JP2021045498A - Medical equipment and medical equipment production method - Google Patents

Abstract

To provide medical equipment capable of smoothly bending a tip part of a sheath, and a production method thereof.SOLUTION: Medical equipment (catheter) is equipment comprising a sheath (tubular body 10) which has therein, a reinforcement layer 11 and an operation wire 12 and is formed into a tube shape. The reinforcement layer 11 is formed into a mesh-state, a tip part 12a of the operation wire 12 is fixed to the tip part 10a of the sheath, and when a base end part 12b is drawn, the sheath can be bent. The reinforcement layer 11 comprises: a plurality of first meshes (small meshes 11b); and a plurality of second meshes (large meshes 11d) larger than the first meshes. The plurality of second meshes is arranged in linear or spiral state, for forming a virtual line, and the operation wire 12 is provided along the virtual line.SELECTED DRAWING: Figure 2

Description

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

Various long medical devices such as catheters and endoscopes that introduce media and devices into the body cavity are known. In recent years, not only endoscopes but also catheters have been provided in which the direction of entry into the body cavity can be manipulated by bending the distal end portion.

For example, in Patent Document 1, two wire lumens (described as sublumens) having a smaller diameter are provided around a central lumen (hereinafter referred to as a main lumen) by 180 degrees facing each other. A catheter (also referred to as a sheath) is described. A turning wire (hereinafter referred to as an operation line) is inserted inside this sublumen, and the tip of the catheter can be bent by operating the operation handle on the proximal end side to pull the operation line. ing.

In the catheter of Patent Document 1, two polymer tubes having sublumens (hereinafter referred to as subtubes) are laid along the outer surface of a thin inner layer made of a fluororesin material or the like. An operation line is inserted inside the sub-tube, and a reinforcing wire knitting body (hereinafter referred to as a reinforcing layer) impregnated with an outer layer is arranged around the sub-tube.

Japanese Unexamined Patent Publication No. 2006-192269

The reinforcing layer is preferably used to reinforce the sheath and prevent the sheath from kinking. However, the reinforcing layer increases the rigidity of the sheath, so that the tip of the sheath is towed by the user on the operation line. It was difficult to improve the flexion responsiveness of the part.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a medical device and a method for manufacturing a medical device capable of smoothly bending the tip of the sheath.

The medical device according to the present invention is a medical device having a reinforcing layer and an operation line inside and having a sheath formed in a tube shape, and the reinforcing layer is formed in a mesh shape, and the operation is performed. The tip of the wire is fixed to the tip of the sheath, and the sheath can be bent by pulling the base end, and the reinforcing layer has a plurality of first meshes and the first mesh. It is configured to have a plurality of second meshes larger than one mesh, and the plurality of second meshes are arranged in a straight line or a spiral shape to form a virtual line. The operation line is characterized in that it is arranged along the virtual line.

The medical device manufacturing method according to the present invention is the medical device manufacturing method, in which the sheath includes an inner layer and an outer layer, and the reinforcing layer is formed by winding a plurality of windings. In the reinforcing layer forming step, the step of arranging the operating line and the step of forming the reinforcing layer so that the virtual line overlaps the operating line are provided. It is characterized in that the plurality of windings are wound so that the reinforcing layer has the plurality of the first mesh and the plurality of the second mesh.
Here, "the virtual line overlaps the operation line" means that the virtual line overlaps the radial outside and / or inside of the tubular body with respect to the operation line. As will be described later, in the embodiment shown in FIG. 2, the reinforcing layer 11 is provided on the outer side in the radial direction via the sub tube 14 with respect to the operation line 12.

According to the present invention, since the rigidity of the bent portion of the sheath is reduced, the sheath can be smoothly bent by pulling the operation line.

(A) is a plan view of the catheter according to the embodiment of the present invention. (B) is a plan view of a catheter showing a state in which the wheel operating portion is operated in one direction. (C) is a plan view of a catheter showing a state in which the wheel operating portion is operated in the other direction. It is a vertical sectional view which includes the axis of the tubular body in the distal part of the tubular body. It is a side view which shows the reinforcing layer. The method of forming the reinforcing layer is a schematic explanatory view showing the reinforcing layer developed in a plane, and FIG. 1A is a small winding unit in which the first winding unit and the second winding unit are wound so as to intersect with each other. It is a figure which shows typically the state which formed the mesh. FIG. (B) is a diagram schematically showing a state in which a medium mesh and a large mesh are formed by removing one wire from each of the first winding unit and the second winding unit. When a bending load was applied to the tubular body when (0) the wires were not thinned at all for the sheath provided with the reinforcing layer, (1) the bending load was applied from the center of the tubular body to the part without the virtual line. It is a stress-strain diagram when and (2) a bending load is applied from the center of the tubular body to the virtual line side. It is a side view which shows the reinforcing layer which concerns on a modification. It is a vertical cross-sectional view perpendicular to the axis of the tubular body in the tubular body which concerns on a modification.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
It should be noted that the embodiments described below are merely examples for facilitating the understanding of the present invention, and do not limit the present invention.
That is, the shapes, dimensions, arrangements, quantities, etc. of the members described below can be changed and improved without departing from the gist of the present invention, and it goes without saying that the present invention includes equivalents thereof. is there.

It should be noted that the various components of the present invention do not have to be individually independent, that the plurality of components are configured as a single component, and that one component is divided into a plurality of components. It is allowed that a certain component is a part of another component, a part of a certain component overlaps with a part of another component, and the like.
Further, in all the drawings, similar components are designated by the same reference numerals, and duplicate description will be omitted as appropriate.

<Overview>
First, an outline of the catheter 100 according to the present embodiment will be described with reference to FIGS. 1 to 3.
FIG. 1A is a plan view of the catheter 100 according to the embodiment of the present invention. FIG. 1B is a plan view of the catheter 100 showing a state in which the wheel operating portion 92 is operated in one direction. FIG. 1C is a plan view of the catheter 100 showing a state in which the wheel operating portion 92 is operated in the other direction. FIG. 2 is a vertical cross-sectional view including an axis of the tubular body 10 in the distal portion DE of the tubular body 10, and FIG. 3 is a side view showing the reinforcing layer 11.
Note that FIG. 2 is a vertical cross-sectional view of the mesh intersection portion of the wires 11a constituting the reinforcing layer 11.
Further, in FIG. 2, the non-uniformity of the pitch interval related to the difference in the winding conditions of the wire 11a is not shown. That is, in FIG. 2, for convenience, the state in which all of the multiple wires 11a form intersections is shown as the reinforcing layer 11.

As shown in FIG. 2, the medical device (catheter 100) according to the present embodiment is provided with a reinforcing layer 11 and an operation line 12 inside, and has a sheath (tubular body 10) formed in a tubular shape. is there. The reinforcing layer 11 is formed in a mesh shape.
The tip portion 12a of the operation line 12 is fixed to the tip portion 10a of the sheath (tubular body 10), and the sheath (tubular body 10) can be bent by pulling the base end portion 12b.
As shown in FIG. 3, the reinforcing layer 11 has a plurality of first meshes (small mesh 11b or medium mesh 11c) and a plurality of second meshes (medium mesh 11c or large mesh 11d) larger than the first mesh. The virtual lines LA and LB are formed by arranging a plurality of second meshes (medium mesh 11c or large mesh 11d) side by side in a straight line or a spiral. The operation line 12 is characterized in that it is arranged along the virtual lines LA and LB.

According to the above configuration, since the operation line 12 is arranged along the virtual line LA formed by arranging the second meshes, the operation line 12 is drawn when the tip portion 10a of the tubular body 10 is deformed. As a result, the rigidity of the bent portion of the tubular main body 10 that bends can be reduced.
Specifically, a virtual line is provided in which a portion having a lower rigidity (a region having a second mesh) than a part region in the circumferential direction (a region having a first mesh) extends linearly or spirally. It will form an LA. Then, the operation line 12 provided along the virtual line LA allows the tip portion 10a of the tubular body 10 to be smoothly bent while preventing kinking with a small bending stress.

In the "medical device" according to the present invention, in addition to the catheter 100 for angiography, the orientation of the tip of the sheath can be adjusted by a delivery device such as a stent (not shown) or an endoscope (not shown). Equipment is included.
When the present invention is applied to an endoscope, a stent delivery device, or the like having a tubular body having a diameter generally larger than that of the tubular body 10 of the catheter 100 and having high rigidity, the rigidity of the tubular body can be effectively reduced. It is possible to bend the tubular body more effectively.

Specifically, the compressive load on the inside of the sheath or the tensile load on the outside, which is generated when the tip of the sheath is bent, increases as the diameter of the sheath increases. With the configuration of the reinforcing layer 11, the rigidity inside and / or outside the bent portion of the tubular body 10 can be reduced, so that the tubular body 10 is easily deformed, and in a medical device having a large-diameter tubular body 10. , Can produce a higher effect.

The "first mesh" and the "second mesh" in the present invention are those in which the smaller one is the first mesh and the larger one is the second mesh when comparing arbitrary two sizes. For example, in the present embodiment, when the small mesh 11b is the first mesh, the medium mesh 11c or the large mesh 11d can be the second mesh. When the middle mesh 11c is the first mesh, the large mesh 11d is the second mesh.

<Overall configuration and bending operation>
Hereinafter, the present embodiment will be described in detail. First, with reference mainly to FIGS. 1 and 2, the overall configuration of the catheter 100 of the present embodiment and the bending operation of the distal portion DE of the tubular body 10 included in the catheter 100 will be described.
The catheter 100 of the present embodiment is an intravascular catheter used by inserting a tubular body 10 into a blood vessel.
The catheter 100 communicates with a long tubular main body 10, a main body case 94, an operation portion 90 that pulls an operation line 12 to bend a distal portion DE of the tubular main body 10, and a main lumen 20 of the tubular main body 10. The hub 96 is mainly provided.
By injecting the drug solution or the like into the hub 96, the drug solution or the like can be supplied into the body cavity of the patient via the main lumen 20.

<Bending operation>
The operation unit 90 is provided at the base end portion of the tubular main body 10 and individually pulls a plurality of operation lines 12 (see FIG. 2). The operation unit 90 has a main body case 94 that the user grips by hand, and a wheel operation unit 92 that is rotatably provided with respect to the main body case 94.
The base end portion of the tubular main body 10 is introduced inside the main body case 94. The base end portion of the operation line 12 drawn from each of the two sub-tubes 14 is connected to the wheel operation portion 92.

By rotating the wheel operating unit 92 in either direction, one operating line 12 can be pulled toward the proximal end side to apply tension and loosen the other. As a result, the towed operation line 12 bends the distal portion DE of the tubular body 10 (see FIGS. 1 (b) and 1 (c)).
Here, the bending of the tubular body 10 includes a mode in which the tubular body 10 is bent in a "dogleg" shape and a mode in which the tubular body 10 is curved in a bow shape.

In this way, by selectively pulling the two operation lines 12 by the operation of the operation unit 90 with respect to the wheel operation unit 92, the distal portions DE of the tubular body 10 are included in the first or the same plane with each other. It can be selectively bent in the second direction.

By rotating the operation unit 90 around the axis of the tubular body 10, the distal portion DE of the tubular body 10 can be torque-rotated at a predetermined angle. By combining the operation of the wheel operation unit 92 and the rotation of the entire axis of the operation unit 90, the orientation of the distal portion DE of the catheter 100 can be freely controlled.

<Structure of tubular body>
Next, the configuration of the tubular main body 10 will be described with reference to FIG. 3 in addition to FIG. FIG. 3 is a side view showing the reinforcing layer 11.
The tubular body 10 is also called a sheath, and is a hollow tubular and long member having a main lumen 20 formed therein.

The sheath (tubular body 10) includes a tubular inner layer 15, a sub tube 14 arranged outside the inner layer 15, a reinforcing layer 11 provided on the outside of the sub tube 14, and a reinforcing layer 11 and a sub tube 14. It is formed including an outer layer 16 made of a resin containing the above.
The tubular body 10 may be configured by laminating more layers (for example, a reinforcing layer). In particular, when the strength of the inner layer 15 is low, it is preferable that a reinforcing layer is formed around the inner layer 15.

A ring-shaped marker 13 is provided on the distal DE of the tubular body 10. The marker 13 is for visually recognizing the position of the tip of the tubular body 10 in the body cavity (blood vessel) under radiation (X-ray) observation, and is made of a material such as platinum that is opaque to radiation such as X-rays. ing.

The inner layer 15 and the outer layer 16 are made of a flexible resin material, and each has a circular tubular shape and a substantially uniform thickness.
The inner layer 15 is the innermost layer of the tubular body 10, and the main lumen 20 is defined by the inner wall surface thereof. Examples of the material of the inner layer 15 include a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy alkane resin (PFA).

As the material of the outer layer 16, a thermoplastic polymer material can be used. Examples of the thermoplastic polymer material include polyimide (PI), polypropyleneimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), and polyether blockamide (PEBA). Nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP) can be mentioned.

Inside the outer layer 16, a sub tube 14 and a reinforcing layer 11 described later are provided. The sub-tube 14 extends along the axial direction of the tubular body 10 so as to come into contact with a part of the outer peripheral surface of the inner layer 15. The operation line 12 is arranged in the sub tube 14, the operation line 12 is movably inserted inside the sub tube 14, and the tip portion 12a thereof is connected to the distal portion DE of the tubular body 10. There is.

The tip portion 12a of the operation line 12 according to the present embodiment is fixed to the inner peripheral surface of the marker 13. The tip portion 12a may be fixed to the outer peripheral surface of the marker 13. By pulling the operation line 12, the distal DE is bent. The mode of fixing the operation line 12 to the marker 13 is not particularly limited, and examples thereof include solder bonding, heat welding, laser welding, adhesion by an adhesive, and mechanical hooking of the operation line 12 and the marker 13.
The operation line 12 is slidably loosely inserted with respect to the sub tube 14. By pulling the operation line 12 toward the base end side, a tensile force is applied to a position eccentric with respect to the axial center of the tubular body 10, so that the tubular body 10 bends.

As the operation wire 12, low carbon steel (piano wire), stainless steel (SUS), corrosion-resistant coated steel wire, titanium or titanium alloy, or a metal wire such as tungsten can be used. In addition, as the operation line 12, polyvinylidene fluoride (PVDF), high-density polyethylene (HDPE), poly (paraphenylene benzobisoxazole) (PBO), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), etc. Polymer fibers such as polybutylene terephthalate (PBT), polyimide (PI), polytetrafluoroethylene (PTFE), or boron fiber can be used.

<Reinforcing layer>
Next, the reinforcing layer 11 according to the present embodiment will be described with reference to FIG. 4 in addition to FIGS. 2 and 3.
FIG. 4 is a schematic explanatory view showing a method of forming the reinforcing layer 11 by expanding the reinforcing layer 11 in a plane, and FIG. 4A shows a first winding unit 17 and a second winding unit. It is a figure which shows typically the state which formed the small mesh 11b by winding so that 18 intersects. FIG. 4B is a diagram schematically showing a state in which the middle mesh 11c and the large mesh 11d are formed by removing one wire 11a from each of the first winding unit 17 and the second winding unit 18. is there.

The reinforcing layer 11 is a layer of the tubular body 10 that is provided radially outside the operation line 12 (sub tube 14) and has a function of fixing the sub tube 14 to the inner layer 15, and is a layer that has the function of fixing the sub tube 14 to the inner layer 15. It is arranged coaxially. The presence of the reinforcing layer 11 radially outside the operation line 12 prevents the operation line 12 from breaking the sub-tube 14 and the outer layer 16 and being exposed to the radial outside of the tubular body 10.

The reinforcing layer 11 is formed of a plurality of windings (wires 11a) braided in a mesh shape wound around the inner layer 15. “Around the inner layer 15” means “around the inner layer 15” and does not mean that it is in direct contact with the inner layer 15. Actually, the reinforcing layer 11 according to the present embodiment is formed on the outer side of the inner layer 15 via the sub tube 14.
The material of the wire 11a includes metal materials such as tungsten (W), stainless steel (SUS), nickel-titanium alloy, steel, titanium, copper, titanium alloy or copper alloy, as well as shear strength higher than that of the inner layer 15 and the outer layer 16. A resin material such as polyimide (PI), polyamideimide (PAI) or polyethylene terephthalate (PET) having a high value can be used. In the present embodiment, the wire 11a is a thin stainless steel wire.

As described above, the reinforcing layer 11 has a plurality of first meshes (small mesh 11b or middle mesh 11c) and a plurality of second meshes (medium mesh 11c or medium mesh 11c) larger than the first mesh (small mesh 11b or middle mesh 11c). It is configured to have a large mesh 11d).

In the present embodiment, the small mesh 11b and the large mesh 11d are formed in a similar rhombic shape, and the area of the large mesh 11d is four times the area of the small mesh 11b.
The middle mesh 11c is formed in a parallel quadrilateral shape, and its area is twice the area of the small mesh 11b.

As shown in FIG. 3, a plurality of second meshes (large meshes 11d) are arranged in a straight line to form a virtual line LA. That is, the virtual line LA passing through the plurality of second meshes (large mesh 11d) extends linearly.
According to the above configuration, the rigidity of the tubular body 10 is locally reduced by extending the virtual line LA in a straight line, and the reinforcing layer is provided so that the virtual line LA overlaps the sub tube 14 (operation line 12). By disposing the 11, the tubular main body 10 can be smoothly bent by pulling the operation line 12 on the virtual plane including the operation line 12 and the virtual line LA.

Further, a plurality of second meshes (middle meshes 11c) formed by the method shown in FIG. 4 are arranged side by side to form a virtual line LB. This virtual line LB extends spirally when viewed three-dimensionally.
According to the above configuration, the rigidity of the tubular body 10 can be locally reduced by extending the virtual line LB in a spiral shape. For example, when the operation line 12 is arranged in a spiral shape and the virtual line LB is arranged so as to overlap the operation line 12 and the operation line 12 is pulled to the proximal side, the tubular body 10 is smoothly bent while being twisted. Can be made to. In the present embodiment, since the two virtual lines LB are formed, the operation line 12 may be arranged along at least one virtual line LB.

The virtual line LA includes a first line LA1 at the first position and a second line LA2 at a position 180 degrees off the first position about the axis of the sheath (tubular body 10).
The operation line 12 is arranged along at least one of the first line LA1 and the second line LA2 (both in the present embodiment).
When the tubular body 10 is bent by pulling the operation line 12, the inside of the bent portion is compressed and the outside is extended.

According to the above configuration, at least two virtual lines (first line LA1 and second line LA2) are positioned 180 degrees apart, and the operation line 12 is two virtual lines (first line LA1 and second line LA1). By being arranged along at least one of LA2), the rigidity inside and / or outside the bent portion can be reduced. Therefore, the tubular body 10 is easily deformed, and the tubular body 10 can be smoothly bent.

As a method of forming the reinforcing layer 11 according to the present embodiment, first, as shown in FIG. 4A, the first winding unit 17 of Article 8 is wound in one direction in the circumferential direction and intersects the first winding unit 17. In the circumferential direction, the second winding unit 18 of Article 8 is wound in the opposite direction to one direction.
In this way, the first winding unit 17 and the second winding unit 18 are wound so as to intersect each other to form the fine mesh 11b.
Next, as shown in FIG. 4B, the wires 11a are removed one by one from each of the first winding unit 17 and the second winding unit 18 to form the middle mesh 11c and the large mesh 11d.
Note that FIG. 4 is a diagram for explaining the reinforcing layer 11 in an expanded manner. In FIG. 4, the first winding unit 17 and the second winding unit 18 extend linearly and are extended only once as a whole. Although they intersect, they are actually arranged so as to extend spirally and intersect many times.

As shown in FIG. 4B, the plurality of windings (wires 11a) according to the present embodiment have different second windings that intersect the first winding unit 17X that is wound in the first direction. It constitutes a second winding unit 18X that is wound in a direction.
The first winding unit 17X and the second winding unit 18X each have at least a part of adjacent windings (wires 11a) spaced apart from the other adjacent windings (wires 11a). A mesh (small mesh 11b or medium mesh 11c) and a second mesh (medium mesh 11c or large mesh 11d) are formed.
In the present embodiment, as much as one wire 11a is removed from each of the first winding unit 17 and the second winding unit 18, the distance between the wires 11a on both sides thereof is increased by the other adjacent wires 11a. It is larger than the interval of.

According to the above configuration, the distance between at least a part of the adjacent wires 11a in each of the first winding unit 17X and the second winding unit 18X is different from the distance between the other adjacent wires 11a. The second mesh can be easily formed.

In the reinforcing layer 11 of the present embodiment, seven wires 11a of 14 threads are spirally wound in the opposite direction in the circumferential direction and braided, and seven intersections of the wires 11a are formed in the circumferential direction of the inner layer 15. Has been done.
That is, the seven wires 11a are wound in a right spiral from the tip of the tubular body 10 toward the base end, and the other seven wires 11a are wound in a left spiral.
The right-handed spiral means winding in the right-handed screw direction with the direction from the tip end to the base end of the tubular body 10 as the spiraling direction. The left spiral means winding in the left screw direction with respect to this spiral direction.

Here, when the number of wires 11a of the right spiral and the wire 11a of the left spiral are the same and the winding pitches are the same, the intersections of the meshes of the wires 11a are aligned in a straight line in the axial direction of the tubular body 10.
Therefore, depending on the delicate positional relationship between the sub-tube 14 and the reinforcing layer 11, the sub-tube 14 may be arranged directly above so as to connect the intersections of the meshes, or conversely, may be arranged so as not to overlap the intersections of the meshes at all. To do.

The reinforcing layer 11 is formed by winding multiple wires 11a around the inner layer 15 so as to intersect each other at an angle. The angle formed by the extending direction of the wire 11a with respect to the radial direction of the inner layer 15 is referred to as the pitch angle of the wire 11a. When the wires 11a are wound at a dense pitch, the pitch angle becomes a small angle. On the contrary, when the wire 11a is wound at a shallow angle along the axis of the tubular body 10, the pitch angle becomes a large angle close to 90 degrees.
The pitch angle of the wire 11a of the present embodiment is not particularly limited, but is set to about 10 degrees.

<Bending characteristics of tubular body>
Next, the bending characteristics of the tubular main body 10 will be described with reference mainly to FIG.
FIG. 5 shows (1) virtual from the center of the tubular body 10 when a bending load is applied to the tubular body 10 when (0) the wires 11a are not thinned out at all with respect to the tubular body 10 provided with the reinforcing layer 11. It is a stress-strain diagram when a bending load is applied to a portion without a line LA, and (2) a bending load is applied from the center of the tubular body 10 to the virtual line LA side.
When the wires 11a are not thinned at all when the reinforcing layer 11 is formed, that is, when the middle mesh 11c and the large mesh 11d are not formed and only the small mesh 11b is formed, the bending characteristic of the tubular body 10 is As shown in FIG. 5 (0), the flexural modulus was 10 MPa, the maximum bending stress was 325 kPa, and the bending strength bending strain (bending strain corresponding to the maximum bending stress) was 13.2%.

On the other hand, when the wires 11a are thinned one by one from the first winding unit 17 and the second winding unit 18, the bending characteristics from the center of the tubular body 10 to a position deviated from the virtual line LA by 90 degrees are shown in FIG. As shown in (1), the flexural modulus was 8.4 ± 0.4 MPa, the maximum bending stress was 300 ± 17 kPa, and the bending strength bending strain was 15.3 ± 0.7%.
The bending characteristics from the center of the tubular body 10 to the virtual line LA side are as shown in FIG. 5 (2), with a flexural modulus of 7.6 ± 0.4 MPa, a maximum bending stress of 276 ± 2 kPa, and bending. The strength bending strain was 14.7 ± 1.2%.

As a result, it can be seen that the flexural modulus differs between the virtual line LA side and the position deviated by 90 degrees from the virtual line LA, and the virtual line LA side is easier to bend.
In addition, it can be seen that by thinning out, the bending strength and bending strain become larger than in the case where thinning is not performed.
Further, at the position deviated by 90 degrees from the virtual line LA shown in FIG. 5 (1), more than the case where the wire 11a shown in (0) was not thinned at all with a small bending stress (load). It can be seen that the strain of is applied to the sheath.
On the other hand, the bending strain corresponding to the maximum bending stress at a position 90 degrees away from the virtual line LA shown in FIG. 5 (1) is maintained at the same level as when the wire 11a shown in (0) is not thinned at all. It suggests that there is.
Further, it is suggested that the virtual line LA side shown in (2) can reach the maximum strain with less bending stress (load) than in (0) and (1).
The bending characteristic values are the values of the tubular main body 10 having the reinforcing layer 11 without including the operation line 12 (sub tube 14).

In the above, one wire 11a is pulled out from each of the eight first winding units 17 and the second winding unit 18 wound around the inner layer 15, and the fine mesh 11b, the middle mesh 11c, and the middle mesh 11c are pulled out. It has been described as forming the reinforcing layer 11 having the large mesh 11d. However, it is not limited to such a configuration.

For example, when the reinforcing layer 11 is formed by using a braid having a plurality of bobbins (not shown), the wires 11a are not set on a part of the plurality of bobbins, and the intervals between the adjacent wires 11a are set from the beginning. It may be different so that a mesh of each size is formed at the time of knitting.
That is, the distance between the adjacent windings (wires 11a) of the first winding unit 17X and the second winding unit 18X is formed to be larger than the distance between the other adjacent windings (wires 11a), and the second winding unit 17X and the second winding unit 18X are formed. A mesh (medium mesh 11c and a large mesh 11d) is formed, and a second mesh (medium mesh 11c and / or a large mesh 11d) is periodically formed in the elongated direction of the sheath (tubular body 10). May be good.

According to the above configuration, the middle mesh 11c and / or the large mesh 11d can be easily formed by making the intervals of the wires 11a different. Further, since the middle mesh 11c and / or the large mesh 11d are formed periodically, the virtual lines LA and LB can be easily arranged so as to overlap the operation line 12 (sub tube 14).

<Catheter manufacturing method>
A method for manufacturing a medical device (catheter 100) according to another aspect of the present embodiment includes an operation line arrangement step for arranging the operation line 12, and an operation line 12 (sub tube 14) after the operation line arrangement step. A reinforcing layer forming step of forming the reinforcing layer 11 so that the virtual lines LA (LB) overlap each other is provided.
In the reinforcing layer forming step, a plurality of windings are provided so that the reinforcing layer 11 has a plurality of first meshes (small mesh 11b or medium mesh 11c) and a plurality of second meshes (medium mesh 11c or large mesh 11d). Wind around the inner layer 15.
In the present embodiment, the reinforcing layer 11 is provided on the outer side in the radial direction of the operation line 12 via the sub tube 14.
By providing the sub-tube 14 in this way, the operation line 12 can be slidably and suitably accommodated. However, the present invention is not limited to such a configuration, and if a hole having a wall surface having a strength capable of preventing the operation line 12 from penetrating while slidably passing through the operation line 12 is formed in the outer layer 16, the presence or absence of the sub tube 14 is present. It doesn't matter.

According to the above configuration, a plurality of second meshes (medium mesh 11c or large mesh 11d) are formed so as to form a virtual line LA (LB), and the operation lines 12 are arranged along the virtual line LA (LB). By doing so, the rigidity of the bent portion of the tubular body 10 that is bent by drawing the operation line 12 when the tubular body 10 is deformed is lowered, and the tubular body 10 can be smoothly bent.

As will be described later, when the reinforcing layer 11 is radially inside the operation line 12, the operation line arrangement step may be performed after the reinforcement layer forming step. In this case, the operation line 12 may be arranged so as to overlap the virtual line LA (virtual line LB) of the reinforcing layer 11.
The positions of the virtual lines LA and LB formed by the middle mesh 11c and the large mesh 11d can be determined in advance by the thinning position of the wires 11a at the time of braiding.
Then, regardless of whether the reinforcing layer 11 and the operation line 12 (sub tube 14) are located inside or outside, the reinforcing layer 11 is formed in advance so that the virtual lines LA and LB overlap the operation line 12. can do.

The plurality of windings (wires 11a) include a first winding unit 17X wound in the first direction and a second winding unit 18X wound in different second directions intersecting the first direction. It is configured.
In the reinforcing layer forming step, the distance between at least a part of the adjacent windings (wires 11a) in each of the first winding unit 17X and the second winding unit 18X is the same as the distance between the other adjacent windings (wires 11a). Differently, the winding (wire 11a) is wound around the inner layer 15 to form a first mesh (small mesh 11b or middle mesh 11c) and a second mesh (medium mesh 11c or large mesh 11d).

According to the above configuration, in each of the first winding unit 17X and the second winding unit 18X having different winding directions, the spacing between the adjacent wires 11a is set to be different from the other spacing, and this is wound around the inner layer 15. By turning, a first mesh (small mesh 11b or medium mesh 11c) and a second mesh of different sizes (medium mesh 11c or large mesh 11d) can be formed at the intersection of the wires 11a.

<Modification example>
Next, the tubular main body 10X and the reinforcing layer 11X according to the modified example will be described mainly with reference to FIGS. 6 and 7. FIG. 6 is a side view showing the reinforcing layer 11X according to the modified example, and FIG. 7 is a vertical sectional view of the tubular main body 10X according to the modified example perpendicular to the axis of the tubular main body 10X.
In the above embodiment, the linear virtual line LA is composed of two lines (first line LA1 and second line LA2) provided at positions shifted by 180 degrees with respect to the axis of the tubular body 10. Explained as a thing.

As shown in FIG. 6, there are a total of four virtual lines LA according to this modification at positions shifted by 90 degrees with respect to the axis of the sheath (tubular body 10X) (first line LA1, second line LA2, 3rd line LA3 and 4th line LA4).
Further, as shown in FIG. 7, the operation line 12 (the sub-tube 14 in which the operation line 12 is interpolated) is formed in at least one set of at least adjacent virtual line LAs (for example, the first line LA1 and the fourth line LA4). It is arranged along the line.
When the tubular body 10X is bent, the inside of the bent portion is compressed and the outside is extended. As described above, when the four virtual lines LA are located at positions shifted by 90 degrees, it is possible to reduce the rigidity of the inner and outer sides of the bent portion of the tubular body 10X in the directions included in the two virtual planes.

The two operation lines 12 (sub-tubes 14) are arranged along the adjacent virtual lines (first line LA1 and fourth line LA4), so that the first line LA1 and the second line LA2 The tubular body 10X can be easily bent in the direction included in the virtual plane including the third line LA3 and the tubular body 10X can be easily bent in the direction included in the virtual plane including the third line LA3 and the fourth line LA4.

In addition to pulling the operation line 12 to deform the distal DE of the tubular body 10 (10X), pushing the operation line 12 deforms the distal DE of the tubular body 10 (10X). It may be.
Even with such a configuration, if the virtual line LA is arranged so as to overlap the operation line 12, the distal portion DE of the tubular main body 10 (10X) can be easily deformed. Further, in this case, the operation line 12 may be arranged on the side facing the virtual line LA by 180 degrees with respect to the axis of the tubular main body 10 (10X).

In this example, a configuration in which only two subtubes 14 are arranged at positions overlapping the adjacent virtual line LA has been described, but the configuration is not limited to such a configuration.
The number of operation lines 12 in the sub-tube 14 and the sub-tube 14 can be arbitrarily set. For example, even in a configuration in which one of these is provided at a position overlapping one virtual line LA, 4 One of these may be provided for each of the virtual lines LA of the book.

Further, for example, only the sub tube 14 may be provided along all the virtual lines LA.
That is, while providing four sub-tubes 14 at positions offset by 90 degrees with respect to the axis of the tubular body 10X, and inserting the operation lines 12 into the two adjacent sub-tubes 14, the other two adjacent sub-tubes are inserted. The operation line 12 may not be inserted into the sub-tube 14 of the above.
According to such a configuration, in the tubular main body 10X that bends repeatedly, the rigidity of the tubular main body 10X in the radial direction is balanced, and it is possible to prevent the outer layer 16 from peeling off from the inner layer 15 or the reinforcing layer 11X.

Further, the present invention is not limited to the configuration of the above embodiment, and when there are a plurality of virtual lines LA (LB), the operation line 12 is arranged along a part of the plurality of virtual lines LA (LB). I just need to be there.
At least a part of the plurality of second meshes (medium mesh 11c or large mesh 11d) may be arranged linearly or spirally to form a virtual line LA (LB), and covers the entire tubular body 10. The virtual line is not limited to the one formed at the same angle.

In the above embodiment, it has been described that the reinforcing layer 11 (11X) provided radially outside the sub tube 14 is provided with a mesh of each size, but the present invention is limited to such a configuration. It's not a thing.
For example, a reinforcing layer (not shown) may be provided inside the sub-tube 14 in the radial direction, and a mesh of each size may be provided for the reinforcing layer.
Even with such a configuration, by locally reducing the rigidity of the reinforcing layer inside the sub tube 14 in the radial direction, the tip of the tubular body 10 by the operation line 12 arranged in the sub tube 14 can be formed. , Can be suitably bent with a small bending stress while preventing kinking.

Further, in the above embodiment, it has been described that a mesh of each size is formed by adjusting the number of wires 11a of each of the first winding unit 17X and the second winding unit 18X. Is not limited to such a configuration.
For example, a portion of the braided wire may be manually brought together (in other words, one portion of the wire separated from the other portion) to intentionally form a large mesh and a small mesh.

The above embodiment includes the following technical ideas.
(1) A medical device having a reinforcing layer and an operation line inside and having a sheath formed in a tubular shape.
The reinforcing layer is formed in a mesh shape and has a mesh shape.
The tip of the operation line is fixed to the tip of the sheath, and the sheath can be bent by pulling the base end.
The reinforcing layer is configured to have a plurality of first meshes and a plurality of second meshes larger than the first mesh.
A virtual line is formed by arranging the plurality of second meshes side by side in a straight line or a spiral shape.
The operation line is a medical device characterized in that it is arranged along the virtual line.
(2) The virtual line includes a first line at the first position and a second line at a position 180 degrees away from the first position about the axis of the sheath.
The medical device according to (1), wherein the operation line is arranged along at least one of the first line and the second line.
(3) The medical device according to (1) or (2), wherein the virtual line extends in a straight line.
(4) The medical device according to (1) or (2), wherein the virtual line extends in a spiral shape.
(5) The sheath is formed to include an inner layer and an outer layer.
The reinforcing layer is formed of a plurality of windings wound around the inner layer.
The plurality of windings constitute a first winding unit that is wound in the first direction and a second winding unit that is wound in different second directions that intersect the first direction. ,
The distance between the first mesh and the second mesh is such that the distance between at least a part of the adjacent windings in each of the first winding unit and the second winding unit is different from the distance between the other adjacent windings. The medical device according to any one of (1) to (4) forming a mesh.
(6) The distance between the adjacent windings of the first winding unit and the second winding unit is formed larger than the distance between the other adjacent windings to form the second mesh. The medical device according to (5), wherein the second mesh is periodically formed in the elongated direction of the sheath.
(7) There are a total of four virtual lines at positions offset by 90 degrees with respect to the axis of the sheath.
The medical device according to any one of (1) to (6), wherein the operation line is arranged along at least one set of adjacent virtual lines.
(8) The method for manufacturing the medical device according to any one of (1) to (7).
The sheath includes an inner layer and an outer layer.
The reinforcing layer is formed by winding a plurality of windings.
The operation line arrangement step for arranging the operation line and
A reinforcing layer forming step of forming the reinforcing layer so that the virtual line overlaps the operation line is provided.
A method for manufacturing a medical device, which comprises winding the plurality of windings so that the reinforcing layer has a plurality of the first mesh and a plurality of the second mesh in the reinforcing layer forming step.
(9) The plurality of windings constitute a first winding unit wound in the first direction and a second winding unit wound in different second directions intersecting the first direction. And
In the reinforcing layer forming step, the distance between at least a part of the adjacent windings in each of the first winding unit and the second winding unit is different from the distance between the other adjacent windings. The medical device manufacturing method according to (8), wherein the winding is wound to form the first mesh and the second mesh.

10, 10X tubular body (sheath)
10a Tip 11, 11X Reinforcing layer 11a Wire (winding)
11b Small mesh (1st mesh)
11c Medium mesh (1st mesh or 2nd mesh)
11d large mesh (second mesh)
12 Operation line 12a Tip 12b Base end 13 Marker 14 Subtube 15 Inner layer 16 Outer layer 17, 17X 1st winding unit 18, 18X 2nd winding unit 20 Main lumen 90 Operation part 92 Wheel operation part 94 Main body case 96 Hub 100 catheter (medical device)
DE Distal LA, LB Virtual Line LA1 1st Line LA2 2nd Line LA3 3rd Line LA4 4th Line

Claims (9)

A medical device having a tubular sheath with a reinforcing layer and an operation line inside.
The reinforcing layer is formed in a mesh shape and has a mesh shape.
The tip of the operation line is fixed to the tip of the sheath, and the sheath can be bent by pulling the base end.
The reinforcing layer is configured to have a plurality of first meshes and a plurality of second meshes larger than the first mesh.
A virtual line is formed by arranging the plurality of second meshes side by side in a straight line or a spiral shape.
The operation line is a medical device characterized in that it is arranged along the virtual line. The virtual line includes a first line at the first position and a second line at a position 180 degrees off the first position about the axis of the sheath.
The medical device according to claim 1, wherein the operation line is arranged along at least one of the first line and the second line. The medical device according to claim 1 or 2, wherein the virtual line extends linearly. The medical device according to claim 1 or 2, wherein the virtual line extends in a spiral shape. The sheath is formed to include an inner layer and an outer layer.
The reinforcing layer is formed of a plurality of windings wound around the inner layer.
The plurality of windings constitute a first winding unit that is wound in the first direction and a second winding unit that is wound in different second directions that intersect the first direction. ,
The distance between the first mesh and the second mesh is such that the distance between at least a part of the adjacent windings in each of the first winding unit and the second winding unit is different from the distance between the other adjacent windings. The medical device according to any one of claims 1 to 4, which forms a mesh. The distance between the adjacent windings of the first winding unit and the second winding unit is formed larger than the distance between the other adjacent windings to form the second mesh. The medical device according to claim 5, wherein the second mesh is periodically formed in the elongated direction of the sheath. There are a total of four virtual lines at positions offset by 90 degrees with respect to the axis of the sheath.
The medical device according to any one of claims 1 to 6, wherein the operation line is arranged along at least one set of adjacent virtual lines. The method for manufacturing the medical device according to any one of claims 1 to 7.
The sheath includes an inner layer and an outer layer.
The reinforcing layer is formed by winding a plurality of windings.
The operation line arrangement step for arranging the operation line and
A reinforcing layer forming step of forming the reinforcing layer so that the virtual line overlaps the operation line is provided.
A method for manufacturing a medical device, which comprises winding the plurality of windings so that the reinforcing layer has a plurality of the first mesh and a plurality of the second mesh in the reinforcing layer forming step. The plurality of windings constitute a first winding unit that is wound in the first direction and a second winding unit that is wound in different second directions that intersect the first direction. ,
In the reinforcing layer forming step, the distance between at least a part of the adjacent windings in each of the first winding unit and the second winding unit is different from the distance between the other adjacent windings. The medical device manufacturing method according to claim 8, wherein the winding is wound to form the first mesh and the second mesh.

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