HK1152260B

HK1152260B - Guide tube having balloons for puncture

Info

Publication number: HK1152260B
Application number: HK11105428.8A
Authority: HK
Inventors: Hideto Oishi; Yukihiko Sakaguchi
Original assignee: Sumitomo Bakelite Co., Ltd.; Hideto Oishi
Filing date: 2007-12-18
Publication date: 2013-03-28

Description

Catheter with puncture balloon

Technical Field

The present invention relates to a device for safely and reliably securing a route for percutaneous access to the inside of a body, and more particularly to a catheter with a puncture balloon in which an inner balloon is formed so that the inner balloon can be inserted into a tube holding the balloon and used, using as a target a balloon that does not immediately rupture even if punctured with a puncture needle or the like.

Background

Conventionally, as a method for enteral nutrition administration, Percutaneous Endoscopic Gastrostomy (PEG), which is one of endoscopic operations for forming a fistula hole in the surface of the skin of the stomach lumen and abdominal wall using an endoscope, was developed in 1979 by Gaudert and Ponsky surgeons Ponsky (see, for example, patent document 1), and a variety of surgical procedures using this gastrostomy have been developed and widely used.

However, since the puncture is made through the stomach wall or the abdominal wall, it cannot be used or is difficult to use in cases such as "a case with a large amount of ascites accumulation", "a case where the liver and the transverse colon are located between the stomach and the abdominal wall", "a case of a previous gastric surgery", and the like.

In addition, in the method of placing a tube in the stomach through the nose, when the tube is placed for a long time, pain in the nostrils, nasal cavity, and throat becomes strong, and ulcer may be formed in the nostrils, and it may be difficult to keep the tube, and further, pneumonia may be caused by difficulty in expectoration discharge. These are also not preferable from the viewpoint of QOL (quality of life).

On the other hand, a method of forming a cervical esophageal fistula under X-ray fluoroscopy was developed in 1993 by midfield et al. In the indwelling method, a tube with a balloon is inserted into the esophagus through the nose, and a contrast medium is injected into the balloon through the cervical esophagus to expand the lumen of the cervical esophagus. Next, the cervical esophagus was punctured percutaneously under X-ray fluoroscopy, creating a cervical esophageal fistula, and the feeding tube was left behind. The indwelling method is simple and convenient, causes little invasion and pain to patients, and is useful for long-term nutrition management.

However, this method only punctures under X-ray fluoroscopy, and has a possibility of being accompanied by danger in view of the anatomy of the neck. In this method, a balloon catheter was used instead of a Foley catheter for indwelling a bladder, and whether or not the puncture needle reached the esophageal lumen was identified by balloon rupture at the time of puncture. Therefore, there is a fear that the esophageal wall is damaged by the needle tip after the balloon is ruptured, or the puncture needle is detached from the esophageal wall due to a shallow needle puncture.

In 1997, a method of forming a cervical esophageal fistula by X-ray fluoroscopy of middle-field et al, which is the inventor of the present application, was improved, and as a method of puncturing a balloon of a balloon catheter (cathter), a method of safely and reliably puncturing the balloon by puncturing while confirming the balloon position from the outside of the body using an ultrasonic probe was devised (for example, see non-patent documents 1 and 2).

The present inventors have further improved the above-described method for forming a cervical esophageal fistula by providing a balloon that does not rupture immediately even if the balloon of a punctured balloon catheter is punctured and combining a dedicated introduction tool (see, for example, patent document 2), thereby realizing implementation at the bedside without using an X-ray device.

Patent document 1: japanese Kohyo publication Hei 6-503243

Patent document 2: international publication No. 99/36120 pamphlet

Non-patent document 1: dashi, J.J., J.Sci.J.J.J.Soc., 1997 for percutaneous transluminal esophageal gastrostomy, and its adaptation and usefulness.

Non-patent document 2: dashi, the journal of the Japanese society for digestive organ surgery, 1997 for percutaneous transluminal esophageal gastrostomy and its major and minor injuries.

Disclosure of Invention

The present invention has been made in view of the current situation of the catheter with a balloon for puncture described above, and an object thereof is to provide a catheter with a balloon for puncture for safely and reliably securing a route for percutaneous approach to the inside of the body, and to improve the catheter so that a deeper puncture amount can be secured when the balloon is punctured by a puncture needle.

Namely, the invention of the present application:

(1) a catheter with a balloon for puncture, comprising a main tube having a balloon on the front end side surface, a main lumen for endoscope insertion extending from the rear end to the front end, and a sub-lumen for gas-liquid communication with the inside of the balloon, an endoscope insertion section is provided at the rear end of the main lumen, and an operation connector for inflating and deflating the balloon is provided at the rear end of the sub lumen, the catheter is characterized in that the balloon on the front end side surface is an outer balloon, a needle insertion hole through which a puncture needle can sufficiently pass is formed in a wall surface of a main tube positioned inside the outer balloon, the hole is hermetically closed by an expandable sealing material, the sealing material is an inner balloon, and the inner balloon is formed so that when the outer balloon is expanded, the inner balloon is expanded from the needle insertion hole to the inside of the main lumen by the internal pressure of the outer balloon, and the tip of the puncture needle can be inserted into the expanded portion.

(2) In the catheter with a puncture balloon according to the present invention, the outer balloon and the inner balloon are preferably formed of the same material in the above-described configuration, but need not be formed of the same material.

(3) The size of the long hole for inserting the lancet is preferably about 10mm × 20 mm.

(4) In the above insertion hole, preferably, a mark for identifying a position on the outer peripheral wall of the body tube of the hole is provided on a line along the longitudinal direction of the body tube including the hole. The mark may be provided on the side of the hand of the body tube or from the side of the hand to somewhere near the hole.

(5) Further, a reinforcing pipe is provided on the inner surface of the main cavity of the main body pipe, the main cavity being provided with the elongated hole. The reinforcing tube prevents deformation and breakage of the cavity provided with a long hole for needle insertion when the outer balloon is inflated.

(6) The balloon for puncture according to any one of the above (1) to (4), wherein the outer balloon has a wall thickness of 0.01 to 1mm, a tensile strength of 8 to 25MPa, a 100% modulus of 3 to 6MPa, an elongation of 300 to 460%, and a balloon internal pressure of 2.8 to 75psi, and the inner balloon has the same material characteristics as the outer balloon or material characteristics that are more easily expandable than the outer balloon.

(7) In the catheter according to any one of the above (1) to (5), the main body tube has transparency enabling the inside of the outer balloon to be visually recognized from the endoscope.

(8) In the catheter according to any one of the above (1) to (6), the outer balloon attaching portion on at least the distal end side of the main body tube is provided so as to be disposed inside the outer balloon with respect to the longitudinal direction of the outer balloon.

(9) The catheter according to any one of the above (1) to (7), wherein a membrane-like sealing member provided with a slit or a hole is attached to a rear end portion of the endoscope insertion lumen.

By using the catheter with a balloon for puncture of the present invention, the puncture needle can be inserted deeper when the balloon is punctured by the puncture needle, and therefore, the catheter is extremely suitable for safely and reliably creating percutaneous routes for various purposes to all luminal organs (esophagus, stomach, bile duct, pancreatic duct, intestine, ureter, bladder, and the like).

Drawings

Fig. 1 is a side sectional view of a conventional catheter.

Fig. 2 is a schematic view showing a method of using the catheter of fig. 1.

Fig. 3 is a side sectional view of a catheter with a puncture balloon according to an embodiment of the present invention.

Fig. 4 is a side sectional view of a catheter according to an embodiment of the present invention.

Fig. 5 is a right side sectional view of fig. 4.

Fig. 6 is a plan view of fig. 4.

Fig. 7 is an enlarged side sectional view of the distal end portion showing a state where the puncture needle is punctured at the time of inflation of the catheter which is one embodiment of the present invention.

Fig. 8 is a right side sectional view of fig. 7.

Description of the reference symbols

1: body tube

2: outer balloon

3: connector with a locking member

4: film-like sealing part

5: main cavity for inserting endoscope

6: auxiliary cavity

7: mounting part of outer balloon 2

8: reinforced pipe

9: inner balloon

10: long hole

11: marking

Detailed Description

Next, the present invention will be specifically described with reference to the drawings.

Fig. 1 is a side sectional view of a conventional catheter with a balloon for puncture (hereinafter, simply referred to as "catheter"), fig. 2 is a schematic view showing a method of using the catheter of fig. 1, fig. 3 is a side sectional view of a catheter as an embodiment of the present invention, fig. 4 is an enlarged side sectional view of a distal end of the catheter as an embodiment of the present invention, fig. 5 is a right side sectional view of fig. 4, fig. 6 is a plan view of fig. 4, fig. 7 is an enlarged side sectional view of the distal end showing a state where a puncture needle is punctured at the time of inflation of the catheter as an embodiment of the present invention, and fig. 8 is a right side sectional view of fig. 7.

First, an example of an endoscope insertion type conventional catheter with a puncture balloon will be described with reference to fig. 1 and 2. As shown in fig. 1, the conventional catheter includes a main body tube 1, a balloon 2, a connector 3, a membrane-like sealing portion 4 for endoscope insertion, a main lumen (lumen)5 for endoscope insertion, a sub-lumen 6, and a balloon attaching portion 7.

The main body tube 1 of fig. 1 is a thin-walled tube and has 1 or more inner lumens, one of which is a sub-lumen 6 for balloon inflation, and the front end of the inner lumen is closed and has a side hole 6a opening to the balloon lumen. The main lumen 5 for endoscope insertion is formed to have substantially the same thickness as the endoscope 20 to be used and to have an appropriate length in consideration of the patient's physique, the insertion site, and the like. Further, the main body tube 1 has appropriate flexibility and elasticity at normal room temperature and body temperature, and as a material for forming the main body tube, a synthetic resin such as a soft vinyl chloride resin, a polyurethane resin (polyurethane resin), a silicone rubber, or the like is generally used. It is important that the balloon be a material having transparency to the extent that the inside of the balloon can be visually recognized by an endoscope.

Next, as an example of a method of using the conventional catheter described with reference to fig. 1, a method of securing an insertion path from the neck to the esophagus through the skin will be described with reference to fig. 2. As shown in fig. 2, an endoscope insertion main lumen 5 for inserting an endoscope 20 for an upper digestive organ, a bronchus, or other uses into a guide tube is inserted into a portion over the esophageal entrance via the mouth in a state where the endoscope 20 is extended from the distal end of the guide tube. Next, a catheter is inserted along the endoscope 20, and a connector 3 to which a syringe 21 or the like is connected in advance is injected with a physiological saline solution or the like at a position where the balloon 2 passes over the esophageal entrance portion 23 to inflate the balloon 2, and further, in order to secure a wide puncture site, the endoscope 20 is pulled backward, and the position of the balloon 2 is confirmed by an ultrasonic probe attached to the neck portion from the body surface.

The puncture needle 22 is inserted into the balloon 2 in a state in which the thyroid, trachea, artery, vein, and the like are shifted to the left and right with respect to the balloon 2 by strongly pressing the ultrasonic probe. At the moment when the puncture needle 22 is inserted, the balloon 2 does not crack or contract, and it is confirmed from the endoscopic image and the ultrasonic image that the distal end of the puncture needle 22 is reliably positioned inside the balloon 2.

After the above-described operation, the puncture needle 22 is removed by inserting a lead wire (not shown) by a necessary amount from the distal end of the puncture needle 22. The endoscope 20 and the puncture balloon 2 are pushed in, and the guide wire is detached from the balloon 2 while being oriented toward the stomach side. Then, the balloon 2 is deflated by sucking the physiological saline or the like in the balloon 2 with the syringe 21, the endoscope 20 is pulled back to the upper portion of the esophagus, a sheathed (sheath) dilator (not shown) is inserted from the distal end of the guide wire to dilate the puncture site while visually recognizing and confirming with the endoscope 20, and a path into the esophagus is secured by merely pulling out the dilator. By ensuring this path, then, the appropriate catheter is inserted.

In the conventional catheter described with reference to fig. 1 and 2, when the balloon 2 is punctured with the puncture needle 22, the tip of the needle 22 abuts against the surface of the auxiliary lumen 6 or the endoscope insertion lumen 5 in the balloon 2 and then does not puncture by more than that amount, so that the puncture depth is shallow and there is a limit to the extent that the puncture needle 22 cannot be said to be detached from the balloon 2.

In the present invention, the balloon 2 of the main lumen 5 for endoscope insertion is an outer balloon, an elongated hole 10 of about 10 × 20mm is formed as a needle insertion hole through which the puncture needle 22 can sufficiently pass in a portion located inside the outer balloon 2, and an inflatable sealing material capable of hermetically sealing the elongated hole 10 is provided as the inner balloon 9. With this configuration, when the liquid is injected from the sub-chamber 6 into the outer balloon 2 and the balloon 2 is inflated, the inner balloon 9 bulges out from the elongated hole 10 toward the inside of the main chamber 5 due to the internal pressure in the balloon (see fig. 7 and 8). As a result, when the puncture needle 22 punctures the outer balloon 2, the tip 22a of the puncture needle 22 can be inserted into the inner balloon 9 bulging toward the inside of the hole 10 through the long hole 10. Here, since the outer balloon 2 is first deflated by sucking the liquid in the balloon 2 without immediately rupturing the outer balloon 2, it can be confirmed by the endoscope and the ultrasonic wave that the distal end 22a of the puncture needle 22 is located inside the swollen inner balloon 9. Further, since the puncture needle 22 can be inserted further, the needle 22 can be prevented from coming out of the outer balloon 2, and the lumen can be secured until the outer balloon 2 contracts.

It should be noted that the distal end of the main body tube 1 is naturally subjected to chamfering or the like in order to improve the insertability into the body, and although not shown, the distal end of the tube is preferably cut into a shape inclined rather than a right angle in order to improve the insertability.

Next, a specific example of a catheter having a main lumen 5 for inserting an endoscope of the present invention will be described with reference to fig. 3 to 7. As illustrated in fig. 3, the catheter of the present invention includes a main body tube 1, a balloon 2, a connector 3, a membranous sealing portion 4, a main lumen 5 for endoscope insertion, a sub-lumen 6, and a balloon attaching portion 7. This point is the same as that of the conventional catheter shown in fig. 1, but in the present invention, the balloon 2 is referred to as an outer balloon.

The main body tube 1 of fig. 3 is formed of a thin tube, and includes: a main lumen 5 for endoscope insertion, which is formed to have a shape and properties such as an inner diameter that allows the endoscope 20, which penetrates from the distal end to the rear end thereof, to enter and exit; and an auxiliary lumen 6 having a side hole 6a closed at the front end and opened to the inner lumen of the outer balloon 2, and the rear end of the main body tube 1 communicating with the connector 3 to allow the balloon inflation liquid to flow in and out of the inner lumen of the balloon 2.

Note that the shape obtained by chamfering, oblique cutting, or the like for improving the insertion property applied to the distal end of the main body tube 1 of fig. 3 is also the same as the example described above.

The main body tube 1 is preferably thin in that the outer diameter thereof is reduced as much as possible while ensuring the inner diameter into which the endoscope to be used can be inserted, but is set to a suitable size to such an extent that the lumen is not closed by bending. Therefore, it is also one of preferable embodiments to form the body pipe 1 as a composite pipe and embed a resin, a metal mesh, and the like. The length of the body tube 1 is arbitrarily set according to the target site. The body tube 1 has appropriate flexibility and elasticity at normal room temperature and body temperature, and as a material for forming the body tube, for example, a synthetic resin such as a soft vinyl chloride resin, a urethane resin, or a silicone rubber is usually used as appropriate.

Next, the body tube 1 in the present invention is also preferably subjected to a lubricating treatment on the outer periphery or the inner cavity thereof, and examples of the treatment include coating with a fluororesin, kneading with silicone oil to the material, and the like, and coating with various hydrogels is practical, and the hydrogel is preferably collagen, polyvinylpyrrolidone, polyacrylamide, and the like in consideration of toxicity to the human body. The fixation of these hydrogels to the body tube 1 can utilize: a method in which these hydrogels previously set as a solution are applied to a catheter and then crosslinked by glutaraldehyde; a method of crosslinking these monomers of the hydrogel by a polymerization initiator after coating; a method in which a solution of the hydrogel denatured by the photoreactive crosslinking agent is applied to the body tube 1 and fixed by light irradiation, and the like. Further, the main body tube 1 is preferably made of a material having transparency enough to allow the inside of the balloon 2 to be visually recognized under an endoscope.

The outer balloon 2 is formed to have a length of 1 to 20cm, an inflated diameter of 5 to 200mm, and a wall thickness of 0.01 to 1mm, depending on the insertion site. For example, when the balloon is inserted through the nose, the balloon wall thickness is set to, for example, about 0.1 to 0.3mm so as to make the balloon as small as possible (arteria pekinensis 12425 なぃ), and the balloon wall thickness is set to about 3 to 10cm in length and 30mm in inflated diameter in the esophagus and about 5 to 20cm in length and 200mm in inflated diameter in the stomach.

The material for forming the outer balloon 2 is generally selected from synthetic resins having hardness of JISA20 to 80 degrees, tensile strength of 8 to 25MPa, tear strength of 20 to 60kg/cm, 100% modulus of 3 to 6MPa, elongation of 300 to 460%, and balloon internal pressure of 2.8 to 75psi, and for example, soft vinyl chloride resin, polyurethane resin, silicone rubber, etc. are preferably used, but not limited thereto, and polyethylene, polyester, natural rubber latex, etc. may be used.

When the outer balloon 2 is formed using silicone rubber, natural rubber, or the like, there is a possibility that the outer balloon 2 will break at the moment when the puncture needle is inserted due to its elasticity, and therefore, there are cases where nylon mesh or the like is formed on the outer balloon 2 by impregnation or lamination, or synthetic resin is applied to the surface, back surface, or multiple layers of the balloon 2, and improvement is made so that the outer balloon 2 will not break at the moment when the puncture needle is inserted.

For example, when the outer balloon 2 is made of a soft vinyl chloride resin for insertion through the mouth into the esophagus, a material having a hardness of 60 degrees, a tensile strength of 16MPa, a tear strength of 45kg/cm, a 100% modulus of 4.5MPa, and an elongation of about 400% is selected, and the outer diameter of the balloon is made to be about 2/3, which is about 0.1 to 0.3mm in thickness and a desired inflation diameter. Thus, when the puncture needle is inserted and the inner needle is removed after the outer balloon 2 is inflated to a desired inflation diameter, the balloon inflation liquid does not instantaneously burst and has an appropriate internal pressure such that the balloon inflation liquid gradually flows out from the needle base portion due to the internal pressure of the outer balloon 2. The outer balloon 2 is molded into a desired shape by a molding method such as blow molding, dip molding, extrusion molding, or compression molding.

In addition, as for the method of attaching the outer balloon 2, it is preferable to shorten the projection length from the distal end of the endoscope as much as possible as described above, and it is preferable to fold and attach the outer balloon so that at least the balloon attaching portion 7 on the distal end side of the body tube 1 is disposed inside the outer balloon 2, and means such as adhesion or welding is selected for the attachment. This reduces the damage to the tissue inserted into the periphery.

The endoscope insertion site may be any site that satisfies the insertion operability with the endoscope 20 by the material selected for the body tube 1, and for example, it is preferable that: the body tube 1 is made of a different material such as a soft vinyl chloride resin for preventing penetration of the puncture needle 22 and a silicone rubber for flexibility of the endoscope insertion site.

The sub-chamber 6 is connected to the outer balloon 2 and the connector 3 in a gas-liquid flow manner, and is used to flow a liquid for inflating and deflating the outer balloon 2, and the material used is not particularly limited as long as it has flexibility and sufficient strength, and soft vinyl chloride resin, polyurethane resin, silicone rubber, or the like is preferably used.

In the present invention, a slit-like elongated hole 10 penetrating through the main lumen 5 for endoscope insertion is provided at a portion where the outer balloon 2 is attached, specifically, in a range surrounded by the outer balloon 2, on the distal end side of the main tube 1, and the elongated hole 10 is hermetically closed by an inflatable sealing material, whereby the sealing material is the inner balloon 9. The illustrated sealing member is a rectangular member larger than the long hole 10.

In the present invention, a cylindrical sealing material covering the entire circumference of the body tube 1 can be used as the sealing material of the inner balloon 9. When a cylindrical sealing material is used, a communication hole communicating with the side hole 6a at the front end of the sub-chamber 6 is provided. The material and material characteristics of the sealing material of the inner balloon 9 are preferably the same as those of the outer balloon 2, but the inner balloon 9 may be made of a material having material characteristics that are more easily inflated than the outer balloon 2. The material of the inner balloon 9 is not limited to the above example.

Further, in the present invention, in order to identify the position in the circumferential direction of the main body tube 1 where the position of the elongated hole 10 provided with the inner balloon 9 is located (the position is synonymous with the position on the outer periphery of the main lumen 5 for endoscope insertion), a mark 11 is applied on a straight line including the hole 10 in the longitudinal direction of the main body tube 1 (or the lumen 5). The mark 11 may be provided on the side of the main body tube 1 or somewhere near the elongated hole 10 from the side of the side (see fig. 6).

When a liquid for inflating the outer balloon 2 is injected into the balloon 2 by the syringe 21 connected to the rear end of the main body tube 1 via the connector 3 in the state where the inner balloon 9 is provided as described above, the outer balloon 2 inflates outward. The inner balloon 9 to which the pressure inside the inflated outer balloon 2 is applied at this time bulges out from the elongated hole 10 toward the inside of the main lumen 5 for endoscope insertion (see fig. 7).

In the present invention, in order to identify where the elongated hole 10, which is an inner-side bulging portion of the lumen 5 by the inner balloon 9, is located on the inner periphery of the body tube 1 (or the lumen 5), a mark 11 is provided on an extension line of the elongated hole 10 along the longitudinal direction of the body tube 1. The mark 11 may be on the side of the main body tube 1 or somewhere from the side to the vicinity of the elongated hole 10.

By the above-described operation, in the form illustrated in fig. 7 and 8, the distal end 22a of the puncture needle 22 can enter the space inside the main lumen 5 for endoscope insertion, that is, the bulge inside the lumen 5 by the inner balloon 9, in the outer balloon 2 where the outer balloon 2 and the inner balloon 9 face each other.

In the present invention, the main body tube 1 positioned inside the outer balloon 2 is formed with the elongated hole 10, and the inner balloon 9 closes the hole 10, so that the "cylindrical cross section" of the main body tube 1 is formed with the "slit" formed by the elongated hole 10. When the balloon 2 is inflated by injecting a liquid into the outer balloon 2 and the internal pressure of the balloon 2 is applied to the entire circumference of the cavity 5, the "incision effect" by the "incision" cannot be said to cause no risk of deformation or destruction of the cross section of the body tube 1.

Therefore, in the present invention, there is a case where the thin metal or hard synthetic resin reinforcing tube 8 is disposed on the inner surface of the main lumen 5 for endoscope insertion in which the elongated hole 10 is formed so as to be closely fitted to the inner surface, so that the above-described deformation and breakage do not occur. Here, the inner surface of the tube 8 may be disposed on the same surface as the inner surface of the main lumen 5, or may be a mesh tube 8 through which the puncture needle 22 cannot penetrate.

Here, the connector 3 is connected to a syringe so that liquid for inflation of the outer balloon 2 can be injected, and therefore, a luer taper (luer taper) is required, but a plug member (a one-way valve, a two-way plug, a three-way plug, or the like) may be used in some cases, and a member having a connector tip of a lock type may be used. The material of the connector 3 and the plug member is not particularly limited, but a synthetic resin such as a hard vinyl chloride resin, a polycarbonate resin, and an ABS resin is preferably used.

Next, as an example of a method of using the catheter of the present invention described with reference to fig. 3 to 8, a method of securing an insertion path from the neck to the esophagus through the skin will be described as an example. This method is basically the same as the case of the conventional catheter (fig. 1) described above with reference to fig. 2.

As shown in fig. 2, an endoscope insertion main lumen 5 for inserting an endoscope 20 for an upper digestive organ, a bronchus, or other uses into a guide tube is inserted into a portion over the esophageal entrance via the mouth in a state where the endoscope 20 is extended from the distal end of the guide tube. Next, a catheter is inserted along the endoscope 20, and a physiological saline or the like is injected into the outer balloon 2 at a position beyond the esophageal entrance 23 through the connector 3 to which the syringe 21 or the like is connected in advance, thereby inflating the outer balloon 2. Here, the endoscope 20 is pulled backward to secure a wide puncture site, and the position of the outer balloon 2 is confirmed by an ultrasonic probe that is stuck to the neck from the body surface.

Further, the puncture needle 22 is inserted into the outer balloon 2 in a state in which the thyroid, trachea, artery, vein, and the like are shifted from the left to right with respect to the outer balloon 2 by strongly pressing the ultrasonic probe. During the puncture of the puncture needle 22, the puncture needle can be punctured with the mark 11 as an index so that the needle tip 22a does not come off the long hole 10. At the moment when the puncture needle 22 is punctured, the outer balloon 2 does not burst or contract, and it is confirmed that the distal end 22a of the puncture needle 22 is reliably positioned inside the outer balloon 2 by the endoscopic image and the ultrasonic image.

At this time, in the catheter of the present invention, the space into which the puncture needle 22 can enter is formed inside the main lumen 5 through the elongated hole 10 by the outward inflation of the outer balloon 2 and the inward bulging of the inner balloon 9 provided in the elongated hole 10 in the outer balloon 2, so that the puncture needle 22 can be inserted deeper than in the conventional catheter. Further, even if the puncture needle 22 pierces the inner balloon 9, the inner balloon 9 is not broken at once, and there is no risk that the endoscope image and the ultrasonic image cannot be captured immediately.

Next, a lead (not shown) is inserted from the distal end of the puncture needle 22 by a necessary amount, and the puncture needle 22 is removed. The guide wire is detached from the inside of the outer balloon 2 while being oriented to the stomach side while the endoscope 20 and the outer balloon 2 are pushed in. Then, the syringe 21 sucks the physiological saline or the like in the outer balloon 2 to contract the outer balloon 2, the endoscope 20 is pulled back to the upper portion of the esophagus, a sheathed dilator (not shown) is inserted from the distal end of the guide wire to dilate the puncture site while visually recognizing and confirming the puncture site by the endoscope 20, and only the dilator is pulled out to secure a path into the esophagus. Thereby, an appropriate catheter can thereafter be inserted.

The site and method using the catheter of the present invention can ensure a safe and reliable route for percutaneous access to all lumen organs (esophagus, stomach, bile duct, pancreatic duct, intestine, ureter, bladder, etc.) by appropriately changing and selecting the dimensions and materials of the endoscope 20, outer balloon 2, inner balloon 9, puncture needle 22, other guide wires, dilator, and sheath used, in addition to the above-described method of creating a route for percutaneous access from the neck to the esophagus.

The main tube 1, which is a component of the catheter of the present invention, has a main lumen 5 for endoscope insertion extending from the distal end to the rear end thereof for inserting and removing the endoscope as described above, but when an endoscope operation such as suction is required at the time of treatment, a membrane-like seal portion 4 having a slit or a hole may be provided at the rear end of the main lumen 5 in order to secure a negative pressure on the distal end side. The hole or slit is set to a size smaller than that of the endoscope 10, and a synthetic resin such as a soft vinyl chloride resin, a urethane resin, or a silicone rubber is preferably used as a material for the hole or slit.

As described above, the present invention can safely and reliably create percutaneous routes for various purposes to all luminal organs (esophagus, stomach, bile duct, pancreatic duct, intestine, ureter, bladder, etc.) by using the catheter of the present invention, and can perform a surgical operation that conventionally has to be performed by a large number of hands in an operating room or the like by using an X-ray apparatus by two persons and bedside by combining an endoscope and an ultrasonic probe.

In particular, in the present invention, since the inner balloon can be provided to ensure a larger puncture space (depth of penetration of the puncture needle) than the conventional puncture balloon, it is extremely useful in performing the above-described operation at the bedside well at all times.

Claims

1. A catheter with a balloon for puncture, the catheter comprising a main tube provided with a balloon on a distal end side surface, the main tube comprising a main lumen for endoscope insertion extending from a rear end to a distal end, and a sub-lumen for gas-liquid communication with the inside of the balloon, the main tube being provided with an endoscope insertion portion at the rear end of the main tube, and the sub-lumen being provided with an operation connector for inflation and deflation of the balloon at the rear end thereof,

the balloon on the front end side surface is an outer balloon, a needle insertion hole through which a puncture needle can sufficiently pass is formed in a wall surface of the main tube positioned inside the outer balloon, the hole is hermetically closed by an expandable sealing material, the sealing material is an inner balloon, and the inner balloon is formed so that when the outer balloon is expanded, the inner balloon bulges out from the needle insertion hole to the inside of the main lumen due to the internal pressure of the outer balloon, and the front end of the puncture needle can be inserted into the bulging portion.

2. The catheter with a balloon for puncture according to claim 1,

the outer balloon and the inner balloon are formed of the same material.

3. The catheter with a balloon for puncture according to claim 1,

a reinforcing tube is provided on the inner surface of the main cavity at the position where the needle insertion hole is provided.

4. The catheter with a balloon for puncture according to claim 2,

5. The catheter with a balloon for puncture according to claim 1,

the needle insertion hole is arranged on the wall of the main cavity of the body tube, and a mark for identifying the position on the periphery of the main cavity of the needle insertion hole is arranged on a line containing the needle insertion hole along the length direction of the body tube.

6. The catheter with a balloon for puncture according to claim 2,

7. The catheter with a balloon for puncture according to claim 3,

8. The catheter with a balloon for puncture according to claim 4,

9. The catheter with a balloon for puncture according to claim 1,

the outer balloon has material properties of 0.01-1 mm in wall thickness, 8-25 MPa in tensile strength, 3-6 MPa in 100% modulus, 300-460% in elongation, and 2.8-75 psi in balloon internal pressure, and the inner balloon has the same material properties as the outer balloon or material properties that are more expandable than the outer balloon.

10. The catheter with a balloon for puncture according to claim 2,

11. The catheter with a balloon for puncture according to claim 3,

12. The catheter with a balloon for puncture according to claim 4,

13. The catheter with a balloon for puncture according to claim 5,

14. The catheter with a puncture balloon according to claim 6,

15. The catheter with a puncture balloon according to claim 7,

16. The catheter with a puncture balloon according to claim 8,

17. The catheter with a balloon for puncture according to any one of claims 1 to 16, wherein,

the body tube has transparency that enables visual recognition from the endoscope inside the outer balloon.

18. The catheter with a balloon for puncture according to any one of claims 1 to 16, wherein,

the outer balloon attachment portion on at least the distal end side of the body tube is provided so as to be disposed inside the outer balloon in the longitudinal direction of the outer balloon.

19. The catheter with a puncture balloon according to claim 17,

20. The catheter with a balloon for puncture according to any one of claims 1 to 16, wherein,

a film-like sealing member provided with a slit or a hole is attached to the endoscope insertion portion at the rear end of the main lumen.

21. The catheter with a puncture balloon according to claim 17,

22. The catheter with a puncture balloon according to claim 18,

23. The catheter with a puncture balloon according to claim 19,