WO2021140839A1

WO2021140839A1 - Catheter assembly and binding method

Info

Publication number: WO2021140839A1
Application number: PCT/JP2020/046573
Authority: WO
Inventors: 雄紀坂口
Original assignee: テルモ株式会社
Priority date: 2020-01-06
Filing date: 2020-12-14
Publication date: 2021-07-15
Also published as: JP7470717B2; JPWO2021140839A1

Abstract

This catheter assembly comprises a catheter for image diagnosis and an injection tube member. The catheter for image diagnosis is provided with: a tube member that can be inserted into a living body; a tube holding member connected to the tube member; and an insertion member that can move forward and backward along the tube member through a hollow part defined by the tube holding member. The hollow part of the tube holding member comprises a main lumen and an injection lumen communicating with the main lumen at a communication port. One end portion of the injection tube member is connected to the tube holding member to allow fluid communication with the injection lumen. The catheter is provided with a binding member for at least partially binding the part of the injection tube member extending from the one end portion toward the other end side to the tube holding member at a position on a further proximal side than the communication port in the longitudinal direction of the catheter.

Description

Catheter assembly and tying method

This disclosure relates to catheter assembly and tying methods.

A diagnostic imaging catheter is known that has a drive shaft that has a signal transmission / reception unit attached to the tip and can rotate and move forward and backward, and a sheath into which the drive shaft is inserted. The diagnostic imaging catheter may require a priming process in which the lumen of the sheath is filled with a priming solution such as physiological saline prior to use for the purpose of smoothly transmitting and receiving signals such as ultrasonic waves.

For example, in Patent Document 1, the relay connector connected to the base end of the sheath is provided with an injection port for the priming liquid, thereby reducing the flow path resistance of the priming liquid and enabling easy priming processing for diagnostic imaging. The catheter is described. The relay connector described in Patent Document 1 includes a port to which a syringe for performing a priming process is connected. The priming liquid reaches the injection port from the syringe via the port, and flows from this injection port into the lumen into which the drive shaft is movably inserted.

JP-A-2017-205430

In the diagnostic imaging catheter described in Patent Document 1, since the syringe is connected to the port of the relay connector, the flow path resistance of the priming liquid can be reduced as compared with the configuration in which the syringe is connected to the hub. However, the syringe connected to the port of the relay connector may be an obstacle to the healthcare professional during the procedure using the diagnostic imaging catheter. Therefore, the technique described in Patent Document 1 still has room for improvement from the viewpoint of operability during the procedure.

It is an object of the present disclosure to provide a catheter assembly and a bundling method that can reduce the flow path resistance of the priming liquid and improve the operability during the procedure.

The catheter assembly as the first aspect of the present disclosure is a catheter assembly including a diagnostic imaging catheter and an injection tube member connected to the diagnostic imaging catheter, and the diagnostic imaging catheter. Is provided with a tube member that can be inserted into a living body, a tube holding member connected to a proximal end of the tube member, and a signal transmitting / receiving section at the distal end, through a hollow portion defined by the tube holding member. An insertion member that is inserted into the tube member and can move forward and backward in the longitudinal direction of the catheter along the tube member is provided, and the hollow portion of the tube holding member is a main body through which the insertion member is inserted. The tube holding member includes a lumen and an injection lumen capable of injecting priming liquid while communicating with the main lumen at a communication port, and the tube holding member is located proximal to the communication port, and the insertion member is placed in the catheter. A mounting portion that can be mounted on an external device that moves forward and backward in the longitudinal direction is provided, and one end of the injection pipe member is connected to the pipe holding member so as to be fluidly communicated with the injection lumen. A bundling member is provided which binds at least a part of the portion extending from one end toward the other end to the tube holding member at a position proximal to the communication port in the longitudinal direction of the catheter.

In one embodiment of the present disclosure, the bundling member is located between the injection tube member and the tube at a position where the distance between the bundling member and the attachment portion is shorter than the distance between the bundling member and the communication port in the longitudinal direction of the catheter. It binds the holding member.

In one embodiment of the present disclosure, the bundling member is located between the injection tube member and the tube at a position in the longitudinal direction of the catheter where the distance between the injection tube member and the communication port is shorter than the distance between the attachment portion and the attachment portion. It binds the holding member.

In one embodiment of the present disclosure, the tube holding member includes a relay connector connected to a proximal end of the tube member, a unit connector having the mounting portion, and a distal end connected to the relay connector. The bundling member binds the injection tube member to at least one of the relay connector, the unit connector, and the outer tube. ing.

In one embodiment of the present disclosure, the bundling member comprises at least the injection tube member, the relay connector, the unit connector, and the outer tube in a state where the injection tube member extends along the outer tube. One and one are united.

As one embodiment of the present disclosure, the injection pipe member is connected to the pipe holding member from the position of the one end portion toward the other end side in parallel with the main lumen or from the one end portion. It extends so as to approach the main lumen toward the other end side.

The catheter assembly as the second aspect of the present disclosure is a catheter assembly including a diagnostic imaging catheter and an injection tube member connected to the diagnostic imaging catheter, and the diagnostic imaging catheter. Is provided with a tube member that can be inserted into a living body, a tube holding member connected to a proximal end of the tube member, and a signal transmitting / receiving section at the distal end, through a hollow portion defined by the tube holding member. An insertion member that is inserted into the tube member and can move forward and backward in the longitudinal direction of the catheter along the tube member is provided, and the hollow portion of the tube holding member is a main body through which the insertion member is inserted. The tube holding member includes a lumen and an injection lumen capable of injecting priming liquid while communicating with the main lumen at a communication port, and the tube holding member is located proximal to the communication port, and the insertion member is placed in the catheter. The injection lumen is provided with a mounting portion that can be attached to an external device that moves forward and backward in the longitudinal direction, and the injection lumen is provided with a portion extending along the main lumen at a position proximal to the communication port. The member is connected to the tube holding member at the proximal end of the injection lumen that extends along the main lumen and is fluidly communicative with the injection lumen.

In one embodiment of the present disclosure, the injection lumen is connected to the injection tube member at a position where the distance between the injection lumen and the communication port is shorter than the distance between the injection lumen and the communication port. It has a connecting port.

In one embodiment of the present disclosure, the tube holding member includes a relay connector connected to a proximal end of the tube member, a unit connector having the mounting portion, and a distal end connected to the relay connector. The main lumen is partitioned by the relay connector, the unit connector and the outer tube, and the injection lumen is the relay connector. The portion of the injection lumen extending along the main lumen extends along the outer tube.

The binding method as the third aspect of the present disclosure is a binding method for binding the diagnostic imaging catheter and the injection tube member, and the diagnostic imaging catheter includes a tube member that can be inserted into a living body and the tube. A tube holding member connected to the proximal end of the member and a signal transmitting / receiving section at the distal end are provided, and are inserted into the tube member through a hollow portion defined by the tube holding member, and are inserted into the tube member. An insertion member that can move forward and backward in the longitudinal direction of the catheter is provided, and the hollow portion of the tube holding member communicates with and primes the main lumen through which the insertion member is inserted at a communication port with the main lumen. A mounting portion that includes an injection lumen capable of injecting liquid, and the tube holding member can be attached to an external device that moves the insertion member forward and backward in the longitudinal direction of the catheter at a position proximal to the communication port. One end of the injection pipe member can be connected to the pipe holding member so as to be fluidly communicated with the injection lumen, and extends from the one end portion of the injection pipe member toward the other end side. At least a portion of the portion is bound to at least one of the tube holding member and the external device at a position proximal to the communication port in the longitudinal direction of the catheter.

As one embodiment of the present disclosure, at least a part of the portion of the injection pipe member extending from the one end portion toward the other end portion is formed by a binding member at least one of the pipe holding member and the external device. To unite.

As one embodiment of the present disclosure, at least a part of a portion of the injection pipe member extending from one end to the other end is provided on at least one of the pipe holding member and the external device. By fixing to the fixed portion, it is bound to at least one of the pipe holding member and the external device.

As one embodiment of the present disclosure, the injection tube member is bound to the tube holding member at a position in the longitudinal direction of the catheter where the distance from the attachment portion is shorter than the distance from the communication port. To do.

As one embodiment of the present disclosure, the injection tube member is bound to the tube holding member at a position in the longitudinal direction of the catheter where the distance from the communication port is shorter than the distance from the mounting portion. To do.

In one embodiment of the present disclosure, the tube holding member includes a relay connector connected to a proximal end of the tube member, a unit connector having the mounting portion, and a distal end connected to the relay connector. The injection tube member is bundled with at least one of the relay connector, the unit connector, and the outer tube.

As one embodiment of the present disclosure, the injection tube member is bound to at least one of the relay connector, the unit connector, and the outer tube in a state of extending along the outer tube.

According to the present disclosure, it is possible to provide a catheter assembly and a bundling method that can reduce the flow path resistance of the priming liquid and improve the operability during the procedure.

It is a diagnostic imaging apparatus including the catheter assembly as one embodiment of the present disclosure, and is the figure which shows the case where the catheter assembly is in a contraction limit state. It is the image diagnostic apparatus shown in FIG. 1, and is the figure which shows the case where the catheter assembly is in the extension limit state. It is sectional drawing of the vicinity of the relay connector in the extension limit state shown in FIG. It is sectional drawing of the vicinity of the unit connector in the extension limit state shown in FIG. It is a perspective view which shows the relay connector of the image diagnostic catheter of the catheter assembly shown in FIG. 1 and its vicinity. It is a figure which shows one modification of the catheter assembly shown in FIG. It is a figure which shows one modification of the catheter assembly shown in FIG. It is sectional drawing which shows one modification of the tube holding member in the image diagnostic catheter of the catheter assembly shown in FIG.

Hereinafter, the catheter assembly and the bundling method according to the present disclosure will be illustrated and described with reference to the drawings. The same reference numerals are given to common members and parts in each figure. In the present specification, a group operated by a medical worker from the distal end side of the diagnostic imaging catheter inserted into a living body in the longitudinal direction of the diagnostic imaging catheter (hereinafter, referred to as "catheter longitudinal direction"). The direction toward the distal side is described as "proximal side", and the direction from the proximal end side to the distal end side of the diagnostic imaging catheter is described as "distal side".

1 and 2 are diagrams showing a diagnostic imaging apparatus 100 including a catheter assembly 1 as an embodiment of the present disclosure. Specifically, the diagnostic imaging device 100 includes a catheter assembly 1, an external device 2, a control device 3, and a display device 4. FIG. 1 shows a case where the catheter assembly 1 is in a contraction limit state before the insertion member 13 is pulled back to the proximal side by the external device 2. FIG. 2 shows a case where the catheter assembly 1 is in the extension limit state after the insertion member 13 is moved to the reverse advance limit position by the external device 2 from the state of FIG.

The diagnostic imaging apparatus 100 can acquire tomographic image information capable of generating a tomographic image by imaging the inside of a vessel such as a blood vessel in a living body such as a human body by using a catheter assembly 1, an external device 2 and a control device 3. it can. Further, the diagnostic imaging device 100 can display a tomographic image or the like generated based on the tomographic image information by the control device 3 and the display device 4. The configuration of the diagnostic imaging apparatus 100 is not limited to the configuration shown in this embodiment. In the diagnostic imaging device 100, for example, the control device 3 and the display device 4 may be integrated with the external device 2. In such a case, the diagnostic imaging apparatus 100 may be composed of the catheter assembly 1 and the external apparatus 2.

As shown in FIGS. 1 and 2, the catheter assembly 1 includes a diagnostic imaging catheter 5, an injection tube member 6 connected to the diagnostic imaging catheter 5, an diagnostic imaging catheter 5, and an injection tube member. Includes a binding member 7 that binds 6.

The diagnostic imaging catheter 5 includes a tube member 11 that can be inserted into a living body, a tube holding member 12, and an insertion member 13. The pipe holding member 12 is connected to the proximal end of the pipe member 11. The pipe holding member 12 partitions the hollow portion 12a. The insertion member 13 includes a signal transmission / reception unit 28 at the distal end. Further, the insertion member 13 is inserted into the pipe member 11 through the hollow portion 12a in which the pipe holding member 12 is partitioned. The hollow portion 12a of the pipe holding member 12 includes a main lumen 12a1 through which the insertion member 13 is inserted, and an injection lumen 12a2 that communicates with the main lumen 12a1 at the communication port 14 and can inject the priming liquid. Since the injection lumen 12a2 is provided in the pipe holding member 12 in this way, the portion of the insertion member 13 located proximal to the pipe holding member 12 (for example, the hub 24 described later in the present embodiment) The flow path resistance of the priming liquid can be reduced as compared with the configuration in which the injection lumen 12a2 is provided.

Further, the insertion member 13 can move forward and backward along the tube member 11 in the longitudinal direction A of the catheter. "Advance / retreat movement" means both forward movement from the proximal side to the distal side in the longitudinal direction A of the catheter and backward movement in the opposite direction. Further, the tube holding member 12 includes a mounting portion 12b that can be mounted on an external device 2 that moves the insertion member 13 forward and backward in the longitudinal direction A of the catheter at a position proximal to the communication port 14. The insertion member 13 may move back and forth in the catheter longitudinal direction A with respect to the tube member 11 and the tube holding member 12 by the external device 2 in a state where the mounting portion 12b of the tube holding member 12 is mounted on the external device 2. it can. Details of the diagnostic imaging catheter 5 of this embodiment will be described later.

One end of the injection pipe member 6 is connected to the pipe holding member 12 so as to communicate with the injection lumen 12a2 described above. Details of the injection tube member 6 of this embodiment will be described later.

The binding member 7 binds at least a part of the injection pipe member 6 extending from one end toward the other end to the pipe holding member 12. The position where the binding member 7 binds a part of the injection tube member 6 to the tube holding member 12 is a position proximal to the communication port 14 in the longitudinal direction A of the catheter. When the catheter assembly 1 is provided with such a binding member 7, one end of the injection tube member 6 is connected to the tube holding member 12 of the diagnostic imaging catheter 5 from one end of the injection tube member 6. The portion extending to the other end side is less likely to extend to the distal side than the pipe holding member 12. As a result, it is possible to prevent the injection tube member 6 from interfering with the tube member 11 that can be inserted into the living body. Therefore, for example, when a medical worker operates the tube member 11, the injection tube member 6 becomes an obstacle. It's hard to be. Further, in a state where one end of the injection tube member 6 is connected to the tube holding member 12 of the diagnostic imaging catheter 5, at least a part of the portion extending from one end to the other end of the injection tube member 6 is bound. The member 7 binds the pipe holding member 12 to the tube holding member 12. Therefore, the injection pipe member 6 is less likely to swing freely with respect to the pipe holding member 12. Thereby, for example, when the medical worker moves the diagnostic imaging catheter 5 during the procedure, the injection tube member 6 can be prevented from swinging and becoming an obstacle to the medical worker. Details of the binding member 7 of this embodiment will be described later.

As described above, in the catheter assembly 1, at least a part of the injection tube member 6 extending from one end to the other end connected to the tube holding member 12 is attached to the tube holding member 12. A binding member 7 for binding is provided. Therefore, according to the catheter assembly 1, it is possible to reduce the flow path resistance of the priming liquid and improve the operability during the procedure.

Next, the details of the diagnostic imaging catheter 5 of the present embodiment will be described.

As described above, the diagnostic imaging catheter 5 of the present embodiment includes a tube member 11, a tube holding member 12, and an insertion member 13. In the diagnostic imaging catheter 5, the insertion member 13, the tube member 11, and the tube holding member 12 form a telescopic structure that can be expanded and contracted.

Specifically, the insertion member 13, the pipe member 11, and the pipe holding member 12 are in a contraction limit state in which further contraction is restricted (see FIG. 1) and an extension limit state in which further expansion is restricted (see FIG. 1). It can be expanded and contracted with (see FIG. 2).

The pipe member 11 of the present embodiment includes a reinforcing shaft 19 and a sheath 20. The pipe holding member 12 of the present embodiment includes a relay connector 21, a unit connector 22, and an outer pipe 23. Further, the insertion member 13 of the present embodiment includes a hub 24, an inner pipe 25, a support pipe 26, a drive shaft 27, and a signal transmission / reception unit 28. FIG. 3 is a cross-sectional view showing a cross section in the vicinity of the relay connector 21 in the extension limit state shown in FIG. FIG. 4 is a cross-sectional view showing a cross section in the vicinity of the unit connector 22 in the extension limit state shown in FIG.

As shown in FIGS. 1 to 3, the proximal end of the tube member 11 of the present embodiment is connected to the distal end of the relay connector 21. Specifically, the outer peripheral surface of the proximal end of the sheath 20 of the tube member 11 of the present embodiment is fixed to the inner peripheral surface of the distal end of the relay connector 21 by joining means such as welding. The proximal end of the sheath 20 is abutted against an annular stepped surface provided on the inner peripheral surface of the distal end of the relay connector 21. A reinforcing shaft 19 for suppressing kink is provided on the outer peripheral surface of the proximal end portion of the sheath 20. The proximal end of the sheath 20 protrudes proximally to the proximal end of the reinforcing shaft 19. The inner peripheral surface of the reinforcing shaft 19 is fixed to the outer peripheral surface of the proximal end of the sheath 20 by joining means such as welding. The outer peripheral surface at the proximal end of the reinforcing shaft 19 is fixed to the inner peripheral surface at the distal end of the relay connector 21 by joining means such as welding.

Further, as shown in FIGS. 1 and 2, a tubular guide portion 20a into which a guide wire can be inserted is provided at the distal end of the sheath 20.

The reinforcing shaft 19 and the sheath 20 of the pipe member 11 are preferably made of a flexible material, but the material is not particularly limited. The reinforcing shaft 19 and the sheath 20 are made of various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based. Etc., and one or a combination of two or more of these (polymer alloy, polymer blend, laminate, etc.) may be used. A hydrophilic lubricating coating layer that exhibits lubricity when wet may be arranged on the outer surface of the sheath 20.

The pipe member 11 of the present embodiment is composed of the reinforcing shaft 19 and the sheath 20, but the configuration is not particularly limited. Therefore, the pipe member 11 may be composed of, for example, only the sheath 20.

As shown in FIGS. 1 to 3, the distal end of the outer tube 23 is connected to the proximal end of the relay connector 21. As shown in FIGS. 1, 2, and 4, the distal end of the unit connector 22 is connected to the proximal end of the outer tube 23. The reinforcing shaft 19 and sheath 20 of the pipe member 11, and the relay connector 21, the unit connector 22, and the outer pipe 23 of the pipe holding member 12 are integrated so as not to move relative to each other.

As shown in FIGS. 1 to 3, the relay connector 21 includes a main body portion 21a and a port portion 21b. The main body portion 21a partitions the main body hollow portion penetrating in the longitudinal direction A of the catheter. The port portion 21b protrudes from the main body portion 21a, and partitions the hollow portion of the main body and the hollow portion of the port connected by the communication port 14.

In the hollow portion of the main body of the main body 21a of the relay connector 21, between the inner surface of the main body 21a and the outer peripheral surface of the support pipe 26 among the insertion members 13 inserted, on the proximal side of the communication port 14. A sealing member 16 for sealing is arranged. An X ring is used as the seal member 16. The seal member 16 may be, for example, an O-ring. By providing the sealing member 16, it is possible to prevent the priming liquid from flowing back to the proximal side of the communication port 14. As shown in FIG. 3, the relay connector 21 of the present embodiment is composed of a first member 17 on the distal side and a second member 18 on the proximal side. The first member 17 and the second member 18 are connected to be screwed together with the seal member 16 interposed therebetween. Details of the above-mentioned priming process will be described later.

The unit connector 22 and the outer tube 23 partition a hollow portion penetrating in the longitudinal direction A of the catheter.

The hollow portion 12a of the pipe holding member 12 of the present embodiment is composed of a hollow portion of the relay connector 21, a hollow portion of the unit connector 22, and a hollow portion of the outer pipe 23. The main lumen 12a1 of the hollow portion 12a of the pipe holding member 12 of the present embodiment is composed of a main body hollow portion of the main body portion 21a of the relay connector 21, a hollow portion of the unit connector 22, and a hollow portion of the outer pipe 23. There is. In the present embodiment, the main lumen 12a1 extends over the relay connector 21, the unit connector 22, and the outer pipe 23. The injection lumen 12a2 of the hollow portion 12a of the pipe holding member 12 of the present embodiment is composed of the port hollow portion of the port portion 21b of the relay connector 21.

The injection lumen 12a2 of the present embodiment is composed of a hollow port portion of the port portion 21b projecting from the main body portion 21a of the relay connector 21, but is not limited to this configuration. One end of the injection lumen 12a2 may communicate with the main lumen 12a1 via the communication port 14, and the other end may communicate with the outside of the pipe holding member 12. Therefore, the injection lumen 12a2 does not have to be divided into the port portion 21b protruding from the main body portion 21a, and may branch from the main lumen 12a1 and communicate with the outside of the relay connector 21. Further, although the injection lumen 12a2 of the present embodiment is partitioned by the relay connector 21, it may be partitioned by other members such as the unit connector 22 that constitutes the pipe holding member 12. However, from the viewpoint of reducing the flow path resistance of the priming liquid, it is preferable that the communication port 14 is provided on the distal side of the pipe holding member 12. Therefore, it is preferable that the communication port 14 is provided in the relay connector 21 as in the present embodiment. Therefore, the injection lumen 12a2 is preferably partitioned by the relay connector 21.

In the present embodiment, one end of the injection pipe member 6, which will be described later, is connected to the port portion 21b of the relay connector 21 so as to communicate with the injection lumen 12a2 in a fluid manner. The details will be described later (see FIG. 3).

Further, in the pipe holding member 12 of the present embodiment, the mounting portion 12b that can be mounted on the external device 2 is provided on the unit connector 22. Specifically, the mounting portion 12b of the present embodiment is an annular groove provided in the unit connector 22. The clamp portion 2m provided in the external device 2 sandwiches the unit connector 22 in a state of being fitted into the above-mentioned annular groove as the mounting portion 12b of the unit connector 22. As a result, the unit connector 22 is fixed to the external device 2. However, the mounting portion 12b of the unit connector 22 is not limited to the above-mentioned annular groove, and the configuration is not particularly limited as long as the unit connector 22 can be fixed to the external device 2.

As shown in FIGS. 1 and 2, in the present embodiment, the outer tube 23 located on the distal side of the unit connector 22 is in a state where the mounting portion 12b of the unit connector 22 is mounted on the external device 2. It is supported horizontally from the unit connector 22 in a cantilever shape. In this state, the weight of the relay connector 21 or the like connected to the outer pipe 23 is applied to the free end side (distal end side) of the outer pipe 23. On the other hand, the outer pipe 23 can maintain a state of extending linearly in the horizontal direction. In this way, the outer tube 23 has a flexural rigidity that makes it difficult for the other side to bend even if the weight of the relay connector 21 or the like acts on the other side while one end in the longitudinal direction is cantilevered in the horizontal state. Have. As a result, the inner pipe 25 can easily move back and forth in the outer pipe 23 with the mounting portion 12b of the unit connector 22 mounted on the external device 2. Further, when the inner pipe 25 moves back and forth in the outer pipe 23, the bending state of the outer pipe 23 is unlikely to fluctuate. Therefore, the pipe member 11 and the insertion member 13 in the pipe member 11 are catheterized due to the bending fluctuation of the outer pipe 23. It is possible to suppress unintentional movement in the longitudinal direction A. On the other hand, the sheath 20 described above preferably has flexibility that can be flexibly deformed along the vessels in the living body. Therefore, the bending rigidity of the outer pipe 23 is preferably larger than the bending rigidity of the sheath 20 of the pipe member 11 described above. Flexural rigidity of the outer tube 23 ^is preferably 5 Nm 2 ~ 100 Nm ^{^2,} more preferably 10Nm ² ~ 50Nm 2. The outer tube 23 can be made of various resin materials so that the bending rigidity is larger than that of the sheath 20. The material constituting the outer pipe 23 is not particularly limited, and for example, the same material as the reinforcing shaft 19 and the sheath 20 described above may be used.

Materials of the relay connector 21 and the unit connector 22 include, for example, polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide. Polyethylene; Polyethyleneimide; Polycarbonate; Poly- (4-methylpentene-1); Ionomer; Acrylic resin; Polymethylmethacrylate; Acrylonitrile-butadiene-styrene copolymer (ABS resin); Acrylonitrile-styrene copolymer (AS resin) ); butadiene-styrene copolymer; polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; polyetherketone (PEK); polyetheretherketone (PEEK); Polyetherimide; Polyacetal (POM); Polyphenylene oxide; Modified polyphenylene oxide; Polysulfone; Polyethersulfone; Polyphenylene sulfide; Polyallylate; Aromatic polyester (liquid crystal polymer); Polytetrafluoroethylene, polyvinylidene fluoride, and other fluororesins Various resin materials such as; can be mentioned.

The proximal end of the inner tube 25 is connected to the distal end of the hub 24. The proximal end of the support tube 26 is connected to the distal end of the inner tube 25. The hub 24, the inner pipe 25, and the support pipe 26 are integrated so as not to move relative to each other.

The drive shaft 27 is made of a flexible long body extending in the pipe member 11. The drive shaft 27 is composed of, for example, a multi-layer coil having different winding directions around the shaft. Examples of the coil material include stainless steel and Ni-Ti (nickel-titanium) alloys. The proximal end of the drive shaft 27 is rotatably supported around the central axis O1 with respect to the hub 24. A signal transmission / reception unit 28 is attached to the distal end of the drive shaft 27. The signal transmission / reception unit 28 can transmit a signal (inspection wave) such as an ultrasonic signal or an optical signal to the vessel and receive the reflected signal. The signal transmission / reception unit 28 can be configured by, for example, an ultrasonic vibrator including a piezoelectric element. Inside the drive shaft 27, a signal line (not shown) that enables communication between the signal transmission / reception unit 28 and the control device 3 via the external device 2 is provided. The signal transmission / reception unit 28 can rotate around the central axis O1 integrally with the drive shaft 27.

The drive shaft 27 is inserted into the reinforcing shaft 19, the sheath 20, the relay connector 21, the unit connector 22, the outer pipe 23, the hub 24, the inner pipe 25, and the support pipe 26.

As shown in FIGS. 1 and 2, the hub 24, the inner pipe 25, the support pipe 26, and the drive shaft 27 are relative to the reinforcing shaft 19, the sheath 20, the relay connector 21, the unit connector 22, and the outer pipe 23. , It is possible to move forward and backward as a unit (that is, it is possible to move forward and backward).

As shown in FIG. 1, in the above-described telescopic structure including the insertion member 13, the tube member 11, and the tube holding member 12, the distal end surface of the hub 24 is proximal to the unit connector 22 in the present embodiment. It is configured to be in a contraction limit state when it comes into contact with the end face. Further, as shown in FIG. 4, in the above-mentioned telescopic structure, the extension limit is reached by the stepped surface 25a provided at the distal end of the inner tube 25 coming into contact with the stepped surface 22a provided inside the unit connector 22. It is configured to be in a state. The stepped surface 25a of the inner pipe 25 and the stepped surface 22a of the unit connector 22 each form an annular shape whose diameter increases from the proximal side to the distal side. In the present embodiment, the above-mentioned telescopic structure composed of the insertion member 13, the pipe member 11, and the pipe holding member 12 realizes the contraction limit state and the extension limit state by the contact between the various surfaces described above. There is. However, a telescopic structure that realizes a contraction limit state and an extension limit state by abutting between surfaces different from the surfaces shown here may be used.

The hub 24, the inner pipe 25, the support pipe 26, the drive shaft 27, and the signal transmission / reception unit 28 constituting the insertion member 13 of the present embodiment have a forward limit position (see FIG. 1) in which the above-mentioned telescopic structure is in the contraction limit state. The telescopic structure can be moved back and forth in the longitudinal direction A of the catheter from the backward limit position (see FIG. 2) in which the telescopic structure is in the extension limit state.

The support tube 26 is provided on the outer peripheral surface of the drive shaft 27 along the axial direction, and is configured to move back and forth together with the drive shaft 27 in the longitudinal direction A of the catheter. The distal end of the support tube 26 can be moved to a position distal to the communication port 14 by moving from the backward limit position (see FIG. 2) to the forward limit position (see FIG. 1). The support tube 26 accommodates the drive shaft 27 with a slight gap (not shown) sufficient to allow smooth rotation of the drive shaft 27 and suppress local deformation of the drive shaft 27. .. Therefore, when the support pipe 26 is interposed between the rotating drive shaft 27 and the communication port 14, the drive shaft 27 enters the communication port 14 while being deformed in a toggle shape, resulting in malfunction such as screw breakage. The occurrence can be suppressed.

On the other hand, as shown in FIG. 3, the distal end of the support tube 26 moves from the forward limit position (see FIG. 1) to the reverse limit position (see FIG. 2), thereby being proximal to the communication port 14. It can be moved to the side position. That is, the distal end of the support tube 26 is located proximal to the communication port 14 with the insertion member 13 in the reverse limit position (see FIG. 2). By performing the priming process in this state, the injection resistance of the priming liquid flowing into the main lumen 12a1 from the communication port 14 can be reduced. Therefore, the priming process can be performed more smoothly. Details of the priming process will be described later.

As shown in FIG. 4, the proximal end of the support tube 26 is fixed to the distal end face of the inner tube 25 by an adhesive portion 29 composed of an adhesive. The proximal end of the support tube 26 and the distal end of the inner tube 25 may be fixed to each other by a fixing means such as welding other than an adhesive. The unit connector 22 of the present embodiment is composed of a distal side member 22b having a male threaded portion and a proximal side member 22c having a female threaded portion screwed with the male threaded portion. However, the number of members constituting the unit connector 22 can be increased or decreased as appropriate.

Next, the details of the injection pipe member 6 of the present embodiment will be described.

The injection pipe member 6 is used when injecting the priming liquid. The injection tube member 6 of the present embodiment is composed of a medical tube 31 whose one end is connected to the relay connector 21. A medical female connector 32 is attached to the other end of the medical tube 31 constituting the injection tube member 6 of the present embodiment. During the priming process, a priming liquid supply device such as a syringe is connected to the medical scalpel connector 32. The priming liquid is supplied from this supply device to the injection lumen 12a2 of the relay connector 21 through the medical tube 31 as the injection tube member 6. The priming liquid supplied to the injection lumen 12a2 flows into the main lumen 12a1 through the communication port 14 and is supplied to the distal end of the sheath 20 of the pipe member 11.

As shown in FIG. 3, the injection pipe member 6 of the present embodiment is connected to the relay connector 21 of the pipe holding member 12. More specifically, one end of the injection pipe member 6 is inserted into the port portion 21b from the connecting port 15 of the relay connector 21 so that the hollow portion of the injection pipe member 6 communicates with the injection lumen 12a2 in a fluid manner. , Fixed to the port portion 21b. The injection pipe member 6 and the port portion 21b may be fixed by a joining means such as adhesion or welding.

The injection tube member 6 is preferably made of a flexible material, but the material is not particularly limited. Examples of the material of the injection tube member 6 include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, and fluorine. Various rubber materials such as rubber, and various thermoplastics such as styrene-based, polyolefin-based, polyvinyl chloride-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based. Elastoma may be mentioned, and one or a mixture of two or more of these may be used.

The injection pipe member 6 is preferably configured so that the bending rigidity is smaller than that of the outer pipe 23 described above. Further, the injection pipe member 6 is preferably configured so that the bending rigidity is smaller than that of the sheath 20 described above. By doing so, it becomes easy to dispose the injection tube member 6 along the catheter longitudinal direction A of the diagnostic imaging catheter 5.

Further, the length of the injection tube member 6 may be longer than the distance in the catheter longitudinal direction A from the connection port 15 to which one end of the injection tube member 6 is connected to the housing 2c described later of the external device 2. Good. By doing so, it becomes easy for the medical staff to grasp the injection pipe member 6 and the housing 2c of the external device 2 together with one hand. Therefore, it is possible to improve the operability when the medical staff moves the catheter assembly 1 and the external device 2 during the procedure.

Next, the details of the binding member 7 of the present embodiment will be described.

FIG. 5 is a perspective view showing the relay connector 21 of the diagnostic imaging catheter 5 of the catheter assembly 1 of the present embodiment and its vicinity. As shown in FIGS. 1 to 3 and 5, the binding member 7 of the present embodiment is a binding band that binds the injection pipe member 6 and the pipe holding member 12. Specifically, the binding band as the binding member 7 of the present embodiment is a portion of the injection pipe member 6 extending from one end to the other end connected to the port portion 21b of the relay connector 21. A part is bound to the outer pipe 23 at a position proximal to the communication port 14. As shown in FIGS. 1 to 3 and 5, one end of the medical tube 31 as the injection tube member 6 of the present embodiment is connected to the port portion 21b of the relay connector 21. The medical tube 31 is arranged along the relay connector 21 and the outer tube 23 from one end connected to the relay connector 21 toward the other end. In this state, the medical tube 31 is bound to the outer tube 23 by being surrounded by the binding band as the binding member 7 together with the outer tube 23.

By providing such a binding member 7, the injection tube member 6 extending from the tube holding member 12 is suppressed from freely swinging with respect to the diagnostic imaging catheter 5, which interferes with the procedure of the medical staff. It can be suppressed.

The catheter assembly 1 of the present embodiment includes two binding members 7. Specifically, one of the binding members 7a is located in the catheter longitudinal direction A at a position where the distance between the injection tube member 6 and the tube holding member 12 is shorter than the distance between the communication port 14 and the attachment portion 12b. Is united. A comparison is made between the case where the binding member 7a is provided at such a position and the case where the binding member is arranged at a position where the distance between the bundling member 7a and the communication port 14 is shorter than the distance between the bundling portion 12b and the catheter longitudinal direction A. .. Comparing the two, in the case of the former configuration, even if a tensile force is erroneously applied in the axial direction of the injection pipe member 6, the bending moment acting on the pipe holding member 12 with the position of the mounting portion 12b as a fulcrum is reduced. Can be done. Therefore, bending deformation of the pipe holding member 12 can be suppressed. As a result, it is possible to prevent the tube member 11 connected to the tube holding member 12 and the insertion member 13 in the tube member 11 from unintentionally moving in the longitudinal direction A of the catheter.

Further, the other bundling member 7b of the catheter assembly 1 of the present embodiment is at a position where the distance between the catheter assembly 1 and the communication port 14 is shorter than the distance between the catheter assembly 1 and the attachment portion 12b in the catheter longitudinal direction A. 6 and the pipe holding member 12 are bound together. A comparison is made between the case where the binding member 7b is provided at such a position and the case where the binding member is arranged at a position where the distance between the bundling member 7b and the attachment portion 12b is shorter than the distance between the bundling member 7b in the longitudinal direction A of the catheter. To do. Comparing the two, in the case of the former configuration, the portion extending from one end portion connected to the pipe holding member 12 of the injection pipe member 6 toward the other end side is connected to the pipe holding member 12. The gap between the injection pipe member 6 and the pipe holding member 12 can be kept small in the vicinity of one end portion. Therefore, it is possible to reduce the possibility that another medical device such as a guide wire is erroneously inserted into the above-mentioned gap.

The binding member 7 of the present embodiment binds the injection pipe member 6 and the outer pipe 23, but is not limited to this configuration. The binding member 7 may bind the injection pipe member 6 and the pipe holding member 12 on the proximal side of the communication port 14. Therefore, the binding member 7 of the present embodiment may bind the injection pipe member 6 and at least one of the relay connector 21, the unit connector 22, and the outer pipe 23.

Further, as shown in FIG. 5 and the like, the catheter assembly 1 of the present embodiment includes two

binding members

7a and 7b at different positions in the catheter longitudinal direction A, but is not limited to this configuration. The catheter assembly 1 may include only one of the two

binding members

7a and 7b. However, it is preferable that the catheter assembly 1 has a configuration in which both of the two

binding members

7a and 7b are provided, as compared with a configuration in which only one of the two

binding members

7a and 7b is provided. By doing so, the effects of the two

binding members

7a and 7b described above can be obtained. However, the catheter assembly 1 extends one binding member 7 extending from the position where one binding member 7a is provided to the position where the other binding member 7b is provided in the catheter longitudinal direction A. You may prepare.

Further, the binding member 7 binds the injection pipe member 6 and at least one of the relay connector 21, the unit connector 22, and the outer pipe 23 in a state where the injection pipe member 6 extends along the outer pipe 23. Is preferable. By doing so, the binding member 7 can maintain the state in which the injection pipe member 6 extends along the outer pipe 23. Therefore, the injection tube member 6 can be easily gripped together with the outer tube 23, and the injection tube member 6 does not easily interfere with the medical staff. Further, it is difficult for a gap to be formed between the injection pipe member 6 and the outer pipe 23. Therefore, it is possible to reduce the possibility that the medical staff mistakenly inserts the medical device into the gap between the injection tube member 6 and the outer tube 23 during the procedure.

Further, it is preferable that the injection pipe member 6 extends in parallel with the main lumen 12a1 from the position of one end portion connected to the pipe holding member 12 toward the other end side. Alternatively, as in the present embodiment, the injection pipe member 6 extends so as to approach the main lumen 12a1 from the position of one end connected to the pipe holding member 12 toward the other end. preferable. With such a configuration, it becomes difficult for a gap to be formed between the injection pipe member 6 and the pipe holding member 12 in the vicinity of one end of the injection pipe member 6 described above. When the injection pipe member 6 extends in parallel with the main lumen 12a1, the injection pipe member 6 extends linearly along the central axis O2 of the main lumen 12a1 (the same as the central axis O1 of the drive shaft 27 in this embodiment). It is not limited to the case of extension. The distance between the injection pipe member 6 and the main lumen 12a1 may be constant in a cross section orthogonal to the central axis O2 of the main lumen 12a1. Therefore, the configuration in which the injection pipe member 6 extends while spirally swirling around the main lumen 12a1 is also one aspect of the configuration in which the injection pipe member 6 extends in parallel with the main lumen 12a1.

In the above configuration, the distance between the virtual straight line X and the central axis O2 of the main lumen 12a1 in the cross section orthogonal to the central axis O2 of the main lumen 12a1 becomes constant or as it goes toward the proximal side. The injection lumen 12a2 may be configured so as to approach each other. The virtual straight line X is a straight line obtained by extending the central axis O3 of the injection lumen 12a2 from the connecting port 15 on the opposite side of the communication port 14. In other words, the virtual straight line X is the position of the connecting port 15 of the portion on the main lumen 12a1 side (lower portion in FIG. 3) of the inner peripheral surface for partitioning the injection lumen 12a2 in the cross-sectional view of FIG. It is a straight line parallel to the tangent line of. In FIG. 3, for convenience of explanation, the central axis O3 is shown by a long-dashed line, and the virtual straight line X is shown by a long-dashed line. The virtual straight line X of the injection lumen 12a2 of the present embodiment extends so as to approach the central axis O2 toward the proximal side.

The binding member 7 of the present embodiment is an annular binding band, but the configuration is not particularly limited as long as the injection tube member 6 and the tube holding member 12 of the diagnostic imaging catheter 5 can be bound. Therefore, the binding member 7 may be, for example, a clamp member that clamps and binds the injection tube member 6 and the tube holding member 12 of the diagnostic imaging catheter 5. Further, the binding member 7 may be, for example, an adhesive member composed of an adhesive that is interposed between the injection tube member 6 and the tube holding member 12 of the diagnostic imaging catheter 5 and adheres the two. Good.

Further, in the catheter assembly 1, at least a part of the injection tube member 6 whose one end is fixed to the tube holding member 12 extending from one end to the other end is formed by the binding member 7. Although it is bound to the tube holding member 12, it is not limited to this configuration. As in the modified example shown in FIG. 6, of the injection pipe member 6 whose one end is fixed to the pipe holding member 12, at least a part of the portion extending from one end to the other end is, for example, a pipe. By being fixed to the fixing portion 12c provided on the holding member 12, it may be bound to the pipe holding member 12. As shown in FIG. 6, the fixing portion 12c may be provided on both the relay connector 21 and the unit connector 22, or may be provided on only one of them. Further, of the injection pipe member 6 whose one end is fixed to the pipe holding member 12, at least a part of the portion extending from one end to the other end is provided on, for example, the injection pipe member 6. By being fixed to the fixed portion, it may be bound to the pipe holding member 12. As described above, the injection pipe member 6 and the pipe holding member 12 do not have to be bound by using the binding member 7 which is separate from the injection pipe member 6 and the pipe holding member 12.

Further, in the catheter assembly 1 of the present embodiment, of the injection tube member 6 whose one end is fixed to the tube holding member 12, at least a part of the portion extending from one end to the other end is a tube. Although it is bound to the holding member 12, it is not limited to this configuration. As in the modified example shown in FIG. 7, of the injection pipe member 6 whose one end is fixed to the pipe holding member 12, at least a part of the portion extending from one end to the other end is a pipe holding member. 12 may be bound to the external device 2 by being fixed to the fixing portion 2n provided on the external device 2 to which the 12 is mounted.

Further, the injection pipe member 6 may be bound to both the pipe holding member 12 and the external device 2.

Further, the binding means of the injection pipe member 6, the pipe holding member 12, and the external device 2 may be, for example, joined by welding or the like.

As described above, in the binding method for binding the diagnostic imaging catheter 5 and the injection tube member 6, at least a part of the portion extending from one end to the other end of the injection tube member 6 is formed in the longitudinal direction of the catheter. In A, it may be bound to at least one of the pipe holding member 12 and the external device 2 at a position proximal to the communication port 14. Therefore, as shown in FIGS. 1 to 5, at least a part of the portion extending from one end to the other end of the injection pipe member 6 is covered with a binding member 7 such as a binding band to hold the pipe holding member 12. Alternatively, it may be bound to the external device 2. Further, as shown in FIGS. 6 and 7, at least a part of a portion extending from one end to the other end of the injection pipe member 6 is provided on at least one of the pipe holding member 12 and the external device 2. By fixing to the fixed portion (“fixing portion 12c” in the example shown in FIG. 6 and “fixing portion 2n” in the example shown in FIG. 7), the pipe holding member 12 and the external device 2 are bound to each other. You may. Further, as described above, at least a part of the portion extending from one end to the other end of the injection pipe member 6 is joined by bonding, welding, or the like to at least the pipe holding member 12 and the external device 2. You may bind to one side.

Further, the binding position and binding posture of the injection pipe member 6 to the pipe holding member 12 are not limited by the binding means such as joining, pinching, and enclosing. Therefore, the binding position and the binding posture of the injection pipe member 6 to the pipe holding member 12 may be, for example, the same binding position and binding posture as in the present embodiment shown in FIGS. 1 to 5.

As shown in FIGS. 1 and 2, the external device 2 moves back and forth between the rotary drive unit 2a that rotationally drives the drive shaft 27 and the signal transmission / reception unit 28, and the insertion member 13 including the drive shaft 27 and the signal transmission / reception unit 28. It has an advancing / retreating movement mechanism 2b.

The rotary drive unit 2a has a housing 2c to which the hub 24 of the insertion member 13 can be attached and detached, and a spindle 2d to which the drive shaft 27 can be attached and detached while being arranged inside the housing 2c. The spindle 2d is connected to the proximal end of the drive shaft 27 via a connector (not shown) rotatably supported inside the hub 24 about the central axis O1 so as to be inside the drive shaft 27. The communication line can be communicably connected to the control device 3. Further, the main shaft 2d can be rotated about the central axis O1 by rotating the main shaft 2d around the central axis O1 by a rotary drive source 2e such as a motor in a state of being connected to the drive shaft 27. ..

The advancing / retreating moving mechanism 2b is a base that supports the housing 2c of the rotational driving unit 2a, the rotational driving source 2f such as a motor, the ball screw mechanism 2g that advances / retreats the housing 2c by the rotational driving source 2f, and the ball screw mechanism 2g. It has 2h and a unit connector holding portion 2i that is integrally connected to the base 2h. The ball screw mechanism 2g is composed of a screw shaft 2j which is pivotally supported by the base 2h and is rotationally driven by the rotation drive source 2f, and a nut 2k fixed to the housing 2c. The unit connector holding portion 2i includes a clamp portion 2m that detachably holds and holds the mounting portion 12b of the unit connector 22. Therefore, the unit connector 22 of the diagnostic imaging catheter 5 can be fixed to the unit connector holding portion 2i of the external device 2.

The external device 2 is a drive shaft of the insertion member 13 from a state in which the insertion member 13 is in the forward limit position as shown in FIG. 1 by a control signal from the control device 3 with the diagnostic imaging catheter 5 attached. As shown in FIG. 2, a pullback operation can be performed in which the insertion member 13 is moved backward to a predetermined position in front of the state in which the insertion member 13 is in the reverse advance limit position while rotating the 27 by the rotation drive unit 2a. In the present embodiment, "a state in which the diagnostic imaging catheter 5 is attached to the external device 2" means that the drive shaft 27 of the diagnostic imaging catheter 5 is connected to the rotation drive unit 2a of the external device 2 and is external. It means a state in which the unit connector 22 of the diagnostic imaging catheter 5 is fixed to the unit connector holding portion 2i of the advancing / retreating moving mechanism 2b of the device 2. The rotation speed of the drive shaft 27 is, for example, 1800 rpm. The control device 3 is composed of a processor such as a CPU.

From the start to the end of the pullback operation, the signal transmission / reception unit 28 transmits a signal (inspection wave) to the vessel while rotating, and receives the reflected signal. The signal transmission / reception unit 28 transmits a measurement signal based on this received signal to the control device 3 through a signal line inside the drive shaft 27. The control device 3 causes a display device 4 such as a display to display an image of the vessel based on the measurement signal.

The diagnostic imaging catheter 5 requires a priming process in which the inside of the sheath 20 is filled with a priming solution such as a physiological saline solution prior to imaging the vessel by the pullback operation. The priming process will be described below.

First, when performing the priming process, the insertion member 13 is moved to the reverse limit position (see FIG. 2). By doing so, the distal end of the support tube 26 of the insertion member 13 can be moved to the proximal side of the communication port 14 of the relay connector 21. Next, a supply device capable of supplying the priming liquid is connected to the medical female connector 32. After that, the priming liquid is supplied from the supply device to the injection lumen 12a2 partitioned by the port portion 21b of the relay connector 21 through the medical tube 31 as the injection tube member 6. The priming liquid supplied to the injection lumen 12a2 enters the hollow portion of the main body of the main body 21a of the relay connector 21 through the communication port 14. At this time, since the distal end of the support tube 26 is located proximal to the communication port 14, the injection resistance of the priming liquid can be reduced. The priming liquid that has entered the hollow portion of the main body 21a does not flow to the proximal side of the main lumen 12a1 due to the sealing member 16, but flows to the distal side of the main lumen 12a1 and flows into the sheath 20. At the distal end of the sheath 20, a distal end wall is provided that partitions a discharge port (not shown) capable of discharging the priming liquid from the inside of the sheath 20. In this way, the inside of the sheath 20 is filled with the priming liquid to complete the priming process.

The catheter assembly and bundling method according to the present disclosure are not limited to the specific configuration and method shown in the above-described embodiment, and various modifications and changes are possible as long as they do not deviate from the claims. FIG. 8 is a diagram showing a tube holding member 212 as a modification of the tube holding member 12 of the diagnostic imaging catheter 5 described above. The pipe holding member 212 shown in FIG. 8 partitions the hollow portion 212a. The hollow portion 212a of the pipe holding member 212 includes a main lumen 212a1 through which the insertion member 13 is inserted, and an injection lumen 212a2 that communicates with the main lumen 212a1 at the communication port 14 and can inject the priming liquid.

The injection lumen 212a2 shown in FIG. 8 includes a portion extending along the main lumen 212a1 at a position proximal to the communication port 14. The injection lumen 212a2 shown in FIG. 8 differs from the above-mentioned injection lumen 12a2 (see FIG. 3) in this respect.

Then, as shown in FIG. 8, the medical tube 31 as the injection tube member 6 fluidly communicates with the injection lumen 212a2 at the proximal end of the portion of the injection lumen 212a2 extending along the main lumen 212a1. It is connected to the pipe holding member 212 as described above. With such a configuration, the position where the injection pipe member 6 is connected to the pipe holding member 212 can be formed on the proximal side of the pipe holding member 212. Therefore, the injection tube member 6 is less likely to interfere with the medical staff. In FIG. 8, the injection pipe member 6 and the pipe holding member 212 are connected to each other at the proximal end of the injection lumen 212a2 extending along the main lumen 212a1, but the configuration is not limited to this. There may be a portion of the injected lumen 212a2 that extends beyond the main lumen 212a1 on the proximal side of the portion of the injected lumen 212a2 that extends along the main lumen 212a1. In such a case, the injection pipe member 6 and the pipe holding member 212 may be connected to each other on the proximal side of the injection lumen 212a2 on the proximal side of the portion extending along the main lumen 212a1.

More specifically, the injection tube member 6 is connected to the injection lumen 212a2 at a position where the distance between the injection lumen 212a2 and the attachment portion 12b (see FIG. 1 and the like) is shorter than the distance between the injection lumen 212a2 and the communication port 14 in the longitudinal direction A of the catheter. It is provided with a connecting port 215 to be connected. By providing the connecting port 215 at such a position, even if a tensile force is erroneously applied in the axial direction of the injection pipe member 6, the pipe holding member 212 uses the position of the mounting portion 12b (see FIG. 1 and the like) as a fulcrum. The acting bending moment can be reduced. Therefore, bending deformation of the pipe holding member 212 can be suppressed. As a result, it is possible to prevent the tube member 11 connected to the tube holding member 212 and the insertion member 13 in the tube member 11 from unintentionally moving in the longitudinal direction A of the catheter.

Further, as shown in FIG. 8, the pipe holding member 212 includes a relay connector 221 connected to the proximal end of the pipe member 11 and a unit connector 22 (see FIG. 1 and the like) including a mounting portion 12b (see FIG. 1 and the like). (See) and an outer tube 23 whose distal end is connected to the relay connector 221 and whose proximal end is connected to the unit connector 22. The main lumen 212a1 described above is partitioned by a relay connector 22, a unit connector 22, and an outer pipe 23. Then, as shown in FIG. 8, the injection lumen 212a2 is partitioned by the relay connector 221. The portion of the injection lumen 212a2 extending along the main lumen 212a1 extends along the outer pipe 23, and a connecting port 215 is provided at the proximal end thereof. In this way, it becomes easy to realize a configuration in which a gap is not formed between the injection pipe member 6 and the pipe holding member 212.

In this way, the injection lumen 212a2 is extended longer toward the proximal side than the communication port 14, and the connection position itself of the injection pipe member 6 is formed away from the communication port 14 on the proximal side. May be good. In FIG. 8, the injection lumen 212a2 extending proximally from the communication port 14 is partitioned by the relay connector 221 but may be partitioned by another member as long as it is the pipe holding member 212. However, from the viewpoint of reducing the flow path resistance of the priming liquid, the communication port 14 is preferably located on the distal side of the pipe holding member 212. Therefore, as shown in FIG. 8, it is preferable that the communication port 14 is provided in the relay connector 221. Therefore, as shown in FIG. 8, the injection lumen 212a2 is preferably partitioned by the relay connector 221.

This disclosure relates to catheter assembly and tying methods.

1: Catheter assembly 2: External device 2a: Rotation drive unit 2b: Advance / retreat movement mechanism 2c: Housing 2d: Main shaft 2e: Rotation drive source 2f: Rotation drive source 2g: Ball screw mechanism 2h: Base 2i: Unit connector holding unit 2j: Screw shaft 2k: Nut 2m: Clamp part 2n: Fixing part 3: Control device 4: Display device 5: Diagnostic imaging catheter 6: Injection tube member 7, 7a, 7b: Bundling member 11: Tube member 12, 212: Pipe holding members 12a, 212a: Hollow parts 12a1, 212a1: Main lumen 12a2, 212a2: Injection lumen 12b: Mounting part 12c: Fixed part 13: Inserting member 14: Communication port 15, 215: Connecting port 16: Seal Member 17: First member 18: Second member 19: Reinforcing shaft 20: Sheath 20a: Guide portion 21, 221: Relay connector 21a: Main body portion 21b: Port portion 22: Unit connector 22a: Step surface 22b: Distal member 22c: Proximal side member 23: Outer pipe 24: Hub 25: Inner pipe 25a: Step surface 26: Support pipe 27: Drive shaft 28: Signal transmission / reception part 29: Adhesive part 31: Medical tube 32: Medical female connector 100 : Diagnostic imaging device A: Catheter longitudinal direction O1: Central axis of drive shaft O2: Central axis of main lumen O3: Central axis of injection lumen X: Virtual straight line

Claims

A catheter assembly comprising a diagnostic imaging catheter and an injection tube member connected to the diagnostic imaging catheter.
The diagnostic imaging catheter
Tube members that can be inserted into the living body and
A pipe holding member connected to the proximal end of the pipe member,
An insertion member having a signal transmitting / receiving unit at the distal end, inserted into the tube member through a hollow portion defined by the tube holding member, and movable in the longitudinal direction of the catheter along the tube member. Prepare,
The hollow portion of the pipe holding member includes a main lumen through which the insertion member is inserted, and an injection lumen that communicates with the main lumen at a communication port and is capable of injecting a priming liquid.
The tube holding member includes a mounting portion that can be mounted on an external device that moves the insertion member forward and backward in the longitudinal direction of the catheter at a position proximal to the communication port.
One end of the injection pipe member is connected to the pipe holding member so as to communicate fluidly with the injection lumen.
At least a part of the injection tube member extending from one end to the other end is bound to the tube holding member at a position proximal to the communication port in the longitudinal direction of the catheter. A catheter assembly with a bundling member.
The binding member binds the injection tube member and the tube holding member at a position in the longitudinal direction of the catheter where the distance between the injection tube member and the attachment portion is shorter than the distance between the communication port and the communication port. The catheter assembly according to claim 1.
The binding member binds the injection tube member and the tube holding member at a position where the distance between the injection tube member and the communication port is shorter than the distance between the attachment portion and the catheter in the longitudinal direction of the catheter. The catheter assembly according to claim 1 or 2.
The pipe holding member is
A relay connector connected to the proximal end of the tube member,
A unit connector having the mounting portion and
An outer tube, the distal end of which is connected to the relay connector and the proximal end of which is connected to the unit connector.
The catheter assembly according to any one of claims 1 to 3, wherein the binding member binds the injection tube member to at least one of the relay connector, the unit connector, and the outer tube.
The binding member binds the injection pipe member to at least one of the relay connector, the unit connector, and the outer pipe in a state where the injection pipe member extends along the outer pipe. The catheter assembly according to claim 4.
The injection pipe member has the main lumen from the position of the one end connected to the pipe holding member toward the other end, in parallel with the main lumen, or from the one end toward the other end. The catheter assembly according to any one of claims 1 to 5, which extends so as to approach.
A catheter assembly comprising a diagnostic imaging catheter and an injection tube member connected to the diagnostic imaging catheter.
The diagnostic imaging catheter
Tube members that can be inserted into the living body and
A pipe holding member connected to the proximal end of the pipe member,
An insertion member having a signal transmitting / receiving unit at the distal end, inserted into the tube member through a hollow portion defined by the tube holding member, and movable in the longitudinal direction of the catheter along the tube member. Prepare,
The hollow portion of the pipe holding member includes a main lumen through which the insertion member is inserted, and an injection lumen that communicates with the main lumen at a communication port and is capable of injecting a priming liquid.
The tube holding member includes a mounting portion that can be mounted on an external device that moves the insertion member forward and backward in the longitudinal direction of the catheter at a position proximal to the communication port.
The injection lumen comprises a portion extending along the main lumen at a position proximal to the communication port.
The injection tube member is fluid-communicated with the injection lumen at the proximal end of the injection lumen extending along the main lumen, or at the proximal side of the proximal end. A catheter assembly connected to the tube holding member.
7. The injection lumen is provided with a connection port to which the injection tube member is connected at a position where the distance between the injection lumen and the attachment portion is shorter than the distance between the injection lumen and the communication port in the longitudinal direction of the catheter. The catheter assembly described.
The pipe holding member is
A relay connector connected to the proximal end of the tube member,
A unit connector having the mounting portion and
An outer tube, the distal end of which is connected to the relay connector and the proximal end of which is connected to the unit connector.
The main lumen is partitioned by the relay connector, the unit connector, and the outer pipe.
The injection lumen is partitioned by the relay connector.
The catheter assembly according to claim 7 or 8, wherein the portion of the infusion lumen extending along the main lumen extends along the outer tube.
It is a binding method that binds the diagnostic imaging catheter and the injection tube member.
The diagnostic imaging catheter
Tube members that can be inserted into the living body and
A pipe holding member connected to the proximal end of the pipe member,
An insertion member having a signal transmitting / receiving unit at the distal end, inserted into the tube member through a hollow portion defined by the tube holding member, and movable in the longitudinal direction of the catheter along the tube member. Prepare,
The hollow portion of the pipe holding member includes a main lumen through which the insertion member is inserted, and an injection lumen that communicates with the main lumen at a communication port and is capable of injecting a priming liquid.
The tube holding member includes a mounting portion that can be mounted on an external device that moves the insertion member forward and backward in the longitudinal direction of the catheter at a position proximal to the communication port.
One end of the injection tube member can be connected to the tube holding member so as to communicate fluidly with the injection lumen.
At least a part of the portion of the injection tube member extending from one end to the other end at a position proximal to the communication port in the longitudinal direction of the catheter, the tube holding member and the outside. A binding method that binds to at least one of the devices.
The tenth aspect of the present invention, wherein at least a part of a portion of the injection pipe member extending from one end toward the other end is bound to at least one of the pipe holding member and the external device by a binding member. Bundling method.
By fixing at least a part of the portion of the injection pipe member extending from one end toward the other end to a fixing portion provided on at least one of the pipe holding member and the external device. The binding method according to claim 10, wherein the tube holding member and the external device are bound at least one of the same.
Any of claims 10 to 12, wherein the injection tube member is bound to the tube holding member at a position where the distance between the injection tube member and the attachment portion is shorter than the distance between the injection tube member and the communication port in the longitudinal direction of the catheter. The binding method described in one.
Any of claims 10 to 13, wherein the injection tube member is bound to the tube holding member at a position where the distance between the injection tube member and the communication port is shorter than the distance between the catheter mounting portion in the longitudinal direction of the catheter. The binding method described in one.
The pipe holding member is
A relay connector connected to the proximal end of the tube member,
A unit connector having the mounting portion and
An outer tube having a distal end connected to the relay connector and a proximal end connected to the unit connector.
The binding method according to any one of claims 10 to 14, wherein the injection pipe member is bound to at least one of the relay connector, the unit connector, and the outer pipe.
The binding method according to claim 15, wherein the injection pipe member is bound to at least one of the relay connector, the unit connector, and the outer pipe in a state of extending along the outer pipe.