JPWO2007122908A1 - Medical tools - Google Patents

Abstract

The medical device includes a long linear body that is used by being inserted into a living body from the tip. The linear body of the medical device is formed at the front end portion of the medical device, is formed along the longitudinal direction of the liquid storage space capable of storing the liquid, and communicates with the liquid storage space to store the liquid. It has a space provided with a flow path leading to the space. This linear body is composed of a porous member having a function of permitting the passage of gas and preventing the passage of liquid at least part of the portion facing the space, and when the liquid is injected into the flow path The gas in the space is discharged out of the linear body via the porous member.

Description

  The present invention relates to a medical device.

  In recent years, various forms of treatment have been performed in medicine using, for example, an elongated hollow tubular medical device called a catheter.

  In such a catheter, a contrast agent is injected into a flow path (lumen) formed inside the tube wall, and the tip position in the living body is visually recognized under contrast (for example, see Patent Document 1). In some cases, liquid is injected into the flow path to expand a balloon provided at the tip (see, for example, Patent Document 2).

  Patent Document 1 discloses a catheter having a configuration in which a flow path is opened at both ends of a catheter, a cock is provided at a proximal end, and the cock is closed to hold a contrast medium in the flow path.

  However, in the catheter having such a configuration, when the cock is opened due to malfunction of the cock, the contrast medium flows out from the tip into the living body. Further, even when the cock is closed, the contrast medium may easily flow out into the living body due to body fluid such as blood coming into contact with the opening of the catheter tip. In these cases, depending on the type and concentration of the contrast agent, the patient may be adversely affected.

  On the other hand, Patent Document 2 discloses a catheter (balloon catheter) having a configuration in which a flow path is closed at a distal end and a proximal end is opened at an opening of a branch hub.

  However, in the catheter having such a configuration, since one end of the flow path is closed, when a sufficient amount of liquid is injected into the flow path, for example, a syringe with a three-way cock is connected to the opening of the branch hub. The operation of injecting the liquid into the flow path and the operation of removing the gas from the flow path must be repeated, which is complicated.

Special Table 2002-516132 Publication JP 2000-107293 A

  The objective of this invention is providing the medical device which can supply a liquid easily and reliably to the space formed in the inside of a linear body.

In order to achieve the above object, the present invention provides:
A medical device comprising a long linear body that is used by being inserted into a living body from the tip,
The linear body is formed at a front end portion of the linear body, is formed along a longitudinal direction of the liquid storage space in which the liquid can be stored, communicates with the liquid storage space, and stores the liquid in the liquid storage space. Having a space with a flow path leading to the space,
The linear body is composed of a porous member having a function in which at least a part of the portion facing the space allows the passage of gas and prevents the passage of the liquid,
The medical device is configured such that when the liquid is injected into the flow path, the gas in the space is discharged out of the linear body through the porous member.

  According to the present invention as described above, since at least a part of the portion where the space formed inside the linear body faces is configured by the porous member, the path for discharging the gas existing in the space to the outside of the linear body is provided. Therefore, when a liquid is injected into the space, the liquid can be easily and reliably supplied to the tip.

  Moreover, in the medical device of this invention, it is preferable that the porosity of the said porous member is 10 to 50% in the state which made the inside of the said space normal pressure.

  Thereby, the passage of the liquid can be more reliably prevented while allowing the passage of the gas sufficiently.

  In the medical device of the present invention, it is preferable that the porous member has an average pore diameter of 0.05 to 0.5 μm in a state where the space is at normal pressure.

  Thereby, the passage of the liquid can be more reliably prevented while allowing the passage of the gas sufficiently.

  In the medical device of the present invention, it is preferable that the porous member is poor in stretchability.

  This prevents the pore diameter of the porous member from becoming extremely large even when the pressure in the space rises unnecessarily or when a relatively high-viscosity liquid is supplied into the flow path (space). It is possible to suitably prevent the liquid supplied in the liquid storage space from flowing out (dissipating) out of the linear body.

  In the medical device of the present invention, the porous member preferably has a pore diameter expansion rate of 200% or less when the pressure in the space is 20 atm.

  Thereby, since the expansion / contraction rate of the porous member is sufficiently low, it is possible to more reliably prevent the liquid supplied into the liquid storage space from flowing out of the linear body.

  Moreover, in the medical device of this invention, it is preferable that the said porous member has hydrophobicity in the surface which faces the said space at least.

  Thereby, the effect which blocks | prevents passage of a liquid is exhibited more notably.

  In the medical device of the present invention, the porous member preferably has ultrasonic contrast properties.

  Thereby, the position of the linear body can be confirmed from the ultrasonic image.

  Moreover, in the medical device of this invention, it is preferable that the part comprised with the said porous member is provided in the front-end | tip part of the said linear body.

  Thereby, when the liquid is injected into the flow path, the gas in the space is pressed toward the tip by the liquid, so that the gas in the space can be efficiently discharged out of the linear body.

  In the medical device of the present invention, it is preferable that an absorbent having a function of absorbing and holding the liquid is accommodated at least at a distal end portion in the space.

  When the liquid stored in the liquid storage space has a contrast property, the liquid can be absorbed by the absorbent and can remain (hold) more reliably in the liquid storage space.

  Moreover, in the medical device of this invention, it is preferable that the said liquid storage space is formed over the perimeter of the said linear body.

  When the liquid stored in the liquid storage space has a contrast property, when the linear body is inserted into the living body, the position of the linear body is more easily recognized by the liquid stored in the liquid storage space.

  Moreover, in the medical device of this invention, it is preferable that the said flow path is formed over the perimeter of the said linear body.

  Thereby, it becomes easy to supply the liquid uniformly in the liquid storage space.

  Moreover, in the medical device of this invention, it is preferable that the said flow path is formed in a part of circumferential direction of the said linear body.

  When the liquid passing through the flow path has contrast properties, the degree of twist generated in the linear body in the living body can be visually confirmed (confirmed) by the liquid passing through the flow path.

In the medical device of the present invention, the linear body includes an inner tube and an outer tube provided on the outer peripheral side of the inner tube,
The space is preferably formed between the inner tube and the outer tube.

  As a result, the distal end portion of the space functions as a liquid storage space, and the proximal end portion functions as a flow path.

  Moreover, in the medical device of this invention, it is preferable that the part comprised with the said porous member is provided inside the said outer tube | pipe.

  Thereby, the gas in the space is discharged (exhausted) to the inner tube side.

  Moreover, in the medical device of this invention, it is preferable that the part comprised with the said porous member is provided outside the said inner tube | pipe.

  Thereby, the gas in the space is discharged (exhausted) to the outer tube side.

In the medical device of the present invention, the linear body includes a core portion and a coating layer provided so as to cover at least the distal end side of the core portion,
The space is preferably formed between the core portion and the coating layer.

  As a result, the distal end portion of the space functions as a liquid storage space, and the proximal end portion functions as a flow path.

  Moreover, in the medical device of this invention, it is preferable that the part comprised with the said porous member is provided outside the said core part.

  Thereby, the gas in the space is discharged (exhausted) to the outer tube side.

The medical device of the present invention further includes a hub provided on the proximal end side of the linear body,
It is preferable that the base end side of the channel is open to the side of the hub.

  Thereby, a liquid can be inject | poured in a flow path through the part open | released to the side of the hub of the flow path.

In the medical device of the present invention, at least a part of the inner surface of the space is provided with a substance that exhibits MRI contrast by ionization,
When necessary, it is preferably used by injecting a solution capable of dissolving the substance into the channel.

  Thereby, contrast is developed in the space when necessary.

  The medical device of the present invention is preferably used by injecting a liquid contrast agent exhibiting a contrast property into the flow channel when necessary.

  As a result, it is possible to prevent long-term storage in a state in which the contrast medium is stored, and thus suitable for deterioration or deterioration of the linear body or the contrast medium due to long-term contact between the linear body and the contrast medium. Can be prevented.

  Moreover, in the medical device of this invention, it is preferable that the said medical device is a catheter, a guide wire, or a needle body.

  Thereby, it becomes a suitable thing as a medical device.

FIG. 1 is a longitudinal sectional view showing a first embodiment of a catheter to which the medical device of the present invention is applied. FIG. 2 is a cross-sectional view taken along line AA in FIG. 1 (a) and a cross-sectional view taken along line BB (b). FIG. 3 is a longitudinal sectional view showing a distal end portion of a second embodiment of a catheter to which the medical device of the present invention is applied. FIG. 4 is a longitudinal sectional view showing a distal end portion of a third embodiment of the catheter to which the medical device of the present invention is applied. FIG. 5 is a cross-sectional view taken along line AA in FIG. 4 (a) and a cross-sectional view taken along line BB in FIG. 4 (b). FIG. 6 is a longitudinal sectional view showing a distal end portion of a fourth embodiment of the catheter to which the medical device of the present invention is applied. FIG. 7 is a longitudinal sectional view showing a distal end portion of a fifth embodiment of a catheter to which the medical device of the present invention is applied. FIG. 8 is a longitudinal sectional view showing an embodiment of a guide wire to which the medical device of the present invention is applied.

Hereinafter, the medical device of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.
<Catheter>
First, the case where the medical device of this invention is applied to a catheter is demonstrated.

<< First Embodiment >>
First, a first embodiment of the catheter will be described.

  FIG. 1 is a longitudinal sectional view showing a first embodiment of a catheter to which the medical device of the present invention is applied. FIG. 2 is a sectional view taken along line AA in FIG. FIG. In the following, for convenience of explanation, the right side in FIG. 1 is referred to as “base end” and the left side is referred to as “tip”.

  A catheter 1 shown in FIG. 1 has a flexible catheter body (long linear body) 2 and a hub 3 provided on the proximal end side of the catheter body 2.

  The catheter body 2 is a part used by being inserted into a living body (for example, a tubular organ such as a blood vessel) from the tip.

  The catheter body 2 is formed at a distal end portion inside thereof, and is formed along a longitudinal direction of the liquid storage space 41 in which the liquid can be stored. The catheter main body 2 communicates with the liquid storage space 41 and allows the liquid to be stored in the liquid storage space. A space 4 including a flow path 42 leading to 41 is provided.

  The catheter 1 is used when necessary, for example, by injecting a liquid contrast agent exhibiting MRI contrast (hereinafter simply referred to as “MRI contrast agent”) into the flow path 42 and storing it in the liquid storage space 41. . Thereby, when inserting the catheter 1 in a living body, the front-end | tip part of the catheter main body 2 can be visually recognized by MRI contrast, and the operation can be performed easily and correctly. Further, when necessary, the MRI contrast agent is supplied (injected) into the space 4, that is, the MRI contrast agent is not stored in the space 4 (in the catheter body 2). Deterioration / degradation of the catheter body 2 and the MRI contrast agent due to long-term contact with the agent can be suitably prevented.

  Here, examples of the MRI contrast agent include those obtained by dissolving gadoterate meglumine, gadoteridol, fermoxides, ammonium iron citrate, gadopentetate meglumine and the like in a predetermined solvent (for example, water for injection).

  Below, the catheter 1 of the form which inject | pours an MRI contrast agent in the space 4 as needed is demonstrated to an example.

  As shown in FIG. 1, the catheter body 2 of the present embodiment includes a tubular inner tube 21 having a lumen 20, a circular tubular outer tube 22 provided on the outer peripheral side of the inner tube 21, and a distal end. It is provided with an adhesive layer (intermediate layer) 23 that is provided between the inner tube 21 and the outer tube 22 and joins them. For example, a long object such as a guide wire or a catheter is inserted into the lumen 20 of the catheter body 2.

  As shown in FIG. 2, the inner tube 21 and the outer tube 22 are provided concentrically and spaced apart from each other, so that the inner tube 21 and the outer tube 22 are disposed between the inner tube 21 and the outer tube 22 (of the catheter body 2). A space 4 is formed in the interior) over the entire circumference of the catheter body 2.

  A distal end portion of the space 4 constitutes a liquid storage space 41, and a portion (region) closer to the proximal end constitutes a flow path 42. Therefore, in this embodiment, both the liquid storage space 41 and the flow path 42 are formed over the entire circumference of the catheter body 2 and the cross-sectional shape thereof is an annular shape.

  By forming the liquid storage space 41 over the entire circumference of the catheter body 2, the position of the distal end portion of the catheter body 2 can be more easily recognized by MRI contrast when the catheter 1 is inserted into the living body. Further, since the flow path 42 is formed over the entire circumference of the catheter body 2, the MRI contrast agent can be easily supplied uniformly through the liquid storage space 41.

  The width of the liquid storage space 41 (the width at the tip of the gap between the inner tube 21 and the outer tube 22) is not particularly limited, but is preferably about 0.05 to 0.5 mm, preferably 0.1 to 0. More preferably, it is about 3 mm.

  On the other hand, the width of the flow path 42 (the width at the main portion of the gap between the inner tube 21 and the outer tube 22) is not particularly limited, but is preferably about 0.05 to 0.5 mm, preferably 0.1 to 0. More preferably, it is about 3 mm.

  In the present embodiment, the inner tube 21 includes an inner tube main body 212 and an inner tube distal end portion 211 joined to the distal end portion of the inner tube main body 212, and the inner tube distal end portion (one of the portions facing the space 4). Part) 211 is formed of a porous member. In this configuration, in the space 4, the region from the distal end to the vicinity of the junction between the inner tube distal end portion 211 and the inner tube main body 212 is the liquid storage space 41, and the region on the proximal end side is the flow path 42.

  Here, the porous member used in the present invention includes continuous pores in which adjacent pores are connected to each other, and allows the passage of gas but has the function of preventing the passage of liquid. is there.

  A part of the portion facing the space 4 of the catheter body 2 (in this embodiment, the inner tube tip portion 211 of the inner tube 21) is made of such a porous member, whereby a flow path is formed in the liquid storage space 41. When the MRI contrast medium (liquid) is injected from 42, the gas in the space 4 (for example, air) can be discharged out of the catheter body 2 through the porous member (continuous pores). Can be prevented from becoming high. For this reason, the MRI contrast agent can be easily and reliably supplied into the liquid storage space 41, and the position of the distal end portion of the catheter body 2 can be more easily recognized.

  In the present embodiment, a portion made of a porous member (inner tube tip portion 211) is provided on the inner side (inner peripheral side) of the outer tube 22, and the gas in the space 4 passes through the lumen of the catheter body 2. It is discharged (exhausted) to the 20 side.

  In addition, it is preferable that the part comprised with a porous member is the front-end | tip part of the catheter main body 2 like this embodiment. When the MRI contrast agent is injected into the flow path 42, the gas in the space 4 is pressed toward the distal end by the MRI contrast agent, so that the gas in the space 4 is efficiently discharged out of the catheter body 2. It is because it can do.

  The porous member preferably has a porosity of about 10 to 50%, more preferably about 35 to 45% in a state where the space 4 is at normal pressure. Thereby, the passage of the liquid can be more reliably prevented while allowing the passage of the gas sufficiently. When the porosity exceeds the upper limit, depending on the viscosity of the liquid injected into the space 4 and the degree of stretchability of the porous member, the liquid injected into the space 4 passes through the porous member. The risk of leakage (outflow) out of the catheter body 2 is increased. On the other hand, if the porosity is less than the lower limit, it may take time to discharge the gas in the space 4, that is, it may take time to store the liquid in the liquid storage space 41. Further, there is a possibility that the liquid storage space 41 is not sufficiently filled with the MRI contrast agent.

  The porous member preferably has an average pore diameter of about 0.05 to 0.5 μm, and preferably about 0.05 to 0.15 μm, with the space 4 at normal pressure. Thereby, the passage of the liquid can be more reliably prevented while allowing the passage of the gas sufficiently. When the average pore diameter exceeds the upper limit, depending on the viscosity of the liquid injected into the space 4 and the degree of stretchability of the porous member, the liquid injected into the space 4 may pass through the porous member through the catheter. The risk of leaking out of the main body 2 is increased. On the other hand, if the average pore diameter is less than the lower limit value, it may take time to discharge the gas in the space 4, that is, it may take time to store the liquid in the liquid storage space 41. Further, there is a possibility that the liquid storage space 41 is not sufficiently filled with the MRI contrast agent.

  In addition, the above porosity and average pore diameter can each be measured, for example with a mercury porosimeter etc.

  Moreover, it is preferable that the porous member is poor in stretchability. Thereby, even when the pressure in the space 4 rises unnecessarily, or when a relatively high-viscosity liquid is supplied into the flow path 42 (space 4), the pore diameter of the porous member becomes extremely large. The liquid supplied into the liquid storage space 41 can be suitably prevented from flowing out (dissipating) out of the catheter body 2.

  Here, the degree of stretchability of the porous member can be based on the degree of expansion of the pore diameter of the porous member when the space 4 is set to a predetermined pressure.

  Specifically, when the pressure in the space 4 is 20 atmospheres, the porous member preferably has a pore diameter expansion rate of 200% or less, more preferably 170% or less. Thereby, since the expansion / contraction rate of the porous member becomes sufficiently low, it is possible to more reliably prevent the liquid supplied into the liquid storage space 41 from flowing out of the catheter body 2.

  Note that “when the pressure in the space 4 is set to 20 atm” is that when the liquid is injected into the space 4, the pressure in the space 4 is normally about 10 atm at maximum. Are specified with a slight margin.

  Further, as described above, the average pore diameter of the porous member is preferably set to a maximum value of about 0.5 μm in a state where no pressure is applied in the space 4. However, the porous member shows a tendency that the effect of preventing the passage of the liquid decreases when the average pore diameter exceeds 1 μm regardless of the constituent material thereof. For this reason, when the pressure in the space 4 is set to 20 atmospheres, if a porous member having a pore diameter expansion rate of 200% or less is used, the liquid supplied into the liquid storage space 41 flows out of the catheter body 2. Can be substantially prevented.

  Examples of the constituent material of the porous member include polyolefins such as polyethylene, polypropylene, poly (3-methylbutene-1) and poly (4-methylpentene-1), fluorine such as polyvinylidene fluoride and polytetrafluoroethylene. Based resins, etc., and one or more of these can be used in combination.

  In addition, it is preferable that the constituent material of the porous member (inner tube tip portion 211) contains the constituent material of the inner tube main body 212. As a result, the inner tube tip 211 can be more easily joined to the inner tube main body 212 by fusion, and the joint strength between the inner tube tip 211 and the inner tube main body 212 can be further improved.

  Such a porous member preferably has hydrophobicity on at least the surface facing the space 4. Thereby, the effect which blocks | prevents passage of a liquid is exhibited more notably.

  As such a porous member, for example, a material made of a hydrophobic polymer (for example, a fluororesin) among the materials described above, or a surface that faces the space 4 of the base material made of the material described above is subjected to a hydrophobic treatment. And those that have been applied.

  Examples of the hydrophobization treatment include surface treatment with a coupling agent having a hydrophobic functional group, surface treatment with a plasma of a substance containing fluorine atoms, and formation of a film with a hydrophobic material.

  Furthermore, the porous member preferably has ultrasonic contrast properties (visibility in ultrasonic images). Thereby, in the state which does not inject | pour an MRI contrast agent in the space 4, the position of the front-end | tip part of the catheter main body 2 can be confirmed with an ultrasonic image. That is, as a method for confirming the position of the distal end portion of the catheter body 2, two methods of MRI contrast and ultrasonic contrast can be used properly according to circumstances.

  Here, since the porous member contains many bubbles, the reflectance of the ultrasonic wave is greatly different between the solid phase and the gas phase, and the ultrasonic wave is easily reflected at the solid phase-gas phase interface. However, when the conditions such as the constituent material, porosity (porosity), average pore diameter, etc. are appropriately set, particularly excellent ultrasound contrast properties are exhibited.

  Examples of a method for fixing the inner tube tip portion 211 formed of such a porous member to the inner tube main body 212 include, for example, fusion (thermal fusion, ultrasonic fusion, high frequency fusion), and adhesion. Examples of the method include adhesion using an agent.

  Examples of the form of the porous member include a sponge shape, a mesh (woven fabric in which a plurality of wires are woven), a pore plate (a plate body in which a plurality of through holes are formed), and a nonwoven fabric. It is done.

  The constituent material of the inner pipe body 212 is not particularly limited, but, for example, polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, polyamide, acrylonitrile-butadiene-styrene copolymer Polyesters such as coalescence (ABS resin), acrylonitrile-styrene copolymer (AS resin), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyimide, fluororesin, styrene, polyolefin, polyvinyl chloride, Various thermoplastic elastomers such as polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, chlorinated polyethylene, polyurethane, etc. Body, blends, polymer alloys and the like, can be used singly or in combination of two or more of these (e.g., a laminate of two or more layers).

  In particular, it is preferable to use a material having a low frictional resistance (low friction material) as a constituent material of the inner tube main body 212, whereby a long object such as a guide wire or a catheter is transferred to the lumen 20 of the catheter main body 2. It is possible to easily and reliably perform operations such as insertion and extraction from the lumen 20.

  Examples of such a low friction material include fluorine resin, polyethylene, polypropylene, polyamide and the like.

  Further, a film made of silicone resin or the like may be formed on the inner surface of the inner tube main body 212. Thereby, the frictional force is further reduced on the inner surface of the inner pipe main body 212.

  Although the dimension of each part of the above inner pipes 21 is not specifically limited, For example, each is set as follows, for example.

  The outer diameter of the inner tube tip 211 is preferably about 0.5 to 3.1 mm, and more preferably about 1.0 to 2.4 mm.

  The inner diameter of the inner tube tip 211 is preferably about 0.4 to 2.9 mm, and more preferably about 0.9 to 2.2 mm.

  The length of the inner tube tip 211 is preferably about 5 to 100 mm, and more preferably about 10 to 50 mm.

  The outer diameter of the inner tube main body 212 is preferably about 0.5 to 3.1 mm, and more preferably about 1.0 to 2.4 mm.

  The inner diameter of the inner tube main body 212 is preferably about 0.4 to 2.9 mm, and more preferably about 0.9 to 2.2 mm.

  The length of the inner tube main body 212 is preferably about 150 to 3000 mm, and more preferably about 500 to 1500 mm.

  The length of the joint portion between the inner tube tip 211 and the inner tube main body 212 is preferably about 1 to 20 mm, and more preferably about 5 to 15 mm.

  In such a configuration, the distal end portion of the catheter body 2 is further made proximal by selecting a material more flexible than the constituent material of the inner tube main body 212 as the constituent material of the inner tube distal end portion (porous member) 211. It can be more flexible than the side part. Thereby, the safety | security at the time of inserting the catheter main body 2 into living bodies, such as a blood vessel, can be improved more.

An outer tube 22 is provided on the outer peripheral side of the inner tube 21.
As the constituent material of the outer tube 22, the same materials as those mentioned for the inner tube body 212 can be used.

  Further, at least a part of the outer surface of the outer tube 22 (preferably, a part exposed from the hub 3) may be subjected to a hydrophilic treatment. Thereby, when the outer surface of the catheter body 2 comes into contact with a liquid such as blood or physiological saline, lubricity is exhibited, the frictional resistance of the catheter body 2 is reduced, and the slidability is further improved. The insertion operation into a tubular organ such as a meandering blood vessel becomes easier.

  This hydrophilization treatment is performed, for example, by applying (applying) a surfactant, water-soluble silicon, a hydrophilic polymer material in addition to physical activation treatment such as plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation. Can do.

  Here, the hydrophilic polymer material is not particularly limited, but for example, a cellulose-based polymer substance (for example, hydroxypropyl cellulose), a polyethylene oxide-based polymer substance (for example, polyethylene glycol), maleic anhydride-based material, for example. Examples include high molecular substances (for example, methyl vinyl ether-maleic anhydride copolymer), acrylamide type high molecular substances (for example, acrylamide-glycidyl methacrylate copolymer), water-soluble nylon, etc. Alternatively, two or more kinds can be used in combination.

  In addition, you may make it comprise outer tube | pipe 22 itself using such hydrophilic polymer material. In this case, the hydrophilic treatment on the outer surface of the outer tube 22 can be omitted.

  Although the dimension of the outer tube | pipe 22 as mentioned above is not specifically limited, For example, each is set as follows.

  The outer diameter of the outer tube 22 is preferably about 0.7 to 3.4 mm, and more preferably about 1.3 to 2.7 mm.

  The inner diameter of the outer tube 22 is preferably about 0.6 to 3.3 mm, and more preferably about 1.2 to 2.6 mm.

  The length of the outer tube 22 is preferably about 150 to 3000 mm, and more preferably about 500 to 1500 mm.

  Such an outer tube 22 is joined to the inner tube 21 (inner tube distal end portion 211) at the distal end portion via an adhesive layer 23.

  Examples of the constituent material (adhesive) of the adhesive layer 23 include an epoxy adhesive, an acrylic adhesive, a rubber adhesive, a urethane adhesive, a silicon adhesive, and the like. One kind or a combination of two or more kinds can be used.

  Further, the adhesive layer 23 may contain particles made of a radiopaque material (radiopaque material). Thereby, in the state which does not inject | pour an MRI contrast agent in the space 4, the position of the front-end | tip part of the catheter main body 2 can be confirmed with an X-ray image. That is, as a method for confirming the position of the distal end portion of the catheter body 2, two methods of MRI imaging and X-ray imaging can be used properly depending on the case.

  Examples of such radiopaque materials include metal materials such as gold, platinum, tungsten, iridium or alloys containing these, and metal oxides such as bismuth oxide and barium sulfate. One or two or more of them can be used in combination.

  Instead of such a configuration, a ring shape (annular) made of the radiopaque material between the adhesive layer 23 and the inner tube 21 or between the adhesive layer 23 and the outer tube 22. Alternatively, a filamentary radiopaque marker (radiopaque marker) may be provided.

  The distal end portion of the catheter body 2 has a reduced outer diameter in the distal direction. In other words, it has a shape (tapered shape) whose corners are cut off. Thereby, when inserting the catheter main body 2 into a living body such as a blood vessel, puncture resistance can be reduced, and insertion can be performed more smoothly. Further, damage to the inner wall of the blood vessel can be prevented. For this reason, the operability and safety of insertion of the catheter body 2 can be improved.

  On the proximal end side of the catheter body 2, a hub 3 having a first port and a second port (side port) and having an overall Y shape is provided. The operator can easily operate (push, twist, etc.) the catheter 1 by grasping the hub 3.

  The hub 3 has an inner tube hub 31 fixed to the proximal end portion of the inner tube 21 and an outer tube hub 32 fixed to the proximal end portion of the outer tube 22, and these are joined together. .

The inner pipe hub 31 is configured by a substantially cylindrical member.
The inner pipe hub 31 has a distal end side enlarged portion 311 whose inner diameter is increased at the distal end portion thereof. The inner diameter of the distal end side enlarged diameter portion 311 is set to be approximately equal to the outer diameter of the inner tube 21 (inner tube main body 212).

  The proximal end portion of the inner tube 21 is inserted into the distal-end-side enlarged diameter portion 311, and the inner tube 21 is fixed (adhered) to the inner tube hub 31. Thereby, the lumen of the inner tube hub 31 communicates with the lumen 20 of the inner tube 21 (catheter body 2).

  Examples of a method for fixing the inner tube 21 to the inner tube hub 31 include methods such as fusion (thermal fusion, ultrasonic fusion, high frequency fusion), adhesion with an adhesive, and the like.

  On the other hand, the inner pipe hub 31 has a proximal-side enlarged portion 312 having an enlarged inner diameter at the proximal end, and the proximal-side enlarged portion 312 constitutes the first port of the hub 3. ing.

  A long object such as a guide wire or a catheter is inserted into the lumen 20 of the catheter body 2 through the proximal-side enlarged diameter portion (first port) 312.

  Further, the inner tube hub 31 has an inner tube hub side connecting portion 313 whose outer diameter is reduced at the tip portion. The inner tube hub side connection portion 313 is inserted into an outer tube hub side connection portion 323 of the outer tube hub 32 described later.

The outer tube hub 32 is configured by a substantially cylindrical member.
The outer tube hub 32 has a distal end side enlarged portion 321 whose inner diameter is enlarged at the distal end portion. The inner diameter of the distal end side enlarged diameter portion 321 is set to be approximately equal to the outer diameter of the outer tube 22.

  The proximal end portion of the outer tube 22 is inserted into the distal-side enlarged diameter portion 321, and the outer tube 22 is fixed (fixed) to the outer tube hub 32.

  Examples of a method for fixing the outer tube 22 to the outer tube hub 32 include methods such as fusion (thermal fusion, ultrasonic fusion, high frequency fusion), and adhesion using an adhesive.

  On the side of the base end portion of the outer tube hub 32, a cylindrical projecting portion 322 is formed to project. The projecting portion 322 has a lumen communicating with the lumen of the outer tube hub 32 and constitutes a second port (side port) of the hub 3.

  Further, the outer pipe hub 32 has an outer pipe hub side connection portion 323 at the base end portion thereof. The inner tube hub side connection portion 313 of the inner tube hub 31 described above is inserted into the outer tube hub side connection portion 323, whereby the inner tube hub 31 and the outer tube hub 32 are joined in a liquid-tight manner.

  Examples of a method for fixing the outer tube hub 32 to the inner tube hub 31 include, for example, fitting, caulking, screwing, fusion (thermal fusion, ultrasonic fusion, high frequency fusion), adhesion using an adhesive, and the like. Is mentioned. Note that these methods may be combined.

  Further, the inner tube hub 31 and the outer tube hub 32 may be integrally formed in advance by injection molding or the like.

  Further, the inner diameter of the outer pipe hub 32 is set larger than the outer diameter of the inner pipe 21 (inner pipe main body 212) and smaller (or substantially equal) than the outer diameter of the outer pipe 22, as shown in FIG. In addition, a space 30 is formed (secured) between the outer tube hub 32 and the inner tube 21.

  The space 30 communicates with the space 4 of the catheter body 2 on the distal end side, and communicates with the lumen of the projecting portion (second port) 322 on the proximal end side. In other words, the base end side of the flow path 42 of the catheter body 2 is open to the side of the hub 3 at the protruding portion 322. Thereby, the MRI contrast agent can be injected into the flow path 42 of the catheter body 2 through the protrusion 322.

  With such a configuration, a site (first port) for inserting and removing a long object such as a guide wire or a catheter and a syringe or the like containing an MRI contrast medium are connected to the lumen 20 of the catheter body 2. The part (second port) can be separated. Thereby, the insertion / extraction operation of the long object with respect to the catheter body 2 and the operation of supplying the liquid to the catheter body 2 (in the space 4) can be performed independently, and the operability of the catheter 1 can be improved. It can be improved further.

  The constituent material of such a hub (Y-type branch connector) 3 is not particularly limited. For example, polyolefin such as polyethylene and polypropylene, hard resin material such as polyamide, polycarbonate and polystyrene, various metal materials, and various plastics. One or more of materials can be used in combination.

  When the catheter 1 is used, a check valve, a multiway cock, and the like (not shown) are attached to the proximal end portion of the second port. Thereby, it is possible to prevent the MRI contrast agent (liquid) supplied into the space 4 of the catheter body 2 from flowing out of the catheter 1 from the hub 3 side.

  In such a catheter 1, MRI contrast can be imparted to almost the entire catheter body 2 by supplying the MRI contrast agent to almost the entire space 4 of the catheter body 2.

<< Second Embodiment >>
Next, a second embodiment of the catheter will be described.

  FIG. 3 is a longitudinal sectional view showing a distal end portion of a second embodiment of a catheter to which the medical device of the present invention is applied. In the following description, the right side in FIG. 3 is referred to as “base end”, and the left side is referred to as “tip”.

  Hereinafter, although the second embodiment will be described, the description will focus on differences from the first embodiment, and the description of the same matters will be omitted.

  In the second embodiment, the configurations of the inner tube 21 and the outer tube 22 are different, and the other configurations are the same as those in the first embodiment.

  That is, as for the catheter main body 2 shown in FIG. 3, the inner tube | pipe 21 is comprised with one circular tubular member. On the other hand, the outer tube 22 includes an outer tube main body 222 and an outer tube front end portion 221 joined to the front end portion of the outer tube main body 222, and this outer tube front end portion (part of a portion facing the space 4) 221. Is composed of a porous member.

  In the present embodiment, a portion (outer tube tip portion 221) formed of a porous member is provided on the outer side (outer peripheral side) from the inner tube 21, and the gas in the space 4 is outside the catheter main body 2 (outer peripheral side). ) Is discharged (exhausted).

In addition, the inner tube 21 and the outer tube 22 are joined via an adhesive layer 23 at the tip.
In addition, the outer tube distal end portion 221 and the distal end portion of the outer tube main body 222 are each reduced in outer diameter toward the distal end direction, so that the operability and safety of insertion of the catheter main body 2 are improved. .
Even with such a configuration, the same operations and effects as those of the first embodiment can be obtained.

<< Third Embodiment >>
Next, a third embodiment of the catheter will be described.

  FIG. 4 is a longitudinal sectional view showing a distal end portion of a third embodiment of a catheter to which the medical device of the present invention is applied, and FIG. 5 is a sectional view taken along line AA in FIG. It is B line sectional drawing (b). In the following description, the right side in FIG. 4 will be described as “base end” and the left side as “tip”.

  In the following, the third embodiment will be described. The description will focus on the differences from the first and second embodiments, and the description of the same matters will be omitted.

  In 3rd Embodiment, the adhesive bond layer 23 is abbreviate | omitted and the structure of the flow path 42 differs, and other than that is the same as that of the said 2nd Embodiment.

  That is, in the catheter body 2 shown in FIG. 4, the inner tube 21 and the outer tube 22 are directly joined (fixed) at the distal end portion.

  Examples of a method for fixing the inner tube 21 to the outer tube 22 (outer tube tip 221) include fusion bonding. In this case, the constituent material of the outer tube tip (porous member) 221 preferably contains the constituent materials of both the inner tube 21 and the outer tube main body 222. As a result, the outer tube tip 221 can be more easily bonded to the outer tube main body 222 by welding and the outer tube tip 221 can be bonded to the inner tube 21 by bonding, and the bonding strength between them can be increased. Can be further improved.

  Further, the flow path 42 is defined by a groove formed in the inner surface of the outer tube 22 along the longitudinal direction and the outer surface of the inner tube 21, and forms a straight line. In the illustrated configuration, the shape of the edge of the groove is substantially U-shaped, but is not limited to this, and may be, for example, a semicircular shape, a U shape, a V shape, or the like. .

  Even with such a configuration, the same operations and effects as those of the first and second embodiments can be obtained.

  In particular, in the third embodiment, since the contact area between the inner tube 21 and the outer tube 22 can be increased, the mechanical strength of the catheter body 2 can be improved (the rigidity can be increased). Torque transmission to the tip of the main body 2 can be enhanced.

  Further, since the flow path 42 is formed in a part of the circumferential direction of the catheter body 2, the degree of twist generated in the catheter body 2 in the living body can be visually confirmed (confirmed) by imparting MRI contrast to the flow path 42. ).

<< Fourth Embodiment >>
Next, a fourth embodiment of the catheter will be described.

  FIG. 6 is a longitudinal sectional view showing the distal end portion of the fourth embodiment of the catheter to which the medical device of the present invention is applied, (a) shows the state before the absorbent absorbs the liquid, (b) Indicates the state after the absorbent has absorbed the liquid. In the following description, the right side in FIG. 6 will be described as “base end”, and the left side will be described as “tip”.

  Hereinafter, although the fourth embodiment will be described, the description will focus on the differences from the first to third embodiments, and the description of the same matters will be omitted.

  In 4th Embodiment, the absorber 5 is accommodated in the space 4, and the other than that is the same as that of the said 3rd Embodiment.

  That is, in the catheter main body 2 shown in FIG. 6, the absorbent 5 having a function of absorbing and holding the liquid is stored in the liquid storage space 41 (at least the distal end portion in the space 4) (FIG. 6). (See (a).) As a result, the MRI contrast agent supplied into the liquid storage space 41 is absorbed (see FIG. 6B) by the absorbent 5 (see FIG. 6B), so that the MRI contrast agent is reliably left (held) in the liquid storage space 41. Can do.

  For this reason, after supplying the MRI contrast agent to almost the entire space 4, the MRI contrast agent in the flow path 42 is sucked and removed from the second port, so that the MRI is selectively contained in the liquid storage space 41. The contrast agent can remain.

  The form of the absorbent 5 may be, for example, a lump shape (pellet shape) or a block shape in addition to the granular shape as shown in FIG.

  In addition, it is preferable that the average particle diameter of the granular absorbent 5 is about 20-300 micrometers, and it is more preferable that it is about 50-150 micrometers.

The constituent material of the absorbent 5 is not particularly limited. For example, starch-acrylic nitrile, starch-acrylic acid, starch-acrylamide, starch-sodium acrylate, and starch-based starch (hydrolyzate thereof). Grafted product, partially saponified polyvinyl alcohol, polyacrylate and acrylic acid-vinyl alcohol polymer, polyethylene oxide, cellulose polymer, cross-linked N-vinylcarboxylic acid amide resin, pregelatinized starch, acrylic Examples of these polymers include one or two or more of them.
Even with such a configuration, the same operations and effects as in the first to third embodiments can be obtained.

<< Fifth Embodiment >>
Next, a fifth embodiment of the catheter will be described.

  FIG. 7 is a longitudinal sectional view showing a distal end portion of a fifth embodiment of a catheter to which the medical device of the present invention is applied. In the following description, the right side in FIG. 7 will be referred to as the “base end” and the left side as the “tip”.

  Hereinafter, the fifth embodiment will be described. The description will focus on the differences from the first embodiment, and the description of the same matters will be omitted.

  In the fifth embodiment, the configuration of the inner tube 21 is different, the adhesive layer 23 is omitted, and the rest is the same as in the first embodiment.

That is, in the catheter main body 2 shown in FIG. 7, the entire inner tube 21 is composed of a porous member. Thereby, when injecting the MRI contrast agent from the flow path 42 into the liquid storage space 41, the gas in the space 4 can be discharged from almost the entire inner tube 21 to the outside of the catheter body 2 (the lumen 20). It can prevent more reliably that the pressure in 4 becomes high. For this reason, the MRI contrast agent can be more reliably supplied into the liquid storage space 41, and the MRI contrast property of the entire catheter body 2 can be further ensured.
Even with such a configuration, the same operations and effects as those of the first embodiment can be obtained.

  Instead of the inner tube 21, the entire outer tube 22 may be made of a porous member, or both the inner tube 21 and the outer tube 22 may be made of a porous member. .

  The catheter 1 may be a combination of any two or more configurations (features) of the first to fifth embodiments.

  In the catheter 1 shown in each of the above embodiments, a reinforcing member is installed (embedded) inside the catheter body 2 (inside the tube wall), that is, between the inner tube 21 and the outer tube 22. May be. Thereby, torque transmission property, pushability, kink resistance, followability and the like in the catheter 1 are improved, and operability when the catheter body 2 is inserted into a living body (for example, a blood vessel or the like) is improved. The pressure resistance when the internal pressure (hydraulic pressure) increases is improved.

  In this case, the reinforcing member is preferably disposed over substantially the entire length of the catheter body 2, but is preferably not disposed at the distal end portion of the catheter body 2. Thereby, the softness | flexibility of the front-end | tip part of the catheter main body 2 can fully be ensured, and the followable | trackability at the time of insertion in the biological body and safety | security can be ensured.

  The reinforcing member is preferably arranged so that at least a part thereof is embedded in the outer surface of the inner tube 21 or the inner surface of the outer tube 22.

  As such a reinforcing member, a member made of a wire formed in a mesh shape or a coil shape is preferable. Such a reinforcing member can easily increase the strength of the reinforcing member by appropriately selecting conditions such as the constituent material of the wire, the wire diameter, and the arrangement density (depending on the size of the mesh, the number of turns of the coil, etc.). It can be adjusted to a desired strength.

  Examples of the constituent material of the wire include metal materials such as stainless steel, tungsten, Ti, and Ni—Ti alloys, reinforced resin fibers such as high-density polyethylene, aramid, and Kevlar, and carbon fibers.

  If a radiopaque material such as tungsten is selected as the constituent material of the wire, X-ray contrast can be imparted over almost the entire length of the catheter body 2.

  The wire diameter of the wire is not particularly limited, but is preferably about 3 to 100 μm, and more preferably about 20 to 60 μm.

<Guide wire>
Next, the case where the medical device of this invention is applied to a guide wire is demonstrated.

  FIG. 8 is a longitudinal sectional view showing an embodiment of a guide wire to which the medical device of the present invention is applied. In the following, for convenience of explanation, the right side in FIG. 8 is referred to as “base end” and the left side is referred to as “tip”.

  Hereinafter, the guide wire will be described, but the description will focus on differences from the catheter 1 of the first embodiment, and description of similar matters will be omitted.

  A guide wire 100 shown in FIG. 8 includes a flexible guide wire main body (long linear body) 200, and a guide wire main body 200 provided on the proximal end side of the guide wire main body 200, and a detachable hub. 300.

  The guide wire body 200 is a part used by being inserted into a living body (for example, a tubular organ such as a blood vessel) from the tip.

  The guide wire body 200 is formed at the front end portion of the guide wire body 200 and is formed along the longitudinal direction of the liquid storage space 401 that can store the liquid. The guide wire body 200 communicates with the liquid storage space 401 and stores the liquid. A space 400 including a flow path 402 leading to the space 401 is provided.

  As shown in FIG. 8, the guide wire main body 200 of the present embodiment includes a core portion (core material) 201 having a circular cross-sectional shape, and at least the distal end side (in the present embodiment, the core portion 201). ), And a coating layer 202 provided so as to cover the whole).

  As shown in FIG. 8, the core part 201 and the covering layer 202 are provided such that their main parts are concentrically and spaced apart from each other, and are joined (fixed) at the joint part 2000 at the base end part. ing. Accordingly, a space 400 is formed between the core portion 201 and the coating layer 202 (inside the guide wire body 200) on the distal end side of the joint portion 2000 of the guide wire body 2.

  The main portion of the space 400 is formed over the entire circumference of the guide wire main body, but merges at the tip of the guide wire main body 200 and is integrated.

A distal end portion of the space 400 forms a liquid storage space 401, and a portion (region) on the proximal end side forms a flow path 402. Therefore, in this embodiment, both the liquid storage space 401 (excluding the tip) and the flow path 402 are formed over the entire circumference of the guide wire body 200, and the cross-sectional shape thereof is an annular shape.
The core part 201 is comprised with the wire which has a softness | flexibility or elasticity.

  In the present embodiment, the core portion 201 has a portion whose outer diameter is constant and a portion whose outer diameter gradually decreases toward the distal end (outer diameter gradually decreasing portion). The latter may be one place or two places or more, and in the illustrated embodiment, it has one outer diameter gradually decreasing portion (tapered portion) 2011.

  By having such an outer diameter gradually decreasing portion 2011, the rigidity (bending rigidity, torsional rigidity) of the core portion 201 can be gradually decreased toward the distal end direction. In addition, it is possible to obtain good flexibility, improve followability to blood vessels and safety, and prevent bending and the like.

  In the configuration shown in the drawing, the outer diameter gradually decreasing portion 2011 is formed in a part (tip portion) of the core portion 201 in the longitudinal direction, but the entire core portion 201 may constitute the outer diameter gradually decreasing portion. Further, the taper angle (decrease rate of the outer diameter) of the outer diameter gradually decreasing portion 2011 may be constant along the longitudinal direction of the core portion 201 or there may be a portion that varies along the longitudinal direction. For example, a portion in which a taper angle (an outer diameter reduction rate) and a relatively small portion are alternately formed a plurality of times may be used.

  The portion of the core portion 201 on the proximal end side from the outer diameter gradually decreasing portion 2011 has a constant outer diameter up to the vicinity of the proximal end of the core portion 201.

  The constituent material of the core part 201 is not specifically limited, For example, various metal materials, such as stainless steel, Ti, a Ni-Ti type alloy, and tungsten, can be used.

  The core portion 201 may be made of different materials for the constituent material of the distal end portion (outer diameter gradually decreasing portion 2011) and the constituent material on the proximal end side.

  The total length of the core portion 201 (guide wire body 200) is not particularly limited, but is preferably about 200 to 5000 mm, and more preferably about 1500 to 3000 mm.

  The outer diameter of the core portion 201 (excluding the outer diameter gradually decreasing portion 2011) is not particularly limited, but is preferably about 0.3 to 1.0 mm, and more preferably about 0.4 to 0.8 mm. .

  A covering layer 202 is provided so as to cover the core portion 201, and the covering layer 202 is fixed (joined) to the core portion 201 at the joint portion 2000 at the base end portion.

  The covering layer 202 can be formed for various purposes. As an example, the operability of the guide wire 100 is reduced by reducing the friction (sliding resistance) of the guide wire body 200 and improving the slidability. May be improved.

  Examples of the method for fixing the coating layer 202 to the core portion 201 include methods such as fusion (thermal fusion, ultrasonic fusion, high-frequency fusion), and adhesion using an adhesive.

  In addition, the outer surface (surface) of the base end portion of the core portion 201 is subjected to a treatment (rough surface processing, chemical treatment, heat treatment, etc.) for improving the adhesion of the coating layer 202, or the adhesion of the coating layer 202 is improved. An intermediate layer that can be improved can also be provided.

  The coating layer 202 includes a coating layer body 2022 and a cap-shaped coating layer tip 2021 joined to the tip of the coating layer body 2022, and this coating layer tip (part of a portion facing the space 400). ) 2021 is formed of a porous member. In this configuration, in the space 400, the region from the tip to the vicinity of the junction between the coating layer tip 2021 and the coating layer body 2022 is the liquid storage space 401, and the region on the base end side is the flow path. 402.

A side hole 2023 that opens to the side is formed on the base end side of the covering layer main body 2022.
The coating layer distal end portion 2021 can have the same configuration as the inner tube distal end portion 211 described in the catheter 1 of the first embodiment.

  In the present embodiment, a portion made of a porous member (covering layer tip portion 2021) is provided on the outer side (outer peripheral side) of the core portion 201, and the gas in the space 400 is outside the guide wire main body 200 (outer peripheral side). (Exhaust).

  The covering layer body 2022 can have the same configuration as the outer tube 22 described in the catheter 1 of the first embodiment.

  A guide wire body 200 having a side port and a detachable hub 300 are provided on the proximal end side of the guide wire body 200. The operator can easily operate (push, twist, etc.) the guide wire 100 by gripping the hub 300.

  The hub 300 includes a hub body 301 and a distal end side lid body 302 and a proximal end side lid body 303 respectively provided at the distal end portion and the proximal end portion of the hub body 301, and these are fixed by screwing. It is configured.

The hub main body 301 is composed of a substantially cylindrical member.
A cylindrical projecting portion 3011 is formed at the center of the hub body 301 in the longitudinal direction so as to project sideways. The projection 3011 has a lumen communicating with the lumen of the hub body 301 and constitutes a side port of the hub 300.

  The protruding portion 3011 is disposed to face the side hole 2023 formed in the coating layer main body 2022 in a state where the guide wire main body 200 is fixed to the hub 300. As a result, the base end side of the flow path 402 of the guide wire main body 200 is opened to the side of the hub 300 at the protrusion 3011, and the MRI contrast agent is passed through the protrusion 3011 through the flow path 402 of the guide wire main body 200. It can be injected inside. Furthermore, a check valve, a multiway cock (not shown), or the like can be attached to the protrusion 3011.

  In addition, a pair of ring-shaped convex portions 3012 and 3013 are formed on the inner surface of the hub body 301 so as to protrude at a predetermined interval in the longitudinal direction. The convex portions 3012 and 3013 each have a function (positioning function) for preventing the valve bodies 304 and 305 from moving inwardly more than necessary when the later-described valve bodies 304 and 305 are inserted into the hub body 301. Have

  The distal end side cover body 302 is formed of a substantially columnar member, and a through hole 3021 is formed at a substantially central portion thereof so as to penetrate in the thickness direction (left and right direction in FIG. 8). The guide wire body 200 is inserted through the through hole 3021.

  An annular (ring-shaped) recess 3022 is formed in the base end surface of the distal end side lid 302 so as to be recessed. A screw thread is provided on the outer peripheral side of the recess 3022 and is screwed into a screw groove provided on the tip end side of the hub body 301.

  In addition, an annular flange 3023 is formed to protrude outward from the distal end side of the distal end side cover body 302.

  On the other hand, the base end side cover body 303 is comprised by the substantially columnar member, and the through-hole 3031 penetrated in the thickness direction (left-right direction in FIG. 8) is formed in the substantially center part. The guide wire body 200 is inserted through the through hole 3031.

  An annular (ring-shaped) recess 3032 is formed in the distal end surface of the base end side cover 303 so as to be recessed. A screw thread is provided on the outer peripheral side of the recess 3032 and is screwed into a screw groove provided on the base end side of the hub body 301.

  Further, an annular flange 3033 protrudes outward from the base end side of the base end side cover 303. By grasping the flange 3033 and the flange 3023 of the distal end side lid body 302 described above, the distal end side lid body 302 and the proximal end side lid body 303 are rotated in a predetermined direction with respect to the hub body 301, thereby The bodies 304 and 305 are pressed inward, and the inner diameters of the valve bodies 304 and 305 contract. As a result, the guide wire body 200 can be fixed to the hub 300.

  Further, by grasping the flanges 3023 and 3033 and rotating the distal end side cover body 302 and the proximal end side cover body 303 with respect to the hub main body 301 in the opposite direction to the above, the valve bodies 304 and 305 are compressed. It is cancelled | released and the internal diameter of the valve bodies 304 and 305 expands. As a result, the guide wire body 200 can be removed from the hub 300.

  As the constituent material of the hub 300, the same materials as those described for the hub 3 described in the catheter 1 of the first embodiment can be used.

  In addition, valve bodies 304 and 305 are provided on the distal end side and the proximal end side in the hub main body 301, respectively.

  Each of the valve bodies 304 and 305 is configured by a substantially columnar member, and through holes 3041 and 3051 that penetrate in the thickness direction (left and right direction in FIG. 8) are formed in the substantially central part. . The guide wire body 200 is inserted through each of the through holes 3041 and 3051.

  Each of the valve bodies 304 and 305 is made of an elastic material. Therefore, as described above, the through holes 3041 and 3051 are formed by gripping the flanges 3023 and 3033 and rotating the distal end side lid 302 and the proximal end side lid 303 in a predetermined direction with respect to the hub body 301. By contracting, the valve bodies 304 and 305 are brought into close contact with the outer surface of the guide wire body 200, so that the guide wire body 200 can be fixed to the hub 30. In this state, the liquid tightness of the space (liquid reservoir) 3000 in which the MRI contrast agent in the hub 300 is supplied is ensured.

  Examples of such an elastic material include silicone rubber, latex rubber, butyl rubber, and isoprene rubber.

  The guide wire 100 as described above may be combined with any one or more configurations (features) of the catheter 1 of the second to fifth embodiments.

  In each of the above-described embodiments, the MRI contrast agent (liquid contrast agent exhibiting MRI contrast property) is injected (supplied) into the spaces 4 and 400. May be used by injecting a liquid contrast agent (X-ray contrast agent) exhibiting X-ray contrast properties.

  In this case, as the X-ray contrast agent, for example, a material in which particles made of the above-described X-ray opaque material (radiopaque material) are dispersed in a predetermined dispersion medium (for example, water for injection) is used. Preferably used.

  Further, at least a part of the inner surfaces of the spaces 4 and 400 or in the fourth embodiment, a substance exhibiting MRI contrast is imparted to the absorbent 5 by ionization. It is good also as a form which inject | pours and uses the solution which can melt | dissolve the said substance.

  In this case, examples of the combination of the substance and the solution include a combination of ammonium iron citrate and water for injection, a combination of meglumine gadopentetate and water for injection, and the like.

  As described above, the medical device of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each component constituting the medical device has any configuration that can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  Moreover, in the said embodiment, although the case where the medical device of this invention was applied to a catheter and a guide wire was demonstrated as a representative, the medical device of this invention has a balloon catheter, an indwelling catheter, an indwelling needle (needle body), for example, It can be applied to an introducer sheath and a dilator.

Next, specific examples of the present invention will be described.
A. Manufacture of catheter (Example)
The catheter shown in FIG. 1 was manufactured. In addition, the specification of each part is as showing below.

1. 1. Catheter body 1-1. Inner pipe ・ Inner pipe tip (porous member)
Porosity: 40% (state with normal pressure in the space)
Average pore diameter: 0.1 μm (in a state where the space is at normal pressure)
Composition material: Polypropylene
Inner diameter: 1.8mm
Outer diameter: 2.0mm
Length: 60mm
・ Inner pipe body
Composition material: Polypropylene
Inner diameter: 2.0 mm
Outer diameter: 2.3 mm
Length: 940mm

1-2. Outer tube
Constituent material: Polyester thermoplastic elastomer
Inner diameter: 2.4 mm
Outer diameter: 2.7 mm
Length: 980mm

2. Hub
Constituent material: Polycarbonate The volume of the liquid storage space was about 0.08 mL, and the volume of the flow path was about 0.4 mL. Further, when the pressure in the space was 20 atm, the expansion rate of the hole diameter at the tip of the inner tube was about 150%.

(Comparative example)
A catheter was manufactured in the same manner as in the above example except that the tip of the inner tube was made of a dense member made of polypropylene.

B. Evaluation The tip part of the syringe which accommodated the MRI contrast agent was connected to the side port of the catheter manufactured by the Example and the comparative example, respectively, and MRI contrast agent (the Gerve company make, "Magnescope syringe") was inserted in the space of the catheter. Injected.

  As a result, in the catheter of the example, MRI could be sufficiently injected to the tip of the space (liquid storage space) by one operation of moving the pusher of the syringe. Moreover, the outflow of the MRI contrast agent was not confirmed.

  On the other hand, in the catheter of the comparative example, in order to inject the MRI contrast agent to the distal end portion (liquid storage space) of the space, the injection operation of the MRI contrast agent from the syringe and other syringes are used. It was necessary to repeat the air removal operation.

  Further, when the state of the MRI contrast agent filled in the space was confirmed under MRI contrast, the MRI contrast agent was uniformly injected into the space in the catheter of the example.

  On the other hand, in the catheter of the comparative example, the location where air remained in the space was confirmed. That is, the injection of the MRI contrast agent was not uniform.

  Further, the catheter shown in FIGS. 3, 4, 6, and 7 and the guide wire shown in FIG. 8 were manufactured, and in the same manner as described above, an MRI contrast agent was injected into the space. Similar results were obtained.

  The medical device of the present invention is a medical device provided with a long linear body that is used by being inserted into a living body from the distal end, and the linear body is formed at a distal end portion inside thereof and stores a liquid. A space including a possible liquid storage space and a flow path that is formed along a longitudinal direction of the liquid storage space, communicates with the liquid storage space, and guides the liquid to the liquid storage space. When the liquid is injected into the flow path, at least a part of the portion facing the space is composed of a porous member having a function of allowing the passage of gas and preventing the passage of the liquid, The gas in the space is configured to be discharged out of the linear body through the porous member. Therefore, since at least a part of the portion where the space formed inside the linear body faces is configured by the porous member, it is possible to secure a path for discharging the gas existing in the space to the outside of the linear body. Therefore, when a liquid is injected into the space, the liquid can be easily and reliably supplied to the tip. In addition, by appropriately setting the conditions for the porous member, the gas can be discharged more smoothly and the outflow of the liquid can be more reliably prevented. Therefore, the medical device of the present invention has industrial applicability.

Claims (21)

A medical device comprising a long linear body that is used by being inserted into a living body from the tip,
The linear body is formed at a front end portion of the linear body, is formed along a longitudinal direction of the liquid storage space in which the liquid can be stored, communicates with the liquid storage space, and stores the liquid in the liquid storage space. Having a space with a flow path leading to the space,
The linear body is composed of a porous member having a function in which at least a part of the portion facing the space allows the passage of gas and prevents the passage of the liquid,
A medical device characterized in that when the liquid is injected into the flow path, the gas in the space is discharged out of the linear body through the porous member. 2. The medical device according to claim 1, wherein the porous member has a porosity of 10 to 50% in a state in which the space is at normal pressure. The medical device according to claim 1 or 2, wherein the porous member has an average pore diameter of 0.05 to 0.5 µm in a state where the space is at normal pressure. The medical device according to claim 1 or 2, wherein the porous member has poor stretchability. The medical device according to claim 3, wherein the porous member has a pore diameter expansion rate of 200% or less when the pressure in the space is 20 atmospheres. The medical device according to claim 1 or 2, wherein the porous member has hydrophobicity at least on a surface facing the space. The medical device according to claim 1 or 2, wherein the porous member has ultrasonic contrast properties. The medical device according to claim 1 or 2, wherein the portion constituted by the porous member is provided at a distal end portion of the linear body. The medical device according to claim 1 or 2, wherein an absorbent having a function of absorbing and holding the liquid is stored in at least a distal end portion in the space. The medical device according to claim 1 or 2, wherein the liquid storage space is formed over the entire circumference of the linear body. The medical device according to claim 1 or 2, wherein the flow path is formed over the entire circumference of the linear body. The medical device according to claim 1 or 2, wherein the flow path is formed in a part of a circumferential direction of the linear body. The linear body includes an inner tube and an outer tube provided on the outer peripheral side of the inner tube,
The medical device according to claim 1 or 2, wherein the space is formed between the inner tube and the outer tube. The medical device according to claim 13, wherein the portion constituted by the porous member is provided inside the outer tube. The medical device according to claim 13, wherein the portion constituted by the porous member is provided outside the inner tube. The linear body includes a core portion and a coating layer provided so as to cover at least the distal end side of the core portion,
The medical device according to claim 1 or 2, wherein the space is formed between the core portion and the covering layer. The medical device according to claim 16, wherein the portion constituted by the porous member is provided outside the core portion. Furthermore, it has a hub provided on the base end side of the linear body,
The medical device according to claim 1 or 2, wherein a base end side of the flow path is open to a side of the hub. At least a part of the inner surface of the space is provided with a substance exhibiting MRI contrast by ionization,
The medical device according to claim 1 or 2, which is used by injecting a solution capable of dissolving the substance into the flow path when necessary. The medical device according to claim 1 or 2, wherein the medical device is used by injecting a liquid contrast agent exhibiting a contrast property into the channel when necessary. The medical device according to claim 1 or 2, wherein the medical device is a catheter, a guide wire, or a needle body.

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