JP6885037B2 - Medical equipment - Google Patents

Description

The present invention relates to a medical device.

Medical devices such as catheters and endoscopes that can pull the operation line and bend the distal portion have been proposed. It is possible to select the insertion direction by bending the distal part inside the body cavity or at the bifurcation point.

As an example of such a medical device, Patent Document 1 describes a catheter provided with a dial operation unit slidably provided on the operation unit main body. Two operation lines branched from the tubular body (sheath) of the catheter are mounted and fixed in opposite directions around the dial operation unit.

Then, by moving the dial operation unit back and forth, it is possible to adjust the tension of the operation line.

Specifically, the operation line can be loosened by moving the dial operation unit to the distal side of the catheter. At this time, the traction regulating portion, which is a protrusion provided on the main body of the operating portion, engages with the recess formed so as to expand radially outward from the vicinity of the center of rotation of the dial operating portion, so that the dial operating portion rotates. Operation is regulated.

Further, by moving the dial operation unit to the proximal side of the catheter, the operation line can be strained. At this time, by disengaging the concave portion of the dial operation portion and the traction regulation portion of the operation portion main body, the dial operation portion can be rotated and the catheter can be used.

The tubular body of the catheter is formed by combining an inner layer and an outer layer made of resin and a metal reinforcing layer that reinforces them. The reinforcing layer is made by braiding fine metal wires in a mesh shape. On the other hand, as the operation wire, a single wire or a stranded wire of a metal wire is used in order to obtain high breaking strength.

Japanese Unexamined Patent Publication No. 2014-188335

By the way, in such a medical device, the tubular body is made of a composite of resin and metal, and the operation line is made of metal. Therefore, the linear expansion coefficient and the expansion coefficient are significantly different between the tubular body and the operation line. Specifically, the tubular body has a coefficient of thermal expansion and a coefficient of swelling about 10 times larger than those of the operation line. For this reason, if the thermal environment or humidity environment of the medical device fluctuates after the assembly and molding of the medical device, a large load is applied to the operation line or the tubular body, and the operation line is broken or the tubular body is plastic before being subjected to the procedure. The present inventor has come up with a new problem that the yield is lowered and the product cannot be used for the procedure due to the bending.

In the manufacturing process of medical devices, a hydrophilic coating layer is formed on the surface of the tubular body under high temperature reaction conditions. In this high temperature environment, the coefficient of thermal expansion of the tubular body is larger than that of the operation line, so tension is applied to the operation line in the tensile direction, and compressive force in the axial direction is applied to the tubular body as its drag force. To.

Here, in the case of a relatively small-diameter medical device, particularly a small-diameter microcatheter that can be inserted into a peripheral blood vessel, the operation line is extremely thin and the tubular body is extremely flexible. Therefore, due to thermal expansion in the heating atmosphere of the medical device, the operation line is easily broken by the above tension, and the tubular body is easily bent laterally by the above compressive force and plastically deformed.

Such thermal expansion is not limited to the formation of the hydrophilic coating layer, but is a problem that can occur in various environments after the assembly and packaging of medical devices, such as during heat sterilization after product completion and in the summer transportation environment. is there.

On the other hand, in the catheter of Patent Document 1, the operation line can be loosened by advancing the dial operation unit when a high temperature is applied, and tension is generated in the operation line even when thermal expansion occurs in the catheter. You can avoid that. Then, when the catheter is used, the slack in the operation line can be removed by retracting the dial operation unit.

By the way, with the expansion of the range of use of medical devices in recent years, medical devices having a longer tubular body have been demanded. In such a long medical device, the problem caused by the difference in the coefficient of thermal expansion between the tubular body and the operation line described above becomes more prominent in a high temperature environment. Therefore, there is a demand for a mechanism capable of more effectively preventing damage to the operation line and the tubular body than conventional medical devices.

The present invention has been made in view of the above-mentioned problems, and it is possible to effectively prevent damage to the operation line and the tubular body without reducing the yield even when placed in a high temperature environment during the manufacturing process. It provides medical equipment that can be used.

According to the present invention, a long and flexible tubular body, a plurality of operation lines inserted through the tubular body and having a tip connected to a distal portion of the tubular body, and a base end of the tubular body. The operation unit main body provided in the unit and the operation unit main body are rotatably provided and slidably provided between the fixed position and the operation position, and the base end portion of the operation line is fixed and a plurality of the above are operated by rotation operation. A bending operation portion for individually applying a traction force to the operation line to bend the distal portion of the tubular body is provided, and an engaging protrusion is provided on one of the operation portion main body and the bending operation portion. On the other hand, an engaging groove that can be engaged with the engaging protrusion is provided, and the bending operating portion can move along the extending direction of the engaging groove with respect to the operating portion main body. When the bending operation portion is in the fixed position, the operation line is in a relaxed state, and the engaging protrusion and the engaging groove are engaged to restrict the rotation operation of the bending operation portion, so that the bending operation is performed. When the portion is in the operating position, the operating line becomes more tense than the relaxed state, and the engagement between the engaging protrusion and the engaging groove is released so that the bending operation portion can be rotated. Medical devices are provided that are characterized by being possible.

According to the medical device of the present invention, the yield does not decrease even when placed in a high temperature environment during the manufacturing process, and it is possible to effectively prevent damage to the operation line and the tubular body.

It is an overall side view of the catheter which concerns on embodiment of this invention. It is the whole side view of the catheter which shows the state which operated the bending operation part in one direction. It is the whole side view of the catheter which shows the state which operated the bending operation part in the other direction. FIG. 1 is a cross-sectional view taken along the line AA of FIG. It is a longitudinal sectional view of the distal part of a catheter. It is a top view of the operation part which a bending operation part is in a fixed position. It is a top view explaining the state of the operation line when the bending operation part is in a fixed position. It is a top view of the operation part when the bending operation part is in an operation position. It is a top view which shows the state which the bending operation part was rotated when the bending operation part is in an operation position. It is a top view explaining the state of the operation line when the bending operation part is in an operation position.

Hereinafter, a catheter as an example of the medical device according to the embodiment of the present invention will be described with reference to the drawings. In all drawings, similar components are designated by the same reference numerals, and duplicate description will be omitted as appropriate. Further, in the following description, a catheter will be described as an example of a medical device, but the present invention is not limited to this and includes other medical devices such as an endoscope.

First, the outline of the catheter 1 of the present embodiment will be described.
FIG. 1 is an overall side view of the catheter 1 according to the embodiment of the present invention. FIG. 2 is an overall side view of the catheter showing a state in which the bending operation portion 92 is operated in one direction. FIG. 3 is an overall side view of the catheter showing a state in which the bending operation portion 92 is operated in the other direction. FIG. 4 is a cross-sectional view taken along the line AA of FIG. FIG. 5 is a vertical cross-sectional view of the distal DE of the catheter 1. FIG. 6 is a plan view of the operation unit 90 in which the bending operation unit 92 is in a fixed position. FIG. 7 is a plan view illustrating a state of the operation line 60 when the bending operation portion 92 is in the fixed position. FIG. 8 is a plan view of the operation unit 90 when the bending operation unit 92 is in the operation position. FIG. 9 is a plan view showing a state in which the bending operation unit 92 is rotated while the bending operation unit 92 is in the operating position. FIG. 10 is a plan view illustrating a state of the operation line 60 when the bending operation unit 92 is in the operation position.
Regarding the catheter 1 shown in FIGS. 1 to 3, the left side of the paper surface (the side where the end of the tubular body 10 is located) is referred to as the distal side, and the right side of the paper surface (the side where the operation unit 90 is located) is referred to as the proximal side. ..

The catheter 1 includes a long and flexible tubular body 10, a plurality of operation lines 60 inserted through the tubular body 10 and having a tip connected to a distal DE of the tubular body 10, and a base of the tubular body 10. The operation unit main body 94 provided at the end and the operation unit main body 94 are rotatably provided and slidably provided between the fixed position and the operation position, and the base end portion of the operation line 60 is fixed and a plurality of operations are performed by rotation. The operation line 60 is individually provided with a bending operation portion 92 for bending the distal portion DE of the tubular body 10.
One of the operating portion main body 94 and the bending operating portion 92 is provided with an engaging protrusion 97, and the other is provided with an engaging groove 924 capable of engaging with the engaging protrusion 97.
The bending operation portion 92 can move with respect to the operation portion main body 94 along the extension direction of the engagement groove 924.
When the bending operation portion 92 is in the fixed position, the operation line 60 is in a relaxed state, and the engaging projection 97 and the engaging groove 924 are engaged with each other to restrict the rotation operation of the bending operation portion 92.
When the bending operation unit 92 is in the operation position, the operation line 60 is in a more tense state than in the relaxed state, and the engagement between the engagement protrusion 97 and the engagement groove 924 is released to rotate the bending operation unit 92. Is possible.

Since the engaging projection 97 is movably formed in the engaging groove 924 provided in the bending operation portion 92 of the catheter 1, the engagement projection 97 is formed along the engagement groove 924 of the bending operation portion 92 with respect to the operation portion main body 94. It is possible to slide.

When the bending operation portion 92 slides from the fixed position to the operation position, the engagement projection 97 slides until it is separated from the engagement groove 924. Therefore, the bending operation portion 92 slides. The possible distance can be secured for a long time regardless of the size of the bending operation unit 92. The longer the sliding distance of the bending operation unit 92 is possible, the more tension can be applied when the operation line 60 is moved to the operation position even if the degree of relaxation of the operation line 60 when the operation line 60 is in the fixed position is increased. The degree of relaxation in the catheter can be ensured to be larger than that of the conventional catheter.

Therefore, the length of the catheter 1 is longer than before, and even if the catheter 1 is placed in a high temperature environment during the manufacturing process and the thermal expansion of the operation line 60 and the tubular body 10 is larger than before, the operation line 60 is used. It is possible to prevent tension from being applied to the. As a result, it is possible to effectively prevent a decrease in yield and damage to the operation line and the tubular body.

In the present embodiment, the engagement groove 924 is formed longer than the radius of gyration of the bending operation portion 92.

That is, the slidable distance of the bending operation unit 92 with respect to the operation unit main body 94 can be secured longer than the turning radius of the bending operation unit 92, and the degree of relaxation in the fixed state can be secured larger than that of the conventional catheter. it can. This makes it possible to prevent damage to the catheter 1 due to thermal expansion.

Hereinafter, the present embodiment will be described in detail with reference to FIGS. 1 to 5. The catheter 1 of the present embodiment is an intravascular catheter used by inserting a tubular body 10 into a blood vessel.

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 tubular body 10 has a laminated structure. The tubular main body 10 is formed by laminating an inner layer (main tube) 24 and an outer layer 50 in order from the inner diameter side around the main tube 20. A hydrophilic layer (not shown) is formed on the surface of the outer layer 50. The inner layer 24 and the outer layer 50 are formed of a flexible resin material, and each has a circular tubular shape and a substantially uniform thickness.

The inner layer 24 is the innermost layer of the tubular body 10, and the main lumen 20 is defined by the inner wall surface thereof. The cross-sectional shape of the main lumen 20 is not particularly limited, but is circular in the present embodiment. In the case of the main lumen 20 having a circular cross section, its diameter may be uniform over the longitudinal direction of the tubular body 10 or may differ depending on the position in the longitudinal direction.

Examples of the material of the inner layer 24 include a fluorine-based thermoplastic polymer resin. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy alkane resin (PFA). By forming the inner layer 24 with such a fluorine-based polymer material, the deliverability when supplying the drug solution or the like through the main lumen 20 is improved. Further, the sliding resistance when inserting the guide wire or the like into the main lumen 20 is reduced.

The wire reinforcing layer 30 is a protective layer provided on the inner diameter side of the tubular main body 10 with respect to the operation line 60 to protect the inner layer 24. The presence of the wire reinforcing layer 30 on the inner diameter side of the operation line 60 can prevent the operation line 60 from penetrating from the outer layer 50 to the inner layer 24 and being exposed to the main lumen 20.

The wire reinforcing layer 30 is formed by winding the reinforcing wire 32. The material of the reinforcing wire 32 includes metal materials such as tungsten (W), stainless steel (SUS), nickel-titanium alloys, steel, titanium, copper, titanium alloys or copper alloys, as well as shearing more than the inner layer 24 and the outer layer 50. High-strength resin materials such as polyimide (PI), polyamideimide (PAI) or polyethylene terephthalate (PET) can be used. In this embodiment, a thin stainless steel wire is used as the reinforcing wire 32.

The wire reinforcing layer 30 is a mesh layer. Since the lower layers of the first marker 14, the second marker 16, and the third marker 18 are the wire reinforcing layer 30 formed as a mesh layer in which mechanical deformation is unlikely to occur, the first marker 14, the second marker 16, and the third marker 18 are formed. 3 The marker 18 can be crimped and fixed.

The number of reinforcing wires 32 forming the wire reinforcing layer 30 is not particularly limited, but in the present embodiment, the wire reinforcing layer 30 formed by the 16 reinforcing wires 32 is shown.

The distal DE of the tubular body 10 is provided with a first marker 14 and a second marker 16 located proximal to the first marker 14. The first marker 14 and the second marker 16 are ring-shaped members containing a metal material such as platinum that is opaque to radiation such as X-rays. By using the positions of the two markers of the first marker 14 and the second marker 16 as indexes, the position of the tip of the tubular body 10 in the body cavity (blood vessel) can be visually recognized under radiation (X-ray) observation. Thereby, the optimum timing for performing the bending operation of the catheter 1 can be easily determined.

Further, a third marker 18 is provided further proximal to the second marker 16. The third marker 18 also serves as a marker when operating the catheter 1. In the present embodiment, the distal side surface of the third marker 18 indicates a position 30 mm from the tip of the tubular body 10.

For example, when the catheter 1 is used for introducing the detachable coil into the body of the subject, the operator should grasp the cutting position of the detachable coil in the main lumen 20 of the catheter 1 by using the third marker 18 as a guide. Can be done. The detachable coil is a coil that is placed inside the subject's body to embolize the subject's aneurysm or thrombus. Such a detachable coil can be cut at a predetermined cutting position by being energized in the main lumen 20.

The first marker 14, the second marker 16, and the third marker 18 are all members having the same shape including the same material in the present embodiment.

As described above, when the first marker 14, the second marker 16, and the third marker 18 are made of the same member, they can be produced by using a common mold, and they are produced as members having different shapes. The cost required for manufacturing can be reduced as compared with the above.

The wire reinforcing layer 30 described above is formed in the lower layer of the first marker 14, the second marker 16, and the third marker 18, and is not formed in the region between the first marker 14 and the second marker 16. , The region is a non-formed region of the wire reinforcing layer 30.

There is a discontinuity in bending rigidity between the non-formed region of the wire reinforcing layer 30 and the region where the wire reinforcing layer 30 is formed, and the bending rigidity is smaller in the non-formed region of the wire reinforcing layer 30. .. Therefore, when the operation line 60 is towed, the tubular main body 10 can be sharply bent in the non-formed region of the wire reinforcing layer 30.

Further, the first marker 14, the second marker 16, and the third marker 18 are fixed by caulking, but if there is no wire reinforcing layer 30, they are directly caulked and fixed to the inner layer 24. However, since the inner layer 24 is made of a flexible material, it is easily deformed, and it is difficult to directly crimp and fix the first marker 14, the second marker 16, and the third marker 18 to the inner layer 24, and even if the inner layer 24 is fixed, the inner layer 24 is easily deformed. It is easily detached due to the deformation of 24.

On the other hand, in the present embodiment, the wire reinforcing layer 30, which is a mesh layer that is less likely to be mechanically deformed than the inner layer 24, is provided in the lower layers of the first marker 14, the second marker 16, and the third marker 18. The first marker 14, the second marker 16, and the third marker 18 can be crimped and fixed, and detachment after fixing can be prevented.

The sub-tube 40 is a hollow tubular member that defines the sub-lumen 42. The sub tube 40 is embedded inside the outer layer 50. The subtube 40 can be made of, for example, a thermoplastic polymer material. Examples of the thermoplastic polymer material include low friction resin materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and fluorinated ethylene / propylene hexafluoride copolymer (FEP). The sub-tube 40 is made of a material having a higher bending rigidity and tensile elastic modulus than the outer layer 50.

The outer surface of the sub tube 40 is subjected to an etching treatment such as a metallic sodium treatment or a plasma treatment. This improves the adhesion between the sub tube 40 and the outer layer.

As shown in FIGS. 4 and 5, two sub-tubes 40 are arranged around the wire reinforcing layer 30 so as to face each other 180 degrees, and an operation line 60 is inserted through each of the two sub-tubes 40. There is. The two subtubes 40 are parallel to the axial direction of the tubular body 10.

The two subtubes 40 are arranged on the same circumference so as to surround the main lumen 20. Instead of this embodiment, three or four subtubes 40 may be arranged around the main lumen 20 at equal intervals. In this case, the operation lines 60 may be arranged on all the sub-tubes 40, or the operation lines 60 may be arranged on some of the sub-tubes 40.

The operation line 60 is slidably inserted with respect to the sub tube 40. The tip of the operation line 60 is fixed to the distal DE of the tubular body 10. By pulling the operation line 60 toward the proximal 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. Since the operation line 60 of the present embodiment is extremely thin and highly flexible, even if the operation line 60 is pushed to the distal side, no pushing force is substantially applied to the distal portion DE of the tubular body 10.

The operation wire 60 may be composed of a single wire rod, or may be a stranded wire composed of a plurality of thin wires twisted together.

As the operation wire 60, 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 60, 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.

The tip of the operation line 60 is fixed to the outer peripheral portion of the first marker 14. The mode of fixing the operation line 60 to the first marker 14 is not particularly limited, and examples thereof include solder bonding, heat fusion, adhesion with an adhesive, and mechanical hooking of the operation line 60 and the first marker 14. However, in the present embodiment, the operation line 60 is fixed to the outer peripheral portion of the first marker 14 by using a solder joint.

The holding wire 70 is co-wound with a sub tube 40, a first marker 14, a second marker 16, a third marker 18, and a wire reinforcing layer 30. The holding wire 70 is formed by winding a coil or braiding in a mesh shape around the sub tube 40.

The holding wire 70 of the present embodiment is a coil, and more specifically, a coil in which a plurality of strands are wound in multiple rows (multi-row coil).

The holding wire 70 is spirally wound around the outside of a pair of subtubes 40 arranged to face each other around the main lumen 20. The winding shape of the holding wire 70 of the present embodiment is a substantially elliptical shape or a substantially rhombic shape in which the arrangement direction of the sub tubes 40 is the major axis direction. In FIGS. 3 to 5, the holding wire 70 having a substantially rhombic winding shape is shown by a broken line. The holding wire 70 is in contact with the peripheral surface of the sub tube 40, specifically, the outer surface of the main cavity 20 opposite to the axis. Here, the substantially rhombus means that the first diagonal line is longer than the second diagonal line, and the first diagonal line and the second diagonal line are substantially orthogonal to each other. The abbreviated rhombus here includes not only rhombuses but also kites (kites) and flat polygons such as flat hexagons and flat octagons. Further, the substantially elliptical shape includes an eccentric circle such as an oval shape as well as an elliptical shape and an oval shape.

In the formation region of the wire reinforcing layer 30, the holding wire 70 is in contact with the outer surface of the wire reinforcing layer 30 on both sides or one side in the minor axis direction orthogonal to the major axis direction.

The inner surface of the subtube 40 is in contact with the outer surfaces of the first marker 14, the second marker 16 and the third marker 18 (see FIG. 2). The holding wire 70 is spirally wound in contact with the outer surface of the pair of subtubes 40. When viewed in the longitudinal direction of the tubular body 10, the holding wire 70 is wound over substantially the entire length of the sub tube 40.

As a result, the holding wire 70 is the wire reinforcing layer 30 under the sub-tube 40, the first marker 14, the second marker 16, the third marker 18, and the first marker 14, the second marker 16, and the third marker 18. And are tightly attached to each other and wound together. Therefore, the sub tube 40 can be kept parallel to the first marker 14, the second marker 16, the third marker 18, and the wire reinforcing layer 30 with high accuracy even after the forming step of the outer layer 50, and the sub tube 40 can be maintained in a parallel state with high accuracy. It is possible to prevent the tube 40 from being displaced. The misalignment of the sub-tube 40 can be prevented more effectively because the holding wire 70 is a multi-row coil and the tightening force is increased.

As the material of the holding wire 70, either the above-mentioned metal material or resin material that can be used as the reinforcing wire 32 can be used. In this embodiment, the holding wire 70 contains a different material than the reinforcing wire 32. The ductility of the holding wire 70 is preferably higher than the ductility of the reinforcing wire 32. Specifically, austenitic soft stainless steel (W1 or W2) or copper or copper alloy, which is a blunting material, can be used for the holding wire 70, while tungsten or stainless spring steel can be used for the reinforcing wire 32. ..

By using a highly ductile material for the holding wire 70, the holding wire 70 is unwound when the holding wire 70 is coil-wound or braided in a mesh shape (coil-wound in this embodiment) around the sub-tube 40. The sub-tube 40 is fixed by plastically stretching and deforming without any problem.

The proximal end of the wire reinforcing layer 30 is located within the proximal end of the tubular body 10, i.e. the operating portion 90.

The distal end of the inner layer 24 may reach the distal end of the tubular body 10 or may be terminated closer to the proximal end than the distal end. The position where the inner layer 24 ends may be inside the arrangement region of the first marker 14.

The outer layer 50 is a circular tubular portion that constitutes the main wall thickness of the tubular body 10. Inside the outer layer 50, a wire reinforcing layer 30, a first marker 14, a second marker 16, a third marker 18, a sub tube 40, and a holding wire 70 are provided in this order from the inner diameter side. The wire reinforcing layer 30, the first marker 14, the second marker 16, the third marker 18, and the holding wire 70 are arranged coaxially with the tubular body 10.

As the material of the outer layer 50, 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.

Inorganic filler may be mixed in the outer layer 50. Examples of the inorganic filler include contrast media such as barium sulfate and bismuth subcarbonate. By mixing the contrast medium in the outer layer 50, the X-ray contrast property of the tubular body 10 in the body cavity can be improved.

The catheter 1 of the present embodiment will be described in more detail with reference to FIGS. 6 to 10.

The catheter 1 has an operating portion 90 provided at the proximal end of the tubular body 10. The operation unit 90, together with the operation line 60 (see FIG. 1), constitutes an operation mechanism for bending the distal portion DE of the tubular body 10.

The operation unit 90 of the present embodiment has an operation unit main body 94 that the user grips by hand, and a bending operation unit 92 that is rotatably and slidably provided with respect to the operation unit main body 94. There is. The base end portion of the tubular main body 10 is introduced inside the operation portion main body 94.

The operation unit 90 includes a hub 96 provided so as to communicate with the main lumen 20 of the tubular body 10. A syringe (not shown) is attached to the hub 96. The hub 96 is provided at the rear end of the operation unit main body 94, and a syringe is mounted from the rear of the hub 96. By injecting the drug solution or the like into the hub 96 with a syringe, the drug solution or the like can be supplied into the body cavity of the subject through the main lumen 20. Chemical solutions include contrast media, liquid anti-cancer agents, physiological saline, chemical solutions such as NBCA (n-butyl-2-cyanoacrylate) used as instant adhesives, detachable coils, beads (embroidery spherical substances), and the like. Medical devices can be mentioned.

The operation line 60 and the sub tube 40 are branched from the tubular main body 10 inside the front end portion of the operation unit main body 94. The base end portion of the operation line 60 drawn from each of the two sub-tubes 40 is directly or indirectly connected to the bending operation portion 92.

The bending operation portion 92 is a disk-shaped dial, and a concave-convex engaging portion 921, which is a corrugated vertical knurl, is formed on the peripheral surface. Two engaging grooves 924 formed in parallel with the rotation axis of the bending operation portion 92 interposed therebetween are formed on the upper surface of the bending operation portion 92.

The engagement groove 924 is formed longer than the radius of gyration of the bending operation portion 92. The width of the engaging groove 924 is a width that allows the engaging projection 97 formed in the operation unit main body 94 to enter.

Further, in the present embodiment, the engagement groove 924 is formed so as to connect both ends of the chord with respect to the circular outer circumference of the bending operation portion 92. Since the engaging groove 924 is formed in this way, the length of the engaging groove 924 can be secured as long as possible on the upper surface of the bending operation portion 92.

However, the present invention is not limited to the embodiment in which the engaging groove 924 is formed to have a length connecting both ends of the string of the bending operation portion 92, as long as at least one end of the engaging groove 924 passes through one end of the string. , The engagement groove 924 may be interrupted in the middle of the string.

Further, in the present embodiment, the width of the engaging groove 924 is uniformly formed over the entire length of the engaging groove 924. However, the present invention is not limited to this embodiment, and may be an embodiment in which the width gradually increases from the distal side to the proximal side, for example.

Further, in the present invention, the shape of the bending operation portion 92 is not limited to the disk shape, and the bending operation portion 92 may have an elliptical shape or a polygonal shape in a plan view. However, in the case of the bending operation portion 92 whose plan view is other than the circular shape as described above, the term longer than the radius of gyration of the bending operation portion 92, which is the length of the engaging groove 924, means a minor axis.

The bending operation unit 92 is slidable between the distal side (fixed position) and the proximal side (operation position) with respect to the operation unit main body 94.

When the bending operation portion 92 is in the fixed position shown in FIGS. 6 and 7, the engagement projection 97 of the operation portion main body 94 is engaged in the engagement groove 924 formed in the bending operation portion 92. .. Therefore, the rotation of the bending operation portion 92 is restricted by the engaging projection 97. In this state, the two operation lines 60 are in a relaxed state as shown in FIG.

On the other hand, when the bending operation portion 92 is in the operation position shown in FIGS. 8 and 10, the engagement protrusion 97 is disengaged from the engagement groove 924. Therefore, the restriction by the engaging protrusion 97 is released, and the bending operation portion 92 is in a state where it can rotate as shown in FIG. In this state, the two operation lines 60 are towed as the bending operation portion 92 slides from the fixed position to the operation position, so that the two operation lines 60 are in a more tense state than in the relaxed state as shown in FIG.

Then, by rotating the bending operation unit 92 at the operation position in any direction, one of the two operation lines 60 can be pulled toward the proximal end side to apply tension, and the other can be loosened. As a result, the towed operation line 60 bends the distal portion DE of the tubular body 10.

Specifically, as shown in FIG. 2, when the bending operation portion 92 is rotated in one direction (clockwise), one operation line 60 is pulled toward the proximal end side. Then, a tensile force is applied to the distal portion DE of the tubular body 10 via the one operating line 60. As a result, the distal portion DE of the tubular body 10 bends toward the side of the sub-tube 40 through which one of the operation lines 60 is inserted, with reference to the axis of the tubular body 10.

Further, as shown in FIG. 3, when the bending operation portion 92 is rotated in the other direction (counterclockwise) around its rotation axis, the other operation line 60 is pulled toward the proximal end side. Then, a tensile force is applied to the distal portion DE of the tubular body 10 via the other operating line 60. As a result, the distal portion DE of the tubular body 10 bends toward the side of the sub-tube 40 through which the other operation line 60 is inserted, with reference to the axis of the tubular body 10.

In this way, by selectively pulling the two operation lines 60 by the operation of the operation unit 90 with respect to the bending 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.

As described above, the bending operation unit 92 is slidably attached to the operation unit main body 94. When the bending operation portion 92 is in the fixed position, the engaging groove 924 and the engaging projection 97 are engaged with each other, so that the bending operation portion 92 cannot rotate and the operation line 60 is in a relaxed state. On the other hand, when the bending operation portion 92 is in the operation position, the engagement between the engagement groove 924 and the engagement protrusion 97 is released, the bending operation portion 92 becomes rotatable, and the operation line 60 is in a tense state. Become.

In the present embodiment, the engagement groove 924 is provided in the bending operation portion 92. The engaging protrusion 97 is provided on the operation unit main body 94.

Since the engaging groove 924 is provided in the bending operation portion 92, the bending operation portion 92, which is an operating portion, can be made lighter and easier to operate.

Further, in the present invention, the bending operation portion 92 may be provided with the engaging protrusion 97, and the operating portion main body 94 may be provided with the engaging groove 924. However, when the bending operation portion 92 is rotated at the operating position by providing the engaging groove 924 in the bending operation portion 92 which is the operating portion and providing the engaging projection 97 in the operating portion main body 94 on the fixed side. It is possible to prevent the bending operation portion 92 from interfering with the peripheral member.

A plurality of engaging protrusions 97 and a plurality of engaging grooves 924 are provided, and the plurality of engaging grooves 924 are provided in parallel with each other.

Since a plurality of engaging protrusions 97 and a plurality of engaging grooves 924 are provided, it is possible to increase the movement restricting force of the bending operation portion 92 by these. Further, since the plurality of engaging grooves 924 are provided in parallel with each other, the bending operation portion 92 can be slid in the extending direction of the engaging groove 924 even when the engaging projections 97 are engaged with each of them. Can be done.

When the bending operation portion 92 is in the fixed position, the engaging projection 97 is a position (disengagement position) in which the engaging projection 97 is disengaged from the engaging groove 924 when the bending operation portion 92 is moved from the fixed position to the operating position. It is in a state of entering the engaging groove 924 longer than the radius of gyration of the bending operation portion 92.

The position of the engaging protrusion 97 when the bending operation portion 92 is in the fixed position is set as the initial position of the engaging protrusion 97. The distance from the initial position to the detached position is longer than the radius of gyration of the bending operation unit 92. Therefore, a large degree of relaxation in the fixed state can be ensured, and damage to the catheter 1 due to thermal expansion can be prevented.

Further, it is assumed that the torque when rotating the bending operation unit 92 is N (N ・ m), the distance from the rotation axis to the point of action of the force is r (m), and the force applied to the bending operation unit 92 is F (N). , N = rF holds. Since the torque for rotating the bending operation unit 92 by a predetermined angle is constant, it can be seen that the farther the distance from the rotation shaft is, the smaller the torque can be generated.

On the other hand, since the force required to suppress the rotation of the bending operation unit 92 is the same as the torque at the point where the deterrent force is applied, the farther the distance from the rotation axis is, the smaller the deterrent force is to rotate the bending operation unit 92. Can be deterred. This means that the farther the distance from the rotation axis is, the easier it is to suppress the rotation of the bending operation unit 92.

In the catheter 1 of the present embodiment, the initial position of the engaging protrusion 97, that is, the position of the engaging protrusion 97 when the bending operation portion 92 is in a state of suppressing rotation is the center line of the circle and the engaging groove. It is located proximal to the one orthogonal to 924 and away from the center of rotation. Therefore, the rotation restraining force of the bending operation portion 92 by the engaging protrusion 97 can be strengthened, and the rotation restraining can be effectively performed when the bending operation portion 92 is in the fixed position.

A recess 95 is formed in the operation unit main body 94 at a position in contact with the bending operation unit 92. The recess 95 is provided with a slider 98 that slides freely forward and backward toward the bending operation portion 92. A protrusion (not shown) is formed at a tip portion below the slider 98 (on the back side of the paper surface in FIG. 1) and facing the bending operation portion 92.

The protrusion is smaller than the opening width of the uneven engaging portion (vertical knurling) 921 on the peripheral surface of the bending operation portion 92. Therefore, when the slider 98 is slid toward the bending operation portion 92, the protrusion is hooked on the peripheral surface of the bending operation portion 92 to regulate the rotation of the bending operation portion 92. As a result, the rotation of the bending operation portion 92 can be restricted in a state where the distal portion DE of the tubular body 10 is bent, and the bent state of the catheter 1 can be maintained.

Further, by rotating the operation unit 90 itself 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. Therefore, the orientation of the distal DE of the catheter 1 can be freely controlled by combining the operation of the bending operation unit 92 and the rotation of the entire axis of the operation unit 90. Further, by adjusting the rotation angle of the bending operation portion 92 to a large or small size, the traction length of the operation line 60 is adjusted to a predetermined length, and the bending angle of the distal portion DE of the catheter 1 can be controlled. Therefore, it is possible to push the catheter 1 into a body cavity such as a blood vessel that branches at various angles.

The components of the medical device of the present invention do not have to be individually independent. A plurality of components are formed as one member, one component is formed of a plurality of members, one component is a part of another component, and one of the components. Allows overlaps between parts and some of the other components, etc.

The above embodiment includes the following technical ideas.
(1) A long and flexible tubular body, a plurality of operation lines inserted through the tubular body and having a tip connected to a distal portion of the tubular body, and a base end portion of the tubular body. The operation unit main body is rotatably provided on the operation unit main body and slidably provided between the fixed position and the operation position, and the base end portion of the operation line is fixed to a plurality of the operation lines by rotation operation. A bending operation portion for individually applying a traction force to bend the distal portion of the tubular body is provided, and one of the operation portion main body and the bending operation portion is provided with an engaging protrusion and the other. Is provided with an engaging groove that can be engaged with the engaging protrusion, and the bending operating portion can move along the extending direction of the engaging groove with respect to the operating portion main body, and the bending operating portion. When is in the fixed position, the operation line is in a relaxed state, the engaging protrusion and the engaging groove are engaged, and the rotation operation of the bending operation portion is restricted, and the bending operation portion is the said. When in the operating position, the operating line becomes more tense than the relaxed state, and the engagement between the engaging protrusion and the engaging groove is released, so that the bending operation portion can be rotated. A medical device characterized by that.
(2) The medical device according to (1), wherein the engaging groove is formed longer than the radius of gyration of the bending operation portion.
(3) When the bending operation portion is in the fixed position, the engaging projection disengages from the engaging groove when the bending operation portion is moved from the fixed position to the operating position. The medical device according to (2), which is in a state of entering the engaging groove longer than the radius of gyration of the bending operation portion from the position.
(4) The medical device according to any one of (1) to (3), wherein the engaging groove is provided in the bending operation portion.
(5) The medical device according to any one of (1) to (4), wherein a plurality of the engaging protrusions and the engaging grooves are provided, and the plurality of engaging grooves are provided in parallel with each other.

1 Catheter 10 Tubular body 14 1st marker 16 2nd marker 18 3rd marker 20 Main lumen 24 Inner layer 30 Wire reinforcing layer 32 Reinforcing wire 40 Subtube 42 Secondary lumen 50 Outer layer 60 Operation line 70 Holding wire 90 Operation part 92 Bending operation Part 94 Operation part Main body 95 Recessed 96 Hub 97 Engaging protrusion 98 Slider 921 Concavo-convex engaging part 924 Engaging groove DE Distal

Claims (4)

With a long and flexible tubular body,
A plurality of operation lines inserted through the tubular body and having a tip connected to the distal portion of the tubular body.
An operation unit main body provided at the base end portion of the tubular main body and
The operation unit body is rotatably provided and slidably provided between the fixed position and the operation position, the base end portion of the operation line is fixed, and traction force is individually applied to the plurality of operation lines by the rotation operation. A bending operation portion for bending the distal portion of the tubular body is provided.
The engaging projection on the operating unit present body is provided, in the bending operation portion have is provided the engaging projection engageable with the engaging groove,
The bending operation portion can move with respect to the operation portion main body along the extension direction of the engagement groove.
When the bending operation portion is in the fixed position, the operation line is in a relaxed state, and the engaging projection and the engaging groove are engaged to restrict the rotation operation of the bending operation portion.
When the bending operation portion is in the operation position, the operation line becomes more tense than the relaxed state, and the engagement between the engagement protrusion and the engagement groove is released to release the bending operation portion of the bending operation portion. rotatable operation and Do Ri,
A medical device characterized in that one end of the engaging groove is formed up to the outer peripheral end of the bending operation portion. The medical device according to claim 1, wherein the engaging groove is formed longer than the radius of gyration of the bending operation portion. When the bending operation portion is in the fixed position, the engaging protrusion is from a position where the engaging protrusion is disengaged from the engaging groove when the bending operation portion is moved from the fixed position to the operating position. The medical device according to claim 2, wherein the medical device is in a state of entering the engaging groove longer than the radius of gyration of the bending operation portion. The medical device according to any one of claims 1 to 3 , wherein a plurality of the engaging protrusions and the engaging grooves are provided, and the plurality of engaging grooves are provided in parallel with each other.

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