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WO2025164296A1 - Instrument de drainage et son utilisation - Google Patents

Instrument de drainage et son utilisation

Info

Publication number
WO2025164296A1
WO2025164296A1 PCT/JP2025/000924 JP2025000924W WO2025164296A1 WO 2025164296 A1 WO2025164296 A1 WO 2025164296A1 JP 2025000924 W JP2025000924 W JP 2025000924W WO 2025164296 A1 WO2025164296 A1 WO 2025164296A1
Authority
WO
WIPO (PCT)
Prior art keywords
drainage
sheath
hole
balloon
stent
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/JP2025/000924
Other languages
English (en)
Japanese (ja)
Inventor
晃久 加藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nagoya City University
Original Assignee
Nagoya City University
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 Nagoya City University filed Critical Nagoya City University
Publication of WO2025164296A1 publication Critical patent/WO2025164296A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • 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
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • 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

  • This disclosure relates to a drainage device.
  • This application is based on Japanese Patent Application No. 2024-013883, filed February 1, 2024, the contents of which are incorporated herein by reference.
  • endoscopic biliary drainage involves dilating the strictured bile duct using a balloon dilation device, then temporarily removing the dilation device, and then inserting and leaving a plastic or metal drainage stent in place.
  • endoscopic ultrasound biliary drainage may also be performed.
  • the present invention can be realized in the following forms:
  • a drainage device includes a balloon catheter having an expandable balloon portion, a distal end portion connected to the distal end of the balloon portion, and a shaft portion connected to the proximal end of the balloon portion; and a sheath having a through hole formed along the longitudinal direction and into which the shaft portion is inserted.
  • the through hole is configured to allow a drainage stent to be inserted when the balloon catheter is removed, and the diameter of the through hole is larger than the outer diameter of the drainage stent.
  • the diameter of the through hole may be 7.3 Fr. or more and 9.0 Fr. or less, and the outer diameter of the sheath may be 8.5 Fr. or more and 10.0 Fr. or less.
  • This form of drainage device can prevent a decrease in the insertability of the sheath while preventing a decrease in the insertability of the drainage stent into the through hole.
  • the difference between the diameter of the through hole and the outer diameter of the shaft portion may be 0.5 Fr. or more and 1.5 Fr. or less.
  • the difference between the diameter of the through hole and the outer diameter of the shaft portion is 0.5 Fr. or more and 1.5 Fr. or less, which prevents a decrease in the force transmission between the sheath and the balloon catheter, thereby preventing a decrease in the breakthrough force of the balloon catheter.
  • the outer diameter of the balloon portion in the expanded state may be 3 mm or more and 6 mm or less.
  • the outer diameter of the balloon portion in the expanded state is 3 mm or more and 6 mm or less, thereby preventing a decrease in operability.
  • the sheath may include a metal mesh.
  • the inclusion of a metal mesh can prevent the sheath from bending or becoming blocked.
  • the drainage device described in any one of (1) to (5) above may further include the drainage stent. This type of drainage device can prevent a decrease in convenience.
  • the drainage stent may be made of plastic. This type of drainage device allows for easy placement of a plastic drainage stent.
  • the drainage stent may be made of metal. This type of drainage device allows for easy placement of a metal drainage stent.
  • the drainage device described in any one of (1) to (8) above may be a biliary drainage device. This type of drainage device can reduce problems with placement of a drainage stent in the biliary tract.
  • This endoscopic biliary drainage method includes a first step of inserting the sheath, into which the balloon catheter in an unexpanded state has been inserted, from the duodenal papilla into the bile duct; a second step of expanding the balloon portion after the balloon portion has reached a stricture in the bile duct; a third step of unexpanding the balloon portion while advancing the sheath to the stricture or after the sheath has reached the stricture; a fourth step of removing the balloon catheter from the through-hole; a fifth step of inserting the drainage stent into the through-hole to reach the stricture; and a sixth step of removing the sheath from the bile duct while leaving the drainage stent in a region including the stricture.
  • This type of endoscopic biliary drainage method allows for easy placement of the drainage stent, thereby
  • This method for endoscopic ultrasound biliary drainage includes step A of inserting the sheath, into which the balloon catheter in an unexpanded state is inserted, into the duodenum or stomach; step B of expanding the balloon portion after reaching a perforation formed from the duodenum or stomach to the gallbladder or bile duct; step C of advancing the sheath to reach the perforation while keeping the balloon portion in an unexpanded state; step D of removing the balloon catheter from the through-hole; step E of inserting the drainage stent into the through-hole to reach the perforation; and step F of removing the sheath from the perforation while leaving the drainage stent in place in an area including the perforation.
  • This type of ultrasound-assisted gallbladder drainage method can prevent bile from leaking from the perforation, thereby reducing problems with
  • the present disclosure can be realized in various forms, such as a biliary drainage kit including a balloon catheter and a sheath, a method for manufacturing a biliary drainage instrument, or a method for assisting treatment using a biliary drainage instrument.
  • the present disclosure can also be realized in various forms, such as a drainage kit including a balloon catheter and a sheath, a method for manufacturing a drainage instrument, or a method for assisting treatment using a drainage instrument.
  • FIG. 1 is an explanatory diagram illustrating a schematic configuration of a biliary drainage instrument.
  • FIG. 1 is an explanatory diagram showing an example of a method of using a biliary drainage instrument.
  • FIG. 1 is a flow chart showing a method for endoscopic biliary drainage.
  • FIG. 10 is an explanatory diagram showing details of the third step.
  • FIG. 10 is an explanatory diagram showing the endoscopic biliary drainage method of a comparative example.
  • FIG. 10 is an explanatory diagram showing another example of a method of using the biliary drainage instrument.
  • FIG. 1 is a process diagram showing a method for endoscopic ultrasound biliary drainage.
  • FIG. 10 is an explanatory diagram showing the state of an ultrasonic endoscopic gallbladder drainage method of a comparative example.
  • FIG. 10 is an explanatory diagram showing another example of a method of using the drainage instrument.
  • a drainage device 100 is provided.
  • the drainage device 100 is used to place a drainage stent during drainage procedures.
  • Applicable drainage procedures include, but are not limited to, biliary drainage, pancreatic duct drainage, pseudocyst drainage, and intraperitoneal abscess drainage.
  • a biliary drainage device 100 is described as an example of a preferred embodiment of the drainage device 100 of the present disclosure.
  • FIG. 1 is an explanatory diagram showing a schematic diagram of the overall configuration of a biliary drainage device according to one embodiment of the present disclosure.
  • the biliary drainage device 100 of the present disclosure is used to place a drainage stent during biliary drainage.
  • the biliary drainage device 100 comprises a balloon catheter 10 and a sheath 20. Note that because each component is shown schematically in FIG. 1, the dimensions of each component differ from the actual dimensions.
  • the balloon catheter 10 has a tubular appearance that is generally circular in cross section.
  • the balloon catheter 10 has a balloon portion 12, a tip portion 14, and a shaft portion 16.
  • the balloon portion 12 is configured to be expandable.
  • the balloon portion 12 is expanded by an inflator (not shown) or the like connected to the rear end of the balloon catheter 10.
  • Figure 1 shows the balloon portion 12 in an expanded state.
  • the outer diameter of the balloon portion 12 in an expanded state is preferably 3 mm or more and 6 mm or less, and more preferably 4.0 mm or more and 6 mm or less, from the viewpoint of preventing a decrease in operability.
  • the tip portion 14 is connected to the tip of the balloon portion 12.
  • the tip portion 14 is tapered, with the diameter decreasing toward the tip. The tapered tip portion 14 prevents a decrease in breakthrough force.
  • the shaft portion 16 is connected to the rear end of the balloon portion 12.
  • the outer diameter of the shaft portion 16 is preferably 7.0 Fr. or less, and more preferably 6.5 Fr. or less, from the viewpoint of preventing a decrease in insertability into the through-hole 22. It is more preferable that it be less than 1 mm. In this disclosure, 1 mm is equivalent to 3 Fr. (French).
  • the sheath 20 has a tubular external shape that is generally circular in cross section.
  • a through-hole 22 is formed in the sheath 20 along the longitudinal direction.
  • the shaft portion 16 of the balloon catheter 10 is inserted into the through-hole 22. Therefore, the diameter of the through-hole 22, i.e., the inner diameter of the sheath 20, is larger than the outer diameter of the shaft portion 16.
  • the diameter of the through-hole 22 is also larger than the outer diameter of the balloon portion 12 in an unexpanded state and the outer diameter of the tip portion 14.
  • the through-hole 22 is configured to allow a drainage stent to be inserted when the balloon catheter 10 is removed. Therefore, the biliary drainage device 100 of the present disclosure is used together with a drainage stent that can be inserted into the through-hole 22.
  • the diameter of the through-hole 22 is larger than the outer diameter of the drainage stent.
  • the difference between the diameter of the through hole 22 and the outer diameter of the shaft portion 16 of the balloon catheter 10 is preferably 0.5 Fr. or more and 1.5 Fr. or less, and more preferably 0.8 Fr. or more and 1.2 Fr. or less.
  • This configuration prevents an excessive gap from forming between the through hole 22 and the shaft portion 16, thereby preventing a decrease in the transmission force and, as a result, preventing a decrease in the breakthrough force of the balloon catheter 10.
  • the diameter of the through hole 22 of the sheath 20 is preferably 7.3 Fr. or greater, from the viewpoint of preventing a decrease in the insertability of the drainage stent into the through hole 22.
  • a diameter of 7.3 Fr. or greater is also preferable from the viewpoint of easily removing the balloon catheter 10 in an unexpanded state.
  • the diameter of the through hole 22 is preferably 9.0 Fr. or less, from the viewpoint of ensuring the wall thickness of the sheath 20 while preventing the outer diameter from becoming excessively large.
  • the diameter of the through hole 22 is preferably 7.3 Fr. or greater but not greater than 9.0 Fr., more preferably 7.3 Fr. or greater but not greater than 8.8 Fr., and even more preferably 7.5 Fr. or greater but not greater than 8.5 Fr.
  • the outer diameter of the sheath 20 is preferably 10.0 Fr. or less, from the viewpoint of preventing a decrease in the insertability of the sheath 20. Furthermore, the outer diameter of the sheath 20 is preferably 8.5 Fr. or greater, from the viewpoint of ensuring the diameter of the through hole 22.
  • the outer diameter of the sheath 20 is preferably 8.5 Fr. or more and 10.0 Fr. or less, and more preferably 8.5 Fr. or more and 9.5 Fr. or less. Therefore, from the perspective of preventing a decrease in the insertability of the sheath 20 while preventing a decrease in the insertability of the drainage stent into the through-hole 22, it is preferable that the diameter of the through-hole 22 be 7.3 Fr. or more and 9.0 Fr. or less, and the outer diameter of the sheath 20 be 8.5 Fr. or more and 10.0 Fr. or less.
  • the sheath 20 includes a metal mesh.
  • the inclusion of the metal mesh can prevent kinking of the sheath 20. In other words, bending or occlusion of the sheath 20 can be prevented.
  • the inner surface of the metal mesh of the sheath 20 is preferably coated, and it is more preferable that both the inner and outer surfaces are coated. Coating the inner surface of the metal mesh can prevent a decrease in the insertability of the drainage stent inserted into the through-hole 22. Coating the outer surface of the metal mesh can prevent a decrease in the insertability of the sheath 20.
  • the material of the metal mesh is not particularly limited, but examples include stainless steel, titanium, nickel, tungsten, etc., and may also be an alloy of various metals.
  • the material of the coating is not particularly limited, but examples include silicon and PTFE (polytetrafluoroethylene).
  • the drainage stent used with the biliary drainage device 100 of the present disclosure may be made of plastic or metal.
  • plastic drainage stents are easy to remove, while metal drainage stents have excellent expandability.
  • the biliary drainage device 100 of the present disclosure allows for easy placement of plastic or metal drainage stents.
  • Figure 2 is an explanatory diagram showing an example of how to use the biliary drainage device 100.
  • Figure 3 is a process diagram showing an endoscopic biliary drainage method.
  • Figure 2 chronologically illustrates the placement of a drainage stent at a stricture 210 in a bile duct 200 during transpapillary biliary drainage, an endoscopic biliary drainage method.
  • Figure 2 shows, as an example, an example in which the stricture 210 is located in an intrahepatic bile duct. It is assumed that the biliary drainage device 100 is inserted and removed along a guidewire (not shown). For this reason, it is assumed that the endoscopic biliary drainage method will be performed with a guidewire (not shown) already placed in the bile duct 200.
  • step P110 the sheath 20 with the unexpanded balloon catheter 10 inserted therein is inserted through the duodenal papilla 220 into the bile duct 200 (step P110).
  • step P110 will also be referred to as the first step.
  • step P120 After the balloon portion 12 reaches the stricture 210 in the bile duct 200, it is expanded (step P120).
  • step P120 will also be referred to as the second step.
  • the balloon portion 12 is expanded by an inflator (not shown) or the like connected to the rear end of the shaft portion 16.
  • Figure 2 shows the balloon portion 12 expanded in the second step, spanning both the front and rear of the stricture 210.
  • step P130 is also referred to as the third step.
  • Figure 2 shows the third step in which the balloon portion 12 is brought into a non-expanded state while the sheath 20 is advanced to reach the stricture 210.
  • Figure 4 is an explanatory diagram showing the details of the third step.
  • the forward movement direction of the sheath 20 is indicated by an arrow pointing to the left side of the page, and the position of the stricture 210 is indicated by a triangle.
  • the sheath 20 In the third step, from the viewpoint of preventing the balloon catheter 10 from advancing excessively, it is preferable to advance the sheath 20 to reach the stenosis 210 while placing the balloon portion 12 in an unexpanded state. If there is space within the bile duct 200 to allow the balloon catheter 10 to advance further, the sheath 20 may be advanced to reach the stenosis 210 and then the balloon portion 12 may be placed in an unexpanded state. In the third step, the pressure in the balloon portion 12 may be gradually released by an inflator (not shown) or the like connected to the rear end of the shaft portion 16, or the pressure in the balloon portion 12 may be released all at once.
  • an inflator not shown
  • the tip of the sheath 20 breaks through the stenosis 210, and the sheath 20 maintains the expansion of the stenosis 210.
  • step P140 the balloon catheter 10 is removed from the through-hole 22 (step P140).
  • step P140 is also referred to as the fourth step.
  • the balloon catheter 10 is removed in an unexpanded state.
  • the sheath 20 alone bridges the front and rear of the stenosis 210.
  • step P150 The drainage stent 30 is inserted into the through-hole 22 until it reaches the stenosis 210 (step P150).
  • step P150 is also referred to as the fifth step.
  • the sheath 20 is removed from the bile duct 200 while the drainage stent 30 is left in place in the area including the stenosis 210 (step P160).
  • step P160 is also referred to as the sixth step. This completes the placement of the drainage stent 30.
  • Figure 5 is an explanatory diagram showing the endoscopic biliary drainage method of the comparative example.
  • Figure 5 chronologically illustrates the placement of a drainage stent 430 at the stricture 210 of the bile duct 200 during transpapillary biliary drainage as endoscopic biliary drainage.
  • the instrument 400 used in this comparative example does not include the sheath 20.
  • a balloon catheter 410 inserted into the bile duct 200 from the duodenal papilla 220 reaches the stricture 210 and is then expanded. After the balloon catheter 410 is removed, a drainage stent 430 is inserted into the bile duct 200 to break through the stricture 210.
  • a path can be secured using the sheath 20 after the balloon portion 12 is expanded, making it possible to easily place the drainage stent 30.
  • problems such as the inability to break through the stricture 210 can be prevented when placing the drainage stent 30 during endoscopic biliary drainage.
  • Figure 6 is an explanatory diagram showing another example of how to use a biliary drainage device.
  • Figure 7 is a process diagram showing a method for endoscopic ultrasound biliary drainage.
  • Figure 6 shows endoscopic ultrasound gallbladder drainage (EUS-GBD) as an example of endoscopic ultrasound (EUS: Endoscopic Ultrasonography) biliary drainage, which is shown chronologically from the top to the bottom of the page. More specifically, the process of perforating the gallbladder 310 from the duodenum 300 and placing a drainage stent 30 is shown schematically. It is assumed that the biliary drainage device 100 is inserted and removed along a guide wire (not shown).
  • EUS-GBD endoscopic ultrasound gallbladder drainage
  • EUS Endoscopic Ultrasonography
  • the ultrasound endoscopic biliary drainage method involves puncturing the duodenum 300 through the gallbladder 310 in advance, forming a perforation 330, through observation using an ultrasound endoscope (not shown), and then placing a guidewire (not shown) in the area including the perforation 330.
  • step P210 the sheath 20 with the balloon catheter 10 inserted in an unexpanded state is inserted into the duodenum 300 (step P210).
  • step P210 will also be referred to as step A.
  • step P220 the balloon portion 12 is expanded by an inflator (not shown) or the like connected to the rear end of the shaft portion 16.
  • Figure 6 shows the state in which the balloon portion 12 is expanded in step B, straddling both the front and rear of the perforation 330.
  • step P230 is also referred to as step C.
  • step C even if the relative positions of the duodenum 300 and the gallbladder 310 change, the sheath 20 can be pushed into the gallbladder 310 by deflating the balloon portion 12 and advancing the sheath 20 at the same time.
  • the pressure in the balloon portion 12 may be gradually released by an inflator (not shown) or the like connected to the rear end of the shaft portion 16, or the pressure in the balloon portion 12 may be released all at once.
  • step C places the duodenum 300 and the gallbladder 310 in communication with each other via the perforation 330 via the sheath 20.
  • step P240 The balloon catheter 10 is removed from the through-hole 22 (step P240).
  • step P240 will also be referred to as step D.
  • a drainage stent 30 is inserted into the through-hole 22 to reach the perforation 330 (step P250).
  • step P250 will also be referred to as step E.
  • the drainage stent 30 used in step E is preferably made of metal from the perspective of excellent expandability.
  • Figure 6 shows a shaft 90 for delivering the drainage stent 30. While the drainage stent 30 is placed in the area including the perforation 330, the sheath 20 is removed from the perforation 330 (step P260). In the following explanation, step P260 will also be referred to as step F. This completes the placement of the drainage stent 30, and a fistula is formed between the duodenum 300 and the gallbladder 310.
  • FIG 8 is an explanatory diagram showing a comparative example of an endoscopic ultrasound gallbladder drainage method.
  • Figure 8 shows endoscopic ultrasound gallbladder drainage as endoscopic biliary drainage, chronologically from top to bottom of the page.
  • the instrument 500 used in this comparative example does not include the sheath 20.
  • the gallbladder 310 is visualized by ultrasound from the duodenum 300 using observation with the EUS 320, and then the needle 510 is inserted from the duodenum 300 to the gallbladder 310. After that, the guidewire 520 is placed, and the puncture path at the puncture site 340 is expanded with the balloon catheter 530. The balloon catheter 530 is then removed, and a drainage stent is inserted.
  • this method of the comparative example is unsafe because bile leakage may cause peritonitis.
  • a path can be secured using the sheath 20 after the balloon portion 12 is expanded, making it possible to easily place the drainage stent 30.
  • bile leakage from the perforation 330 can be suppressed. This prevents problems from occurring when placing the drainage stent 30, thereby preventing a decrease in safety.
  • bile leakage from the perforation 330 can be further suppressed, thereby further preventing a decrease in safety.
  • the biliary drainage device 100 may further include a drainage stent 30.
  • This configuration can prevent a decrease in convenience.
  • the drainage stent 30 included in the biliary drainage device 100 may be made of plastic. This configuration allows a plastic drainage stent 30 to be easily placed.
  • the drainage stent 30 included in the biliary drainage device 100 may be made of metal. This configuration allows a metal drainage stent 30 to be easily placed.
  • a biliary drainage device 100 including a metal drainage stent 30 is suitable for use in forming a fistula in ultrasound-assisted biliary drainage.
  • the biliary drainage device 100 is described as being applied to transpapillary biliary drainage and endoscopic ultrasound gallbladder drainage, but the present disclosure is not limited to this.
  • endoscopic ultrasound biliary drainage is not limited to EUS-GBD.
  • the device may also be used in EUS-HGS (hepaticogastrostomy), which forms a fistula between the stomach and bile duct, or EUS-CDS (choledochoduodenostomy), which forms a fistula between the duodenum and bile duct.
  • EUS-HGS hepaticogastrostomy
  • EUS-CDS choledochoduodenostomy
  • a method for endoscopic ultrasound biliary drainage may generally include step A of inserting the sheath 20, into which the unexpanded balloon catheter 10 is inserted, into the duodenum 300 or stomach, and step B of expanding the balloon portion 12 after it reaches the perforation 330, which has been perforated from the duodenum 300 or stomach to the gallbladder 310 or bile duct 200.
  • FIG. 9 is an explanatory diagram showing another example of how to use the drainage instrument 100.
  • FIG. 9 shows the drainage instrument 100 of the present disclosure being used for pancreatic duct drainage.
  • Pancreatic duct drainage can be performed using a method similar to that used for biliary duct drainage described above.
  • drainage instruments 100 used in areas other than the biliary tract can also employ a configuration similar to that of the biliary tract drainage instrument 100, which is an example of a preferred embodiment described above.
  • EPS endoscopic pancreatic stenting
  • EPS is performed primarily to treat pancreatic duct strictures due to chronic pancreatitis.
  • a stricture 620 in the pancreatic duct 600 is confirmed from the duodenal papilla 220 using a side-viewing endoscope 610 for contrast imaging.
  • a sheath 20 with an unexpanded balloon catheter 10 inserted therein is inserted from the duodenal papilla 220 into the pancreatic duct 600.
  • the balloon portion 12 is expanded across the stricture 620 and both its anterior and posterior regions.
  • the balloon portion 12 is deflated while the sheath 20 is advanced to reach the stricture 620.
  • the sheath 20 maintains the dilation of the stricture 210 and bridges the area in front of and behind the stricture 620, and the undilated balloon catheter 10 is removed.
  • a drainage stent 30 is inserted into the through-hole 22 of the sheath 20 and placed in the area anterior to the stricture 620 where drainage is required.
  • the sheath 20 is removed from the pancreatic duct 600. This completes the EPS procedure.
  • This method includes the following steps: 1', inserting a sheath 20, into which a non-expanded balloon catheter 10 has been inserted, from the duodenal papilla 220 into the pancreatic duct 600; 2', expanding the balloon portion 12 after it has reached the stricture 620 in the pancreatic duct 600; 3', advancing the sheath 20 to reach the stricture 620 and then unexpanding the balloon portion 12; 4', removing the balloon catheter 10 from the through-hole 22; 5', inserting a drainage stent 30 into the through-hole 22 to reach the stricture 620; and 6', removing the sheath 20 from the pancreatic duct 600 while leaving the drainage stent 30 in place in the area including the stricture 620.
  • EUS-GBD has been described as an example of endoscopic ultrasound-guided drainage, but the present disclosure is not limited to this.
  • the drainage instrument 100 of the present disclosure may be used, for example, for endoscopic ultrasound-guided cyst drainage (EUS-CD), abscess drainage, etc.
  • the drainage instrument 100 of the present disclosure may be applied to abscesses in the broad sense, such as pancreatic pseudocysts and infection of fluid retention (pancreatic juice, bile, intestinal juice) after abdominal surgery.
  • This type of drainage can also be performed in the same manner as the above-mentioned EUS-GBD, by inserting a needle from the stomach or duodenum into the target pseudocyst or abscess.
  • This method includes step A of inserting a sheath 20 with an unexpanded balloon catheter 10 inserted into the duodenum 300 or stomach; step B' of expanding the balloon portion 12 after it reaches a perforation 330 formed in the duodenum 300 or stomach leading to a pseudocyst or abscess; step C of advancing the sheath 20 to reach the perforation 330 while unexpanding the balloon portion 12; step D of removing the balloon catheter 10 from the through-hole 22; step E of inserting a drainage stent 30 into the through-hole 22 so that it reaches the perforation 330; and step F of removing the sheath 20 from the perforation 330 while leaving the drainage stent 30 in place in the area including the perforation 330.
  • the present invention is not limited to the above-described embodiments, and can be realized in various configurations without departing from the spirit of the present invention.
  • the technical features in the embodiments and examples corresponding to the technical features in each aspect described in the Summary of the Invention section can be replaced or combined as appropriate to solve some or all of the above-described problems or to achieve some or all of the above-described effects.
  • a technical feature is not described as essential in this specification, it can be deleted as appropriate.

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Abstract

L'invention concerne une technique permettant d'éliminer des défauts dans le placement d'endoprothèse de drainage. Cet instrument de drainage comprend : un cathéter à ballonnet qui comporte une partie ballonnet expansible, une partie d'extrémité avant continue avec l'extrémité avant de la partie ballonnet, et une partie corps continue avec l'extrémité arrière de la partie ballonnet ; et une gaine dans laquelle un trou traversant est formé dans le sens de la longueur, et dans laquelle la partie corps est insérée dans le trou traversant. Le trou traversant est configuré pour qu'une endoprothèse de drainage puisse y être insérée dans un état dans lequel le cathéter à ballonnet a été retiré. Le diamètre du trou traversant est supérieur au diamètre extérieur de l'endoprothèse de drainage.
PCT/JP2025/000924 2024-02-01 2025-01-15 Instrument de drainage et son utilisation Pending WO2025164296A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024-013883 2024-02-01
JP2024013883 2024-02-01

Publications (1)

Publication Number Publication Date
WO2025164296A1 true WO2025164296A1 (fr) 2025-08-07

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PCT/JP2025/000924 Pending WO2025164296A1 (fr) 2024-02-01 2025-01-15 Instrument de drainage et son utilisation

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WO (1) WO2025164296A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0576602A (ja) * 1991-09-20 1993-03-30 Olympus Optical Co Ltd 生体管路拡張具
JPH11235386A (ja) * 1997-05-20 1999-08-31 Sumitomo Bakelite Co Ltd 拡張バルーンカテーテル
JP2011521680A (ja) * 2008-05-12 2011-07-28 エクスルメナ， インコーポレイテッド 経管腔アクセスのためのシステムおよび方法

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