JP2013180156A - Medical equipment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide medical equipment with excellent operability.SOLUTION: A catheter 10 includes: a tubular body (a sheath) 16 which includes a main lumen 20 formed inside the catheter 10 along the longitudinal direction thereof, has a distal end with an opened end surface, and in which an opening 201 communicating with the main lumen 20 is formed; and a projection part 18 extending along the longitudinal direction of the tubular body 16 and projecting from the distal end of the tubular body 16. When the tubular body 16 is inserted into a body cavity, the projection part 18 guides the insertion of the tubular body 16 into the body cavity. The projection part 18 has flexibility. A diameter of the projection part 18 is smaller than a diameter of the tubular body 16.

Description

  The present invention relates to a medical device.

  In recent years, catheters have been provided that can adjust the direction of entry into a body cavity by bending the distal end. For example, in Patent Literature 1, two wire lumens (sublumens) having a smaller diameter are provided around the central lumen (main lumen) so as to face each other by 180 degrees, and a deflection wire is provided inside the sublumen. A catheter through which is inserted is described.

  In such a catheter, the user moves the deflecting wire to adjust the orientation of the distal end of the catheter and allow the catheter to enter the body cavity.

JP 2006-192269 A

However, the catheter disclosed in Patent Document 1 has been found to have the following problems.
When the catheter is advanced into the body cavity, the distal end of the catheter may collide with the inner wall of the body cavity and stimulate the inner wall of the body cavity, so that the body cavity may contract.
In such a case, it becomes difficult to further advance the catheter into the body cavity, and the operability of the catheter is deteriorated.

  According to the present invention, the medical device is a long medical device, the main lumen is formed in the inside along the longitudinal direction of the medical device, the end surface of the distal end is opened, and communicates with the main lumen. A tubular body having an opening, and a protrusion that guides the insertion of the tubular body into the body cavity when the tubular body is inserted into the body cavity; Provided by a medical device that extends along a longitudinal direction and protrudes from a distal end of the tubular body, the protrusion has flexibility, and the diameter of the protrusion is smaller than the diameter of the tubular body Is done.

  According to this invention, the protrusion is provided at the distal end of the tubular body. The protrusion guides the insertion of the tubular body into the body cavity when the tubular body is inserted into the body cavity. The protrusion has a diameter smaller than that of the tubular main body and has flexibility. For this reason, even if the protrusion comes into contact with the inner wall of the body cavity, the stimulation to the inner wall of the body cavity is relatively small. Thereby, contraction of the body cavity can be suppressed, and the operability of the medical device can be ensured.

  ADVANTAGE OF THE INVENTION According to this invention, the medical device with favorable operativity is provided.

It is sectional drawing of the front-end | tip part of the catheter concerning one Embodiment of this invention. It is a perspective view which shows the front-end | tip part of a catheter. It is a top view which shows the front-end | tip part of a catheter. It is a top view which shows the front-end | tip part of a catheter. It is sectional drawing of the direction orthogonal to the longitudinal direction of a catheter, and is sectional drawing of the VV direction of FIG. It is sectional drawing of the direction orthogonal to the longitudinal direction of a catheter. It is a schematic diagram which shows the operation example of a catheter. It is sectional drawing which shows the front-end | tip part of a catheter. It is sectional drawing which shows the manufacturing process of a catheter.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and detailed description thereof is appropriately omitted so as not to overlap.

First, an outline of the medical device of the present embodiment will be described with reference to FIGS.
The medical device of the present embodiment is a long catheter 10.
The catheter 10 has a tubular body (sheath) in which a main lumen 20 is formed inside along the longitudinal direction of the catheter 10, an end surface of a distal end is opened, and an opening 201 communicating with the main lumen 20 is formed. ) 16 and a protrusion 18 that extends along the longitudinal direction of the tubular body 16 and protrudes from the distal end of the tubular body 16.
The protrusion 18 guides the insertion of the tubular body 16 into the body cavity when the tubular body 16 is inserted into the body cavity. The protrusion 18 has flexibility. Further, the diameter of the protrusion 18 is smaller than the diameter of the tubular body 16. The distal end of the protrusion 18 has a blunt shape.

Next, the catheter 10 of this embodiment will be described in detail.
The catheter 10 includes a sheath 16, a blade layer 50, a hollow tube 32, a coat layer 64, an operation line 40, and a marker 66.
The catheter 10 is provided with a main lumen 20 for supplying a liquid or particulate drug to the affected area in the longitudinal direction (left and right direction in FIG. 1). Then, the operation line 40 is inserted into the sub-lumen 30 provided separately from the main lumen 20, and the distal end portion 15 of the catheter 10 can be bent.

  The catheter 10 has a sheath (tubular body) 16 that forms the main body of the catheter 10. The sheath 16 is formed by laminating a tubular inner layer 21 in which the main lumen 20 is formed, and an outer layer 60 made of the same or different resin composition as the inner layer 21 and formed around the inner layer 21.

For example, a fluorine-based thermoplastic polymer material can be used for the inner layer 21. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used.
By using a fluorine-based resin for the inner layer 21, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 10 is improved.

  As the main component of the outer layer 60 constituting the main thickness of the sheath 16, a thermoplastic polymer is widely used. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly One or more materials selected from the group consisting of vinyl chloride (PVC) or polypropylene (PP) and a polyether block amide copolymer which is a thermoplastic elastomer can be used.

An opening 201 communicating with the distal end side of the main lumen 20 is formed at the distal end DE of the sheath 16. On the other hand, an opening communicating with the base end side of the main lumen 20 is formed on the end surface or the peripheral surface of the proximal end portion 17 (see FIG. 7). Here, the distal end portion 15 of the catheter 10 refers to a predetermined length region including the distal end DE of the catheter 10. Similarly, the proximal end portion 17 (see FIG. 7) of the catheter 10 refers to a predetermined length region including the proximal end PE of the catheter 10.
The opening plane of the opening on the distal end side of the sheath 16 and the opening plane of the opening 201 on the proximal end side of the sheath 16 are orthogonal to the longitudinal direction of the sheath 16. That is, the end surface on the distal end side and the end surface on the proximal end side of the sheath 16 are orthogonal to the longitudinal direction of the sheath 16. In the present embodiment, the outer shape of the cross section perpendicular to the longitudinal direction of the sheath 16 is circular over the entire length of the sheath 16.

Here, as shown in FIG. 1, a thick portion 161 is formed on the distal end side of the sheath 16. The thick wall portion 161 projects from the part of the inner peripheral edge of the sheath 16 on the main lumen 20 side in a convex shape toward the main lumen 20 side, and extends in the longitudinal direction of the sheath 16.
The thick portion 161 is constituted by a part of the outer layer 60 and a part of the inner layer 21, but is mainly constituted by a part of the outer layer 60.
Here, as shown in FIG. 1, the thickness T2 in the main lumen radial direction of the thick portion 161 may be substantially equal from the distal end side of the sheath 16 toward the proximal end side. The thickness T2 in the main lumen diameter direction 161 may be gradually decreased from the distal end side of the sheath 16 toward the proximal end side. By doing in this way, it can suppress that the rigidity of the sheath 16 changes suddenly toward the distal end side of the sheath 16.

A part of the core material 181 is inserted into the thick portion 161.
Here, the protrusion 18 will be described in detail.
As shown in FIGS. 1 and 2, the protrusion 18 extends along the longitudinal direction of the sheath 16 and protrudes from the distal end of the sheath 16.
More specifically, the protruding portion 18 protrudes from the end face of the distal end of the sheath 16 and is connected (embedded) to the thick portion 161 described above. The protrusion 18 has flexibility, and its diameter is smaller than the diameter of the sheath 16. The distal end portion of the protrusion 18 is convexly curved toward the distal end side of the catheter 10 and has a blunt shape.
The flexibility of the protrusion 18 is obtained by appropriately selecting the material of the core material 181, the resin layer 184, and the coil 182 constituting the protrusion 18, and the protrusion 18 is excellent in kink resistance. .

The protruding portion 18 includes a core member 181, a coil 182 disposed so as to surround the periphery of the core member 181, and a fixing portion 183.
The protruding portion 18 has a bending rigidity higher than that of the sheath 16.
The core material 181 has a diameter of 5 to 20 μm and is made of a metal such as a Ni—Ti alloy, a Cu—Zn—X alloy (X = Be, Si, Sn, Al, Ga), a Ni—Al alloy or the like. Composed of elastic alloy. The bending rigidity of the core member 181 is higher than the bending rigidity of the distal end portion of the sheath 16.
The core member 181 includes a first portion 181A protruding from the end face of the distal end of the sheath 16, and a second portion 181B embedded in the thick portion 161 of the sheath 16.
The first portion 181 </ b> A protrudes from the thick wall portion 161 at the distal end of the sheath 16 toward the distal end side of the catheter 10, and extends along the longitudinal direction of the sheath 16. The first portion 181A has the same diameter from the proximal end side to the distal end side, and the first portion 181A has, for example, a cylindrical shape.

The second portion 181 </ b> B extends along the longitudinal direction of the sheath 16 and is embedded in the thick portion 161 of the sheath 16.
The length dimension in the extending direction of the sheath 16 of the second portion 181B is about 1 to 2 cm.
In the second portion 181B, the radial thickness T of the main lumen 20 continuously decreases from the distal end side toward the proximal end, and is thinned. However, as shown in the plan view of FIG. 3, the thickness direction of the second portion 181 </ b> B and the width W in the direction orthogonal to the extending direction of the core member 181 are uniform from the distal end side to the proximal end. .

As shown in FIG. 4, the width W of the second portion 181 </ b> B may continuously increase from the distal end side toward the proximal end. By doing in this way, it becomes difficult for the 2nd part 181B to come off from the thick part 161. FIG.
3 and 4 are views of the catheter 10 as viewed from the direction orthogonal to the longitudinal direction, and are viewed from the second portion 181B side.

In the present embodiment, the thickness T continuously decreases from the distal end side toward the proximal end over the entire second portion 181B. However, the present invention is not limited to this. For example, a part of the second portion 181B is used. For example, the thickness of only the region near the proximal end may be continuously reduced.
Furthermore, since the second portion 181B is embedded in the thick portion 161, the second portion 181B is embedded in a region inside the reinforcing layer 50 of the sheath 16. And in the state which looked at the catheter 10 from the direction orthogonal to the longitudinal direction (state seen from the 2nd part 181B side), the proximal end part of the 2nd part 181B has overlapped with the reinforcement layer 50. Yes. The reinforcing layer 50 will be described later in detail.

The coil 182 surrounds the first portion 181 </ b> A of the core material 181. Examples of the material of the coil 182 include gold, platinum, silver, bismuth, tungsten, two or more kinds of these alloys (for example, platinum-tungsten), or alloys with other metals (for example, gold-iridium, platinum-iridium). ) And the like. The bending rigidity of the coil 182 is higher than the bending rigidity of the distal end portion of the sheath 16.
The coil 182 is provided in contact with the first portion 181A. The winding which comprises the coil 182 may be wound around the 1st part 181A, the coil 182 may be created previously, and the 1st part 181A may be inserted in the coil 182 inside.
The end portion on the proximal end side of the coil 182 is preferably fixed to the core material 181 with an adhesive or soldering. On the other hand, the end on the distal end side of the coil 182 is fixed to the core member 181 by a fixing portion 183.

The fixing portion 183 is curved in a convex shape toward the distal end side of the catheter 10 and can be made of the same metal as the core material 181. The fixing portion 183 is melted and fixed to the distal end portion of the first portion 181A, and the end portion of the coil 182 is fixed to the fixing portion 183. The fixing portion 183 constitutes a distal end portion of the protruding portion 18, and the distal end of the protruding portion 18 is closed.
The curved surface of the fixed portion 183 is curved in an arc shape. By doing so, when the catheter is advanced into the body cavity, the protrusion 18 can be brought into surface contact with the inner wall of the body cavity, and stimulation to the body cavity can be reduced.

At least the first portion 181A, the coil 182 and the fixing portion 183 are integrally covered with the resin layer 184. The second portion 181B may also be covered with the resin layer 184, but may not be covered with the resin layer 184. For example, in order to firmly fix the protrusion 18 to the sheath 16, the surface of the second portion 181B is roughened to form fine irregularities so that the resin material of the sheath 16 anchors to the second portion 181B. May be. In such a case, it is preferable that the second portion 181B is not covered with the resin layer 184.
As the resin layer 184, polyurethane, polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polystyrene, fluorine resin, silicone, or each elastomer (for example, polyester elastomer) and composite materials thereof can be suitably used.

Here, the protrusion dimension of the protrusion 18 from the sheath 16 is, for example, 1 cm or less. By setting the length to 1 cm or less, the protrusion 18 does not get in the way when the drug is supplied from the main lumen 20 into the body cavity.
Moreover, the outer diameter of the area | region which protruded from the sheath 16 of the protrusion part 18 is smaller than the outer diameter of the distal end of the sheath 16, for example, is 10 micrometers-50 micrometers.
It is preferable that A: B, which is a ratio of the outer diameter A of the distal end of the sheath 16 and the outer diameter B of the region protruding from the sheath 16 of the protrusion 18, is 20: 1 to 100: 1.
Thus, by making the diameter of the protrusion 18 very small, stimulation to the inner wall of the body cavity can be reduced, and blood vessel selectivity can be improved.

Next, the sub-lumen 30 will be described.
Inside the outer layer 60, one or more sub-lumens 30 are formed from the distal end 15 to the proximal end 17.
As shown in FIG. 5, in the catheter 10 of the present embodiment, a plurality of sublumens 30 are arranged in a distributed manner in the circumferential direction of the main lumen 20. Further, the main lumen 20 and the sub-lumen 30 are provided separately from each other. Specifically, in the case of the catheter 10 of the present embodiment, four sub-lumens 30 are arranged around the main lumen 20 at intervals of 90 degrees. In FIG. 5, only three sub-lumens 30 are shown, but the fourth sub-lumen 30 is on the extension line of the second portion 181B of the protrusion 18 and is closer to the second portion 181B. It is provided on the distal end side. Therefore, it is not shown in the sectional view of FIG. Also in the cross-sectional view of FIG. 1, the sub-lumen 30 on the extension line of the second portion 181B of the protrusion 18 is disposed closer to the proximal end side of the catheter 10 than the second portion 181B, and the second portion 181B. It is not shown in the figure because it is arranged at a position distant from.
The number of sub-lumens 30 is not limited to this.

In the present embodiment, only one operation line 40 is provided. As shown in FIG. 5, the operation line 40 and the protrusion 18 (the second portion 181 </ b> B is illustrated in FIG. 5) The main lumen 20 is opposed to the center position of the main lumen 20. That is, in a plan view from the opening 201 side formed on the end surface on the distal end side of the sheath 16, the operation line 40 and the protrusion 18 are disposed to face each other with the center position of the main lumen 20 interposed therebetween. .
By arranging the operation line 40 in this way, the operation line 40 can be easily pulled, the tip of the catheter can be easily bent toward the operation line 40 (see FIG. 7), and the operation of hooking the protrusion 18 on a branching blood vessel or the like is facilitated. .

  The operation line 40 is fixed (locked) to the distal end portion 15 of the catheter 10. Specifically, in the present embodiment, the operation line 40 is fixed to a marker 66 constituting the distal end portion 15 of the catheter 10.

The operation wire 40 is a wire having a circular cross section or a stranded wire composed of a plurality of thin wires, and has an outer diameter of about 30 to 60 μm.
Examples of the material of the operation wire 40 include PEEK, PPS, polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or stainless steel (SUS), a corrosion-resistant steel wire, titanium, or a titanium alloy. A flexible metal wire such as can be used.
In the present embodiment, the number of operation lines 40 is one. However, the number of operation lines 40 is not limited to this, and a plurality of operation lines 40 may be provided. One operation line 40 may be inserted through each of the two sub-lumens 30 facing each other so as to be slidable.

That is, as shown in FIG. 6, the two operation lines 40 form a straight line connecting the protrusion 18 (the second portion 181 </ b> B is shown in FIG. 6) and the center point of the opening of the main lumen 20. It may be arranged in a symmetrical position on both sides. That is, in a plan view from the opening side of the distal end side of the sheath 16, the two operation lines 40 are symmetrical with respect to a straight line connecting the projection 18 and the center point of the opening of the main lumen 20. It may be arranged at a position.
By arranging the operation line 40 in this way, when the sheath 16 is bent toward the one operation line 40 side, it becomes difficult to cause a difference in operability when the sheath 16 is bent toward the other operation line 40 side. It can be set as the catheter 10 excellent in property.

The hollow tube 32 defines the sub-lumen 30 described above, and is a tubular member formed by penetrating the sub-lumen 30 therein. The hollow tube 32 extends along the longitudinal direction of the sheath 16 as shown in FIG.
The hollow tube 32 is made of a thermoplastic resin composition having higher heat resistance, flexibility and slidability than the resin composition constituting the outer layer 60. Examples include PTFE, PFA or fluoropolymer materials such as tetrafluoroethylene / hexafluoropropylene copolymer (FEP), PI, PAI, polysulfone (PSF), polyethersulfone (PES), polyphenylene. Non-fluorinated polymer materials such as sulfide (PPS), polyether ether ketone (PEEK), polyether imide (PEI), or liquid crystal polymer (LCP) are used.

The polymer material for forming the hollow tube 32 may be mixed with an inorganic filler such as silica, talc, calcium carbonate, aluminum hydroxide, magnesium hydroxide, and titanium dioxide. By mixing the inorganic filler with the polymer material to improve the smoothness of the inner wall surface of the hollow tube 32, the workability when inserting the operation line 40 into the hollow tube 32 is improved. Friction reduction during traction operation is achieved.
Note that the tensile elastic modulus of the hollow tube 32 is higher than the tensile elastic modulus of the outer layer 60.

A hydrophilic coat layer 64 formed as the outermost layer of the catheter 10 is laminated around the outer layer 60. The coat layer 64 is provided in a partial length region on the distal end DE side of the sheath 16.
The coat layer 64 is formed of a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone, or is lubricated on the outer surface so that at least the outer surface is hydrophilic.

The catheter 10 of this embodiment has a reinforcing layer 50 for reinforcing the sheath 16. The reinforcing layer 50 is a blade layer 50 formed by knitting wires 52 around the inner layer 21. The blade layer 50 is included in the outer layer 60.
In the catheter 10 of the present embodiment, as shown in FIGS. 1 and 5, the sub-lumen 30 through which the operation lines 40 are inserted is formed inside the outer layer 60 and outside the blade layer 50.
The reinforcing layer is not limited to the blade layer 50 and may be a coil layer.
By providing such a reinforcing layer 50, the sheath 16 is reinforced and the medicine can be easily discharged from the catheter 10.

  As shown in FIG. 1, the distal end portion 15 of the catheter 10 is provided with a ring-shaped marker 66 made of a material that does not transmit radiation such as X-rays. Specifically, a metal material such as platinum can be used for the marker 66. The marker 66 of the present embodiment is provided around the main lumen 20 and inside the outer layer 60.

  The distal end (distal end) of the operation line 40 is fixed to the distal end portion 15 of the catheter 10. A mode of fixing the tip of the operation line 40 to the distal end portion 15 is not particularly limited. For example, the tip of the operating line 40 may be fastened to the marker 66, welded to the distal end 15 of the sheath 16, or adhesively fixed to the marker 66 or the distal end 15 of the sheath 16 with an adhesive. May be.

Here, typical dimensions of the catheter 10 of the present embodiment will be described. The radius of the main lumen 20 is about 200 to 300 μm, the thickness of the inner layer 21 is about 10 to 30 μm, the thickness of the outer layer 60 is about 50 to 150 μm, and the outer diameter (diameter) of the reinforcing layer 50 is about 500 μm to 860 μm. The inner diameter (diameter) of the layer 50 can be about 420 μm to 660 μm. The radius from the axial center of the catheter 10 to the center of the sublumen 30 can be about 300 to 350 μm, the inner diameter of the sublumen 30 can be about 40 to 100 μm, and the thickness of the operation line 40 can be about 30 to 60 μm. . The wall thickness of the hollow tube 32 can be about 3 to 15 μm. And the outermost diameter (radius) of the catheter 10 can be about 350-490 micrometers.
That is, the outer diameter of the catheter 10 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. The catheter 10 of this embodiment is for blood vessel insertion.

  Next, operation | movement of the catheter 10 of this embodiment is demonstrated using FIG.

  As shown in FIG. 7A, the proximal end 41 of the operation line 40 protrudes proximally from the sub-lumen 30. Further, on the proximal side of the operation line 40, an operation unit 70 that pulls the operation line 40 and bends the distal end portion 15 of the catheter 10 is provided. Detailed illustration and description regarding the structure of the operation unit 70 are omitted.

In the catheter 10 of the present embodiment, as shown in FIG. 7B, when the proximal end 41 of the operation line 40 is pulled to the proximal end side (the right side in the figure), the distal end 15 of the catheter 10 Is given a tensile force. When the tensile force is greater than or equal to a predetermined value, the distal end portion 15 bends from the axial center of the catheter 10 toward the sub-lumen 30 through which the operation line 40 is inserted. For this reason, the catheter 10 of this embodiment can be made to approach in a desired direction, for example with respect to body cavities, such as a branching blood vessel.
Furthermore, since the protrusion 18 is flexible and has higher bending rigidity than the sheath 16, the protrusion 18 is inserted into the branch blood vessel (branch body cavity) branched from the main blood vessel (main body cavity). , The projection 18 is bent at a desired angle, and the projection 18 can be inserted from the main blood vessel into the branch blood vessel. The sheath 16 follows the protrusion 18 and is guided by the protrusion 18 to advance in the branch blood vessel. This also allows the catheter 10 of the present embodiment to enter a desired direction into a body cavity such as a branching blood vessel.

Since the operation line 40 is made of a very fine diameter wire, when the proximal end 41 is pushed into the sheath 16, the operation line 40 is buckled, and the distal end portion 15 of the catheter 10 is bent. The pushing force is not practically given.
For this reason, even if the operator pushes the operation line 40 into the catheter 10, the operation line 40 does not come off the distal end portion 15 of the catheter 10 and protrude from the distal end DE. For this reason, when operating the catheter 10 inserted into the body cavity, the safety of the subject is ensured.

In the present invention, as shown in FIG. 8, the protrusion 18 may be reshaped in advance.
In this way, the catheter 10 can be easily entered into a branching blood vessel or the like.
When the protrusion 18 is bent and reshaped, the windings of the coil 182 extend and the coil 182 is plastically deformed. Then, the force that holds the shape of the coil 182 is superior to the restoring force of the core member 181, and the protrusion 18 is bent. However, since the core material 181 is superelastic, it is not plastically deformed, and by changing the shape of the coil 182, it is possible to return the protrusion 18 to a straight shape or to have another shape. .

<Catheter production method>
Next, a method for manufacturing the catheter 10 will be described with reference to FIG.
First, the protrusion 18 is prepared in advance. A coil 182 is wound around the first portion 181 </ b> A of the core material 181, and the coil 182 and the core material 181 are fixed by a fixing portion 183. Thereafter, the coil 182, the fixing portion 183, and the core material 181 are covered with the resin layer 184.

Next, the sheath 16 is produced.
As shown in FIG. 9, a mandrel M (core material) is prepared. In the mandrel M, a groove portion M1 corresponding to the thick portion is formed at the tip. The material of the inner layer 21 is extruded around the mandrel M. The material of the inner layer 21 enters the groove M1.
Next, the blade layer 50 is placed around the inner layer 21. On the other hand, on the inner layer 21 in the groove part M1 of the mandrel M, the second part 181B of the core member 181 of the protrusion part 18 is disposed so as to overlap.
On the other hand, the outer layer 60 is extruded in advance. However, here, only the region closer to the proximal end side than the marker 66 (outer layer 601 in the region on the right side of the drawing from the dotted line in FIG. 1) of the outer layer 60 is extruded. That is, the outer layer 601 created here has a shorter length than the outer layer 60.
Specifically, a material containing a resin constituting the outer layer 601 is extruded around a mandrel (core material) (not shown). At this time, in the outer layer 601, the gas is so formed that a long hollow portion (hole) along the longitudinal direction is formed at each position where the sub-lumen 30 is formed by the hollow tube 32 being embedded later. Extruding while discharging fluid such as.
After extrusion, the hollow outer layer 601 can be formed by pulling out the mandrel.

  Further, the hollow tube 32 is also formed by extruding a material containing a resin constituting the hollow tube 32. The material of the hollow tube 32 is extruded while discharging a fluid such as a gas so that a long hollow portion along the longitudinal direction is formed.

Thereafter, the outer layer 601 is covered around the blade layer 50 in a state where the blade layer 50 is covered around the inner layer 21.
Next, the hollow tube 32 is inserted into the hollow portion of the outer layer 601.
Thereafter, a resin heat shrinkable tube (not shown) is placed around the outer layer 601. Next, the heat shrinkable tube is contracted by heating, and the outer layer 601, the blade layer 50, the inner layer 21, and the hollow tube 32 are pressurized from the outside in the radial direction of the inner layer 21. Further, the outer layer 601 is melted by the heating. The heating temperature is higher than the melting temperature of the outer layer 601 and lower than the melting temperature of the inner layer 21 and the hollow tube 32. By this heating, the outer layer 601 and the inner layer 21 are joined by welding. At this time, the material constituting the outer layer 12 includes the blade layer 50. Further, the outer layer 601 and the hollow tube 32 are joined by welding.

  Next, the heat shrinkable tube is removed from the outer layer by making a cut in the heat shrinkable tube and tearing the heat shrinkable tube. Thereafter, the operation line 40 is inserted into the hollow tube 32.

Separately, a marker 66 that is an annular metal member is prepared.
Next, the tip of the operation line 40 is projected from the hollow tube 32 to the distal end side, and the tip of the operation line 40 is fixed to the marker 66. Then, the operation line 40 is pulled to the proximal end side, the operation line 40 is returned into the hollow tube 32, and the marker 66 is brought into contact with the outer layer 601. After that, the resin material of the outer layer 602 (see FIG. 1) constituting the region on the distal end side with respect to the marker 66 is melted, and the melted resin material is embedded in the marker 66 and the second portion of the protrusion 18. It supplies to the front-end | tip of the outer layer 601 so that the part 181B may be embedded.
Thereby, the thick part 161 is formed, and the second part 181B of the protrusion 18 is embedded in the thick part 161.
The radius of the marker 66 is larger than the distance from the first portion 181 </ b> A of the protrusion 18 and the center point of the main lumen 20 in plan view from the opening 201 side.
Thereafter, the outer layer 60 may be molded by covering the outer layer 60 again with a heat-shrinkable tube.
In the present embodiment, the second portion 181B of the core material 181 is disposed in the groove portion M1 of the mandrel M. However, the present invention is not limited to this, and a dummy core material is prepared and the groove portion M1 of the mandrel M is provided. A dummy core material may be arranged. After the operation line 40 is fixed to the marker 66, the dummy core material is replaced with the core material 181 of the protrusion 18. Thereafter, the resin material of the outer layer 602 constituting the region closer to the distal end than the marker 66 is melted to form the outer layer 602 in the region distal to the marker 66.

Next, the base end portion of the operation line 40 is connected to the separately created operation unit.
Next, the coat layer 64 is formed.
From the above, the catheter 10 can be obtained.

Next, the effect of this embodiment is demonstrated.
In the present embodiment, a protrusion 18 is provided at the distal end of the sheath 16. Therefore, when the catheter 10 is inserted into a body cavity such as a blood vessel, the protrusion 18 provided at the distal end of the sheath 16 enters the body cavity before the sheath 16. The protrusion 18 guides the progression of the sheath 16 into the body cavity when the sheath 16 is inserted into the body cavity, and its diameter is smaller than that of the sheath 16 and has flexibility. For this reason, even if the protrusion 18 contacts the inner wall of the body cavity, the stimulation to the inner wall of the body cavity is relatively small. Thereby, contraction of the body cavity can be suppressed, and the operability of the catheter 10 can be ensured. In particular, since the contraction of the body cavity can be prevented, the catheter 10 can be easily entered into the body cavity.
Furthermore, since contraction of the body cavity can be prevented, an appropriate amount of liquid or particulate medicine can be supplied to the affected area via the main lumen 20. There are particulate drugs that are used by selecting a particle size corresponding to the diameter of a normal blood vessel that is not contracted, but such a particulate drug is reliably supplied to the affected area via the main lumen 20. It becomes possible.

  Furthermore, since the outer diameter of the protrusion 18 protruding from the sheath 16 is smaller than the outer diameter of the distal end of the sheath 16, it is easy to insert into the blood vessel. For example, when inserting the catheter 10 into a branched blood vessel branch, the catheter can be inserted into a desired blood vessel branch, resulting in a catheter 10 having excellent blood vessel selectivity.

Further, in the present embodiment, the distal end of the protrusion 18 is closed by the fixing portion 183. Thereby, it can prevent that bodily fluids, such as blood, enter into the projection part 18.
The opening 201 is formed in the distal end surface of the sheath 16. Thereby, the medicine can be supplied from the main lumen 20 to a desired position.
Furthermore, when the opening surface of the opening 201 on the distal end side of the sheath 16 is inclined with respect to the longitudinal direction of the sheath 16, the medicine may be placed at a desired position depending on the rotational angle of the sheath 16 in the circumferential direction. It becomes difficult to supply. On the other hand, in the present embodiment, the opening surface of the opening 201 on the distal end side of the sheath 16 is orthogonal to the longitudinal direction of the sheath 16. Thereby, the medicine can be supplied from the main lumen 20 to a desired position.

Furthermore, in the present embodiment, when the catheter 10 is viewed in a plan view from a direction orthogonal to the longitudinal direction, the second portion 181B of the core member 181 and the reinforcing layer 50 overlap each other. By doing in this way, it is prevented that a catheter is bent and a kink is generated in a gap between the reinforcing layer 50 and the core material 181.
Further, in the present embodiment, the thickness of the second portion 181B in the radial direction of the sheath 16 continuously decreases from the distal end side toward the proximal end, and is thinned. Thereby, the rapid change of the bending rigidity in the boundary part of the reinforcement layer 50 and the core material 181 can be suppressed.

Further, the second portion 181 </ b> B of the core material 181 is embedded in the outer layer 60 inside the reinforcing layer 50. Thereby, the core material 181 is less likely to come out of the reinforcing layer 50.
Furthermore, in the present embodiment, a thick wall portion 161 that protrudes toward the main lumen 20 side from a part of the peripheral edge of the sheath 16 on the main lumen 20 side is formed at the distal end portion of the sheath 16. And the core material 181 is fixed to this thick part 161, and it has the structure where the projection part 18 protrudes from the thick part 161. FIG. By adopting such a structure, the outer shape of the cross section in the direction orthogonal to the longitudinal direction can be made circular at the distal end portion of the sheath 16, and the sheath 16 itself can easily enter the body cavity. Can do.

In this embodiment, the blade layer 50 is provided as a reinforcing layer. Thereby, the rigidity of the catheter 10 can be ensured. On the other hand, the flexibility of the distal end of the catheter 10 can be ensured by the protrusion 18.
Thus, the catheter 10 of the present embodiment has an excellent balance between rigidity and flexibility.

Japanese Patent Application Laid-Open No. 2008-86476 discloses a suction catheter provided with a guide wire lumen protruding at the tip of the suction lumen. Furthermore, Japanese Patent Application Laid-Open No. 2008-132256 discloses a vascular access catheter in which a blood return lumen is provided at the tip rather than a blood removal lumen.
The guide wire lumen and the blood return lumen are made of a resin tube in each catheter and are relatively soft. Therefore, unlike the protrusion of the present invention, it does not have a function of guiding the sheath when it is inserted into the body cavity.
For example, when a catheter is advanced from a main blood vessel into a branch blood vessel without using a guide wire, the guide tube lumen and the resin tube constituting the blood return lumen are soft in the catheter disclosed in the above publication. Even if the resin tube is caught at the corner between the main blood vessel and the branch blood vessel, the resin tube bends in two (the resin tube has an acute angle so that the tip of the resin tube faces the proximal end side of the catheter). Bend). In this state, when the catheter is further pushed into the main blood vessel, the catheter advances in the main blood vessel and cannot enter the branch blood vessel.

It should be noted that the present invention is not limited to the above-described embodiments, and modifications, improvements, and the like within the scope that can achieve the object of the present invention are included in the present invention.
For example, in the above-described embodiment, the catheter 10 is arranged so that the blade layer 50 and the second portion 181B of the core member 181 overlap each other in plan view from a direction orthogonal to the longitudinal direction. It is not limited. For example, in the plan view of the catheter 10 from the direction orthogonal to the longitudinal direction, the blade layer 50 and the second portion 181B of the core member 181 do not overlap with each other, but the blade layer 50 and the second portion 181B of the core member 181 are not overlapped. The core material 181 may be arranged so that no gap is formed between them.
By doing in this way, the local change of the rigidity along the longitudinal direction of the catheter 10 can be suppressed.

  Furthermore, although the thick part 161 which protrudes toward the main lumen 20 side was formed from a part of peripheral edge of the sheath 16 on the main lumen 20 side, the thick part protrudes on the opposite side to the main lumen 20. It is good. By doing in this way, the cross section orthogonal to the longitudinal direction of the main lumen 20 does not become small due to the presence of the thick portion 161, and the medicine can be easily discharged.

Furthermore, in the embodiment, the operation line 40 is provided at the first position facing the protrusion 18 across the center point of the opening in a plan view from the opening 201 side. Not limited to this, it may be arranged at a second position facing the first position across the center point of the opening 201. For example, the operation line 40 may be disposed on the extension line in the longitudinal direction of the protrusion 18. By arranging the operation line 40 in this way, the distal end portion of the catheter can be easily bent at an acute angle.
Furthermore, in the said embodiment, although the catheter had the operation line 40, there may not be an operation line. Even when the operation line is not provided, since the sheath is guided by the projection 18 by providing the projection 18, the sheath can be inserted at a desired position.
Moreover, although the catheter was shown as an example of a medical device in the said embodiment, it is not restricted to this.

10 Catheter 15 Distal End 16 Sheath (Tubular Body)
17 Proximal end 18 Protrusion 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 40 Operation line 41 Proximal end 50 Blade layer (reinforcing layer)
52 Wire 60 Outer layer 64 Coat layer 66 Marker 70 Operation part 161 Thick part 181 Core material 181A First part 181B Second part 182 Coil 183 Fixing part 184 Resin layer 201 Opening part 601 Outer layer 602 Outer layer DE Distal end M Mandrel M1 Groove part PE Proximal end

Claims (17)

A long medical device,
A tubular body in which a main lumen is formed inside along the longitudinal direction of the medical device, an end surface of a distal end is opened, and an opening communicating with the main lumen is formed;
A projection that guides insertion of the tubular body into the body cavity when the tubular body is inserted into the body cavity;
The protrusion extends along a longitudinal direction of the tubular body and protrudes from a distal end of the tubular body;
The protrusion has flexibility, and the diameter of the protrusion is smaller than the diameter of the tubular body. The medical device according to claim 1, wherein
The distal end of the protrusion is a medical device that is closed. The medical device according to claim 1 or 2,
The distal end of the protrusion is a medical device having a blunt shape. The medical device according to any one of claims 1 to 3,
A medical device in which an opening plane of the opening of the tubular body is orthogonal to a longitudinal direction of the tubular body. The medical device according to any one of claims 1 to 4,
The protrusion is a medical device having a metal core. The medical device according to claim 5,
The protrusion is a coil disposed so as to surround the core material;
A medical device comprising: a fixing portion that fixes the core material and the coil and constitutes a distal end portion of the protruding portion. The medical device according to claim 6,
The core material is a medical device made of a superelastic alloy. The medical device according to any one of claims 5 to 7,
A metal reinforcing layer arranged to surround the main lumen;
A medical device in which a proximal end of the core material and the reinforcing layer overlap each other when the medical device is viewed in a plan view from a direction orthogonal to the longitudinal direction. The medical device according to claim 8,
The reinforcing layer is embedded in the tubular body made of resin,
A medical device in which a proximal end of the core member is embedded in a region inside the reinforcing layer of the tubular body. The medical device according to claim 8 or 9,
The core includes a first portion protruding from a distal end of the tubular body, and a second portion connected to the first portion and embedded in the tubular body toward the proximal end of the tubular body. Prepared,
The second part is a medical device in which the thickness is continuously reduced from the distal end side of the core member toward the proximal end of the core member to reduce the thickness. The medical device according to claim 10,
The distal end of the tubular body has a thickness protruding from the part of the inner peripheral surface of the tubular body on the main lumen side toward the main lumen side and extending in the longitudinal direction of the tubular body. A medical device in which a meat part is formed, and the second part of the core is embedded in the thick part. The medical device according to any one of claims 1 to 11,
A distal end having an operating line engaged with the tubular body;
A medical device in which a distal end of the tubular body is bent by pulling a proximal end of the operation line. The medical device according to claim 12,
In a plan view from the opening side, the operation line is located at a first position facing the protruding portion across the central point of the opening, or the first position across the central point of the opening. And a medical device arranged in a second position opposite. The medical device according to claim 12,
Having two operation lines,
The two operation lines are medical devices arranged in symmetrical positions across a straight line connecting the protrusion and the center point of the opening in a plan view from the opening. The medical device according to any one of claims 1 to 14,
A medical device in which the protrusion is bent. The medical device according to any one of claims 1 to 15,
The medical device is a medical device that is a catheter. The medical device according to claim 16,
The medical device is a device for discharging liquid or particulate medicine from the opening through the main lumen.

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