JP7074431B2 - Treatment method and medical equipment set - Google Patents

Description

The present invention relates to a treatment method and a medical device set.

As a medical device for treating a lesion (for example, a stenosis) in a biological lumen such as a blood vessel, a self-expandable stent and a self-expandable stent that keep the stenosis in an expanded state are delivered to the lesion. A stent delivery system including a long shaft portion is widely known (see, for example, Patent Document 1).

In the treatment using the above-mentioned stent delivery system, the self-expandable stent is placed between the inner tube and the outer tube of the shaft portion, and the self-expandable stent is placed up to the treatment target site (lesion). Deliver. A long wire that moves the outer pipe relative to the inner pipe is connected to the base end side of the shaft portion. After delivering the self-expandable stent to the treatment target site, a surgeon such as a doctor moves the outer tube to the proximal side with respect to the inner tube by manipulating the wire at hand, and then the inner tube and the operator. Release the self-expandable stent from between the outer tube. When released from between the inner and outer tubes, the self-expandable stent self-expands and is placed in the lesion while maintaining the lesion in an expanded state.

Japanese Patent Publication No. 2007-512061

Treatments using medical devices with wires, such as the stent delivery system described above, can, for example, cause the following problems.

The wire is relatively long and has a small diameter. For this reason, when the treatment member (stent or the like) of the medical device is delivered to the treatment target site and then the wire is operated (for example, the pulling operation to the proximal end side), the wire is deformed such as bending. There is. When the wire is operated in such a state, the operating force applied to the wire on the hand side is not satisfactorily transmitted to the tip side of the wire, and the treatment member may perform the treatment in a state not intended by the operator or the like. There is sex. For example, when the treatment member is a self-expandable stent, if the wire is pulled while the tip of the shaft is stacked on a lesion such as a stenosis, the outer tube smoothly moves in conjunction with the operation of the wire. The outer tube may suddenly move to the proximal end side when the wire traction amount reaches a certain size without moving. At this time, since the self-expandable stent is released so as to pop out from between the inner tube and the outer tube, it may not be expanded to the desired expansion diameter or may be displaced from the desired indwelling position.

It should be noted that the above-mentioned problems may occur similarly when various treatments are performed using a medical device equipped with a treatment member (for example, a microcatheter) other than the self-expandable stent.

Therefore, an object of the present invention is to provide a treatment method and a medical device set capable of appropriately transmitting the operation on the hand side to the tip side.

The medical device set according to the present invention that achieves the above object includes a treatment member that is introduced into the living body from the radial artery of a patient and performs a predetermined treatment on a treatment target site existing in a blood vessel of the lower limb , and the treatment member at the tip thereof. A long shaft portion holding a lumen and a long traction wire including a traction wire capable of suppressing bending deformation that changes the treatment member into a feasible state by being traction-operated. A medical device including a portion, a hand operation portion that enables a traction operation of the traction portion, a main body portion in which a lumen through which the shaft portion is inserted is formed, and a tip opening that communicates with the lumen. The main body portion has a tubular member formed longer than the exposed length in which the shaft portion is exposed in the longitudinal direction from the tip opening in a state where the shaft portion is inserted into the lumen. However, the tubular member further includes a proximal end opening that communicates with the lumen on the proximal end side, and the main body portion is from the tip of the hand operation portion in a state where the shaft portion is inserted into the lumen. The shaft portion is formed to be longer than the exposed length exposed in the longitudinal direction up to the proximal end opening of the tubular member, the total length L1 of the shaft portion is 200 cm, the length L2 of the main body portion is 150 cm, and the tip opening. The exposed length L3 from the portion is 43 cm, and the treatment member inserts the shaft portion into the lumen of the tubular member, and the portion of the shaft portion holding the treatment member is the tubular member. It is used in a state where it protrudes from the tip opening. Further, as another combination of the above dimensions, the total length L1 of the shaft is 200 cm, the length L2 of the main body portion is 120 cm, and the exposed length L3 from the tip opening is 73 cm.

In the medical instrument set according to the present invention, the shaft portion is formed on a tubular member formed to be longer than the exposed length in which the shaft portion is exposed in the longitudinal direction from the tip opening in a state where the shaft portion is inserted into the lumen of the main body portion. Predetermined treatment is performed with the inserted state. Therefore, it is possible to suppress deformations and the like that the operator does not intend, such as bending, and it is possible to more appropriately transmit the operation on the hand side to the tip side.

It is a figure which shows the medical instrument set which concerns on one Embodiment of this invention. It is a figure which shows the state which removed the catheter from the medical device in the medical device set of FIG. It is a figure which shows the medical instrument which constitutes the medical instrument set of FIG. It is sectional drawing which shows the tip side part of the medical instrument of FIG. It is sectional drawing which follows the 5-5 line of FIG. It is a partially enlarged sectional view of FIG. It is sectional drawing which follows the 7-7 line of FIG. It is sectional drawing which follows the 8-8 line of FIG. It is sectional drawing which follows the line 9-9 of FIG. It is a figure which shows the inside of the operation part which constitutes a medical instrument. It is an exploded view of the operation part. It is an axis orthogonal cross section on the proximal end side when a catheter is inserted through a medical instrument constituting a medical instrument set. It is a flowchart which shows the treatment method which concerns on one Embodiment of this invention. It is a figure which shows the introduction site of the medical device and the treatment target part which performs a treatment in the medical device set which concerns on one Embodiment of this invention. It is a figure which shows the state of introducing the guide wire into a living body as the treatment method which concerns on one Embodiment of this invention. FIG. 15 is a diagram showing a case where an introducer sheath is punctured at a position where a guide wire is introduced into a living body following FIG. FIG. 16 is a diagram showing a state in which an introducer sheath is placed on the surface of a living body following FIG. It is a figure which shows the time of inserting a guide wire into an introducer sheath following FIG. FIG. 18 is a diagram showing a case where a catheter constituting a medical device set is inserted into an introducer sheath following FIG. 18. FIG. 19 is a diagram showing the time when the tip opening of the guiding catheter reaches the treatment target site following FIG. FIG. 20 is a diagram showing a case where the tip of the shaft portion is projected from the tip opening of the catheter following FIG. FIG. 21 is a diagram showing a case where the first outer tube constituting the outer tube of the shaft portion is retracted with respect to the stent and the stent corresponding to the treatment member is expanded following FIG. 21. It is a figure which shows the modification of the medical instrument set of FIG.

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope and the meaning of the terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

1 to 12 are views provided for explaining a medical device set according to an embodiment of the present invention. The medical instrument set 100 according to the present embodiment is used, for example, when dilating a narrowed portion in a biological lumen such as a blood vessel.

As shown in FIG. 1, the medical device set 100 includes a medical device 1, a catheter 110, and an introducer sheath 120. The details will be described below.

(Medical equipment)
As shown in FIG. 3, the medical instrument 1 includes a treatment member that performs a predetermined treatment on a treatment target site existing in the living lumen of a patient, and a long shaft portion 10 that holds the treatment member at the tip portion. , Equipped with. Further, the medical instrument 1 includes a long traction unit 50 that changes the treatment member into a state in which the treatment can be performed by a traction operation, and a hand operation unit 80 that enables the traction operation of the traction unit 50. Be prepared.

As shown in FIG. 3, the shaft portion 10 includes an inner tube 20 through which a guide wire is inserted, and an outer tube 40 having a lumen capable of accommodating the inner tube 20. Further, the shaft portion 10 includes a tip member 60 arranged at the most advanced end of the medical instrument 1 and a tow wire insertion tube 70 through which the tow portion 50 is inserted. In the present embodiment, the treatment member is configured to include a stent 30 that expands the treatment target site as a predetermined treatment with respect to the treatment target site existing in the living lumen of the patient. Further, as shown in FIG. 3, the traction portion 50 is a traction that moves the first outer pipe 41 and the second outer pipe 42 of the outer pipe 40 constituting the shaft portion 10 relatively to the proximal end side with respect to the stent 30. The wires 50a and 50b are provided.

In the present specification, the side inserted into the living lumen is referred to as the tip side (direction of arrow A in the figure), and the side on which the hand operation unit 80 is provided is the base end side (arrow B in the figure). Direction). Further, the arrow A direction and the B direction in FIG. 3 are referred to as a longitudinal direction. Further, in the cross section perpendicular to the axis of the tubular member shown in FIGS. 7 to 9, the reference numeral r is referred to as a radial direction or a radial direction, and the reference numeral θ is referred to as a circumferential direction or an angular direction of each tubular member described below.

(Inner pipe, tip member)
As shown in FIG. 3, the inner tube 20 is composed of a tubular member having a guide wire lumen 20a penetrating from the tip end to the base end. A guide wire G (see FIG. 18 and the like) that guides the medical device 1 to the lesion portion of the biological lumen is inserted into the guide wire lumen 20a.

As shown in FIG. 3, a tip member 60 is arranged at the tip of the shaft portion 10. The tip member 60 is fixed to the tip portion of the inner pipe 20 by a stopper 22. The stopper 22 is embedded in the tip member 60 to prevent the tip member 60 from coming off. The stopper 22 is preferably formed of a metal (for example, stainless steel). The tip member 60 has a shape that gradually reduces in diameter toward the tip, and is formed so that it can be easily inserted into the living lumen. An opening 20b into which the guide wire G is inserted is formed at the tip of the tip member 60. The tip member 60 can be configured by a member separate from the inner tube 20, or may be integrally configured by the same member as the inner tube 20.

As shown in FIG. 5, the proximal end side of the inner tube 20 is formed diagonally so as to incline toward the proximal end side, and is provided so as to be able to communicate with the lead wire G lead-out hole 43d in the outer tube 40 described later. ing. This facilitates the guidance of the guide wire G.

As the material for forming the inner tube 20, it is preferable to use a flexible material. For example, polyolefins such as polyethylene and polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluoropolymers such as ETFE, PEEK, polyimide and the like can be used. Among the above resins, a resin having thermoplasticity can be preferably used.

As the material for forming the tip member 60, it is preferable to use a material having flexibility. For example, synthetic resin elastomers such as olefin elastomers, polyamide elastomers, styrene elastomers, polyurethanes, urethane elastomers, and fluororesin elastomers, synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, and natural rubbers such as latex rubber. Rubbers are used.

(Stent)
The stent 30 is a self-expandable stent. The stent 30 is shown by a alternate long and short dash line in FIG. 4 and the like, and is arranged in the accommodating portion 41a described later in a state of being compressed inward in the radial direction r about the longitudinal axis of the outer tube 40 at the time of insertion into the living lumen. To. When the first outer tube 41 and the second outer tube 42 of the outer tube 40 move toward the proximal end relative to the stent 30, the accommodating portion 41a is exposed outward, and the stent 30 is a lesion in the living lumen. It is released to the treatment target site such as a part. As a result, the stent 30 expands outward in the radial direction r and expands and deforms to the shape before compression. The stent 30 is formed in a mesh-like and substantially cylindrical shape with a large number of openings. As the material constituting the stent 30, for example, a superelastic alloy such as a Ni—Ti alloy can be preferably used.

(Towing wire)
The tow wires 50a and 50b are fixed to each of the first outer pipe 41 and the second outer pipe 42 included in the outer pipe 40, which will be described later, and the base ends of the first outer pipe 41 and the second outer pipe 42 included in the outer pipe 40. Tow to the side. The tow wires 50a and 50b change the stent 30 corresponding to the treatment member into a state in which the treatment is possible by pulling the tow wires 50a and 50b. Specifically, the traction causes the stent 30 to be released from the outer tube 40 of the shaft portion 10, and the stent 30 expands. Details will be described later. As the material for forming the tow wires 50a and 50b, it is preferable to use a material having relatively high rigidity. For example, a metal such as Ni—Ti, brass, stainless steel, or aluminum, or a resin having relatively high rigidity, for example, polyimide, vinyl chloride, polycarbonate, or the like can be used.

(Towing wire insertion tube)
As shown in FIG. 3, the tow wire insertion tube 70 has a tow wire lumen 70a penetrating from the tip end to the base end, and is formed in a tubular shape. The tow wires 50a and 50b are inserted into the tow wire lumen 70a and guided to the hand operation unit 80 on the proximal end side. As shown in FIGS. 5 and 9, the tip portion of the tow wire insertion tube 70 is arranged in the lumen of the proximal end side tube 43b constituting the outer tube 40 and fixed to the proximal end portion of the inner tube 20. The base end portion of the tow wire insertion pipe 70 is fixed to the hand operation unit 80 as shown in FIG.

As the material for forming the tow wire insertion tube 70, it is preferable to use a material having flexibility. For example, polyolefins such as polyethylene and polypropylene, nylon, polyethylene terephthalate, fluoropolymers such as ETFE, PEEK, polyimide and the like can be preferably used. The outer surface of the tow wire insertion tube 70 may be coated with a resin having biocompatibility, particularly antithrombotic property. As the antithrombotic material, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene, or the like can be used.

Further, as shown in FIG. 5, a base shaft wire 70b is arranged inside the tow wire insertion pipe 70. The base shaft wire 70b is provided from the tip of the hand operation portion 80 to the movement limiting portion 43c to improve the rigidity of the base end side of the shaft portion 10. The base shaft wire 70b is made of the same material as the tow wires 50a and 50b, and is thicker than the tow wires 50a and 50b.

(Outer pipe)
As shown in FIGS. 3 and 4, the outer tube 40 is arranged on the distal end side and is arranged so as to be close to the first outer tube 41 accommodating the stent 30 and the proximal end side of the first outer tube 41. It has a second outer pipe 42 and a third outer pipe 43 arranged on the proximal end side of the second outer pipe 42.

As shown in FIG. 3, the first outer tube 41 includes an accommodating portion 41a that can accommodate the stent 30 in a compressed state inward in the radial direction r between the stent 30 and the inner tube 20. The first outer tube 41 corresponds to a hollow storage member for storing the stent 30 in the present specification. As shown in FIG. 4, on the outer surface of the inner tube 20, a movement limiting portion 23 that abuts on the distal end side of the stent 30 and restricts movement to the distal end side, and a proximal end that abuts on the proximal end side of the stent 30. A movement limiting unit 24 that restricts movement to the side is fixed. The movement limiting portions 23 and 24 are formed in an annular shape with the longitudinal direction of the outer tube 40 as the rotation axis. The accommodating portion 41a is formed by a portion surrounded by a movement limiting portion 24, a movement limiting portion 23, and a first outer pipe 41.

After the accommodating portion 41a is arranged at the treatment target site such as the lesion portion of the living lumen, the first outer tube 41 is moved to the proximal end side with respect to the inner tube 20 by the operation of the hand operation unit 80. At this time, a frictional force that tends to move the first outer tube 41 to the proximal end side acts on the stent 30 as the first outer tube 41 moves. However, the stent 30 is restricted from moving toward the proximal end side by abutting on the movement limiting portion 24. As a result, the stent 30 can release the stent 30 at the treatment target site without moving from the treatment target site such as the arranged lesion. The movement limiting portion 23 forms a tapered surface whose diameter is reduced toward the proximal end side in the proximal end portion. Therefore, when the stent 30 is released, the movement restriction unit 23 does not become an obstacle, and the medical device 1 after the release of the stent 30 can be easily recovered.

The first outer pipe 41 is not fixed to the inner pipe 20, and the first outer pipe 41 is configured to be relatively movable in the longitudinal direction of the outer pipe 40 with respect to the inner pipe 20. As shown in FIG. 6, the first outer pipe 41 includes a cylindrical member main body 41b having a small diameter portion 41c whose diameter is reduced toward the proximal end side, and a tubular portion 41d provided so as to cover the small diameter portion 41c. , Further prepare. The base end side of the small diameter portion 41c is formed so as to protrude from the tubular portion 41d. The first outer pipe 41 further includes a gap portion 41e formed between the small diameter portion 41c and the tubular portion 41d. The end portions of the tow wires 50a and 50b on the distal end side are fixed to the first outer pipe 41 (outer surface of the small diameter portion 41c) by the adhesive filled in the gap portion 41e. As the adhesive, an epoxy resin, an ultraviolet curable resin, a cyanoacrylate resin, or the like can be preferably used.

It is preferable that the outer surface of the first outer pipe 41 is subjected to a treatment for exhibiting lubricity. Such treatment includes, for example, coating a hydrophilic polymer such as polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, polyvinylpyrrolidone, a copolymer of dimethylacrylamide and glycidyl methacrylate, and a copolymer of dimethyl ether and maleic anhydride. Alternatively, a method of fixing or the like can be mentioned. Further, in order to improve the slidability of the stent 30, the above-mentioned one may be coated or fixed on the inner surface of the first outer tube 41. Further, the first outer tube 41 may be formed by a combination of the above-mentioned two-layer structure of a polymer (for example, nylon on the outer surface and PTFE on the inner surface).

As the material for forming the first outer tube 41, it is preferable to use a resin having flexibility, kink resistance, elasticity and the like. For example, a fluoropolymer such as polyethylene, polypropylene, nylon, polyethylene terephthalate, polyimide, PTFE, ETFE, a thermoplastic elastomer, or the like can be used. In the present embodiment, the first outer pipe 41, the second outer pipe 42, and the third outer pipe 43 can be formed of the same material, but the present invention is not limited to this, and the first outer pipe 41, the second outer pipe 42, and the third outer pipe 43 may be formed of different materials. good.

As shown in FIG. 5, the second outer pipe 42 is composed of two tubular members having different outer diameters, a tip side tubular portion 42a and a main body portion 42b. The second outer pipe 42 is not fixed to the first outer pipe 41, and is configured to be movable toward the proximal end side together with the first outer pipe 41 by the traction of the tow wires 50a and 50b.

As shown in FIG. 6, the distal end side cylindrical portion 42a includes hollow tubular members 42c and 42d adjacent to each other in the longitudinal direction, and tubular members 42e arranged in the lumen of the tubular members 42c and 42d. The distal end side cylindrical portion 42a includes a ring-shaped member 42f that has substantially the same diameter as the tubular member 42e and is arranged adjacent to the tubular member 42e in the axial direction.

As shown in FIG. 6, the tubular members 42c and 42d are fixed to the tubular member 42e in a state where the tubular member 42e is arranged in the lumen. The tubular member 42d is fixed so as to cover the tip portion of the main body portion 42b, and the tubular members 42c and 42d have an outer diameter substantially equal to the outer diameter of the first outer pipe 41. The tubular member 42e has a diameter smaller than that of the tubular members 42c and 42d, and is fixed to the tubular members 42c and 42d. The ring-shaped member 42f is arranged between the tubular member 42e and the main body portion 42b in the longitudinal direction of the lumen of the tubular members 42c and 42d, and is configured to be in contact with the main body portion 42b. As shown in FIG. 7, the ring-shaped member 42f has the tow wires 50a and 50b fixed to the wall surface.

As shown in FIGS. 5 and 8, the main body portion 42b has an outer diameter smaller than the inner diameter of the distal end side tube 43a of the third outer tube 43, which will be described later, and is configured to be able to be accommodated in the lumen of the distal end side tube 43a. .. By configuring the second outer pipe 42 in this way, when the tow wires 50a and 50b are towed to the proximal end side, the ring-shaped member 42f moves to the proximal end side, and the ring-shaped member 42f comes into contact with the main body portion 42b. The main body portion 42b moves toward the base end side together with the ring-shaped member 42f. As a material for forming the tip side tubular portion 42a, a resin having thermoplasticity can be preferably used.

As shown in FIG. 5, the third outer tube 43 includes a distal end tube 43a having an inner diameter larger than that of the main body 42b of the second outer tube 42 and a proximal end tube fixed to the proximal end side of the distal tube 43a. It has 43b and.

The distal end side tube 43a is not fixed to the main body portion 42b, and the main body portion 42b can be slid toward the proximal end side and accommodated in the distal end side tube 43a. As shown in FIG. 5, a movement limiting portion 43c for limiting the movement of the second outer tube 42 is provided on the proximal end side in the distal end side tube 43a. The second outer pipe 42 is configured to be movable only to the tip side of the movement limiting portion 43c by the movement limiting portion 43c.

In the present embodiment, the distal end side tube 43a of the third outer tube 43 is configured to accommodate the main body portion 42b of the second outer tube 42. However, the present invention is not limited to this, and the tip side tube 43a may be slid and accommodated in the main body portion 42b by making the inner diameter of the main body portion 42b larger than the outer diameter of the tip side tube 43a.

As shown in FIG. 5, the proximal end side tube 43b is provided with a guide wire G lead-out hole 43d whose proximal end portion is obliquely displaced outward in the radial direction r of the third outer tube 43 to open. The lead-out hole 43d is an end portion on the base end side of the outer pipe 40, and is provided at an intermediate portion in the longitudinal direction of the shaft portion 10. Here, the intermediate portion of the shaft portion 10 provided with the lead-out hole 43d means a portion other than both ends in the longitudinal direction of the shaft portion 10, and the position thereof is not limited to FIGS. 2 and 4. The lead-out hole 43d is provided so as to be able to communicate with the guide wire lumen 20a of the inner pipe 20, and one end of the guide wire G can be led out to the outside of the outer pipe 40. Further, as shown in FIG. 9, the tow wire insertion tube 70 is fixed to the lumen of the proximal end side tube 43b by the fixing member 43e.

(Hand operation unit)
The hand operation unit 80 winds up the tow wires 50a and 50b that enable the tow operation of the tow unit 50. As shown in FIG. 3, the hand operation unit 80 is fixed to the base end portion of the tow wire insertion pipe 70 through which the tow wires 50a and 50b are inserted. The hand operation unit 80 winds the tow wires 50a and 50b to move the first outer pipe 41 and the second outer pipe 42 constituting the outer pipe 40 to the base end side.

As shown in FIG. 10, the hand operation unit 80 winds up a storage case 81 for accommodating each component, a cylinder portion 82 extending from the tip end side of the hand operation unit 80, and tow wires 50a and 50b. It has a reverse rotation restricting member 84 that limits the reverse rotation of the 83 and the rotary roller 83.

As shown in FIG. 11, the storage case 81 is composed of a storage case main body 81a, a lid member 81b, and a cap member 81c. The storage case 81 is configured such that the base end side and the central portion are bent and have a rounded shape. The storage case 81 is configured as described above so that it can be easily gripped and the rotary roller 83 can be easily operated in the gripped state. The storage case main body 81a is configured to accommodate the rotary roller 83, and forms a storage case opening 81d in order to project a part of the rotary roller 83 to the outside. As shown in FIG. 11, the accommodating case 81 further includes a bearing portion 81e for accommodating one end of the rotating shaft 83b of the rotating roller 83, which will be described later, and a bearing portion 81f for accommodating the other end of the rotating rotating shaft 83b.

As shown in FIG. 10, the tubular portion 82 includes a connector 82a for connecting to the tow wire insertion tube 70 and a sealing member 82b, and a tip portion of the connector 82a is provided at the base end portion of the tow wire insertion tube 70. It is fixed. Further, the sealing member 82b connected to the base end portion of the connector 82a is housed in the housing case 81.

As shown in FIGS. 10 and 11, the rotary roller 83 includes a disk-shaped roller main body portion 83a having uneven teeth and a rotary shaft 83b. Further, the rotary roller 83 includes a take-up shaft portion 83c that rotates by the rotation of the rotary shaft 83b, and a gear portion 83d provided on the opposite side of the take-up shaft portion 83c with respect to the roller main body portion 83a. A part of the rotary roller 83 protrudes from the housing case 81, and the protruding portion is rotated in the arrow R direction (direction in which the tow wires 50a and 50b are wound) to rotate the rotary shaft 83b in the arrow R direction.

The take-up shaft portion 83c is formed around the rotating shaft 83b, and the base end portions of the tow wires 50a and 50b are gripped or fixed to the outer surface of the take-up shaft portion 83c. By rotating the rotary shaft 83b in the direction of the arrow R as described above, the take-up shaft portion 83c is rotated, and the tow wires 50a and 50b are taken up on the outer surface of the take-up shaft portion 83c.

As shown in FIG. 10, the reverse rotation restricting member 84 is provided at a portion of the rotary roller 83 facing the gear portion 83d, and includes an engaging portion 84a capable of engaging with the gear portion 83d. When the rotary roller 83 is to be rotated in the direction of arrow F, which is the direction opposite to the direction in which the tow wires 50a and 50b are wound, one tooth of the gear portion 83d and the engaging portion 84a of the reverse rotation restricting member 84 are engaged. And prevent rotation. This limits the rotation of the rollers in the direction opposite to the winding direction of the tow wires 50a and 50b.

(catheter)
The catheter 110 is a long tubular member having a lumen 115 through which the shaft portion 10 is inserted, as shown in FIGS. 1, 2, and 12. The catheter 110 is also referred to as a guiding catheter because it may be used to guide an instrument such as the medical instrument 1 to a treatment target site in the living lumen. The catheter 110 is configured such that the length L2 in the longitudinal direction shown in FIG. 1 is at least half of the total length L1 of the shaft portion 10 in the medical instrument 1.

In other words, the length L2 in the longitudinal direction of the catheter 110 is longer than the length L3 where the shaft portion 10 is exposed from the tip opening 119a of the catheter 110 when the shaft portion 10 is inserted into the lumen 115 of the catheter 110. It is composed. The treatment member is used in a state where the shaft portion 10 is inserted into the lumen 115 of the catheter 110 and the portion of the shaft portion 10 holding the treatment member is projected from the tip opening 119a of the catheter 110.

As a result, unintentional deformation such as bending of the tow wires 50a and 50b in the procedure using the medical instrument 1 described later can be suppressed, and treatment such as placement of the stent 30 can be performed with high accuracy.

The length L2 in FIG. 1 corresponds to the length from the tip opening 119a to the proximal end side where the size of the lumen is constant, and in FIG. 1, the distal end of the kink-resistant protector 114 described later corresponds to the proximal end. In the present embodiment, the size of the lumen on the proximal end side of the catheter 110 on the L2 side is larger than that on the distal end side where the lumen size is constant.

Further, the length L4 corresponds to a portion where the shaft portion 10 is exposed from the tip of the hand operation portion 80 to the proximal end opening 119b of the catheter 110 in a state where the shaft portion 10 is inserted into the lumen of the catheter 110, and is shown in FIG. The length L4 becomes 0. As shown in FIG. 1, the length L2 of the main body portion 111 is formed longer than the length L4 in which the shaft portion 10 is exposed from the catheter 110.

Further, the length L5 represents the length of a portion of the catheter 110 in which the traction wires 50a and 50b are housed in a section where the size of the lumen is constant. The tip of the length L5 corresponds to the end E of the tow wires 50a and 50b shown in FIGS. 4 and 6, and the base end is the same as that of L2.

It is more preferable that the length L5 in which the traction wires 50a and 50b are housed in the section of the catheter 110 in which the size of the lumen is constant is larger than the length L4 in which the shaft portion 10 is exposed from the catheter 110.

The tow wires 50a and 50b can be unintentionally deformed by being deformed so as to bulge in the radial direction r and the like. Therefore, by configuring as described above, it is possible to more effectively suppress unintended deformation of the traction wires 50a and 50b, and to accurately place the stent 30 and the like. Specific dimensions of the shaft portion 10 and the catheter 110 will be described later in Examples.

As shown in FIGS. 1, 2, and 12, the catheter 110 includes a main body 111, a tip 112 provided at the tip of the main body 111, and a hub 113 provided at the proximal end side of the main body 111. A kink-resistant protector 114 provided at a portion where the main body portion 111 and the hub 113 are connected is provided. As shown in FIG. 12, the main body 111 is formed of a flexible tubular body, and a lumen 115 through which the medical device 1 is inserted is formed in a substantially central portion thereof over the entire length of the main body 111. The main body 111 is formed by inserting the inside of the hub 113 and the kink-resistant protector 114.

Here, the outer diameter d1 of the tow wire insertion tube 70 provided on the proximal end side of the shaft portion 10 shown in FIG. 12 is configured to be 45% or more of the inner diameter d2 of the catheter 110. The tow wire insertion tube 70 and the catheter 110 are shown as a perfect circle in FIG. 12, but may be an ellipse or the like instead of a perfect circle. In the case of an ellipse or the like, the long axis of the tow wire insertion tube 70 is 45% or more of the long axis of the catheter 110.

As shown in FIG. 12, the main body portion 111 includes an inner layer 116 that constitutes the inner wall of the lumen 115, an outer layer 117 that forms the outer wall, and a reinforcing portion 118 that is embedded in the outer layer 117.

Examples of the material of the outer layer 117 include various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based. One of these or a combination of two or more thereof (polymer alloy, polymer blend, laminate, etc.) can be used.

The constituent material of the inner layer 116 shall be made of a material that causes low friction at least in a portion in contact with the medical device such as the stent 30 and the outer tube 40 described above when the medical device such as the stent 30 and the outer tube 40 is inserted into the lumen. Is preferable. As a result, the medical instrument inserted into the main body 111 can be moved in the longitudinal direction with a smaller sliding resistance, which contributes to the improvement of operability. Of course, the entire inner layer 116 may be made of a low friction material. Examples of the low friction material include a fluororesin material such as polytetrafluoroethylene (PTFE).

The reinforcing portion 118 is embedded in the outer layer 117 to reinforce the main body portion 111, and as shown in FIG. 12, is provided with a reinforcing material composed of a plurality of reinforcing wires (linear bodies). The resin of the outer layer 117 or the inner layer 116 enters into the gaps between the plurality of reinforcing lines in the reinforcing portion 118. In the present embodiment, the reinforcing wires are formed so that a plurality of reinforcing wires are wound around the surface of the inner layer 116. Examples of the reinforcing material include those in which the reinforcing wire is formed into a spiral shape or a mesh shape. The reinforcing wire is made of metal such as stainless steel and Ni—Ti.

Specific examples of the reinforcing wire include a flat plate-shaped wire obtained by crushing a stainless steel wire into a flat plate shape so that the wall thickness of the main body 111 in the radial direction r becomes thin. Further, as the reinforcing material, a spiral one using a plurality of 8 to 32 reinforcing materials, a braided material, or the like can be mentioned. The number of reinforcing lines is preferably a multiple of 8 in order to reinforce the tubular shape in a well-balanced manner. The reinforcing wire is not limited to the above-mentioned flat wire, and may be, for example, a round wire or an elliptical wire. Further, one reinforcing wire may be a bundle of two or more reinforcing wires.

The chip 112 is made of a flexible material, and the tip thereof preferably has a rounded shape. By providing the tip 112, it is possible to run smoothly and safely even in a curved, bent, or branched blood vessel. The constituent materials of the chip 112 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluororubber, and styrene-butadiene rubber, and styrene-based, polyolefin-based, polyurethane-based, polyester-based, and polyamide. Examples thereof include various thermoplastic elastomers such as based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based.

The length of the chip 112 is not particularly limited, but is usually preferably about 0.5 to 3 mm, more preferably about 1 to 2 mm.

The hub 113 is attached to the base end of the main body 111. The hub 113 is formed with a passage that communicates with the lumen 115 of the main body 111. This passage has an inner diameter substantially equal to the inner diameter of the lumen 115 of the main body 111, and is continuous with the inner surface of the base end portion of the lumen 115 of the main body 111 without causing a step or the like.

The kink-resistant protector 114 is formed of an elastic material and is put on a portion connecting the main body portion 111 and the hub 113 to play a role of preventing bending (kink) in the vicinity of the portion.

(Introducer Sheath)
The introducer sheath 120 is used when introducing the medical device 1 and the catheter 110 into the living lumen. The introducer sheath 120 is formed to have a diameter larger than that of the medical device 1 and the catheter 110, and includes a lumen through which the catheter 110 is inserted. As shown in FIG. 1, the introducer sheath 120 includes a body portion 121 punctured into the living lumen and a hub portion 122 fixed to the proximal end portion of the body portion 121. The introducer sheath 120 can be inserted into the lumen of the fuselage 121 and used with a dilator D (see FIG. 16) used to dilate the punctured site.

The body portion 121 is preferably flexible so that the medical device 1 or the like can be inserted while being punctured on the surface of the living body. The constituent materials of the body portion 121 and the hub portion 122 are not particularly limited, and for example, polyethylene, polypropylene, polyolefins such as ethylene-vinyl acetate copolymer, polyolefin elastomer, polyvinyl chloride and the like can be used.

(Treatment method using medical equipment)
Next, a treatment method using the medical instrument set 100 will be described. 13 to 22 are diagrams for explaining a treatment method using the medical device set 100 according to the present embodiment. To outline the treatment method according to the present embodiment with reference to FIG. 13, a medical instrument 1 and an instrument such as a catheter 110 are prepared (ST1), and the tip of the catheter 110 is delivered in the vicinity of the treatment target site (ST1). ST4). Next, the shaft portion 10 is inserted into the lumen 115 of the catheter 110, and the portion of the shaft portion 10 holding the stent 30 is projected from the distal end opening 119a of the catheter 110 and delivered to the treatment target site (ST5). Next, the hand operation unit 80 is operated to perform treatment on the treatment target site with the stent 30 (ST6). The details will be described below.

As shown in FIG. 14, the medical device 1 constituting the medical device set 100 is introduced into the living body from the radial artery Ra and sent to a treatment target site such as a lower limb blood vessel L such as an iliac artery or a femoral artery. Take the prescribed procedure.

For the above-mentioned treatment method, first, the above-mentioned medical instrument set 100 or the like is prepared. In this embodiment, a puncture needle (not shown) and a dilator D (see FIG. 16) to be inserted into the lumen of the introducer sheath 120 are prepared together with the medical instrument set 100 (ST1).

Next, a puncture needle (not shown) is inserted from the surface of the living body to the living lumen Bl to form an insertion site, and the guide wire G is introduced into the living lumen Bl from the puncturing site as shown in FIG. Next, as shown in FIG. 16, the dilator D and the introducer sheath 120 are percutaneously punctured into the patient's artery (ST2). When the tip of the introducer sheath 120 is punctured into the artery, it can be confirmed that blood flows in from the opening of the tip due to the internal pressure of the artery, flows back through the introducer sheath 120, and reaches the hub portion 122. After confirming that the tip of the introducer sheath 120 has been punctured into the living lumen Bl as shown in FIG. 17, the dilator D is removed.

Next, the guide wire G is inserted into the lumen of the introducer sheath 120 as shown in FIG. The degree of entry of the guide wire G into the living lumen Bl can be confirmed, for example, under fluoroscopy. After the guide wire G reaches the treatment target site such as the lower limb blood vessel L, the catheter 110 is then introduced into the living body from the introducer sheath 120 as shown in FIG. 19 (ST3). Then, the catheter 110 is moved along the guide wire G, and the tip opening 119a is moved to the vicinity of the treatment target site such as the lower limb blood vessel L as shown in FIG. 20 (ST4).

When the tip opening 119a of the catheter 110 reaches the vicinity of the treatment target site, the guide wire G is inserted through the opening 20b of the tip member 60 of the medical device 1 and led out from the outlet hole 43d. Next, the shaft portion 10 is moved to the tip end side of the biological lumen Bl along the guide wire G introduced into the biological lumen Bl. At this time, the shaft portion 10 passes through the lumen 115 of the catheter 110 introduced into the biological lumen Bl before the shaft portion 10, and the first outer tube 41 of the shaft portion 10 is treated as shown in FIG. 21. Place on the site.

As a result, the stent 30 housed in the housing portion 41a of the first outer tube 41 is in a state of being delivered to the treatment target site such as the lower limb blood vessel L (ST5). Stents generally dilate to dilate the narrowed part of the living lumen. Therefore, in the present embodiment, "the portion of the shaft portion holding the treatment member protrudes from the distal end opening of the tubular member" means that the entire stent 30 in the longitudinal direction is arranged on the distal end side of the distal end opening 119a of the catheter 110. Means to do.

When the stent 30 reaches the treatment target site, the traction wires 50a and 50b are wound up by using the hand operation unit 80. As a result, the tow wires 50a and 50b are wound around the outer peripheral surface of the take-up shaft portion 83c, and the first outer pipe 41 to which the tow wires 50a and 50b are fixed and the ring-shaped member 75 move to the proximal end side. When the ring-shaped member 75 moves to the proximal end side, the second outer pipe 42 arranged adjacent to the ring-shaped member 75 also moves to the proximal end side, and a part of the lumen of the third outer pipe 43 is partially inserted. Be housed.

With the movement of the first outer tube 41 and the second outer tube 42 to the proximal end side, the stent 30 arranged inside the first outer tube 41 also tries to move to the proximal end side, but the movement limiting portion. 24 prevents the movement to the proximal end side. As a result, as shown in FIG. 22, the stent 30 is released to the outside from the distal end side of the first outer tube 41, and the diameter of the stent 30 is expanded by the release, and the stent 30 is placed in the narrowed portion in the living body. Due to the outward expansion force of the stent 30 in the radial direction r, the stenosis in the living body is expanded, and the stenosis is eliminated or the degree of stenosis is alleviated.

As shown in FIG. 21, the traction wires 50a and 50b are pulled by the stent 30 and the catheter in the longitudinal direction when the first outer tube 41 and the second outer tube 42 of the shaft portion 10 are moved with respect to the catheter 110. This is performed with a gap L6 between the 110 and 110. After confirming that the stent 30 has expanded, the medical instrument set 100 excluding the stent 30 is removed from the biological lumen Bl (ST7).

As described above, the medical instrument set 100 according to the present embodiment includes the medical instrument 1 and the catheter 110. The medical instrument 1 includes a treatment member that performs a predetermined treatment on a treatment target site existing in the living lumen BL of the patient, and a long shaft portion 10 that holds the treatment member at the tip portion. Further, the medical instrument 1 includes a long traction unit 50 that changes the treatment member into a state in which the treatment can be performed by a traction operation, and a hand operation unit 80 that enables the traction operation of the traction unit 50. Be prepared. The catheter 110 includes a main body portion 111 in which a lumen 115 through which the shaft portion 10 is inserted is formed, and a tip opening 119a communicating with the lumen 115. The catheter 110 forms a main body portion 111 longer than the length L3 in which the shaft portion 10 is exposed in the longitudinal direction from the tip opening portion 119a in a state where the shaft portion 10 is inserted into the lumen 115. The treatment member corresponding to the stent 30 is used in a state where the shaft portion 10 is inserted into the lumen 115 of the catheter 110 and the portion of the shaft portion 10 holding the treatment member is projected from the tip opening 119a of the catheter 110.

Further, in the treatment method using the medical instrument set 100, the medical instrument 1 and the catheter 110 described above are prepared, the shaft portion 10 is inserted into the lumen 115 of the catheter 110, and the shaft portion 10 of the medical instrument 1 is used. It includes a step of projecting a portion holding the treatment member from the tip opening 119a of the catheter 110, and a step of operating the hand operation unit 80 to perform treatment on the treatment target site by the treatment member. The treatment member corresponding to the stent 30 is introduced into the living body from the radial artery Ra in the human body and is carried to the lower limb blood vessel L corresponding to the treatment target site.

The tow wire constituting the tow portion is formed to be long so that it can be inserted into a living lumen having a long distance and a complicated shape. However, when the tow wire is inserted into a living lumen having a complicated shape and operated, the tow wire exposed to the outside of the living body may be deformed unintentionally. In this case, the configuration corresponding to the shaft portion may cause unintended behavior for the operator or the like in the longitudinal direction due to deformation such as bending of the tow wire. As a result, the stent discharged from the tubular member corresponding to the first outer tube may not be placed at the intended position.

On the other hand, in the present embodiment, the shaft portion 10 is formed in the catheter 110 having a length L2 longer than the length L3 where the shaft portion 10 is exposed from the catheter 110 when the shaft portion 10 is inserted through the catheter 110 as described above. The treatment is performed in the state where the catheter is inserted. The reason why the treatment member such as the stent 30 cannot be properly placed in the lumen of the living body is that the traction wires 50a and 50b are deformed such as bending at a position in the middle of the outside of the living body in the longitudinal direction as described above. Therefore, as described above, the traction wire 50a is tentatively treated by inserting the shaft portion 10 into the catheter 110 whose length L2 of the catheter 110 is longer than the length L3 where the shaft portion 10 is exposed from the catheter 110. Even if the catheter 110 is bent or the like, a force is applied in contact with the lumen wall of the catheter 110, so that the deformation of the tow wires 50a and 50b can be suppressed. Therefore, the stent 30 can be accurately placed in the living body. It should be noted that the above can be applied to medical devices other than stents as long as the treatment member suppresses deformation such as bending of the tow wires 50a and 50b.

Further, before the step of projecting the portion of the shaft portion 10 holding the treatment member from the tip opening 119a of the catheter 110, the tip opening 119a of the catheter 110 is delivered to the vicinity of the treatment target site of the biological lumen. After the shaft portion 10 is projected from the tip opening 119a of the catheter 110, the portion of the shaft portion 10 holding the treatment member is delivered to the treatment target site. Therefore, the catheter 110 can guide the treatment member to the treatment target site, and the procedure can be smoothly performed.

Further, the catheter 110 includes a proximal end opening 119b communicating with the lumen on the proximal end side. The length L2 of the main body portion 111 is from the length L4 in which the shaft portion 10 is exposed in the longitudinal direction from the tip of the hand operation portion 80 to the proximal end opening 119b of the catheter 110 in a state where the shaft portion 10 is inserted into the lumen. Is also formed long. By using a shaft portion having a relatively short length exposed not only on the distal end side but also on the proximal end side in this way, deformation such as bending of the tow wires 50a and 50b can be further suppressed, and the stent 30 can be formed. It can be placed in the living body with high accuracy.

Further, as a specific configuration of the medical instrument set, the treatment member includes a stent 30 that expands the treatment target site in the biological lumen Bl as described above, and the shaft portion 10 is a hollow first outer surface that accommodates the stent 30. A tube 41 is provided. Then, the traction portion 50 is configured to include the traction wires 50a and 50b that move the first outer tube 41 relatively to the proximal end side with respect to the stent 30, so that the stent 30 can be attached to the living tube as described above. It can be placed in an appropriate position in the cavity Bl.

Further, the step of performing the treatment with the stent 30 is performed in a state where the shaft portion 10 is relatively moved in the longitudinal direction with respect to the catheter 110 and a gap L6 is provided between the stent 30 and the catheter 110 in the longitudinal direction. Have steps. In order to suppress deformation such as bending of the traction wires 50a and 50b as described above, it is desirable to perform the treatment with the shaft portion 10 accommodated in the catheter 110 as much as possible in the longitudinal direction. However, if the site to be actually treated, such as the first outer tube 41, and the catheter 110 are too close to each other, it may be difficult to perform the treatment. Therefore, by performing treatment with the proximal end of the stent 30 and the distal end of the catheter 110 provided with a certain distance L6 in the longitudinal direction, the shaft is suppressed from being deformed such as bending of the tow wires 50a and 50b. The treatment by the unit 10 can be smoothly carried out.

Further, the shaft portion 10 constitutes the outer diameter d1 of the tow wire insertion tube 70 that constitutes the outer shape of the shaft portion 10 on the proximal end side to 45% or more of the inner diameter d2 of the catheter 110. Therefore, deformation such as bending on the proximal end side of the tow wires 50a and 50b can be effectively suppressed, and the treatment of the treatment member such as the stent 30 can be accurately performed.

Further, the medical instrument set 100 is configured to have an introducer sheath 120 having a lumen through which the catheter 110 is inserted, which is used when introducing the catheter 110 into the biological lumen Bl. Therefore, the shaft portion 10 and the catheter 110 can be smoothly introduced into the living lumen Bl.

Further, the shaft portion 10 includes a long inner tube 20 having a guide wire lumen 21 through which the guide wire G is inserted, and an outer tube 40 having a lumen capable of accommodating the inner tube 20. Further, the proximal end side tube 43b constituting the outer tube 40 is configured to include a lead-out hole 43d for leading one end portion of the guide wire G to the outside in the intermediate portion in the longitudinal direction of the shaft portion 10. Therefore, since it is not necessary to insert the guide wire G to the base end portion of the hand operation unit 80 in the medical instrument 1, the medical instrument 1 can be easily replaced.

(Example)
Examples of the present invention will be described below.

In this embodiment, an example and a comparative example having the combination of the medical instrument 1 and the catheter 110 described above are introduced into a lumen simulating a biological lumen, respectively, and the stent 30 is placed when the traction wires 50a and 50b are towed. I confirmed the difference in position.

In this example, Examples were composed of Examples 1 to 4, and Comparative Examples were composed of Comparative Examples 1 to 4. In Example 1, a shaft portion 10 having a total length L1 of 200 cm and a catheter 110 having a length L2 of 150 cm was used. Further, the length of the kink-resistant protector 114 of the catheter 110 is 5 cm, and the length of the portion where the size of the lumen is not constant is 2 cm, and the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110. The lengths L3 and L4 were set to 43 cm and 0 cm, respectively. The length of the kink-resistant protector 114 in the longitudinal direction and the length of the portion of the lumen of the catheter 110 where the size is not constant are the same in Examples 2 to 4 and Comparative Examples 1 to 4.

In Example 2, a shaft portion 10 having a total length L1 of 200 cm and a catheter 110 having a length L2 of 120 cm was used. Further, the lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 73 cm and 0 cm, respectively.

In Example 3, a shaft portion 10 having a total length L1 of 200 cm and a catheter 110 having a length L2 of 150 cm was used. Further, the lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 17 cm and 26 cm.

In Example 4, a shaft portion 10 having a total length L1 of 200 cm and a catheter 110 having a length L2 of 120 cm was used. Further, the lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 17 cm and 56 cm, respectively.

On the other hand, in Comparative Example 1, a shaft portion 10 having a total length L1 of 135 cm and a catheter 110 having a length L2 of 45 cm was used. Further, the lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 83 cm and 0 cm, respectively.

In Comparative Example 2, a shaft portion 10 having a total length L1 of 135 cm and a catheter 110 having a length L2 of 10 cm was used. Further, the lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 118 cm and 0 cm.

In Comparative Example 3, a shaft portion 10 having a total length L1 of 135 cm and a catheter 110 having a length L2 of 45 cm was used. The lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 17 cm and 66 cm, respectively.

In Comparative Example 4, a shaft portion 10 having a total length L1 of 135 cm and a catheter 110 having a length L2 of 10 cm was used. The lengths L3 and L4 where the shaft portion 10 is exposed from the distal end side and the proximal end side of the catheter 110 are set to 17 cm and 101 cm, respectively.

The inner diameter of the catheter 110 and the outer diameter of the first outer tube 41 of the shaft portion 10 are the same in Examples 1 to 4 and Comparative Examples 1 to 4, and the inner diameter of the catheter 110 is 2.2 mm and the shaft portion 10 is the first. 1 The outer diameter of the outer pipe 41 is about 2 mm (6 Fr).

The living lumen was simulated by a circular pipe made of PVC (polyvinyl chloride) with an inner diameter of 10 mm. The pipe is a straight pipe with one bend so that the placement position of the stent can be changed according to the specifications of the medical device. The angle of the bent portion was about 90 degrees, and the R (radius of curvature of the arc) of the bent portion was 10 mm.

In this example, the medical instruments of Examples 1 to 4 and Comparative Examples 1 to 4 were introduced into the simulated living lumen. Then, the tow wires 50a and 50b are towed by the hand operation unit 80 with the medical instrument introduced up to 30 mm after the bending point is crossed, and when the stent 30 is released from the first outer tube 41, the stent 30 is in the longitudinal direction. It was confirmed whether or not it deviated from the expected position. The experimental results are shown below.

As shown in Table 1, in Comparative Examples 1 to 4, the stent 30 was displaced in the longitudinal direction of the simulated biological lumen, but in Examples 1 to 4, the stent 30 was longitudinally displaced in the simulated biological lumen. It was confirmed that the positional deviation did not occur.

The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. In the above, the embodiment in which the medical instrument set 100 has the medical instrument 1, the catheter 110, and the introducer sheath 120 has been described. However, the present invention is not limited to this, and a medical device set without an introducer sheath 120 is also included in one embodiment of the present invention. Further, FIG. 1 shows an embodiment in which the length L4 from the proximal end opening 119b of the catheter 110 to the hand operating portion 80 is 0, but the present invention is not limited thereto. As shown in FIG. 23, a predetermined procedure may be performed with the catheter 110 arranged with respect to the medical device 1 so that L4 is not 0.

Further, in the above description, the procedure in which the shaft portion 10 includes the stent 30 and the stent 30 is placed in the living lumen Bl in the procedure has been described, but the procedure is not limited to this. In addition to the above, as shown in FIG. 23, the shaft portion 10 includes a microcatheter instead of the stent 30, and the tip portion of the microcatheter is used as a portion for holding the treatment member from the tip opening 119a of the catheter 110 during the procedure. Is also included in one embodiment of the present invention. In this case, the traction portion changes the tip of the microcatheter into a treatable state. Specifically, the tip of the microcatheter can be curved in the radial direction or the like.

1 medical equipment,
10 Shaft part,
20 inner tube,
30 Stent (treatment member),
40 outer pipe,
41 First outer pipe (storage member),
43d lead-out hole,
50 tow part,
50a, 50b tow wire,
80 Hand control unit,
100, 100a medical equipment set,
110 Catheter (tubular member),
115 lumen (of tubular member),
119a Tip opening,
119b Base end opening,
120 Introducer Sheath,
Bl biological lumen,
G guide wire,
L lower limb blood vessels,
L1 (longitudinal direction in the shaft part of the medical device) total length,
Length of L2 (in a section where the size of the lumen in the longitudinal direction of the tubular member is constant),
L3 (exposure that the shaft part is exposed from the tip opening of the tubular member) Length,
L4 (Exposure that the shaft part is exposed from the tip of the hand operation part to the base end opening of the tubular member) Length,
Length of L5 (of the tow wire in which the size of the lumen in the tubular member is housed in a fixed section),
L6 (between the treatment member and the tubular member when the treatment member is delivered to the treatment target site),
Ra radial artery.

Claims (5)

A treatment member introduced into the living body from the radial artery of the patient to perform a predetermined treatment on a treatment target site existing in a blood vessel of the lower limbs , and a long shaft portion holding the treatment member at the tip portion, and a traction operation is performed. Thereby, the treatment member has a long traction portion including a traction wire capable of suppressing bending deformation that changes the treatment member into a state in which the treatment can be performed, and a hand operation portion that enables traction operation of the traction portion. And equipped with medical equipment and
A main body portion having a lumen through which the shaft portion is inserted is provided, and a tip opening portion communicating with the lumen portion is provided. It has a tubular member formed longer than the exposed length at which the shaft portion is exposed in the longitudinal direction from the opening portion.
The tubular member further comprises a proximal opening communicating with the lumen on the proximal side.
The main body portion is longer than the exposed length in which the shaft portion is exposed in the longitudinal direction from the tip of the hand operation portion to the proximal end opening of the tubular member in a state where the shaft portion is inserted into the lumen. Formed,
The total length L1 of the shaft portion is 200 cm, the length L2 of the main body portion is 150 cm, and the exposed length L3 from the tip opening is 43 cm.
The treatment member is used in a state where the shaft portion is inserted into the lumen of the tubular member and the portion of the shaft portion holding the treatment member is projected from the tip opening of the tubular member. Medical equipment set. A treatment member introduced into the living body from the radial artery of the patient to perform a predetermined treatment on a treatment target site existing in a blood vessel of the lower limbs, and a long shaft portion holding the treatment member at the tip portion, and a traction operation is performed. Thereby, the treatment member has a long traction portion including a traction wire capable of suppressing bending deformation that changes the treatment member into a state in which the treatment can be performed, and a hand operation portion that enables traction operation of the traction portion. And equipped with medical equipment and
A main body portion having a lumen through which the shaft portion is inserted is provided, and a tip opening portion communicating with the lumen portion is provided. It has a tubular member formed longer than the exposed length at which the shaft portion is exposed in the longitudinal direction from the opening portion.
The tubular member further comprises a proximal opening communicating with the lumen on the proximal side.
The main body portion is longer than the exposed length in which the shaft portion is exposed in the longitudinal direction from the tip of the hand operation portion to the proximal end opening of the tubular member in a state where the shaft portion is inserted into the lumen. Formed,
The total length L1 of the shaft portion is 200 cm, the length L2 of the main body portion is 120 cm, and the exposed length L3 from the tip opening is 73 cm.
The treatment member is used in a state where the shaft portion is inserted into the lumen of the tubular member and the portion of the shaft portion holding the treatment member is projected from the tip opening of the tubular member . Medical equipment set. The medical device set according to claim 1 or 2, wherein the shaft portion has an outer diameter on the proximal end side of 45% or more of the inner diameter of the tubular member. The medical device set according to any one of claims 1 to 3, further comprising an introducer sheath having a lumen used for introducing the tubular member into the living body from the radial artery through which the tubular member is inserted. The shaft portion includes a long inner tube having a lumen through which a guide wire is inserted, and a long inner tube.
Further comprising a long outer tube with a lumen capable of accommodating the inner tube.
6. Medical equipment set.

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