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WO2019122487A1 - Dispositif pour hémostasie d'orifice de trocart intrapéritonéal - Google Patents

Dispositif pour hémostasie d'orifice de trocart intrapéritonéal 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
Authority
WO
WIPO (PCT)
Prior art keywords
probe
instrument
balloons
aponeurosis
balloon
Prior art date
Application number
PCT/ES2018/070821
Other languages
English (en)
Spanish (es)
Inventor
Francisco Javier PÉREZ LARA
Original Assignee
Servicio Andaluz De Salud
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from ES201731557U external-priority patent/ES1203693Y/es
Priority claimed from ES201731610U external-priority patent/ES1204712Y/es
Application filed by Servicio Andaluz De Salud filed Critical Servicio Andaluz De Salud
Publication of WO2019122487A1 publication Critical patent/WO2019122487A1/fr

Links

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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif pour l'hémostasie d'un orifice de trocart intrapéritonéal qui comprend une sonde présentant deux ballonnets gonflables situés au niveau d'une partie distale, la sonde comprenant deux conduits qui présentent une extrémité proximale ouverte et une extrémité distale reliée à un ballonnet gonflable respectif, et la sonde présentant un diamètre extérieur compris entre 1,5 mm et 2,5 mm et une séparation entre les deux ballonnets gonflables comprise entre 2,5 mm et 3,5 mm.
PCT/ES2018/070821 2017-12-20 2018-12-20 Dispositif pour hémostasie d'orifice de trocart intrapéritonéal WO2019122487A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ESU201731557 2017-12-20
ES201731557U ES1203693Y (es) 2017-12-20 2017-12-20 Dispositivo para hemostasia de orificio de trocar intraperitoneal
ESU201731610 2017-12-28
ES201731610U ES1204712Y (es) 2017-12-28 2017-12-28 Instrumento laparoscópico para realización de funduplicatura en cirugía de reflujo gastroesofágico

Publications (1)

Publication Number Publication Date
WO2019122487A1 true WO2019122487A1 (fr) 2019-06-27

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PCT/ES2018/070821 WO2019122487A1 (fr) 2017-12-20 2018-12-20 Dispositif pour hémostasie d'orifice de trocart intrapéritonéal

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WO (1) WO2019122487A1 (fr)

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 (fr) * 1990-03-12 1991-09-13 Lefebvre Jean Marie Obturateur vasculaire percutane.
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 (fr) * 1990-03-12 1991-09-13 Lefebvre Jean Marie Obturateur vasculaire percutane.
US20150342641A1 (en) * 2007-02-09 2015-12-03 Michael A. Belfort Balloon tamponade

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