JP5111767B2 - Triple lumen catheter - Google Patents

Description

  The present invention relates to a triple lumen catheter used in the medical field.

  As a means of extracorporeal circulation treatment such as hemodialysis required for short-term blood purification therapy such as emergency dialysis, drug addiction, fulminant hepatitis, etc., blood is drained out of the body with blood removal lumen and purified with return blood lumen A double-lumen catheter that returns the blood to the body is widely used.

  In hemodialysis, it is important to secure a sufficient blood flow volume stably in order to increase the dialysis efficiency. A side-by-side double lumen catheter having an opening at the distal end and a plurality of side holes in the side wall has been developed and used (for example, see Non-Patent Document 1). Furthermore, various end-hole type (end-opening type) double-lumen catheters have been developed to improve the problem of the above-mentioned side-by-side double-lumen catheter, which is a problem with blood removal due to adsorption of side holes to the inner wall of blood vessels during blood aspiration. (For example, refer to Patent Document 1).

  However, the double-lumen catheter for hemodialysis described above has a drawback that it cannot be easily used for administration of a drug solution by intravenous injection or central venous pressure (CVP) measurement regardless of whether it is during extracorporeal circulation. In addition, triple lumen catheters for hemodialysis have been developed (see, for example, Patent Documents 2 to 5).

Among them, the triple lumen catheter disclosed in Patent Document 5 includes a main body 22 having a tapered distal end portion 23 and three lumens 24, 25 and 26, as shown in FIG. It consists of three connection tubes (not shown) communicating with the three lumens 24, 25 and 26 respectively provided in the. The third lumen 26 is juxtaposed with the lumens 24 and 25 and communicates with the outside through a tip opening provided at the tip. FIG. 4B shows the AA ′ cross section of FIG. 4A, but the second lumen 25 has a side hole 25a that faces the side wall and communicates with the outside. FIG. 4C shows the BB ′ cross section of FIG. 4A, and the first lumen 24 has a structure having a side hole 24a communicating with the outside on the side wall.
Shaldon, S.et al Trans.Am.Soc.Artif.Intern.Organs.10: 133-135,1964 JP 2001-104486 A JP-A-2-209159 Japanese Patent Publication No. 1-23142 US Pat. No. 5,212,256 JP-A-9-276410

  The triple lumens disclosed in Patent Documents 2 to 4 are side-by-side types, and have problems such as poor blood removal due to adsorption to the inner wall of the blood vessel or reduction in blood flow. In addition, in the side-by-side triple lumen shown in FIG. 4 with an improvement, there is a problem that if one of the side holes is adsorbed to the inner wall of the blood vessel, the area of the suction part that can be used for blood removal decreases, resulting in a flow rate trouble. It was.

  The inventors previously filed a patent application for a triple lumen catheter in which the blood removal lumen and the blood return lumen are end-hole type, and the third lumen is an opening method at a side hole or a slit-type tip (special feature). Application No. 2005-176547). However, when the third lumen is used for infusion or drug administration, the infused drug or the like is discharged from the side hole laterally with respect to the flow in the blood vessel due to its structure, so that it is partially sucked into the blood removal route and reused. Circulation was assumed to occur.

  By the way, in general, as a method of indwelling a catheter, it is necessary to indwell as quickly as possible while minimizing the amount of bleeding, so the catheter is inserted along a guide wire that has been inserted in advance to a predetermined position in the blood vessel. In many cases, an indwelling method (Seldinger method) is used. An example of a conventional end-hole type catheter tip is shown in FIG. 3. In the case of indwelling by the Seldinger method, a double lumen (FIG. 3 (a)) has two steps, a triple lumen (FIG. 3 (b), ( In c)), three steps are generated. As described above, in the end-hole type catheter, the number of steps at the distal end increases as the number of end openings increases, and the insertion resistance increases. In order to suppress this insertion resistance, it is necessary to use an introducer or the like that is slightly thicker than the catheter, and as such, when the blood vessel is inserted, the puncture site becomes larger, bleeding at the time of placement is much difficult, and the chance of infection increases, etc. There was a problem of giving an extra burden to the patient.

  The present invention solves the above-mentioned problems, prevents the blood removal port from being blocked by the blood removal suction force, prevents insufficient flow, prevents insufficient blood removal, poor blood removal, and the like, and injects from the infusion lumen, etc. An object of the present invention is to provide a triple lumen catheter having a structure suitable for efficiently performing blood purification and the like with less burden on the operator and patient when the catheter is indwelled. .

  As a result of intensive studies to solve the above-mentioned problems, the present inventors made the catheter tip of the triple lumen catheter the same shape as the end hole type tip shape of the double lumen catheter, and shifted from the catheter tip to the base side. It has been found that by providing a special shape in which a third lumen end hole type opening is provided at a position, it is possible to prevent sticking of the blood vessel wall and to obtain an insertability equivalent to that of an end hole type double lumen. The present invention has been reached.

  That is, the present invention includes a first lumen and a second lumen formed by a partition wall provided in the longitudinal direction, and the first lumen penetrates to the distal end of the catheter and externally passes through an end-hole type opening. The second lumen communicates with the outside through an end-hole type opening at a position 1 to 11 cm away from the opening of the first lumen toward the base side, and from the opening of the second lumen. A narrow-diameter portion is formed on the distal end side, and a third lumen communicating with the outside through an end-hole type opening provided in the narrow-diameter portion is provided at the intersection of the side wall and the partition wall. The above-mentioned triple-lumen catheter is a gist, and preferably, the narrow-diameter portion has a taper so as to become thinner as it approaches the distal end of the catheter. Has a circular cross-sectional shape at the distal end of the catheter, and preferably the opening of the second lumen has an angle α between the opening surface of the opening and the axis of the catheter of 15 to 90 °. Further, preferably, a side hole communicating with the second lumen is provided on the side wall of the catheter body in the vicinity of the opening of the second lumen.

  According to the present invention, resistance at the time of catheter insertion can be suppressed to the same level as an end-hole type double lumen, and the burden on the patient and the operator can be reduced. Furthermore, by making the angle of the opening surface of the blood removal port (opening portion of the second lumen) provided in the catheter body within the range of 15 ° to 90 °, the insertability can be further improved. In addition, since the blood removal port is an end-hole type, the opening area of the blood removal port can be increased, sufficient blood flow can be secured and adsorption of the blood removal port to the blood vessel wall is prevented, Poor blood removal is unlikely to occur. Furthermore, by providing a side hole communicating with the blood removal lumen (second lumen) in the side wall of the catheter body in the vicinity of the blood removal opening, a larger blood flow on the blood removal side can be secured. In addition, by making the opening for infusion (the opening of the third lumen) an end-hole type opening, the medicine is discharged in the same direction as the flow direction of the blood vessel, so that the medicine is recirculated. Can be prevented.

  Use the triple lumen catheter of the present invention to perform temporary infusions, drug administration, or CVP monitoring while performing extracorporeal circulation (blood access) for hemodialysis and blood purification. Can do.

  The triple-lumen catheter of the present invention is generally composed of a first lumen used as a return lumen for extracorporeal circulation, a second lumen usually used as a blood removal lumen for extracorporeal circulation, an infusion, and a drug. Consists of a branch tube (or extension tube) to connect to the catheter body, branching part, extracorporeal circuit and infusion circuit CVP measuring machine, etc. where a third lumen used for routes such as administration and CVP measurement is formed . A connector for connecting to a circuit or the like is attached to the end of the branch pipe. The branch pipe is attached with a clamp because it is necessary to close the branch pipe with a clamp when performing treatments such as connection to and removal from the blood circuit, and heparin lock.

  The triple lumen catheter of the present invention is characterized by the shape in the vicinity of the distal end portion of the catheter body, and conventionally known branching portions, branch pipes, clamps, and connectors are preferably used.

  The triple lumen catheter of the present invention will be described with reference to the drawings. FIG. 1 (a) shows an example of a triple lumen catheter 1 of the present invention. A branch tube 5 extends to the base side of the catheter body 2 via the branch portion 4, and a connector 6 is attached to the tip of the branch tube 5. FIG. 1E is an enlarged plan view of the distal end portion side of the catheter body 2, and FIG. 1F is an enlarged top view of the distal end portion side of the catheter body 2. The first lumen 8 extends from the base portion to the distal end portion of the catheter body 2 and communicates with the outside through the opening 11. In order to increase the return blood flow volume through the first lumen 8, a side hole (not shown) that communicates the first lumen with the outside may be provided on the side wall in the vicinity of the opening 11.

  The second lumen 7 formed by separating the first lumen 8 and the partition wall communicates with the outside through an end hole-type opening 12 provided at a location 1 to 11 cm away from the distal end to the base side. It penetrates to the main body base. The position where the opening 12 is provided is preferably a place of 1 to 8 cm, more preferably 1.5 to 5 cm from the tip to the base side. If this distance is shorter than 1 cm, the purified blood returned to the body through the opening 11 of the first lumen 8 is sent again to the dialysis circuit. Conversely, if the distance is longer than 11 cm, the effective length of the catheter becomes longer and the indwelling position is increased. This is not possible because the number of blood vessels to be used is limited.

  The angle α of the opening surface of the opening 12 of the second lumen 7 is preferably inclined toward the base side with respect to the axial direction of the catheter. The angle α is preferably 15 to 90 °, more preferably 15 to 60 °, and most preferably 25 to 50 °. If the angle α is smaller than 15 °, the blood vessel wall may be adsorbed and blocked by the opening 12 due to the suction pressure of the extracorporeal circulation circuit. If the angle α is larger than 90 °, the opening 12 may be opened when the catheter is inserted into the body. This is not preferable because it may damage blood vessels.

  Since the suction pressure of the opening 12 of the second lumen 7 can be reduced and the amount of blood removal can be increased, it is preferable to provide a side hole 14 communicating with the outside on the side wall closer to the base than the opening 12. Even if the position of the side hole 14 is too close to the base side from the opening 12, it is not located in a sufficiently thick blood vessel, so it is preferably located 1 mm to 50 mm from the blood removal port, more preferably 2 mm to 35 mm. is there. Although the shape of a side hole is not specifically limited, Preferably circular and elliptical are good.

  In the present invention, the catheter body closer to the distal end than the position where the opening 12 of the second lumen 7 is located needs to be the narrow-diameter portion 3 having a small cross-sectional area. An opening 10 of an end-hole type third lumen 9 is provided at an arbitrary position of the narrow-diameter portion 3, and the third lumen 9 communicating with the outside through the opening 10 is an intersection of the side wall and the partition wall. Is provided. The third lumen 9 penetrates to the base of the catheter body. The position of the opening 10 of the third lumen 9 may be between the opening 11 of the first lumen 8 and the opening 12 of the second lumen 7, and is preferably 0.1 cm to 10.5 cm from the tip. , 0.25 cm to 7.5 cm is more preferable from the tip, and 0.5 cm to 4.5 cm is most preferable from the tip. The shape of the opening is not particularly limited as long as it is an end hole type, but a circular or elliptical shape is preferable.

  The cross-sectional area of the narrow-diameter portion 3 only needs to be smaller than the cross-sectional area of the catheter main body at the position where the opening 12 is located.

  FIGS. 1B, 1C and 1D respectively show the A-A ′ cross section, the B-B ′ cross section and the C-C ′ cross section shown in FIG. FIG. 1 (b) shows a second lumen 7 having a semicircular cross section and a lower half with a semicircular shape sandwiching the partition wall, and a part of the shape is cut obliquely from the upper side toward the lower side of the circumference. A first lumen 8 and a circular third lumen 9 are shown at the intersection of the side wall and the partition. 1C and 1D are cross sections of the narrow-diameter portion 3. In FIG. 1C, the first cross section 8 and the third lumen 9 are formed, and the overall cross section is a semicircular shape. It has become. Although the shape of the front-end | tip part of the narrow diameter part 3 is not specifically limited, Preferably circular is good, for example, FIG.1 (d) has shown the circular cross section.

  FIG. 1 (g) is a right side view of FIG. 1 (e), in which three lumens are opened in an end hole shape. FIG. 1 (h) is a DD ′ cross-sectional view shown in FIG. 1 (g), showing only the narrow-diameter portion at the tip, and the third lumen 9 is opened in an end hole shape at the tip, and blood It shows a structure where chemicals are discharged in the same direction as the flow.

  Since the triple lumen catheter of the present invention is an end-hole type, the area of the openings 11 and 12 is increased in order to increase the blood flow rate in the second lumen 7 used as a blood removal lumen and the first lumen 8 used as a blood return lumen. However, when using a small-diameter guide wire, a large gap is formed between the inner wall of the first lumen 8 and this gap makes the triple lumen catheter a guide wire with less resistance. There is a problem in insertability such as being unable to follow. In order to fill this gap, a stylet 16a may be used in which a guide wire is inserted into the lumen and inserted into the first lumen as shown in FIG. The stylet 16a penetrates from the tip to the base. Further, a stylet 16b whose tip is blocked to prevent blood inflow may be inserted on the second lumen side in order to improve insertability, and the hardness of the catheter may be increased. It is necessary to make the length so as not to protrude from the portion 12. The stylet 16 is connected to the stylet connector 18 on the base side, and preferably has a structure that can be fitted to the connector 6 in terms of operability.

  In the triple lumen catheter of the present invention, the material of the catheter body is polyurethane, polyvinyl chloride, silicone, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyamide, etc., maintaining a stable inner shape in the blood vessel and damaging the blood vessel. Any polyurethane can be used as long as it is not hard, but polyurethane is most preferably hard enough not to impair the catheter insertion property and hard at room temperature and soft at the body temperature. Further, since the material of the catheter body recognizes the position of the catheter in the body, it is preferable to provide contrast properties by including a contrast agent such as barium sulfate, bismuth tungstate, and bismuth oxide.

  The soft tip 13 may be formed by welding a softer material made of the same material as that of the catheter in order to make it difficult to damage the blood vessel.

  As the material of the branch tube of the catheter, a material having the same hardness as the material of the catheter body or a soft material is used. For example, polyurethane, polyvinyl chloride, silicone, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, etc. can be mentioned. Particularly preferred are vinyl chloride and silicone.

  As the material of the connector, any resin may be used as long as it can be formed of a resin having high hardness and strength and excellent chemical resistance against sterilizing agents and dimensional stability. This resin may be, for example, polycarbonate, hard polyvinyl chloride, polyurethane, polyamide, polyetherimide, or a mixture of these resins with another resin to further increase the strength.

  When the triple lumen catheter of the present invention is placed in a patient and is not used in order to prevent blood from the indwelling blood vessel from flowing back into the lumen and coagulating the lumen, etc. An amount of heparin can be charged or an obturator can be used. Applicable lumens can be applied to any of the first, second and third lumens. The obturator used here may be an obturator that has been subjected to anti-thrombotic treatment to prevent occlusion due to thrombus and the like, and lubrication treatment to improve insertion (for example, Japanese Patent Publication No. 4-61663). JP, 10-248919, A). Since the inner lumen of the third lumen is small, it is preferable that the obturator is made of a flexible metal material such as a metal guide wire rather than a plastic. Moreover, you may utilize the obturator which gave this metal material the antithrombotic process or the lubricity process.

  The triple lumen catheter of the present invention has a lubrication treatment such as coating the surface of a base material with a hydrophilic polymer compound in order to facilitate insertion and placement in a living organ (for example, JP-A-10-248919). No. gazette). Many methods are known for the lubricity treatment, and any method may be selected. The range of the lubrication treatment may be any part as long as it is a part that comes into contact with the human body or a part that comes into contact with a tool or the like for placing the catheter.

  The triple-lumen catheter of the present invention is one in which the surface of the base material is subjected to a biocompatible treatment, for example, an antithrombotic treatment, in order to prevent a foreign body reaction from coming into contact with a body fluid or tissue during placement in a living organ. There may be. Biocompatible treatment is a method in which plasminogen activator such as urokinase is immobilized on the catheter surface of the base material by chemical bonding method (for details, refer to Patent No. 1406830), and anticoagulation factor such as heparin is immobilized on the catheter surface. Various methods are known, such as a method of making them, but are not limited to specific methods. The range of the biocompatibility process may be any part as long as it is a part that comes into contact with the living body.

  The triple lumen catheter of the present invention has a base catheter surface coated with an antibacterial agent, antibiotics, or the like in order to prevent infection with bacteria, fungi, viruses, etc. during catheter placement (for example, JP-A-2001 2001). No. -276210) or an antibacterial agent directly kneaded with the substrate (for example, see JP-A-8-157441).

  In the embodiment configured as shown in FIG. 1, for example, when hemodialysis is performed, a guide wire previously inserted into the blood vessel is connected to the opening 11 of the first lumen 8 of the triple lumen catheter 1. The triple lumen catheter 1 is inserted into the blood vessel using this guide wire and the like and is placed. Next, the guide wire is removed from the triple lumen catheter 1, the connector 6a connected to the branch lumen of the first lumen is connected to the blood return side of the dialysis circuit, and the connector 6c connected to the branch lumen of the second lumen is connected. Connect to the blood removal side of the dialysis circuit and start hemodialysis.

  In the case where the stylet is inserted as shown in FIG. 2, for example, when hemodialysis is performed, a guide wire inserted in advance into the blood vessel is inserted into the first lumen of the triple lumen catheter 1. The stylet 16a is inserted through the stylet lumen from the distal end opening 16c, and the triple lumen catheter 1 is inserted into the blood vessel using this guide wire and the like and placed. Next, the stylet is removed, and then the guide wire is removed from the triple lumen catheter, and the connector 6a connected to the branch lumen of the first lumen is connected to the blood return side of the dialysis circuit and connected to the branch lumen of the second lumen. The connector 6c thus connected is connected to the blood removal side of the dialysis circuit to start hemodialysis.

  Hereinafter, the present invention will be described specifically by way of examples.

Example 1
As shown in FIG. 1, the polyurethane triple-lumen catheter body 2 (outer diameter: 4.0 mm, length: 200 mm) has an angle α of 30 ° at the opening surface of the second lumen (blood removal lumen). The position of the opening 12 (blood removal port) is 25 mm from the tip, and the tip side of the opening 12 (blood removal port) is tapered, and the cross section of each part is as shown in FIG. ), Has a tapered structure from the semicircular cross-sectional shape (c) having a radius of 2.0 mm toward the tip, and has a cross-section (d) having an outer diameter of 2.2 mm and an inner diameter of 1.6 mm. A triple lumen catheter was prepared in which the position of the opening 10 of the 3 lumen (infusion lumen) was 6 mm from the tip.

Comparative Example 1
As shown in FIG. 5, a polyurethane triple-lumen catheter main body 27 (outer diameter: 4.0 mm, length: 200 mm) has an opening surface of each lumen at an angle of 90 ° with respect to the axis. Are provided with branch pipes, connectors, etc. (not shown) communicating with the three lumens of the main body 27, respectively. The position of the blood removal port is 25 mm from the tip, and as shown in FIG. 5, the cross-section of each part is as shown in FIG. A triple lumen catheter having a cross-sectional shape (d) excluding the third lumen portion and having the infusion port 10 at a position 6 mm from the tip was prepared.

Comparative Example 2
As shown in FIG. 6, a polyurethane double-lumen catheter main body 28 (outer diameter 4.0 mm, length 200 mm) has an angle α of the opening surface of the blood removal lumen of 30 °, and is located at the base of the main body 28. Are provided with branch pipes, connectors, etc. (not shown) communicating with the two lumens of the main body 28, respectively. The position of the blood removal port is 25 mm from the tip, the tip side from the blood removal port is a taper structure, and each section has a cross-sectional shape of (b) with an outer diameter of 4.0 mm and a radius of 2.0 mm as shown in FIG. A double-lumen catheter having a tapered structure from the semicircular cross-sectional shape (c) to the distal end side and a cross-section (d) having an outer diameter of 2.2 mm and an inner diameter of 1.6 mm was produced.

Comparative Example 3
As shown in FIG. 7, a polyurethane double-lumen catheter body 29 (outer diameter: 4.0 mm, length: 200 mm) with a long diameter of 3 mm communicating from the blood return lumen to the outside at positions of 9 mm and 15 mm from the distal end toward the base side. An ellipse-shaped blood return hole 31 with a minor axis of 1.2 mm, and an ellipse with a major axis of 3 mm and a minor axis of 1.2 mm that communicates from the blood removal lumen to the outside at positions of 34 mm, 41 mm, and 48 mm from the blood return hole 31 toward the base side A blood removal hole 30 is formed, and a branch pipe, a connector, etc. (not shown) communicating with the two lumens of the main body 29 are provided at the base of the main body 29. The cross section of each part is shown in FIG. As described above, the double-lumen having a longitudinal cross-sectional view (b) and a cross-sectional shape (d) having a cross-sectional shape of (c) having an outer diameter of 4.0 mm and a semicircular filling filled in the distal end of the blood removal lumen A catheter was prepared.

Comparative Example 4
As shown in FIG. 8, in the polyurethane triple-lumen catheter body 2 (outer diameter 4.0 mm, length 200 mm), the opening angle α of the second lumen 8 (blood removal lumen) has an angle of 30 °. The position of the opening 12 (blood removal port) is 25 mm from the tip, the tip side from the opening 12 (blood removal port) is tapered, and the cross section of each part has an outer diameter of 4.0 mm as shown in FIG. b) having a cross-sectional shape, a tapered structure from the semicircular cross-sectional shape (c) having a radius of 2.0 mm on the tip side, and a cross-section (d) having an outer diameter of 2.2 mm and an inner diameter of 1.6 mm, A triple lumen catheter was produced in which the position of the side hole 34 of the third lumen 9 (infusion lumen) was 6 mm from the tip.
FIG. 8G is a right side view of FIG. 8E, and the opening of the third lumen 9 is a side hole 34. FIG. 8 (h) is a cross-sectional view taken along the line DD ′ shown in FIG. 8 (g) and shows only the narrow-diameter portion at the tip, and laterally from the side hole 34 of the third lumen 9 with respect to the blood flow. It shows a structure where chemicals are discharged.

Test example 1 (catheter insertion resistance test)
Using the catheters prepared in Example 1 and Comparative Examples 1 and 2, the resistance value when inserted along the guide wire was measured by the following method. That is, a needle hole is made with a metal puncture needle 17G in a 1 mm thick silicone rubber sheet, then a guide wire 0.038 ”(0.97 mm) is passed through the needle hole, and a dilator (outer diameter φ4.0 mm) is passed through the guide wire. The dilator was pulled out with the silicone rubber sheet hole extended and the guide wire left behind, and a catheter that measures insertion resistance through the expanded guide wire (cut at 70 mm from the catheter tip). Was inserted into a guide wire and set in a compression tester (EZ-TEST manufactured by Shimadzu Corporation), and the resistance value when the catheter was inserted into the silicone rubber sheet along the guide wire was measured.

  The results of the catheter insertion test are shown in FIG. As is apparent from FIG. 11, in Comparative Example 1 (50), since there are three end-hole-shaped openings, three peaks of insertion resistance are observed. On the other hand, Example 1 (49) has almost the same value as Comparative Example 2 (51), which is an end-hole type double lumen catheter, with only two relatively small peaks. Although it is a triple lumen, it has structurally two end-hole-like openings, and therefore shows a resistance value similar to that of Comparative Example 2.

Test Example 2 (Bloodlet adsorption test on blood vessel wall)
Using the catheters prepared in Example 1 and Comparative Examples 1, 2, and 3, a catheter blood removal port (a blood removal hole in Comparative Example 3; the same applies to this test example) The flow rate when adsorbing was measured. That is, as shown in FIG. 9, a cylindrical tube 40 made of a polyethylene film having a thickness of 0.02 mm is regarded as a blood vessel, and a catheter 35 is inserted into the tube 40 to remove blood from the catheter. The device was assembled to be located underwater. The blood removal connector 6c and the blood return connector 6a of the catheter were connected to the blood removal side connector 36 and the blood return side connector 37 of the blood circuit (not shown) connected to the dialyzer. 37 ° C. water 39 was circulated by a dialyzer pump through a blood circuit from the catheter blood removal port and back into the beaker 38 through the catheter blood return port. The flow rate of the circulating water was gradually increased, and the flow rate when the blood removal port adsorbed to the tube was measured.

  As a result of carrying out the blood removal port adsorption test on the blood vessel wall, in Comparative Example 3, it was confirmed that the blood removal port was adsorbed on the tube at a flow rate of 200 mL / min. On the other hand, in Example 1, Comparative Example 1, and Comparative Example 2, even when the flow rate was increased to a flow rate of 300 mL / min, adsorption to the blood removal port was not confirmed. In the end hole type (Example 1, Comparative Example 1, Comparative Example 2), the adsorption to the cylinder 38 did not occur even when the high flow rate, that is, the suction pressure applied to the blood removal port was increased.

Test Example 3 (Measurement of recirculation)
A blood circuit as shown in FIG. 10 is assembled using the catheters produced in Example 1 and Comparative Example 4, and the flow rate of the simulated blood vessel is 200 mL / min (37 ° C. water), and the infusion pump 41 is used from the third lumen. The blood flow of the dye solution 45 is 5 mL / min, the blood flow of the blood removal pump 42 is set to 200 mL / min, and the flow rate of the blood return pump 43 is set to 200 mL / min. The pigment concentration of the liquid 46 from the mouth was measured, and the recirculation rate was calculated.

  As a result of measuring the recirculation of the third lumen, the recirculation rate was 10% in Comparative Example 4, but the recirculation rate was 0% in Example 1.

It is the schematic which shows an example of the triple lumen catheter of this invention. (A) Schematic showing an example of the overall shape, (b) Catheter AA ′ cross section, (c) Catheter BB ′ cross section, (d) Catheter CC ′ cross section, (e) Catheter tip (F) Top view of the distal end of the catheter, (g) Right side view of FIG. 1 (e), (h) Cross section of catheter DD ′ It is the schematic which shows an example of the triple lumen catheter of this invention. (A) Schematic diagram showing an example of the overall shape, (b) catheter A-A 'sectional view, (c) catheter B-B' sectional view, (d) catheter C-C 'sectional view It is the schematic which shows an example of an end hole type tip structure. (A) Double lumen type, (b) and (c) Triple lumen type It is the schematic of the conventional catheter shape. (A) Schematic showing the shape of the distal end portion, (b) Cross section of catheter A-A ', (c) Cross section of catheter B-B' 3 is a schematic view of a catheter shape produced in Comparative Example 1. FIG. (A) Schematic diagram showing the shape of the tip portion, (b) Cross section of catheter A-A ', (c) Cross section of catheter B-B', (d) Cross section of catheter C-C ' 10 is a schematic view of a catheter shape produced in Comparative Example 2. FIG. (A) top view of catheter tip, (b) top view of catheter tip, (c) catheter AA ′ sectional view, (d) catheter BB ′ sectional view, (e) catheter CC ′ Cross section 10 is a schematic view of a catheter shape produced in Comparative Example 3. FIG. (A) Cross section of catheter tip, (b) Cross section of catheter A-A ', (d) Cross section of catheter B-B' 10 is a schematic view of a catheter shape produced in Comparative Example 4. FIG. (A) Schematic showing an example of the overall shape, (b) Catheter AA ′ cross section, (c) Catheter BB ′ cross section, (d) Catheter CC ′ cross section, (e) Catheter tip (F) Top view of the distal end portion of the catheter, (g) Right side view of FIG. 8 (e), (h) Cross section of the catheter DD ′ It is the schematic which shows the model of the blood removal hole adsorption test to the blood vessel wall in this invention. It is the schematic which shows the model of the recirculation test in this invention. Catheter insertion resistance diagram

Explanation of symbols

1 Triple lumen catheter 2 Triple lumen catheter body 3 Narrow diameter portion 4 Branch portion 5a Branch pipe (first lumen)
5b Branch pipe (third lumen)
5c Branch pipe (second lumen)
6a connector (first lumen)
6b connector (third lumen)
6c connector (second lumen)
7 Second lumen 8 First lumen 9 Third lumen 10 Infusion port 11 First lumen opening 12 Second lumen opening 13 Soft tip 14 Side hole 15a Clamp (first lumen)
15b Clamp (third lumen)
15c clamp (second lumen)
16a Stylet (for the first lumen)
16b Stylet (for second lumen)
16c Stylet tip opening 17a Stylet lumen (for first lumen)
17b Stylet lumen (for second lumen)
18a Stylet connector (for first lumen)
18b stylet connector (for second lumen)
19 Double-lumen catheter body 20 End opening 21 Triple-lumen catheter body 22 Triple-lumen catheter body 23 Tip 24 Blood return lumen 24a Side hole (for blood return)
25 Blood removal lumen 25a Side hole (for blood removal)
26 Infusion lumen 27 Triple lumen catheter body (Comparative Example 1)
28 Double lumen catheter body (Comparative Example 2)
29 Double lumen catheter body (Comparative Example 3)
30 Blood removal hole 31 Blood return hole 32 Stuffing 33 Triple lumen catheter body (Comparative Example 4)
34 Side hole 35 Catheter 36 Blood circuit connector (return side)
37 Blood circuit connector (Bleeding side)
38 Beaker 39 37 ° C water 40 Tube 41 Infusion pump 42 Blood removal pump 43 Blood return pump 44 Simulated blood vessel tube 45 Dye aqueous solution 46 Blood removal side recovery solution 47 37 ° C water (simulated blood return)
48 37 ℃ water (simulated blood)
49 Example 1
50 Comparative Example 1
51 Comparative Example 2

Claims (4)

Comprising a first lumen and a second lumen formed by a partition wall provided in the longitudinal direction, further comprising a third lumen;
A second lumen having a semicircular cross section is formed on one side of the partition wall, and a first lumen and a third lumen are formed on the other side of the partition wall so that the overall cross-sectional shape is a semicircular shape. ,
The first lumen penetrates to the distal end of the catheter and communicates with the outside through an end hole type opening,
The second lumen communicates with the outside through an end-hole type semicircular opening at a position 1 to 11 cm away from the opening of the first lumen toward the base side, and from the opening of the second lumen. On the tip side, a narrow-diameter portion where the first lumen and the third lumen are arranged is formed,
The opening of the second lumen is inclined toward the base side with respect to the axial direction of the catheter,
Furthermore, a third lumen that communicates with the outside through an end-hole-type opening provided in the narrow-diameter portion is provided at the intersection of the side wall and the partition wall,
The narrow diameter portion is tapered so that it narrows from the position where the opening of the second lumen is located toward the distal end of the catheter, and the opening of the third lumen is formed in the taper. Lumen catheter.   The triple lumen catheter according to claim 1, wherein the cross-sectional shape of the catheter tip is circular.   The triple lumen catheter according to claim 1 or 2, wherein the opening portion of the second lumen is formed such that an angle α between the opening surface of the opening portion and the axis of the catheter is 15 to 90 °. The triple lumen catheter according to any one of claims 1 to 3, wherein a side hole communicating with the second lumen is provided in a side wall of the catheter body in the vicinity of the opening of the second lumen.