JPS6122988B2 - - Google Patents

Description

[Detailed Description of the Invention] Background of the Invention [Technical Field] This invention allows blood to be circulated extracorporeally, continuously monitoring the blood, continuously fractionating the blood, and furthermore, using an artificial organ such as an artificial kidney or an artificial liver to improve blood circulation in a patient. The present invention relates to an intravascular indwelling catheter that is punctured and fixed into a blood vessel in order to aspirate and return blood from a patient during purification.

[Prior art and problems]

For example, in the currently commonly used hemodialysis using an artificial kidney, the patient's artery is separated into two veins.
A book needle is placed in place to perform suction and return. Puncturing the needle in two locations in this manner is not necessarily satisfactory, as it places a heavy burden on the patient and shortens the life of the shunt. Therefore, a method of simultaneously suctioning and returning blood using a catheter with a double tube structure has been developed and is viewed as promising. This double-tube structure catheter generally consists of an inner tube through which an inner needle is inserted to guide the catheter tube into the blood vessel, and an outer tube that forms an annular passage outside the inner tube. A tube is connected to a hub, and a side hole communicating with the annular passage is provided in the outer tube at the tip of the annular passage.

By the way, in a conventional catheter of this type with a double tube structure, a branch tube communicating with the outer annular passage is provided in the hub portion of the catheter, and an elastic tube is connected to this branch tube, and a connector is connected to the tip of the branch tube. A container with a sealed stopper was used. When communicating with a blood vessel using this conventional catheter, first puncture the inner needle into the blood vessel and confirm with the inner needle hub that the inner needle has passed into the blood vessel, then insert the catheter tube further into the blood vessel, A side hole is placed inside the blood vessel. If the side hole is placed correctly in the blood vessel, blood will enter the annular passage through the side hole, but to confirm this, the seal is removed and attached each time, and the side hole is It was necessary to confirm that it was placed correctly within the blood vessel, which was complicated and troublesome. In addition, there was a drawback that blood may leak to the outside at that time. Furthermore, before communicating with the extracorporeal blood circulation circuit, it is necessary to perform so-called priming to exhaust the air inside the branch pipe, elastic tube, etc., and this operation is extremely troublesome.

Purpose of the Invention The present invention has been made in view of the above circumstances, and it is possible to omit the priming operation when connecting the catheter to the extracorporeal blood circulation circuit, and it is also possible to easily confirm continuity between the side hole and the blood vessel. An object of the present invention is to provide an intravascular indwelling catheter with a double tube structure that allows for

That is, the present invention provides an inner needle comprising a hub; an inner tube forming an inner passage through which the inner needle is penetrated in close contact with its outer peripheral surface at least at its tip; and an annular passage outside the inner tube. a flexible catheter tube having an outer tube that is in close contact with the inner tube at its distal end and has one or more side holes communicating with the annular passage; a catheter hub attached to an end; a branch tube connected to the catheter hub and communicating with the annular passage; a transparent or translucent soft tube connected to the branch tube at one end; An intravascular indwelling device comprising: a connector provided at the other end of the flexible tube; and an air-permeable leak-proof thrombus detachably connected to the other end of the connector and permeable to gas within the tube. The purpose is to provide catheters.

A further object of the present invention is to provide an intravascular indwelling catheter as described above, wherein the outer tube is made of transparent or translucent synthetic resin.

A further object of the present invention is to provide an intravascular indwelling catheter as described above, wherein the inner tube is made of a synthetic resin mixed with an X-ray contrast agent.

A further object of the present invention is to provide an intravascular indwelling catheter as described above, characterized in that the air-permeable leak-proof thrombus is provided with a breathable blood-leak-proof member.

A further object of the present invention is to provide an intravascular indwelling catheter as described above, characterized in that the breathable blood-leakproof member is a membrane filter made of a polyester resin aggregate coated with polyvinyl chloride. .

A further object of the present invention is to provide an intravascular indwelling catheter as described above, in which the entire air-permeable leak-proof thrombus is formed of a breathable blood-leak-proof member, particularly a sintered body.

DETAILED DESCRIPTION OF THE INVENTION The present invention will be described below with reference to illustrated embodiments.

FIG. 1 shows an overall view of an intravascular indwelling catheter according to an embodiment of the present invention, and FIG.
As shown in exploded view in FIG. 3 and FIG. 3, it consists of a catheter side assembly 1 and an inner needle side assembly 2. This catheter side assembly 1 includes a flexible catheter tube 3 made of, for example, fluororesin.
For example, the catheter tube 3 consists of a catheter hub 4 made of polycarbonate resin and made by injection molding, and as shown in FIG. It has a double tube structure in which a molded outer tube 6 is connected concentrically, and an inner passage 7 with both ends open is formed inside the inner tube 5, and the outer wall surface of the inner tube 5 and the inner wall surface of the outer tube 6 An annular passage 8 is formed between the inner tube 5 and the outer tube 6 which are tightly closed at their distal ends. Further, near the tip of the outer tube 6, at least one side hole 11 communicating with the front end of the annular passage 8 is bored.

The catheter hub 4 has a branch pipe 10 slantingly protruding from approximately the center thereof, and the annular passage 8 communicates with the inner lumen of the branch pipe 10 . A connector portion 10a is formed at the open end of this branch pipe 10, and one end of a transparent or translucent soft tube 12 (made of soft polyvinyl chloride or silicone resin, for example) is connected to this connector portion 10a. The other end of the soft tube 12 is injection molded with resin or the like onto polycarbonate, and is a connector 1 that facilitates the connection between the soft tube 12 and the breathable leakage-resistant thrombus 15.
3 is connected to the tube, and at its open end there is an air-permeable blood-leakage-proof member 1, which is made of a membrane filter made of, for example, polyester resin aggregate coated with polyvinyl chloride, which allows gas in the tube to pass therethrough but prevents blood from passing therethrough.
An air permeable leakage-proof clot 15 having a diameter of 4 is detachably attached. In addition to the above-mentioned materials, the membrane filter may be made of a polytetrafluoroethylene membrane filter laminated with a polypropylene nonwoven fabric, or an acetate membrane coated with a silicone resin. The air-permeable leak-proof thrombus 15 may be entirely a sintered body made of powdered polyethylene, polypropylene, nylon, etc., put into a mold, and then heated and compressed.

By molding the entire air-permeable blood-leakage-proof part at the proximal opening of the catheter hub 4 from a sintered body, the number of manufacturing steps can be reduced. A soft tube 16 made of the same material as the soft tube 12 is connected at one end, and a connector 17 is attached to the other end, to which a sealing cap 18 can be detachably fitted. The sealing cap 18 is made of soft or hard synthetic resin such as polyvinyl chloride or polyethylene, and is provided with an insertion hole 20 through which an inner needle 19 made of stainless steel (to be described later) can be inserted in close contact with the outer peripheral surface thereof. It is something.

A stopper receiver 21 is provided protruding from the rear end of the catheter hub 4 on the branch pipe 10 side, and the tip of a stopper rod 22 of the inner needle side assembly 2, which will be described later, comes into contact with this.

On the other hand, the inner needle side assembly 2 consists of an injection molded hub 23 made of transparent or translucent synthetic resin attached to the rear end of the inner needle 19.
3 communicates with the inner needle 19, and the rear end opening is provided with a membrane filter of the same quality as the breathable blood leakage-resistant member 14.
4 is attached. Further, the air-permeable leak-proof thrombus may be formed entirely of a sintered body. Further, a stopper rod 22 is provided on the hub 23 of the inner needle 19 in parallel with the inner needle 19 and protrudes toward the distal end side of the inner needle 19. That is, when the inner needle 19 is inserted into the catheter side assembly 1, the stopper rod 2
The insertion depth of the inner needle 19 into the catheter tube 3 is set such that the tip of the inner needle 19 hits the stopper receiver 21 and the tip of the inner needle 19 protrudes from the tip of the catheter tube 3 by approximately the blade surface.

The stopper receiver 21 is formed with a hole 25 into which the tip of the stopper rod 22 is inserted, and by fitting the tip of the stopper rod 22 into the hole 25, the catheter side assembly 1 of the inner needle side assembly 2 is inserted. The position of the inner needle 19 relative to the catheter tube 3 is determined, and rotation of the hub 23 is prevented, so that the direction of the blade surface of the inner needle 19 relative to the catheter tube 3 is always constant.

Next, a method of using this intravascular catheter for artificial dialysis will be described.

First, this intravascular indwelling catheter is used in an integrated state in which the inner needle assembly 2 is assembled into the catheter assembly 1. That is, the inner needle 19 of the inner needle side assembly 2 is inserted into the insertion hole 2 of the sealing cap 18.
0, the tip of the stopper rod 22 is inserted into the stopper receiver 21, and the tip of the inner needle 19 is slightly protruded from the tip of the catheter tube 3 (see Fig. 1 or 4). It's summery.

First, the entire catheter is held and the inner needle 19 is punctured into the blood vessel with the insertion direction facing the blood flow direction. When the tip of the inner needle 19 communicates with the inside of the blood vessel, blood flows into the inner needle 19 and the breathable blood leakage-proof member 1
Due to the breathability of 4, this inflow blood quickly passes through the inner needle 1.
9 into the hub 23. Here, this hub 23
Since the inner needle 19 is transparent or semi-transparent, this inflowing blood can be easily observed from the outside, thereby making it possible to confirm whether or not the tip of the inner needle 19 is reliably located within the blood vessel.

After this confirmation, push the catheter tube 3 in using the inner needle 19 as a guide, and
allows it to enter the blood vessels. At this time, blood enters the annular passage 8 of the catheter tube 3 through the side hole 11, and the blood easily flows to the soft tube 12 and further to the connector 13 due to the air permeability of the breathable leakage-resistant thrombus 15 connected to the rear of the branch tube 10. The communication between the blood vessel and the side hole 11 can be easily confirmed through the transparent or translucent soft tube 12 or connector 13.

Next, while holding the catheter hub 4 of the catheter side assembly 1 with one hand, hold the inner needle side assembly 2 with the other hand and gently pull out the inner needle 19 backward, leaving the catheter tube 3 intact. .
Then, the tip of the inner needle 19 is connected to the sealing cap 1.
Just before reaching 6, it is paused. Next, the inside of the soft tube 16 is closed off by pinching the middle of the soft tube 16 with fingers or forceps. In this closed state, the sealing cap 18 is removed from the connector 17 of the catheter assembly 1 together with the inner needle assembly 2. Since the tube 16 is closed during this operation, blood will not leak out even if the sealing cap 18 and inner needle 19 are removed.

Next, by loosening the grip with fingers or forceps, the closed soft tube 16 is slightly opened. And connector 1
Blood is introduced into the connector 7 and the connector 17 is filled with blood. Note that since the inside of the connector 17 has a relatively small diameter, blood is retained by surface tension and does not naturally flow out. Then, when the inside of the connector 17 is filled with blood, the soft tube 16 is completely closed again.

Therefore, one end of a blood circulation circuit or the like is connected to the connector 17. At this time, the inside of the connector 17 is filled with blood, so when the connection terminal of the blood circulation circuit is inserted and connected thereto, no air is mixed in. That is, when the circuit is connected to the catheter side assembly 1, no air is mixed in, and therefore, air can be prevented from flowing into the body.

On the side of the branch pipe 10, the inside of the soft tube 12 is closed by pinching it with fingers or forceps, and in this state, the air-permeable leakage-resistant thrombus 15 is removed from the connector 13. At this time, the soft tube 12
Since it is occluded, blood will not leak out even if the breathable leak-proof thrombus 15 is removed. Also, at this time, the blood flows through the soft tube 12 and the connector 13.
Since the inside of the connector 13 is almost filled, an extracorporeal circulation circuit (not shown) can be connected to the connector 13 without introducing air into the connector 13 without special priming as in the conventional case.

As mentioned above, the tip of the catheter tube 3 is pierced into the blood vessel in the same direction as the blood flow direction, so the tip opening of the inner passage 7 is downstream and the side hole 11 of the annular passage 8 is upstream. The blood is taken in from this side hole 11, and the blood that has passed through the extracorporeal circulation circuit is returned into the blood vessel from the distal opening of the inner passage 7. Therefore, the blood that has passed through the extracorporeal circulation circuit does not immediately flow back into the extracorporeal circulation circuit and mix with the blood.

Note that it is also possible to puncture the catheter tube 3 in the opposite direction to the blood flow direction, in which case the inner passage 7 is the blood inflow side and the annular passage 8 is the blood outflow side. use.

Specific Effects of the Invention As detailed above, according to the present invention, in an intravascular indwelling catheter having a double tube structure, a transparent or translucent soft tube is provided at the end opening of the branch tube communicating with the outer annular passage. A breathable leak-proof thrombus is disposed through the branch pipe, whereby air in the flexible tube is automatically discharged from the breathable leak-proof thrombus as blood flows into the blood branch pipe,
Since the above-mentioned soft tube etc. are allowed to be filled and blood leakage is prevented, when connecting the catheter to an extracorporeal circulation circuit, the priming operation that is conventionally required can be omitted.
This type of intravascular indwelling catheter can significantly save labor in use.

Furthermore, when the side hole communicates with the inside of the blood vessel, blood quickly flows into the branch tube and then into the soft tube, as described above, and since the soft tube is transparent or translucent, it can be quickly and easily connected to the side hole and the blood vessel from the outside. This makes it possible to confirm continuity with the device, eliminating the need for troublesome operations such as removing and attaching the seal plug for confirmation. Furthermore, blood does not leak to the outside. Note that by making the outer tube 6 of the catheter tube 3 transparent or translucent, the continuity between this side hole and the blood vessel can be confirmed more quickly. The use of a transparent or translucent outer tube 6 is also preferred for precise positioning of the side hole in relation to the end of the annular passage.

Moreover, if the inner tube 5 etc. are molded using a synthetic resin material mixed with an X-ray opaque agent such as barium sulfate, bismuth oxide, bismuth chloride, etc.,
In the event that the catheter tube breaks and circulates within the blood vessel, it can be easily detected using X-ray photography.
Further, the breathable blood leakage resistant member 14 has excellent blood leakage resistance and can be manufactured at low cost by using a membrane filter made of polyester resin aggregate coated with polyvinyl chloride. Further, by forming the entire air-permeable leak-proof thrombus from a breathable blood-leak-proof member, particularly a sintered body, the number of manufacturing steps can be reduced.

In the above embodiment, the catheter side assembly is provided with the soft tube 16 and the stopper receiver 21, but the present invention is not limited to this, and the present invention can be applied to all other double-tube intravascular catheters. The invention could be applied. In short, it is sufficient that the breathable blood-leakproof member is connected via a soft tube to the end of the branch pipe that communicates with the outer passage of the double pipe, and other configurations may be modified as desired.

The inner needle side assembly is not particularly related to the gist of the present invention, and therefore, any modifications other than the above-described embodiments are possible in relation to the structure of the catheter side assembly.

[Brief explanation of the drawing]

FIG. 1 is a side view of an intravascular indwelling catheter according to an embodiment of the present invention, FIG. 2 is a side view of the catheter side assembly of the intravascular indwelling catheter of FIG. 1, and FIG. 3 is shown in FIG. 1. FIG. 4 is a side view of the inner needle side assembly of the intravascular indwelling catheter, and FIG. 4 is a partially cutaway sectional view of the intravascular indwelling catheter shown in FIG. 1. In the figure, 1...catheter side assembly, 2...inner needle side assembly, 3...catheter tube, 4...catheter hub, 5...inner tube, 6...outer tube, 7...inner passage, 8... Circular passage, 1
0...branch pipe, 10a...connector part, 11...
... Side hole, 12 ... Soft tube, 13 ... Connector, 14 ... Breathable blood leakage-proof member, 15 ... Breathable leakage-proof blood clot, 16 ... Soft tube, 17 ... Connector, 18 ... Sealing cap, 19...
Inner needle, 20...Insertion hole, 21...Stopper receiver, 2
2... Stopper rod, 23, 24... Breathable leakage-resistant thrombus, 25... Hole.

Claims (1)

[Scope of Claims] 1. An inner needle comprising a hub; an inner tube forming an inner passage through which the inner needle is penetrated in close contact with its outer peripheral surface at least at its tip; a flexible catheter tube that forms an annular passage and has an outer tube that is in close contact with an inner tube at its distal end and has one or more side holes that communicate with the annular passage; a catheter hub attached to the proximal end of the catheter hub; a branch pipe connected to the catheter hub and communicating with the annular passageway; a transparent or translucent soft body with one end connected to the branch pipe; A tube; a connector provided at the other end of the flexible tube; and an air permeable leak-proof thrombus detachably connected to the other end of the connector and permeable to gas within the tube. Intravascular catheter. 2. The intravascular indwelling catheter according to claim 1, wherein the outer tube is made of a transparent or translucent synthetic resin. 3. The intravascular indwelling catheter according to any one of claims 1 to 2, wherein the inner tube is formed from a synthetic resin mixed with an X-ray contrast agent. 4. The intravascular indwelling catheter according to any one of claims 1 to 3, wherein the breathable leakage-resistant thrombus is provided with a breathable blood-leakage-resistant member. 5. The intravascular indwelling catheter according to claim 4, wherein the breathable blood leakage-resistant member is a membrane filter made of a polyester resin aggregate coated with polyvinyl chloride. 6. The intravascular indwelling catheter according to any one of claims 1 to 3, wherein the air-permeable leakage-resistant thrombus is entirely formed of a breathable blood-leakage-resistant member. 7. The intravascular indwelling catheter according to claim 6, wherein the breathable blood leakage-resistant member is a sintered body.