CATHETER DEVICE AND CATHETER PACKAGE

Provided are a catheter device and a catheter package which are capable of preventing a bend from being formed in a catheter body. The catheter body includes a wire state discrimination portion which discriminates a protruding state and a non-protruding state, in which the wire state discrimination portion includes a stopper which allows a transition from the protruding state to the non-protruding state, and blocks a transition from the non-protruding state to the protruding state.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority under 35 U.S.C § 119(a) to Japanese Patent Application No. 2020-122666 filed on Jul. 17, 2020, which is hereby expressly incorporated by reference, in its entirety, into the present application.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a medical catheter device which is inserted into a body cavity and a catheter package.

2. Description of the Related Art

As a catheter device which is inserted into a body cavity, for example, a curved assembly of a medical flexible tube disclosed in JP1988-111833A (JP-563-111833A) is known.

The curved assembly is configured by an outer cylinder member and an interpolation member inserted into the outer cylinder member, in which the interpolation member includes at least two or more bending portions to which a bend is imparted, and the outer cylinder member includes a restraining portion which restrains the bend of the bending portion. In this curved assembly, a curve control is performed by inserting the curved assembly into the body cavity, relatively moving back and forth the outer cylinder member and the interpolation member to change the positional relationship between the bending portion and the restraining portion.

SUMMARY OF THE INVENTION

In the catheter device which is used by inserting the bent wire formed and bent in a curved shape into the catheter body, due to the relative position between the wire and the catheter body, in a case of delivery, a bend of the wire may be transferred to the catheter body, and a bend may be formed in the catheter body.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a catheter device and a catheter package which are capable of preventing a bend from being formed in a catheter body.

In order to achieve the object of the present invention, a catheter device according to an aspect of the present invention comprises a flexible catheter body which has a distal end opening and a proximal end opening, is inserted into a body cavity starting from the distal end opening, and includes a wire insertion passage provided therein; and a wire which has a higher rigidity than the catheter body, is inserted into the wire insertion passage, and includes a distal end portion and a proximal end portion, in which the distal end portion is formed in a curved shape, in which the catheter body includes a wire state discrimination portion which discriminates a protruding state in which the distal end portion of the wire protrudes from the distal end opening, and a non-protruding state in which the distal end portion of the wire does not protrude from the distal end opening, and the wire state discrimination portion includes an allowing and blocking member which allows a transition from the protruding state to the non-protruding state, and blocks a transition from the non-protruding state to the protruding state.

It is preferable that the catheter device according to the aspect of the present invention further comprise a moving object provided to be movable integrally with the wire, in which the allowing and blocking member includes a stopper which allows or restricts a movement of the moving object, and the stopper allows the movement of the moving object to enable the transition from the protruding state to the non-protruding state in a case in which the wire is moved in a direction from the distal end opening toward the proximal end opening, and restricts the movement of the moving object to disable the transition from the non-protruding state to the protruding state in a case in which the wire is moved in a direction from the proximal end opening toward the distal end opening.

In the catheter device according to the aspect of the present invention, it is preferable that the moving object be provided to be movable integrally with the wire in the wire insertion passage, and the stopper be provided in the wire insertion passage.

In the catheter device according to the aspect of the present invention, it is preferable that the stopper include a stepped portion provided in the wire insertion passage, and the moving object include a moving object side-climbing surface which abuts on the stepped portion and climbs over the stepped portion in a case in which the moving object is moved in a direction toward the proximal end opening, and a restricted surface which abuts on the stepped portion and of which a movement is restricted in a case in which the moving object is moved in a direction toward the distal end opening.

In the catheter device according to the aspect of the present invention, it is preferable that the stopper include a stepped portion provided in the wire insertion passage, and the stepped portion include a stopper side-climbing surface which abuts on the moving object and over which the moving object climbs in a case in which the moving object is moved in a direction toward the proximal end opening, and a restricting surface which abuts on the moving object and restricts the movement of the moving object in a case in which the moving object is moved in a direction toward the distal end opening.

In the catheter device according to the aspect of the present invention, it is preferable that at least one of the moving object or the stopper be made of an elastic member.

In the catheter device according to the aspect of the present invention, it is preferable that the catheter body include an outer circumferential surface, and a liquid supply port which supplies a liquid to the wire insertion passage be formed on the outer circumferential surface between the distal end opening and the proximal end opening, and a water stop valve which prevents the liquid from leaking to an outside from the proximal end opening be provided in the wire insertion passage between the liquid supply port and the proximal end opening.

In the catheter device according to the aspect of the present invention, it is preferable that the catheter body include a multi-lumen tube having the wire insertion passage and a liquid insertion passage, the catheter body include an outer circumferential surface, and a liquid supply port which supplies a liquid to the liquid insertion passage be formed on the outer circumferential surface on a proximal end opening side from the stopper, and in a longitudinal direction of the catheter body, a range from the liquid supply port to the stopper be configured as at least the multi-lumen tube.

In the catheter device according to the aspect of the present invention, it is preferable that in the longitudinal direction of the catheter body, the stopper be provided to be closer to the proximal end opening side than to a distal end opening side.

In the catheter device according to the aspect of the present invention, it is preferable that in the longitudinal direction of the catheter body, the stopper be provided to be closer to a distal end opening side than to the proximal end opening side.

In the catheter device according to the aspect of the present invention, it is preferable that in the longitudinal direction of the catheter body, the stopper be provided on a halfway side between the proximal end opening and the distal end opening.

In the catheter device according to the aspect of the present invention, it is preferable that the allowing and blocking member include an elastic valve member provided in the wire insertion passage, an insertion hole through which the wire is inserted be provided in the elastic valve member, and the elastic valve member close the insertion hole in a case in which the wire is not disposed in the insertion hole.

It is preferable that the catheter device according to the aspect of the present invention further comprise a wire operating portion which operates the wire in a wire axis direction and a direction around a wire axis, in which the wire operating portion is connected to the proximal end portion of the wire extended from the proximal end opening to an outside.

It is preferable that the catheter device according to the aspect of the present invention further comprise a fixing member which temporarily fixes a position of the wire relative to the catheter body, in which the fixing member is provided in the proximal end portion of the wire extended from the proximal end opening to an outside.

In order to achieve the object of the present invention, a catheter package according to another aspect of the present invention comprises a catheter device, and a package body which accommodates the catheter device, in which the catheter device includes a flexible catheter body which has a distal end opening and a proximal end opening, is inserted into a body cavity starting from the distal end opening, and includes a wire insertion passage provided therein, and a wire which has a higher rigidity than the catheter body, is inserted into the wire insertion passage, and includes a distal end portion and a proximal end portion, in which the distal end portion is formed in a curved shape, and the catheter device is accommodated in the package body in a protruding state in which the distal end portion of the wire protrudes from the distal end opening.

According to the present invention, it is possible to prevent a bend from being formed in the catheter body.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Hereinafter, a catheter device and a catheter package according to an embodiment of the present invention will be described with reference to the accompanying drawings.

First Embodiment

FIG. 1is an overall perspective view of a catheter device10according to a first embodiment.FIG. 2is an enlarged cross sectional view of a main portion including a partially broken portion of the catheter device10shown inFIG. 1.

As shown inFIGS. 1 and 2, the catheter device10according to the first embodiment comprises a catheter body12and a slide wire14.

The catheter body12according to the present embodiment includes a long tube20which is inserted into a body cavity in a case of clinical use, a three-way tube22which is connected to a proximal end portion of the tube20, and a connecting tube26which is connected to a proximal end portion of a first tube24which configures the three-way tube22, in a longitudinal direction A shown inFIG. 1. Further, the catheter body12has a configuration which a distal end opening12A is provided in a distal end portion of the tube20, and a proximal end opening12B (seeFIG. 2) is provided in a proximal end portion of the connecting tube26.

As shown inFIG. 2, the tube20is configured by a single lumen tube in which one passage28which communicates the distal end portion with the proximal end portion is provided. The passage28functions as one passage which configures a wire insertion passage of the slide wire14, and the distal end portion of the passage28is communicated with the distal end opening12A. Further, the tube20is formed of a flexible material which is inserted into the curved body cavity. The material of the tube20is not particularly limited as long as it has flexibility that enables movement along the body cavity, and examples thereof include a synthetic resin or the like used for a known catheter.

The three-way tube22includes a main tube30, and a first tube24, a second tube32, and a third tube34which are respectively connected to a proximal end side of the main tube30. The distal end portion of the main tube30is connected to the proximal end portion of the tube20, the main tube30and the first tube24are disposed along the same axis, and the second tube32and the third tube34are disposed to face each other with the first tube24interposed therebetween.

In the three-way tube22according to the present embodiment, a passage36of the main tube30and a passage38of the first tube24function together with the passage28as one passage which configures the wire insertion passage. Further, a passage40of the second tube32and the passage36are communicated with each other via a liquid supply port42formed on an outer circumferential surface of the main tube30and function as an injection passage of a liquid such as a contrast medium. Further, a passage44of the third tube34and the passage36are communicated with each other via a guide wire insertion port46formed on the outer circumferential surface of the main tube30and function as an insertion passage of a guide wire (not shown) inserted into, for example, an inside of a bile duct (not shown). The liquid or the guide wire is ejected or protrudes from the distal end opening12A via the passage28in a case of clinical use.

Further, a water stop valve39is provided in the passage38. The water stop valve39is formed in a disk shape by, for example, an elastic member such as rubber, and the outer peripheral portion thereof is attached to an inner wall38A of the passage38, and an insertion hole (not shown) into which the slide wire14is inserted is formed in the center portion thereof. The water stop valve39is provided on the proximal end opening12B side from the liquid supply port42, and has a function of stopping the contrast medium flowed back into the passage38among the contrast media supplied from the liquid supply port42. This makes it possible to prevent the contrast medium from leaking from the proximal end opening12B.

A passage48which communicates the distal end portion with the proximal end portion is provided in the connecting tube26. The proximal end portion of the passage48is communicated with the proximal end opening12B. The passage48is disposed on the same axis with the passage38in a case in which the distal end portion50of the connecting tube26is connected to the proximal end portion of the first tube24as will be described below. As a result, the passage48functions as one passage which configures the wire insertion passage together with the passage28, the passage36, and the passage38, and in the catheter body12according to the present embodiment, the four passages28,36,38, and48which communicate with each other configure the wire insertion passage.

The catheter body12includes a wire state discrimination portion15in the passage38. The wire state discrimination portion15will be described below.

The distal end portion50of the connecting tube26is formed in a truncated cone shape that the outer diameter is reduced toward the distal end opening12A. By inserting the distal end portion50into the proximal end opening52of the first tube24, the distal end portion50is connected to the proximal end portion of the first tube24as described above. Further, in order to strengthen the connection described above, the catheter body12according to the present embodiment has a nut54.

The nut54is formed in a tubular shape and is attached externally on the connecting tube26, a female screw54A is formed on an inner circumferential surface on the distal end side, and a flange54B is formed on the inner circumferential surface on the proximal end side. Further, a male screw24A into which the female screw54A is screwed is formed on the outer circumferential surface of the first tube24on the proximal end side, and a flange26B on which the flange54B abuts is formed on the outer circumferential surface of the connecting tube26. With the nut54, in a case in which the female screw54A is screwed into the male screw24A, the flange54B abuts on the flange26B and presses the flange26B in the direction toward the distal end opening12A. As a result, the outer circumferential surface of the distal end portion50is pressed on the inner circumferential surface of the proximal end opening52, and thus the connection described above can be strengthened. A braking portion56and a handle58are provided at the proximal end portion of the connecting tube26, and the description of the braking portion56and the handle58will be made below.

Hereinafter, the slide wire14will be described.

The slide wire14is an example of the wire according to the embodiment of the present invention and has a higher rigidity than the tube20. The slide wire14is inserted into the passages28,36,38, and48, which are the wire insertion passages, as will be described below. In this case, the shape of the tube20is determined by the shape of the slide wire14inserted into the passage28, and is elastically deformed along the shape of the slide wire14. For example, the slide wire14is formed of a metal wire made of stainless steel or a nickel-titanium alloy.

The slide wire14includes a distal end portion14A and a proximal end portion14B (seeFIG. 2), and in particularly, the distal end portion14A is formed in a curved shape in order to elastically deform the distal end portion20A of the tube20in a curved shape in a case of clinical use. As shown inFIGS. 1 and 2, the distal end portion14A can protrude from the distal end opening12A of the tube20to the outside.

As shown inFIG. 2, the proximal end portion14B of the slide wire14is inserted into a thin metal guide tube60, which has a rigidity and is inserted into the passages38and48, and is fixed to the distal end portion60A of the guide tube60. The guide tube60is extended from the proximal end opening12B to the outside, and the proximal end portion60B of the extended guide tube60is connected to the handle58via the braking portion56. The guide tube60configures a part of the slide wire14as a whole.

For example, the slide wire14configured as described above is inserted, starting from the proximal end portion60B of the guide tube60, into the passages28,36,38, and48in this order from the distal end opening12A of the tube20. Therefore, the slide wire14is inserted into the wire insertion passage of the catheter body12together with the guide tube60. A moving object18is provided in the slide wire14. The moving object18will be described below.

Hereinafter, the braking portion56and the handle58will be described.

As shown inFIG. 2, the braking portion56is an example of a fixing member, and includes a brake pad62and a fastening member64. The brake pad62is formed in a tubular shape by an elastic member such as silicon rubber, and is attached to the inside of a cylindrical portion26C formed in the proximal portion of the connecting tube26. Further, the brake pad62has an insertion hole62A formed therein, and the guide tube60is inserted and disposed in the insertion hole62A so as to be rotatable, and capable of being pushed and pulled. The guide tube60is also inserted into the fastening member64, and the proximal end portion60B thereof is connected to the handle58as described above.

The fastening member64is formed in a tubular shape as a whole, and a male screw portion66is provided in the distal end portion and a knob portion68is provided in the proximal end portion. The male screw portion66is screwed into a female screw26D formed on the inner circumferential surface of the cylindrical portion26C. In this state, in a case in which the male screw portion66is screwed into the female screw26D by rotating the knob portion68, the brake pad62is interposed and compressed between the male screw portion66and the cylindrical portion26C. Then, the diameter of the insertion hole62A is reduced and the intimate attachment force of the brake pad62to the guide tube60is increased, so that the rotating operation and the pushing and pulling operation of the guide tube60are restricted by the brake pad62. As a result, the position of the slide wire14relative to the catheter body12is temporarily fixed.

On the other hand, the handle58is an example of a wire operating portion, and the proximal end portion of the guide tube60is connected to the distal end portion thereof. Therefore, the slide wire14can be rotated in the direction around an axis14C (seeFIG. 3) via the guide tube60by the rotating operation of the handle58, and the slide wire14can be moved in a direction of the axis14C via the guide tube60by the pushing and pulling operation of the handle58.

Hereinafter, the wire state discrimination portion15will be described.

As shown inFIG. 2, the catheter device10according to the first embodiment comprises the wire state discrimination portion15which discriminates a protruding state in which the distal end portion14A of the slide wire14protrudes from the distal end opening12A, and a non-protruding state in which the distal end portion14A of the slide wire14does not protrude from the distal end opening12A. The wire state discrimination portion15includes a stopper16that is provided in the passage38of the catheter body12and functions as an allowing and blocking member which allows a transition from the protruding state to the non-protruding state, and blocks a transition from the non-protruding state to the protruding state.

The stopper16has a function of discriminating a region in which the slide wire14is movable into a protruding region R1in which the protruding state is enabled, and a non-protruding region R2in which the non-protruding state is enabled, by allowing or restricting the movement of the moving object18to be described below. The protruding region R1and the non-protruding region R2will be described below.

Further, the stopper16is disposed on the inner wall38A of the passage38as an example. Specifically, the stopper16is provided in the distal end of the distal end portion50of the connecting tube26, and is disposed in the inner wall38A of the passage38by connecting the distal end portion50to the proximal end opening52of the first tube24as shown inFIG. 2. The disposition form of the stopper16is not limited to the above form, and the stopper16may be provided directly on the inner wall38A.

FIG. 3is an enlarged cross sectional view of the stopper16and the vicinity thereof.

As shown inFIG. 3, as an example, the stopper16is formed in a tubular shape, and an insertion hole16A into which the slide wire14including the guide tube60is inserted is formed in the center portion thereof. Further, the inner peripheral portion of the stopper16, which includes the inner circumferential surface of the insertion hole16A, is configured as a stepped portion16B. The surface on the distal end side of the stepped portion16B is formed as a vertical surface16C which is vertical to the axis14C of the slide wire14, and the surface on the proximal end side of the stepped portion16B is formed as a vertical surface16D which is vertical to the axis14C of the slide wire14. The stopper16is made of an elastic member such as rubber, as an example.

Hereinafter, the moving object18will be described.

As shown inFIG. 3, the moving object18is disposed in the passage36and fixed to the distal end portion60A of the guide tube60which is moved together with the slide wire14. As a result, the moving object18is provided to be movable integrally with the slide wire14. The fixed form of the moving object18is not limited to the above form, and the moving object18may be directly fixed to the slide wire14.

As an example, the moving object18is formed in a tubular shape, and an insertion hole18A into which the proximal end portion14B of the slide wire14is inserted is formed in the center portion thereof. Further, the outer peripheral portion of the moving object18, which includes the outer circumferential surface, is configured as a stepped portion18B. The surface on the proximal end side of the stepped portion18B is formed as a truncated cone surface18C of which the outer diameter is reduced toward the proximal end opening12B (seeFIG. 2), and the surface on the distal end side of the stepped portion18B is formed as a vertical surface18D which is vertical to the axis14C of the slide wire14.

The truncated cone surface18C functions as a moving object side-climbing surface which can climb over the stepped portion16B of the stopper16in a case in which the slide wire14is moved in a direction from the distal end opening12A toward the proximal end opening12B (seeFIG. 2) in the protruding region R1to be described below.

Further, the vertical surface18D functions as a restricted surface which abuts on the stepped portion16B of the stopper16and restricts the movement of the moving object18in a case in which the slide wire14is moved in a direction from the proximal end opening12B toward the distal end opening12A in the non-protruding region R2to be described below.

The moving object18configured as described above may be made of an elastic member as in the stopper16, but in a case in which the stopper16is made of an elastic member, for example, it may be made of a hard member such as plastic. That is, at least one of the moving object18or the stopper16may be made of an elastic member.

Next, an example for setting the protruding region R1and the non-protruding region R2will be described with reference toFIG. 3.

About Protruding Region R1

As described above, the protruding region R1is a region in the moving region of the slide wire14, which enables the protruding state. The protruding region R1is set, for example, as follows.

That is, as shown inFIG. 3, a total length of the curved shaped distal end portion14A of the slide wire14is L1, and this total length L1protrudes from the distal end opening12A to the outside. In that case, a length of the slide wire14from a distal end14D of the slide wire14to the vertical surface16C of the stopper16is L2. Then, a length of the catheter body12from the distal end opening12A to the vertical surface16C is L3. In this case, L1, L2, and L3are set by satisfying the relationship of Expression (1) below.

As described above, the non-protruding region R2is a region in the moving region of the slide wire14, which enables the non-protruding state. The non-protruding region R2is set, for example, as follows.

That is, as shown inFIG. 3, a length from the distal end14D of the slide wire14to the vertical surface18D of the moving object18is L4. Then, a length of the catheter body12from the distal end opening12A to the vertical surface16D of the stopper16is L5. In this case, L4and L5are set by satisfying the relationship of Expression (2) below.

That is, the protruding region R1and the non-protruding region R2are set by providing the stopper16and the moving object18at positions satisfying Expression (1) and (2) above, respectively. In this case, with the stopper16as a boundary, the protruding region R1is set in the direction toward the distal end opening12A, and the non-protruding region R2is set in the direction toward the proximal end opening12B.

Further, the stopper16has a function of allowing the movement of the moving object18to enable the transition from the protruding state to the non-protruding state in a case in which the slide wire14is moved in the direction from the distal end opening12A toward the proximal end opening12B, and restricting the movement of the moving object18to disable the transition from the non-protruding state to the protruding state in a case in which the slide wire14is moved in the direction from the proximal end opening12B toward the distal end opening12A.

Hereinafter, a specific example of the function described above of the stopper16will be described with reference to the operation explanatory view of the catheter body12shown inFIG. 4.

IVA ofFIG. 4shows a state of the catheter device10in a case in which the slide wire14is most moved in the direction toward the distal end opening12A by the handle58. In this case, the moving object18is positioned at a most distal end position P1of the protruding region R1, and the distal end portion14A of the slide wire14is in the protruding state in which the total length thereof protrudes from the distal end opening12A. In this protruding state, in a case in which the slide wire14is moved in the direction toward the proximal end opening12B by the handle58, the moving object18is moved from the position P1toward a most proximal end position P2(position of the vertical surface16C of the stopper16) of the protruding region R1, and the distal end portion14A of the slide wire14is accommodated in the passage28(seeFIG. 2) starting from the distal end opening12A of the tube20. Then, in a case in which the moving object18reaches the position P2, the distal end portion14A of the slide wire14is accommodated in the passage28and leaves, for example, a part of the distal end portion14A (for example, the distal end14D). In this case, the distal end portion20A of the tube20is elastically deformed in a curved shape along the curved shape of the distal end portion14A.

Next, in a case in which the slide wire14is further moved in the direction toward the proximal end opening12B by the handle58from the position in which the moving object18reaches the position P2, due to the force, the truncated cone surface18C of the moving object18shown inFIG. 3advances while expanding the insertion hole16A. As a result, the stepped portion18B climbs over the stepped portion16B, and the moving object18is positioned at the most distal end position P3of the non-protruding region R2from the position P2(see IVB ofFIG. 4). That is, in a case in which the slide wire14is moved in the direction from the distal end opening12A toward the proximal end opening12B, the stopper16allows the movement of the moving object18and enables the transition from the protruding state to the non-protruding state.

In this case, as shown in IVB ofFIG. 4, the total length of the distal end portion14A of the slide wire14is accommodated in the passage28. Then, in this state, in a case in which the slide wire14is attempted to be moved in the direction toward the distal end opening12A by the handle58, the vertical surface18D of the moving object18abuts on the vertical surface16D of the stopper16, and the movement of the moving object18is restricted. That is, in a case in which the slide wire14is moved in the direction from the proximal end opening12B toward the distal end opening12A, the stopper16restricts the movement of the moving object18and disables the transition from the non-protruding state to the protruding state. The specific function of the stopper16is described above.

On the other hand, in the form of IVB ofFIG. 4, in a case in which the slide wire14is further moved in the direction toward the proximal end opening12B by the handle58, the moving object18is moved toward the proximal end opening12B, and the distal end portion14A of the slide wire14is further accommodated toward the proximal end side of the passage28. Then, as shown in IVC ofFIG. 4, in a case in which the moving object18abuts on the brake pad62, that is, in a case in which the moving object18reaches the most proximal end position P4of the non-protruding region R2, the movement of the slide wire14by the handle58in the direction toward the proximal end opening12B is restricted.

As described above, in the catheter device10according to the present embodiment, a region between the position P1and the position P2is set as the protruding region R1, and a region between the distal end position P3and the proximal end position P4is set as the non-protruding region R2.

Next, an example of a form of the catheter device10in a case of delivery and a case of clinical use configured as described above will be described.

Form in Case of Delivery

FIG. 5is an overall view of a catheter package100according to the embodiment of the present invention, and shows a form of the catheter device10in a case of delivery.

As shown inFIG. 5, the catheter package100according to the present embodiment includes the catheter device10and a package body102, and the catheter device10is accommodated in the package body102.

In the package body102, an accommodating portion which is blocked from the external space is formed. Furthermore, the package body102is made of a transparent material.

The catheter device10is accommodated in the package body102in the protruding state in which the total length of the curved shaped distal end portion14A protrudes from the distal end opening12A of the tube20. This form is the form of the catheter device10in a case of delivery.

As described above, in the catheter device10according to the present embodiment, the relative position between the catheter body12and the slide wire14in a case of delivery can be defined as a position that enables the protruding state, so that a bend of the distal end portion14A is prevented from being transferred to the tube20in a case of delivery. Therefore, it is possible to prevent a bend from being formed in the catheter body12.

Form in Case of Clinical Use

In a case of clinical use, the package body102ofFIG. 5is opened, and the catheter device10is extracted from the package body102. In this case, since the distal end portion14A is in the protruding state, the slide wire14is moved in the direction toward the proximal end opening12B by the handle58, and the protruding state is transitioned to the non-protruding state. This form is the form of the catheter device10in a case of clinical use.

As described above, in the catheter device10according to the present embodiment, the relative position between the catheter body12and the slide wire14in a case of clinical use can be defined as a position that enables the non-protruding state. This makes it possible to prevent the distal end portion14A of the slide wire14from protruding toward the inside of the body cavity in a case of clinical use.

As described above, with the catheter device10according to the first embodiment, the catheter body12includes the wire state discrimination portion15which discriminates the protruding state and the non-protruding state, and the wire state discrimination portion15includes the stopper16as an allowing and blocking member which allows the transition from the protruding state to the non-protruding state, and blocks the transition from the non-protruding state to the protruding state, so that the suitable relative position between the catheter body12and the slide wire14in a case of delivery and clinical use can be defined.

Next, an example of a treatment example in a case in which the catheter device10according to the present embodiment is used for double balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) will be described with reference to a flowchart shown inFIG. 6.

At first, in step (S)200, the package body102is opened, and the catheter device10is extracted from the package body102.

In this case, since the distal end portion14A of the slide wire14is in the protruding state, in S210, the slide wire14is moved in the direction toward the proximal end opening12B by the handle58, and the protruding state is transitioned to the non-protruding state. An operator who operates the handle58can confirm that the protruding state is transitioned to the non-protruding state with the feeling of operation of a case in which the stepped portion18B shown inFIG. 3climbs over the stepped portion16B.

Next, in S220, a double-balloon endoscope, which is a direct-vision endoscope, is used, and the tube20is inserted, starting from the distal end opening12A of the tube20, into the insertion part of the double-balloon endoscope from the forceps port of the double-balloon endoscope. In this case, since the distal end portion14A of the slide wire14does not protrude from the distal end opening12A, the tube20can be smoothly inserted into the insertion part.

Next, in S230, the distal end portion of the insertion part of the double-balloon endoscope is inserted from the mouth to the vicinity of the papilla of the duodenum while appropriately expanding and contracting the balloon. This insertion operation is performed while observing a body cavity image sent from an imaging unit provided at the distal end portion of the insertion part on a monitor.

Next, in S240, the distal end portion20A of the tube20protrudes from the distal end portion of the insertion part. In this case, the distal end portion20A is elastically deformed in a curved shape along the shape of the curved shaped distal end portion14A of the slide wire14accommodated in the distal end portion20A.

Next, in S250, the handle58of the catheter device10is operated such that the distal end portion20A is directed toward the papilla while observing the image of the papilla and the distal end portion20A of the tube20displayed on the monitor. That is, in a case in which the handle58is rotated, the slide wire14rotates around the axis14C, so that the curved distal end portion20A of the tube20can be rotated around the axis14C. Further, in a case in which the handle58is pulled or pushed in, the slide wire14is moved along the axis14C, so that the curved angle of the distal end portion20A of the tube20can be changed. Such an operation is appropriately performed to direct the distal end portion20A toward the papilla.

Next, in S260, the distal end portion20A of the tube20is inserted into the papilla.

Next, in S270, in a state in which the distal end portion20A of the tube20is inserted into the papilla, the handle58is operated to be rotated, the direction of the bile duct is searched while rotating the distal end portion20A of the tube20, and the direction of the distal end portion20A is aligned with the direction of the bile duct. Thereafter, the slide wire14is fixed to be inoperative by the braking portion56shown inFIG. 2, and the direction of the distal end portion20A is fixed.

Next, in S280, the guide wire is inserted from the passage44of the three-way tube22shown inFIG. 2, and the distal end portion of the guide wire protrudes from the distal end opening12A of the tube20and inserted into the bile duct.

Next, in S290, the tube20is inserted into the back side of the bile duct by using the guide wire as a guide, if necessary.

Next, in S300, if necessary, the contrast medium is sent from the passage40of the three-way tube22shown inFIG. 2, and the contrast medium is injected into the bile duct from the distal end opening12A of the tube20.

Next, in S310, if necessary, another device such as a balloon or a stent is inserted into the bile duct by using the guide wire as a guide to treat the affected area. The above is an example of a treatment example by using the catheter device10according to the present embodiment.

Here, the difference of a treatment method between the DB-ERCP described above and the ERCP of a normal case will be briefly described.

In the ERCP, the duodenoscopy is inserted from the mouth to the duodenum and the distal end portion of the tube is derived from the distal end portion of the duodenoscopy. Next, the treatment tool elevator provided in the distal end portion of the duodenoscopy is operated to align the direction of the distal end portion of the tube with the direction of the papilla, and then the distal end portion of the tube20is inserted into the bile duct via the papilla (hereinafter referred to as “cannulation”).

On the other hand, in the DB-ERCP, since the duodenoscopy cannot be inserted into the papilla, a direct-vision endoscope such as a double-balloon endoscope is used instead of the duodenoscopy, but the direct-vision endoscope does not comprise the treatment tool elevator. In addition, the direction of the papilla varies, especially in the postoperative intestine. Due to such circumstances, in the DB-ERCP, it is very difficult to align the distal end portion of the tube with the direction of the papilla, and it may not be possible to easily perform cannulation.

Therefore, in a case in which the catheter device10according to the present embodiment is used for the DB-ERCP, in the catheter device10according to the present embodiment, the direction of the distal end portion20A of the tube20can be freely adjusted by the rotating operation and the pushing and pulling operation of the handle58, and thus the direction of the distal end portion20A of the tube20can be easily aligned with the direction of the papilla. As a result, it is possible to easily perform cannulation.

Some embodiments of the catheter device according to the present invention will be described below.

Second Embodiment

FIG. 7is an enlarged cross sectional view of a main portion of a catheter device110according to a second embodiment, and shows a moving object112and a stopper114. The difference between the catheter device110according to the second embodiment and the catheter device10according to the first embodiment shown inFIGS. 1 to 5is the shape of the moving object112and the stopper114shown inFIG. 7, and other portions are the same, the description thereof will be omitted.

In the moving object112shown inFIG. 7, the slide wire14is inserted and disposed therein, and the moving object112is fixed to the slide wire14. The moving object112is formed in a truncated cone shape that the outer diameter is reduced in a direction toward the proximal end opening12B, and the outer circumferential surface thereof is formed as a truncated cone surface112A. Further, the surface on the distal end side of the moving object112is formed as a vertical surface112B which is vertical to the axis14C.

Further, the stopper114includes a stepped portion114A. The stepped portion114A includes a truncated cone surface114B which abuts on the truncated cone surface112A of the moving object112and over which the moving object112climbs, in a case in which the moving object112is moved in the direction toward the proximal end opening12B. Further, the stepped portion114A includes a vertical surface114C which abuts on the vertical surface112B of the moving object112and restricts the movement of the moving object112, in a case in which the moving object112is moved in the direction toward the distal end opening12A. Here, the truncated cone surface114B functions as a stopper side-climbing surface, and the vertical surface114C functions as a restricting surface.

With the catheter device110according to the second embodiment, in a case in which the slide wire14is moved in the direction from the distal end opening12A toward the proximal end opening12B, the stopper114allows the movement of the moving object112and enables the transition from the protruding state to the non-protruding state. Also, in a case in which the slide wire14is moved in the direction from the proximal end opening12B toward the distal end opening12A, the stopper114restricts the movement of the moving object112and disables the transition from the non-protruding state to the protruding state. As a result, the catheter device110according to the second embodiment can prevent a bend from being formed in the catheter body12as in the catheter device10according to the first embodiment, and can define the suitable relative position between the catheter body and the wire in a case of delivery and clinical use.

Third Embodiment

FIG. 8is a schematic cross sectional view of the catheter device120according to a third embodiment, and shows a tube122including a multi-lumen tube124.

As shown inFIG. 8, the multi-lumen tube124includes a wire insertion passage126, a liquid passage128which is communicated with the liquid supply port42, and a guide wire insertion passage130which is communicated with the guide wire insertion port46.

Further, a catheter body132shown inFIG. 8includes the stopper16to be closer to the proximal end opening12B side than to the distal end opening12A (seeFIG. 2) side in the longitudinal direction A, and the liquid supply port42is formed on the proximal end opening12B side from the stopper16. A range F1from the liquid supply port42to the stopper16is configured by the multi-lumen tube124described above.

With the catheter device120configured in this way, the contrast medium supplied from the liquid supply port42to the liquid passage128is smoothly flowed from the distal end opening128A of the liquid passage128into the tube122configured by the single lumen tube. As described above, by configuring the range F1from the liquid supply port42to the stopper16by the multi-lumen tube124, the backflow of the contrast medium to the proximal end opening12B side can be prevented without using the water stop valve39for backflow prevention shown inFIG. 2.

The range of the multi-lumen tube124in the tube122is not limited to the range F1, at least the range F1need only be configured by the multi-lumen tube124, and thus the range beyond the range F1may be configured by the multi-lumen tube124. For example, the total length of the tube122may be configured by the multi-lumen tube124.

Further, in the multi-lumen tube124shown inFIG. 8, the liquid passage128and the guide wire insertion passage130are respectively independently configured, but a multi-lumen tube may be adopted in which the liquid passage128and the guide wire insertion passage130are configured as one passage.

Fourth Embodiment

FIG. 9is a schematic cross sectional view of the catheter device140according to a fourth embodiment, and shows a tube142including a multi-lumen tube144. The difference between the catheter device140according to the fourth embodiment and the catheter device120according to the third embodiment shown inFIG. 8is that the stopper16shown inFIG. 9is disposed to be closer to the distal end opening12A side than to the proximal end opening12B side.

As shown inFIG. 9, the multi-lumen tube144includes a wire insertion passage146, a liquid passage148which is communicated with the liquid supply port42, and a guide wire insertion passage150which is communicated with the guide wire insertion port46.

Further, in a catheter body152shown inFIG. 9, the liquid supply port42is formed on the proximal end opening12B side from the stopper16. A range F2from the liquid supply port42to the stopper16is configured by the multi-lumen tube144.

With the catheter device140configured in this way, the contrast medium supplied from the liquid supply port42to the liquid passage148is smoothly flowed from the distal end opening148A of the liquid passage148into the tube142configured by the single lumen tube. As described above, by configuring the range F2from the liquid supply port42to the stopper16by the multi-lumen tube144, the backflow of the contrast medium to the proximal end opening12B side can be prevented without using the water stop valve39for backflow prevention shown inFIG. 2.

The range of the multi-lumen tube144in the tube142is not limited to the range F2, at least the range F2need only be configured by the multi-lumen tube144, and thus the range beyond the range F2may be configured by the multi-lumen tube144. For example, the total length of the tube142may be configured by the multi-lumen tube144.

Fifth Embodiment

FIG. 10is a schematic cross sectional view of the catheter device160according to a fifth embodiment, and shows a tube162including a multi-lumen tube164. The difference between the catheter device160according to the fifth embodiment and the catheter device120according to the third embodiment shown inFIG. 8is that the stopper16shown inFIG. 10is disposed on a halfway side between the proximal end opening12B and the distal end opening12A.

As shown inFIG. 10, the multi-lumen tube164includes a wire insertion passage166, a liquid passage168which is communicated with the liquid supply port42, and a guide wire insertion passage170which is communicated with the guide wire insertion port46.

Further, in a catheter body172shown inFIG. 10, the liquid supply port42is formed on the proximal end opening12B side from the stopper16. A range F3from the liquid supply port42to the stopper16is configured by the multi-lumen tube164described above.

With the catheter device160configured in this way, the contrast medium supplied from the liquid supply port42to the liquid passage168is smoothly flowed from the distal end opening168A of the liquid passage168into the tube162configured by the single lumen tube. As described above, by configuring the range F3from the liquid supply port42to the stopper16by the multi-lumen tube164, the backflow of the contrast medium to the proximal end opening12B side can be prevented without using the water stop valve39for backflow prevention shown inFIG. 2.

The range of the multi-lumen tube164in the tube162is not limited to the range F3, at least the range F3need only be configured by the multi-lumen tube164, and thus the range beyond the range F3may be configured by the multi-lumen tube164. For example, the total length of the tube162may be configured by the multi-lumen tube164.

Further, in the multi-lumen tube164shown inFIG. 10, the liquid passage168and the guide wire insertion passage170are respectively independently configured, but the present invention is not limited to this, and a multi-lumen tube may be adopted in which the liquid passage168and the guide wire insertion passage170are configured as one passage.

In the first to fifth embodiments described above, the catheter device in which the stopper and the moving object are respectively provided in the wire insertion passage is described as an example, but the catheter device according to the embodiment of the present invention is not limited to these embodiments. For example, a configuration may be adopted in which an adapter which comprises the stopper, and configures a part of the catheter body is attached to the outside of the catheter body, the wire is arranged on the adapter, and the stopper in the adapter allows or restricts the movement of the moving object. That is, the stopper need only be provided in the catheter body.

Further, in the first embodiment shown inFIGS. 1 and 2, the catheter body12configured by the tube20, the three-way tube22, and the connecting tube26is described as an example, but the present invention is not limited to this, and for example, the catheter body may be configured by only the tube20. In this case, the tube20need only be provided with the stopper16.

Sixth Embodiment

FIG. 11is a schematic cross sectional view of a catheter device180according to a sixth embodiment.

In the catheter device180shown inFIG. 11, a tube182is configured by the multi-lumen tube. A valve member186which functions as an allowing and blocking member is attached to a distal end opening184A of a wire insertion passage184in the multi-lumen tube.

The valve member186is an elastic valve member made of an elastic member such as rubber, and is attached to the distal end opening184A by fixing the outer peripheral portion thereof to the inner wall of the distal end opening184A. Further, an insertion hole186A into which the slide wire14is inserted is formed in the center portion of the valve member186.

According to the sixth embodiment, as shown inFIG. 11, in a case of delivery, the distal end portion14A of the slide wire14protrudes from the insertion hole186A of the valve member186. As a result, it is possible to prevent a bend of the distal end portion14A from being transferred to the tube182, so that it is possible to prevent a bend from being formed in the catheter body. Further, as shown inFIG. 12, in a case of clinical use, the distal end portion14A is accommodated in the wire insertion passage184. As a result, the insertion hole186A is closed, and it is possible to prevent the distal end portion14A from protruding toward the inside of the body cavity.

In this case, it is preferable that the diameter of the wire insertion passage184be made larger than the diameter of the slide wire14. Then, in a case in which the distal end portion14A is accommodated in the wire insertion passage184, the relative position between the distal end14D and the insertion hole186A shifts in the radial direction of the valve member186, so that the distal end14D can be blocked from being inserted again into the insertion hole186A. As a result, the protrusion described above can be surely prevented.

The embodiments of the present invention have been described above, but the present invention is not limited to the above examples, and it is noted that various modifications or changes may be made without departing from the gist of the present invention. For example, the package body102shown inFIG. 5can accommodate the catheter devices110,120,140,160, and180according to the second to sixth embodiments.

Hereinafter, an example of a catheter device different from that of the present invention will be described.

In the present invention, the transition from the non-protruding state to the protruding state is blocked by the allowing and blocking member, but in a case of clinical use, in a case in which the distal end portion14A may protrude from the distal end opening12A, the transition from the non-protruding state to the protruding state may be allowed.

In this case, for example, in the stopper114shown inFIG. 7need only have a configuration in which the shape of the vertical surface114C is formed into the truncated cone surface, and the movement of the moving object112is allowed in a case in which the slide wire14is moved in the direction from the proximal end opening12B toward the distal end opening12A.

EXPLANATION OF REFERENCES

12A: distal end opening

12B: proximal end opening

14: slide wire

14A: distal end portion

14B: proximal end portion

15: wire state discrimination portion

16C: vertical surface

16D: vertical surface

18: moving object

18C: truncated cone surface

18D: vertical surface

20A: distal end portion

24: first tube

24A: male screw

26D: female screw

30: main tube

32: second tube

34: third tube

38A: inner wall

39: water stop valve

42: liquid supply port

46: guide wire insertion port

50: distal end portion

52: proximal end opening

54A: female screw

60: guide tube

60A: distal end portion

60B: proximal end portion

66: male screw portion

102: package body

112: moving object

112A: truncated cone surface

112B: vertical surface

114B: truncated cone surface

114C: vertical surface

126: wire insertion passage

130: guide wire insertion passage

146: wire insertion passage

150: guide wire insertion passage

166: wire insertion passage

170: guide wire insertion passage

184A: distal end opening

186: valve member