WO2014203343A1

WO2014203343A1 - Medical device and method for manufacturing medical device

Info

Publication number: WO2014203343A1
Application number: PCT/JP2013/066815
Authority: WO
Inventors: 兼政　賢一
Original assignee: 住友ベークライト株式会社
Priority date: 2013-06-19
Filing date: 2013-06-19
Publication date: 2014-12-24

Abstract

The objective of the present invention is to provide a technology that provides a medical device with favorable operability. A catheter (100) comprises: a tubular main body (10) in which are formed a main lumen (20) and a sub-lumen (80) which is disposed around the main lumen (20) and extends along a longitudinal direction of the main lumen (20); and an operating line (70) which is disposed inside the sub-lumen (80) and a distal end of which is fixed to a distal end of the tubular main body (10). The operating line (70) is circular in a cross section orthogonal to the longitudinal direction or the operating line (70) is a stranded wire composed of multiple filaments which are circular in a cross section orthogonal to the longitudinal direction. The cross sectional shape of the sub-lumen (80 (80a, 80b)) orthogonal to the longitudinal direction is a flat shape which is flat in a circumferential direction of the main lumen (20).

Description

Medical device and method for manufacturing medical device

The present invention relates to a medical device and a method for manufacturing the medical device.

In recent years, catheters have been provided that can be manipulated in 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 this catheter, the tip of the catheter is bent by operating the deflection wire.

JP 2006-192269 A

It has been found that the catheter disclosed in Patent Document 1 has the following room for improvement.
When the deflection wire that is the operation line is operated with the catheter bent, it may be difficult to operate the operation line. Since the operation line can be easily operated with the catheter bent, the inner diameter of the circular wire lumen (sublumume) needs to be larger than the diameter of the operation line. As a result, the diameter of the catheter is increased.
In addition, although the catheter was demonstrated and demonstrated here, the same subject is a subject which arises not only in a catheter but in the medical device which operates with an operation line.

According to the present invention, a main body, a tubular body formed around the main lumen and a sub-lumen extending along a longitudinal direction of the main lumen, and the sub-lumen are arranged in the sub-lumen, An operating line fixed to the distal end of the tubular body, and the operating line has a circular cross section perpendicular to the longitudinal direction, or the operating line extends in the longitudinal direction. A medical device is provided which is a twisted wire obtained by twisting a plurality of thin wires having a circular cross section orthogonal to each other, and the cross-sectional shape of the sub-lumen orthogonal to the longitudinal direction is a flat shape flat in the circumferential direction of the main lumen. The
In such a medical device, the operation line in the sub-lumen is a stranded wire formed of a plurality of thin wires having a circular cross section or a circular cross section. On the other hand, the cross-sectional shape of the sub-lumen is flat in the circumferential direction of the main lumen. Therefore, in the cross section orthogonal to the longitudinal direction of the main lumen, a space is formed between the peripheral wall of the sub-lumen on the circumferential direction side of the main lumen and the operation line.
As a result of the study by the present inventors, it is possible to form a gap between the operation line and the sublumen even when the medical device is bent by setting it in such a shape, and reducing the diameter of the catheter. It was found that the operability can be improved while keeping it small.

Furthermore, according to this invention, the manufacturing method of the medical device mentioned above can also be provided.
That is, according to the present invention, a hollow tube in which a sub-lumen having a circular shape in a cross section perpendicular to the longitudinal direction is formed, and a core wire is loosely inserted (inserted in a state where there is a sufficient space) inside, a resin Arranging the main body portion and the hollow tube in a radial direction of the main body portion, and heating the main body portion and the hollow tube; It is also possible to provide a method for manufacturing a medical device including a step of pressurizing from the outer peripheral side to make the shape of the cross section of the sublumen flat.

According to the present invention, a technique for providing a medical device with good operability is provided.

It is sectional drawing of the front-end | tip part of the catheter concerning one Embodiment of this invention. It is sectional drawing of the II-II direction of FIG. (A) (b) is a figure which shows the cross section orthogonal to the longitudinal direction of the main lumen of a catheter. (A) (b) is sectional drawing of an operation line. It is a side view which shows the whole catheter, and a side view which shows the bending example of a front-end | tip part, Comprising: (a) is a side view which shows the whole before bending a catheter, (b) is a tip by operating a slider. (C) is a side view showing a state where the tip is bent upward with a larger curvature than (b) by operating the slider. It is a side view which shows the state which operated the slider and bent the front-end | tip downward, (e) is a side view which shows the state which operated the slider and bent the front-end | tip with the curvature larger than (d). It is. It is sectional drawing orthogonal to the longitudinal direction of a catheter, (a) is sectional drawing of the state in which the catheter is not bent, (b) is sectional drawing of the state in which the catheter was bent. (C) is a side view showing a state in which the catheter is bent. It is sectional drawing which shows the manufacturing process of a catheter. It is sectional drawing of the VIII-VIII direction of FIG. It is sectional drawing which shows the manufacturing process of a catheter. It is a figure which shows typically the state which the operation line moved in the sub-lumen. It is sectional drawing of the conventional catheter, (a) is sectional drawing of the state in which the catheter is not bent, (b) is sectional drawing of the state in which the catheter was bent.

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.
[Configuration example]
With reference to FIG. 1, 2, the outline | summary of the catheter 100 which is a medical device of this embodiment is demonstrated. 1 is a cross-sectional view taken along the longitudinal direction of the catheter 100, and FIG. 2 is a cross-sectional view taken along the II-II direction of FIG.
The catheter 100 of the present embodiment is a tubular body in which a main lumen 20 and a sub-lumen 80 (80a, 80b) disposed around the main lumen 20 and extending along the longitudinal direction of the main lumen 20 are formed. 10 and an operation line 70 (70a, 70b) disposed in the sub-lumen 80 (80a, 80b) and having a distal end fixed to the distal end of the tubular body 10.
The operation line 70 (70a, 70b) has a circular cross section perpendicular to the longitudinal direction, or the operation line 70 (70a, 70b) is composed of a plurality of thin lines having a circular cross section orthogonal to the longitudinal direction. It is a twisted wire.
As shown in FIG. 2, the cross-sectional shape of the sub-lumen 80 (80a, 80b) orthogonal to the longitudinal direction is a flat shape that is flat in the circumferential direction of the main lumen 20.

Next, the structure of the catheter 100 will be described in detail.
The catheter 100 includes a coat layer 50 and an operation unit 60 in addition to the tubular body 10 and the operation line 70 described above.

The tubular main body 10 includes a sheath including an inner layer 11 having a main lumen therein and an outer layer (main body portion) 12 covering the inner layer 11, a reinforcing layer 30, a hollow tube 82, and a marker 40.
Hereinafter, the distal ends of the sheath 10 and the catheter 100 are referred to as a distal end DE, but the rear end of the sheath 10 is referred to as a proximal end PE, and the rear end of the catheter 100 is referred to as a proximal end CE.

The inner layer 11 is a hollow tubular layer, and a main lumen 20 extending along the longitudinal direction of the catheter 100 is formed therein. For example, a fluorine-based thermoplastic polymer material can be used for the inner layer 11. 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 11, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 100 is improved.
The main lumen 20 has a circular cross section perpendicular to the longitudinal direction of the catheter 100.

The outer layer 12 is a resin tubular body that covers the inner layer 11. The outer layer 12 is thicker than the inner layer 11 and constitutes the main thickness of the sheath.
A thermoplastic polymer is widely used for the outer layer 12. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.

The reinforcing layer 30 surrounds the inner layer 11 and is included in the outer layer 12. This reinforcing layer 30 is a coil layer. As the wire material constituting the reinforcing layer 30, in addition to fine metal wires such as stainless steel (SUS) and nickel titanium alloy, fine fiber wires such as PI, PAI, and PET can be used. Moreover, the cross-sectional shape of the wire material 31 is not specifically limited, A round wire or a flat wire may be sufficient.
In the catheter 100 of the present embodiment, the sub-lumen 80 through which the operation lines 70 are inserted is formed inside the outer layer 12 and outside the reinforcing layer 30.

The hollow tubes 82 (82a, 82b) are embedded in the outer layer 12, and are arranged around the main lumen 20 so that the longitudinal direction thereof is along the longitudinal direction of the main lumen 20.
The hollow tube 82 defines the sub-lumen 80. The hollow tube 82 that defines the sublumen 80 is provided along the longitudinal direction of the catheter 100, and although not shown, the proximal end PE side of the sheath 10 is open. The distal end side of the sheath 10 of the hollow tube 82 is closed by the marker 40.

The hollow tube 82 is disposed outside the reinforcing layer 30, and the inner side of the reinforcing layer 30, that is, the main lumen 20 protects the operation line 70 (70 a, 70 b) disposed inside the hollow tube 82. Has been.
In the present embodiment, as shown in FIG. 2, a plurality of hollow tubes 82 are provided. Specifically, a plurality of hollow tubes 82 are arranged on the same circumference so as to surround the main lumen 20. In the present embodiment, four hollow tubes 82 are arranged at equal intervals. And the operation line 70 is arrange | positioned inside a pair of hollow tube 82 which opposes on both sides of the center of the main lumen 20. Further, the operation line 70 is not disposed inside the other pair of hollow tubes 82 facing each other across the center of the main lumen 20.
Note that the number of the hollow tubes 82 and the sub-lumens 80 is not limited to four, and can be appropriately selected as necessary.

The sub-lumen 80 in each hollow tube 82 has a flat shape in which the cross-sectional shape orthogonal to the longitudinal direction of the catheter 100 is flat in the circumferential direction of the main lumen 20.
More specifically, in the cross section orthogonal to the longitudinal direction of the catheter 100, the sub-lumen 80 has a length A in the circumferential direction of the main lumen 20 longer than a length B in the radial direction of the main lumen 20.
Thereby, the torsional rigidity of the sheath 10 is increased. The torsion of the sheath 10 acts on the hollow tube 82 as a force in the bending direction, and the hollow tube 82 is longer in the bending direction than the hollow tube having a circular cross section. The secondary moment increases and the torsional rigidity of the sheath 10 increases.
The length B in the radial direction of the main lumen 20 is preferably 1 to 3 times the predetermined diameter of the operation line 70, and more preferably 1 to 1.5 times. From the viewpoint of preventing the diameter of the catheter 100 from becoming large, 1 to 1.2 times is particularly preferable. The ratio (A / B) between the circumferential length A and the radial length B of the main lumen 20 is preferably 1.2-4. From the viewpoint of operability when the catheter 100 is bent, 1.2 to 2.5 is more preferable. From the viewpoint of improving torsional rigidity, A / B is particularly preferably 1.8 to 2.5.

Further, as shown in FIG. 2, in the present embodiment, the sub-lumen 80 is curved along the outer shape of the main lumen 20 in a cross section orthogonal to the longitudinal direction of the catheter 100. Of the peripheral edges that define the sub-lumen 80, the inner peripheral edge positioned on the main lumen 20 side and the outer peripheral edge positioned on the outer peripheral side of the sheath 10 are curved in a convex arc shape toward the outer peripheral side of the sheath 10. is doing. The cross section of the sub-lumen 80 has a so-called Magatama, Comma-shaped beads shape. The operation line 70 is loosely inserted in such a subroutine 80.

The hollow tube 82 is made of a material different from that of the outer layer 12. By doing in this way, the hollow tube 82 can be comprised with the material whose bending rigidity and tensile elasticity modulus are higher than the outer layer 12. FIG. Examples of the material constituting the hollow tube 82 include materials such as polytetrafluoroethylene (PTFE), perfluoroalkoxy fluororesin (PFA), and tetrafluoroethylene / hexafluoropropylene copolymer (FEP). . It is preferable that any one or more of these materials are the main component. These materials can improve the slidability (slidability) of the operation line and have high heat resistance.
By using such a hollow tube 82, the torsional rigidity of the catheter 100 can be increased, and the sheath can be prevented from being locally twisted when the sheath is rotated with its longitudinal direction as the rotation axis.

The cross-sectional shape of the sub-lumen 80 is not limited to the shape illustrated in FIG. 2, and may be a flat shape that is long and flat in the circumferential direction of the main lumen 20, that is, a shape that is crushed in the radial direction of the main lumen 20. . For example, an oval shape may be used as shown in FIG. 3A, and an elliptical shape may be used as shown in FIG.

The operation line 70 is loosely inserted in the sub-lumen 80 and extends along the longitudinal direction of the sub-lumen 80.
The operation line 70 may be constituted by a single line, or may be a stranded line constituted by twisting a plurality of thin wires 72 as shown in FIG. When the operation line 70 is composed of a single line, the cross section perpendicular to the longitudinal direction has a circular shape. On the other hand, when the operation line 70 is composed of a stranded wire, the cross section orthogonal to the longitudinal direction of the thin wire 72 constituting the operation line 70 has a circular shape.
Here, the circular shape of the cross section is not limited to a perfect circle.
When the operation wire 70 is formed of a stranded wire, the thin wire 72 is arranged so that each thin wire 72 constituting the outline of the operation wire 70 is inscribed in one circle R in a cross section orthogonal to the longitudinal direction. Preferably there is.
Here, the number of fine wires constituting one stranded wire is not particularly limited, but is preferably 3 or more. A suitable example of the number of thin wires is three or seven. When the number of fine lines is 3, the three fine lines are arranged point-symmetrically in the cross section. When the number of fine lines is seven, the seven fine lines are arranged point-symmetrically in a honeycomb shape in the cross section.

As shown in FIG. 1, the distal end portion 71 (71 a, 71 b) of the operation line 70 (70 a, 70 b) is fixed to the marker 40 at the distal end DE of the sheath 10. The tip portions 71 (71a, 71b) of 70a, 70b) are fixed to the distal end DE. The operation line 70 is slidably inserted into the sub-lumen 80 (80a, 80b). Then, the distal end 15 of the catheter 100 is bent by pulling the proximal end of each operation line 70 (70a, 70b) (see FIG. 5). Further, in the catheter 100 of the present embodiment, the curvature and direction of the bent distal end portion 15 change in a plurality of ways depending on selection of the operation line 70 (70a, 70b) to be pulled.

Here, as a specific material of the operation line 70, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or SUS, Corrosion-resistant coated steel wires, metal wires such as titanium or titanium alloys can be used. In addition to the above materials, PVDF, high density polyethylene (HDPE), polyester, or the like can also be used.

Further, as shown in FIG. 5, the catheter 100 includes an operation unit 60. The operation unit 60 is provided at the proximal end portion 17 of the catheter 100. A portion between the distal end portion 15 and the proximal end portion 17 is referred to as an intermediate portion 16.

The operation unit 60 includes a shaft portion 61 extending in the longitudinal direction of the catheter 100, a slider 64 (64a, 64b) that moves forward and backward in the longitudinal direction of the catheter 100 with respect to the shaft portion 61, and a handle portion that rotates the shaft portion 61 about its axis. 62 and a gripping portion 63 through which the sheath 10 is rotatably inserted. Further, the proximal end portion 17 of the sheath 10 is fixed to the shaft portion 61. Moreover, the handle | steering-wheel part 62 and the axial part 61 are comprised integrally. Then, the entire sheath 10 including the operation line 70 is torque-rotated together with the shaft portion 61 by rotating the grip portion 63 and the handle portion 62 relative to each other.

Therefore, the operation unit 60 of the present embodiment rotates the distal end portion 15 of the tubular main body (sheath 10). In the present embodiment, a handle portion 62 as a rotation operation portion for torque-rotating the sheath 10 and a slider 64 as a bending operation portion for bending the sheath 10 are integrally provided. However, the present invention is not limited to this, and the handle portion 62 and the slider 64 may be provided separately.

The proximal end of the first operation line 70 a protrudes from the proximal end portion 17 of the sheath 10 to the proximal end side, and is connected to the slider 64 a of the operation portion 60. Similarly, the proximal end of the second operation line 70 b is also connected to the slider 64 b of the operation unit 60. Then, by sliding the slider 64a and the slider 64b individually to the proximal end side with respect to the shaft portion 61, the first operation line 70a or the second operation line 70b connected thereto is pulled and the distal end of the sheath 10 is pulled. A tensile force is applied to the end portion 15. As a result, the distal end portion 15 bends toward the pulled operation line 70.

As shown in FIG. 1, a marker 40 is provided at the distal end DE of the sheath 10. The marker 40 is a ring-shaped member 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 40. The marker 40 of this embodiment is provided around the main lumen 20 and inside the outer layer 12.

The coat layer 50 constitutes the outermost layer of the catheter 100 and is a hydrophilic layer. For the coat layer 50, a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

Here, typical dimensions of the catheter 100 of the present embodiment will be described. The radius of the main lumen 20 can be about 200 to 300 μm, the thickness of the inner layer 11 can be about 10 to 30 μm, the thickness of the outer layer 12 can be about 100 to 150 μm, and the thickness of the reinforcing layer 30 can be 20 to 30 μm. The radius from the axial center of the catheter 100 to the center of the sublumen 80 can be about 300 to 350 μm, the inner diameter of the sublumen 80 can be about 40 to 100 μm, and the thickness of the operation line 70 can be about 30 to 60 μm. . The outermost diameter of the catheter 100 can be about 350 to 450 μm.

That is, the outer diameter of the catheter 100 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. Further, the catheter 100 according to the present embodiment is operated freely by pulling the operation line 70 (70a, 70b), so that the catheter 100 can be advanced in a desired direction even in a branching blood vessel, for example. Is possible.

[Operation example]
Next, an operation example of the catheter 100 of the present embodiment will be described with reference to FIG. First, in the catheter 100 of the present embodiment, when the proximal end of the operation line 70 (the first operation line 70a or the second operation line 70b) is pulled, a tensile force is applied to the distal end portion 15 of the catheter 100, Part or all of the distal end portion 15 bends toward the sub-lumen 80 (sub-lumen 80a or sub-lumen 80b) through which the operation line 70 (first operation line 70a or second operation line 70b) is inserted. To do. On the other hand, when the proximal end of the operation line 70 is pushed into the catheter 100, a pushing force is not substantially applied from the operation line 70 to the distal end portion 15 of the catheter 100.

Note that the distal end portion 15 of the catheter 100 refers to a predetermined length region including the distal end DE of the catheter 100. Similarly, the proximal end portion 17 of the catheter 100 refers to a predetermined length region including the proximal end CE of the catheter 100. The intermediate portion 16 refers to a predetermined length region between the distal end portion 15 and the proximal end portion 17. The bending of the catheter 100 means that a part or all of the catheter 100 is bent or bent.

In the catheter 100 of this embodiment, the operation line 70 to be pulled is only the first operation line 70a, only the second operation line 70b, or whether the two

operation lines

70a and 70b are pulled simultaneously. The curvature of the bent distal end portion 15 changes in a plurality of ways. Thereby, the catheter 100 can be freely entered into a body cavity that branches at various angles.

The catheter 100 of the present embodiment can individually pull the proximal ends of the plurality of operation lines 70 (the first operation line 70a or the second operation line 70b). The bending direction can be changed by the operating line 70 to be pulled. Specifically, when the first operation line 70a is pulled as shown in FIGS. 5B and 5C, the first operation line 70a is bent to the side where the first operation line 70a is provided, as shown in FIGS. 5D and 5E. When the second operation line 70b is pulled, the second operation line 70b is bent. Further, the curvature of curvature (the radius of curvature) can be changed by adjusting the pulling amount of each operation line 70 (70a, 70b). Specifically, as shown in FIGS. 5B and 5D, when the first or

second operation lines

70a and 70b are slightly pulled, the distal end portion 15 has a small curvature (a large radius of curvature). Bend. On the other hand, as shown in FIGS. 5C and 5E, when the first or

second operation line

70a, 70b is pulled longer, the distal end portion 15 bends with a large curvature (the curvature radius is small). .

Here, the catheter 100 bends by operating the operation line 70 as described above. In addition to this, the shape of the blood vessel into which the catheter 100 is inserted may be bent even when the operation line 70 is not operated.
In such a case, the cross-sectional shape of the bent portion of the catheter 100 changes as shown in FIG. 6A shows a cross-sectional view of the catheter 100 that is not bent and is linear, and FIG. 6B is a cross-sectional view in the bb direction of FIG. 6C. FIG. 3 is a cross-sectional view of the catheter 100 in a bent state.
When the catheter 100 is bent, a tensile stress is applied to the outer portion of the bent portion along the longitudinal direction of the sheath 10 as shown in FIG. Due to this force, the resin constituting the sheath 10 contracts slightly in accordance with the Poisson's ratio in the outer portion of the bent portion of the sheath 10.

On the other hand, when the catheter 100 is bent, a compressive stress is applied along the longitudinal direction of the sheath 10 to the inner portion of the bent portion, as shown in FIG. Due to this force, the resin constituting the sheath 10 expands, albeit slightly, in accordance with the Poisson's ratio in the inner portion of the bent portion of the sheath 10.
This expansion occurs more significantly in the radial direction substantially orthogonal to the circumferential direction (in the directions of arrows Y1 and Y2 in FIG. 6B) than in the circumferential direction of the main lumen 20 (in the directions of arrows Y3 and 4 in FIG. 6B). ). This is because the circumferential direction of the main lumen 20 is restrained by the resin constituting the sheath 10. In particular, as shown in FIG. 6B, of the expansion in the radial direction of the inner portion of the bent portion, the expansion toward the direction opposite to the main lumen 20 (expansion in the direction of arrow Y1 in FIG. 6B) is: This is more noticeable than the expansion toward the main lumen 20 (expansion in the direction of arrow Y2 in FIG. 6B). This is because the reinforcing layer 30 is provided around the main lumen 20, so that the main lumen 20 does not easily expand.

With the expansion of the sheath 10, the hollow tube 82 inside the bent portion greatly expands in the radial direction of the main lumen 20 substantially perpendicular to the circumferential direction of the main lumen 20, so that the radial direction of the main lumen 20 increases. The distance between the peripheral wall of the sub-lumen 80 and the operation line 70 increases. On the other hand, as described above, the expansion of the sheath 10 occurs more significantly in the radial direction substantially orthogonal to the circumferential direction than in the circumferential direction of the main lumen 20 (arrows Y3 and 4 in FIG. 6B) (see FIG. 6). 6 (b) (in the direction of arrows Y1 and Y2), the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20 may slightly approach the operation line 70. However, since the sub-lumen 80 has a flat shape that is flat in the circumferential direction of the main lumen 20, a space can be secured between the operation line 70 and the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20.
Thereby, when the catheter 100 is bent, for example, the cross-sectional shape of the hollow tube 82 becomes a substantially circular shape.
Therefore, the operation line 70 in the hollow tube 82 is less likely to come into contact with the hollow tube 82, and the operability of the operation line 70 is improved.

In the present embodiment, the sub-lumen 80 has a flat shape that is flat in the circumferential direction of the main lumen 20. Therefore, when the catheter 100 is not bent (straight state), the diameter of the main lumen 20 of the sub-lumen 80 is The distance between the peripheral wall and the operation line 70 is shortened. Therefore, there is a possibility that the peripheral wall of the main lumen 20 in the radial direction of the sub lumen 80 is likely to come into contact with the operation line 70. However, in a state where the catheter 100 is not bent, a large tension is not applied to the operation line 70, so even if the operation line 70 and the peripheral wall of the sub-lumen 80 come into contact with each other, a large friction is unlikely to occur. Since the operability of the line 70 is not greatly affected, no problem occurs.

〔Production method〕
Next, a method for manufacturing the catheter 100 of the present embodiment will be described with reference to FIGS.
First, an outline of a method for manufacturing the catheter 100 will be described.
In the method of manufacturing the catheter 100 according to the present embodiment, the sub-lumen 80 having a circular cross section perpendicular to the longitudinal direction is formed, and the hollow tube 82 in which the core wire 90 is loosely inserted is used as the main lumen 20 of the outer layer 12. Arranging around the formation region;
Heating the outer layer 12 and the hollow tube 82, pressurizing the outer layer 12 and the hollow tube 82 from the outer peripheral side in the radial direction of the outer layer 12, and making the shape of the cross section of the sub-lumen 80 flat. including.

Next, the manufacturing method of the catheter 100 will be described in detail.
First, the outer layer 12 is extruded. A material containing resin constituting the outer layer 12 is extruded around a mandrel (core material) (not shown). At this time, in the outer layer 12, the gas is so formed that a long hollow portion (hole) along the longitudinal direction is formed at each position where the sub-lumen 80 is formed by the hollow tube 82 being embedded later. Extruding while discharging fluid such as.
After the extrusion molding, the hollow outer layer 12 can be formed by pulling out the mandrel.

On the other hand, the inner layer 11 is also prepared by extrusion molding. As in the case of forming the outer layer, a material containing a resin constituting the inner layer 11 may be extruded around a mandrel (core material) M shown in FIG.
Thereafter, the coil 31 is placed around the inner layer 11 with the core material M. Therefore, at this stage, the mandrel M is still inserted in the inner layer 11.

The hollow tube 82 is also formed by extruding a material containing a resin constituting the hollow tube 82. Extrusion molding is performed while discharging a fluid such as gas to the material of the hollow tube 82 so that a long hollow portion along the longitudinal direction is formed. The hollow tube 82 manufactured in this way has a ring shape with a circular cross section perpendicular to the longitudinal direction.
Next, the core wire 90 is inserted into the hollow tube 82. The core wire 90 has a circular cross section perpendicular to the longitudinal direction.
However, the diameter of the core wire 90 is larger than the diameter of the operation wire 70 (the diameter of the circle R in the case of a stranded wire).
As will be described later, the hollow tube 82 may be extruded around the core wire 90, the core wire 90 and the hollow tube 82 may be peeled off, and the core wire 90 may be loosely inserted into the hollow tube 82. By adopting a method of inserting the core wire 90 after forming the portion, the hollow portion of the hollow tube 82 can be surely formed into a desired shape.

Thereafter, the outer layer 12 is covered around the coil 31 in a state where the coil 31 is covered around the inner layer 11.
Next, the hollow tube 82 containing the core wire 90 is inserted into the hollow portion of the outer layer 12.
Thereafter, as shown in FIG. 7, a heat shrinkable tube 91 is placed around the outer layer 12. FIG. 8 shows a cross-sectional view in the VIII-VIII direction of FIG. In FIG. 8, the coil 31 is omitted. At this time, the sub-lumen in the hollow tube 82 has a circular cross section perpendicular to the longitudinal direction. Note that a circular cross section is not limited to a perfect circle.
Next, the heat shrinkable tube 91 is contracted by heating, and the outer layer 12, the coil 31, the inner layer 11, and the hollow tube 82 are pressurized from the outside in the radial direction of the inner layer 11. Further, the outer layer 12 is melted by the heating. The heating temperature is higher than the melting temperature of the outer layer 12 and lower than the melting temperature of the inner layer 11 and the hollow tube 82. By this heating, the outer layer 12 and the inner layer 11 are joined by welding. At this time, the material constituting the outer layer 12 encloses the coil 31 and the outer layer 12 is impregnated with the coil. Further, the outer layer 12 and the hollow tube 82 are joined by welding.
In this step, the outer peripheral surface of the outer layer 12 is substantially circular by tightening the outer peripheral surface of the outer layer 12 with the heat shrinkable tube 91.
On the other hand, the hollow tube 82 is crushed in the radial direction of the outer layer 12 by being pressurized in this step, and the cross section perpendicular to the longitudinal direction of the sub-lumen 80 inside the hollow tube 82 is the circumference of the outer layer 12. It becomes a flat shape flat in the direction.
Even in a state where the cross section of the hollow tube 82 has a flat shape, it is preferable that the core wire 90 is loosely inserted into the hollow tube 82.

Next, the heat shrinkable tube 91 is cut from the outer layer 12 by cutting the heat shrinkable tube 91 and tearing the heat shrinkable tube 91.

Next, as shown in FIG. 9, the operation line 70 is inserted into the hollow tube 82. For this purpose, one end of the operation line 70 is connected to one end of the core wire 90. Next, by pulling out the other end of the core wire 90 from the hollow tube 82, the core wire 90 and the operation wire 70 are interchanged, and the operation wire 70 is disposed in the hollow tube 82.

Separately, a marker 40 that is an annular metal member is prepared.
Next, fixing of the tip of the operation line 70 to the marker 40 and caulking and fixing of the marker 40 to the periphery of the tip of the outer layer 12 (Permanent Mechanical Assembly) are performed.

Next, a member (not shown) serving as an inlet for a chemical solution or the like is connected to the base end portion of the main lumen 20.
Next, the mandrel M in the inner layer 11 is pulled out. The mandrel M is pulled out in a state where the mandrel M is reduced in diameter by pulling both ends in the longitudinal direction of the mandrel M. As a result, a hollow serving as the main lumen 20 is formed at the center of the inner layer 11.

Next, the base end portion of the operation line 70 is connected to the separately created operation unit.
Next, the coat layer 50 is formed.
From the above, the catheter 100 can be obtained.

Next, the effect of this embodiment is demonstrated.
As described above, when the catheter 100 is bent, the resin constituting the sheath 10 expands in the inner portion of the bent portion, and the cross-sectional shape of the sub-lumen 80 is deformed. Specifically, as shown in FIG. 6B, the sub-lumen 80 inside the bent portion expands in the radial direction of the main lumen 20 that is substantially orthogonal to the circumferential direction of the main lumen 20. In the present embodiment, the cross-sectional shape orthogonal to the longitudinal direction of the sub-lumen 80 is a flat shape that is flat in the circumferential direction of the main lumen 20 in advance, and the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20 A large space is formed between the operation line 70 and the operation line 70. Therefore, even if the sub-lumen 80 expands in the radial direction of the main lumen 20 and the peripheral wall of the sub-lumen 80 in the circumferential direction of the main lumen 20 approaches the operation line 70, contact between the inner wall of the sub-lumen 80 and the operation line 70 is maintained. Can be suppressed. In a state where the catheter 100 is bent, since the tension is applied to the operation line 70 (70b) in the sub-lumen 80 inside the bent portion, the contact between the operation line 70 and the inner wall of the sub-lumen 80 is suppressed. That is particularly important.

As described above, when the catheter 100 is bent, the distance between the peripheral wall of the sub-lumen 80 in the radial direction of the main lumen 20 and the operation line 70 is increased. On the other hand, the peripheral wall of the sub-lumen 80 on the circumferential direction side of the main lumen 20 slightly approaches the operation line 70. Thereby, the distance from the center of the sub-lumen 80 to the peripheral wall of the sub-lumen 80 becomes relatively uniform. For example, the cross-sectional shape of the sub-lumen 80 is a substantially circular shape. Therefore, the operation line 70 in the hollow tube 82 can be freely moved in the sub-lumen 80, and the operability of the operation line 70 is improved. Since a body cavity such as a blood vessel is bent three-dimensionally, the bent catheter 100 may be bent further in various directions. In the present embodiment, even when the catheter 100 is bent, the operation line 70 in the hollow tube 82 can be freely moved in the sub-lumen 80, which is very useful.

Here, the operability of the conventional catheter will be described with reference to FIG.
FIG. 11 discloses a cross-sectional view orthogonal to the longitudinal direction of the catheter 900 disclosed in Patent Document 1.
As shown in FIG. 11A, the catheter 900 has a spaghetti tube 901 that partitions a wire lumen (sublumen), and a deflection wire 902 is inserted into the spaghetti tube 901. In Patent Document 1, a pressurized fluid is supplied into the spaghetti tube 901 at the time of manufacture to prevent the spaghetti tube 901 from collapsing. Therefore, the cross-sectional shape orthogonal to the longitudinal direction of the spaghetti tube 901 is a circle.
When such a catheter 900 is bent, the cross-sectional shape of the bent portion is as shown in FIG. In the inner portion of the bent portion, the resin constituting the catheter 900 expands, the spaghetti tube 901 extends in the radial direction perpendicular to the circumferential direction of the main lumen, and the width in the circumferential direction of the main lumen becomes narrow. Therefore, the turning wire 902 can easily come into contact with the spaghetti tube 901. Therefore, friction is generated between the turning wire 902 and the spaghetti tube 901, and the operability of the turning wire is deteriorated when the catheter is bent. Even if the deflecting wire 902 does not contact the spaghetti tube 901 with the catheter 900 bent, the deflecting wire 902 is difficult to move in the width direction of the spaghetti tube 901. The operability of 902 is deteriorated.
On the other hand, when the catheter 900 is bent, the operability of the turning wire 902 is not deteriorated, so that the inner diameter of the circular spaghetti tube 901 needs to be larger than the diameter of the turning wire 902. As a result, the diameter of the catheter 900 is increased.
In contrast, as described above, the catheter 100 of the present embodiment has good operability of the operation line 70 while keeping the diameter of the catheter 100 small even when the catheter 100 is bent.

Further, in the present embodiment, the hollow tube 82 constituting the sub-lumen 80 is made of a material having a higher tensile elastic modulus and bending rigidity than the outer layer 12. In addition, the cross-sectional shape orthogonal to the longitudinal direction of the sub-lumen 80 is a flat shape that is flat in the circumferential direction of the main lumen 20. In other words, the cross-sectional shape of the sub-lumen 80 is such that the length in the circumferential direction of the main lumen 20 is long, although the length in the radial direction of the main lumen 20 that is substantially orthogonal to the circumferential direction of the main lumen 20 is short.
Therefore, the rigidity is increased with respect to the force along the circumferential direction of the main lumen 20, specifically, the force that twists the sheath 10, as compared with the case of forming a sub-lumen having a circular cross section as in the past. be able to. Thereby, the torsional rigidity of the sheath 10 is increased, and the sheath 10 can be prevented from being locally twisted.
In particular, the sub-lumen 80 is twisted by setting A / B to 1.2 to 4 when the circumferential length of the main lumen 20 is A and the radial length of the main lumen 20 is B. The above-mentioned effect that can be prevented can be exhibited remarkably.

Moreover, in this embodiment, in the cross section orthogonal to the longitudinal direction of the sub-lumen 80, among the peripheries that define the sub-lumen 80, an inner peripheral edge located on the main lumen 20 side and an outer peripheral edge located on the sheath outer peripheral side are In addition, the outer surface of the sheath 10 is curved in a convex arc shape. By setting the cross-sectional shape of the sub-lumen 80 to such a shape, the distance r from the center C of the main lumen 20 to the operation line 70 is almost equal even when the position of the operation line 70 varies as shown in FIG. It will be the same. Therefore, regardless of the position of the operation line 70, the force when operating the operation line 70 can be made substantially the same, and the catheter 100 with high operability can be obtained.

Furthermore, in this embodiment, the sub-lumen 80 is partitioned using the hollow tube 82. In order to make the cross-sectional shape of the sub-lumen 80 flat, the circular hollow tube 82 may be crushed in the radial direction of the main lumen 20, so that the flat sub-lumen 80 can be easily formed.
In particular, the hollow tube 82 is mainly made of a relatively soft material such as polytetrafluoroethylene (PTFE), perfluoroalkoxy fluororesin (PFA), or tetrafluoroethylene / hexafluoropropylene copolymer (FEP). Since the material included as a component is used, the hollow tube 82 can be easily crushed to form a flat-shaped sub-lumen 80.

In this embodiment, when the catheter 100 is manufactured, the core wire 90 is disposed in the circular hollow tube 82, and then the hollow tube 82 is crushed into a flat shape. Thereafter, the operation wire 70 having a diameter smaller than that of the core wire 90 is inserted into the hollow tube 82. Thereby, a gap can be reliably formed between the inner wall of the hollow tube 82 having a flat shape and the operation line 70, and the catheter 100 can be easily operated.

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 embodiment, one of the two operation lines and the two sub-lumens 80 (80a, 80b) is selected as one operation line 70 (the first operation line 70a or the second operation line 70b). However, the present invention is not limited to this. That is, as described above, three or more operation lines 70 may be inserted into the sheath 10 and then one or two or more of them may be pulled. Further, the distal end portions 71 (71a, 71b) of the two operation lines 70 (70a, 70b) are separately fixed to the distal end DE of the sheath 10, but one continuous operation line is used. Then, both ends may be wound around a dial type operation unit, and the towing direction and the amount of towing may be adjusted by operating the dial.

Moreover, although the said medical device was used as the catheter, it is not restricted to this.
Furthermore, in the above-described embodiment, the hollow tube 82 is inserted into the hollow portion formed in the outer layer 12 during the manufacturing method of the catheter 100. However, the present invention is not limited to this. For example, the outer circumferential surface of the outer layer 12 may be cut out to form a groove, and the hollow tube 82 may be inserted into the groove.
In the above embodiment, the core wire 90 in the hollow tube 82 is replaced with the operation line 70 when the catheter 100 is manufactured. However, the core wire 90 may be used as the operation line.

Furthermore, in the said embodiment, after manufacturing the hollow tube 82, the core wire 90 was inserted, However, The insertion method of the core wire 90 is not restricted to this.
For example, the hollow tube 82 is extruded (coating extrusion) so as to cover the core wire 90, and then both ends of the core wire 90 are pulled to expand the core wire 90 and reduce the diameter. Remove completely. As a result, the core wire 90 is loosely inserted into the hollow tube 82.
Then, what is necessary is just to insert the hollow tube 82 in the hollow part (or groove | channel mentioned above) formed in the outer layer 12. FIG.
Further, the hollow tube 82 is extruded (coating extrusion) so as to cover the core wire 90, and then the hollow portion (or the groove described above) formed in the outer layer 12 as in the above embodiment. Insert into. Next, the both ends of the core wire 90 are pulled, the core wire 90 is extended and reduced in diameter, and the core wire 90 is completely peeled off from the hollow tube. The core wire 90 may be loosely inserted into the hollow tube 82.
By doing in this way, the process which inserts the core wire 90 in the hollow tube 82 can be skipped, and the productivity of a catheter can be improved.

Furthermore, in the above-described embodiment, the cross-sectional shape of the four sub-lumens 80 is a flat shape. However, for example, the cross-sectional shape of the sub-bloom 80 in which the operation line 70 is not inserted may not be a flat shape, and may be a circular shape. There may be.

10 Sheath (Tubular body)
11 Inner layer 12 Outer layer (main part)
15 distal end portion 16 intermediate portion 17 proximal end portion 20 main lumen 30 reinforcing layer 31 coil 40 marker 50 coat layer 60 operation portion 61 shaft portion 62 handle portion 63 gripping portion 64 slider 64a slider 64b slider 70 operation line 70a first Operation line 70b Second operation line 71 Tip 71a Tip 71b Tip 72 Fine wire 80 Sublumen 80a Sublumen 80b Sublumen 82 Hollow tube 82a Hollow tube 82b Hollow tube 90 Core wire 91 Heat-shrinkable tube 100 Catheter 900 Catheter 901 Spaghetti tube 902 turning wire CE proximal end DE distal end M mandrel PE proximal end

Claims

A tubular body formed with a main lumen and a sub-lumen disposed around the main lumen and extending along a longitudinal direction of the main lumen;
An operating line disposed within the sublumen and having a distal end secured to the distal end of the tubular body;
The operation line has a circular cross section perpendicular to the longitudinal direction,
Or
The operation line is a stranded wire formed by twisting a plurality of thin wires having a circular cross section perpendicular to the longitudinal direction,
A medical device in which a cross-sectional shape of the sublumen orthogonal to the longitudinal direction is a flat shape flat in a circumferential direction of the main lumen.
The medical device according to claim 1,
The operation line is slidably inserted into the sub-lumen (slidable),
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 1 or 2,
In the cross-sectional shape of the sub-lumen that is orthogonal to the longitudinal direction, the length in the circumferential direction of the main lumen is A, and the length in the radial direction of the main lumen that is orthogonal to the circumferential length A of the main lumen is B. If
A medical device having A / B of 1.2 or more and 4 or less.
The medical device according to any one of claims 1 to 3,
The tubular body is
A tubular main body made of resin in which the main lumen is formed;
A medical device provided with the hollow tube which is provided in the main-body part, divides the sub-lumen, and a cross-sectional shape orthogonal to the longitudinal direction is a flat shape flat in the circumferential direction of the main lumen.
The medical device according to claim 4,
The said hollow tube is a medical device comprised with the material whose tensile elasticity modulus is higher than the said main-body part.
The medical device according to claim 4 or 5,
The hollow tube is a medical device containing one or more of the group consisting of polytetrafluoroethylene, perfluoroalkoxy fluororesin, and tetrafluoroethylene / hexafluoropropylene copolymer as a main component.
The medical device according to any one of claims 1 to 6,
In the cross section perpendicular to the longitudinal direction, of the peripheral edges that define the sub-lumen, an inner peripheral edge located on the main lumen side and an outer peripheral edge located on the outer peripheral side of the tubular body face the outer peripheral side of the tubular body. Medical devices that are curved in a convex shape.
The medical device according to any one of claims 1 to 7,
The medical device is a medical device that is a catheter.
Around the main lumen formation area of the resin tubular body,
A sub-lumen having a circular cross section perpendicular to the longitudinal direction is formed, and a hollow tube having a core wire loosely inserted therein is disposed.
Heating the main body and the hollow tube, pressurizing the main body and the hollow tube from the outside in the radial direction of the main body, and making the shape of the cross section of the sublumen flat And a method for manufacturing a medical device.
The method of manufacturing a medical device according to claim 9,
In the step of setting the hollow tube around the main lumen forming region,
While extruding the material constituting the hollow tube, the fluid is discharged to the material, forming a hollow portion to form a hollow tube,
The manufacturing method of the medical device which inserts the said core wire in the said hollow part of the obtained hollow tube.
The method of manufacturing a medical device according to claim 9,
In the step of setting the hollow tube around the main lumen forming region,
Extrude the material constituting the hollow tube so as to cover the core wire,
Thereafter, the core wire is stretched and reduced in diameter, and the core wire is peeled off from the hollow tube so that the core wire is loosely inserted into the hollow tube.
The method of manufacturing a medical device according to claim 11,
In the step of setting the hollow tube around the main lumen forming region,
Extrude the material constituting the hollow tube so as to cover the core wire,
Insert the hollow tube into the hole or groove formed in the main body,
Thereafter, the core wire is stretched, reduced in diameter, peeled off from the hollow tube, and the core wire is loosely inserted into the hollow tube.
In the manufacturing method of the medical device in any one of Claims 9 thru | or 12,
After the step of making the cross-sectional shape of the sublumen a flat shape,
The core wire is removed from the sub-lumen and a process of inserting an operation line into the sub-lumen is performed.
The operation line has a circular cross section perpendicular to the longitudinal direction,
Or
The operation line is a stranded wire formed by twisting a plurality of thin wires having a circular cross section perpendicular to the longitudinal direction,
The diameter of the said core wire is a manufacturing method of a medical device larger than the diameter of the said operation wire.