WO2023073942A1 - ダイレータキット - Google Patents

ダイレータキット Download PDF

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Publication number
WO2023073942A1
WO2023073942A1 PCT/JP2021/040072 JP2021040072W WO2023073942A1 WO 2023073942 A1 WO2023073942 A1 WO 2023073942A1 JP 2021040072 W JP2021040072 W JP 2021040072W WO 2023073942 A1 WO2023073942 A1 WO 2023073942A1
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WO
WIPO (PCT)
Prior art keywords
dilator
catheter
peripheral surface
distal end
proximal
Prior art date
Application number
PCT/JP2021/040072
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English (en)
French (fr)
Japanese (ja)
Inventor
貴行 堀
Original Assignee
朝日インテック株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to PCT/JP2021/040072 priority Critical patent/WO2023073942A1/ja
Priority to JP2023556047A priority patent/JPWO2023073942A1/ja
Publication of WO2023073942A1 publication Critical patent/WO2023073942A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a dilator kit.
  • a dilator is known as a device that assists the insertion of a catheter into living tissue.
  • the dilator is elongated and has a pointed tip.
  • the dilator is inserted into the catheter, the dilator is accommodated in the lumen of the catheter, and the tip of the dilator is exposed from the tip side opening of the catheter (hereinafter also referred to as the "assembled state"). call).
  • the distal end portion of the guide wire is previously inserted into the biological tissue using a puncture needle or the like, and the assembled dilator kit is inserted into the biological tissue from the distal end of the dilator along the guide wire. Since the tip of the dilator can dilate the subcutaneous tissue, the insertion resistance of the catheter into the living tissue can be reduced.
  • Patent Literature 1 discloses a catheter assembly that includes a catheter and a dilator.
  • the distal end of the catheter is configured only along the outer peripheral surface of the dilator-side base portion having a substantially constant outer diameter, so the catheter receives a pushing force from the hand.
  • the dilator stretches in the pushing direction or receives resistance from the skin and withdraws (moves) toward the proximal side within the catheter, making it difficult to insert the catheter into the living tissue. .
  • the present invention has been made to solve at least part of the above-described problems, and aims to provide a dilator kit that allows easy insertion of a catheter into living tissue.
  • the present invention has been made to solve at least part of the above problems, and can be implemented as the following forms.
  • a dilator kit comprising a catheter having a lumen and a dilator, wherein the dilator is accommodated in the lumen of the catheter in an assembled state.
  • the catheter has a distal side engaging portion and a proximal side engaging portion that respectively engage with the dilator in the assembled state, and the dilator has the dilator in the assembled state.
  • the length between the distal end side engaged portion and the proximal side engaged portion of the dilator is the same as the distal end side engaging portion and the proximal end of the catheter. It is longer than the length between the end side engaging portions. Therefore, in an assembled state in which the dilator is accommodated in the lumen of the catheter, the distal end side engaging portion and the distal end side engaged portion are engaged with each other while the catheter is elongated in the longitudinal direction. The end side engaging portion and the base end side engaged portion are engaged. In this way, in the dilator kit of this configuration, the catheter is already stretched in the assembled state. direction) can be suppressed.
  • the distal engaging portion and the distal engaged portion are engaged, and the proximal engaging portion and the proximal engaged portion are engaged. It is possible to suppress the occurrence of an event in which the dilator that receives resistance from the catheter retracts toward the proximal side within the catheter. As a result, with the dilator kit having this configuration, the catheter can be easily inserted into the living tissue.
  • the first length is the length between the distal side engaging portion and the proximal side engaging portion of the catheter in the assembled state
  • the length of the catheter in the separated state is
  • the difference between the first length and the second length is within a range of 1 mm or more and 30 mm or less.
  • the difference from the second length between (first length - second length) is in the range of 1 mm or more and 30 mm or less. Therefore, it is possible to suppress the expansion of the catheter in the pushing direction when receiving the pushing force from the hand, and it is possible to suppress the excessive expansion of the catheter when changing from the separated state to the assembled state.
  • the difference between the first length and the second length may be in the range of 5 mm or more and 15 mm or less.
  • the difference between the first length and the second length (the first length - the second length) is within the range of 5 mm or more and 15 mm or less, so that when a pushing force is applied from the hand, The extension of the catheter in the direction in which it is pushed in can be further suppressed, and excessive extension of the catheter when changing from the separated state to the assembled state can be further suppressed.
  • the elastic modulus of the catheter may be smaller than the elastic modulus of the dilator. According to this configuration, since the elastic modulus of the catheter is smaller than that of the dilator, the deliverability of the catheter can be improved, and the skin can be easily expanded by the dilator.
  • the catheter has a hollow shaft portion, the dilator has an elongated main body portion, and the main body portion of the dilator has a dilator extending from the distal end side to the proximal end side.
  • a tapered portion with an outer diameter gradually increasing toward the shaft is provided.
  • An inner peripheral surface of a tip portion of the hollow shaft portion may function as the tip side engaging portion, and an outer peripheral surface of the tapered portion may function as the tip side engaged portion.
  • the inner peripheral surface of the distal end portion of the hollow shaft portion of the catheter is engaged with the outer peripheral surface of the tapered portion of the dilator, so that the inner peripheral surface of the distal end portion of the hollow shaft portion is engaged with the distal end side.
  • the outer peripheral surface of the tapered portion functions as a tip side engaged portion.
  • the catheter further has a first connector provided at the proximal end portion of the hollow shaft portion, and the dilator is further provided at the proximal end portion of the body portion.
  • the outer peripheral surface of the first connector engages with the inner peripheral surface of the second connector, so that the outer peripheral surface of the first connector
  • the inner peripheral surface of the second connector may function as the end side engaging portion, and the base end side engaged portion.
  • the outer peripheral surface of the first connector of the catheter and the inner peripheral surface of the second connector of the dilator are engaged with each other, so that the outer peripheral surface of the first connector functions as a proximal side engaging portion,
  • the inner peripheral surface of the second connector functions as a proximal side engaged portion. Therefore, the engagement structure between the proximal side engaging portion and the proximal side engaged portion can be realized using a connector that is generally provided in many catheters and dilators.
  • the hollow shaft portion of the catheter includes a tip taper portion whose outer diameter and inner diameter are gradually enlarged from the tip side to the base end side, and the tip taper portion. and a large-diameter portion having a substantially constant outer diameter disposed on the proximal end side of the hollow shaft portion, and in the longitudinal section of the hollow shaft portion, the outer peripheral surface of the tip taper portion and the outer periphery of the large-diameter portion.
  • the first acute angle is defined as a first acute angle
  • the second acute angle is defined as an acute angle formed between the inner peripheral surface of the tip tapered portion and the outer peripheral surface of the large-diameter portion. can also be large.
  • the first acute angle formed by the outer peripheral surface of the tip tapered portion and the outer peripheral surface of the large diameter portion is the inner peripheral surface of the tip tapered portion and the outer peripheral surface of the large diameter portion. Since it is larger than the second acute angle formed by the two surfaces, the thickness of the tapered portion at the distal end of the catheter can be gradually reduced from the proximal end side to the distal end side. As a result, the distal end side of the distal tapered portion can be configured more flexibly than the proximal end side, and the step between the distal end of the catheter and the dilator in the assembled state can be reduced.
  • the present invention can be implemented in various aspects, for example, a dilator, a catheter, a dilator kit having a dilator and a catheter, a dilator kit having a medical device other than a dilator and a catheter, manufacturing methods thereof, and the like.
  • a dilator, a catheter a dilator kit having a dilator and a catheter
  • a dilator kit having a medical device other than a dilator and a catheter manufacturing methods thereof, and the like.
  • FIG. 4 is an explanatory diagram illustrating the configuration of a dilator kit
  • FIG. 4 is an explanatory diagram illustrating the configuration of the dilator kit in an assembled state
  • FIG. 3 is an explanatory view illustrating the cross-sectional configuration of the distal end side of the dilator kit of FIG. 2
  • FIG. 4 is a diagram showing how the dilator kit of the present embodiment is inserted into a living tissue
  • FIG. 10 is a diagram showing how a dilator kit of a comparative example is inserted into a living tissue
  • FIG. 10 is a diagram showing how a dilator kit of a comparative example is inserted into a living tissue
  • FIG. 10 is a diagram showing how a dilator kit of a comparative example is inserted into a living tissue
  • FIG. 10 is a diagram showing how a dilator kit of a comparative example is inserted into a living tissue
  • FIG. 10 is a diagram showing how a
  • FIG. 10 is an explanatory diagram illustrating the configuration of the dilator kit of the second embodiment
  • FIG. 11 is an explanatory diagram illustrating the configuration of a dilator kit according to a third embodiment
  • FIG. 11 is an explanatory diagram illustrating the configuration of a dilator kit according to a fourth embodiment
  • FIG. 11 is an explanatory diagram illustrating the configuration of a dilator kit according to a fifth embodiment
  • FIG. 11 is an explanatory diagram illustrating the configuration of a dilator kit according to a sixth embodiment
  • FIG. 11 is an explanatory diagram illustrating the configuration of a dilator kit of a seventh embodiment
  • FIG. 1 is an explanatory diagram illustrating the configuration of a dilator kit.
  • the dilator kits 1 and 2 comprise a catheter 1 and a dilator 2.
  • FIG. 1 shows the dilator kits 1 and 2 in a state in which the catheter 1 and the dilator 2 are separated (hereinafter also referred to as "separated state").
  • the lumens formed inside the catheter 1 and the dilator 2 are illustrated by dashed lines.
  • the dilator kits 1 and 2 of the present embodiment have a configuration described later, so that the catheter 1 can be easily inserted into living tissue.
  • FIG. 1 illustrates XYZ axes that are orthogonal to each other.
  • the X-axis corresponds to the longitudinal direction of the catheter 1 and the dilator 2
  • the Y-axis corresponds to the height direction of the catheter 1 and the dilator 2
  • the Z-axis corresponds to the width direction of the catheter 1 and the dilator 2.
  • the left side ( ⁇ X axis direction) of FIG. 1 is called the “distal side” of the catheter 1, the dilator 2, and each component, and the right side (+X axis direction) of FIG. 1 is the catheter 1, the dilator 2, and each component. Called “proximal”.
  • one end located on the distal side is called the "distal end”
  • the other end located on the proximal side is called the "proximal end”.
  • the distal end and the vicinity thereof are referred to as the "distal portion”
  • the proximal end and the vicinity thereof are referred to as the "basal end portion”.
  • the distal side is inserted into the living body, and the proximal side is operated by an operator such as a doctor.
  • the catheter 1 of the present embodiment is a guiding catheter for passing through and delivering medical devices such as guide wires and balloon catheters.
  • the catheter 1 has a hollow shaft portion 100 and a first connector 190 provided at the proximal end portion of the hollow shaft portion 100 .
  • the hollow shaft portion 100 is a long tube-shaped member having a tip tapered portion 101 on the tip side and a large diameter portion 102 on the base end side.
  • the distal tapered portion 101 is a portion where both the outer diameter and the inner diameter of the hollow shaft portion 100 are gradually enlarged from the distal side toward the proximal side.
  • the large-diameter portion 102 is located closer to the proximal side than the distal tapered portion 101, and is a portion in which both the outer diameter and the inner diameter of the hollow shaft portion 100 have substantially constant sizes.
  • substantially constant is synonymous with “substantially constant”, and means to be substantially constant while allowing fluctuations caused by manufacturing errors or the like.
  • the outer diameter, inner diameter, and length of the hollow shaft portion 100, the tip tapered portion 101, and the large diameter portion 102 can be determined arbitrarily.
  • the first connector 190 is, for example, a member used by the operator to hold the catheter 1.
  • the first connector 190 has a housing portion 191, a wing portion 192, and a connection portion 193 from the distal end side to the proximal end side.
  • the accommodating portion 191 is a cylindrical member having an outer diameter that gradually increases from the distal end side to the proximal end side. Inside the accommodating portion 191, the proximal end portion of the large-diameter portion 102 of the hollow shaft portion 100 is accommodated and fixed.
  • the blade portion 192 is a tubular member having a pair of blades for the operator to grasp.
  • the connecting portion 193 is a cylindrical member having a disk-shaped protruding portion protruding in the circumferential direction (YZ-axis direction) at its base end portion.
  • a male thread for screwing with the connecting portion 291 of the second connector 290 of the dilator 2 is formed on the outer peripheral surface of the projecting portion of the connecting portion 193 .
  • the accommodating portion 191, the blade portion 192, and the connecting portion 193 may be integrally molded.
  • the lumen of the hollow shaft portion 100 and the lumen of each member of the first connector 190 communicate with each other to form a device lumen 1L.
  • the device lumen 1L is a lumen for inserting a medical device such as a guide wire or a balloon catheter into the catheter 1 .
  • the device lumen 1L is also a lumen for inserting the dilator 2 through the catheter 1.
  • An opening at the distal end of the catheter 1 that communicates the device lumen 1L with the outside is also called a "tip opening 1a”.
  • an opening communicating between the device lumen 1L and the outside is also referred to as a "base end opening 1b".
  • the hollow shaft portion 100 and the first connector 190 can be made of, for example, polyamide, polyester, polyurethane, fluororesins such as polytetrafluoroethylene (PTFE), or other known resin materials.
  • the hollow shaft portion 100 of the catheter 1 may have a single-layer structure or a multi-layer structure consisting of two or more layers. In the case of a multi-layer structure, the constituent materials in each layer may be the same or different.
  • a metal reinforcing member may be embedded in the hollow shaft portion 100 or between the layers. For the reinforcing member, a coil shape obtained by spirally winding a wire or a mesh shape obtained by weaving the wire can be used.
  • the first connector 190 may be made of known resin materials such as polyamide, polypropylene, polycarbonate, polyacetal, and polyethersulfone.
  • the dilator 2 of this embodiment is an instrument that assists the insertion of a catheter into living tissue by dilating the skin, subcutaneous tissue, and blood vessel wall.
  • the dilator 2 has a body portion 200 and a second connector 290 provided at the proximal end portion of the body portion 200 .
  • the main body part 200 is a long tubular member having a tapered part 201 on the distal end side and a large diameter part 202 on the proximal end side.
  • the tapered portion 201 is a portion having an outer diameter that gradually increases from the distal side toward the proximal side.
  • the large-diameter portion 202 is arranged closer to the base end side than the tapered portion 201 and is a portion having a substantially constant outer diameter of the body portion 200 .
  • the outer diameter ⁇ 202 of the large diameter portion 202 is smaller than the inner diameter ⁇ 102 of the large diameter portion 102 of the catheter 1 .
  • the inner diameter of the tapered portion 201 and the inner diameter of the large diameter portion 202 are substantially constant.
  • the second connector 290 is, for example, a member used by the operator to hold the dilator 2.
  • the second connector 290 has a connection portion 291 and a grip portion 292 from the distal end side to the proximal end side.
  • the connecting portion 291 is a cylindrical member, and an internal thread for screwing with the connecting portion 193 of the first connector 190 of the catheter 1 is formed on the inner peripheral surface of the cylinder.
  • the connection portion 291 is attached to the grip portion 292 so as to be rotatable in the circumferential direction.
  • the grasping portion 292 is a cylindrical member, and a plurality of grooves are formed on the outer peripheral surface of the cylinder. Note that the connection portion 291 and the grip portion 292 may be integrally molded.
  • the lumen of the body portion 200 and the lumen of each member of the second connector 290 communicate with each other to form a guidewire lumen 2L.
  • the guidewire lumen 2L is a lumen through which a guidewire is passed through the dilator 2.
  • An opening at the distal end of the dilator 2 that communicates the guide wire lumen 2L with the outside is also called a “tip opening 2a”.
  • an opening that communicates the guide wire lumen 2L with the outside is also called a "base end opening 2b”.
  • the main body part 200 and the second connector 290 can be made of known resin materials such as fluororesin, polyamide, and polyester.
  • the material of the dilator 2 is preferably selected such that the elastic modulus of the catheter 1 is smaller than the elastic modulus of the dilator 2 .
  • the elastic modulus of the catheter 1 and the dilator 2 the elastic modulus in the linear region among the test results obtained according to the "breaking strength measurement method" defined in JIS T 3268 may be adopted.
  • the step of immersion in an aqueous solution in the "breaking strength measurement method" defined in JIS T 3268 is omitted.
  • the elastic modulus of the hollow shaft portion 100 may be regarded as the "elastic modulus of the catheter 1", and the elastic modulus of the main body portion 200 may be regarded as the "elastic modulus of the catheter 1".
  • the catalog value of the material constituting the hollow shaft portion 100 may be adopted as the elastic modulus of the catheter 1
  • the elastic modulus of the dilator 2 may be the main body. Catalog values for the materials that make up part 200 may be employed.
  • FIG. 2 is an explanatory diagram illustrating the configuration of the dilator kit in the assembled state.
  • illustration of the guide wire lumen 2L (lumen) of the dilator 2 is omitted.
  • FIG. 3 is an explanatory diagram illustrating the cross-sectional configuration of the distal end side of FIG. 2 .
  • the longitudinal section shown in FIG. 3 is a longitudinal section including the axis O.
  • the operator When using the dilator kits 1 and 2, the operator inserts the distal end of the dilator 2 into the device lumen 1L (lumen) of the catheter 1 from the proximal end opening 1b of the catheter 1, and inserts the dilator 2 into the device lumen 1L. to protrude the tip of the dilator 2 from the tip opening 1 a of the catheter 1 .
  • the operator rotates the connecting portion 291 of the dilator 2 in the circumferential direction (black arrow in FIG. 2) to screw the connecting portion 193 of the catheter 1 and the connecting portion 291 of the dilator 2 together.
  • the proximal end portion of the hollow shaft portion 100 of the catheter is engaged with the inner peripheral surface of the distal end portion of the hollow shaft portion 100 of the catheter 1 and the outer peripheral surface of the tapered portion 201 of the dilator 2. is pulled toward the proximal end together with the connector 190, the proximal engaging portion 12 and the proximal engaged portion 22 are engaged with each other while the catheter 100 is stretched in the longitudinal direction. Then, as shown in FIG. 2 , the dilator 2 is housed in the device lumen 1L (lumen) of the catheter 1 .
  • this state is also referred to as an "assembled state”.
  • the inner peripheral surface of the distal end portion of the hollow shaft portion 100 of the catheter 1 and the outer peripheral surface of the tapered portion 201 of the dilator 2 are engaged.
  • a portion where the distal end side of the catheter 1 engages with the distal end side of the dilator 2 is referred to as a "distal side engaging portion 11".
  • the inner peripheral surface of the distal end portion of the hollow shaft portion 100 of the catheter 1 functions as the distal end side engaging portion 11 .
  • the portion where the distal end side of the dilator 2 engages with the distal end side engaging portion 11 of the catheter 1 is referred to as "the distal end side engaged portion 21".
  • the outer peripheral surface of the tapered portion 201 of the dilator 2 functions as the tip side engaged portion 21 .
  • the outer peripheral surface of the first connector 190 (specifically, the connecting portion 193) of the catheter 1 and the second connector 290 (specifically, the connecting portion 291) of the dilator 2 are connected to each other. is engaged with the inner peripheral surface of the
  • the portion where the proximal side of the catheter 1 engages with the proximal side of the dilator 2 is called a "basic side engaging portion 12".
  • the outer peripheral surface of the first connector 190 of the catheter 1 functions as the proximal side engaging portion 12 .
  • the portion where the proximal side of the dilator 2 engages with the proximal side engaging portion 12 of the catheter 1 is referred to as "the proximal side engaged portion 22".
  • the inner peripheral surface of the second connector 290 of the dilator 2 functions as the proximal side engaged portion 22 .
  • the length in the longitudinal direction (X-axis direction) from the distal end side engaging portion 11 to the proximal end side engaging portion 12 of the catheter 1 is L0.
  • the length in the longitudinal direction (X-axis direction) from the distal end side engaged portion 21 to the proximal side engaged portion 22 of the dilator 2 is La.
  • the length La between the distal-side engaged portion 21 and the proximal-side engaged portion 22 is greater than the length L0 between the distal-side engaging portion 11 and the proximal-side engaging portion 12. is also long (separation state shown in FIG. 1: La>L0).
  • L1 be the length in the longitudinal direction (X-axis direction) from the distal end side engaging portion 11 to the proximal end side engaging portion 12 of the catheter 1 in the assembled state.
  • L1 between the distal-side engaging portion 11 and the proximal-side engaging portion 12 in the assembled state and the distance between the distal-side engaging portion 11 and the proximal-side engaging portion 12 in the separated state are The difference (L1-L0) from the length L0 is in the range of 1 mm or more and 30 mm or less.
  • the difference (L1-L0) between the length L1 in the assembled state and the length L0 in the separated state is more preferably in the range of 5 mm or more and 15 mm or less.
  • the difference (L1-L0) between the length L1 in the assembled state and the length L0 in the separated state is approximately 10 mm.
  • the length L1 in the assembled state corresponds to the "first length”
  • the length L0 in the separated state corresponds to the "second length”.
  • the acute angle formed by the outer peripheral surface of the tip tapered portion 101 and the outer peripheral surface of the large diameter portion 102 is defined as a first acute angle ⁇ 1.
  • the acute angle formed by the inner peripheral surface of tip tapered portion 101 and the outer peripheral surface of large diameter portion 102 is defined as a second acute angle ⁇ 2.
  • the first acute angle ⁇ 1 is larger than the second acute angle ⁇ 2 (FIG. 3: ⁇ 1> ⁇ 2).
  • the thickness of the tip taper portion 101 can be gradually reduced from the base end side to the tip end side.
  • the thickness T1 at the distal end portion of the distal tapered portion 101 can be made thinner than the thickness T2 at the proximal end portion of the distal tapered portion 101 .
  • FIG. 4 is a diagram showing how the dilator kit of this embodiment is inserted into a living tissue.
  • the dilator kit is pushed along a guide wire (not shown) whose distal end portion has been previously inserted into the living tissue, and is inserted into the living tissue.
  • the length La between the distal-side engaged portion 21 and the proximal-side engaged portion 22 of the dilator 2 is It is longer than the length L0 between the proximal side engaging portions 12 of the catheter 1 (separated state shown in FIG. 1: La>L0). Therefore, as shown in FIGS.
  • the catheter 1 in the dilator kits 1 and 2 of the present embodiment, the catheter 1 is already stretched in the assembled state. For this reason, as shown in FIG. 4, when the tip of the dilator 2 is pressed against the skin 301 in order to insert the catheter 1 into the living tissue, the catheter 1 receives a pushing force from the hand 302.
  • the catheter 1 can be easily inserted into living tissue.
  • the first length L1 between the distal end side engaging portion 11 and the proximal end side engaging portion 12 of the catheter 1 in the assembled state and the distal end side of the catheter 1 in the separated state The difference between the second length L0 between the engaging portion 11 and the proximal side engaging portion 12 (first length L1 - second length L0) is within the range of 1 mm or more and 30 mm or less. Therefore, it is possible to suppress the expansion of the catheter 1 in the pushing direction when receiving the pushing force from the hand 302, and suppress the excessive expansion of the catheter 1 when changing from the separated state to the assembled state.
  • the pushing force from the hand 302 can be The extension of the catheter 1 in the pushing direction when it receives it can be further suppressed, and the excessive extension of the catheter 1 when changing from the separated state to the assembled state can be further suppressed.
  • the elastic modulus of the catheter 1 is smaller than that of the dilator 2, it is possible to improve the deliverability of the catheter 1 in the biological lumen and insert the dilator 2 into the skin 301. (more specifically, insertion into the skin hole through which the guide wire is inserted) and dilation of the skin 301 by the dilator (more specifically, expansion of the skin hole through which the guide wire is inserted) are facilitated.
  • the inner peripheral surface of the distal end portion of the hollow shaft portion 100 of the catheter 1 and the outer peripheral surface of the tapered portion 201 of the dilator 2 are engaged, so that the distal end portion of the hollow shaft portion 100
  • the inner peripheral surface of the tapered portion 201 functions as the tip-side engaging portion 11
  • the outer peripheral surface of the tapered portion 201 functions as the tip-side engaged portion 21 .
  • the lumen (device lumen 1L) generally provided in the catheter 1 and the tapered structure on the distal end side generally provided in the dilator 2 are used to achieve the distal end engaging portion 11 and the distal end.
  • An engagement structure with the side engaged portion 21 can be realized.
  • the outer peripheral surface of the first connector 190 of the catheter 1 and the inner peripheral surface of the second connector 290 of the dilator 2 are engaged, so that the outer peripheral surface of the first connector 190 is It functions as the proximal side engaging portion 12 , and the inner peripheral surface of the second connector 290 functions as the proximal side engaged portion 22 . Therefore, by using the connectors 190 and 290 that are generally provided in the catheter 1 and the dilator 2, the engagement structure between the proximal side engaging portion 12 and the proximal side engaged portion 22 can be realized. .
  • the first acute angle ⁇ 1 formed by the outer peripheral surface of the tip taper portion 101 and the outer peripheral surface of the large diameter portion 102 is the tip taper portion It is larger than the second acute angle ⁇ 2 formed by the inner peripheral surface of 101 and the outer peripheral surface of large diameter portion 102 (FIG. 3: ⁇ 1> ⁇ 2). Therefore, the thickness of the tip tapered portion 101 of the catheter 1 can be gradually reduced from the base end to the tip end. As a result, the distal end side of the distal taper portion 101 can be configured more flexibly than the proximal end side, and the step ST (FIG. 3) between the distal end of the catheter 1 and the dilator 2 in the assembled state can be reduced.
  • FIGS. 5 and 6 are diagrams showing how the dilator kit of the comparative example is inserted into living tissue.
  • the upper balloon in FIG. 5 shows the change in state of the dilator kit of the comparative example as it is pushed.
  • a comparative dilator kit includes a catheter 1x and a dilator 2x.
  • Catheter 1x is a conventional guiding catheter that does not have distal tapered portion 101, distal engaging portion 11, and proximal engaging portion 12.
  • the dilator 2x is a conventional dilator that does not have a distal side engaged portion 21 and a proximal side engaged portion 22. As shown in FIG. In the example of FIG.
  • the dilator 2x has a small-diameter portion, an enlarged-diameter portion, a large-diameter portion, and a reduced-diameter portion from the distal end side to the proximal end side.
  • the catheter 1x pushes in the pushing direction (longitudinal direction, shown in FIG. 5). direction of the black arrow), or the dilator 2x receives resistance from the skin 301 and retracts toward the proximal side within the catheter 1x (in other words, the dilator 2x moves in the direction opposite to the black arrow in FIG. 5).
  • the catheter 1x and the dilator 2x assume the positional relationship shown by the dashed line in FIG. 5, and the catheter 1x is not inserted into the skin 301 by the same length as the length of the catheter 1x pushed by the operator.
  • the step ST (upper part of FIG. 5) between the tip of the catheter 1x and the dilator 2x increases. As a result, it was difficult to insert the catheter 1x into the living tissue with the dilator kit of the comparative example.
  • FIG. 7 is an explanatory diagram illustrating the configuration of the dilator kit of the second embodiment. Similar to FIG. 3, FIG. 7 shows a longitudinal section including the axis O of the distal end side of the dilator kit in the assembled state. An enlarged view of a portion surrounded by a dashed circle frame is shown in the upper balloon of FIG.
  • the dilator kit 1, 2A of the second embodiment includes a dilator 2A instead of the dilator 2 in the configuration described in the first embodiment.
  • a main body portion 200A of the dilator 2A has a tip-side engaged portion 21A instead of the tip-side engaged portion 21, a tapered portion 201A instead of the tapered portion 201, and a thick portion instead of the large-diameter portion 202. It has a diameter portion 202A. At the tip of the large-diameter portion 202A, a step is formed in which the thick portion protrudes such that the front and rear outer diameters are different.
  • the inner peripheral surface of the distal end portion of the hollow shaft portion 100 of the catheter 1 and the step formed on the outer peripheral surface of the large diameter portion 202A of the dilator 2A are different. They are engaged (inside the upper balloon in FIG. 7). That is, in the dilator 2A, the step formed on the outer peripheral surface of the large-diameter portion 202A functions as the tip-side engaged portion 21A.
  • the configuration of the distal end side engaged portion 21A can be changed in various ways, and it does not have to be formed on the outer peripheral surface of the tapered portion 201A.
  • the distal end side engaged portion 21A may have a configuration different from the configuration described in FIG. good too.
  • the inner peripheral surface of the distal end portion of the shaft 100 of the catheter 1 may be provided with a stepped portion that engages with the stepped portion of the distal side engaged portion 21A.
  • FIG. 8 is an explanatory diagram illustrating the configuration of the dilator kit of the third embodiment. Similar to FIG. 3, FIG. 8 shows a longitudinal section including the axis O of the distal end side of the dilator kit in the assembled state.
  • the dilator kits 1B and 2B of the third embodiment have a catheter 1B in place of the catheter 1 and a dilator 2B in place of the dilator 2 in the configuration described in the first embodiment.
  • a hollow shaft portion 100B of the catheter 1B has a distal end side engaging portion 11B instead of the distal end side engaging portion 11, does not have the distal end tapered portion 101 described in the first embodiment, and has a large diameter portion 102. It has a large-diameter portion 102B instead. At the tip of the large-diameter portion 102B, a protrusion is formed in which the inner peripheral surface protrudes inward.
  • a main body portion 200B of the dilator 2B has a tip-side engaged portion 21B instead of the tip-side engaged portion 21, a tapered portion 201B instead of the tapered portion 201, and a thick portion instead of the large-diameter portion 202. It has a diameter portion 202B.
  • the dilator kits 1B and 2B of the third embodiment have convex portions formed on the inner peripheral surface of the hollow shaft portion 100B of the catheter 1B and concave portions formed on the outer peripheral surface of the main body portion 200B of the dilator 2B. , are engaged.
  • the convex portion formed on the inner peripheral surface of the large diameter portion 102B functions as the distal end side engaging portion 11B
  • the concave portion formed on the outer peripheral surface of the large diameter portion 202B functions as the distal end side. It functions as the engaged portion 21B.
  • the configurations of the distal end side engaging portion 11B and the distal end side engaged portion 21B can be modified in various ways, and may be realized by an uneven engagement structure.
  • the convex portion is formed on the side of the catheter 1B and the concave portion is formed on the side of the dilator 2B, but these may be reversed.
  • the catheter 1B is configured without the tip tapered portion 101, it has the tip tapered portion 101, and the tip end side engagement is realized by the uneven engagement structure on the inner peripheral surface of the tip taper portion 101.
  • a configuration including the portion 11B may be employed.
  • FIG. 9 is an explanatory diagram illustrating the configuration of the dilator kit of the fourth embodiment. Similar to FIG. 3, FIG. 9 shows a longitudinal section including the axis O of the distal end side of the dilator kit in the assembled state.
  • the dilator kit 1, 2C of the third embodiment includes a dilator 2C instead of the dilator 2 in the configuration described in the first embodiment.
  • the frictional force imparting means 23 is provided on the outer peripheral surface of the tapered portion 201 of the main body portion 200 and on the portion that functions as the tip side engaged portion 21 .
  • the frictional force application means 23 is a member or portion for generating a frictional force with the distal end side engaging portion 11 (that is, the inner peripheral surface of the distal end portion of the hollow shaft portion 100).
  • the frictional force applying means 23 for example, a ring member made of silicon or rubber can be used.
  • the frictional force imparting means 23 may be an uneven surface provided on the outer peripheral surface of the tapered portion 201 .
  • the concave-convex processed surface can be realized, for example, by processing the outer peripheral surface of the tapered portion 201 by well-known laser processing or the like.
  • the configuration of the dilator 2C can be modified in various ways, and may have other configurations such as the frictional force imparting means 23 described in FIG.
  • the frictional force imparting means 23 is provided on the side of the distal end engaging portion 11 (that is, on the inner peripheral surface side of the catheter 1), not on the distal end side engaged portion 21 side (that is, on the outer peripheral surface side of the dilator 2C).
  • the catheter 1 can be more easily inserted into the living tissue.
  • FIG. 10 is an explanatory diagram illustrating the configuration of the dilator kit of the fifth embodiment.
  • FIG. 10 shows a longitudinal section including the axis O of the proximal side of the dilator kit in the assembled state.
  • the dilator kits 1D and 2D of the fifth embodiment have a catheter 1D instead of the catheter 1 and a dilator 2D instead of the dilator 2 in the configuration described in the first embodiment.
  • a first connector 190D of the catheter 1D has a proximal side engaging portion 12D instead of the proximal side engaging portion 12, and a connecting portion 193D instead of the connecting portion 193.
  • the connecting portion 193D is a tubular member, and a columnar projection t protruding from the outer peripheral surface is provided on the outer peripheral surface of the base end portion of the tube.
  • the second connector 290D of the dilator 2D has a proximal side engaged portion 22D instead of the proximal side engaged portion 22, and a connecting portion 291D instead of the connecting portion 291.
  • the connecting portion 291D is a tubular member, and an L-shaped groove m is formed in the inner peripheral surface of the tubular member.
  • the operator inserts the protrusion t of the first connector 190D of the catheter 1D into the groove m of the second connector 290D of the dilator 2D, and moves the protrusion t along the groove m toward the proximal end. push in. Thereafter, the operator rotates the second connector 290D together with the connecting portion 291D fixed thereto at the abutting portion of the groove m, thereby fitting the projection t into the depth of the L-shaped groove m.
  • the groove m formed in the inner peripheral surface of the second connector 290D of the dilator 2D and the outer peripheral surface of the first connector 190D of the catheter 1D The formed projection t and are engaged. That is, in the catheter 1D, the protrusion t formed on the outer peripheral surface of the connecting portion 193D functions as the proximal side engaging portion 12D, and in the dilator 2D, the groove m formed on the inner peripheral surface of the connecting portion 291D serves as the proximal end. It functions as the side engaged portion 22D.
  • the configurations of the proximal side engaging portion 12D and the proximal side engaged portion 22D can be variously modified, and are realized with a configuration different from the so-called luer lock structure described in the first embodiment. good too.
  • the grooves m are formed on the side of the dilator 2D and the projections t are formed on the side of the catheter 1D, but these may be reversed.
  • a notch formed in a cylindrical member can be used instead of the groove m.
  • FIG. 11 is an explanatory diagram illustrating the configuration of the dilator kit of the sixth embodiment. Similar to FIG. 3, FIG. 11 shows a longitudinal section including the axis O of the distal end side of the dilator kit in the assembled state.
  • the dilator kits 1E and 2 of the sixth embodiment have a catheter 1E instead of the catheter 1 in the configuration described in the first embodiment.
  • the catheter 1E has a hollow shaft portion 100E instead of the hollow shaft portion 100.
  • the hollow shaft portion 100E defines an acute angle formed between the outer peripheral surface of the distal end tapered portion 101 and the outer peripheral surface of the large diameter portion 102 as a first acute angle ⁇ 1, and the inner peripheral surface of the distal end tapered portion 101 and the thick portion.
  • the thickness T1 at the distal end portion of the distal tapered portion 101 and the thickness T2 at the proximal end portion of the distal tapered portion 101 are substantially equal.
  • the configuration of the catheter 1E can be changed in various ways, and the thickness of the tip tapered portion 101 may be made substantially uniform.
  • the dilator kits 1E and 2 of the sixth embodiment as described above, the same effects as those of the above-described first embodiment can be obtained.
  • FIG. 12 is an explanatory diagram illustrating the configuration of the dilator kit of the seventh embodiment. Similar to FIG. 3, FIG. 12 shows a longitudinal section including the axis O of the distal end side of the dilator kit in the assembled state.
  • the dilator kits 1F, 2 of the seventh embodiment have a catheter 1F instead of the catheter 1 in the configuration described in the first embodiment.
  • the catheter 1F has a hollow shaft portion 100F instead of the hollow shaft portion 100.
  • Hollow shaft portion 100F in the vertical cross section shown in FIG.
  • the acute angle formed with the outer peripheral surface of the diameter portion 102 is smaller than the second acute angle ⁇ 2 (FIG. 12: ⁇ 1 ⁇ 2). Therefore, the thickness of the tip tapered portion 101 of the catheter 1F gradually increases from the base end to the tip end.
  • the thickness T1 at the distal end portion of the distal tapered portion 101 can be made thicker than the thickness T2 at the proximal end portion of the distal tapered portion 101 .
  • the configuration of the catheter 1E can be changed in various ways, and the thickness of the tapered portion 101 may be gradually increased from the proximal side to the distal side.
  • the length L1 between the distal side engaging portion 11 and the proximal side engaging portion 12 in the assembled state and the length between the distal side engaging portion 11 and the proximal side engaging portion 12 in the separated state may be less than 1 mm and may be greater than 30 mm.
  • the elastic modulus of the catheter may be greater than the elastic modulus of the dilator.
  • the modulus of elasticity of the catheter and the modulus of elasticity of the dilator may be the same.
  • the catheters 1, 1B, 1D, 1E, and 1F are shown.
  • tip taper portion 101 may be omitted.
  • the distal end portion of the hollow shaft portion 100 may be provided with a radiopaque marker portion.
  • the catheter 1 may be configured as a catheter other than a guiding catheter.
  • the catheter 1 may be configured as a multi-lumen catheter with multiple lumens.
  • the distal end side and the proximal end side of the hollow shaft portion 100 may be made of different materials and have different elastic moduli. In this case, it is preferable that at least the distal end side of the hollow shaft portion 100 have a smaller elastic modulus than the dilator 2 .
  • the configuration of the dilator 2 can be modified in various ways.
  • a small-diameter portion may be provided on the distal end side of the tapered portion 201, and an enlarged-diameter portion or a second large-diameter portion larger than the large-diameter portion 202 may be provided on the proximal end side of the large-diameter portion 202.
  • the distal end side and the proximal end side of the body portion 200 may be made of different materials and have different elastic moduli. In this case, it is preferable that at least the distal end side of the body portion 200 has a higher elastic modulus than the catheter 1 .
  • the catheter of the first to seventh embodiments is a dilator kit comprising a catheter having a lumen and a dilator, wherein the dilator is accommodated in the lumen of the catheter in an assembled state, wherein the catheter and the dilator are Based on the separated separated state, the catheter in the assembled state is stretched in its length direction (for example, within the range of 1 mm or more and 30 mm or less, preferably 5 mm or more and 15 mm or less). , supported by the dilator. Therefore, it is possible to suppress elongation of the catheter in the pushing direction (longitudinal direction) when receiving a pushing force from the hand when inserting the catheter into the living tissue. As a result, the catheter of the assembled dilator kit can be easily inserted into living tissue.

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PCT/JP2021/040072 2021-10-29 2021-10-29 ダイレータキット WO2023073942A1 (ja)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003325671A (ja) * 2002-05-16 2003-11-18 Nipro Corp イントロデューサー
WO2012172861A1 (ja) * 2011-06-15 2012-12-20 テルモ株式会社 イントロデューサー用シース、およびイントロデューサー組立体
WO2018225331A1 (ja) * 2017-06-09 2018-12-13 テルモ株式会社 カテーテル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003325671A (ja) * 2002-05-16 2003-11-18 Nipro Corp イントロデューサー
WO2012172861A1 (ja) * 2011-06-15 2012-12-20 テルモ株式会社 イントロデューサー用シース、およびイントロデューサー組立体
WO2018225331A1 (ja) * 2017-06-09 2018-12-13 テルモ株式会社 カテーテル

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