JP2510887B2 - Medical valve and its manufacturing method and catheter with valve - Google Patents

Description

TECHNICAL FIELD The present invention relates to a medical valve body, a method for producing the same, and a catheter with a valve body.

[Prior Art] Generally, in medical devices such as catheters, for example, a guide wire for introducing and guiding the catheter into the organs of the body, an injection for injecting a drug or the like into each organ via the catheters. A tubular body such as a collector for taking out the body fluid of each organ can be inserted through the container and the catheter. Especially in the auxiliary circulation such as acute heart failure, the blood vessel can be secured percutaneously because of the acute nature. Then, in these medical devices, a tubular body can be inserted in a passage that allows the tubular body to be inserted therethrough, and a valve body that is closed when the tubular body is not inserted is attached, It is possible to prevent liquid from flowing out from the passage.

As a conventional medical valve body, for example, one in which a plurality of slits penetrating from one end face to the other end face are crossed with each other as in USP4798594, or on one end face as in JP-A-59-133877. There is one in which a first slit that opens only in one end and a second slit that opens only in the other end face intersect in the valve body.

[Problems to be Solved by the Invention] However, in the above-described conventional technology, the restoring force of each slit from the open state to the closed state is weak. For this reason, when the tubular body is placed, the adhesion of each slit to the periphery of the tubular body is weak, and liquid leakage may occur. Further, when the tubular body is removed, the restoring force of each slit to the closed state is weak, and the slit does not close immediately after the removal, which may cause liquid leakage.

On the other hand, in the above-mentioned conventional technology, the restoring force from the open state of each slit to the closed state is strong, and although the liquid tightness at the time of tubular body indwelling and removal is high, the slit does not penetrate to both end surfaces of the valve body. Only the thin tubular body of the insertion tip can be inserted.

It is an object of the present invention to provide a medical valve body which can be inserted even in a tubular body having a thick insertion tip and which is highly liquid-tight when the tubular body is left in place and when it is removed.

Another object of the present invention is to provide a manufacturing method capable of easily manufacturing the valve body.

It is another object of the present invention to provide a catheter that includes the valve body and can reliably prevent the liquid from flowing out from the base opening.

[Means for Solving the Problems] The present invention according to claim 1 is made of a flexible elastic material having at least two surfaces, and a first slit provided from one surface to the other surface, and one In a medical valve body in which a second slit provided from one surface to the other surface is made to intersect with each other, the first slit has different first and second opening widths provided on both surfaces. The first and second opening widths of the second slits provided on both surfaces are different from each other.

According to a second aspect of the present invention, in the medical valve element according to the first aspect, of both opening widths of the first slit,
A surface having a short opening width and a surface having a short opening width out of both opening widths of the second slit are different from each other.

The present invention according to claim 3 is the method for producing a medical valve body according to claim 1, wherein the valve body material is wound such that one surface of the valve body material is in close contact with the outer peripheral surface of the cylindrical body. , Making a notch with a blade at a right angle to the cylindrical axis direction from the other surface of the valve body material wound around the cylindrical body to the contact surface with the cylindrical body, and then turning over the valve body material , Rotate about 90 degrees and repeat the above process again,
The respective slits are formed.

A fourth aspect of the present invention is a catheter with a valve body including the medical valve body according to the first aspect, wherein a hollow main body portion having an open distal end and a hollow portion of the main body portion communicate with each other. And a base portion having a conduction path provided with the valve body.

It should be noted that the term “crossing” as used herein means that lines or surfaces intersect in a cross shape, and also includes that the lines or surfaces partially contact like a T-shape or an X-shape.

[Operation] According to the present invention described in claim 1, there are the following operations.

Since each of the first and second slits penetrates both sides of the valve body, even a tubular body with a thick insertion tip can be easily inserted.

Each of the first and second slits makes one of the opening widths opened on each of both sides of the valve body shorter than the other,
With this short opening width portion, a strong restoring force from the opened state to the closed state of the slit can be secured. Thereby, while preventing the liquid leakage by strengthening the adhesive force of each slit around the tubular body when the tubular body is placed,
When the tubular body is removed, the restoring force of each slit to the closed state is strengthened, and the tubular body is closed immediately after the removal to prevent liquid leakage.

With the above, a tubular body having a thick insertion tip can be inserted, and a medical valve body having high liquid tightness when the tubular body is placed and removed can be provided.

According to the present invention described in claim 2, the following effects are obtained.

Each of the first and second slits has their short opening width portions that can secure a strong restoring force arranged on different surfaces of the valve body. Therefore, the short opening width portions of both slits are not concentratedly arranged on one surface of the valve body, thereby avoiding the reduction of the insertion area due to that and securing the liquid tightness to the tubular body while maintaining the insertion tip portion. Even a thick tubular body can be inserted more easily.

According to the present invention described in claim 3, there is the following action.

A valve body material is wound around a cylindrical body, and a blade having a normal blade shape such as a straight cutting edge is used to form the cylindrical body from the other surface of the valve body material wound around the cylindrical body. Make a notch with a blade at right angles to the cylinder axis direction across the contact surface,
Then, the valve body material is turned upside down, rotated about 90 degrees, and the above steps are repeated again, whereby a slit having a long opening width at the free end face and a short opening width at the contact end face can be extremely easily formed. That is, the medical valve body of the present invention can be easily manufactured without a specially shaped blade or a special operation of the blade.

According to the present invention described in claim 4, there is the following action.

When the medical valve body of the present invention is provided in the conduit provided at the base of the catheter, when a tubular body such as a guide wire, an injector, or a collector is inserted into the valve body and left or left in the catheter. , With the action of ~,
It is possible to reliably prevent the liquid from flowing out from the base opening.

[Embodiment] FIG. 1 is a schematic view showing a medical valve body according to a first embodiment of the present invention, and FIG. 2 is a schematic view showing a medical valve body according to a second embodiment of the present invention. FIG. 4 is a schematic diagram showing a medical valve body according to a third embodiment of the present invention, FIG. 4 is a schematic diagram showing an example of a method for producing the valve body of the present invention, and FIG. 5 is a catheter body with a valve body of the present invention. FIG. 6 is a schematic view showing the main part of an example of a connector used with the catheter with a valve body of the present invention, and FIG. 7 shows an example of a vasodilator used with the catheter with a valve body of the present invention. Sectional view, FIG. 8 is a sectional view showing a usage state of the catheter with a valve element, and FIG. 9 is a schematic view showing an indwelling state of the catheter with a valve element.

(First Embodiment of Valve Body) (See FIG. 1) The valve body 10 is made of a flexible elastic material, and has a first slit 13 provided from one end face 11 to the other end face 12, and
Second provided from one end surface 11 to the other end surface 12
The slits 14 are crossed so as to form a cross. In the valve body 10, the first slit 13 has the first opening width 15 provided on the end face 11 shorter than the second opening width 16 provided on the end face 12, and the second slit 14 has the first slit width provided on the end face 11. The first opening width 17 is made longer than the second opening width 18 provided in the end face 12. That is, in the valve body 10, the end face (11) having the shorter opening width 15 of the opening widths 15, 16 of the first slit 13 and the opening widths 17, 18 of the second slit 14 are formed. Among them, the end face (12) having a shorter opening width 18 is different from each other.

The soft elastic material of the valve body 10 is preferably synthetic rubber such as silicone rubber, urethane rubber, fluororubber, or natural rubber.

 The valve body 10 has the following effects.

Since each of the first and second slits 13 and 14 penetrates both end faces 11 and 12 of the valve body, it is possible to easily insert even a tubular body having a thick insertion tip.

The first and second slits 13 and 14 are provided on both end faces 11 and 12 of the valve body.
One of the opening widths (15, 18) that is open to each of them is made shorter than the other (16, 17), and at this short opening width portion, the slits 13 and 14 are changed from the open state to the closed state. It is supposed to be able to secure a strong resilience. Thereby, while preventing the liquid leakage by strengthening the adhesion force of the respective slits 13 and 14 around the tubular body at the time of leaving the tubular body, the restoring force to the closed state of each slit 13, 14 at the time of removing the tubular body is strengthened. Then, it can be closed immediately after it is removed to prevent liquid leakage.

Due to the above, it is possible to insert even a tubular body having a thick insertion tip portion, and it is possible to provide the valve body 10 which is highly liquid-tight when the tubular body is left in place and when it is removed.

Each of the first and second slits 13, 14 has a short opening width (15, 18) that enables a strong restoring force to be secured.
The parts are arranged on different end faces 11 and 12 of the valve body 10. Therefore, on one end face of the valve body 10, short opening width portions of both slits 13 and 14 are not concentratedly arranged, avoiding reduction of the insertion area due to that, while ensuring liquid tightness to the tubular body, Even a tubular body with a thick insertion tip can be inserted more easily.

(Second Embodiment of Valve Body) (See FIG. 2) Like the valve body 10, the valve body 10A has a first slit 13A provided from one end face 11 to the other end face 12.
And the second slits 14A provided from one end surface 11 to the other end surface 12 intersect each other in a cross shape. In the valve body 10, the first opening width 15A of the first slit 13A provided on the end surface 11 is made shorter than the second opening width 16A of the end surface 12 and the second slit 14A is provided at the end surface 11. A second opening width 1 having an opening width 17A of 1 on the end face 12
It is shorter than 8A.

Therefore, according to the valve element 10A, the above-described effects (1) to (5) which the valve element 10 has are exhibited.

However, in the valve body 10A, the end face (1) having the shorter opening width 15A of the opening widths 15A, 16A of the first slit 13A
1) and the end face (11) having the shorter opening width 17A of the two opening widths 17A, 18A of the second slit 14A are the same surface, and the above-described action of the valve body 10 does not occur.

(Third Embodiment of Valve Body) (See FIG. 3) A valve body 10B includes a first slit 13B provided from one end face 11 to the other end face 12 and one end face 11 to the other end face 12 The second slits 14B provided across the above are crossed so as to form a T shape. And valve body 10
B is the first opening width with which the first slit 13B is provided on the end surface 11.
15B is shorter than the second opening width 16B provided on the end face 12, and the second slit 14B has a first opening width 17B provided on the end face 11 is longer than the second opening width 18B provided on the end face 12. . That is, in the valve body 10B, similarly to the valve body 10, the end face (11) having the shorter opening width 15B of the opening widths 15B and 16B of the first slit 13B and the second slit 14B. Both opening width 17
The end face (12) having the shorter opening width 18B of B and 18B is different from each other.

Therefore, according to the valve body 10B, the above-mentioned effects (1) to (3) which the valve body 10 exhibits are exhibited.

(One Example of Manufacturing Method of Valve Body) (See FIG. 4) The valve body 10 (10A, 10B) is prepared as follows, for example.

(1) The valve body material 100 is wound around the cylindrical body 101 so that one end surface 11 of the valve body material 100 is in close contact with the outer peripheral surface of the cylindrical body 101 as a cylindrical body.

(2) Cut from the free end surface 12 of the valve body material 100 wound around the cylindrical body 101 to the contact end surface 11 with the cylindrical body 101 at a right angle to the cylindrical axis direction with a blade 102, and then The valve body material 100 is turned upside down, rotated about 90 degrees, and the above steps are repeated again.

At this time, the cutting edge of the cutting tool 102 is pushed into the inside of the cylindrical body 101, or the cutting edge of the cutting tool 102 is brought into contact with the surface of the cylindrical body 101 and rocked to open the contact end face 11. The width can be formed.

 According to the above manufacturing method, there are the following effects.

The valve body material 100 is wound around the cylindrical body 101, and the blade 102 having a normal blade shape such as a straight cutting edge extends from the free end surface 11 of the valve body material 100 to the contact end surface 12 with the cylindrical body 101. By making a cut, a slit having a long opening width at the free end face 11 and a short opening width at the close contact end face 12 can be formed very easily. That is, the valve body 10 can be easily manufactured by forming the first and second slits 13 and 14 described above without impairing the specially shaped blade and the special operation of the blade.

(Example of Catheter with Valve Body) (See FIGS. 5 to 8) The catheter 20 with valve body is configured to include the medical valve body 10, and constitutes the catheter assembly 1 together with the connector 30. The catheter assembly 1 additionally includes a vasodilator 40.

As shown in FIG. 5, the catheter 20 includes a body portion 21 and a base portion.
And 22.

The main body 21 is used by percutaneously inserting it into a blood vessel. At this time, the body portion 21 is provided with a front end hole 21E and a plurality of side holes 21H.

The base portion 22 holds one end portion of the main body portion 21 by joining and holding the main body portion.
A communication path 23 is provided so as to communicate with 21. The above-mentioned valve element 10 (10A or 10B is also possible) is provided at the opening of the conduction path 23 to prevent the leakage of blood from the main body 21 side to the outside.

The base portion 22 also includes a sub passage 27. This passage 27
Communicates with a tube having a stopcock at the tip and functions as a drug solution inlet, a blood sampling port, and the like.

In addition, in order to facilitate percutaneous intubation of the main body portion 21 of the catheter 20, the inner diameter of the main body portion 21 is set to 2 m.
It is preferable to set it in the range of m to 10 mm. If it is less than 2 mm, there is a fear that the amount of blood removal and blood supply necessary for emergency auxiliary circulation may not be sufficiently obtained, and if it exceeds 10 mm, it may be difficult to percutaneously insert a catheter.

In the case of the catheter 20, the tip end hole 21E of the main body 21
Is S1 and the total area of all side holes 21H is S2 (where N is the number of side holes 21H and Sh is the area of each side hole 21H, S2 = N × Sh)
In this case, 2 × S1 ≧ S2 ≧ 0.5 × S1 is established. That is, the total area S2 of the side holes 21H is preferably in the range of 1/2 to twice the area S1 of the tip hole 21H. S2 is 1/2 of S1
In the case of the blood removal side catheter described above, the amount of blood removed from the area where the side hole is provided, that is, the vena cava becomes insufficient, and when S2 is larger than 2S1, the blood removal from the superior vena cava becomes smaller. Insufficient blood volume.

As shown in FIG. 9, the side hole 21H is located in the inferior vena cava from the entrance of the right atrium B to the bifurcation D of the inferior vena cava C when inserted from the femoral vein A as shown in FIG. Preferred (E is the superior vena cava). This is because the blood volume is sufficient to ensure the necessary blood removal amount. Therefore, the position of the side hole 21H of the main body portion 21 in the catheter 20 is applied to this. It is 30-40 cm, and the distance from the bifurcation to the site where the catheter is placed percutaneously in the femoral vein is 15-20 cm + α (α: the part exposed on the body surface), and a total length of 60 cm is required. . Therefore, as described above, in order to obtain the required blood removal amount, it is preferable that the side hole 21H exists up to 40 cm from the tip. Therefore, the main body 21
From the tip to the side hole closest to the base 22
The relationship between L1 (40 cm) and the length L2 (60 cm) of the main body 21 is 2 / 3L
2 ≧ L1. Furthermore, in the case of the Japanese, patients with extracorporeal circulation using this catheter are often small. From the right atrium to the bifurcation of the inferior vena cava, it is 20 cm, 2/3 times that of the Americans mentioned above. Since it is a degree, the relation of L1 ≧ 1 / 3L2 is established. Therefore, as a whole, it is preferable that L1 and L2 have the following relationship.

2 / 3L2 ≧ L1 ≧ 1 / 3L2 That is, a catheter in this range can obtain a necessary blood removal amount regardless of the size of the body.

The main body 21 is made of fluororesin, polyethylene, polypropylene, polyester elastomer or the like. The base 22 is made of polyethylene, polypropylene, polyamide, polycarbonate, polystyrene or the like.

As shown in FIG. 6, the connector 30 can be connected to a conduction path 23 provided in the base portion 22 of the catheter 20.
It has a tubular portion 31 through which the valve body 10 can be inserted in a liquid-tight manner. A blood removal line or a blood donation line of the extracorporeal blood circulation circuit is connected to the tubular portion 31. The connector 30 includes a connection cap 32 on the outer peripheral portion of the tubular portion 31, and the female screw portion 32A of the connection cap 32 is screwed to the male screw portion 23A provided around the conduction path 23 of the base portion 22. The connector 30 can be fixed to the catheter 20 by means of.

Further, in the catheter assembly 10, as shown in FIG. 8, the distal end of the tubular portion 31 of the connector 30 is placed under the condition that the connector 30 is connected to the conducting path 23 of the catheter 20.
It is configured so as to be brought close (abutting in this embodiment) to the inner surface of the main body 21.

Furthermore, the inner surface of the tubular portion 31 of the connector 30 is formed in a tapered shape whose diameter decreases toward the tip thereof.

At this time, it is preferable that the taper angle θ (see FIG. 8) given to the inner surface of the tubular portion 31 is 5 ° to 15 °.

When the angle is less than 5 degrees, the cross section of the flow path portion spreads little in the blood flow direction, and it becomes difficult to suppress the pressure loss to a low level. If it exceeds 15 degrees, the inner diameter of the tube communicating with the connection tool becomes large, which leads to an increase in priming volume.

The tubular portion 31 is made of polycarbonate, vinyl chloride resin, polypropylene or the like, and the cap 32 is made of polyamide, polycarbonate, vinyl chloride resin or the like.

The vasodilator 40 is inserted so as to penetrate the valve body 10 and the main body portion 21 of the conduction path 23 provided in the base portion 22 of the catheter 20, and guides the main body portion 21 to the blood vessel. At this time, the vasodilator
As shown in FIG. 7, 40 is provided with a connection cap 42 around the proximal end of the dilator main body 41, and the female thread portion of the connection cap 42.
The blood vessel dilator 40 and the catheter 20 can be integrated by screwing 42A onto the male screw portion 23A provided around the conduction path 23 of the base portion 22. Further, the dilator body 41 of the blood vessel dilator 40 can liquid-tightly insert the valve body 10 provided in the conduction path 23 of the catheter 20. Further, the blood vessel dilator 40 has a check valve 43 on the outer end surface of the connection cap 42, and a mini guide wire 44 penetrating the check valve 43 in a liquid-tight manner can be inserted therein.

The dilator body 41 is made of polyethylene, polypropylene, polyester elastomer, or the like, and the connection cap 42 is made of polyamide, polycarbonate, vinyl chloride resin, or the like.

The procedure for placing the catheter 20 of the catheter assembly 10 in a blood vessel will be described below.

(1) An indwelling needle in which an inner needle and an outer needle are fitted together is percutaneously inserted into a blood vessel.

(2) The inner needle of the indwelling needle is removed, and the mini guide wire 44 is placed in the blood vessel through the outer needle. After that, the outer needle is also removed.

(3) With the vasodilator 40 integrated with the catheter 20, the catheter 20 and the vasodilator 40 are inserted into the blood vessel along the mini guide wire 44. After that, the mini guide wire 44 and the vasodilator 40 are removed, and the catheter 20 is placed in the blood vessel.

At this time, the dilator body 41 of the vascular dilator 40 is connected to the catheter.
The valve body 10 included in the conduction path 23 of 20 can be inserted in a liquid-tight manner, and at the time of indwelling, the slits 13 and 14 are tightly adhered to the periphery of the dilator body portion 41 by the strong adhesion force as described above to prevent blood leak. .
Further, when the vasodilator 40 is removed, the strong restoring force of the slits 13 and 14 to the closed state allows the slits 13 and 14 to be closed immediately after the removal to prevent blood leakage.

Next, a method of using the catheter 20 placed in the blood vessel as described above will be described.

(1) First, when performing cardiac treatment such as PTCA and IABP,
For acute myocardial infarction and heart failure, a connecting tool 30 is inserted into the conducting path 23 of the catheter 20 when performing blood assist circulation. At this time, the connector 30 can be inserted liquid-tightly into the valve body 10 including the conduction path 23 of the catheter 20, and the slits 13 and 14 are tightly adhered to the periphery of the connector 30 by the strong adhesion force as described above to cause blood leakage. Prevent.

(2) A catheter assembly intubated on the blood removal side
The blood removal line of the extracorporeal blood circulation circuit is connected to the connector 30 of 10 to remove blood in the body from the main body 21 of the catheter 20 through the tubular portion 31 of the connector 30.

(3) Further, the blood supply line of the extracorporeal blood circulation circuit is connected to the connector 30 of the catheter assembly 10 intubated on the blood donor side, and the extracorporeal blood circulated blood is fed from the tubular portion 31 of the connector 30 to the catheter. Blood is donated via the main body 21 of 20.

The catheter 20 is inserted into the femoral vein percutaneously so that the distal end hole 21E of the main body 21 is located near the right atrium, and the catheter 21 is extracorporeally removed to remove blood from the right atrium and the vena cava. Can communicate with the blood removal line of the circulation circuit. At this time, the positions of the side holes 21H provided in the main body portion 21 are distributed from the vicinity of the descending vena cava branch to the vicinity of the right atrium.

(4) Due to the above-mentioned termination of blood-assisted circulation, the catheter 20
The connector 30 is removed from the conduction path 23 of.

At this time, the valve element 10 of the conduction path 23 from which the connection tool 30 is removed is
Due to the strong restoring force of the slits 13 and 14 in the closed state, it is possible to prevent the blood leak by closing the connection tool 30 immediately after the connection tool 30 is removed.

Therefore, the catheter with valve body 20 has the following effects.

Since the medical valve body 10 of the present invention is provided in the communication path 23 provided in the base portion of the catheter 20, the dilator body 41 or the connector.
When the valve body 10 is inserted into the catheter 20 and left or left in the catheter 20, the above-described effects (1) to (3) of the valve body 10 can be obtained to reliably prevent blood leakage from the base opening of the catheter 20.

Further, in the practice of the present invention, a blood removal line of an extracorporeal blood circulation circuit, insertion of a connecting device to which a blood supply line is connected to the valve body of a conduction path provided in a base portion of a catheter with a valve body, heart treatment, etc. Other inserts such as a catheter (a guide catheter, a balloon catheter guided by the guide catheter, etc.) or a connecting tool to which a drug solution supply line is connected may be inserted.

Further, in the practice of the present invention, the slit provided in the valve body may form a twisted surface between both surfaces.

[Effects of the Invention] According to the present invention as set forth in claims 1 and 2, a medical valve body that can be inserted even in a tubular body having a thick insertion tip and has high liquid tightness when the tubular body is placed and removed. Can be provided.

According to the present invention described in claim 3, it is possible to provide a manufacturing method capable of easily manufacturing the valve body.

According to the present invention described in claim 4, it is possible to provide a catheter that includes the valve body and can reliably prevent the liquid from flowing out from the base opening.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing a medical valve body according to a first embodiment of the present invention, FIG. 2 is a schematic diagram showing a medical valve body according to a second embodiment of the present invention, and FIG. FIG. 4 is a schematic view showing a medical valve body according to a third embodiment of the present invention, FIG. 4 is a schematic view showing an example of a manufacturing method of the valve body of the present invention, and FIG. 5 is a schematic view showing a catheter with a valve body of the present invention, FIG. 6 is a sectional view of an essential part showing an example of a connecting tool used with the catheter with a valve body of the present invention, and FIG. 7 is a sectional view showing an example of a vasodilator used with the catheter with a valve body of the present invention. FIG. 8 is a cross-sectional view showing a usage state of the valve body-equipped catheter, and FIG. 9 is a schematic view showing an indwelling state of the valve body-equipped catheter. 10, 10A, 10B …… Valve disc, 11, 12 …… End face, 13, 13A, 13B
...... First slit, 14, 14A, 14B ...... Second slit, 15, 15A, 15B, 17, 17A, 17B ...... First opening width, 1
6, 16A, 16B, 18, 18A, 18B …… Second opening width, 20 ……
Catheter with valve body, 100 ... Valve body material, 101 ... Cylindrical body,
102 …… Blade.

Claims (4)

(57) [Claims] 1. A first slit made of a flexible elastic material having at least two surfaces and provided from one surface to the other surface, and a second slit provided from one surface to the other surface. In a medical valve body in which the first slit and the second opening width are different from each other, and the second slit is provided on the both surfaces. A medical valve body, wherein the first and second opening widths are different from each other. 2. A surface having a short opening width of both opening widths of the first slit and a surface having a short opening width of both opening widths of the second slit are different from each other. Item 1. The medical valve body according to Item 1. 3. The method for producing a medical valve body according to claim 1, wherein the valve body material is wound so that one surface of the valve body material is in close contact with an outer peripheral surface of the cylindrical body, Make a notch with a blade at a right angle to the cylinder axis direction from the other surface of the valve body material wound around it to the contact surface with the cylinder body, then turn over the valve body material and rotate about 90 degrees Then, the method for producing a medical valve body in which the first and second slits are formed by repeating the above steps again. 4. A catheter with a valve body, comprising the medical valve body according to claim 1, wherein a hollow main body portion having an open tip and a hollow portion of the main body portion are communicated with each other, the valve body A catheter with a valve body, the catheter having a valve body and a base portion having a conduction path.