JP6720135B2 - Puncture tool - Google Patents

Description

The present invention relates to a puncture device.

For example, in TRI (Transradial Coronary Intervention), a catheter is inserted to a target site along a guide wire previously inserted into a radial artery. To insert the guide wire, the medical staff first attaches the puncture aid (see, for example, Patent Document 1) to the middle finger of one hand, and then the puncture aid in the attached state is used to radiate the radial artery from above the skin. To fix. Next, the introduction needle is grasped by the other hand to puncture the fixed radial artery. Then, a guide wire is inserted into the radial artery for a predetermined length through the introduction needle that punctures the radial artery. After that, if the introduction needle is removed, the guide wire can be inserted into the radial artery.

However, in such a guide wire insertion method, even if the phalanx radial artery is fixed with a puncture aid attached to one hand, the radial artery is swayed by vibration of the one hand, etc., resulting in introduction. It may be difficult to accurately puncture the radial artery with the needle. In addition, the puncture aid is attached to one hand and the introduction needle is held by the other hand, that is, the puncture aid and the introduction needle cannot be operated collectively by one hand. Was complicated and it was difficult to perform quick puncture.

Utility Model Registration No. 3182465

An object of the present invention is to provide a puncture device that can puncture a blood vessel that is a puncture target quickly and accurately.

Such an object is achieved by the present invention described in (1) to ( 6 ) below.
(1) A puncture needle that has a sharp needle tip at the tip and punctures a blood vessel,
A regulation member that is provided in connection with the puncture needle and that can assume a regulation state that regulates the position of the blood vessel,
Wherein when puncturing the blood vessel by the puncture needle, have a forward moving mechanism for the biopsy needle toward the vessel remains in the restricted state in advanceable relative to the regulating member,
The regulation member includes two elongated bodies that are arranged side by side and are spaced apart from each other, and have a tip end portion having a contact surface that comes into contact with the living body surface in the regulation state.
Between the one elongated body and the other elongated body, the puncture needle is arranged,
The puncture device characterized in that the gap distance between the elongated bodies is smaller on the distal end side than on the proximal end side .

( 2 ) The puncture device according to ( 1 ), wherein the contact surface is inclined with respect to the longitudinal direction of the elongated body.

( 3 ) In the advancing movable mechanism, the puncture needle includes a protrusion and an engaging portion formed to extend toward the elongated body, and the elongated body includes the protrusion and the engaging portion. The puncture device according to the above ( 1 ) or ( 2 ), which has a groove portion and a tooth portion that receive the puncture needle and can advance the puncture needle stepwise.

( 4 ) The advancement movable mechanism is configured to continuously advance the puncture needle,
Wherein comprises at least two or more divided body coaxially of each elongate body, each of said split body by mutual is provided slidably, the add flexibility to the entire length of the elongated body (1) Alternatively, the puncture device according to ( 2 ).

( 5 ) The puncture device according to any one of ( 1 ) to ( 4 ), wherein the restriction member has a connecting portion that connects the two elongated bodies.

( 6 ) The puncture device according to any one of (1) to ( 5 ), wherein the puncture needle is an introduction needle that introduces a guide wire into the blood vessel while the blood vessel is punctured.

According to the present invention, when a blood vessel that is a puncture target is punctured by a puncture needle, it can be brought into a regulated state prior to the puncture. Then, the puncture needle can be advanced toward the blood vessel in this restricted state. As a result, the blood vessel is fixed until it is punctured, and thus punctured quickly and accurately.

FIG. 1 is a diagram sequentially showing a method of using the puncture device of the present invention (first embodiment). FIG. 2 is a diagram sequentially showing a method of using the puncture device (first embodiment) of the present invention. FIG. 3 is a diagram sequentially showing a method of using the puncture device (first embodiment) of the present invention. FIG. 4 is a diagram sequentially showing a method of using the puncture device (first embodiment) of the present invention. FIG. 5 is a cross-sectional view taken along the line AA in FIG. FIG. 6 is a partial cross-sectional front view showing in sequence the method of using the puncture device (second embodiment) of the present invention.

Hereinafter, the puncture device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
<First Embodiment>
1 to 4 are views ((a) is a partial cross-sectional front view and (b) is a partial cross-sectional side view) sequentially showing the method of using the puncture device (first embodiment) of the present invention. FIG. 5 is a cross-sectional view taken along the line AA in FIG. Note that, for convenience of description, the upper side in FIGS. 1 to 4 (the same applies to FIG. 6) will be referred to as a “base end”, and the lower side will be referred to as a “tip” below.

The puncture device 1 shown in FIGS. 1 to 3 includes a puncture needle 2 and a restriction member 3. In the present embodiment, as an example, a case where the puncture device 1 is used in TRI (Transradial Coronary Intervention) will be described.

The puncture needle 2 is a member that punctures the blood vessel BV that is a puncture target by TRI. In the case of TRI, the blood vessel BV that is the target of puncture is the radial artery. Then, the puncture needle 2 functions as an introduction needle for introducing the guide wire 20 into the blood vessel BV in a state where the blood vessel BV is punctured (see FIG. 3 ).

As shown in FIGS. 1 to 3, the puncture needle 2 has a hollow needle 21 and a hub 22.
The hollow needle 21 has a sharp needle tip 211 at the tip. With this needle point 211, the blood vessel BV under the skin can be easily punctured following the skin (living body surface) S.

Further, the hollow needle 21 has a blade surface 212 formed from the needle tip 211 toward the base end direction. The blade surface 212 is formed so as to be inclined with respect to the longitudinal direction of the hollow needle 21. Thereby, the puncture resistance of the hollow needle 21 to the blood vessel BV can be reduced.

The constituent material of the hollow needle 21 is not particularly limited, and is made of, for example, a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.

A hub 22 is fixed to the base end of the hollow needle 21. The fixing method is not particularly limited, and includes, for example, a method of fitting, a method of bonding (bonding with an adhesive or a solvent), and a method of fusion (heat fusion, high frequency fusion, ultrasonic fusion, etc.). Methods and the like.

The hub 22 is formed of a hollow body having a tubular shape, and the hollow portion 221 communicates with the hollow portion 213 of the hollow needle 21. As a result, the guide wire 20 can be inserted from the hub 22 to the hollow needle 21, and further can be protruded from the hollow needle 21 in the distal direction (see FIG. 3 ).

In addition, it is preferable that the inner diameter of the hub 22 is gradually reduced toward the front end. That is, the inner peripheral portion of the hub 22 is preferably tapered. Accordingly, the insertion operation of inserting the guide wire 20 from the proximal end opening portion 222 of the hub 22 can be easily performed.

The constituent material of the hub 22 is not particularly limited, and examples thereof include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene. Various hard resin materials such as copolymers, polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, polyamides (for example, nylon 6, nylon 6.6, nylon 6/10, nylon 12) are listed. To be

The puncture needle 2 is provided with a restriction member 3 connected thereto. The regulation member 3 is an auxiliary member that assists the puncture by the puncture needle 2, and a state that regulates the position of the blood vessel BV with respect to the puncture direction of the puncture needle 2 (hereinafter, this state will be referred to as “regulated state (FIG. 1A, FIG. (A), refer to FIG. 3(a))”).

As shown in FIGS. 1 to 3, the regulating member 3 includes a long body 4A and a long body 4B that are spaced apart from each other and arranged side by side, and a connecting portion 5 that connects the long body 4A and the long body 4B. And have.

Since the long body 4A and the long body 4B have the same configuration, the long body 4A will be representatively described below.

The long body 4A is a member having a long plate shape. The total length L of the elongated body 4A is, for example, preferably 10 mm or more and 200 mm or less, and more preferably 20 mm or more and 150 mm or less. Further, the width w (maximum width) of the elongated body 4A is, for example, preferably 1 mm or more and 20 mm or less, and more preferably 2 mm or more and 10 mm or less. The thickness t of the elongated body 4A is constant along the longitudinal direction of the elongated body 4A, and is preferably 0.5 mm or more and 5 mm or less, for example, 1 mm or more and 2 mm or less. More preferable.

The elongated body 4A has a first bent portion 41 and a second bent portion 42 that are bent in opposite directions at two points in the longitudinal direction. The gap distance D from the elongated body 4B is the minimum on the tip side of the first bent portion 41. Further, the gap distance D from the elongated body 4B is the maximum on the base end side of the second bent portion 42. In the portion between the first bent portion 41 and the second bent portion 42, the gap distance D from the elongated body 4B gradually decreases in the distal direction. Therefore, in the restriction member 3, the maximum gap distance portion 31, the minimum gap distance portion 32, and the minimum gap distance portion 32 are sequentially arranged from the base end side based on the size of the gap distance D between the elongated bodies 4A and 4B. Part 33.
As will be described later, the puncture needle 2 is movably supported at the maximum gap distance portion 31.

As shown in FIG. 1(a) (the same applies to FIG. 2(a) and FIG. 3(a)), in the minimum gap distance portion 33, the blood vessel BV may be sandwiched from the skin S side to be in a restricted state. it can. In addition, when the blood vessel BV is a radial artery, the gap distance D (minimum gap distance) in the minimum gap distance portion 33 is preferably 0.5 times or more and 3 times or less than the average diameter of the radial artery. More preferably, it is 1 time or more and 2 times or less.

As shown in FIG. 1A, the distal end surface of the elongated body 4A is a contact surface 43 that is pressed against and abuts against the skin S in a regulated state. The contact surface 43 is inclined at an inclination angle θ with respect to the longitudinal direction of the elongated body 4A. As a result, the puncture posture of the puncture needle 2 with respect to the skin S can be maintained at the inclination angle θ (see FIGS. 1B and 2B). The inclination angle θ is, for example, preferably 5° or more and 90° or less, and more preferably 10° or more and 60° or less.

The contact surface 43 is preferably configured to increase the friction with the skin S. This structure is not particularly limited, and examples thereof include a method of forming the contact surface 43 with an elastic material such as urethane rubber, and a method of roughening the contact surface 43 to form minute irregularities. With such a contact surface 43, it is possible to reliably prevent the restriction member 3 from sliding on the skin S and releasing the restriction state when the contact surface 43 is pressed against the skin S. it can.

In the present embodiment, the connecting portion 5 is provided between the base end portion of the long body 4A and the base end portion of the long body 4B, and is composed of two strip-shaped bridge portions 51. Although the number of the bridge portions 51 is two in the present embodiment, the number is not limited to this and may be one or three or more. Further, these two bridge portions 51 are separated from each other in the width direction of the elongated body 4A. To maintain the positional relationship between the elongated bodies 4A and 4B, that is, the gap distance D between the elongated bodies 4A and 4B, by the two bridge portions 51 arranged in this manner. You can

The connecting portion 5 may be formed integrally with the elongated body 4A or the elongated body 4B, or may be formed separately from the elongated body 4A or the elongated body 4B. May be.

As shown in FIGS. 1 to 3, the puncture needle 2 is arranged between the elongated body 4A and the elongated body 4B. Further, a connecting portion 700 that connects the elongated body and the puncture needle 2 is formed between the elongated body 4A and the elongated body 4B and the puncture needle 2. The connecting portion 700 is provided with a forward moving mechanism that moves the puncture needle 2 so as to be able to move forward. As a result, the puncture needle 2 is movably supported along the longitudinal direction of the elongated body 4A and the elongated body 4B.

The forward moving mechanism in the connecting portion 700 between the puncture needle 2 and the regulating member 3 will be described below. As shown in FIG. 5, a groove 44 is formed along the longitudinal direction of the elongated body 4A in a portion of the elongated body 4A that constitutes the maximum gap distance portion 31. A large number of teeth 45 are arranged inside the groove 44 along the formation direction of the groove 44. A groove 44 in which similar teeth 45 are arranged is also formed in a portion of the long body 4B that constitutes the maximum gap distance portion 31.

On the other hand, the hub 22 of the puncture needle 2 is formed with protrusions 23 that are respectively inserted into the grooves 44 of the elongated body 4A and the grooves 44 of the elongated body 4B (see, for example, FIG. 1A). As shown in FIG. 5, the protruding portion 23 is formed with an engaging portion 231 that is engaged between the adjacent teeth 45. The engaging portion 231 is rounded. At least one of the engaging portion 231 and the tooth 45 preferably has elasticity.

Then, the puncture needle 2 can move by that amount each time the engaging portion 231 crosses over one tooth 45. As a result, the movement of the puncture needle 2 in the distal direction, that is, the forward movement, is performed stepwise until the puncture is completed. Such forward movement contributes to ease of fine adjustment of the forward movement amount after the forward movement is stopped. That is, when puncturing the blood vessel BV with the puncture needle 2, the puncture needle 2 is advanced to an appropriate distance with respect to the living body surface S, and then fine adjustment for inserting the puncture needle 2 to an appropriate depth is facilitated. be able to.

Since the puncture needle 2 is thus supported on both the long body 4A side and the long body 4B side, it can move stably.

The movable distance of the puncture needle 2 is not particularly limited and is, for example, preferably 1 mm or more and 30 mm or less, more preferably 2 mm or more and 15 mm or less. With such a configuration, the movement start position (initial position) and the movement completion position of the puncture needle 2 can be appropriately changed depending on, for example, the patient or the procedure.

The constituent material of the regulating member 3 is not particularly limited, and for example, the same constituent material as the hollow needle 21 or the same constituent material as the hub 22 can be used.

Next, a method of using the puncture device 1 will be described with reference to FIGS.
[1] First, the unused puncture device 1 is prepared. The puncture device 1 is in a state in which the puncture needle 2 is most retracted to the base end side. Then, for example, the middle finger, ring finger, and little finger of the dominant hand are collectively attached to the side surface of the elongated body 4A of the puncture device 1, the thumb is attached to the side surface of the elongated body 4B, and the puncture device 1 is sandwiched by these fingers. Hold it. Further, the index finger is attached to the hub 22 of the puncture needle 2.

After that, as shown in FIG. 1, the contact surface 43 of the elongated body 4A of the regulation member 3 and the contact surface 43 of the elongated body 4B of the regulating member 3 are positioned so that the puncture needle 2 of the puncture tool 1 is located immediately above the blood vessel BV. To the skin S. Then, the entire puncture device 1 is pressed against the skin S as it is. As a result, the blood vessel BV is regulated, that is, the blood vessel BV is fixed, and thus the blood vessel BV is reliably prevented from escaping in the left-right direction in FIG.
At this time, the needle tip 211 of the puncture needle 2 is separated from the skin S.

[2] Next, in the regulated state, the index finger attached to the hub 22 of the puncture needle 2 is moved toward the tip side. As a result, as shown in FIG. 2, the puncture needle 2 can reliably advance toward the blood vessel BV, and punctures the skin S and the blood vessel BV in order. Since the blood vessel BV is fixed as described above, it is accurately punctured by the puncture needle 2. Then, by visually confirming the flashback of blood, it is possible to confirm that the blood vessel BV is secured by the puncture needle 2.

[3] Next, as shown in FIG. 3, the guide wire 20 is inserted into the blood vessel BV for a predetermined length through the puncture needle 2 that secures the blood vessel BV.

[4] Next, as shown in FIG. 4, the puncture device 1 is removed from the blood vessel BV along the guide wire 20 and removed from the skin S. Then you can move on to the next procedure.

As described above, in the puncture device 1, when the blood vessel BV is punctured by the puncture needle 2, the puncture needle 2 can be advanced to the blood vessel BV in the restricted state prior to the puncture. As a result, the blood vessel BV is fixed until it is punctured, and thus punctured quickly and accurately.

In addition, the puncture device 1 can perform the operation in the restricted state and the puncture operation with one hand. Such an operation can prevent the operation from becoming complicated as compared with the case where the restricted operation and the puncturing operation are performed with different hands, thus contributing to speeding up of the procedure.

<Second Embodiment>
FIG. 6 is a partial cross-sectional front view showing in order the method of using the puncture device of the present invention (second embodiment).

Hereinafter, the second embodiment of the puncture device of the present invention will be described with reference to this figure, but the description will be focused on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the structure of the regulating member is different. In addition, in the present embodiment, the advancing movable mechanism is provided in the regulating member 3 instead of the connecting portion 700 of the first embodiment.

As shown in FIG. 6, the regulating member 3 has an elongated body 6A and an elongated body 6B that are arranged in parallel with each other.

Since the long body 6A and the long body 6B have the same configuration, the long body 6A will be representatively described below.

The elongated body 6A is composed of four flat tubular bodies (divided bodies) having different sizes. These four cylinders are referred to as a "first cylinder 61", a "second cylinder 62", a "third cylinder 63", and a "fourth cylinder 64" in this order from the base end side.

The first tubular body 61 can slidably accommodate the second tubular body 62. The puncture needle 2 is fixed to the outer peripheral portion of the first tubular body 61 via the protruding portion 23.

The second tubular body 62 can slidably accommodate the third tubular body 63.
The third tubular body 63 can slidably accommodate the fourth tubular body 64.

The fourth tubular body 64 has a first bent portion 641 and a second bent portion 642 that are bent in opposite directions at two points in the longitudinal direction. As a result, the gap distance between the long body 6A and the long body 6B changes. Therefore, also in the present embodiment, the restriction member 3 can be divided into the maximum gap distance portion 31, the minimum gap distance portion 32, and the minimum gap distance portion 33 in this order from the base end side based on the size of the gap distance. Further, the tip end surface of the fourth tubular body 64 is a contact surface 643 that is pressed against the skin S and abuts against the skin S in a regulated state.

By having such first to fourth cylinders 61 to 64, the lengths of the elongated body 6A and the elongated body 6B can be expanded and contracted. Thereby, as shown in FIG. 6, the elongated body 6A and the elongated body 6B can be contracted as the puncture needle 2 advances. Further, the advancement of the puncture needle 2 is continuously performed. Thereby, the blood vessel BV can be punctured more quickly.

Although the embodiment of the puncture device of the present invention has been described above, the present invention is not limited to this, and each part constituting the puncture device has an arbitrary configuration capable of exhibiting the same function. Can be replaced with In addition, any constituent may be added.

Further, the puncture device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

Further, the restriction member may be configured to bend or curve stepwise or continuously as the puncture needle advances.

Further, the puncture device may be provided with a scale for grasping the amount of movement of the puncture needle and the puncture depth.

Further, the puncture needle may be a needle having a combined structure of an inner needle and an outer tube.
Further, the blood vessel to be punctured was the radial artery in each of the above-mentioned embodiments, but it goes without saying that it is not limited to the radial artery.

The puncture device of the present invention has a puncture needle that has a sharp needle tip at the tip and punctures a blood vessel, and a regulation member that is provided in connection with the puncture needle and that can assume a regulation state that regulates the position of the blood vessel. the provided, when puncturing the blood vessel by the puncture needle, have a forward moving mechanism for the biopsy needle toward the vessel remains in the restricted state in advanceable relative to the regulating member, the regulating The members are provided in parallel with each other so as to be spaced apart from each other, and have two elongated bodies each having a contact surface at a tip portion thereof that abuts on the surface of the living body in the regulated state. One elongated body and the other elongated body. And the puncture needle is arranged between the two, and the gap distance between the elongated bodies is smaller on the distal end side than on the proximal end side . Therefore, it is possible to puncture the blood vessel that is the puncture target quickly and accurately. Therefore, the puncture device of the present invention has industrial applicability.

1 Puncturing Tool 2 Puncturing Needle 21 Hollow Needle 211 Needle Point 212 Blade Surface 213 Hollow Part 22 Hub 221 Hollow Part 222 Base End Opening 23 Protrusion 231 Engaging Part 3 Restricting Member 31 Maximum Gap Distance 32 Gap Distance Gradual Part 33 Gap Minimum distance portion 4A, 4B Long body 41 First bent portion 42 Second bent portion 43 Contact surface 44 Groove 45 Teeth 5 Connecting portion 51 Bridge portion 6A, 6B Long body 61 First tubular body 62 Second Tubular body 63 third tubular body 64 fourth tubular body 641 first bent portion 642 second bent portion 643 abutment surface 20 guide wire 700 connection portion BV blood vessel D gap distance L total length S skin (living body surface)
t thickness w width θ inclination angle

Claims (6)

A puncture needle that has a sharp needle tip at the tip and punctures a blood vessel,
A regulation member that is provided in connection with the puncture needle and that can assume a regulation state that regulates the position of the blood vessel,
Wherein when puncturing the blood vessel by the puncture needle, have a forward moving mechanism for the biopsy needle toward the vessel remains in the restricted state in advanceable relative to the regulating member,
The regulation member includes two elongated bodies that are arranged side by side and are spaced apart from each other, and have a tip end portion having a contact surface that comes into contact with the living body surface in the regulation state.
Between the one elongated body and the other elongated body, the puncture needle is arranged,
The puncture device characterized in that the gap distance between the elongated bodies is smaller on the distal end side than on the proximal end side . The puncture device according to claim 1 , wherein the contact surface is inclined with respect to the longitudinal direction of the elongated body. In the advancing mechanism, the puncture needle has a protrusion and an engaging portion that extend toward the elongated body, and the elongated body receives a groove for receiving the protrusion and the engaging portion. and by having a toothing, puncture device according to claim 1 or 2 to enable advancing the puncture needle stepwise. The advancing mechanism allows the puncture needle to be continuously advanced,
Wherein comprises at least two or more divided body coaxially of each elongate body, each of said split body by mutual is provided slidably claim 1 add flexibility to the entire length of the elongated body or The puncture device according to 2 . The puncture device according to any one of claims 1 to 4 , wherein the restriction member has a connecting portion that connects the two elongated bodies to each other. The puncture device according to any one of claims 1 to 5 , wherein the puncture needle is an introduction needle that introduces a guide wire into the blood vessel while puncturing the blood vessel.

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