. 3 shows an enlarged view of the distal portion of another example of device according to the invention where the distal portion of the probe and the inflatable balloons are coated with an anti-hemorrhagic substance.
  • Fig. 4 shows a schematic section of the abdominal tissue of a patient traversed by a trocar orifice.
  • Fig. 5 shows a schematic section of abdominal tissue with the example of device of the invention arranged to cause hemostasis.
  • Figs. 1-2 show schematically the device (1) of the present invention formed by a probe (2) in whose distal portion there are two inflatable balloons (3a, 3b).
  • the probe (2) has two internal parallel conduits connecting respectively a first proximal inlet hole with a first proximal balloon (3a) and a second proximal inlet with a second balloon ( 3b).
  • a medical professional can selectively inflate / deflate the first balloon (3a) or the second balloon (3b) by injecting a fluid through the first proximal entry orifice or the second proximal entry orifice.
  • the probe (2) of this example device (1) has a diameter of 2 mm, and the distance between the two balloons (3a, 3b) is 3 mm.
  • the balloons (3a, 3b) have a somewhat flattened shape to increase the surface of the aponeurosis (AP) that receives the compression effect, and to decrease the volume of the balloons (3a, 3b) housed inside from the layers surrounding the aponeurosis (AP).
  • Fig. 3 shows a configuration of the device (1) of the invention where the distal portion of the probe (2) and the two balloons (3a, 3b) are coated with an anti-hemorrhagic substance, in this case oxidized cellulose.
  • an anti-hemorrhagic substance in this case oxidized cellulose.
  • an orifice (O) is left in the patient's abdominal wall as shown in Fig. 4.
  • This orifice (O) passes through all the layers of the abdominal wall at this point, specifically from the outside to the inside. , skin (P), subcutaneous tissue (TS), aponeurosis (AP), muscle (M), and peritoneum (PR).
  • the device (1) of the invention is introduced with the inflatable balloons (3a, 3b) in a deflated state until the first proximal balloon (3a) is positioned on the outer side of the aponeurosis ( AP) and the second balloon (3b) distal on the inner side of the aponeurosis (AP).
  • the distance between both globes (3a, 3b), as mentioned above, is 3 mm, and the thickness of the aponeurosis (AP) at this point is also about 2-3 mm.
  • the medical professional tightens closing points fixed at the beginning of the procedure on the skin portion (P) surrounding the hole (O). Then, the medical professional injects adequate fluid through the proximal orifices of the ducts of the probe (2) and causes the balloons to swell (3a, 3b), so that they compress the aponeurosis (AP) portion interspersed between them.
  • the inflation of the balloons (3a, 3b) also compresses the subcutaneous tissue (TS) and the skin (P), located above the aponeurosis (AP), and the muscle (M) and the peritoneum (PR), situated by under the aponeurosis (AP).
  • TS subcutaneous tissue
  • P skin
  • M muscle
  • PR peritoneum
  • Fig. 5 The situation at this point is shown in Fig. 5.
  • the device (1) remains inflated inside the abdominal wall for 24 or 48 hours.
  • the medical professional deflates the balloons (3a, 3b) by extracting the liquid through the proximal orifices of the respective conduits of the probe (2).
  • the medical professional pulls from the proximal end of the probe (2) to extract it completely from the hole (O). Thanks to its very small diameter of 2 mm, the hole (O) is closed for practical purposes.
  • the present invention belongs in a general way to the field of medicine, and more particularly to gastroesophageal reflux surgery
  • the object of the present invention is a new laparoscopic instrument that facilitates the completion of the fundoplication in a gastroesophageal reflux surgery operation.
  • Gastroesophageal reflux disease occurs when the lower esophageal sphincter (LES), a valve that controls the passage of contents of the esophagus into the stomach, is altered or is inappropriately relaxed, allowing the content to pass back into the esophagus. thus irritating the mucosa.
  • the surgical treatment of gastroesophageal reflux disease is currently performed laparoscopically, since this allows a more easy approach and a reduction in the rate of post-operative complications.
  • the surgical technique currently used, or Nissen technique involves the realization of a gastric fundoplication around the esophagus.
  • the gastric fundus (FG) is first passed through the retroesophageal tunnel (TR) to surround the esophagus (E) from behind (Figs 6a-6c). Then, as shown in Fig. 6d, the gastric fundus (FG) is stitched to the stomach itself (ES). The mouth of the stomach (ES) is thus compressed by the stomach portion (ES) that surrounds it, thus facilitating the function of closing the lower esophageal sphincter and making it difficult to return to the esophagus (E) of the stomach contents (ES).
  • a retractor to open the retroesophageal tunnel (TR);
  • tweezers to grasp the gastric fundus (FG) and pull it through the retroesophageal tunnel (TR);
  • suture instruments I to suture the gastric fundus (FG) to the rest of the stomach (ES).
  • the most complicated step in this type of intervention is to pass the gastric fundus (FG) through the retroesophageal tunnel (TR).
  • TR retroesophageal tunnel
  • P forceps of general purpose
  • the grip by means of the forceps (P) may not be firm enough when performing the traction and as a consequence the gastric fundus (FG) may be released, forcing the operation to start again.
  • the completion of fundoplication is particularly difficult in certain circumstances such as obese patients, reoperations, etc.
  • the present invention solves the above problems thanks to a new laparoscopic instrument particularly designed for this purpose that greatly facilitates reaching both the gastric fundus after passing through the retroesophageal tunnel, and grasping the gastric fundus securely to pull it.
  • proximar and distar have the usual meaning of these terms in the field of medicine.
  • distar refers to an element or portion of the instrument of the invention located farther from the person who handles the instrument
  • proximal refers to an element or portion of the instrument of the invention located closer of the person who operates the instrument.
  • the present invention describes a laparoscopic instrument for performing fundoplication in gastroesophageal reflux surgery.
  • the instrument comprises a shank having a distal end and a proximal end, and has the following features: a) The distal end of the shank comprises an eyelet hole.
  • an eyelet hole refers to a suitable hole for passing a conventional suture thread therethrough.
  • the presence of this hole will allow the gastric fundus to be fixed to the distal end of the stem of the instrument of the invention through a suture point. In this way, it is ensured that the gastric fundus does not detach when traction is made on it during its passage through the retroesophageal tunnel.
  • the shank comprises a mechanism configured to bend a bendable portion of the shank, so that the shank can alternate between a straight configuration and a curved configuration.
  • the bending mechanism of the rod can in principle be of any type known in the art.
  • Documents US20090171161, US8721630 or US9668720 are examples of mechanisms designed to bend an endoscopic instrument.
  • the mechanism for bending the curved portion of this instrument comprises an actuating means located at its proximal end, so that the surgeon can actuate it to alternate the stem between a straight configuration and a curved configuration when necessary during the procedure surgical.
  • the driving means may take the form of a rotating wheel or a trigger.
  • the bendable portion may be bent in any way, for example by an essentially constant curvature along the bendable portion, or through one or more point elbows interspersed between substantially straight portions of the bendable portion.
  • the bendable portion is configured to curl at two specific points. This configuration is advantageous because it allows the section passing through the retroesophageal tunnel to be substantially straight.
  • the curvable portion of the stem is located in a distal portion of said stem that spans the most distal half of its length or, more preferably, the most distal third of its length. It has been found that this position of the curved portion is suitable for performing the surgical procedure described above, since during its realization only the distal portion of the stem is introduced through the retroesophageal tunnel.
  • the bendable portion is configured to bend an angle of between 15 ° and 90 °, more preferably between 20 ° and 45 °, and even more preferably between 25 ° and 35 °. It has also been proven that this range of curvatures is ideal for the most distal portion of the instrument to surround the patient's esophagus, leaving the distal end in view for attachment to the gastric fundus.
  • This new instrument makes it much easier to perform the surgical procedure described earlier in this document. Specifically, first the surgeon introduces, with the help of a retractor, the instrument of the invention in its straight configuration through the retroesophageal tunnel. Next, the surgeon actuates the drive means located at the proximal end of the instrument of the invention, causing the appearance of a curve in a distal portion of the instrument. As a consequence, the distal end is much more easily visible on the opposite side of the esophagus, next to the angle of the stomach of the patient, regardless of the difficulties posed by the anatomy of the particular patient.
  • the surgeon then uses an auxiliary instrument to give a suture point to the gastric fundus of the patient and to pass the thread through the eyelet hole of the distal end of the instrument of the invention. Once the thread is knotted, the gastric fundus is fixed completely securely to the instrument of the invention, so that it is possible to pull it to pass the gastric fundus through the retroesophageal tunnel. During this operation, the surgeon uses the actuating means to move the instrument back to its straight configuration. Once the gastric fundus has passed through the retroesophageal tunnel, it is proceeded to be sewn to the rest of the stomach in a similar way to how it is currently performed.
  • Figs. 6a-6d schematically show the main steps of a conventional gastroesophageal reflux surgery operation.
  • Fig. 7 shows a schematic view of the instrument of the present invention in its straight configuration.
  • Fig. 8 shows a schematic view of the instrument of the present invention in its curved configuration.
  • Figs. 9a-9f schematically show the main steps of a gastroesophageal reflux surgery performed using the instrument of the present invention.
  • Figs. 7 and 8 show an example of instrument (1) according to the present invention respectively in its straight configuration and its curved configuration.
  • the instrument (1) is essentially formed by a rod (2) having a distal end (ED) and a proximal end (EP).
  • the instrument (1) At the proximal end (EP), the instrument (1) comprises a means (4) for actuating a mechanism located inside the stem (2), which is not shown in this document, and which allows it to be alternated between the straight configuration of Fig. 7 and the curved configuration of Fig. 8.
  • the curving of the shank (2a) occurs in a curved portion (2a) which in this example is located in the most distal half of the shank (2).
  • the curved portion (2a) of the shank (2) is bent through two point elbows.
  • the instrument (1) at the distal end (ED), the instrument (1) comprises an eyelet hole (3).
  • Figs. 9a-9f show schematically the main steps of a gastroesophageal reflux surgery performed using the instrument (1) of the invention.
  • the distal end (ED) of the instrument (1) is passed in its straight configuration through the retroesophageal tunnel (TR).
  • the surgeon drives the drive means (4) to cause the bending of the curvable portion (2a) of the shank (2) thereby passing the instrument (1) of the straight configuration to the curved configuration.
  • Fig. 9a-9f show schematically the main steps of a gastroesophageal reflux surgery performed using the instrument (1) of the invention.
  • the surgeon ties the gastric fundus (FG) of the stomach (E) of the patient to the eyelet hole (3) by applying a suture point.
  • the gastric fundus (FG) is thus firmly fixed to the instrument (1) of the invention, so that the surgeon can pull the instrument (1) to pull the gastric fundus (FG) until it passes through the retroesophageal tunnel (TR) .
  • the surgeon drives the drive means (4) again to move the instrument (1) to its straight configuration.
  • the surgeon sews it to fix it to the rest of the stomach (E) in a similar way to the conventional one.
  • Laparoscopic instrument (1) for performing fundoplication in gastroesophageal reflux surgery comprising a stem (2) having a distal end (ED) and a proximal end (EP), characterized in that:
  • the distal end (ED) of the stem (1) comprises an eyelet hole (3);
  • the shank (1) comprises a mechanism configured to bend a curved portion (2a) of the shank (2), so that the shank (2) can alternate between a straight configuration and a curved configuration.
  • Instrument (1) according to clause 1, wherein the mechanism for bending the curved portion (2a) comprises a drive means (4) located at the proximal end of the instrument (1). 3. Instrument (1) according to any of the preceding clauses, wherein the bending portion (2a) is configured to be bent at two points.

Abstract

The invention relates to a device for haemostasis of an intraperitoneal trocar orifice, comprising a probe having two inflatable balloons located in a distal portion, said probe comprising two tubes having an open proximal end and a distal end connected to a corresponding inflatable balloon. In addition, the outside diameter of the probe measures between 1.5 mm and 2.5 mm and the two inflatable balloons are separated by a distance of between 2.5 mm and 3.5 mm.

Description

DESCRIPCIÓN  DESCRIPTION
DISPOSITIVO PARA HEMOSTASIA DE ORIFICIO DE TROCAR INTRAPERITONEAL  DEVICE FOR INTRAPERITONEAL TROCAR HOLE HEMOSTASIA
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención pertenece en general al campo de la cirugía laparoscópica, y más particularmente a la aplicación de hemostasia en un orificio de trocar practicado durante una operación quirúrgica laparoscópica intraperitoneal. The present invention belongs in general to the field of laparoscopic surgery, and more particularly to the application of hemostasis in a trocar orifice practiced during an intraperitoneal laparoscopic surgical operation.
El objeto de la presente es un nuevo dispositivo de tipo sonda de doble globo particularmente diseñado para el cierre y compresión de la aponeurosis en un orificio de trocar practicado durante una operación quirúrgica laparoscópica intraperitoneal. The object of the present is a new device of type double balloon probe particularly designed for the closure and compression of the aponeurosis in a trocar orifice practiced during an intraperitoneal laparoscopic surgical operation.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Las actuales intervenciones por cirugía laparoscópica requieren la realización de uno o varios orificios a través de la pared abdominal y el peritoneo para la colocación de uno o varios trocares, a través de los cuales se introduce el instrumental para la intervención quirúrgica. Una vez terminada la operación, se extrae el instrumental utilizado y los correspondientes trocares, quedando uno o varios orificios que atraviesan la pared abdominal del paciente. Estos orificios atraviesan una pluralidad de tejidos del abdomen del paciente, que incluyen la piel, tejido subcutáneo, aponeurosis, tejido muscular, y peritoneo. En ocasiones, posteriormente a la finalización de la intervención quirúrgica, puede producirse un sangrado persistente que es necesario contener, requiriendo para ello la atención continua de un profesional médico. The current interventions for laparoscopic surgery require the realization of one or several holes through the abdominal wall and the peritoneum for the placement of one or more trocars, through which the instruments for surgical intervention are introduced. Once the operation is completed, the instruments used and the corresponding trocars are removed, leaving one or several holes that go through the patient's abdominal wall. These orifices traverse a plurality of tissues of the patient's abdomen, including the skin, subcutaneous tissue, aponeurosis, muscle tissue, and peritoneum. Occasionally, after the end of the surgical intervention, persistent bleeding may occur that must be contained, requiring the continuous attention of a medical professional.
Actualmente, el control del sangrado de estos orificios se realiza aplicando puntos de sutura sobre la piel del paciente para tratar de cerrar el orificio del trocar. Este procedimiento requiere tiempo por parte del profesional médico, y además no es muy eficiente en el sentido de que es habitual que el sangrado vuelva a aparecer en algún momento del post-operatorio. Currently, bleeding control of these holes is performed by applying stitches on the patient's skin to try to close the trocar orifice. This procedure requires time on the part of the medical professional, and also is not very efficient in the sense that it is usual for the bleeding to reappear at some point during the post-operative period.
En definitiva, existe un problema en este campo de la técnica que aún no está completamente solucionado. DESCRIPCIÓN DE LA INVENCIÓN In short, there is a problem in this field of technology that is not yet completely solved. DESCRIPTION OF THE INVENTION
La presente invención resuelve los problemas anteriores gracias a un nuevo dispositivo para el control del sangrado de un orificio de trocar intraperitoneal que está formado fundamentalmente por una sonda, denominada de doble globo, que está dotada de dos globos hinchables. The present invention solves the above problems thanks to a new device for the control of bleeding of an intraperitoneal trocar orifice which is essentially formed by a probe, called a double balloon, which is provided with two inflatable balloons.
Actualmente, son conocidos diversos dispositivos configurados como una sonda de doble globo, aunque están particularmente diseñados para propósitos muy diferentes del propuesto en esta solicitud. Por ejemplo, es conocido el uso de sondas de doble globo para la inducción del parto en mujeres embarazadas (véase el documento “Single-balloon com pared with double-balloon catheters for induction of labor: a randomized controlled triar, Salim R. et al, Obstet Gynecol. 2011 , Jul; 118(1):79-86. De acuerdo con otro ejemplo, es conocido el uso de sondas de doble globo para la implantación de un stent (véase la patente estadounidense US 5,226,889 titulada “Double balloon catheter for stent implantation"). También a modo de ejemplo, se puede mencionar el uso de catéteres de doble globo para la reconstrucción vertebral (véase el producto comercial“Stop’go Balloon Kyphoplasty’ de Joline GmbH). Existen más usos de los catéteres de doble globo, aunque no se mencionan aquí de forma explícita. Currently, various devices configured as a double balloon probe are known, although they are particularly designed for purposes very different from the one proposed in this application. For example, the use of double-balloon probes for induction of labor in pregnant women is known (see the document "Single-balloon com pared with double-balloon catheters for induction of labor: a randomized controlled triar, Salim R. et al. , Obstet Gynecol, 2011, Jul; 118 (1): 79-86 According to another example, it is known to use double balloon probes for the implantation of a stent (see US patent 5,226,889 entitled "Double balloon catheter". For example, the use of double-balloon catheters for vertebral reconstruction can also be mentioned (see the commercial product "Stop'go Balloon Kyphoplasty" by Joline GmbH). double globe, although they are not mentioned here explicitly.
Sin embargo, en ningún caso se ha propuesto el uso de una sonda de doble globo para el control del sangrado en orificios de trocar de cirugía laparoscópica intraperitoneal. El inventor de la presente solicitud describe un nuevo diseño de sonda de doble globo que permite llevar a cabo un innovador procedimiento para el control de la hemostasia en orificios de trocar en una operación laparoscópica intraperitoneal. Este nuevo procedimiento comprende fundamentalmente la introducción de la sonda de doble globo de la invención a través de un orificio del trocar que presenta un sangrado persistente de manera que los dos globos se ubican respectivamente a un lado y otro de la aponeurosis. Una vez se han hinchado los globos, éstos comprimen la aponeurosis y promueven así la hemostasia. Este novedoso procedimiento, que se describe con mayor detalle más adelante en este documento, permite controlar el sangrado de un orificio de trocar de una manera rápida y sencilla. La sonda de doble globo de la invención se diferencia de las sondas de doble globo conocidas en que presenta características y dimensiones particularmente diseñadas para el uso descrito. However, in no case has the use of a double balloon probe for the control of intraperitoneal laparoscopic surgery trocar orifice bleed. The inventor of the present application describes a new double balloon probe design that allows to carry out an innovative procedure for the control of hemostasis in trocar orifices in an intraperitoneal laparoscopic operation. This new procedure basically comprises the introduction of the double balloon probe of the invention through a trocar orifice that presents a persistent bleeding so that the two balloons are respectively located on one side and the other of the aponeurosis. Once the balloons have been inflated, they compress the aponeurosis and thus promote hemostasis. This novel procedure, which is described in greater detail later in this document, allows to control the bleeding of a trocar orifice in a quick and simple manner. The double balloon probe of the invention differs from the double balloon probes known in that presents features and dimensions particularly designed for the described use.
En este documento, los términos“ próxima G y“distar se interpretan con relación a un profesional médico que maneja el dispositivo de la invención. Es decir, el término “proximar se refiere a una posición del dispositivo cercana al profesional médico y el término“distar se refiere a una posición del dispositivo alejada del profesional médico. In this document, the terms "next G" and "distar" are interpreted in relation to a medical professional who handles the device of the invention. That is, the term "proximal refers to a device position close to the medical professional and the term" distar refers to a position of the device remote from the medical professional.
La presente invención describe un dispositivo para hemostasia de orificio de trocar intraperitoneal que comprende una sonda que tiene dos globos hinchables situados en una porción distal. La sonda comprende dos conductos, cada uno de los cuales tiene un extremo proximal abierto y un extremo distal conectado a un respectivo globo hinchable. De esta manera, un profesional médico puede hinchar o deshinchar los globos hinchables mediante la inyección o extracción de un fluido a través del extremo proximal abierto del conducto correspondiente al globo hinchable deseado. Normalmente, se utiliza un fluido inocuo tal como solución salina o similar. Hasta este punto, se ha descrito la configuración genérica de una sonda de doble globo de tipo conocido. The present invention describes a device for intraperitoneal trocar hole hemostasis comprising a probe having two inflatable balloons located in a distal portion. The probe comprises two conduits, each of which has an open proximal end and a distal end connected to a respective inflatable balloon. In this manner, a medical professional can inflate or deflate the inflatable balloons by injecting or withdrawing a fluid through the open proximal end of the conduit corresponding to the desired inflatable balloon. Normally, a harmless fluid such as saline or the like is used. Up to this point, the generic configuration of a double balloon probe of known type has been described.
El dispositivo propuesto se diferencia de los dispositivos similares actualmente conocidos por que la sonda tiene un diámetro exterior de entre 1 ,5 mm y 2,5 mm y una separación entre los dos globos hinchables de entre 2,5 mm y 3,5 mm. Estas dimensiones están particularmente diseñadas para permitir el uso de este dispositivo en el procedimiento de hemostasia descrito. The proposed device differs from similar devices currently known in that the probe has an outer diameter of between 1.5 mm and 2.5 mm and a spacing between the two inflatable balloons of between 2.5 mm and 3.5 mm. These dimensions are particularly designed to allow the use of this device in the described hemostasis procedure.
En efecto, el pequeño diámetro de la sonda de la invención permite que ésta se introduzca en un orificio de trocar de muy pequeño diámetro que está parcialmente cerrado por una sutura. Esto es importante porque, como se describe a continuación, el procedimiento para conseguir la hemostasia implica la permanencia de la sonda en el orificio del trocar durante un período de tiempo de entre 24 y 48 horas. Cuanto más estrecha sea la sonda, más estrecho es el orificio en la piel a través del cual pasa ésta, y por tanto menor es la probabilidad de que se produzcan infecciones. Indeed, the small diameter of the probe of the invention allows it to be introduced into a very small diameter trocar orifice that is partially closed by a suture. This is important because, as described below, the procedure for achieving hemostasis involves the permanence of the probe in the trocar orifice for a period of time between 24 and 48 hours. The narrower the probe, the narrower the hole in the skin through which it passes, and therefore the less likely that infections will occur.
Por otra parte, la separación entre los dos globos hinchables está particularmente configurada en función del grosor de la aponeurosis con el propósito de que, cuando el dispositivo está instalado, la aponeurosis quede comprimida entre los dos globos una vez se han hinchado. En efecto, el espesor de la aponeurosis en la zona donde se suelen realizar los orificios para la colocación de los trocares en cirugía laparoscópica intraperitoneal se encuentra dentro del orden de los 2-3 mm, por lo que la distancia entre los globos hinchables del dispositivo de la invención está particularmente dimensionada para que éstos queden justo a cada lado de la aponeurosis, comprimiéndola y deteniendo así el sangrado. On the other hand, the separation between the two inflatable balloons is particularly configured as a function of the thickness of the aponeurosis so that, when the device is installed, the aponeurosis is compressed between the two balloons a Once they have bloated. Indeed, the thickness of the aponeurosis in the area where the holes are usually made for placement of the trocars in intraperitoneal laparoscopic surgery is within the order of 2-3 mm, so the distance between the inflatable balloons of the device of the invention is particularly dimensioned so that these are just on each side of the aponeurosis, compressing it and thus stopping the bleeding.
El procedimiento para conseguir la hemostasia con el dispositivo descrito es fundamentalmente el siguiente. Una vez terminada la intervención quirúrgica laparoscópica y después de extraer los trocares, se detecta que alguno de los orificios presenta un sangrado incoercible. Se cose entonces la piel alrededor del orificio en cuestión pero se dejan los puntos sin anudar. Con los globos en estado deshinchado, se inserta la sonda a través del orificio hasta ubicar los globos hinchables uno a cada lado de la aponeurosis. Se anudan entonces los puntos para cerrar la piel alrededor de la sonda y, a continuación, se introduce un fluido a través de los respectivos conductos de la sonda para hinchar los globos. El globo situado en posición más proximal, es decir, en el lado exterior de la aponeurosis, comprime la zona del tejido celular subcutáneo, mientras que el globo situado en posición más distal, es decir, en el lado interior de la aponeurosis, comprime la zona muscular y pre-peritoneal. El dispositivo se mantiene en esta posición con los globos hinchados comprimiendo la aponeurosis durante un período de entre 24 y 48 horas. Durante este intervalo de tiempo, la presión de hinchado de los globos provoca la hemostasia tanto de la propia aponeurosis como de las capas adyacentes. Finalmente, el profesional médico deshincha los globos mediante la extracción del fluido que rellena los globos a través de los conductos de la sonda, y a continuación tira del extremo proximal de la sonda para extraer el dispositivo. Dado el pequeño diámetro de la sonda, tanto la piel como la aponeurosis quedan prácticamente cerradas. Se trata de un procedimiento rápido y sencillo que puede ser llevado a cabo con el sencillo dispositivo de la invención. The procedure for achieving hemostasis with the described device is fundamentally the following. Once the laparoscopic surgery is finished and after the trocars are removed, it is detected that some of the orifices present an incoercible bleeding. The skin is then stitched around the hole in question but the stitches are left untied. With the balloons in a deflated state, the probe is inserted through the hole until the inflatable balloons are placed one on each side of the aponeurosis. The stitches are then knotted to close the skin around the probe, and then a fluid is introduced through the respective conduits of the probe to inflate the balloons. The balloon located more proximally, that is, on the outer side of the aponeurosis, compresses the area of the subcutaneous cellular tissue, while the balloon located more distally, that is, on the inner side of the aponeurosis, compresses the muscle and pre-peritoneal zone. The device is held in this position with the balloons compressed compressing the aponeurosis for a period of between 24 and 48 hours. During this time interval, the inflation pressure of the balloons causes haemostasis of both the aponeurosis itself and the adjacent layers. Finally, the medical professional deflates the balloons by removing the fluid that fills the balloons through the tubes of the probe, and then pulls the proximal end of the probe to remove the device. Given the small diameter of the probe, both the skin and the aponeurosis are practically closed. It is a quick and simple procedure that can be carried out with the simple device of the invention.
En una realización particularmente preferida de la invención, los globos hinchables tienen una forma achatada. Es decir, los globos hinchables tienen un diámetro mayor dentro de un plano perpendicular a la dirección general de la sonda. Esto ayuda a que la presión ejercida sobre la aponeurosis cubra una mayor superficie de la misma en la zona circundante al orificio, mejorando así el efecto hemostático. Además, disminuye la deformación que sufren las capas donde alojan los globos, concretamente la piel y tejido subcutáneo, en el exterior de la aponeurosis, y la zona muscular y pre- peritoneal, en el interior de la aponeurosis. In a particularly preferred embodiment of the invention, the inflatable balloons have a flattened shape. That is, the inflatable balloons have a larger diameter within a plane perpendicular to the general direction of the probe. This helps the pressure exerted on the aponeurosis cover a greater area of the aponeurosis in the area surrounding the orifice, thus improving the hemostatic effect. In addition, it diminishes the deformation suffered by the layers where the balloons lodge, specifically the skin and subcutaneous tissue, on the outside of the aponeurosis, and the muscular and pre-peritoneal area, inside the aponeurosis.
En otra realización preferida, los globos y/o la porción distal de la sonda están impregnados con una sustancia antihemorrágica. Así, cuando el dispositivo de la invención se introduce a través del orificio de trocar, esta sustancia antihemorrágica entra en contacto con los tejidos del abdomen del paciente, promoviendo así la hemostasia. In another preferred embodiment, the balloons and / or the distal portion of the probe are impregnated with an anti-hemorrhagic substance. Thus, when the device of the invention is introduced through the trocar orifice, this anti-hemorrhagic substance comes into contact with the tissues of the patient's abdomen, thus promoting hemostasis.
En principio, podría utilizarse cualquier sustancia antihemorrágica que pueda ser aplicada a la superficie exterior de los globos y/o de la porción distal de la sonda, aunque de acuerdo con una realización particularmente preferida de la invención la sustancia antihemorrágica es celulosa oxidada. In principle, any anti-haemorrhagic substance that can be applied to the outer surface of the balloons and / or the distal portion of the probe could be used, although according to a particularly preferred embodiment of the invention the anti-haemorrhagic substance is oxidized cellulose.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
La Fig. 1 muestra una vista esquemática de un ejemplo de dispositivo de acuerdo con la presente invención con los globos en estado deshinchado. Fig. 1 shows a schematic view of an example of a device according to the present invention with the balloons in the deflated state.
La Fig. 2 muestra una vista esquemática del ejemplo de dispositivo de la invención de la Fig. 1 con los globos en estado hinchado. Fig. 2 shows a schematic view of the example device of the invention of Fig. 1 with the balloons in the inflated state.
La Fig. 3 muestra una vista ampliada de la porción distal de otro ejemplo de dispositivo según la invención donde la porción distal de la sonda y los globos hinchables están recubiertos por una sustancia antihemorrágica. Fig. 3 shows an enlarged view of the distal portion of another example of device according to the invention where the distal portion of the probe and the inflatable balloons are coated with an anti-hemorrhagic substance.
La Fig. 4 muestra una sección esquemática del tejido abdominal de un paciente atravesado por un orificio de trocar. Fig. 4 shows a schematic section of the abdominal tissue of a patient traversed by a trocar orifice.
La Fig. 5 muestra una sección esquemática de tejido abdominal con el ejemplo de dispositivo de la invención dispuesto para provocar la hemostasia. Fig. 5 shows a schematic section of abdominal tissue with the example of device of the invention arranged to cause hemostasis.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN Se describe a continuación un ejemplo de realización de la presente invención haciendo referencia a las figuras adjuntas. PREFERRED EMBODIMENT OF THE INVENTION An exemplary embodiment of the present invention is described below referring to the attached figures.
Las Figs. 1-2 muestran esquemáticamente el dispositivo (1) de la presente invención formado por una sonda (2) en cuya porción distal hay dos globos (3a, 3b) hinchables. Aunque no se aprecia de manera explícita en las figuras, la sonda (2) tiene dos conductos paralelos internos que conectan respectivamente un primer orificio proximal de entrada con un primer globo (3a) proximal y un segundo orificio proximal de entrada con un segundo globo (3b). De ese modo, un profesional médico puede hinchar/deshinchar selectivamente el primer globo (3a) o el segundo globo (3b) mediante la inyección de un fluido a través del primer orificio proximal de entrada o el segundo orificio proximal de entrada. La sonda (2) de este ejemplo de dispositivo (1) tiene un diámetro de 2 mm, y la distancia entre los dos globos (3a, 3b) es de 3 mm. Además, como se aprecia en las Figs. 1-2, los globos (3a, 3b) tienen una forma algo achatada para incrementar la superficie de la aponeurosis (AP) que recibe el efecto de compresión, y para disminuir el volumen de los globos (3a, 3b) alojado en el interior de las capas circundantes a la aponeurosis (AP). Figs. 1-2 show schematically the device (1) of the present invention formed by a probe (2) in whose distal portion there are two inflatable balloons (3a, 3b). Although not shown explicitly in the figures, the probe (2) has two internal parallel conduits connecting respectively a first proximal inlet hole with a first proximal balloon (3a) and a second proximal inlet with a second balloon ( 3b). Thus, a medical professional can selectively inflate / deflate the first balloon (3a) or the second balloon (3b) by injecting a fluid through the first proximal entry orifice or the second proximal entry orifice. The probe (2) of this example device (1) has a diameter of 2 mm, and the distance between the two balloons (3a, 3b) is 3 mm. In addition, as seen in Figs. 1-2, the balloons (3a, 3b) have a somewhat flattened shape to increase the surface of the aponeurosis (AP) that receives the compression effect, and to decrease the volume of the balloons (3a, 3b) housed inside from the layers surrounding the aponeurosis (AP).
La Fig. 3 muestra una configuración del dispositivo (1) de la invención donde la porción distal de la sonda (2) y los dos globos (3a, 3b) están recubiertos por una sustancia antihemorrágica, en este caso celulosa oxidada. Fig. 3 shows a configuration of the device (1) of the invention where the distal portion of the probe (2) and the two balloons (3a, 3b) are coated with an anti-hemorrhagic substance, in this case oxidized cellulose.
El uso de este nuevo dispositivo es por tanto como sigue. Después de la retirada del trocar, en la pared abdominal del paciente queda un orificio (O) como el mostrado en la Fig. 4. Este orificio (O) atraviesa todas las capas de la pared abdominal en este punto, concretamente de fuera a dentro, la piel (P), el tejido subcutáneo (TS), la aponeurosis (AP), el músculo (M), y el peritoneo (PR). Para favorecer la hemostasia en este orificio (O), se introduce el dispositivo (1) de la invención con los globos (3a, 3b) hinchables en estado deshinchado hasta posicionar el primer globo (3a) proximal en el lado exterior de la aponeurosis (AP) y el segundo globo (3b) distal en el lado interior de la aponeurosis (AP). La distancia entre ambos globos (3a, 3b), como se ha mencionado anteriormente, es de 3 mm, y el espesor de la aponeurosis (AP) en este punto es también de aproximadamente 2-3 mm. En este momento, el profesional médico aprieta unos puntos de cierre fijados al principio del procedimiento en la porción de piel (P) circundante al orificio (O). Entonces, el profesional médico inyecta un fluido adecuado a través de los orificios proximales de los conductos correspondientes de la sonda (2) y provoca el hinchado de los globos (3a, 3b), de modo que éstos comprimen la porción de aponeurosis (AP) intercalada entre ambos. El hinchado de los globos (3a, 3b) comprime además el tejido subcutáneo (TS) y la piel (P), situados por encima de la aponeurosis (AP), y el músculo (M) y el peritoneo (PR), situados por debajo de la aponeurosis (AP). La situación en este punto se muestra en la Fig. 5. Como consecuencia de la compresión generalizada de la porción de tejido cercana al orificio, se promueve la hemostasia. El dispositivo (1) se mantiene hinchado en el interior de la pared abdominal durante 24 o 48 horas. Una vez transcurrido ese tiempo, con la hemostasia ya completamente consolidada, el profesional médico deshincha los globos (3a, 3b) mediante la extracción del líquido a través los orificios proximales de los respectivos conductos de la sonda (2). Una vez deshinchados, el profesional médico tira desde el extremo proximal de la sonda (2) para extraerla completamente del orificio (O). Gracias a su muy pequeño diámetro de 2 mm, el orificio (O) queda a efectos prácticos cerrado. The use of this new device is therefore as follows. After removal of the trocar, an orifice (O) is left in the patient's abdominal wall as shown in Fig. 4. This orifice (O) passes through all the layers of the abdominal wall at this point, specifically from the outside to the inside. , skin (P), subcutaneous tissue (TS), aponeurosis (AP), muscle (M), and peritoneum (PR). To favor hemostasis in this hole (O), the device (1) of the invention is introduced with the inflatable balloons (3a, 3b) in a deflated state until the first proximal balloon (3a) is positioned on the outer side of the aponeurosis ( AP) and the second balloon (3b) distal on the inner side of the aponeurosis (AP). The distance between both globes (3a, 3b), as mentioned above, is 3 mm, and the thickness of the aponeurosis (AP) at this point is also about 2-3 mm. At this time, the medical professional tightens closing points fixed at the beginning of the procedure on the skin portion (P) surrounding the hole (O). Then, the medical professional injects adequate fluid through the proximal orifices of the ducts of the probe (2) and causes the balloons to swell (3a, 3b), so that they compress the aponeurosis (AP) portion interspersed between them. The inflation of the balloons (3a, 3b) also compresses the subcutaneous tissue (TS) and the skin (P), located above the aponeurosis (AP), and the muscle (M) and the peritoneum (PR), situated by under the aponeurosis (AP). The situation at this point is shown in Fig. 5. As a consequence of the generalized compression of the tissue portion near the hole, hemostasis is promoted. The device (1) remains inflated inside the abdominal wall for 24 or 48 hours. Once that time has elapsed, with the hemostasis already fully consolidated, the medical professional deflates the balloons (3a, 3b) by extracting the liquid through the proximal orifices of the respective conduits of the probe (2). Once deflated, the medical professional pulls from the proximal end of the probe (2) to extract it completely from the hole (O). Thanks to its very small diameter of 2 mm, the hole (O) is closed for practical purposes.
INVENCIÓN 2  INVENTION 2
Instrumento laparoscópico para realización de funduplicatura en cirugía de reflujo gastroesofágico Laparoscopic instrument for performing fundoplication in gastroesophageal reflux surgery
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención pertenece de manera general al campo de la medicina, y más particularmente a la cirugía de reflujo gastroesofágico The present invention belongs in a general way to the field of medicine, and more particularly to gastroesophageal reflux surgery
El objeto de la presente invención es un nuevo instrumento laparoscópico que facilita la realización de la funduplicatura en una operación de cirugía de reflujo gastroesofágico. The object of the present invention is a new laparoscopic instrument that facilitates the completion of the fundoplication in a gastroesophageal reflux surgery operation.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
La enfermedad del reflujo gastroesofágico (ERGE) aparece cuando el esfínter esofágico inferior (EEI), válvula que controla el paso de contenido del esófago hacia el estómago, está alterada o se relaja de forma inadecuada, permitiendo que el contenido vuelva a pasar al esófago e irritando así la mucosa. El tratamiento quirúrgico de la enfermedad del reflujo gastroesofágico se realiza actualmente por vía laparoscópica, ya que ello permite un más fácil abordaje y una reducción la tasa de complicaciones post-operatorias. La técnica quirúrgica actualmente más empleada, o técnica de Nissen, implica la realización de una funduplicatura gástrica alrededor del esófago. En esta técnica, en primer lugar se hace pasar el fundus gástrico (FG) a través del túnel retroesofágico (TR) para rodear el esófago (E) por detrás (Figs. 6a-6c). A continuación, como se aprecia en la Fig. 6d, se cose el fundus gástrico (FG) al propio estómago (ES). La boca del estómago (ES) queda así comprimida por la porción de estómago (ES) que la rodea, facilitando así la función de cierre del esfínter esofágico inferior y dificultando el retorno al esófago (E) del contenido del estómago (ES). Gastroesophageal reflux disease (GERD) occurs when the lower esophageal sphincter (LES), a valve that controls the passage of contents of the esophagus into the stomach, is altered or is inappropriately relaxed, allowing the content to pass back into the esophagus. thus irritating the mucosa. The surgical treatment of gastroesophageal reflux disease is currently performed laparoscopically, since this allows a more easy approach and a reduction in the rate of post-operative complications. The surgical technique currently used, or Nissen technique, involves the realization of a gastric fundoplication around the esophagus. In this technique, the gastric fundus (FG) is first passed through the retroesophageal tunnel (TR) to surround the esophagus (E) from behind (Figs 6a-6c). Then, as shown in Fig. 6d, the gastric fundus (FG) is stitched to the stomach itself (ES). The mouth of the stomach (ES) is thus compressed by the stomach portion (ES) that surrounds it, thus facilitating the function of closing the lower esophageal sphincter and making it difficult to return to the esophagus (E) of the stomach contents (ES).
Actualmente, para realizar esta operación se utilizan fundamentalmente los siguientes instrumentos la paroscópicos: en primer lugar, un retractor (R) para abrir el túnel retroesofágico (TR); en segundo lugar, unas pinzas (P) para agarrar el fundus gástrico (FG) y tirar de él a través del túnel retroesofágico (TR); y finalmente instrumentos de sutura (I) para suturar el fundus gástrico (FG) al resto del estómago (ES). Currently, to perform this operation, the following paroscopic instruments are fundamentally used: first, a retractor (R) to open the retroesophageal tunnel (TR); second, tweezers (P) to grasp the gastric fundus (FG) and pull it through the retroesophageal tunnel (TR); and finally suture instruments (I) to suture the gastric fundus (FG) to the rest of the stomach (ES).
El paso más complicado en este tipo de intervenciones es el de hacer pasar el fundus gástrico (FG) a través del túnel retroesofágico (TR). En efecto, utilizando pinzas (P) rectas de propósito general resulta complicado llegar hasta la posición donde se encuentra el fundus gástrico (FG), ya que es necesario pasar por detrás del esófago (E) y apartar gran cantidad de tejidos. Además, el agarre mediante las pinzas (P) puede no ser lo suficientemente firme al realizar la tracción y como consecuencia el fundus gástrico (FG) puede soltarse, obligando a comenzar de nuevo la operación. La realización de la funduplicatura es particularmente difícil en determinadas circunstancias tales como pacientes obesos, reintervenciones, etc. The most complicated step in this type of intervention is to pass the gastric fundus (FG) through the retroesophageal tunnel (TR). In fact, using straightforward (P) forceps of general purpose, it is difficult to reach the position where the gastric fundus (FG) is located, since it is necessary to pass behind the esophagus (E) and set aside a large number of tissues. In addition, the grip by means of the forceps (P) may not be firm enough when performing the traction and as a consequence the gastric fundus (FG) may be released, forcing the operation to start again. The completion of fundoplication is particularly difficult in certain circumstances such as obese patients, reoperations, etc.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
La presente invención resuelve los problemas anteriores gracias a un nuevo instrumento laparoscópico particularmente diseñado para este propósito que facilita enormemente tanto llegar hasta el fundus gástrico tras pasar por el túnel retroesofágico, como agarrar con seguridad el fundus gástrico para tirar de él. En este documento, los términos“proximar y“distar tienen el significado habitual de estos términos en el campo de la medicina. Concretamente, el término“distar hace referencia a un elemento o porción del instrumento de la invención situado más lejos de la persona que maneja el instrumento, mientras que el término“proximar hace referencia a un elemento o porción del instrumento de la invención situado más cerca de la persona que maneja el instrumento. The present invention solves the above problems thanks to a new laparoscopic instrument particularly designed for this purpose that greatly facilitates reaching both the gastric fundus after passing through the retroesophageal tunnel, and grasping the gastric fundus securely to pull it. In this document, the terms "proximar and" distar have the usual meaning of these terms in the field of medicine. Specifically, the term "distar" refers to an element or portion of the instrument of the invention located farther from the person who handles the instrument, while the term "proximal refers to an element or portion of the instrument of the invention located closer of the person who operates the instrument.
La presente invención describe un instrumento laparoscópico para realización de funduplicatura en cirugía de reflujo gastroesofágico. El instrumento comprende un vástago que tiene un extremo distal y un extremo proximal, y presenta las siguientes particularidades: a) El extremo distal del vástago comprende un orificio de ojal. The present invention describes a laparoscopic instrument for performing fundoplication in gastroesophageal reflux surgery. The instrument comprises a shank having a distal end and a proximal end, and has the following features: a) The distal end of the shank comprises an eyelet hole.
En este contexto, un orificio de ojal hace referencia a un orificio adecuado para hacer pasar a través del mismo un hilo de sutura convencional. La presencia de este orificio permitirá fijar el fundus gástrico al extremo distal del vástago del instrumento de la invención a través de un punto de sutura. De ese modo, se asegura que el fundus gástrico no se desprenda cuando se realiza tracción sobre el mismo durante su paso a través del túnel retroesofágico. b) El vástago comprende un mecanismo configurado para curvar una porción curvable del vástago, de modo que el vástago puede alternar entre una configuración recta y una configuración curvada. In this context, an eyelet hole refers to a suitable hole for passing a conventional suture thread therethrough. The presence of this hole will allow the gastric fundus to be fixed to the distal end of the stem of the instrument of the invention through a suture point. In this way, it is ensured that the gastric fundus does not detach when traction is made on it during its passage through the retroesophageal tunnel. b) The shank comprises a mechanism configured to bend a bendable portion of the shank, so that the shank can alternate between a straight configuration and a curved configuration.
El mecanismo de curvado del vástago puede ser en principio de cualquier tipo conocido en la técnica. A modo de ejemplo, puede hacerse referencia a mecanismos basados en hilos dispuestos a lo largo del interior del vástago para provocar el curvado del vástago cuando se aplica tensión sobre los mismos. En cualquier caso, sería posible utilizar cualquier otro tipo de mecanismo conocido en la técnica que permita hacer pasar el vástago de una configuración recta a una configuración curvada y viceversa. Los documentos US20090171161 , US8721630 o US9668720 constituyen ejemplos de mecanismos diseñados para curvar un instrumento endoscópico. Preferentemente, el mecanismo para curvar la porción curvable de este instrumento comprende un medio de accionamiento ubicado en su extremo proximal, de modo que el cirujano puede hacer accionarlo para hacer alternar el vástago entre una configuración recta y una configuración curvada cuando sea necesario durante el procedimiento quirúrgico. Por ejemplo, el medio de accionamiento puede adoptar la forma de una rueda giratoria o un gatillo. The bending mechanism of the rod can in principle be of any type known in the art. By way of example, reference may be made to mechanisms based on wires disposed along the inside of the stem to cause the stem to bend when tension is applied thereto. In any case, it would be possible to use any other type of mechanism known in the art that allows the rod to pass from a straight configuration to a curved configuration and vice versa. Documents US20090171161, US8721630 or US9668720 are examples of mechanisms designed to bend an endoscopic instrument. Preferably, the mechanism for bending the curved portion of this instrument comprises an actuating means located at its proximal end, so that the surgeon can actuate it to alternate the stem between a straight configuration and a curved configuration when necessary during the procedure surgical. For example, the driving means may take the form of a rotating wheel or a trigger.
Por otra parte, la porción curvable puede curvarse de cualquier modo, por ejemplo mediante una curvatura esencialmente constante a lo largo de la porción curvable, o bien a través de uno o más codos puntuales intercalados entre porciones sustancialmente rectas de la porción curvable. En una realización particularmente preferida de la invención, la porción curvable está configurada para curvarse en dos puntos concretos. Esta configuración es ventajosa porque permite que el tramo que pasa a través del túnel retroesofágico sea sustancialmente recto. On the other hand, the bendable portion may be bent in any way, for example by an essentially constant curvature along the bendable portion, or through one or more point elbows interspersed between substantially straight portions of the bendable portion. In a particularly preferred embodiment of the invention, the bendable portion is configured to curl at two specific points. This configuration is advantageous because it allows the section passing through the retroesophageal tunnel to be substantially straight.
De acuerdo con otra realización preferida de la invención, la porción curvable del vástago está situada en una porción distal de dicho vástago que abarca la mitad más distal de su longitud o, más preferentemente, el tercio más distal de su longitud. Se ha comprobado que esta posición de la porción curvable es idónea para la realización del procedimiento quirúrgico descrito anteriormente, ya que durante su realización únicamente la porción distal del vástago se introduce a través del túnel retroesofágico. According to another preferred embodiment of the invention, the curvable portion of the stem is located in a distal portion of said stem that spans the most distal half of its length or, more preferably, the most distal third of its length. It has been found that this position of the curved portion is suitable for performing the surgical procedure described above, since during its realization only the distal portion of the stem is introduced through the retroesophageal tunnel.
De acuerdo con otra realización preferida de la invención, la porción curvable está configurada para curvarse un ángulo de entre 15° y 90°, más preferentemente entre 20° y 45°, y aún más preferentemente entre 25° y 35°. Se ha comprobado también que este rango de curvaturas es idóneo para que la porción más distal del instrumento rodee esófago del paciente, quedando el extremo distal a la vista para su fijación al fundus gástrico. According to another preferred embodiment of the invention, the bendable portion is configured to bend an angle of between 15 ° and 90 °, more preferably between 20 ° and 45 °, and even more preferably between 25 ° and 35 °. It has also been proven that this range of curvatures is ideal for the most distal portion of the instrument to surround the patient's esophagus, leaving the distal end in view for attachment to the gastric fundus.
Este nuevo instrumento permite realizar mucho más fácilmente el procedimiento quirúrgico descrito con anterioridad en este documento. Concretamente, en primer lugar el cirujano introduce, con ayuda de un retractor, el instrumento de la invención en su configuración recta a través del túnel retroesofágico. A continuación, el cirujano acciona el medio de accionamiento ubicado en el extremo proximal del instrumento de la invención, provocando la aparición de una curva en una porción distal del instrumento. Como consecuencia, el extremo distal es mucho más fácilmente visible por el lado opuesto del esófago, junto al ángulo de his del estómago del paciente, independientemente de las dificultades que plantee la anatomía del paciente particular. El cirujano utiliza entonces un instrumento auxiliar para dar un punto de sutura al fundus gástrico del paciente y hacer pasar el hilo a través del orificio de ojal del extremo distal del instrumento de la invención. Una vez anudado el hilo, el fundus gástrico queda fijado de manera completamente segura al instrumento de la invención, de modo que es posible tirar del mismo para hacer pasar el fundus gástrico a través del túnel retroesofágico. Durante esta operación, el cirujano utiliza el medio de accionamiento para hacer pasar el instrumento de nuevo a su configuración recta. Una vez el fundus gástrico ha pasado a través del túnel retroesofágico, se procede a coserlo al resto del estómago de una manera similar a como se realiza actualmente. This new instrument makes it much easier to perform the surgical procedure described earlier in this document. Specifically, first the surgeon introduces, with the help of a retractor, the instrument of the invention in its straight configuration through the retroesophageal tunnel. Next, the surgeon actuates the drive means located at the proximal end of the instrument of the invention, causing the appearance of a curve in a distal portion of the instrument. As a consequence, the distal end is much more easily visible on the opposite side of the esophagus, next to the angle of the stomach of the patient, regardless of the difficulties posed by the anatomy of the particular patient. The surgeon then uses an auxiliary instrument to give a suture point to the gastric fundus of the patient and to pass the thread through the eyelet hole of the distal end of the instrument of the invention. Once the thread is knotted, the gastric fundus is fixed completely securely to the instrument of the invention, so that it is possible to pull it to pass the gastric fundus through the retroesophageal tunnel. During this operation, the surgeon uses the actuating means to move the instrument back to its straight configuration. Once the gastric fundus has passed through the retroesophageal tunnel, it is proceeded to be sewn to the rest of the stomach in a similar way to how it is currently performed.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
Las Figs. 6a-6d muestran esquemáticamente los pasos principales de una operación de cirugía de reflujo gastroesofágico convencional. Figs. 6a-6d schematically show the main steps of a conventional gastroesophageal reflux surgery operation.
La Fig. 7 muestra una vista esquemática del instrumento de la presente invención en su configuración recta. Fig. 7 shows a schematic view of the instrument of the present invention in its straight configuration.
La Fig. 8 muestra una vista esquemática del instrumento de la presente invención en su configuración curvada. Fig. 8 shows a schematic view of the instrument of the present invention in its curved configuration.
Las Figs. 9a-9f muestran esquemáticamente los pasos principales de una operación de cirugía de reflujo gastroesofágico realizada utilizando el instrumento de la presente invención. Figs. 9a-9f schematically show the main steps of a gastroesophageal reflux surgery performed using the instrument of the present invention.
REALIZACIÓN PREFERENTE DE LA SEGUNDA INVENCIÓN PREFERRED EMBODIMENT OF THE SECOND INVENTION
Se describe a continuación un ejemplo de instrumento laparoscópico de acuerdo con la presente invención haciendo referencia a las figuras adjuntas. Las Figs. 7 y 8 muestran un ejemplo de instrumento (1) según la presente invención respectivamente en su configuración recta y su configuración curvada. El instrumento (1) está formado fundamentalmente por un vástago (2) que tiene un extremo distal (ED) y un extremo proximal (EP). En el extremo proximal (EP), el instrumento (1) comprende un medio (4) de accionamiento de un mecanismo ubicado en el interior del vástago (2), que no se muestra este documento, y que permite hacerlo alterna entre la configuración recta de la Fig. 7 y la configuración curvada de la Fig. 8. El curvado del vástago (2a) se produce en una porción curvable (2a) que en este ejemplo está ubicada en la mitad más distal del vástago (2). Concretamente, en este ejemplo la porción curvable (2a) del vástago (2) se curva a través de dos codos puntuales. Por otro lado, en el extremo distal (ED), el instrumento (1) comprende un orificio (3) de ojal. An example of a laparoscopic instrument according to the present invention is described below with reference to the attached figures. Figs. 7 and 8 show an example of instrument (1) according to the present invention respectively in its straight configuration and its curved configuration. The instrument (1) is essentially formed by a rod (2) having a distal end (ED) and a proximal end (EP). At the proximal end (EP), the instrument (1) comprises a means (4) for actuating a mechanism located inside the stem (2), which is not shown in this document, and which allows it to be alternated between the straight configuration of Fig. 7 and the curved configuration of Fig. 8. The curving of the shank (2a) occurs in a curved portion (2a) which in this example is located in the most distal half of the shank (2). Specifically, in this example the curved portion (2a) of the shank (2) is bent through two point elbows. On the other hand, at the distal end (ED), the instrument (1) comprises an eyelet hole (3).
Las Figs. 9a-9f muestran esquemáticamente los pasos principales de una operación quirúrgica de reflujo gastroesofágico realizada usando el instrumento (1) de la invención. En primer lugar, como se muestra en la Fig. 9a, se hace pasar el extremo distal (ED) del instrumento (1) en su configuración recta a través del túnel retroesofágico (TR). A continuación, como se aprecia en la Fig. 9b, el cirujano acciona el medio (4) de accionamiento para provocar el curvado de la porción curvable (2a) del vástago (2) haciendo así pasar el instrumento (1) de la configuración recta a la configuración curvada. Esto facilita enormemente la visibilidad del extremo distal (ED) del vástago (2) junto al ángulo de His del estómago (E) del paciente. Entonces, como se muestra en la Fig. 9c, el cirujano anuda el fundus gástrico (FG) del estómago (E) del paciente al orificio (3) de ojal mediante la aplicación de un punto de sutura. El fundus gástrico (FG) queda así firmemente fijado al instrumento (1) de la invención, de modo que el cirujano puede traccionar del instrumento (1) para tirar del fundus gástrico (FG) hasta hacerlo pasar a través del túnel retroesofágico (TR). Durante esta operación, mostrada en las Figs. 9e-9f, el cirujano acciona de nuevo el medio (4) de accionamiento para hacer pasar el instrumento (1) a su configuración recta. Una vez el fundus gástrico (FG) ha pasado a través del túnel retroesofágico (TR), como se aprecia en la Fig. 9f, el cirujano lo cose para fijarlo al resto del estómago (E) de un modo similar al convencional. CLÁUSULAS Figs. 9a-9f show schematically the main steps of a gastroesophageal reflux surgery performed using the instrument (1) of the invention. First, as shown in Fig. 9a, the distal end (ED) of the instrument (1) is passed in its straight configuration through the retroesophageal tunnel (TR). Then, as seen in Fig. 9b, the surgeon drives the drive means (4) to cause the bending of the curvable portion (2a) of the shank (2) thereby passing the instrument (1) of the straight configuration to the curved configuration. This greatly facilitates the visibility of the distal end (ED) of the stem (2) next to the angle of His of the stomach (E) of the patient. Then, as shown in Fig. 9c, the surgeon ties the gastric fundus (FG) of the stomach (E) of the patient to the eyelet hole (3) by applying a suture point. The gastric fundus (FG) is thus firmly fixed to the instrument (1) of the invention, so that the surgeon can pull the instrument (1) to pull the gastric fundus (FG) until it passes through the retroesophageal tunnel (TR) . During this operation, shown in Figs. 9e-9f, the surgeon drives the drive means (4) again to move the instrument (1) to its straight configuration. Once the gastric fundus (FG) has passed through the retroesophageal tunnel (TR), as shown in Fig. 9f, the surgeon sews it to fix it to the rest of the stomach (E) in a similar way to the conventional one. CLAUSES
1. Instrumento (1) laparoscópico para realización de funduplicatura en cirugía de reflujo gastroesofágico que comprende un vástago (2) que tiene un extremo distal (ED) y un extremo proximal (EP), caracterizado por que: 1. Laparoscopic instrument (1) for performing fundoplication in gastroesophageal reflux surgery comprising a stem (2) having a distal end (ED) and a proximal end (EP), characterized in that:
- el extremo distal (ED) del vástago (1) comprende un orificio (3) de ojal; y - the distal end (ED) of the stem (1) comprises an eyelet hole (3); Y
- el vástago (1) comprende un mecanismo configurado para curvar una porción curvable (2a) del vástago (2), de modo que el vástago (2) puede alternar entre una configuración recta y una configuración curvada. - the shank (1) comprises a mechanism configured to bend a curved portion (2a) of the shank (2), so that the shank (2) can alternate between a straight configuration and a curved configuration.
2. Instrumento (1) de acuerdo con la cláusula 1 , donde el mecanismo para curvar la porción curvable (2a) comprende un medio (4) de accionamiento ubicado en el extremo proximal del instrumento (1). 3. Instrumento (1) de acuerdo con cualquiera de las cláusulas anteriores, donde la porción curvable (2a) está configurada para curvarse en dos puntos. 2. Instrument (1) according to clause 1, wherein the mechanism for bending the curved portion (2a) comprises a drive means (4) located at the proximal end of the instrument (1). 3. Instrument (1) according to any of the preceding clauses, wherein the bending portion (2a) is configured to be bent at two points.
4. Instrumento (1) de acuerdo con cualquiera de las cláusulas anteriores, donde la porción curvable (2a) del vástago (2) está situada en una porción distal de dicho vástago (2) que abarca la mitad más distal de su longitud. 4. Instrument (1) according to any of the preceding clauses, wherein the curvable portion (2a) of the shank (2) is located in a distal portion of said shank (2) that spans the most distal half of its length.
5. Instrumento (1) de acuerdo con la cláusula 4, donde la porción distal del vástago (1) abarca el tercio más distal de su longitud. 6. Instrumento (1) de acuerdo con cualquiera de las cláusulas anteriores, donde la porción curvable (2a) está configurada para curvarse un ángulo de entre 15° y 90°. 5. Instrument (1) according to clause 4, wherein the distal portion of the stem (1) covers the most distal third of its length. 6. Instrument (1) according to any of the preceding clauses, wherein the curved portion (2a) is configured to bend an angle between 15 ° and 90 °.
7. Instrumento (1) de acuerdo con la cláusula 6, donde la porción curvable (2a) está configurada para curvarse un ángulo de entre 20° y 45°. 7. Instrument (1) according to clause 6, wherein the bendable portion (2a) is configured to bend an angle between 20 ° and 45 °.
8. Instrumento (1) de acuerdo con la cláusula 7, donde la porción curvable (2a) está configurada para curvarse un ángulo de entre 25° y 35°. 8. Instrument (1) according to clause 7, wherein the bending portion (2a) is configured to bend an angle between 25 ° and 35 °.

Claims

REIVINDICACIONES
1. Dispositivo (1) para hemostasia de orificio de trocar intraperitoneal, que comprende una sonda (2) que tiene dos globos (3a, 3b) hinchables situados en una porción distal, donde la sonda (2) comprende dos conductos que tienen un extremo proximal abierto y un extremo distal conectado a un respectivo globo (3a, 3b) hinchable, caracterizado por que la sonda (2) tiene un diámetro exterior de entre 1 ,5 mm y 2,5 mm y por que una separación entre los dos globos (3a, 3b) hinchables es de entre 2,5 mm y 3,5 mm. Device (1) for hemostasis of intraperitoneal trocar orifice, comprising a probe (2) having two inflatable balloons (3a, 3b) located in a distal portion, where the probe (2) comprises two conduits having one end open proximal and a distal end connected to a respective inflatable balloon (3a, 3b), characterized in that the probe (2) has an outer diameter of between 1, 5 mm and 2.5 mm and that a separation between the two balloons (3a, 3b) inflatable is between 2.5 mm and 3.5 mm.
2. Dispositivo (1) de acuerdo con la reivindicación 1 , donde los globos (3a, 3b) tienen una forma achatada. Device (1) according to claim 1, wherein the balloons (3a, 3b) have a flattened shape.
3. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde los globos (3a, 3b) y/o la porción distal de la sonda (2) están impregnados con una sustancia antihemorrágica. Device (1) according to any one of the preceding claims, wherein the balloons (3a, 3b) and / or the distal portion of the probe (2) are impregnated with an anti-hemorrhagic substance.
4. Dispositivo (1) de acuerdo con la reivindicación 3, donde la sustancia antihemorrágica es celulosa oxidada. 4. Device (1) according to claim 3, wherein the anti-hemorrhagic substance is oxidized cellulose.
PCT/ES2018/070821 2017-12-20 2018-12-20 Device for haemostasis of an intraperitoneal trocar orifice WO2019122487A1 (en)

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Application Number Priority Date Filing Date Title
ES201731557U ES1203693Y (en) 2017-12-20 2017-12-20 Device for intraperitoneal trocar orifice hemostasis
ESU201731557 2017-12-20
ES201731610U ES1204712Y (en) 2017-12-28 2017-12-28 Laparoscopic instrument for performing fundoplication in gastroesophageal reflux surgery
ESU201731610 2017-12-28

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Citations (6)

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US3411506A (en) * 1966-04-11 1968-11-19 Velasco Adolfo Guevara Method and apparatus for hemostasis
US4836204A (en) * 1987-07-06 1989-06-06 Landymore Roderick W Method for effecting closure of a perforation in the septum of the heart
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US20150342641A1 (en) * 2007-02-09 2015-12-03 Michael A. Belfort Balloon tamponade

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB846779A (en) * 1957-11-08 1960-08-31 Vincent Joseph Oddo Improvements in haemostatic catheter
US3154077A (en) * 1962-06-04 1964-10-27 Joseph P Cannon Hemostatic device for anal surgery
US3411506A (en) * 1966-04-11 1968-11-19 Velasco Adolfo Guevara Method and apparatus for hemostasis
US4836204A (en) * 1987-07-06 1989-06-06 Landymore Roderick W Method for effecting closure of a perforation in the septum of the heart
FR2659239A1 (en) * 1990-03-12 1991-09-13 Lefebvre Jean Marie Percutaneous vascular obturator
US20150342641A1 (en) * 2007-02-09 2015-12-03 Michael A. Belfort Balloon tamponade

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