JP3594251B2 - Medical check valve - Google Patents

Description

[0001]
[Industrial applications]
The present invention is incorporated in a medical device used when introducing various medical instruments into a living body lumen such as a blood vessel, and is a medical check valve for preventing leakage of blood and gas components, blocking the outside, and the like. About the valve.
[0002]
[Prior art]
In introducing various medical devices such as catheters, guidewires, endoscopes and forceps into the body lumen for the purpose of diagnosis and treatment, extremely careful, safe and reliable treatment operations are required. For example, percutaneously introducing a vascular catheter into a blood vessel involves inserting a guide wire into the blood vessel by the cell singer method, and then combining the dilator with a medical device (a catheter loudspeaker). ) Is introduced into the blood vessel along the guide wire, and then the dilator and the guide wire are removed to leave the tip of the medical device, and the catheter is intubated into the blood vessel along the guidance of the medical device. The process of doing is adopted.
[0003]
In this process, as shown in FIG. 8, the medical device (introducer) is inserted into the blood vessel from the rear end opening 10 of the main body portion 1 of the medical device (introducer) through a sheath 11 provided on the distal end side. The catheter 12 is guided to a target site while being manipulated (twisted, pushed, pulled) at hand. In order to prevent blood from leaking in the process, the hemostatic valve 3 is incorporated in the introducer. Have been. The hemostatic valve 3 is required to have a function such that the catheter does not leak during the operation of the guide wire and the catheter, and even after the catheter is withdrawn, and the catheter can be inserted smoothly. You.
[0004]
Conventionally, as this type of medical check valve, as shown in FIGS. 9 (perspective view) and FIG. 10 (cross-sectional view), a guide wire is provided on the rear end side (upper side of the figure) of a valve material made of a rubber-like elastic body. A small hole 7 having a diameter slightly smaller than that of-is provided to prevent blood from leaking when a guide wire or a catheter is inserted, and a plurality of slits 6 are cut in the front side (lower side in the figure) to provide a flap mechanism. Is known to prevent leakage of blood at the time of no insertion.
[0005]
However, the conventional check valve has the following various problems.
(1) Because the valve shape is flat, reducing the thickness and hardness of the valve material impairs the function of preventing blood leakage, and increasing the thickness and hardness of the valve material increases the operability of inserting medical equipment. Since a worsening phenomenon occurs, it is difficult to satisfy both of these functions at the same time.
(2) The small hole 7 formed on the rear end side needs to secure a sufficient sealing property even when only the guide wire is inserted at the stage of replacement of the catheter or the like. For example, when a lateral force is applied to the valve by the action of the weight of the guide wire or the like, the small holes cannot follow the deformation force, and a gap is generated, thereby causing a phenomenon of blood leakage.
(3) When a single valve is formed, the slit 6 on the front side may be torn to the outside due to the insertion resistance of the medical device. Blood leakage occurs, and the adhesive laminate structure increases the insertion resistance of the medical device and increases the cost.
[0006]
In addition, as a medical check valve, a trocar inserted into the abdominal wall and placed in the abdominal wall when an endoscope or forceps is introduced into the abdominal cavity during endoscopic surgery is sent to the abdominal cavity. There are applications such as preventing leakage of the carbon dioxide gas that has entered, and placing it in the lumen where the endoscope forceps and puncture needle are introduced and blocking it from the outside world. Is required.
[0007]
[Problems to be solved by the invention]
SUMMARY OF THE INVENTION The present invention has been made to solve the problems of a hemostatic material having a conventional structure and to develop a check valve applicable to all medical uses. A catheter, a guidewire, an endoscope, and forceps are provided. For the purpose of providing a medical check valve that combines the reliable leakage prevention of contents and the excellent operability of inserting medical equipment when conducting diagnosis and treatment by introducing various medical equipment such as into the body lumen. I have.
[0008]
[Means for Solving the Problems]
Medical check valve according to the present invention for achieving the above object, there is provided a check valve disposed within a medical device for introducing a medical instrument into a body lumen, the distal end side of the medical device And a rubber-like elastic plate having a plurality of slits radially cut from the center, a planar inner valve of a rubber-like elastic plate piece, and a rubber-like elastic plate located on the rear end side of the medical device and having a small hole in the center Composed with a single mortar-shaped outer valve, the mortar-shaped outer valve presents an inclined surface having a tip apex angle of 150 ° or less from the center small hole toward the rear end of the medical device , and The configuration is characterized in that the top portion is built into the medical device in a state of being tightly or adhered to the center portion of the planar inner valve.
[0009]
[Action]
The medical check valve according to the present invention is provided inside a main body portion of a medical device, and is used by inserting a medical device at the center thereof. The outer valve of the inserted portion is small at the center of the rubber-like elastic plate piece. Since it has a mortar shape with holes and is tightly adhered or adhered while pressing the center of the slit of the planar inner valve, small holes open without resistance when inserting equipment, and the insertion operation proceeds extremely smoothly At the same time, the small hole of the mortar-shaped outer valve performs a close contact action of tightening the interface with the insertion device when there is external pressure resistance, and in combination with the flap action of the planar inner valve, the small hole from the living body lumen is removed. It exerts a check function that reliably prevents blood and gas leakage. Further, since the mortar-shaped outer valve skillfully follows the force applied from the lateral direction when the equipment is inserted, there is no fear of leakage of the seal. When the medical equipment is not inserted, the slit piece of the planar inner valve is closed to prevent leakage.
[0010]
Through the above actions, reliable prevention of leakage of contents and excellent operability of inserting medical equipment at the same time are provided, and the valve material is not damaged during operation. Becomes possible.
[0011]
【Example】
Hereinafter, the present invention will be specifically described based on the illustrated embodiments. In addition, although an Example demonstrates the hemostatic valve for introducers when a catheter is used for a medical device for convenience, this invention is not limited to this use, and other endoscopes are used. It can also be installed on a medical device when using medical equipment such as forceps and forceps, and the same effect is brought about.
[0012]
FIG. 1 is a perspective view showing a medical check valve according to the present invention, FIG. 2 is a side sectional view thereof, 4 is a planar inner valve, and 5 is a mortar-shaped outer valve. The planar inner valve 4 and the mortar-shaped outer valve 5 are formed of rubber-like elastic plate pieces, and usually have a disk shape with a wall thickness of 0.5 to 1 mm and an outer diameter of 6 to 10 mm. As a specific material of the rubber-like elastic body constituting these valve members, it is preferable to select a silicone rubber, particularly a medical silicone rubber made of dimethylpolysiloxane from the viewpoint of safety.
[0013]
The planar inner valve 4 is formed with a plurality of slits 6 cut radially from the center. The number of the slits 6 to be formed is three to provide the highest sealing effect, but is not limited to this number. A small hole 7 is formed at the center of the mortar-shaped outer valve 5. Since the small hole 7 is for preventing blood leakage at the time of inserting a catheter, a guide wire, or the like, it is necessary to form the small hole at least one diameter smaller than the outer diameter of the guide wire. For example, when a guide wire having an outer diameter of 0.9 mm is used, the diameter of the small hole 7 is preferably formed in the range of 0.6 to 0.8 mm. The hemostatic effect can be further enhanced by forming not only one but also a plurality of the planar inner valves 4 in a laminated form. However, in this case, it is necessary to reduce the thickness of each layer or to increase the material elasticity so that the insertion of the medical device is not impaired.
[0014]
The inclined shape of the mortar-shaped outer valve 5 is designed so as to exhibit an inclined surface in which the tip apex 9 is 150 ° or less, preferably 90 ° or less from the central small hole 7 toward the inside. If the tip apex angle 9 exceeds 150 °, the check valve effect decreases and it is difficult to reliably prevent blood leakage.
[0015]
The shape of the mortar-shaped outer valve 5 is not only a simple cone shape as shown in FIG. 2, but also a tapered wall shape as shown in FIG. 3, a stepped cone shape as shown in FIG. The design can be changed to an appropriate form such as a curved conical shape or a conical shape in which a pedestal with the planar inner valve 4 is provided on the outer periphery as shown in FIG. 6, and these shapes are included in the embodiment of the present invention.
[0016]
The planar inner valve 4 and the mortar-shaped outer valve 5 are disposed on an introducer (medical tool) such that the top 8 of the mortar-shaped outer valve 5 is in close contact with or adheres to the center of the planar inner valve 4. You. The above-mentioned adhesion can be performed by fusing the contact portions or joining them using an appropriate adhesive. FIG. 7 is a cross-sectional view showing a state in which the valve material is disposed in the introducer. The planar inner valve 4 is provided in an intermediate portion of the main body portion 1 of the introducer having the sheath tube 11 at the distal end. The mortar-shaped outer valve 5 is compression-fitted to the upper portion thereof by the cap portion 2 at the upper end of the medical device. At this time, the mortar-shaped outer valve 5 may be formed in advance in a mortar shape, but in order to make the mortar shape hard to return to the rear end side and to increase the pressure resistance, the medical device main body portion 1 and the cap are required. It is preferable to form the mortar in a mortar-like shape by compression fitting with the part 2, and to form the top part 8 in close contact with the center of the planar inner valve 4.
[0017]
【The invention's effect】
As described above, according to the present invention, the planar inner valve and the mortar-shaped outer valve are combined, and the top of the mortar-shaped outer valve having a specific inclination angle is brought into close contact with or bonded to the center of the planar inner valve. Accordingly, it is possible to provide a medical check valve that has both reliable leakage prevention of contents and excellent operability of inserting medical equipment and does not cause damage during operation. Therefore, when various medical instruments such as a catheter, a guide wire, an endoscope, and forceps are introduced into a living body lumen to perform diagnosis and treatment, a medical effect capable of improving operability and safety is provided. Brought.
[Brief description of the drawings]
FIG. 1 is a perspective view showing an embodiment of a medical check valve according to the present invention.
FIG. 2 is a longitudinal sectional view of FIG.
FIG. 3 is a longitudinal sectional view showing another embodiment in which the shape of the mortar-shaped outer valve is different.
FIG. 4 is a longitudinal sectional view showing another embodiment in which the shape of the mortar-shaped outer valve is different.
FIG. 5 is a longitudinal sectional view showing another embodiment in which the shape of the mortar-shaped outer valve is different.
FIG. 6 is a longitudinal sectional view showing another embodiment in which the shape of the mortar-shaped outer valve is different.
FIG. 7 is a cross-sectional view showing a state in which a planar inner valve and a mortar-shaped outer valve are disposed on a medical device.
FIG. 8 is a cross-sectional view showing a medical device provided with a hemostatic valve having a conventional structure.
FIG. 9 is a perspective view showing a medical check valve having a conventional structure.
FIG. 10 is a longitudinal sectional view of FIG. 9;
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Main body part 2 Cap part 3 Hemostasis valve 4 Planar inner valve 5 Mortar-shaped outer valve 6 Slit 7 Small hole 8 Top 9 Top angle 10 Rear open end 11 Sheath tube 12 Catheter

Claims (2)

A check valve disposed in a medical device for introducing a medical device into a living body lumen, the check valve being located on a distal end side of the medical device and including a plurality of slits cut radially from a center. A planar inner valve of a rubber-like elastic plate piece, and a mortar-like outer valve of a rubber-like elastic plate piece located at the rear end side of the medical device and having a small hole in the center, are combined. The medical device has an inclined surface with a tip apex angle of 150 ° or less from the central small hole toward the rear end side of the medical device , and the top of the mortar-shaped outer valve is closely or adhered to the center of the planar inner valve. A medical check valve which is built into a tool. The medical check valve according to claim 1, wherein the planar inner valve is formed in a plurality of stacked forms.

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