ITBO20000511A1 - APPARATUS AND METHOD FOR THE CONSTRUCTION OF GASTROSTOMY - Google Patents

Description

DESCRIPTION

of the patent for industrial invention

The present invention relates to an apparatus for making percutaneous-endoscopic gastrostomy.

Percutaneous-endoscopic gastrostomy, which hereinafter will be referred to by the commonly used term "PEG", is a method used in medicine to ensure that a patient is fed enterally, that is to say directly into the digestive tract, if the patient itself cannot take advantage of the normal swallowing routes and the need to feed it is prolonged over time.

PEG consists of introducing a gastrostomy tube orally through the esophagus and stomach by making it exit from the inside of the stomach to the outside, that is, by making it pass through the stomach wall to make it exit the skin; the gastrostomy tube is subsequently pulled, locked in place, and connected to means of introducing a nutrient mixture from the outside to the inside of the stomach.

Currently the PEG is carried out by means of an apparatus comprising a gastroscopy which is introduced through the mouth through the esophagus up to the patient's stomach.

The gastroscope is normally an elongated cylindrical body equipped with illumination means, optical means for endoscopic vision, and with an insufflation channel through which air is pumped into the stomach to expand the stomach until it reaches contact with the abdominal wall.

The known type gastroscope described above comprises an orientable end portion, which is directed towards the area in which the PEG is to be made so as to transilluminate the abdominal wall and the external tissues.

Furthermore, the aforementioned apparatus comprises an needle cannula, which, once the point in which the stoma is to be made has been determined thanks to the endoscopic vision and the transillumination, is introduced from the outside towards the inside through the external tissues and the abdominal wall up to to position yourself in front of the end of the gastroscope. When the needle cannula is positioned facing the end of the gastroscope, a guide wire is advanced on the guide of the needle-cannula and is hooked by the gastroscope itself. For this purpose, the aforementioned gastroscope is provided with an operative channel in which a biopsy forceps can be introduced, through which the thread is grasped and dragged outwards through the esophagus and mouth.

In a subsequent phase, in which the gastroscope is completely extracted from the patient, the end of the thread coming out of the mouth is fixed to a gastrostomy tube, which is equipped with a dilating cone-cannula and is dragged into the stomach by operating a traction on the end of the thread protruding from the stomach itself; once the cone-cannula comes into contact with the internal wall of the stomach, exerting a counter-pressure from the outside on the skin and further pulling the thread, the cone-cannula and a portion of the gastrostomy tube are extracted outside the patient thanks to the progressive dilation of the percutaneous stoma. Once outside the cone-cannula is separated from the gastrostomy tube, which is locked in position so as to have one end inside the stomach and one end outside the patient.

The apparatus described above used to make the PEG has a series of drawbacks; first of all, the aforementioned gastroscope, due to its high cost, is a reusable gastroscope and is often only available in hospitals with a gastroenterology department.

Furthermore, the use of the aforementioned equipment involves carrying out a long sequence of maneuvers, during the execution of which it is inevitable that there is a transmission of bacterial contamination from the esophagus towards the inside of the stomach and above all through the stoma, because the gastrostomy tube, going down through the esophagus, collects with it a part of mucosa and bacteria and, when the cone-cannula is extracted, the stoma is dilated and the gastrostomy tube is cleaned from the tissues it perforates, but at the at the same time it transfers the mucosa and bacteria to the tissues themselves, creating an area of infection.

Furthermore, the apparatus described above has a further drawback since the transillumination carried out by means of the gastroscope is the less accentuated the thicker the adipose layer of the skin and of the abdominal wall. Consequently, if the patient is obese, it can become difficult to infer the needle-cannula from the outside to the inside in the optimal position, particularly if a PEG is to be performed in a stomach where a gastric tissue ulcer is present.

The object of the present invention is to provide an apparatus for making percutaneous-endoscopic gastrostomy, which is free from the drawbacks described above and, moreover, is easy and economical to implement.

According to the present invention, an apparatus is provided for the realization of percutaneous-endoscopic gastrostomy according to what is claimed in claim 1.

The present invention also relates to a method for making percutaneous endoscopic gastrostomy.

According to the present invention there is provided a method for the realization of percutaneous endoscopic gastrostomy according to what is claimed in claim 23.

The invention will now be described with reference to the attached drawings, which illustrate a non-limiting example of embodiment, in which:

- figure 1 schematically illustrates a preferred embodiment of an apparatus for the realization of a percutaneous-endoscopic gastrostomy realized according to the dictates of the present invention;

Figure 2 is an exploded perspective view, on an enlarged scale and with parts removed for clarity, of a detail of Figure 1;

- figure 3 is a section on an enlarged scale, with parts removed for clarity, of the detail of figure 2;

- Figures 4 to 7 show a detail of Figure 1 in four different operating positions. With reference to Figure 1, 1 indicates, as a whole, an apparatus for making percutaneous-endoscopic gastrostomy.

The apparatus 1 comprises a gastroscope 2 which can be connected at one end to a control device 3.

The gastroscope 2, according to what is illustrated in Figures 2 and 3, comprises an elongated tubular body 4 comprising, in turn, a first tubular body 5, a second tubular body 6, and a fitting 7 interposed between the tubular body 5 and the body tubular 6 and integrally connected to the tubular bodies 5 and 6 themselves.

The tubular body 5 is made of a flexible material, for example in polyvinyl chloride, and is stiffened, along the periphery, by means of a spiral spring 8 embedded in its thickness, while the tubular body 6 is made of a rigid material, for example in polyethylene.

The fitting 7 comprises an external steel spring 9 and an internal polyethylene spring 10, which are integrally connected to both tubular bodies 5 and 6, and a protective film 11, made of flexible material, wrapped around the external spring 9 and to the adjacent end portions of the tubular bodies 5 and 6.

The tubular body 4 is provided with a cylindrical channel 12, which extends along a longitudinal axis 13 of the tubular body 4 itself through the tubular bodies 5 and 6 and, in the portion of the fitting 7, is delimited by the internal spring 10.

The gastroscope 2 also comprises a plurality of channels 14 extending parallel to the axis 13 through the tubular bodies 5 and, respectively, 6. The channels 14 comprise, in this case, four channels 15 which house respective lighting fibers 16 (of of which only three are shown), a channel 17 in which an optical vision probe 18 of a known type can be inserted in a removable manner, an insufflation line comprising a channel 19 which houses a respective insufflation tube 20, and two channels 21 , which house respective metal guide cables 22 which, in use, are selectively subjected to traction, by means of the control device 3, to orient the tubular body 6, which defines the orientable end portion of the gastroscope 2.

According to an alternative embodiment, the insufflation tube 20 is missing, and the insufflation line is defined by the channel 19.

Obviously, the number of channels 15 and of the relative lighting fibers 16, the number of channels 21 and of the relative guide cables 22, the number of insufflation lines and the number of optical probes 18 is indicated by way of non-limiting example, and can vary according to your needs.

Along the connector 7, the lighting fibers 16, the optical probe 18, the insufflation tube 20, and the guide cables 22 are arranged between the external spring 9 and the internal spring 10.

Inside the channel 12 a gastrostomy tube 23 is arranged in an axially sliding manner, which is part of the gastroscope 2 and extends along the axis 13. The tube 23 comprises a cannula 24 made of a flexible material, which is provided of an internal cylindrical channel 25 extending along the axis 13 and having a determined diameter.

The cannula 24 is provided, in correspondence with its peripheral end portion, with an inflatable cuff 26 and, at the other end, with a penetration element 27.

The cap 26 is connected to an air inlet tube 28, which extends parallel to the axis 13 and is arranged for most of its length in the thickness of the cannula 24, while an end portion thereof comprising a valve non-return (known and not illustrated) is inserted inside channel 25.

The penetration element 27 comprises a flexible dilator conocannula 29, which is integrally connected to the end of the cannula 24, has an internal cylindrical channel 30 extending along the axis 13 and having a smaller diameter than that of the channel 25, and it is preferably provided, at the penetration tip, with a metal insert 31.

The gastroscope 2 comprises a tubular guide 32, which is arranged inside the channel 25, extends along the axis 13 and is fixed, at its end facing the cone-cannula 29, to a seat 33 made in the cone-cannula 29 itself.

The gastroscope 2 also comprises a perforation and traction element 34 comprising, in turn, a needle 35, which is integrally connected to a steel traction wire 36 and is mounted in a sliding manner inside the tubular guide 32. and of the channel 30 of the cone-cannula 29.

The perforation and traction element 34 also comprises a cylindrical enlargement 37, which is integrally connected to the element 34 itself between the needle 35 and the wire 36 and has a diameter greater than the diameter of the channel 30.

According to an alternative embodiment not shown, the enlargement 37 is achieved by bringing the diameter of the wire 36 to a value greater than the diameter of the channel 29 of the cone-cannula 28.

The gastroscope 2 comprises a second inflatable cuff 38, which is arranged on the outer peripheral wall of the tubular body 5 and communicates with the insufflation tube 20 through a channel 39 transversal to the axis 13 made through the thickness of the tubular body 5 and of the tube 20 of insufflation.

The control device 3, according to what is illustrated in Figure 1 and by way of non-limiting example, comprises a gun 40 of a known type to which, in use, an end portion of the gastroscope 2 is connected.

The gun 40 comprises a control lever 41 which can be selectively connected, by means of a selector 42 movable between two positions A and B, to the tube 23 or to the wire 36, a terminal 43 which can be connected to a light source 44, an eyepiece 45 which can be connected to optical probe 18, a movable selector 46 connectable to the guide cables 22, and an inlet 47 connectable to the insufflation tube 20 and to a pumping device 48 through the interposition of a non-return valve (known and not shown).

In use, the gastroscope 2 is connected to the control device 3, in this case to the gun 40, and is inserted through the patient's mouth until it enters the stomach. Once in the stomach, the inlet 47 of the gun 40 is connected to the pumping device 48 so as to blow air into the stomach through the insufflation tube 20 to cause the stomach to expand until the stomach wall comes into contact with the abdominal wall. During the insufflation of the air through the insufflation tube 20, the cuff 38, which communicates with the insufflation tube 20 itself and is arranged along the tubular body 5 so as to be approximately at the height of the esophagus, is inflated ensuring so the estate.

In a subsequent step, the tubular body 6, defining the tip of the gastroscope 2, is oriented towards the internal wall of the stomach in which to perform the gastrostomy and locked in position by acting on the cables 22 by means of the selector 46.

Subsequently, after having positioned the tip of the gastroscope 2, the tube 23 is pushed and made to advance along the channel 12 by acting on the control lever 41, with the selector 42 locked in position A, until the end of the cone-cannula 29 comes into contact with the inner wall of the stomach.

When the end of the cone-cannula 29 is positioned in the area chosen to perform the gastrostomy, the selector 42 is moved to position B and, again by acting on the control lever 41, the wire 36 is pushed and, consequently, it is advanced. the needle 35 along the tubular guide 32 and the channel 30 until the needle 33 pierces the internal wall of the stomach, penetrating through the abdominal wall and the skin until it comes out outside the patient (see fig.

4).

Before proceeding with the perforation, it is preferable to check from the outside, by means of a manual pressure, the area where the needle 35 will come out.

Naturally, all the aforementioned phases are carried out under endoscopic vision thanks to the illumination of the internal wall of the stomach, and are monitored by the eyepiece 45 connected to the optical probe 18.

After having pierced, the needle 35 is made to come out, is recovered and pulled, so that the thread 36 is subjected to traction and the enlargement 37 abuts at one end of the channel 30 of the cone-cannula 29, acting by the end-of-stroke for the needle 35 itself and, subsequently, by the expulsion means for the gastrostomy tube 23. This allows, while continuing to exert traction from the outside on the needle 35 and making circular movements to facilitate the dilation of the stoma, the progressive extraction of the cone-cannula 29 and, subsequently, of the cannula 24 outside the patient.

Once the cone-cannula 29 has been extracted, the cuff 38 is deflated and the tubular body 4 is extracted from the patient's mouth (see fig. 5), the optical probe 18 is removed to be reused, and the tubular body 4, which is disposable, it is disconnected from the gun 40 to be thrown away.

In an alternative embodiment not shown, the optical probe 18 is an integral part of the gastroscope 2 and is therefore thrown away each time together with the tubular body 4 itself.

After having partially extracted the cannula 24 (fig. 6), the cone-cannula 29 is separated from the cannula 24, the end portion of the tube 28 is extracted from the channel 25 and connected to a pumping device 49, and the cuff 26 is inflated (fig. 7). Obviously, the tube 28 is provided with a non-return valve (known and not illustrated) to keep the cuff 26 inflated.

In the final step, the cannula 24 is locked in position from the outside by means of a fastening ring 50 of a known type.

The gastroscope 2 has a plurality of advantages in that it is disposable, with the exception of the optical viewing probe 18 which can be reusable, and therefore can be economically accessible to a greater number of users.

Furthermore, the fact of extracting the gastrostomy tube 23 from the tubular body 4 only when the tube 23 itself is in position, has the advantage of ensuring that the tube 23 is not subject to contamination and remains sterile even during the passage of the gastroscope 2 through the the patient's esophagus.

A further advantage is represented by the fact that by placing the needle 35 and the traction thread 36 inside the tube 23 to carry out the perforation of the stomach from the inside towards the outside, it is possible to choose exactly the position in which to carry out the perforation even without transilluminating, or without transilluminating excessively, an important advantage when this is difficult, for example when PEG is performed on obese patients.

Claims (30)

CLAIMS 1. Apparatus for making percutaneous-endoscopic gastrostomy comprising a gastroscope (2) which can be inserted through the mouth into the stomach of a patient and optical vision means (18) for inspecting the internal wall of the stomach itself, said gastroscope (2) comprising a first tubular body (4) extending along a longitudinal axis (13) and provided with lighting means (16) for illuminating said internal wall of the stomach, characterized in that it further comprises a gastrostomy tube (23) provided at one of its ends of a penetration element (27) and slidably mounted inside said first tubular body (4) to exit from one end of said gastroscope (2) with said penetration element (27); a perforation and traction element (34) mounted to slide inside said gastrostomy tube (23) so as to exit from said penetration element (27) to perforate said internal wall of the stomach from the inside out, and being provided with expulsion means (37) for dragging said penetration element (27) following a traction and / or thrust on said perforation and traction element (34) towards said internal wall of the stomach. The apparatus according to claim 1, wherein said gastroscope (2) comprises orienting means (22) for directing said end of the gastroscope (2). 3. Apparatus according to claim 2, wherein said first tubular body (4) comprises at least two first channels (21) parallel to said longitudinal axis (13), said orienting means (22) comprising two cables (22) of orientation inserted in the respective said first channels (21) and selectively operable to orient the said end of the gastroscope (2). 4. Apparatus according to any one of the preceding claims, wherein said piercing and traction element (34) comprises a needle (35) and a traction wire (36) integrally connected to each other. 5. Apparatus according to claim 4, wherein said expulsion means (37) comprise a cylindrical enlargement (37) arranged along said perforation and traction element (34), in particular between said needle (35) and said traction wire (36), to limit the sliding of the perforation and traction element (34) itself with respect to said gastrostomy tube (23). 6. Apparatus according to claim 5, wherein said penetration element (27) comprises a dilator cone-cannula (29) provided with a longitudinal channel (30) having a first determined diameter, and said cylindrical enlargement (37) has a respective second diameter greater than said first diameter. 7. Apparatus according to claim 4, wherein said penetration element (27) comprises a dilator cone-cannula (29) provided with a longitudinal channel (30) having a first determined diameter, and said traction wire (36) it has a respective second diameter which is larger than said first diameter, said expulsion means (37) being defined by the traction wire (36) itself. 8. Apparatus according to any one of the preceding claims, wherein said first tubular body (4) comprises at least a second channel (17) parallel to said longitudinal axis (13), and said optical viewing means (18) comprise a probe optics (18) which can be inserted, in an extractable manner, into said second channel (17). 9. Apparatus according to one of claims 1 to 7, wherein said optical viewing means (18) comprise an optical probe (18) inserted in said gastroscope (2) and defining an integral part of the gastroscope (2) itself. 10. Apparatus according to any one of the preceding claims, wherein said first tubular body (4) comprises at least one insufflation line for blowing air into the stomach. 11. Apparatus according to claim 10, wherein said first tubular body (4) comprises at least a third channel (19) parallel to said longitudinal axis (13) and defining said insufflation line. Apparatus according to claim 11, wherein said insufflation line comprises an insufflation tube (20) inserted along said third channel (19). 13. Apparatus according to claim 10, 11 or 12, wherein said first tubular body (4) is provided with an inflatable peripheral cuff (38) communicating with said insufflation line. 14. Apparatus according to any one of the preceding claims, wherein said first tubular body (4) comprises at least a fourth longitudinal channel (15), and said lighting means (16) comprise at least one optical fiber (16) inserted in said fourth channel (15). 15. Apparatus according to any one of claims 2 to 14, and further comprising control means (3) connectable to said gastroscope (2), wherein said control means (3) comprise at least one eyepiece (45) connectable to said optical vision means (18), at least one inlet (47) for a pumping device (48) connectable to said insufflation line, a terminal (43) connectable to a source (44) of lighting and to said means (16) lighting, selective advancement means (41, 42) for advancing said perforation and traction element (34) or said gastrostomy tube (23) along said first tubular body (4), and maneuvering means (46) which can be connected to the said orienting means (22) for positioning the said end of the gastroscope (2). 16. Apparatus according to any one of the preceding claims, wherein said first tubular body (4) comprises a second tubular body (5), a third tubular body (6), and a flexible fitting (7) interposed between said second ( 5) and third (6) tubular body and integrally connected thereto. 17. Apparatus according to claim 16, wherein said third tubular body (6) comprises said end of the gastroscope (2). 18. Apparatus according to claim 16 or 17, wherein said flexible fitting (7) comprises a first (9) and a second (10) spring coaxial with each other, of which the second spring (10) is internal to the first spring ( 9), and an external protective film (11) wrapped around said first spring (9). 19. Apparatus according to claims 2 and 18, wherein said optical viewing means (18), said illumination means (16) and said orientation means (22) are arranged along said flexible fitting (7) , between said first (9) and second (10) spring, and said gastrostomy tube (23) is mounted to slide, along said flexible fitting (7), inside said second spring (10). 20. Apparatus according to claims 12 and 18, wherein said insufflation tube (20) is arranged, along said flexible fitting (7), between said first (9) and second (10) spring. 21. Apparatus according to any one of the preceding claims, wherein said gastrostomy tube (23) comprises locking means (26, 28) for securing an end portion of said gastrostomy tube (23) inside said inner wall of the stomach . 22. Apparatus according to claim 21, wherein said locking means (26, 28) comprise an inflatable cuff (26) disposed on the outer periphery of said end portion of the gastrostomy tube (23) and an inflation line (28) communicating with said inflatable cap (26) and connectable to a pumping device (49). 23. Method for performing percutaneous-endoscopic gastrostomy, the method comprising the steps of inserting a portion of a gastroscope (2) through the mouth to the inside of a patient's stomach, illuminating the inner wall of the stomach and submitting it for visual inspection through the gastroscope (2) itself, said gastroscope comprising illumination means (16) and optical means (18) for visual inspection, characterized in that said gastroscope (2) comprises a first tubular body (4), a gastrostomy tube (23) slidably mounted inside said first tubular body (4), and a perforation and traction element (34) slidably mounted inside said gastrostomy tube (23); the said perforation and traction element (34) being advanced to make a perforation from the inside of the stomach towards the outside, the said gastrostomy tube (23) being advanced to be inserted from the inside of the stomach towards the outside through said perforation by progressively dilating the perforation itself; and said gastrostomy tube (23) being extracted from said first tubular body (4) after having inserted the gastroscope (2) itself inside the stomach. 24. Method according to claim 23, comprising the step of insufflating the stomach with air, through an insufflation line (19, 20) made in said first tubular body (4), to cause the stomach to expand until it reaches the stomach wall itself in contact with the abdominal wall before performing said perforation. Method according to claim 23 or 24, wherein said perforation is carried out by pushing and subsequent pulling of said perforation and traction element (34). Method according to one of the preceding claims, wherein said gastroscope (2) comprises orienting means (22) for orienting an end of said gastroscope (2) arranged inside the stomach, said end being oriented and locked in the selected position before making said perforation. Method according to claim 26, wherein said gastrostomy tube (23) is provided, at one end thereof, with a penetration element (27), said penetration element (27) being extracted from said first tubular body ( 4) and advanced until it comes into contact with the said stomach wall after having locked the said end of the gastroscope in position (2). Method according to claim 27, wherein said puncture and traction element (34) is extracted from said gastrostomy tube (23) to carry out said puncture after bringing one end of said penetration element (27) into contact with the said inner wall of the stomach. 29. Method according to claim 28, comprising the steps of picking up and subjecting said drilling and pulling element (34) to and pulling from the outside, said drilling and pulling element (34) comprising expulsion means (37) arranged inside the gastrostomy tube such that, following said traction phase, the penetration element (27), and subsequently the gastrostomy tube (23), are progressively extracted from the inside of the stomach to the outside. Method according to claim 29, wherein said gastrostomy tube (23) comprises locking means (26, 28, 50) and is locked in position with one end disposed inside the stomach and one end disposed outside stomach,