CN114599297A - Balloon catheter for removing foreign matter - Google Patents

Balloon catheter for removing foreign matter Download PDF

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Publication number
CN114599297A
CN114599297A CN202080073921.4A CN202080073921A CN114599297A CN 114599297 A CN114599297 A CN 114599297A CN 202080073921 A CN202080073921 A CN 202080073921A CN 114599297 A CN114599297 A CN 114599297A
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CN
China
Prior art keywords
catheter
balloon
foreign matter
distal end
lumen
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
CN202080073921.4A
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Chinese (zh)
Inventor
泊晃平
富永恭代
李正权
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Zeon Corp
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Zeon Corp
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Publication date
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Publication of CN114599297A publication Critical patent/CN114599297A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/50Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon

Abstract

The invention provides a balloon catheter for removing foreign matter, which has a simple structure and excellent convenience and can well discharge the foreign matter in the body to the outside of the body even under the condition that the method under the common way is difficult to adopt. The balloon catheter (100) for removing foreign matter comprises: a catheter (200) formed of a flexible material and having a balloon lumen (220) and a guide wire lumen (230) formed therein in an axial direction; and a balloon (300) which is disposed near the distal end of the catheter (200), is inflated by the fluid discharged from the fluid outlet, wherein the distal end of the catheter (200) is formed into a tapered shape with a narrow tip, and the balloon (300) is inflated eccentrically with respect to the axial center of the catheter (200) by inserting a reinforcing tube (216) having improved rigidity of the catheter (200) into the guide wire lumen (230).

Description

Balloon catheter for removing foreign matter
Technical Field
The present invention relates to a balloon catheter for removing foreign matter, which is used for removing foreign matter in a body such as gallstones occurring in bile ducts.
Background
As a method for removing gallstones occurring in bile ducts, for example, a method using a balloon catheter for removing foreign matter is known. For example, patent document 1 below discloses a method in which a balloon catheter for removing foreign matter is inserted into the bile duct from the duodenal papilla, and a balloon provided at the distal end of the catheter (catheter tube) is used to draw out a cholelithiasis from the duodenal papilla to the outside of the bile duct. In the present specification, a method of inserting a balloon catheter for removing foreign matter into the biliary tract from the duodenal papilla is referred to as an ERCP (endoscopic retrograde cholangiopancreatography) method.
In the endoscopic cholelithiasis removal operation using the ERCP method, as shown in fig. 8, the distal end of an endoscope 900 is disposed in the vicinity of a duodenal papilla 940 serving as an entrance of a bile duct 930, and a catheter 902, which is a balloon catheter for removing foreign substances, is inserted into the bile duct 930 from the duodenal papilla 940 via the endoscope 900. Then, as shown in fig. 9, the balloon 903 is positioned at the deep position of the bile duct 930, and the balloon 903 is inflated, and the catheter 902 is pulled back from the inside of the bile duct 930 in the direction of the duodenal papilla 940 (the direction of the arrow in fig. 9), whereby the gallstone 950 present on the proximal end side of the balloon 903 can be pulled out of the bile duct 930 from the duodenal papilla 940.
Documents of the prior art
Patent document
Patent document 1: japanese patent laid-open No. 2019-10297.
Disclosure of Invention
Problems to be solved by the invention
However, in cases of, for example, duodenal stenosis, a balloon catheter cannot be inserted into the biliary tract from the duodenal papilla, and it may be difficult to use the ERCP method.
The invention aims to provide a balloon catheter for removing foreign matters, which has a simple structure and excellent convenience and can well discharge foreign matters in vivo such as gallstones generated in bile ducts to the outside even under the condition that the conventional methods such as an ERCP method are difficult to use.
Means for solving the problems
In order to achieve the above object, a balloon catheter for removing foreign matter according to the present invention is a balloon catheter for removing foreign matter in a body, the balloon catheter comprising:
a catheter made of a flexible material and having a balloon lumen for allowing a fluid to flow therethrough, the fluid being led out from a fluid outlet port provided near a distal end thereof, and a guide wire lumen, through which a guide wire led out from a guide wire insertion hole provided at a distal end thereof is inserted, formed therein in an axial direction; and
a balloon disposed near the distal end of the catheter, inflated by the fluid conducted out of the fluid outlet port,
the distal-most end of the catheter is formed in a tapered shape with a thin tip,
a reinforcing tube for increasing the rigidity of the catheter is inserted into the guide wire lumen,
the balloon is inflated eccentrically with respect to the axial center of the catheter.
Thus, a balloon catheter for removing foreign matter having a simple structure and excellent convenience can be realized, and even when it is difficult to adopt a method in a usual route such as the ERCP method, it is possible to suitably discharge foreign matter in vivo such as gallstones to the outside of the body by passing through a puncture hole provided in an in vivo tissue such as a stomach wall or a bile duct wall.
The balloon catheter for removing foreign matter of the present invention realizes a structure in which the distal end of the catheter is formed into a tapered shape with a thin tip, and the following performance of a guide wire advancing along the guide wire and the expansion performance of an in vivo tissue are improved. Thus, the distal end of the balloon catheter for removing foreign matter can be passed through a puncture hole provided in an in vivo tissue such as a stomach wall or a bile duct wall, and the balloon can be easily and quickly disposed at the target site.
The balloon catheter for removing foreign matter of the invention realizes a structure that a reinforcing tube for improving the rigidity of the catheter is inserted into a guide wire lumen, and the pushing performance of the catheter is improved. The pushability of the catheter means a pushability to transmit a pushing force acting on the proximal end to the distal end when the catheter is pushed in the axial direction from the proximal end to the distal end. This allows the pushing force acting on the proximal end to be reliably transmitted to the distal end, and the balloon to be moved in the distal direction with a desired force.
The balloon catheter for removing foreign matter according to the present invention can be arranged such that the distal end of the catheter is displaced from the center of the balloon by inflating the balloon eccentrically with respect to the axis of the catheter. Thus, the distal end of the catheter is less likely to hit a foreign object, and the balloon can be reliably pushed out by hitting the foreign object.
In the balloon catheter for removing foreign matter according to the present invention, the catheter is composed of a small diameter portion on a distal end side and a large diameter portion on a proximal end side having a larger outer diameter than the small diameter portion, and the reinforcing tube is inserted into the large diameter portion. This can improve the rigidity of the large diameter portion on the distal end side of the catheter while maintaining the flexibility of the small diameter portion on the distal end side of the catheter.
In the balloon catheter for removing foreign matter according to the present invention, the reinforcing tube is made of polyether ether ketone. This makes it possible to improve the rigidity of the catheter with a simple structure in which a reinforcing tube made of polyetheretherketone is inserted into the guide wire lumen.
In the balloon catheter for removing foreign matter according to the present invention, the balloon catheter is configured to push the catheter from the proximal end side to the distal end side in a state where the balloon is inflated, move the balloon toward the duodenal papilla in the bile duct, and push the foreign matter in the bile duct out of the bile duct at the distal end side of the balloon. Thus, even when it is difficult to adopt the ERCP method, it is possible to realize a balloon catheter for removing foreign matter, which has a simple structure and excellent convenience, and which can be suitably discharged to the bile duct by, for example, disposing the balloon in the bile duct through a puncture hole provided in an in vivo tissue such as a stomach wall or a bile duct wall, and pushing out a foreign matter such as a calculus generated in the bile duct toward the duodenal papilla on the distal end side of the balloon.
Drawings
Fig. 1 is a plan view showing an example of the structure of a balloon catheter for removing foreign matter according to an embodiment of the present invention.
Fig. 2 is an enlarged side view of the vicinity of the region X of fig. 1.
Fig. 3 is a sectional view showing a section a-a of fig. 1.
Fig. 4 is a schematic axial sectional view in the vicinity of the region Y of fig. 1.
Fig. 5 is a schematic axial sectional view in the vicinity of the region Z of fig. 1.
Fig. 6 is a schematic diagram for explaining an example of use of the foreign substance removal balloon catheter according to the embodiment of the present invention for removing a biliary stone from a bile duct.
Fig. 7A is a diagram of a comparative example of the embodiment of the present invention, and is a schematic diagram showing a case where the center of the balloon is arranged at a position matching the axial center of the catheter.
Fig. 7B is a view of the embodiment of the present invention, and is a schematic view showing a case where the center of the balloon is arranged at a position deviated from the axial center of the catheter.
Fig. 8 is a schematic diagram for explaining an example of use of the conventional foreign matter removal balloon catheter for removing a biliary stone from a bile duct.
Fig. 9 is an enlarged view of the vicinity of the duodenal papilla and the bile duct of fig. 8.
Detailed Description
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
Fig. 1 is a plan view showing an example of the structure of a balloon catheter for removing foreign matter according to an embodiment of the present invention. The balloon catheter 100 for removing foreign matter shown in fig. 1 is used, for example, by an endoscope, and includes a catheter 200, a balloon 300, a branching portion 400, and three branch tubes 500a to 500 c.
Hereinafter, the extending direction of the balloon catheter for foreign object removal 100 is defined as the axial direction, the balloon 300 side of the balloon catheter for foreign object removal 100 is defined as the distal end side, and the three branch tubes 500a to 500c side of the balloon catheter for foreign object removal 100 is defined as the proximal end side.
Catheter 200 is a tube formed of a flexible material. In fig. 1, the middle portion of the duct 200 is not shown, but the duct 200 is actually connected to each other and has an elongated shape in the axial direction.
The catheter 200 has a small diameter portion 210 on the distal end side inserted into the body by the endoscope, and a large diameter portion 215 on the end side of the small diameter portion 210. The overall length of the duct 200 is, for example, 500 to 2500mm, and the axial dimension of the small-diameter portion 210 is 30 to 800 mm. The outer diameter of the small-diameter portion 210 is 50 to 95%, for example, 1.0 to 4.2mm, of the outer diameter of the large-diameter portion 215. The material of the catheter 200 is not particularly limited as long as it has flexibility, but from the viewpoint of moldability, a thermoplastic resin or a thermoplastic elastomer is preferable, and for example, a polyamide resin or a polyamide elastomer can be used.
At least one contrast ring 250 is attached to the small diameter portion 210 of the catheter 200. In the catheter 200 shown in fig. 1, for example, two contrast rings 250 are attached near the attachment position of the balloon 300, but the shape of the contrast rings 250, the position where the contrast rings 250 are attached, the number of the contrast rings 250, and the like are not particularly limited. The contrast ring 250 is a member for confirming the position of the distal end of the catheter 200 when inserted into the body by X-ray contrast, and thereby the position of the balloon 300 can be confirmed. As a material of the contrast ring 250, a metal such as gold, platinum, or tungsten can be used.
A tapered portion 211 formed in a tapered shape with a narrow tip is provided at the distal end of the small diameter portion 210 of the catheter 200. The tapered portion 211 is provided to improve the expansion (division) performance when the material is inserted into a puncture hole or a body lumen provided in a body tissue such as a stomach wall.
Fig. 2 is an enlarged side view of the vicinity of the region X of fig. 1. As shown in fig. 2, the tapered portion 211 is shaped as follows: for example, the diameter of the distal end is smaller than the diameter of the straight tube portion of the small diameter portion 210 by having a taper-like inclination formed so as to be tapered from the distal end to the axial dimension L1. The axial dimension L1 of the tapered portion 211 is not particularly limited, and is, for example, 0.5 to 20 mm. The tapered portion 211 may be tapered so as to have a narrow tip, and the inclination angle of the tapered portion 211, the size of the outer diameter of the distal end, and the like are not particularly limited.
The method of providing the tapered portion 211 formed in a tapered shape with a thin tip end is not particularly limited, and the tapered portion 211 formed in a tapered shape with a thin tip end can be formed by processing the distal end of the catheter 200 using a forming die or the like, for example. Further, the distal end of the catheter 200 may be tapered so that the distal end includes the tapered portion 211, and the distal end of the catheter 200 is joined to the manufactured member.
The catheter 200 is a multi-lumen tube (multiple lumen tube). For example, as shown in fig. 3, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed inside a catheter 200, and the lumens 220 to 240 are separated from each other.
The balloon lumen 220 is a lumen used as a flow path for supplying a fluid such as air to the inside of the balloon 300 in order to expand and contract the balloon 300. The balloon lumen 220 extends from the proximal end of the catheter 200 to a fluid communication port, not shown. The fluid flow port is an opening that opens inside the balloon 300 provided in the small-diameter portion 210 of the catheter 200. As will be described later, the balloon lumen 220 communicates with the branch tube 500a at the branch portion 400.
Guidewire lumen 230 is a lumen used as a path through guidewire 235. A guidewire lumen 230 extends through the catheter 200 from the proximal end to a guidewire insertion hole 231 at the distal end. The guide wire insertion hole 231 is an opening portion that opens at the distal end of the catheter 200. As will be described later, the guidewire lumen 230 communicates with the branch tube 500b at the branch portion 400.
The contrast agent lumen 240 is a lumen used as a flow path of a contrast agent at the time of X-ray contrast. The contrast lumen 240 passes from the proximal end of the catheter 200 to a contrast outflow port, not shown. The contrast agent outflow port is an opening provided in the small diameter portion 210 of the catheter 200. The balloon catheter 100 for removing foreign matter according to the embodiment of the present invention is particularly suitable for use in an application in which a biliary stone in a bile duct existing ahead is pushed out using the balloon 300, and for example, by providing a contrast agent outflow port on the distal end side of the balloon 300, a contrast agent can be ejected into the biliary stone. As will be described later, the contrast agent lumen 240 communicates with the branch tube 500c at the branch portion 400.
The cross-sectional shapes of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 may be any shapes that can be effectively disposed in the catheter 200, and since the reinforcing tube 216 is inserted into the guide wire lumen 230 and the cross-sectional shape of the guide wire 235 inserted into the reinforcing tube 216 is generally circular, the cross-sectional shape of the guide wire lumen 230 is preferably substantially circular. The cross-sectional areas of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 are not particularly limited, but the cross-sectional area of the guide wire lumen 230 is preferably set to be relatively large with respect to the cross-sectional areas of the balloon lumen 220 and the contrast agent lumen 240, and the cross-sectional area of the balloon lumen 220 is, for example, 0.03 to 1.0mm2The cross-sectional area of the guide wire lumen 230 is 0.5-6.0 mm2The cross-sectional area of the contrast agent tube cavity 240 is 0.08-4.0 mm2
Further, a reinforcing tube 216 for improving the pushability (pushability) of the catheter 200 is inserted into the guide lumen 230 over the entire large diameter portion 215, that is, over a range from the proximal end to the distal end of the large diameter portion 215. By inserting the reinforcing tube 216 into the guide wire lumen 230 so as to extend in the axial direction, the rigidity of the catheter 200, particularly the axial rigidity and bending rigidity of the catheter 200, is increased, and the pushability of the catheter 200 can be improved.
Since the cross-sectional shape of the guide wire 235 inserted into the reinforcing tube 216 is generally circular, the cross-sectional shape of the reinforcing tube 216 is preferably circular. The outer diameter of the reinforcing tube 216 is substantially the same as the inner diameter of the guide wire lumen 230 and is closely inserted into the inner circumferential surface of the guide wire lumen 230. The inner diameter of reinforcing tube 216 is larger than the outer diameter of guide wire 235 and is sized to be inserted through guide wire 235. The material of the reinforcing tube 216 is not particularly limited, but from the viewpoint of moldability and rigidity, a thermoplastic resin is preferable, and among them, polyether ether ketone (PEEK) having high rigidity is particularly preferably used.
The reinforcing tube 216 inserted into the guide wire lumen 230 will be described with reference to fig. 3 to 5.
Fig. 3 is a sectional view showing a section a-a of fig. 1. As shown in fig. 3, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed in the large diameter portion 215 of the catheter 200, and a reinforcing tube 216 is inserted into the guide wire lumen 230.
The cross-sectional view of catheter 200 in fig. 3 is an example, and the cross-sectional shapes of lumens 220 to 240 are not limited to those shown in fig. 3. In fig. 3, a three-lumen catheter is illustrated as an example, but a two-lumen catheter having two lumens used as the balloon lumen 220 and the guidewire lumen 230, for example, may be used. Here, the reinforcing tube 216 is inserted only in the guide wire lumen 230, and the reinforcing tube 216 may be inserted in one or both of the balloon lumen 220 and the contrast agent lumen 240.
Fig. 4 is a schematic axial sectional view in the vicinity of the region Y of fig. 1. Fig. 4 illustrates the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 of the catheter 200, and schematically illustrates a state in which three lumens, i.e., a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240, are provided inside the catheter 200.
As shown in fig. 4, three lumens, i.e., a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240, are formed inside the small diameter portion 210 and the large diameter portion 215, and the lumens 220 to 240 inside the small diameter portion 210 communicate with the lumens 220 to 240 inside the large diameter portion 215. The outer diameter of the small diameter portion 210 is smaller than the outer diameter of the large diameter portion 215, and the cross-sectional area of each lumen 220-240 inside the small diameter portion 210 is also smaller than the cross-sectional area of each lumen 220-240 inside the large diameter portion 215. The reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the distal end of the reinforcing tube 216 is located near the distal end of the large diameter portion 215, that is, near the boundary between the small diameter portion 210 and the large diameter portion 215. The reinforcing tube 216 has an outer diameter substantially equal to or slightly smaller than the inner diameter of the large-diameter portion 215 and larger than the inner diameter of the small-diameter portion 210, for example, and the reinforcing tube 216 can be inserted into the large-diameter portion 215 but cannot be inserted into the small-diameter portion 210.
Fig. 5 is a schematic axial sectional view in the vicinity of the region Z of fig. 1. Fig. 5 shows the connection between the large diameter portion 215 of the catheter 200 and the branch tubes 500a to 500c, that is, the vicinity of the branch portion 400, and schematically shows a state in which three lumens, that is, the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240, are provided inside the catheter 200. In fig. 5, the capacity label 700 shown in fig. 1 is not shown.
As shown in fig. 5, three lumens, i.e., a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240, are formed inside the large diameter portion 215, and the lumens 220 to 240 inside the large diameter portion 215 communicate with the branch tubes 500a to 500 c. The reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the proximal end of the reinforcing tube 216 is located near the proximal end of the large diameter portion 215, that is, near the boundary between the large diameter portion 215 and the branch tube 500 b. Further, a method of communicating the respective lumens 220 to 240 with the respective branch tubes 500a to 500c is not particularly limited, and fig. 5 schematically illustrates a state in which the distal ends of the respective branch tubes 500a to 500c are inserted into the respective lumens 220 to 240 to communicate with each other, as an example.
As shown in fig. 4 and 5, the reinforcing tube 216 is inserted into the guide wire lumen 230 from the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 to the vicinity of the boundary between the large diameter portion 215 and the branch tube 500b, that is, the entire large diameter portion 215. The method of inserting the reinforcing tube 216 into the large diameter portion 215 of the catheter 200 is not particularly limited, and for example, the reinforcing tube 216 may be inserted into the large diameter portion 215 before the guide wire lumen 230 of the catheter 200 is communicated with the branch tube 500 c.
Specifically, a catheter 200 having a small diameter portion 210 on the distal end side and a large diameter portion 215 on the proximal end side is prepared, a reinforcing tube 216 is inserted into a guide lumen 230 that opens at the proximal end surface of the large diameter portion 215 on the proximal end side, and the reinforcing tube 216 is pushed to the distal end side. When the distal end of the pushed reinforcing tube 216 reaches the vicinity of the boundary between the small-diameter portion 210 and the large-diameter portion 215, it cannot enter the small-diameter portion 210 having a small cross-sectional area, and it is in a state of being in contact with the distal end of the small-diameter portion 210. In this state, the reinforcing tube 216 protruding from the proximal end surface of the large diameter portion 215 is cut in alignment with the proximal end surface of the large diameter portion 215, whereby the reinforcing tube 216 is inserted into the guide wire lumen 230 over the entire large diameter portion 215. In the embodiment of the present invention, since the branch tube 500b is connected to the reinforcing tube 216 as described later to prevent the reinforcing tube 216 from coming off the guide wire lumen 230, the reinforcing tube 216 and the guide wire lumen 230 are not directly fixed to each other, but may be fixed to each other by a method such as adhesion using an adhesive agent, if necessary, between the reinforcing tube 216 and the guide wire lumen 230.
The balloon 300 is a tubular thin film that can be inflated by introducing a fluid into the inside, and is attached to the small-diameter portion 210 of the catheter 200 so as to cover a fluid outlet port, not shown. The balloon 300 is made of a stretchable material, and is inflated by introducing a fluid into the inside through the balloon lumen 220 and the fluid outlet of the catheter 200. In the embodiment of the present invention, foreign matter such as gallstones can be removed by pushing out the foreign matter on the distal end side of the inflated balloon 300.
The stretchable material forming the balloon 300 is preferably a material having a 100% modulus (measured in accordance with JIS K6251) of 0.1 to 10MPa, and particularly preferably 1 to 5 MPa. Specific examples of the stretchable material preferable for forming the balloon 300 include natural rubber, silicone rubber, and urethane elastomer.
The balloon 300 is cylindrical as a whole, and engagement portions 310 and 320 that engage with the outer peripheral surface of the catheter 200 are formed on the distal end side and the proximal end side. The joining portions 310 and 320 are portions where the balloon 300 is joined to the outer peripheral surface of the catheter 200 in a cylindrical shape, and the axial dimension of the joining portions 310 and 320 is, for example, 0.5 to 5.0 mm. The method of joining the joining portions 310 and 320 of the balloon 300 to the outer peripheral surface of the catheter 200 is not particularly limited, and for example, bonding using an adhesive, thermal welding, welding with a solvent, ultrasonic welding, or the like can be performed.
An inflation portion 330, which is not engaged with the outer peripheral surface of the catheter 200 and is inflated by introducing a fluid into the interior, is formed between the engagement portions 310 and 320 of the balloon 300. The maximum outer diameter of the inflated portion 330 of the balloon 300 in the inflated state is preferably 200 to 1500% of the outer diameter in the deflated state. If the ratio is too small, the balloon 300 may not be inflated to a sufficient size, and if it is too large, the balloon 300 may become an obstacle when the catheter 200 is inserted into the body. The expansion part 330 has an axial dimension of, for example, 5 to 20mm and a film thickness of, for example, 0.10 to 0.50 mm.
In order to eccentrically expand the expansion portion 330 with respect to the axial center of the catheter 200, an offset sheet (offset sheet)340 is bonded to a part of the expansion portion 330. The biasing piece 340 has, for example, an elongated shape in which the axial dimension of the biasing piece 340 is set longer than the axial dimension of the expanded portion 330. The biasing piece 340 is adhered to a part of the expansion part 330 in the axial direction, and both ends thereof are fixed to the engaging parts 310, 320 or the outer circumferential surface of the catheter 200.
Since a part of the expansion part 330 to which the biasing sheet 340 is bonded is fixed to the catheter 200, the expansion part 330 on the side to which the biasing sheet 340 is bonded is in a state of being difficult to expand or in a state of being unable to expand. As a result, the expansion portion 330 on the side to which the biasing piece 340 is not attached expands while being displaced, and expands in a shape eccentric with respect to the axis of the catheter 200.
The material of the biasing piece 340 is not particularly limited, and for example, the same resin as the duct 200 can be used. The fixing method of the bias sheet 340 is not particularly limited, and for example, adhesion, thermal welding, high-frequency welding, or the like can be performed. As an example, the bias sheet 340 coated with an adhesive on the back surface is used, and the bias sheet 340 is bonded to a part of the balloon 300 including the inflation portion 330 in the circumferential direction and a part of the catheter 200. The width of the biasing piece 340 is, for example, a width equal to or less than 1/2 of the circumferential length of the outer peripheral surface of the catheter 200, and preferably a width of 1/3 to 1/5. If the width is too small, it is difficult to inflate the balloon 300 eccentrically, and if the width is too large, it becomes difficult to inflate the balloon 300 itself.
In the embodiment of the present invention, the balloon 300 is inflated to a shape eccentric to the axial center of the catheter 200 by attaching the biasing piece 340, but the balloon 300 may be inflated in a state eccentric to the axial center of the catheter 200 by adopting a configuration other than the above configuration in which the inflating portion 330 is provided so as to be biased to a part of the outer peripheral surface of the catheter 200, for example.
The branch part 400 is provided at the connection part connecting the guide pipe 200 and the branch pipes 500a to 500 c. The branch portion 400 is configured such that the balloon lumen 220 communicates with the branch tube 500a, the lumen of the reinforcing tube 216 inserted into the guide wire lumen 230 communicates with the branch tube 500b, and the contrast agent lumen 240 communicates with the branch tube 500 c. The method of connecting the lumens 220 to 240 in the catheter 200 or the inner cavity of the reinforcing tube 216 to the branch tubes 500a to 500c is not particularly limited, and for example, a method of forming the distal ends of the branch tubes 500a to 500c to be thin, inserting the thin portions into the corresponding lumens 220 to 240, and fixing them with an adhesive can be employed. In this case, it is preferable to cover and protect the connection portions between the connection pipe 200 and the branch pipes 500a to 500c by the branch portions 400, which are cylindrical covering members made of a polymer material such as a synthetic resin. The material of the branch pipes 500a to 500c is not particularly limited, and a polymer material such as a synthetic resin can be used.
The branch tube 500a is a balloon branch tube, and a balloon hub 600a having, for example, a two-way cock valve is connected to the proximal end of the branch tube 500 a. The balloon hub 600a and the branch tube 500a communicate with the balloon lumen 220 at the branch portion 400, and fluid can be introduced from the balloon hub 600a into the balloon 300 through the branch tube 500a, the balloon lumen 220, and the fluid communication port.
The branch tube 500b is a guide wire branch tube, and a guide wire bush 600b of a luer lock (luer lock) type, for example, is connected to a proximal end of the branch tube 500 b. The guide wire bush 600b and the branch tube 500b communicate with the inner cavity of the reinforcing tube 216 inserted into the guide wire lumen 230 in the branch portion 400, and the guide wire 235 can be projected to the outside from the guide wire bush 600b through the branch tube 500b, the reinforcing tube 216, the guide wire lumen 230, and the guide wire insertion hole 231 provided at the distal end of the catheter 200.
The branch tube 500c is a contrast branch tube, and a luer-lock contrast hub 600c, for example, is connected to the proximal end of the branch tube 500 c. The contrast liner 600c and the branch tube 500c communicate with the contrast agent lumen 240 in the branch portion 400, and the contrast agent can be ejected from the contrast liner 600c to the outside through the branch tube 500c, the contrast agent lumen 240, and the contrast agent outflow port.
A volume label 700 is attached to the outer periphery of the catheter 200 on the distal end side of the branch portion 400. The volume label 700 stores information unique to the balloon catheter 100 for removing foreign matter, such as the relationship between the outer diameter of the balloon 300 and the internal pressure or gas volume of the balloon 300.
As described above, the foreign matter removal balloon catheter 100 according to the embodiment of the present invention is configured as follows: a tapered portion 211 having a tapered shape with a narrow tip is formed at the distal end of the catheter 200 as a first feature, a reinforcing tube 216 for improving the rigidity of the catheter 200 is inserted into the guide wire lumen 230 as a second feature, and the balloon 300 is expanded eccentrically with respect to the axial center of the catheter 200 as a third feature.
Hereinafter, with attention paid to the first to third features, a description will be given of a use example of the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention with reference to fig. 6. In the use example described below, when it is confirmed that it is difficult to adopt the ERCP method due to the occurrence of stricture in the duodenum of a patient or the like, puncture holes are provided in the stomach wall and the inner liner wall (liver) of the patient, and the foreign matter removal balloon catheter 100 is inserted into the inner liner through the puncture holes.
As shown in fig. 6, when the balloon catheter for removing a foreign object 100 according to the embodiment of the present invention is used to remove a gall stone 850 from a bile duct 830, first, the distal end of an endoscope 800, which is an ultrasonic endoscope, is inserted into the body, and the position of the intrahepatic bile duct 820 is confirmed by drawing an ultrasonic image from the stomach 810 to the intrahepatic bile duct 820. Next, while observing with an ultrasonic image, a puncture needle is punctured from the digestive tract wall such as the stomach wall into the intrahepatic bile duct 820, and a guide wire (not shown in fig. 6) inserted into the balloon catheter for foreign object removal 100 is inserted from the intrahepatic bile duct 820 into the bile duct 830 through the puncture hole by the endoscope 800. Then, the foreign matter removal balloon catheter 100 is inserted into the body with the balloon 300 deflated, and the distal end of the catheter 200 is inserted from the intrahepatic bile duct 820 to the bile duct 830 through the puncture hole along a guide wire (not shown in fig. 6).
Next, the contrast agent is ejected with the balloon 300 disposed in the bile duct 830, and after the inside of the bile duct 830 and the gallstone 850 are confirmed using an X-ray contrast image, the balloon 300 is inflated. Then, by pushing the proximal end of the catheter 200 in the distal direction (arrow direction in fig. 6) with the balloon 300 inflated, the balloon 300 moves toward the duodenal papilla 840 side (arrow direction in fig. 6) within the bile duct 830, and the gallstone 850 can be pushed out from the duodenal papilla 840 to the outside of the bile duct 830 on the distal end side of the inflated balloon 300.
As described above, the foreign substance removal balloon catheter 100 according to the embodiment of the present invention is suitable for use in a case where it is difficult to adopt the ERCP method, for example, the distal end of the catheter 200 is inserted from the intrahepatic bile duct to the bile duct through the puncture hole provided in the stomach wall and the intrahepatic bile duct wall. However, since a puncture hole, an intrahepatic bile duct, or the like is very narrow, it is not easy to insert the distal end of the catheter of the balloon catheter of the related art into the puncture hole or advance the catheter in the lumen of the body.
In contrast, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the distal end of the catheter 200 is formed in a tapered shape with a narrow tip, and the distal end of the catheter 200 can advance while expanding the route without damaging the in vivo tissue such as the peripheral wall of the puncture hole. That is, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the structure for improving the guide wire followability and the expandability to advance the guide wire 235 is realized by the first feature that the distal end of the catheter 200 is formed in a tapered shape with a thin tip.
As described above, when the balloon catheter 100 for removing foreign matter in the embodiment of the present invention is used to remove gallstones, unlike the ERCP method in which the balloon catheter is inserted retrogradely into the bile duct in the related art, the balloon catheter 100 for removing foreign matter is inserted antegradely into the bile duct, and the proximal end of the catheter 200 is pushed in the distal direction in a state where the balloon 300 is inflated, so that the balloon 300 is moved in the distal direction, and gallstones are pushed out of the duodenal papilla of the balloon 300 to the outside of the bile duct. However, in the balloon catheter of the related art, sometimes the pushing force acting on the proximal end of the catheter is not reliably transmitted to the distal end of the catheter. As a result, the balloon may not be moved in the distal direction by a desired force, and the gallstone may not be pushed out of the bile duct on the distal end side of the balloon.
In contrast, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the reinforcing tube 216 having increased rigidity of the catheter 200 is inserted into the guide wire lumen 230, and the pushing force acting on the proximal end of the catheter 200 is reliably transmitted to the distal end of the catheter 200, so that the balloon 300 can be moved in the distal direction with a desired force. That is, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the second feature that the reinforcing tube 216, which enhances the rigidity of the catheter 200, is inserted into the guide wire lumen 230 is utilized, and a configuration that enhances the pushing performance (pushing ability) for transmitting the pushing force acting on the proximal end of the catheter 200 to the distal end of the catheter 200 is realized.
As described above, when the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention is used to remove gallstones, unlike the ERCP method in which gallstones are scooped out on the proximal side of the balloon in the related art, gallstones are pushed out on the distal side of the inflated balloon 300. However, since the gallstones present on the distal end side of the balloon are pushed out by the balloon, if a balloon catheter of the related art is used, the distal end of the catheter may hit the gallstones when the balloon is moved in the distal direction, and the movement of the catheter in the distal direction may be hindered. As a result, the balloon cannot be moved in the distal direction, and the gallstone cannot be pushed out of the bile duct on the distal end side of the balloon.
In contrast, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the balloon 300 is inflated eccentrically with respect to the axial center of the catheter 200, so that the distal end of the catheter 200 can be disposed at a position deviated from the center of the balloon 300. That is, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the configuration is realized in which the distal end of the catheter 200 can be disposed at a position that does not become an obstacle when the balloon 300 hits the gall stone, and the balloon 300 can be reliably hit and pushed out of the gall stone, utilizing the third feature that the balloon 300 is inflated eccentrically with respect to the axial center of the catheter 200.
The third feature will be described in more detail with reference to fig. 7A and 7B. Fig. 7A is a diagram of a comparative example according to an embodiment of the present invention, and is a schematic diagram showing a case where the center of the balloon 300 is arranged at a position matching the axial center of the catheter 200. On the other hand, fig. 7B is a diagram of an embodiment of the present invention, and is a schematic diagram showing a case where the center of the balloon 300 is disposed at a position deviated from the axial center of the catheter 200.
As shown in fig. 7A, when the center of the balloon 300 coincides with the axial center of the catheter 200, the balloon 300 moves in the distal direction (the direction of the arrow in fig. 7A) in a state where the distal-most end of the catheter 200 having the tapered portion 211 formed thereon is disposed substantially at the center of the balloon 300. In this case, the distal end of the catheter 200 hits the gallstone 850, and the movement of the catheter 200 to the distal end side is obstructed, and the balloon 300 cannot be moved to the distal end side, and the gallstone 850 cannot be pushed out to the distal end side of the balloon 300.
On the other hand, as shown in fig. 7B, when the center of the balloon 300 is disposed at a position deviated from the axial center of the catheter 200, the balloon 300 moves in the distal direction (the direction of the arrow in fig. 7B) in a state where the distal-most end of the catheter 200 on which the tapered portion 211 is formed is positioned laterally with respect to the moving direction of the balloon 300. In this case, the distal end of the catheter 200 does not hit the gallstone 850, and the distal end side of the balloon 300 can be smoothly pushed against the gallstone 850, so that the gallstone 850 can be reliably pushed out by the distal end side of the balloon 300.
The embodiments described above are described for the convenience of understanding the present invention, and are not described for the purpose of limiting the present invention. Therefore, each element disclosed in the above embodiments is intended to include all design modifications and equivalents falling within the technical scope of the present invention.
For example, in the above-described embodiment, the foreign substance removal balloon catheter 100 is used in a case where a puncture hole is provided in the stomach wall and the intrahepatic duct wall (liver) of a patient, the foreign substance removal balloon catheter 100 is inserted from the intrahepatic duct to the bile duct through the puncture hole, and a foreign substance such as a gall stone is discharged (removed) from the bile duct, but the foreign substance removal balloon catheter of the present invention is not limited thereto, and may be used in other cases as the foreign substance removal balloon catheter. However, the balloon catheter for removing foreign matter of the present invention is particularly suitable for use in a case where a method of passing through a puncture hole provided in a body tissue is employed, in a case where it is difficult to employ a method in a usual way such as the ERCP method.
Description of the reference numerals
100: balloon catheter for removing foreign matter
200. 902: catheter tube
210: small diameter part
211: cone part
215: large diameter part
216: reinforcing pipe
220: balloon lumen
230: guidewire lumen
231: guide wire through hole
235: guide wire
240: contrast agent lumen
250: radiography ring
300: balloon
310. 320, and (3) respectively: joint part
330: expansion part
340: offset sheet
400: branching part
500a to 500 c: branch pipe
600 a: lining for balloon
600 b: bushing for guide wire
600 c: bushing for radiography
700: capacity label
800. 900: endoscope with a detachable handle
810: stomach (stomach)
820: intrahepatic bile duct
830. 930: bile duct
840. 940: duodenal papilla
850. 950: gallstone

Claims (4)

1. A balloon catheter for removing foreign matter, which is used for removing foreign matter in vivo,
the foreign matter removal balloon catheter comprises:
a catheter made of a flexible material and having a balloon lumen for allowing fluid to flow therethrough, the fluid being led out from a fluid outlet port provided near a distal end, and a guide wire lumen, the guide wire lumen being inserted through a guide wire insertion hole provided at a distal end, the balloon lumen being formed therein in an axial direction; and
a balloon disposed near the distal end of the catheter, inflated by the fluid conducted out of the fluid outlet port,
the distal-most end of the catheter is formed in a tapered shape with a thin tip,
a reinforcing tube for increasing the rigidity of the catheter is inserted into the guide wire lumen,
the balloon is inflated eccentrically with respect to the axial center of the catheter.
2. The balloon catheter for foreign matter removal according to claim 1,
the catheter is composed of a small diameter portion on a distal end side and a large diameter portion on a proximal end side having an outer diameter larger than the small diameter portion, and the reinforcing tube is inserted into the large diameter portion.
3. The balloon catheter for removing foreign matter according to claim 1 or 2,
the reinforcing tube is made of polyether ether ketone.
4. The foreign matter removal balloon catheter according to any one of claims 1 to 3,
the foreign matter removal balloon catheter is configured to push the catheter from the proximal end side to the distal end side in a state where the balloon is inflated, move the balloon toward the duodenal papilla in the bile duct, and push the foreign matter in the bile duct out of the bile duct at the distal end side of the balloon.
CN202080073921.4A 2019-10-31 2020-10-29 Balloon catheter for removing foreign matter Pending CN114599297A (en)

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WO2022246386A1 (en) * 2021-05-17 2022-11-24 Boston Scientific Scimed, Inc. Medical systems, devices, and related methods
CN114469291B (en) * 2022-02-14 2023-08-08 郑州大学 Negative pressure tracheal foreign body extraction forceps and use method thereof

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US4775371A (en) * 1986-09-02 1988-10-04 Advanced Cardiovascular Systems, Inc. Stiffened dilatation catheter and method of manufacture
US20040019324A1 (en) * 2002-07-23 2004-01-29 Duchamp Jacky G. Catheter having a multilayered shaft section with a reinforcing mandrel
US20070260177A1 (en) * 2006-05-05 2007-11-08 Boris Warnack Balloon having a double compliance
JP2014511233A (en) * 2011-02-19 2014-05-15 ホットスパー テクノロジーズ,インコーポレイテッド Apparatus and method for treating obstruction in a body lumen
JP2019010297A (en) * 2017-06-30 2019-01-24 日本ゼオン株式会社 Production method for balloon catheter for removal of foreign matter in body
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