JP4283945B2 - Intravascular catheter - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an indwelling catheter having a blood flow control function and a wing that can be easily fixed to the skin.
[0002]
[Prior art]
Intravascular catheters have problems such as blood leaking when the inner needle is removed after puncturing the blood vessel. Blood leaks are detrimental to the patient, and if there is potentially infectious blood, the operator performing the indwelling procedure may be contaminated and as a result may infect the patient or other patients It is very dangerous.
[0003]
In order to cope with this problem, conventionally, the distal end portion of the indwelling catheter or the base portion of the hub is pressed to stop hemostasis, or an elastic tube is provided at the proximal end portion of the catheter and the tube portion is pressed with a finger or the like when the inner needle is removed. Thus, a method for preventing blood leakage or a method for embedding an elastic tube with a hump at the proximal end of the catheter and pressing the hump to prevent blood leakage (US Pat. No. 3856010) has been proposed.
[0004]
In addition, there is a method of providing a blood flow control device such as a check valve, a stopper plug, or a forceps stopper to an elastic tube portion.
[0005]
Furthermore, a method has been proposed in which a compression portion is provided in the wing portion and the elastic tube is compressed with the wing interposed therebetween (Japanese Patent Publication No. 1-15303, Japanese Patent Application Laid-Open No. Hei 8-41078, Japanese Patent Publication No. 9-509075).
[0006]
[Problems to be solved by the invention]
However, in the method of hemostasis by pressing the distal end of the catheter or the base of the hub with a finger, pressure is applied to the vicinity of the patient's puncture site, so the pain to the patient is great and the catheter presses the hub base that is most likely to be crushed. There may also be a risk of inducing an accident. Also, the method of pressing the tube part by providing an elastic tube has the disadvantage that the positional relationship between the catheter and the inner needle tends to shift due to the elastic tube, and at least one finger cannot be used because it is pressed directly with the finger Since both hands cannot be used, the subsequent connection of external circuits such as medicinal solutions and infusions becomes troublesome, and this method also presses the vicinity of the patient's puncture site and causes considerable pain to the patient.
[0007]
In addition, the conventional blood flow control device can cause a disturbance (resistance) in the flow at the time of opening. Furthermore, the valve is prone to blood clots, the stopper plugs are expensive and bulky, and there is a danger that the elastic tube will be damaged by the forceps, and that the forceps are large, and the operation is troublesome because the forceps are large. If the forceps are later mistakenly removed from the hand, an unexpected force is applied to the elastic tube part or the intravascular catheter part due to the weight of the forceps, resulting in an accident that the catheter may come off or the patient may be injured.
[0008]
Also, even if the elastic tube is pressed by the compression part with the wing sandwiched between fingers, at least one hand is blocked during compression, so it is impossible to connect external circuits such as chemicals and infusions with both hands, which is quite troublesome. It becomes.
[0009]
[Means for Solving the Problems]
The present invention has been made in view of the above circumstances, and has a structure that is simple in structure, does not require the use of forceps and the like, is simple and safe to operate, and can prevent blood leakage and skin The present invention provides an intravascular catheter with a wing having excellent fixation. That is, this invention is solved by the following means.
[0010]
(1) Consists of a catheter part, an inner needle provided so as to penetrate the catheter part, and a wing provided on the left and right sides of the catheter major axis direction, and a flexible resin tube on the proximal end side of the catheter part An intravascular catheter having a compression portion that is capable of pressing the flexible resin tubular member, and a fixing mechanism that can fix the compression portion in a compressed state. It is provided integrally with the wing, and the fixing mechanism fixes the left and right wings, and is a claw portion provided on at least one wing of the left and right wings. The left and right wings can be fixed to each other by being engaged, and the claw portion has a plate-shaped portion extended outside the claw portion, and the plate-shaped portion And the claw part is provided Intravascular catheters, characterized in that by picking the end of the wings, in which a fixed state raised claw portion from the engaged position is releasable.
[0020]
(2) The intravascular placement according to (1), wherein the flexible resin tubular member is integrally formed with the catheter portion and / or a connector portion provided at a proximal end portion of the flexible resin tubular member. catheter.
[0021]
(3) In the cross-sectional shape of the flexible resin tubular member, the ratio A / B between the thickest thick part A and the thinnest thick part B is 1 to 10, according to (1) and (2) Intravascular catheter.
[0022]
(4) The intravascular structure according to any one of (1) to (3), wherein the flexible resin tubular member has an elliptical cross-sectional shape and a ratio C / D of the major axis C to the minor axis D is 1 to 4. Indwelling catheter.
[0023]
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will be described below. In addition, the figure used below is an example and is not limited by this.
[0024]
As shown in FIGS. 1 and 2, a catheter portion 1 and an inner needle 2 are provided so as to penetrate the catheter portion 1. An inner needle hub 4 is provided at the rear end of the inner needle 2, and a cap 6 containing a blood leakage resistant filter is disposed at the rear end. Although a flexible resin tubular member 5 is provided at the proximal end of the catheter, a hub portion 3 may be disposed between the catheter portion 1 and the flexible resin tubular member 5, and these May be the same material as the catheter part 1 or the flexible resin tubular member 5 and may be a continuous body. Moreover, the connector part 10 may be arrange | positioned at the base end part of the flexible resin tubular member 5, even if this is the same material and continuous body as the flexible resin tubular member 5. good.
[0025]
Further, the wing part is a wing-like part that exists on the left and right between the catheter part and the connector part and can press and fix the flexible resin tubular member, and is used for fixing to the skin contact surface. It may be the same part as the wing part or a separate part. The wing portion 7 is arranged on the left and right with respect to the long axis direction of the flexible resin tubular member 5, and the hub portion 3 as shown in FIGS. The present invention is not limited to this, and the catheter portion 1, the flexible resin tubular member 5, the connector portion 10 and the like may be used, and are not particularly limited as long as they can be fixed to the main body.
[0026]
The wing part 7 is provided with a fixing mechanism part 9 and a compression part 8, and the fixing mechanism part 9 is engaged with the claw part by closing the left and right wings as shown in FIGS. A method for fixing the closed state by providing a convex portion and a concave portion on the left and right wings and fitting the convex portion and the concave portion as shown in FIG. Alternatively, as shown in FIG. 7 as an example, there is a method in which one wing 12 covers the flexible resin tubular member 5 and engages with a claw portion of the other wing 13 to fix the closed state. In particular, in this method, when a somewhat flexible material is used for the wing material, the shape is easy to maintain a fixed state even when the wing is curved.
[0027]
In any case, the fixing mechanism is not particularly limited as long as the wing can be fixed in a state where blood leakage can be prevented.
[0028]
In addition, a shape that can be released from the fixed state only by a simple operation after fixing, for example, FIGS. 8, 9, and 10 shows an example. A plate-shaped portion 14 extending outside the claw portion of one wing, It is more preferable that the fixed state can be easily released by picking up the wing end 15 and the fixed state can be easily released, and it is very convenient if the fixed state can be set and released with one hand. , It does not interfere with speedy procedures of medical staff.
[0029]
Further, the compression portion is a portion having an action of deforming the flexible resin tubular member. For example, it may be a convex object provided in the wing and may be in a symmetrical position on the left and right wings, but when the left and right pressing portions 8 are alternately shifted as shown in FIG. 11, the wings are closed. As shown in FIGS. 12 and 13, the flexible resin tubular member 5 is sometimes bent by the alternately displaced compression portions, so that the flexible resin tubular member 5 can be closed with a small force, which is effective. Furthermore, as the shape of the compression portion, a plurality of shapes as shown in FIG. 14 and a triangular prism shape as shown in FIG. 15 are conceivable, but the lumen of the flexible resin tubular member 5 is closed by bending the wing portion. There is no particular limitation as long as it is possible.
[0030]
Furthermore, as shown in FIG. 16, if the flexible resin tubular member is formed integrally with the catheter portion or the connector portion, there is no connection portion between the respective parts, so that the catheter portion can be pulled for some reason. In addition, since there is no extraction between the connector portion and the flexible resin tubular member, and the steps in the lumen can be reduced, it is difficult for the blood flow to drift and stay, and the occurrence of thrombus and the like can be prevented.
[0031]
Further, if the cross-sectional shape of the flexible resin tubular member 5 is a rhombus, an ellipse or a flat shape as shown in FIG. 17, the compression portion 8 can be easily closed, which is more effective. In the case of a rhombus, etc., the specific shape range is effective if the ratio A / B of the thickest part A to the thinnest part B is 1 to 10; This is not preferable because the strength of the thick portion is weakened and the strength of the flexible resin tubular member 5 cannot be maintained. In addition, when the cross-sectional shape is an elliptical shape, it is effective if the ratio C / D of the major axis C to the minor axis D is 1 to 4, and if the ratio is higher than this, the flexible resin tubular member 5 is too crushed. As a result, the flow path becomes narrow and it is difficult to ensure a smooth flow of blood, infusion, etc., which is not preferable.
[0032]
Hereinafter, a method for operating the intravascular catheter will be described. First, as shown in FIGS. 18 and 19, both wing portions 7 are bent upward, the lower surface of the wing is sandwiched between fingers, and the flexible resin tubular member 5 and the inner needle 2 are gripped by the compression portion 8 on both wings. Let it be in the state you let it. Thereafter, the distal end of the inner needle 2 is punctured into the blood vessel, and the catheter 1 is inserted into the blood vessel using the inner needle 2 as a guide. Puncture of the inner needle 2 into the blood vessel can be determined by blood flowing out from the rear end of the inner needle of the inner needle hub 4 shown in FIG. Further, the blood that has flowed out is prevented from leaking to the outside by the blood leakage resistance filter of the cap 6 provided at the rear end of the inner needle hub 4. Then, after the catheter 1 is inserted into the blood vessel, the inner needle 2 is removed from the blood vessel and the catheter 1. In this case, the wing portion 7 is slightly released from the finger so that the inner needle 2 can be easily removed. . The inner needle 2 is removed, and immediately after the tip of the inner needle 2 has passed through the wing 7, the wing 7 is immediately pressed by the finger, and the right and left wings are fixed by the fixing mechanism 9 as shown in FIGS. 5 and 19. Blood leakage from the connector portion 10 can be completely prevented from inside the blood vessel through the catheter, and since it is further fixed, the work of connecting an external circuit such as an infusion to the connector portion 10 thereafter is performed with both hands. I can do it. After an external circuit such as infusion is connected to the connector part 10, the fixing mechanism 9 of the wing part 7 is released, the wing part 7 is expanded to the original state, and each wing part 7 is fixed to the skin surface with a tape or the like.
[0033]
As an application example of the present invention, it can be applied to an indwelling needle for veins, an indwelling needle for arteries, an indwelling needle for dialysis, etc., but can also be applied to an introduce circuit or IVH catheter kit, but is not limited thereto. Is not to be done.
[0034]
An example of the operation method as an introduction circuit is shown in FIGS. 20, 21, and 22. As shown in FIG. 20, the wing portion 7 is picked with a finger while the inner needle 2 is inserted, and the compression portion 8 is flexible. The tubular member 5 made of the flexible resin and the inner needle 2 are held and punctured and placed in the blood vessel. After the inner needle is removed, the wing portion is further pressed to close the flexible resin tubular member 5 and the fixing mechanism 9 The occlusion state is fixed by the step shown in FIG. 21 to suppress blood leakage. Further, when the external catheter such as the guide wire 16 is introduced, after the fixing mechanism 9 is released, the guide wire 16 is introduced while the pressure of the compression portion is slowly released with the finger of one arm, and the guide wire 16 becomes the compression portion 8. 22 when the guide wire is further pushed in while the flexible resin tubular member 5 and the guide wire 16 are gripped at the compression portion by further increasing the pressure with the finger when passing through the blood vessel, as shown in FIG. It is possible to introduce the guide wire 16 into the blood vessel while suppressing blood leakage due to the back flow.
[0035]
Next, the material of the present invention will be described. The following materials are examples, and are not limited by these. The material of the wing part is made of flexible resin and may be the same material as the flexible resin tubular member and connector part. For example, olefin elastomer such as 1,2-polybutadiene resin, styrene elastomer, urethane resin Polyethylene, polypropylene, nylon resin, silicone resin, polyvinyl chloride, and natural rubber may be used.
[0036]
In addition, the material of the compression part may be an elastic body or an inelastic body, and may be the same material as the wing part or a different material. For example, olefin elastomer such as 1,2-polybutadiene resin, styrene elastomer, urethane resin, polyethylene, polypropylene, nylon resin, silicone resin, polyvinyl chloride, natural rubber, etc. The non-elastic material may be an engineering plastic such as polysulfone, polyethersulfone, polycarbonate or polyimide, or a metal or alloy such as iron, silver, copper, aluminum or stainless steel.
[0037]
The material of the fixing mechanism portion may be an elastic body or an inelastic body, and may be the same material as the wing portion or a different material. For example, olefin elastomer such as 1,2-polybutadiene resin, styrene elastomer, urethane resin, polyethylene, polypropylene, nylon resin, silicone resin, polyvinyl chloride, natural rubber, etc. The non-elastic material may be an engineering plastic such as polysulfone, polyethersulfone, polycarbonate or polyimide, or a metal or alloy such as iron, silver, copper, aluminum or stainless steel.
[0038]
The material for the catheter portion is made of thermoplastic resin, and is preferably, but not limited to, fluororesin, urethane resin, nylon resin, polyester resin, polyethylene, and polypropylene.
[0039]
The flexible resin tubular member is a part for connecting the catheter part and the connector part, but may be the same material and continuous body as the catheter part and the connector part, and the material is made of a flexible resin. Olefin-based elastomers such as 2-polybutadiene resin and styrene-based elastomers, urethane resins, polyethylene, polypropylene, nylon resins, silicone resins, polyvinyl chloride, and natural rubber may also be used.
[0040]
Further, a hub portion may exist between the catheter portion and the flexible resin tubular member, and this material may or may not be the same material and continuous body as the catheter portion and the flexible resin. . The hub is made of flexible resin, such as olefin elastomer such as 1,2-polybutadiene resin, styrene elastomer, urethane resin, polyethylene, polypropylene, nylon resin, silicone resin, polyvinyl chloride, and natural rubber. Etc.
[0041]
The connector portion is a connection portion for connecting to another liquid circuit, but may be a continuous body with a flexible resin tubular member, and the material is made of a flexible resin, and the flexible resin tubular portion The material may be the same as the material, for example, olefin elastomer such as 1,2-polybutadiene resin, styrene elastomer, urethane resin, polyethylene, polypropylene, nylon resin, silicone resin, polyvinyl chloride, and natural rubber. .
[0042]
【Example】
Hereinafter, the present invention will be described with reference to specific examples, but the present invention is not limited to these examples. First, application examples to dialysis, arterial, and intravenous intravascular catheters are shown.
[0043]
In FIG. 1, 1 is a flexible tube having an outer diameter of 0.3 to 3.0 mm and a wall thickness of 0.08 mm to 0.3 mm made of, for example, urethane resin. The base end is slightly larger than the outer diameter of the inner needle 2 and is connected to the hub portion 3. The hub portions are fitted to each other as shown in FIG. 1, and are, for example, injection molded from 1,2-polybutadiene or the like, and a flexible resin tubular member 5 is fitted to the hub portion. 5 is formed by extrusion molding or injection molding using, for example, 1,2-polybutadiene, etc., and the blood flow volume varies depending on the site of use such as dialysis, arterial, venous, and central arterial. The sizes of the tubular member 5 and the wing part 7 are also changed. For example, the outer diameter is 1.0 mm to 10 mm, the wall thickness is 0.08 mm to 2.0 mm, the length is 3 mm to 38 mm, the outer diameter is 1.2 mm to 8.0 mm, and the wall thickness is 0.1 mm. More preferably, the length is 1.5 mm and the length is 5.0 mm to 32 mm. A connector portion 10 for connecting to an external liquid circuit such as an infusion is formed at the rear end of the flexible resin tubular member 5. A pair of flexible wings 7 injection-molded with, for example, 1,2-polybutadiene, for example, extend symmetrically in a direction substantially perpendicular to the axial direction of the catheter at the left and right ends of the flexible resin tubular member 5. . The width of the wing portion 7 is slightly smaller than the length of the flexible resin tubular member 5, and the length from the main body side to the end portion changes accordingly, and the wing width is 2 mm to 35 mm, from the main body side to the end portion. More preferably, the length is 5 to 30 mm, the wing width is 3 to 30 mm, and the length from the main body side to the end is 8 to 28 mm. On the upper surface of the wing portion 7, a compression portion 8 is preferably formed integrally with the wing portion. The height of the compressed portion is 0.8 mm to 5.0 mm, and more preferably 1.0 mm to 4.0 mm.
[0044]
Next, an application example to an introductory circuit is shown. The catheter part 1 in FIGS. 20 and 21 is made of, for example, urethane resin and is a flexible tube having an outer diameter of 0.5 to 20 mm and a wall thickness of 0.1 to 5.0 mm. This catheter portion is connected to a hub portion 3 in the figure, and this hub portion is injection-molded with, for example, 1,2-polybutadiene, etc., and a flexible resin tubular member 5 is fitted to this hub portion. Yes. 5 is, for example, formed by extrusion molding or injection molding with 1,2-polybutadiene or the like, and has an outer diameter of 1.0 mm to 40 mm, a wall thickness of 0.1 mm to 10 mm, a length of 5 mm to 100 mm, and an outer diameter of 3 mm to More preferably, the thickness is 30 mm, the thickness is 0.5 mm to 8 mm, and the length is 8 to 80 mm. A connector portion 10 is formed at the rear end of the flexible resin tubular member 5. A pair of flexible wings 7 injection-molded with, for example, 1,2-polybutadiene, for example, extend symmetrically in a direction substantially perpendicular to the axial direction of the catheter at the left and right ends of the flexible resin tubular member 5. . The width of the wing portion 7 is slightly smaller than the length of the flexible resin tubular member 5, and the length from the main body side to the end portion is changed accordingly, and the wing width is 3 mm to 80 mm, from the main body side to the end portion. More preferably, the length is 10 mm to 100 mm, the wing width is 5 mm to 70 mm, and the length from the main body side to the end is 15 mm to 80 mm. On the upper surface of the wing portion 7, a compression portion 8 is preferably formed integrally with the wing portion. The height of the compressed portion is 1 mm to 50 mm, and more preferably 3 mm to 40 mm.
[0045]
【The invention's effect】
The indwelling catheter of the present invention is provided with a fixing function and a compression portion on the wing, and by pressing and closing the flexible resin tubular member at the proximal end portion of the catheter by sandwiching both wing portions so as to be bent. Therefore, it is possible to easily prevent blood leakage when the inner needle is removed, and to keep the closed state by the fixing mechanism of the wing part after removing the inner needle. Can be done. Furthermore, when the fixing mechanism is the engagement of the claw portion, the fixed state can be easily released by making the claw portion movable, and the closed state can be easily fixed and released.
[0046]
In addition, even when used as an introduction circuit when introducing an external catheter such as a guide wire, it is possible to prevent blood leakage after removing the inner needle, and the wing portion can be fixed and kept in a closed state so that the guide wire or the like Even when the external catheter is introduced, blood leakage can be suppressed by grasping the wing portion and pressing the flexible resin tubular member.
[Brief description of the drawings]
Each figure shows an example of the present invention, and the present invention is not limited by the figure.
FIG. 1 is a plan view of an intravascular indwelling catheter according to the present invention.
FIG. 2 is a side view of FIG.
FIG. 3 is a perspective view of the wing portion of the present invention.
FIG. 4 is a cross-sectional view of the present invention.
FIG. 5 is a cross-sectional view showing an engaged state in a fixing mechanism using a claw.
FIG. 6 is a perspective view showing an application example of a fixing mechanism using concave and convex portion fitting.
FIG. 7 is a sectional view showing a fixing mechanism of a type in which one wing covers the other wing.
8 and 9 are cross-sectional views showing examples of shapes in which a one-touch fixing release function is given to the fixing mechanism.
FIG. 10 is a perspective view of a shape example provided with a one-touch fixing function.
FIG. 11 is a perspective view when there are three compression portions.
12 and 13 show a state in which the flexible resin tubular member is closed by three-point bending at the three compression portions.
14 and 15 are perspective views of modifications of the compression portion on the wing.
FIG. 16 is a cross-sectional view showing an application example to the hub, clamp, and connector integral molding.
FIG. 17 is a sectional view showing a modification of the flexible resin tubular member.
FIG. 18 is a side view showing a use state of the catheter shown in FIG. 1 during blood vessel puncture.
FIG. 19 is a side view showing a state in which the inner needle is removed and the wing is fixed after puncturing.
FIG. 20 is a plan view showing an application example of the present invention to an introduction circuit.
FIG. 21 is a side view showing a state in which the wing is fixed using a wing fixing mechanism.
FIG. 22 is a conceptual diagram in which a guide wire is introduced using the present invention.
[Explanation of symbols]
1. ・ Catheter part
2.Inner needle
3.Hub part
4. ・ Inner needle hub
5 ・ ・ Flexible resin tubular member
6 ・ ・ Cap
7 ・ ・ Wing
8.Pressing part
9 ・ ・ Fixing mechanism
10. ・ Connector part
11.Lower compression part
12 ... Left wing
13.Right wing
14. ・ Claw outer plate shape part
15.Wing edge
16. ・ Guide wire

Claims (4)

The catheter portion, the inner needle is provided so as to penetrate the catheter portion, and Ri Tona wings provided on the left and right relative to the catheter axial direction, the flexible resin tubular member proximally of the catheter portion In an indwelling catheter provided with a compression part that is provided and capable of pressing the flexible resin tubular member, and a fixing mechanism that can fix the compression part in a compressed state ,
The compression part is provided integrally with the left and right wings,
The fixing mechanism fixes the left and right wings, and is a claw portion provided on at least one wing of the left and right wings, and the left and right wings are engaged with each other by engaging with the other wing. Can be fixed,
The claw portion has a plate-shaped portion extending outside the claw portion, and the nail portion is picked by pinching the plate-shaped portion and the end portion of the wing provided with the claw portion. An indwelling catheter, wherein the part is lifted from the engagement position and the fixed state can be released. The indwelling catheter according to claim 1 , wherein the flexible resin tubular member is integrally formed with the catheter portion and / or a connector portion provided at a proximal end portion of the flexible resin tubular member. 3. The indwelling catheter according to claim 1, wherein the ratio A / B of the thickest thick part A to the thinnest thick part B is 1 to 10 in the cross-sectional shape of the flexible resin tubular member. The intravascular catheter according to any one of claims 1 to 3 , wherein the flexible resin tubular member has an elliptical cross-sectional shape and a ratio C / D of the major axis C to the minor axis D is 1 to 4.

Images