JP2007000209A - Puncture device and guidewire insertion tool - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a puncture device and a guidewire insertion tool which are capable of, for example, inserting a guidewire into vessels without fail while preventing the tip section of the guidewire from bending. <P>SOLUTION: The guidewire insertion tool has the puncture device. The puncture device has: an insertion passage where a guidewire 2 is inserted; a valve body 434 which is mounted to close the insertion passage and on which a slit 435 is formed; a form control section 451 which has an opening adjacent to the slit 435, has a substantially constant inner diameter equal to or a little larger than the maximum outer diameter of the guidewire 2, and controls the form of the guidewire 2; and an introduction member 44 having a guiding section 452 which decreases inner diameter gradually as the form control section 451 is approached and guides the tip of the guidewire 2 to the form control section 451. When the guidewire 2 is inserted through the insertion passage, the guidewire 2 goes through the slit 435 after its form is controlled to be almost straight as its tip section goes through the form control section 451. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a puncture device and a guide wire insertion device.

  A guide wire insertion tool for inserting a guide wire into a blood vessel is known. This guide wire insertion tool is composed of a blood vessel puncture device provided with a puncture needle and a guide wire supply device for supplying a guide wire. The blood vessel puncture device has a valve body and is provided with a side port to which a guide wire supply device is connected. In addition, a slider chip penetrating the slit of the valve body is provided at the distal end portion of the guide wire supply tool (see, for example, Patent Document 1).

  When inserting the guide wire into the blood vessel, insert the needle tip of the puncture needle of the vascular puncture device into the blood vessel (secure the blood vessel), and then insert the slider tip of the guide wire supply device into the side port of the vascular puncture device . Thereby, a slider chip penetrates the slit of a valve body, and a guide wire supply tool is connected to a side port. Then, the guide wire is pressed against the wire feeding surface of the guide wire supply tool with a finger and slid, and the guide wire is pushed forward and inserted into the blood vessel.

  However, in the guide wire insertion tool described in Patent Document 1, when the tip of the guide wire protrudes from the tip of the slider tip, the slider tip is inserted into the side port and penetrated through the slit of the valve body. The tip of the guide wire is caught in the slit, and in this state, the tip of the guide wire is pushed into the blood vessel puncture tool at the tip of the slider tip and bent.

JP 2004-121514 A

  An object of the present invention is to provide a puncture tool and a guide wire insertion tool that can be reliably inserted into, for example, a blood vessel while preventing the distal end portion of the guide wire from being bent.

Such an object is achieved by the present inventions (1) to (10) below.
(1) A puncture device used to puncture a lumen of a living body and insert a guide wire into the lumen,
An insertion passage for inserting the guide wire;
A valve body that is provided so as to close the insertion passage and in which a slit is formed;
A shape restricting portion that opens in the vicinity of the slit, is substantially equal to or slightly larger than the maximum outer diameter of the guide wire and has a substantially constant inner diameter, and restricts the shape of the guide wire, and the inner diameter is the shape restriction An introduction part comprising a guide part that gradually decreases toward the part and guides the tip of the guide wire to the shape regulation part,
When the guide wire is inserted through the insertion passage, the guide wire passes through the slit after its tip is passed through the shape restricting portion so that its shape is regulated in a substantially linear shape. A puncture device characterized by being configured.

(2) When the maximum outer diameter of the guide wire is d ₁ [mm] and the average inner diameter of the shape restricting portion is d ₂ [mm], d ₁ / d ₂ is 0.3 to 0.99. The puncture device according to (1), which satisfies the above.

  (3) The puncture device according to (1) or (2), wherein the valve body is convex on a side opposite to the introduction portion at a portion where the slit is formed.

  (4) The valve body has a plate shape, and the introduction portion has a protrusion formed on an end surface of the valve body, and the protrusion presses the valve body, whereby the valve body The puncture device according to (3), wherein a portion where the slit is formed is curved so as to be convex on the side opposite to the introduction portion.

  (5) The puncture device according to any one of (1) to (4), wherein an average thickness of the valve body is 0.3 to 2.0 mm.

(6) The puncture device according to any one of (1) to (5) above,
A guide wire insertion tool comprising a guide wire supply tool that is detachably connected to the puncture tool and supplies the guide wire.

  (7) The guide wire supply device includes an insertion portion provided at a distal end portion thereof and a through hole through which the guide wire is inserted, and includes an introduction portion that feeds the guide wire, and the insertion portion is introduced into the introduction device of the puncture device. The guide wire insertion tool according to (6), wherein the guide wire insertion tool is connected to the puncture tool by being inserted into a portion.

  (8) The guide wire insertion device according to (7), wherein the distal end portion of the insertion portion is configured not to pass through the shape regulating portion in a state where the guide wire supply device is connected to the puncture device.

  (9) The guide wire insertion tool according to (7) or (8), wherein an angle formed between side surfaces of the distal end of the insertion portion is an obtuse angle in a longitudinal section thereof.

  (10) The above (7), further comprising a rotation preventing means for preventing the insertion portion from rotating relative to the introduction portion of the puncture device in a state where the guide wire supply device is connected to the puncture device. Thru | or the guide wire insertion tool in any one of (9).

  According to the present invention, since the shape of the distal end portion of the guide wire is regulated so as to be substantially linear, it passes through the slit of the valve body, so that the distal end portion of the guide wire is prevented from being bent. A guide wire can be inserted reliably.

  In addition, the tip of the guide wire can be more easily and reliably installed by placing the plate-like valve body on the opposite side from the start of the introduction of the guide wire, that is, on the living body, in a curved state so as to be convex. Can be passed through the slit of the valve body.

  In addition, by providing rotation prevention means, rotation of the guide wire supply device relative to the puncture device is prevented (blocked), so that the user (operator) can insert the guide wire with confidence when inserting the guide wire. Can be performed. That is, it can concentrate on the operation | work which hold | maintains a puncture tool in a predetermined position in a predetermined position, and operation which sends out a guide wire.

  Hereinafter, a puncture device and a guide wire insertion device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
First, a first embodiment of a guide wire insertion tool to which the puncture device of the present invention is applied will be described.

  FIG. 1 is a side view showing a first embodiment of the guide wire insertion tool of the present invention, FIG. 2 is a longitudinal sectional view showing a hub of the puncture tool shown in FIG. 1, and FIG. 3 is an introduction of the hub shown in FIG. FIG. 4 is a side view showing the delivery / introducing member of the guide wire supply tool shown in FIG. 1, and FIG. 5 is the delivery shown in FIG. FIGS. 6A and 6B are diagrams showing the tip of the introduction member ((a) is a front view, (b) is a side view), FIG. 6 and FIG. 7 are the delivery / introduction member of the guide wire supply tool shown in FIG. It is a longitudinal cross-sectional view which shows the introduction member shown. 1, 2, 4, 5 (b), 6, and 7, the left side in the drawing is “tip”, the right side is “base”, and the upper side is “up”. The lower side will be described as “lower”.

  A guide wire insertion tool 1 shown in these drawings is an instrument (device) for inserting a guide wire 2 into a blood vessel (inside the lumen of a living body), a guide wire supply tool 3 for supplying the guide wire, and a guide wire supply. It has a puncture tool (puncture tool of the present invention) 4 to which the tool 3 is detachably connected.

  The guide wire supply tool 3 includes a guide wire 2, a guide wire storage portion (guide wire case) 5 that stores the guide wire 2, and a delivery / introduction member 6 that is detachably attached (fixed) to the guide wire storage portion 5. And have. Hereinafter, each of these components will be described sequentially.

  As shown in FIG. 1, the puncture device 4 includes a hollow puncture needle (hollow needle) 41 having a sharp needle tip, a syringe (instrument) 42, and a toroid provided between the puncture needle 41 and the syringe 42. (Y-shaped) hub (branch connector) 43.

  As shown in FIG. 2, the hub 43 includes a hub body 430, and the hub body 430 includes a first tubular body 431 and a second tubular body 431 provided in the middle of the first tubular body 431. And the cylindrical body 432. The second cylindrical body 432 is inclined to the base end side (so that the base end side of the second cylindrical body 432 is located upward) with respect to the first cylindrical body 431.

  The second cylindrical body 432 (introduction member 44 described later) is opened at its proximal end to form an opening 438, and the guide wire 2 is introduced into the puncture tool 4 sequentially from the distal end through this opening 438 ( Inserted).

  In addition, a side hole (through hole) 433 is provided in the middle of the first cylindrical body 431, and the inside (lumen) of the first cylindrical body 431 and the second hole are provided via the side hole 433. The inside (inner lumen) of the cylindrical body 432 communicates.

  The size of the side hole 433 is not particularly limited, and is appropriately set according to various conditions such as the outer diameter (diameter) of the guide wire 2 to be used. When the shape of the side hole 433 in the cross section is substantially circular, The diameter of the side hole 433 is preferably about 0.7 to 3.0 mm, and more preferably about 0.8 to 2.0 mm.

  Thereby, the position of the guide wire 2 is regulated, and the guide wire 2 can be moved (inserted) more smoothly in the direction of the puncture needle 41.

  A connector 436 to which a hub 411 provided at the proximal end portion of the puncture needle 41 is detachably attached (connected) is provided at the distal end portion of the first cylindrical body 431. By attaching the hub 411 to the connector 436, the inside (lumen) of the puncture needle 41, the inside (lumen) of the first cylindrical body 431, and the inside (lumen) of the second cylindrical body 432 And communicate.

  In addition, a connector 437 to which a distal end portion of the syringe 42 is detachably attached (connected) is provided at the proximal end portion of the first cylindrical body 431.

  Inside the second cylindrical body 432 of the hub main body 430, a plate-like (flat plate-like) valve body 434 is installed in the middle thereof. A single-character slit (single-character slit) 435 is formed at the center of the valve body 434. The guide wire 2 can be inserted from the proximal end side of the second cylindrical body 432 to the distal end side through the slit 435, and the distal end side of the second cylindrical body 432 ( The liquid tightness (air tightness) between the first cylindrical body 431 side and the base end side (outside) can be maintained.

  In addition, the shape of the slit 435 of the valve body 434 is not limited to a single letter shape, and other examples include a cross shape (cross slit).

  Further, the valve body 434, for example, has a first notch that opens at one end face and does not open at the other end face, and intersects the first notch inside, opens at the other end face, and It may have a second notch that does not open in the end face (provided with a substantially cross slit formed so that one-character slits alternately intersect).

  Examples of the constituent material of the valve body 434 include various rubbers such as silicone rubber and natural rubber, and elastic materials such as thermoplastic elastomers (particularly soft materials are preferable).

  Although the average thickness of this valve body 434 is not specifically limited, It is preferable that it is about 0.3-2.0 mm, and it is more preferable that it is about 0.8-1.2 mm. Thereby, the guide wire 2 can pass the valve body 434 easily and reliably.

  For example, a lubricant such as silicone oil may be applied to the surface of the valve body 434. Thereby, reduction of the passage resistance (sliding resistance) at the time of the guide wire 2 passing the valve body 434 can be aimed at.

  In addition, a cylindrical introduction member (introduction portion) 44 is installed (fixed) inside the second cylindrical body 432 and on the proximal end side of the valve body 434. As a result, the valve body 434 is fixed to the second cylindrical body 432 (inside the hub 43) by the step formed inside the second cylindrical body 432 and the introduction member (female connector) 44. .

  In such a configuration, the inside (lumen) on the tip side from the valve body 434 of the second cylindrical body 432, the inside (inside the inside) on the side hole 433 and the vicinity of the side hole 433 of the first cylindrical body 431, The guide wire 2 is inserted into the puncture device 4 through the inside of the puncture needle 41 and the inside (lumen) of the puncture needle 41 sequentially.

  That is, in this embodiment, these spaces constitute an insertion passage through which the guide wire 2 is inserted. The valve body 434 is provided so as to close the insertion passage.

  The introduction member 44 has an opening in the vicinity of the slit 435 and has a shape restricting portion 451 having a substantially constant inner diameter, and a guide portion 452 whose inner diameter gradually decreases toward the shape restricting portion 451.

  The guide part 452 has a function of guiding the tip of the guide wire 2 to the shape restricting part 451. By providing the guide part 452, the tip of the guide wire 2 can be reliably guided (inserted) into the shape restricting part 451.

  Note that the guide portion 452 may have a configuration in which the inner diameter changes at different ratios (angles) of two or more stages.

  On the other hand, the shape restricting portion 451 has an inner diameter that is set to be approximately equal to or slightly larger than the maximum outer diameter of the guide wire 2, and has a function of restricting the shape of the guide wire 2 that passes through the portion to be substantially linear. . By providing the shape restricting portion 451, when the guide wire 2 is inserted through the insertion passage, the shape of the guide wire 2 is substantially linear when the tip portion 21 passes through the shape restricting portion 451 (needle). After being regulated by the shape, the slit 435 is passed. For this reason, even when the distal end portion 21 of the guide wire 2 is made of a relatively flexible material or has a curved shape, the bending of the distal end portion 21 of the guide wire 2 is prevented. In addition, the slit 435 can be reliably passed.

When the maximum outer diameter of the guide wire 2 is d ₁ [mm] and the average inner diameter of the shape restricting portion is d ₂ [mm], d ₁ / d ₂ satisfies the relationship of 0.3 to 0.99. Is more preferable, and it is more preferable that the relationship of 0.5 to 0.95 is satisfied. By satisfying such a relationship, the shape of the distal end portion 21 of the guide wire 2 can be more reliably changed to a linear (needle-like) shape while preventing an increase in the passage resistance of the guide wire 2 in the shape restricting portion 451. can do.

  The length of the shape restricting portion 451 is not particularly limited, but is preferably about 0.5 to 25 mm, and more preferably about 3 to 8 mm. Thereby, the shape of the front-end | tip part 21 of the guide wire 2 can fully be controlled, preventing the enlargement of the hub 43. FIG.

  As shown in FIG. 2 and FIG. 3, eight grooves (concave portions) 441 are formed on the inner peripheral surface (inner surface) of the introduction member 44 and at the proximal end portion of the introduction member 44, respectively. The second cylindrical body 432) is formed along the longitudinal direction. These four grooves 441 are arranged at equiangular intervals, that is, at 45 ° intervals.

  In the proximal end portion of the second tubular body 432, that is, in the introduction member 44, the introduction portion 7 (chip 76) of the guide wire supply tool 3 is inserted from the distal end side. Thereby, the introduction part 7 is detachably connected to the hub 43. Accordingly, the second cylindrical body 432, the introduction member 44, and the valve body 434 constitute a connection portion (connection port).

  In the present embodiment, the second cylindrical body 432 and the introduction member 44 are formed as separate members, but these members may be formed integrally.

  As shown in FIG. 1, the guide wire supply tool 3 includes a guide wire 2, a guide wire storage portion 5 that stores the guide wire 2, and a delivery / introduction that is detachably attached (fixed) to the guide wire storage portion 5. Member 6.

  The structure and constituent materials of the guide wire 2 are not particularly limited, but the guide wire 2 has, for example, a core material composed of a super elastic body (super elastic wire), and both ends of the core material are respectively It is preferable that a coil is provided.

  By providing a coil at the end of the core of the superelastic body, sufficient flexibility can be obtained at the end, and the diameter can be maintained at a predetermined value.

  Although the constituent material of the core material is not particularly limited, for example, a superelastic alloy such as a Ni-Ti alloy is preferable.

  Moreover, although the constituent material of the said coil is not specifically limited, For example, metal materials, such as stainless steel, etc. are preferable.

  Moreover, the outer diameter (diameter) of the guide wire 2 is not particularly limited, but is preferably 1.0 mm or less, and more preferably about 0.3 to 0.9 mm.

  Further, as shown in the drawing, the distal end portion 21 of the guide wire 2 has a straight shape (a straight shape in a natural state), a J shape (a curved shape in a natural state), or the like. The shape is not particularly limited.

  According to the present invention, the guide wire 2 can be reliably inserted into the puncture device 4 while preventing the distal end portion 21 of the guide wire 2 from being bent regardless of the shape of the distal end portion 21 of the guide wire 2.

  The guide wire storage unit 5 includes a flexible tube (tubular body) 51 in which the guide wire 2 is stored (inserted). The tube 51 is wound in a substantially annular shape (circular shape) and bundled. It has been. That is, the tube 51 is wound and bundled substantially along the circumference.

  The tube 51 is held by two clips (holding members) 52 having two through holes in a state of being wound and bundled in the annular shape.

  In addition, although the winding number (winding amount) of the tube 51 is not specifically limited, In the example of illustration, it is set as about 2 rounds.

  As shown in FIGS. 4 and 6, the delivery / introduction member 6 is delivered from the delivery part (guide wire delivery part) 8 to which the guide wire 2 accommodated in the guide wire storage part 5 is delivered, and from the delivery part 8. The guide wire 2 is received and an introduction portion (guide wire introduction portion) 7 through which the guide wire 2 is fed out is provided. The delivery part 8 and the introduction part 7 are separated from each other by a predetermined distance.

  The delivery part 8 has a cylindrical delivery part main body 81 and a plate-like pedestal (operation part) 82, and the delivery part 8 (especially the outlet 812) is substantially the circumference of the guide wire storage part 5. Located on the top. An opening (tip opening) on the distal end side of the hole (through hole) 811 formed in the delivery portion main body 81 constitutes an outlet 812 of the guide wire 2. The guide wire 2 is inserted through the hole 811 formed in the delivery part main body 81 and delivered from the outlet 812 toward the introduction part 7.

  The pedestal 82 protrudes from the vicinity of the outlet 812 of the delivery part main body 81 and from the lower part of the outlet 812 to the vicinity of the inlet 712 of the introduction part 7 to be described later and below the inlet 712. That is, the pedestal 82 is located in the vicinity of the guide wire 2 and the outlet 812 and between the guide wire 2 and the guide wire storage portion 5.

  The upper surface (upper surface) of the pedestal 82 faces the guide wire 2 (the guide wire 2 positioned between the delivery portion main body 81 and the introduction portion 7), and can contact the guide wire 2 and fingers. A contact surface (opposing surface) 821 is formed.

  With this pedestal 82, the operation of pulling the guide wire 2 to the proximal end side can be easily performed with one hand.

  Further, as shown in FIG. 1, the distal end portion 511 of the tube 51 is connected to the proximal end side of the delivery portion main body 81 so that the hole portion 811 and the lumen of the tube 51 of the guide wire storage portion 5 communicate with each other. (Inserted).

  The space between the delivery part 8 and the introduction part 7, that is, between the distal end of the base 82 of the delivery part 8 and the proximal end of the introduction part 7 and in the vicinity thereof, is a space in which the guide wire 2 is gripped and operated. (Grip space).

  Therefore, the separation distance L1 between the delivery portion 8 and the introduction portion 7, that is, the distance between the distal end of the pedestal 82 of the delivery portion 8 and the proximal end of the introduction portion 7, is the base of the introduction portion 7 and the distal end of the pedestal 82. It is set so that the finger of the user (surgeon) can enter between the ends.

  Specifically, the separation distance L1 is preferably about 20 to 80 mm, and more preferably about 30 to 70 mm.

  Moreover, the length L2 of the longitudinal direction (left-right direction in FIG. 1) of the base 82 is although it does not specifically limit, It is preferable that it is about 5-50 mm, and it is more preferable that it is about 10-30 mm.

  As shown in FIGS. 4 and 6, the introduction portion 7 includes a cylindrical introduction portion main body 71 and a cylindrical tip (insertion portion) that is detachably attached (connected) to the distal end portion of the introduction portion main body 71. 76. The guide wire supply device 3 is connected to the puncture device 4 by inserting the tip 76 into the introduction member 44 (second cylindrical body 432) of the hub 43.

  The inner diameter (diameter) of the base end portion of the tip 76 gradually decreases from the base end side toward the distal end side, and the outer shape (diameter) of the distal end portion of the introduction portion main body 71 extends from the base end side toward the distal end side. The tip end portion of the introduction portion main body 71 is inserted into the proximal end portion of the tip 76. Thereby, the base end part of the chip | tip 76 and the front-end | tip part of the introducing | transducing part main body 71 fit, and these are couple | bonded firmly. That is, the tip 76 is attached to the distal end portion of the introducing portion main body 71.

  Thus, by forming the chip 76 and the introducing portion main body 71 as separate members, the introducing portion 7 can be formed (manufactured) more easily, and productivity is improved.

  Further, since the proximal end portion of the tip 76 and the distal end portion of the introduction portion main body 71 are firmly coupled, the direction in which the introduction portion 7 is rotated relative to the second cylindrical body 432 (introduction member 44). Even when this force is applied, the tip 76 is prevented (blocked) from rotating with respect to the introducing portion main body 71, and as will be described later, the second cylindrical body 432 (introducing member 44) is prevented from rotating. It is possible to prevent (block) the introduction portion 7 from rotating relatively.

  Further, since the proximal end portion of the tip 76 and the distal end portion of the introduction portion main body 71 are firmly coupled, the tip 76 of the introduction portion 7 connected to the second cylindrical body 432 of the hub 43 is connected to the second portion 76. When removing from the cylindrical body 432, the chip 76 is prevented (blocked) from being detached from the introducing portion main body 71, and thus the chip 76 can be easily and reliably removed from the second cylindrical body 432. .

  In the present invention, for example, the chip 76 and the introducing portion main body 71 may be joined (fixed) by fusion, bonding, or the like, and the chip 76 and the introducing portion main body 71 may be integrated (one). May be formed). In this case, since the tip 76 and the introducing portion main body 71 are more firmly coupled, the introducing portion 7 rotates relative to the second cylindrical body 432 (introducing member 44). Can be more reliably prevented (blocked).

  When the tip 76 is attached to the distal end portion of the introducing portion main body 71, a hole (through hole) 711 formed in the introducing portion main body 71 and a hole (through hole) 761 formed in the tip 76 are formed. Communicate. An opening on the proximal end side of the hole portion 711 formed in the introduction portion main body 71 (base end opening) constitutes an inlet 712 of the guide wire 2 and an opening on the distal end side of the hole portion 761 formed in the chip 76. (Tip opening) constitutes an outlet 764 of the guide wire 2.

  The guide wire 2 delivered from the outlet 812 of the guide wire delivery part 8 passes through the hole part 711 formed in the introduction part main body 71 and the hole part 761 formed in the chip 76. That is, the guide wire 2 sent out from the guide wire sending part 8 is inserted from the inlet 712 and sent out from the outlet 764.

  As shown in FIG. 6, the tip (insertion portion) 76 has an obtuse angle (angle θ in FIG. 6) between side surfaces in the longitudinal section. Thereby, even when the guide wire 2 is bent unintentionally with the tip end of the tip 76 as a fulcrum, it is possible to prevent the guide wire 2 from being bent and shaped.

  As shown in FIG. 5, on the outer peripheral surface (outer surface) of the base end portion of the tip 76, four ribs (convex portions) inserted into the corresponding grooves 441 of the introduction member 44 (engaged with the grooves 441). ) 762 are formed along the longitudinal direction of the tip 76 (introducing portion main body 71). These four ribs 762 are arranged at equiangular intervals, that is, at 90 ° intervals.

  When the hub 43 is viewed from the direction of arrow A in FIG. 2, when the position of the groove 441 of the introduction member 44 and the position of the rib 762 of the tip 76 coincide with each other, as shown in FIG. When the tip 76 of the introduction portion 7 of the guide wire supply tool 3 is inserted into the proximal end portion of the second cylindrical body 432, that is, the introduction member 44 from the distal end side, each rib 762 of the tip 76 is respectively The introduction member 7 is inserted into the corresponding groove 441 of the introduction member 44, and the introduction portion 7 is connected to the second cylindrical body 432. That is, each rib 762 of the tip 76 and the corresponding groove 441 of the introduction member 44 are engaged with each other, whereby the introduction portion 7 (the tip 76) with respect to the second cylindrical body 432 (introduction member 44). ) Can be prevented (blocked) from rotating relatively. Therefore, the rib 762 and the groove 441 constitute an engaging portion (rotation preventing means).

  Further, the engagement between the rib 762 and the groove 441 restricts the position in the circumferential direction (rotation direction) of the introduction portion 7 (chip 76) with respect to the second cylindrical body 432 (introduction member 44). That is, the introduction part 7 is positioned in the circumferential direction with respect to the second cylindrical body 432. In this way, the circumferential alignment (angle adjustment) of the introduction portion 7 with respect to the second cylindrical body 432 can be easily and reliably performed.

  Further, as shown in FIG. 7, in the state where the tip 76 is inserted into the introduction member 44, the tip 76 is configured such that the tip thereof is located on the proximal side with respect to the shape restricting portion 451 and does not pass through the shape restricting portion 451. Has been. As a result, the guide wire 2 always passes through the shape restricting portion 451 before the tip of the guide wire 2 reaches the valve body 434, so that the shape restriction of the tip end portion 21 is ensured, and the slit 435 of the valve body 434 is ensured. Can pass through.

  As shown in FIGS. 4 and 6, a plate-like wall portion (barrier) 72 is formed in the central portion of the introduction portion main body 71 and on the upper portion thereof. The wall 72 has a substantially trapezoidal shape in a side view (in FIGS. 4 and 6). The wall 72 has a rib 721 that protrudes from the back side to the front side of the paper surface in FIG. 4 from the upper end to the base end (on the upper side and the right side in FIGS. 4 and 6). Is formed. The rib 721 protrudes to a position beyond a hole 714 described later.

  In addition, a hole 714 is formed in the central portion of the introducing portion main body 71 and in the upper portion thereof. One end side of the hole portion 714 communicates with the hole portion 711, and the other end side is a position corresponding to the wall portion 72 of the introduction portion main body 71, and the rib portion 721 side from the wall portion 72 (in FIG. 4). The front side of the paper surface is open to the outside.

  By providing the hole 714, when blood flows backward through the puncture tool 4, the blood can be released to the outside through the hole 714, thereby preventing blood leakage to the operation area (hand). It can be prevented (blocked). In addition, when the puncture needle 41 of the puncture device 4 is erroneously punctured into the artery, contamination of the operation area can be prevented or suppressed, and an error in the artery may be caused by the magnitude of the flow rate of blood flowing out from the hole 714. Puncture can be detected (detected).

  Further, by providing the wall portion 72, when blood is ejected from the hole portion 714, the wall portion 72 serves as a barrier, and it is possible to prevent (block) blood scattering (especially to the operation area).

  Further, a protrusion (positioning means) 75 for positioning in the circumferential direction (rotation direction) of the tip 76 with respect to the introduction member 44 is formed at the lower end portion of the introduction portion main body 71. The protrusion 75 protrudes toward the lower left. The protruding portion 75 also serves as an index for positioning the tip 76 in the circumferential direction (rotating direction) with respect to the distal end portion of the introducing portion main body 71 when the tip 76 is mounted on the leading end portion of the introducing portion main body 71.

  Here, for example, when the hub 43 is viewed from the direction of the arrow A in FIG. 2, the protrusion 75 is a straight line connecting the center of the first cylindrical body 431 and the center of the second cylindrical body 432 ( (Position of the groove 441) in the circumferential direction of the introduction member 44 relative to the second cylindrical body 432 so that the position of the groove 441 and the position of the rib 762 coincide with each other when positioned on the extension line) The circumferential position of the tip 76 with respect to the introducing portion main body 71 (the position of the rib 762) and the circumferential position of the protruding portion 75 with respect to the introducing portion main body 71 are set.

The tip 76 is attached to the distal end portion of the introducing portion main body 71 using the protruding portion 75 as an index so as to satisfy the positional relationship.
Needless to say, the setting may be different from that described above.

  Further, an arm portion 73 is formed at the lower portion of the central portion of the introduction portion main body 71, and a fixing portion (first fixing portion) 91 is provided at the lower end portion of the arm portion 73. Yes.

  Two grooves 911 are formed in the fixing portion 91, and the tubes 51 of the guide wire storage portion 5 are detachably mounted in the respective grooves 911 as shown in FIG. As a result, the introduction portion 7 is detachably fixed to the guide wire storage portion 5 via the fixing portion 91, and the tube 51 is wound in an annular shape and held by the fixing portion 91 in a bundled state. Is done.

  Further, a fixing portion (second fixing portion) 92 is provided at a lower portion of the sending portion main body 81 of the sending portion 8.

  Two grooves 921 are formed in the fixing portion 92, and the tubes 51 of the guide wire storage portion 5 are detachably mounted in the respective grooves 921 as shown in FIG. As a result, the delivery portion 8 is detachably fixed to the different portion from the introduction portion 7 of the guide wire storage portion 5 through the fixing portion 92, and the tube 51 is wound and bundled in an annular shape. In the state, it is held by the fixing portion 92.

  Further, the fixed portion 91 and the fixed portion 92 are connected by a connecting portion 93. As shown in FIG. 1, the connecting portion 93 has an arc shape substantially the same as the arc of the guide wire storage portion 5 (tube 51). That is, the fixed portion 91 and the fixed portion 92 are connected along the arc of the guide wire storage portion 5 (tube 51) via the connecting portion 93.

  Thereby, the separation distance L1 between the distal end of the pedestal 82 of the delivery part 8 and the proximal end of the introduction part 7 can always be maintained at a constant distance. Moreover, since the connection part 93 has comprised circular arc shape, the connection part 93 does not become obstructive.

  In the present embodiment, the portion other than the tip 76 of the delivery / introduction member 6 is formed integrally (in one member). However, the present invention is not limited to this. A portion other than the tip 76 of the introduction member 6 may be formed.

  In addition, the constituent materials of the feeding / introducing member 6, the hub main body 430, and the introducing member 44 are not particularly limited. For example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polystyrene, polycarbonate, acrylic Resin, acrylonitrile-butadiene-styrene copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), or a copolymer, blend or polymer alloy mainly composed of these.

  Next, an operation (an example of a usage method) of the guide wire insertion tool 1 will be described with reference to FIG. In this case, an example of an operation procedure at the time of insertion of the IVH catheter will be typically described.

  [1] First, the puncture needle 41 of the puncture device 4 is punctured into a predetermined site of the patient, and the needle tip of the puncture needle 41 is inserted into a blood vessel (vein).

  Then, blood is sucked with the syringe 42 and it is confirmed that the needle tip of the puncture needle 41 is located in the blood vessel.

  [2] Next, with the fingers, the guide wire 2 is pressed against the contact surface 821 of the pedestal 82 of the delivery portion 8, the guide wire 2 is pulled to the proximal end side, and a part or all of the distal end portion 21 of the guide wire 2 is removed. It is located in the introduction part 7. Thereby, the front-end | tip part 21 of the guide wire 2 does not get in the way.

  [3] Next, the introduction part 7 of the guide wire supply tool 3 is connected to the second cylindrical body 432 (introduction member 44) of the hub 43 of the puncture tool 4.

  In this case, the projecting portion 75 of the introduction portion 7 is used as an index, and the circumferential direction of the introduction portion 7 with respect to the second cylindrical body 432 (rotation) The tip 76 of the introduction portion 7 is inserted into the introduction member 44 through the opening 438 while positioning in the direction).

  At this time, each rib 762 of the tip 76 is inserted into the corresponding groove 441 of the introduction member 44. That is, each rib 762 of the tip 76 and the corresponding groove 441 of the introduction member 44 are engaged with each other, and the introduction portion 7 rotates with respect to the second cylindrical body 432 (introduction member 44). Can be prevented (blocked).

  At this time, the distal end portion of the tip 76 is positioned on the proximal side with respect to the shape restricting portion 451 without passing through the shape restricting portion 451.

  In this way, the guide wire supply tool 3 (introduction portion 7) is connected to the puncture tool 4 (second cylindrical body 432 of the hub 43).

[4] Next, an operation of inserting the guide wire 2 into the blood vessel is performed.
That is, the guide wire 2 positioned between the delivery part 8 and the introduction part 7 is grasped with fingers, and the guide wire 2 is delivered.

  Thereby, the guide wire 2 accommodated in the guide wire accommodating part 5 is sent out from the exit 812 of the sending-out part 8. And the shape of the guide wire 2 was regulated substantially linearly when the distal end portion 21 passed through the lumen of the distal end portion (shape regulating portion 451) of the introduction member 44 of the hub 43 shown in FIG. After that, it passes through the valve body 434 in order from the tip, and the tip side lumen of the second cylindrical body 432, the side hole 433, the tip portion lumen of the first cylindrical body 431, and the puncture needle 41 of the puncture tool 4. It protrudes from the needle tip of the puncture needle 41 through the lumen and is inserted into the blood vessel.

  [5] Next, with the guide wire 2 left, the puncture device 4 is removed, the guide wire 2 is removed from the guide wire supply device 3, and the guide wire 2 is placed in the blood vessel.

  [6] Next, a catheter (not shown) is inserted into the blood vessel along the guide wire 2.

  [7] Next, with the catheter remaining, the guide wire 2 is removed, and the catheter is placed in the blood vessel.

  As described above, according to the guide wire insertion tool 1, the guide wire 2 passes through the shape restricting portion 451 and passes through the shape restricting portion 451 before passing through the valve body 434. Therefore, the slit 435 of the valve body 434 can be reliably passed.

  In the operation of [2] and [3], even when the distal end portion 21 of the guide wire 2 protrudes from the distal end of the tip 76, the distal end portion 21 of the guide wire 2 has a shape regulating portion 451. After the shape is regulated after passing through the valve body, the tip of the valve reaches the valve body 434, so that the valve body 434 can be reliably passed.

  Further, since the introduction portion 7 of the guide wire supply tool 3 with respect to the introduction member 44 of the hub 43 of the puncture device 4 is prevented from rotating, the user (operator) can safely insert the guide wire 2 into the blood vessel. It is possible to perform an operation of inserting the guide wire 2 in mind. That is, it is possible to concentrate on the operation of holding the puncture device 4 at a predetermined position in a predetermined posture and the operation of feeding out the guide wire 2, whereby the guide wire 2 can be inserted easily and reliably.

  In addition, since the delivery part 8 and the introduction part 7 are separated from each other and a space (gripping space) for holding and operating the guide wire 2 with fingers is formed, the guide wire 2 can be directly held with fingers, Can be easily and reliably operated.

  That is, since the guide wire 2 can be operated by grasping with fingers, when the guide wire 2 is inserted, the guide wire 2 can be reliably inserted, and the guide wire 2 is prevented or suppressed from slipping. Thus, the operation can be easily performed.

  Moreover, since the delivery part 8 and the introducing | transducing part 7 are each being fixed to the different part of the guide wire storage part 5, the flapping of the guide wire supply tool 3 is prevented, and this can perform operation easily. .

  Moreover, since the delivery part 8 (especially exit 812) is located on the substantially circumference of the guide wire storage part 5, it is easy to operate and the guide wire supply tool 3 can be reduced in size.

  In the present embodiment, a groove (concave portion) is provided on the inner peripheral surface (inner surface) of the introduction member 44 and a rib (convex portion) is provided on the outer peripheral surface (outer surface) of the chip 76. For example, a rib (convex portion) may be provided on the inner peripheral surface (inner surface) of the introduction member 44, and a groove (concave portion) may be provided on the outer peripheral surface (outer surface) of the chip 76.

  In this embodiment, the number of ribs and the number of grooves are different, but in the present invention, the number of ribs and the number of grooves may be the same.

  In the present embodiment, a plurality of ribs and grooves are provided. However, in the present invention, at least one rib and groove may be provided. For example, one rib and one groove may be provided, one rib may be provided, and a plurality of grooves may be provided.

Second Embodiment
First, a second embodiment of the guide wire insertion tool to which the puncture device of the present invention is applied will be described.
FIG. 8 is an enlarged longitudinal sectional view showing the vicinity of the valve body included in the puncture device of the second embodiment.

  Hereinafter, the guide wire insertion tool of the second embodiment will be described with a focus on differences from the guide wire insertion tool of the first embodiment, and description of the same matters will be omitted.

  In the second embodiment, the configuration of the introduction member 44 installed (attached) to the second cylindrical body 432 of the hub 43 is different, and the rest is the same as in the first embodiment.

  In the introduction member 44 of the second embodiment, a ring-shaped (annular) protrusion 442 projects from the center of the tip surface. As a result, the valve body 434 is pressed by the protrusion 442 and is curved so as to be convex in the tip direction (on the side opposite to the introduction member 44) at the portion where the slit 435 is formed.

  According to such a configuration, as shown in FIG. 8, the slit 435 of the valve body 434 is open on the distal end side, so that the distal end portion 21 of the guide wire 2 can be more easily and reliably connected to the valve body 434. Can be passed.

  The blood flowing backward in the hub 43 presses the valve body 434 toward the proximal end, and a force is applied to the valve body 434 in a direction to close the slit 435 opened on the distal end side. For this reason, the backflow of blood from the opening 438 is prevented.

  Instead of such a configuration, the valve body 434 is naturally protruded in the distal direction (opposite to the introduction member 44) at the portion where the slit 435 is formed, such as a duck bill valve or the like. One-way valves can also be used.

  As mentioned above, although the puncture device and guide wire insertion tool of this invention were demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is arbitrary structures which have the same function Can be substituted.

  The use of the guide wire insertion tool of the present invention is not particularly limited, and for example, it is used for insertion of a guide wire that serves as a guide for various catheters such as IVH catheters.

It is a side view which shows 1st Embodiment of the guide wire insertion tool to which the puncture device of this invention is applied. It is a longitudinal cross-sectional view which shows the hub of the puncture device shown in FIG. It is a rear view (figure seen from the arrow A direction in FIG. 2) which shows the introduction member of the hub shown in FIG. It is a side view which shows the delivery and introduction member of the guide wire supply tool shown in FIG. It is a figure which shows the chip | tip of the delivery / introduction member shown in FIG. 4, (a) is a front view, (b) is a side view. It is a longitudinal cross-sectional view which shows the delivery / introduction member of the guide wire supply tool shown in FIG. 1, and the introduction member shown in FIG. It is a longitudinal cross-sectional view which shows the delivery / introduction member of the guide wire supply tool shown in FIG. 1, and the introduction member shown in FIG. It is a longitudinal cross-sectional view which expands and shows the valve body vicinity with which the puncture tool of 2nd Embodiment is provided.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Guide wire insertion tool 2 Guide wire 21 Front-end | tip part 3 Guide wire supply tool 4 Puncture tool 41 Puncture needle 411 Hub 42 Syringe 43 Hub 430 Hub main body 431 1st cylindrical body 432 2nd cylindrical body 433 Side hole 434 Valve Body 435 Slit 436, 437 Connector 438 Opening 44 Introducing member 441 Groove 442 Protruding part 451 Shape restricting part 452 Guide part 5 Guide wire storage part 51 Tube 511 Tip part 52 Clip 6 Feeding / introducing member 7 Introducing part 71 Introducing part main body 711 Hole Portion 712 Entrance 714 Hole 72 Wall 721 Rib 73 Arm 75 Projection 76 Tip 761 Hole 762 Rib 764 Outlet 8 Feeding portion 81 Feeding portion main body 811 Hole 812 Exit 82 Base 821 Abutting surface 91 Fixing portion 911 Groove 92 Fixed part 92 Groove 93 connecting part

Claims (10)

A puncture device used to puncture a lumen of a living body and insert a guide wire into the lumen,
An insertion passage for inserting the guide wire;
A valve body that is provided so as to close the insertion passage and in which a slit is formed;
A shape restricting portion that opens in the vicinity of the slit, is substantially equal to or slightly larger than the maximum outer diameter of the guide wire and has a substantially constant inner diameter, and restricts the shape of the guide wire, and the inner diameter is the shape restriction An introduction part comprising a guide part that gradually decreases toward the part and guides the tip of the guide wire to the shape regulating part,
When the guide wire is inserted through the insertion passage, the guide wire passes through the slit after its tip is passed through the shape restricting portion so that its shape is regulated in a substantially linear shape. A puncture device characterized by being configured. When the maximum outer diameter of the guide wire is d ₁ [mm] and the average inner diameter of the shape regulating portion is d ₂ [mm], d ₁ / d ₂ satisfies the relationship of 0.3 to 0.99. The puncture device according to claim 1.   The puncture device according to claim 1 or 2, wherein the valve body is convex on the side opposite to the introduction portion at a portion where the slit is formed.   The valve body has a plate shape, and the introduction portion has a protrusion formed on an end surface of the valve body, and the protrusion presses the valve body, whereby the valve body forms the slit. The puncture device according to claim 3, wherein the punctured portion is curved so as to protrude toward the opposite side to the introduction portion.   The puncture device according to any one of claims 1 to 4, wherein an average thickness of the valve body is 0.3 to 2.0 mm. A puncture device according to any one of claims 1 to 5,
A guide wire insertion tool comprising a guide wire supply tool that is detachably connected to the puncture tool and supplies the guide wire.   The guide wire supply tool has an insertion portion provided at a distal end portion thereof and a through hole through which the guide wire is inserted, and includes an introduction portion that sends out the guide wire, and the insertion portion is inserted into the introduction portion of the puncture device The guide wire insertion tool according to claim 6, wherein the guide wire insertion tool is connected to the puncture tool.   The guide wire insertion tool according to claim 7, wherein the guide wire supply tool is configured so that a distal end portion of the insertion portion does not pass through the shape restricting portion in a state where the guide wire supply tool is connected to the puncture tool.   The guide wire insertion tool according to claim 7 or 8, wherein an angle formed between side surfaces of the distal end of the insertion portion is an obtuse angle in a longitudinal section thereof. The rotation prevention means for preventing the insertion portion from rotating relative to the introduction portion of the puncture device in a state where the guide wire supply device is connected to the puncture device. A guide wire insertion tool according to crab.

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