WO2002019890A2 - Apparatus for placement of a percutaneous endoscopic gastrostomy tube - Google Patents

Apparatus for placement of a percutaneous endoscopic gastrostomy tube Download PDF

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Publication number
WO2002019890A2
WO2002019890A2 PCT/IT2001/000458 IT0100458W WO0219890A2 WO 2002019890 A2 WO2002019890 A2 WO 2002019890A2 IT 0100458 W IT0100458 W IT 0100458W WO 0219890 A2 WO0219890 A2 WO 0219890A2
Authority
WO
WIPO (PCT)
Prior art keywords
stomach
gastroscope
devices
tubular body
perforation
Prior art date
Application number
PCT/IT2001/000458
Other languages
French (fr)
Other versions
WO2002019890A3 (en
Inventor
Gianmario Monza
Original Assignee
Patents Exploitation Company B.V.
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
Application filed by Patents Exploitation Company B.V. filed Critical Patents Exploitation Company B.V.
Priority to AU2001292218A priority Critical patent/AU2001292218A1/en
Publication of WO2002019890A2 publication Critical patent/WO2002019890A2/en
Publication of WO2002019890A3 publication Critical patent/WO2002019890A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • A61B1/2736—Gastroscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • A61M2025/0233—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices

Definitions

  • TECHNICAL FIELD This invention relates to an apparatus for performing percutaneous-endoscopic gastrostomy. BACKGROUND ART
  • PEG Percutaneous-endoscopic gastrostomy
  • PEG consists of orally introducing a gastrostomy tube through the oesophagus and the stomach making it exit from the inside of the stomach to the outside, i.e. running it through the stomach wall to exit from the skin; the gastrostomy tube is subsequently pulled, locked in position and connected to devices for introduction of a nutritional mixture from the outside to the inside of the stomach.
  • PEG is performed by means of an apparatus comprising a gastroscope which is introduced through the mouth and oesophagus until entering the stomach of the patient .
  • the gastroscope is normally an elongated cylindrical body fitted with illumination devices, optical devices for endoscopic vision and an insufflation channel through which air is pumped into the stomach to make it expand until it comes into contact with the abdominal wall.
  • the gastroscope of known type described above comprises an orientable end section which is directed towards the area in which PEG is to be performed in such a way as to transilluminate the abdominal wall and the external tissues .
  • the said apparatus comprises a needle/cannula which, once the point in which the stoma is to be made has been determined thanks to endoscopic vision and transillumination, is introduced from the outside to the inside through the external tissues and the abdominal wall until positioning in front of the end of the gastroscope.
  • a guide wire is made to advance on the needle/cannula guide which is hooked by the gastroscope.
  • the said gastroscope is fitted with an operating channel in which a bioptic forceps can be inserted, by means of which the wire is gripped and drawn towards the outside through the oesophagus and the mouth.
  • the end of the wire exiting the mouth is fixed to a gastrostomy tube which is fitted with a dilating cone/cannula and is drawn into the stomach by exercising traction on the end of the wire exiting the stomach; when the cone/cannula comes into contact with the internal wall of the stomach, by exercising counterpressure on the skin from the outside and further pulling the wire, the cone/cannula and a section of the gastrostomy tube are extracted from the patient thanks to the progressive dilatation of the percutaneous stoma.
  • the cone/cannula is separated from the gastrostomy tube which is locked into position in such a way that one end is on the inside and the other end on the outside of the patient.
  • the above described apparatus used to perform PEG presents a series of problems; first of all, the said gastroscope is reusable because of its high cost and is often only available in hospitals equipped with a gastroenterology department .
  • the use of the said apparatus involves carrying out a long sequence of manoeuvres during which it is inevitable that transmission of bacterial contamination occurs from the oesophagus towards the inside of the stomach and, above all, through the stoma, since the gastrostomy tube, descending through the oesophagus, carries with it some mucosa and bacteria and when the cone/cannula is extracted, the stoma is dilated and the gastrostomy tube cleaned by the tissues it perforates, but at the same time it transfers the mucosa and the bacteria to the tissues, thus creating an infection area.
  • the apparatus described above presents an additional problem, since the thicker the adipose layer of the skin and the abdominal wall the less accentuated the transillumination realised by means of the gastroscope. Consequently, if the patient is obese, it may become complicated to insert the needle/cannula from the outside to the inside in the ideal position, in particular if a PEG needs to be performed in a stomach where an ulcer of the gastric tissue is present .
  • the purpose of this invention is to provide an apparatus for performing percutaneous-endoscopic gastrostomy which does not create the problems described above and which, moreover, is easy and inexpensive to make.
  • an apparatus for performing percutaneous-endoscopic gastrostomy is provided as asserted in Claim 1.
  • This invention moreover relates to a method for performing percutaneous-endoscopic gastrostomy.
  • a method for performing percutaneous-endoscopic gastrostomy is provided as asserted in Claim 23.
  • FIG. 1 schematically illustrates a preferred form of implementation of an apparatus for performing percutaneous-endoscopic gastrostomy according to the principles of this invention
  • FIG. 2 is an exploded perspective view, with sections removed for the sake of clarity, of a detail of Figure 1;
  • FIG. 3 is an enlarged cross-section, with sections removed for clarity, of the detail of Figure 2;
  • 1 indicates an apparatus for performing percutaneous-endoscopic gastrostomy.
  • the apparatus (1) comprises a gastroscope (2) connectable at one end to a control device (3) .
  • the gastroscope (2) as illustrated in Figures 2 and 3, comprises an elongated tubular body (4), in its turn comprising a first tubular body (5) , a second tubular body (6) and a connector (7) interposed between the tubular body (5) and the tubular body (6) and securely connected to the tubular bodies (5 and 6) .
  • the tubular body. (5) is made of a flexible material, for example, polyvinyl chloride, and is stiffened along the periphery by means of a spiral spring (8) inserted across its width, while the tubular body (6) is made of a rigid material, for example, polyethylene.
  • the connector (7) comprises an external steel spring
  • the tubular body (4) is fitted with a cylindrical channel (12) which extends along a longitudinal axis (13) of the tubular body (4) running through the tubular bodies (5 and 6) , and is delimited by the internal spring
  • the gastroscope (2) moreover comprises various channels (14) extending parallel to the axis (13) through the tubular bodies (5) and (6) , respectively.
  • the channels (14) comprise, in the case in point, four channels (15) which house respective illumination fibres
  • a channel (17) in which an extractable optical vision probe (18) of known type can be inserted an insufflation line comprising a channel (19) which houses a respective insufflation tube (20) , and two channels (21) which house respective metallic guide wires (22) which, during use, are selectively subjected to traction by means of the control device (3) to orient the tubular body (6) which defines the orientable end section of the gastroscope (2) .
  • the insufflation tube (20) is absent and the insufflation line is defined by the channel (19) .
  • the number of channels (15) and the relevant illumination fibres (16) , the number of channels (21) and the relevant guide wires (22) , the number of insufflation lines and the number of optical probes (18) is indicated by way of unrestrictive example and may vary depending on requirements .
  • the gastroscope (2) comprises three channels (21) arranged at 120° one with respect to the other around the axis (13) and house respective guide wires (22) which can selectively be subjected to traction to allow better mobility of the tubular body (6) .
  • the illumination fibres (16) , the optical probe (18) , the insufflation tube (20) and the guide wires (22) are arranged between the external spring (9) and the internal spring (10)
  • an axially-sliding gastrostomy tube (23) is arranged which forms 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 fitted with an internal cylindrical channel (25) extending along the axis (13) and having a certain diameter .
  • the cannula (24) is fitted, in correspondence to one peripheral end section, with an inflatable cuff (26) and on the other end with a penetration element (27) .
  • the cuff (26) is connected to an air inlet tube (28) , which extends parallel to the axis (13) and is arranged for most of its length across the width of the cannula (24) , while one end section including a non-return valve (known and not illustrated) is inserted in the channel (25) .
  • the penetration element (27) comprises a flexible dilating cone/cannula (29) which is securely connected to the end of the cannula (24) , has an internal cylindrical channel (30) extending along the axis (13) with a diameter smaller than the diameter of the channel (25) , and is preferably fitted with a metallic insert (31) in correspondence to the penetration point .
  • the gastroscope (2) comprises a tubular guide (32) which is arranged inside the channel (25) extending along the axis (13) and is fixed, in correspondence to the end facing the cone/cannula (29) , to a housing (33) in the cone/cannula (29) .
  • the gastroscope (2) moreover comprises a perforation and traction element (34) in its turn comprising a needle
  • the perforation and traction element (34) moreover comprises a cylindrical enlargement (37) which is securely connected to the element (34) between the needle (35) and the wire (36) and has a diameter greater than the diameter of the channel (30) .
  • the enlargement (37) is obtained by making the diameter of the wire (36) 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 external peripheral wall of the tubular body (5) and communicates with the insufflation tube (20) by means of a channel (39) transversal to the axis (13) realised across the width of the tubular body (5) and the insufflation tube (20) .
  • the control device (3) as illustrated in Figure 1 and by way of unrestrictive example, comprises a gun (40) of known type to which, during use, one end section of the gastroscope (2) is connected.
  • the gun (40) comprises a control lever (41) selectively connectable to the tube (23) or the wire
  • a mobile selector (42) between two positions A and B, a terminal (43) connectable to a light source (44) , a mobile selector (46) connectable to the guide wires (22) , and an inlet (47) connectable to the insufflation tube (20) and to a pumping device (48) by means of interposition of a non-return valve (known and not illustrated) .
  • the gastroscope (2) is connected to the control device (3) , in the case in point, to the gun (40) and is inserted through the mouth of the patient until entering the stomach.
  • the inlet (47) of the gun (40) is connected to the pumping device (48) in such a way as to insufflate air into the stomach through the insufflation tube (20) to make the stomach expand until the stomach wall comes into contact with the abdominal wall .
  • the cuff (38) which communicates with the insufflation tube (20) and is arranged along the tubular body (5) in such a way that it is positioned approximately at the height of the oesophagus, is inflated thus guaranteeing hold.
  • the tubular body (6) defining the tip of the gastroscope (2) , is oriented towards the internal wall of the stomach in which the gastrostomy is to be performed, and locked into position by acting on the wire (22) by means of the selector (46) .
  • the tube (23) is pushed and made to advance along the channel (12) by operating 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 internal wall of the stomach.
  • the selector (42) When the end of the cone/cannula (29) is positioned in the preselected area where the gastrostomy is to be performed, the selector (42) is moved to position B and, again operating the control lever (41) , the wire (36) is pushed and, consequently, the needle (35) made to advance along the tubular guide (32) and the channel (30) until the needle (33) perforates the internal wall of the stomach, penetrating through the abdominal wall and the skin until exiting from the patient (see Fig. 4) .
  • the needle (35) Before proceeding with perforation, it is preferable to check from the outside, by means of manual pressure, the area where the needle (35) will exit. All the above phases are carried out under endoscopic vision thanks to illumination of the internal wall of the stomach, and are monitored through the eyepiece (45) connected to the optical probe (18) . After perforation, the needle (35) is made to exit, retrieved and pulled in such a way that the wire (36) is subjected to traction and the enlargement (37) slips into place in correspondence to one end of the channel (30) of the cone/cannula (29) , functioning as end stop for the needle (35) and, subsequently, as expulsion device for the gastrostomy tube (23) . This allows, continuing to exercise traction on the needle (35) from the outside and making circular movements to facilitate dilatation of the stoma, progressive extraction of the cone/cannula (29) and, subsequently, of the cannula (24) from the patient.
  • the cuff (38) is deflated and the tubular body (4) extracted from the mouth of the patient (see Fig. 5) , the optical probe (18) is removed to be reused, and the tubular body (4) , which is single-use, is disconnected from the gun (40) to be discarded.
  • the optical probe (18) forms an integral part of the gastroscope (2) and is hence always discarded together with the tubular body (4) .
  • the cone/cannula (29) is separated from the cannula (24)
  • the end section of the tube (28) is extracted from the channel (25) and connected to a pumping device (49)
  • the cuff (26) is inflated (Fig. 7) .
  • the tube (28) is fitted with a non-return valve (known and not illustrated) to maintain the cuff (26) inflated.
  • the cannula (24) is locked into position from the outside by means of a retaining ring nut (50) of known type.
  • the gastroscope (2) has many advantages since it is single-use, except for the optical vision probe (18) which may be reusable, and hence is economically affordable to a larger number of users. Moreover, the fact that the gastrostomy tube (23) is extracted from the tubular body (4) only when the tube
  • the tube (23) is in position, has the advantage of assuring that the tube (23) is not subject to contamination and remains sterile also during the passage of the gastroscope (2) through the oesophagus of the patient .
  • a further advantage is the fact that by positioning the needle (35) and the traction wire (36) inside the tube (23) to perform perforation of the stomach from the inside to the outside, it is possible to exactly select the position where to execute the perforation also without transillumination, or without excessive transillumination, a major advantage when this results difficult, for example, when the PEG is performed on obese patients .

Abstract

Apparatus and method for performing percutaneous-endoscopic gastrostomy, according to which a gastroscope (2) partially insertable into the stomach of a patient is fitted with an illumination system (16) and an optical device (18) and has a tubular body (4) inside which a sliding gastrostomy tube (23) is mounted fitted on one end with a penetration element (27); a sliding perforation and traction element (34) is mounted inside the gastrostomy tube (23) and is fitted with an expulsion device (37) in such a way that when traction and/or thrust is exercised on the perforation and traction element (34), the gastrostomy tube (23) is progressively extracted, first with the penetration element (27), from the inside of the stomach to the outside.

Description

"APPARATUS AND METHOD FOR PERFORMING PERCUTANEOUS- ENDOSCOPIC GASTROSTOMY"
TECHNICAL FIELD This invention relates to an apparatus for performing percutaneous-endoscopic gastrostomy. BACKGROUND ART
Percutaneous-endoscopic gastrostomy, hereinafter referred to with the commonly used term "PEG", is a method used in medicine to assure nutrition of a patient by enteral means, i.e. directly into the alimentary tract if the patient is unable to use the normal deglutition tract and needs to be fed for an extended period of time .
PEG consists of orally introducing a gastrostomy tube through the oesophagus and the stomach making it exit from the inside of the stomach to the outside, i.e. running it through the stomach wall to exit from the skin; the gastrostomy tube is subsequently pulled, locked in position and connected to devices for introduction of a nutritional mixture from the outside to the inside of the stomach.
At present, PEG is performed by means of an apparatus comprising a gastroscope which is introduced through the mouth and oesophagus until entering the stomach of the patient .
The gastroscope is normally an elongated cylindrical body fitted with illumination devices, optical devices for endoscopic vision and an insufflation channel through which air is pumped into the stomach to make it expand until it comes into contact with the abdominal wall.
The gastroscope of known type described above comprises an orientable end section which is directed towards the area in which PEG is to be performed in such a way as to transilluminate the abdominal wall and the external tissues .
Moreover, the said apparatus comprises a needle/cannula which, once the point in which the stoma is to be made has been determined thanks to endoscopic vision and transillumination, is introduced from the outside to the inside through the external tissues and the abdominal wall until positioning in front of the end of the gastroscope. When the needle/cannula is in position facing the end of the gastroscope, a guide wire is made to advance on the needle/cannula guide which is hooked by the gastroscope. For this purpose, the said gastroscope is fitted with an operating channel in which a bioptic forceps can be inserted, by means of which the wire is gripped and drawn towards the outside through the oesophagus and the mouth.
In a subsequent phase in which the gastroscope is completely extracted from the patient, the end of the wire exiting the mouth is fixed to a gastrostomy tube which is fitted with a dilating cone/cannula and is drawn into the stomach by exercising traction on the end of the wire exiting the stomach; when the cone/cannula comes into contact with the internal wall of the stomach, by exercising counterpressure on the skin from the outside and further pulling the wire, the cone/cannula and a section of the gastrostomy tube are extracted from the patient thanks to the progressive dilatation of the percutaneous stoma. Once on the outside the cone/cannula is separated from the gastrostomy tube which is locked into position in such a way that one end is on the inside and the other end on the outside of the patient.
The above described apparatus used to perform PEG presents a series of problems; first of all, the said gastroscope is reusable because of its high cost and is often only available in hospitals equipped with a gastroenterology department .
Moreover, the use of the said apparatus involves carrying out a long sequence of manoeuvres during which it is inevitable that transmission of bacterial contamination occurs from the oesophagus towards the inside of the stomach and, above all, through the stoma, since the gastrostomy tube, descending through the oesophagus, carries with it some mucosa and bacteria and when the cone/cannula is extracted, the stoma is dilated and the gastrostomy tube cleaned by the tissues it perforates, but at the same time it transfers the mucosa and the bacteria to the tissues, thus creating an infection area.
Moreover, the apparatus described above presents an additional problem, since the thicker the adipose layer of the skin and the abdominal wall the less accentuated the transillumination realised by means of the gastroscope. Consequently, if the patient is obese, it may become complicated to insert the needle/cannula from the outside to the inside in the ideal position, in particular if a PEG needs to be performed in a stomach where an ulcer of the gastric tissue is present .
DISCLOSURE OF INVENTION
The purpose of this invention is to provide an apparatus for performing percutaneous-endoscopic gastrostomy which does not create the problems described above and which, moreover, is easy and inexpensive to make.
According to this invention, an apparatus for performing percutaneous-endoscopic gastrostomy is provided as asserted in Claim 1.
This invention moreover relates to a method for performing percutaneous-endoscopic gastrostomy.
According to this invention, a method for performing percutaneous-endoscopic gastrostomy is provided as asserted in Claim 23.
BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described with reference to the annexed drawings, which illustrate an example of unrestrictive implementation, in which:
- Figure 1 schematically illustrates a preferred form of implementation of an apparatus for performing percutaneous-endoscopic gastrostomy according to the principles of this invention;
- Figure 2 is an exploded perspective view, with sections removed for the sake of clarity, of a detail of Figure 1;
- Figure 3 is an enlarged cross-section, with sections removed for clarity, of the detail of Figure 2;
- Figures 4-7 illustrate a detail of Figure 1 in four different operating positions. BEST MODE FOR CARRYING OUT THE INVENTION
With reference to Figure 1, 1 as a whole indicates an apparatus for performing percutaneous-endoscopic gastrostomy.
The apparatus (1) comprises a gastroscope (2) connectable at one end to a control device (3) . The gastroscope (2) , as illustrated in Figures 2 and 3, comprises an elongated tubular body (4), in its turn comprising a first tubular body (5) , a second tubular body (6) and a connector (7) interposed between the tubular body (5) and the tubular body (6) and securely connected to the tubular bodies (5 and 6) .
The tubular body. (5) is made of a flexible material, for example, polyvinyl chloride, and is stiffened along the periphery by means of a spiral spring (8) inserted across its width, while the tubular body (6) is made of a rigid material, for example, polyethylene.
The connector (7) comprises an external steel spring
(9) and an internal polyethylene spring (10) , which are securely connected to both the tubular bodies (5 and 6) , and a protection film (11) made of flexible material, wrapped around the external spring (9) and the adjacent end sections of the tubular bodies (5 and 6) .
The tubular body (4) is fitted with a cylindrical channel (12) which extends along a longitudinal axis (13) of the tubular body (4) running through the tubular bodies (5 and 6) , and is delimited by the internal spring
(10) in the section of the connector (7) .
The gastroscope (2) moreover comprises various channels (14) extending parallel to the axis (13) through the tubular bodies (5) and (6) , respectively. The channels (14) comprise, in the case in point, four channels (15) which house respective illumination fibres
(16) (of which only three are illustrated) , a channel (17) in which an extractable optical vision probe (18) of known type can be inserted, an insufflation line comprising a channel (19) which houses a respective insufflation tube (20) , and two channels (21) which house respective metallic guide wires (22) which, during use, are selectively subjected to traction by means of the control device (3) to orient the tubular body (6) which defines the orientable end section of the gastroscope (2) .
According to an alternative form of implementation, the insufflation tube (20) is absent and the insufflation line is defined by the channel (19) .
The number of channels (15) and the relevant illumination fibres (16) , the number of channels (21) and the relevant guide wires (22) , the number of insufflation lines and the number of optical probes (18) is indicated by way of unrestrictive example and may vary depending on requirements .
For example, according to an alternative form of implementation not illustrated, the gastroscope (2) comprises three channels (21) arranged at 120° one with respect to the other around the axis (13) and house respective guide wires (22) which can selectively be subjected to traction to allow better mobility of the tubular body (6) .
Along the connector (7) , the illumination fibres (16) , the optical probe (18) , the insufflation tube (20) and the guide wires (22) are arranged between the external spring (9) and the internal spring (10)
Inside the channel (12) an axially-sliding gastrostomy tube (23) is arranged which forms 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 fitted with an internal cylindrical channel (25) extending along the axis (13) and having a certain diameter . The cannula (24) is fitted, in correspondence to one peripheral end section, with an inflatable cuff (26) and on the other end with a penetration element (27) .
The cuff (26) is connected to an air inlet tube (28) , which extends parallel to the axis (13) and is arranged for most of its length across the width of the cannula (24) , while one end section including a non-return valve (known and not illustrated) is inserted in the channel (25) .
The penetration element (27) comprises a flexible dilating cone/cannula (29) which is securely connected to the end of the cannula (24) , has an internal cylindrical channel (30) extending along the axis (13) with a diameter smaller than the diameter of the channel (25) , and is preferably fitted with a metallic insert (31) in correspondence to the penetration point . The gastroscope (2) comprises a tubular guide (32) which is arranged inside the channel (25) extending along the axis (13) and is fixed, in correspondence to the end facing the cone/cannula (29) , to a housing (33) in the cone/cannula (29) .
The gastroscope (2) moreover comprises a perforation and traction element (34) in its turn comprising a needle
(35) which is securely connected to a steel traction wire
(36) and is mounted in such a way that it slides inside the tubular guide (32) and the channel (30) of the cone/cannula (29) .
The perforation and traction element (34) moreover comprises a cylindrical enlargement (37) which is securely connected to the element (34) between the needle (35) and the wire (36) and has a diameter greater than the diameter of the channel (30) .
According to an alternative form of implementation not illustrated, the enlargement (37) is obtained by making the diameter of the wire (36) 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 external peripheral wall of the tubular body (5) and communicates with the insufflation tube (20) by means of a channel (39) transversal to the axis (13) realised across the width of the tubular body (5) and the insufflation tube (20) . The control device (3) , as illustrated in Figure 1 and by way of unrestrictive example, comprises a gun (40) of known type to which, during use, one end section of the gastroscope (2) is connected. The gun (40) comprises a control lever (41) selectively connectable to the tube (23) or the wire
(36) , by means of a mobile selector (42) between two positions A and B, a terminal (43) connectable to a light source (44) , a mobile selector (46) connectable to the guide wires (22) , and an inlet (47) connectable to the insufflation tube (20) and to a pumping device (48) by means of interposition of a non-return valve (known and not illustrated) .
During use, the gastroscope (2) is connected to the control device (3) , in the case in point, to the gun (40) and is inserted through the mouth of the patient until entering the stomach. Once in the stomach, the inlet (47) of the gun (40) is connected to the pumping device (48) in such a way as to insufflate air into the stomach through the insufflation tube (20) to make the stomach expand until the stomach wall comes into contact with the abdominal wall . During air insufflation through the insufflation tube (20) , the cuff (38) , which communicates with the insufflation tube (20) and is arranged along the tubular body (5) in such a way that it is positioned approximately at the height of the oesophagus, is inflated thus guaranteeing hold.
In a subsequent phase, the tubular body (6) , defining the tip of the gastroscope (2) , is oriented towards the internal wall of the stomach in which the gastrostomy is to be performed, and locked into position by acting on the wire (22) by means of the selector (46) .
Subsequently, after positioning the tip of the gastroscope (2) , the tube (23) is pushed and made to advance along the channel (12) by operating 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 internal wall of the stomach.
When the end of the cone/cannula (29) is positioned in the preselected area where the gastrostomy is to be performed, the selector (42) is moved to position B and, again operating the control lever (41) , the wire (36) is pushed and, consequently, the needle (35) made to advance along the tubular guide (32) and the channel (30) until the needle (33) perforates the internal wall of the stomach, penetrating through the abdominal wall and the skin until exiting from the patient (see Fig. 4) .
Before proceeding with perforation, it is preferable to check from the outside, by means of manual pressure, the area where the needle (35) will exit. All the above phases are carried out under endoscopic vision thanks to illumination of the internal wall of the stomach, and are monitored through the eyepiece (45) connected to the optical probe (18) . After perforation, the needle (35) is made to exit, retrieved and pulled in such a way that the wire (36) is subjected to traction and the enlargement (37) slips into place in correspondence to one end of the channel (30) of the cone/cannula (29) , functioning as end stop for the needle (35) and, subsequently, as expulsion device for the gastrostomy tube (23) . This allows, continuing to exercise traction on the needle (35) from the outside and making circular movements to facilitate dilatation of the stoma, progressive extraction of the cone/cannula (29) and, subsequently, of the cannula (24) from the patient.
When the cone/cannula (29) has been extracted, the cuff (38) is deflated and the tubular body (4) extracted from the mouth of the patient (see Fig. 5) , the optical probe (18) is removed to be reused, and the tubular body (4) , which is single-use, is disconnected from the gun (40) to be discarded.
In an alternative form of implementation not illustrated, the optical probe (18) forms an integral part of the gastroscope (2) and is hence always discarded together with the tubular body (4) . After partially extracting the cannula (24) (Fig. 6) , the cone/cannula (29) is separated from the cannula (24) , the end section 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) . The tube (28) is fitted with a non-return valve (known and not illustrated) to maintain the cuff (26) inflated.
In the final phase, the cannula (24) is locked into position from the outside by means of a retaining ring nut (50) of known type.
The gastroscope (2) has many advantages since it is single-use, except for the optical vision probe (18) which may be reusable, and hence is economically affordable to a larger number of users. Moreover, the fact that the gastrostomy tube (23) is extracted from the tubular body (4) only when the tube
(23) is in position, has the advantage of assuring that the tube (23) is not subject to contamination and remains sterile also during the passage of the gastroscope (2) through the oesophagus of the patient .
A further advantage is the fact that by positioning the needle (35) and the traction wire (36) inside the tube (23) to perform perforation of the stomach from the inside to the outside, it is possible to exactly select the position where to execute the perforation also without transillumination, or without excessive transillumination, a major advantage when this results difficult, for example, when the PEG is performed on obese patients .

Claims

1. Apparatus for performing percutaneous-endoscopic gastrostomy comprising a gastroscope (2) insertable through the mouth into the stomach of a patient, and optical vision devices (18) to inspect the internal wall of the stomach, the said gastroscope (2) comprising a first tubular body (4) extending along the longitudinal axis (13) and fitted with illumination devices (16) to illuminate the said internal wall of the stomach, and characterised by the fact that it also comprises a gastrostomy tube (23) fitted at one end with a penetration element (27) and mounted in such a way that it slides inside the said first tubular body (4) to exit from one end of the said gastroscope (2) with the said penetration element (27) ; a perforation and traction element (34) mounted to slide inside the said gastrostomy tube (23) in such a way that it exits from the said penetration element (27) to perforate the said internal wall of the stomach from the inside to the outside, and being fitted with expulsion devices (37) to draw the said penetration element (27) following traction and/or thrust on the said perforation and traction element (34) towards the said internal wall of the stomach.
2. Apparatus according to Claim 1 in which the said gastroscope (2) comprises orientation devices (22) to direct the said end of the gastroscope (2) .
3. Apparatus according to Claim 2 in which the said first tubular body (4) comprising at least two first channels (21) parallel to the said longitudinal axis (13) , the said orientation devices (22) comprising at least two orientation wires (22) inserted in the respective said first channels (21) and selectively operatable to orient the said end of the gastroscope (2) .
4. Apparatus according to any of the preceding claims in which the said perforation and traction element (34) comprises a needle (35) and a traction wire (36) securely connected to each other.
5. Apparatus according to Claim 5 in which the said expulsion devices (37) comprise a cylindrical enlargement (37) arranged along the said perforation and traction element (34) , in particular between the said needle (35) and the said traction wire (36) , to limit sliding of the perforation and traction element (34) with respect to the gastrostomy tube (23) .
6. Apparatus according to Claim 5 in which the said penetration element (27) comprises a dilating cone/cannula (29) fitted with a longitudinal channel (30) having a first certain diameter, and the said cylindrical enlargement (37) having a respective second diameter greater than the said first diameter.
7. Apparatus according to Claim 4 in which the said penetration element (27) comprises a dilating cone/cannula (29) fitted with a longitudinal channel (30) having a first certain diameter, and the said traction wire (36) having a respective second diameter greater than the said first diameter, the said expulsion devices (37) being defined by the traction wire (36) .
8. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least one second channel (17) parallel to the said longitudinal axis (13) , and the said optical vision devices (18) comprise an extractable optical probe (18) insertable in the said second channel (17) .
9. Apparatus according to one of the Claims from 1 to 7 in which the said optical vision devices (18) comprise an optical probe (18) inserted in the said gastroscope (2) and defining an integral part of the gastroscope (2) .
10. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least one insufflation line to insufflate air into the stomach.
11. Apparatus according to Claim 10 in which the said first tubular body (4) comprises at least a third channel
(19) parallel to the said longitudinal axis (13) and defining the said insufflation line.
12. Apparatus according to Claim 11 in which the said insufflation line comprises an insufflation tube (20) inserted along the said third channel (19) .
13. Apparatus according to Claim 10, 11 or 12 in which the said first tubular body (4) is fitted with a peripheral inflatable cuff (38) communicating with the said insufflation line.
14. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least a fourth longitudinal channel (15) , and the said illumination devices (16) comprise at least one optical fibre (16) inserted in the said fourth channel (15) .
15. Apparatus according to any of the preceding claims from 2 to 14, and moreover comprising control devices (3) connectable to the said gastroscope (2) , in which the said control devices (3) comprise at least one eyepiece (45) connectable to the said optical vision devices (18) , at least one inlet (47) for a pumping device (48) connectable to the said insufflation line, a terminal
(43) connectable to a light source (44) and to the said illumination devices (16) , selective advance devices (41,
42) to advance the said perforation and traction element (34) or the said gastrostomy tube (23) along the said first tubular body (4) , and manoeuvring devices (46) connectable to the said orientation devices (22) to position the said end of the gastroscope (2) .
16. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises a second tubular body (5) , a third tubular body (6) and a flexible connector (7) interposed between the said second (5) and third (6) tubular body and securely connected to them.
17. Apparatus according to Claim 16 in which the said third tubular body (6) comprises the said end of the gastroscope (2) .
18. Apparatus according to Claim 16 or 17 in which the said flexible connector (7) comprises a first (9) and a second (10) spring coaxial between them, of which the second spring (10) fits inside the first spring (9) , and an external protection film (11) wrapped around the said first spring (9) .
19. Apparatus according to Claims 2 and 18 in which the said optical vision devices (18) , the said illumination devices (16) and the said orientation devices (22) are arranged along the said flexible connector (7) between the said first (9) and second (10) spring, and the said gastrostomy tube (23) is mounted to slide along the said flexible connector (7) inside the said second spring
(10) .
20. Apparatus according to Claims 17 and 18 in which the said insufflation tube (20) is arranged, along the said flexible connector (7) , between the said first (9) and second (10) spring.
21. Apparatus according to any of the preceding claims in which the said gastrostomy tube (23) comprises locking devices (26, 28) to fix one end section of the said gastrostomy tube (23) inside the internal wall of the stomach.
22. Apparatus according to Claim 21 in which the said locking devices (26, 28) comprise an inflatable cuff (26) arranged on the external periphery of the said end section of the gastronomy tube (23) and an inflation line (28) communicating with the said inflatable cuff (26) and connectable to a pumping device (49) .
23. Method for performing percutaneous-endoscopic gastrostomy, the method comprising the phases of inserting a section of a gastroscope (2) through the mouth until entering the stomach of a patient, illuminating the internal wall of the stomach and subjecting it to visual inspection by means of the gastroscope (2) , the said gastroscope comprising illumination devices (16) and optical inspection devices (18) , and characterised by the fact that the said gastroscope (2) comprises a first tubular body (4) , a gastrostomy tube (23) mounted in such a way that it slides inside that said first tubular body (4) , and a perforation and traction element (34) mounted in such a way that it slides inside the said gastrostomy tube (23) ; the said perforation and traction element (34) , being advanced to execute perforation from the inside of the stomach to the outside, the said gastrostomy tube (23) being advanced to be inserted from the inside of the stomach to the outside through the said perforation, progressively dilating the perforation; and the said gastrostomy tube (23) being extracted from the said first tubular body (4) after inserting the gastroscope (2) into the stomach.
24. Method according to Claim 23, comprising the phase of insufflating the stomach with air by means of an insufflation line (19, 20) in the said first tubular body (4) to make the stomach expand until the stomach wall comes into contact with the abdominal wall before executing the perforation.
25. Method according to Claim 23 or 24 in which the said perforation is executed by means of thrust and successive traction of the said perforation and traction element (34) .
26. Method according to one of the preceding claims in which the said gastroscope (2) comprises orientation devices (22) to orient one end of the said gastroscope
(2) arranged inside the stomach, the said end being oriented and locked into the preselected position before executing the said perforation.
27. Method according the Claim 26 in which the said gastrostomy tube (23) is fitted at one end with a penetration element (27) , the said penetration element (27) being extracted from the first tubular body (4) and advanced until coming into contact with the said stomach wall after locking the said end of the gastroscope (2) into position.
28. Method according to Claim 27 in which the said perforation and traction element (27) is extracted from the said gastrostomy tube (23) to execute the said perforation after bringing one end of the said penetration element (27) into contact with the said internal wall of the stomach.
29. Method according to Claim 28, comprising the phases of drawing and subjecting the said perforation and traction element to traction from the outside, the said perforation and traction element (34) comprising the expulsion devices (37) arranged inside the gastrostomy tube in such a way that, following the 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.
30. Method according to Claim 29 in which the said gastrostomy tube (23) comprises the locking devices (26, 28, 50) and is locked into position with one end arranged inside the stomach and the other end arranged outside the stomach.
PCT/IT2001/000458 2000-09-05 2001-09-04 Apparatus for placement of a percutaneous endoscopic gastrostomy tube WO2002019890A2 (en)

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ITB02000A000511 2000-09-05
IT2000BO000511A ITBO20000511A1 (en) 2000-09-05 2000-09-05 APPARATUS AND METHOD FOR THE CONSTRUCTION OF GASTROSTOMY

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DE202004021561U1 (en) 2003-08-18 2009-02-12 Univerzita Palackeho Extractor in body cavities of clamped thermoplastic body
US8002764B2 (en) 2003-05-01 2011-08-23 Swan Valley Medical Incorporated Cystotomy catheter capture device and methods of using same
US8118826B2 (en) 2007-09-27 2012-02-21 Swan Valley Medical, Incorporated Method of performing a suprapubic transurethral cystostomy and associated procedures and apparatus therefor
WO2012042475A1 (en) * 2010-09-27 2012-04-05 Kimberly-Clark Worldwide, Inc. Multi-balloon dilation device for placing catheter tubes
US20120184924A1 (en) * 2011-01-14 2012-07-19 Loma Linda University Self-illuminating endogastric tubes and method of placing endogastric tubes
US8382785B2 (en) 2007-09-27 2013-02-26 Swan Valley Medical Incorporated Apparatus and method for performing cystotomy procedures
US8617086B2 (en) 2010-07-01 2013-12-31 Uti Limited Partnership Methods and apparatuses for full-thickness hollow organ biopsy
WO2015021133A3 (en) * 2013-08-06 2015-04-02 Cook Medical Technologies Llc System and method for external percutaneous connections
WO2015054370A1 (en) * 2013-10-08 2015-04-16 Cook Medical Technologies Llc Device for external percutaneous connections
US9271752B2 (en) 2013-03-13 2016-03-01 Swan Valley Medical Incorporated Method and apparatus for placing a cannula in a bladder
US9492644B2 (en) 2012-12-21 2016-11-15 Avent, Inc. Dilation device for placing catheter tubes
EP3677199A3 (en) * 2017-11-16 2020-07-29 Covidien LP Surgical instrument with imaging device

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US8002764B2 (en) 2003-05-01 2011-08-23 Swan Valley Medical Incorporated Cystotomy catheter capture device and methods of using same
DE202004021561U1 (en) 2003-08-18 2009-02-12 Univerzita Palackeho Extractor in body cavities of clamped thermoplastic body
US8382785B2 (en) 2007-09-27 2013-02-26 Swan Valley Medical Incorporated Apparatus and method for performing cystotomy procedures
US8118826B2 (en) 2007-09-27 2012-02-21 Swan Valley Medical, Incorporated Method of performing a suprapubic transurethral cystostomy and associated procedures and apparatus therefor
US8118736B2 (en) 2007-09-27 2012-02-21 Swan Valley Medical, Incorporated Method of accessing a bladder and associated apparatus therefor
US8617086B2 (en) 2010-07-01 2013-12-31 Uti Limited Partnership Methods and apparatuses for full-thickness hollow organ biopsy
WO2012042475A1 (en) * 2010-09-27 2012-04-05 Kimberly-Clark Worldwide, Inc. Multi-balloon dilation device for placing catheter tubes
WO2012042476A1 (en) * 2010-09-27 2012-04-05 Kimberly-Clark Worldwide, Inc. Dilation device for placing catheter tubes
US9339442B2 (en) 2010-09-27 2016-05-17 Avent, Inc. Multi-balloon dilation device for placing catheter tubes
US10322067B2 (en) 2010-09-27 2019-06-18 Avent, Inc. Dilation device for placing catheter tubes
US20120184924A1 (en) * 2011-01-14 2012-07-19 Loma Linda University Self-illuminating endogastric tubes and method of placing endogastric tubes
US9011383B2 (en) * 2011-01-14 2015-04-21 Loma Linda University Self-illuminating endogastric tubes and method of placing endogastric tubes
US9492644B2 (en) 2012-12-21 2016-11-15 Avent, Inc. Dilation device for placing catheter tubes
US10130559B2 (en) 2012-12-21 2018-11-20 Avent, Inc. Dilation device for placing catheter tubes
US9271752B2 (en) 2013-03-13 2016-03-01 Swan Valley Medical Incorporated Method and apparatus for placing a cannula in a bladder
WO2015021133A3 (en) * 2013-08-06 2015-04-02 Cook Medical Technologies Llc System and method for external percutaneous connections
US10155102B2 (en) 2013-08-06 2018-12-18 Cook Medical Technologies Llc System and method for external percutaneous connections
WO2015054370A1 (en) * 2013-10-08 2015-04-16 Cook Medical Technologies Llc Device for external percutaneous connections
US9675526B2 (en) 2013-10-08 2017-06-13 Cook Medical Technologies Llc Device for external percutaneous connections
EP3677199A3 (en) * 2017-11-16 2020-07-29 Covidien LP Surgical instrument with imaging device
US10863987B2 (en) 2017-11-16 2020-12-15 Covidien Lp Surgical instrument with imaging device
US11744586B2 (en) 2017-11-16 2023-09-05 Covidien Lp Surgical instrument with imaging device

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ITBO20000511A1 (en) 2002-03-05
ITBO20000511A0 (en) 2000-09-05
AU2001292218A1 (en) 2002-03-22
WO2002019890A3 (en) 2002-08-22

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