JP4945174B2 - 4 lumen catheter - Google Patents

Description

  The present invention relates to a four-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). Further, a dual flow end-hole type triple lumen catheter for hemodialysis has been proposed (for example, Patent Document 2).

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 3 to 6).
Shaldon, S.et al Trans.Am.Soc.Artif.Intern.Organs.10: 133-135,1964 JP 2001-104486 A JP-T-9-501337 JP-A-2-209159 JP-A-1-23142 US Pat. No. 5,212,256 JP-A-9-276410

  The triple lumen catheter disclosed in Patent Document 2 includes a pair of blood return lumens formed up to a blood return port that opens at a reduced diameter tip, and a pair of openings that are provided on both sides behind the blood return port and open in the axial direction. This is a dual-flow end-hole type triple-lumen catheter for hemodialysis having a blood removal lumen formed on the base side with a blood removal port formed. In this dual flow end-hole type triple lumen catheter, there is no lumen dedicated to infusion, so infusion cannot be infused, and the shape of the catheter tip is sharpened to facilitate insertion of the catheter tip into the body. Since the blood return port is also small, there is a problem that the return blood pressure increases and it is difficult to secure the return blood flow volume.

  The triple lumens disclosed in Patent Documents 3 to 6 are side-by-side types. The side-by-side type has problems such as poor blood removal or decreased blood flow due to adsorption to the inner wall of the blood vessel regardless of double lumen or triple lumen.

  In addition, the limitation of triple lumen catheters is that there is only one structure for the CVP measurement, infusion, drug administration, etc. excluding the return blood lumen. It is necessary to secure a route, which increases the burden on the operator and patient, and increases the number of indwelling catheters, which increases the risk of infection.

  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. 5, but when placed by the Seldinger method, the double lumen (FIG. 5 (a)) has two steps, a triple lumen (FIG. 5 (b), ( In step c)), there are three steps, and four steps in four lumens (FIGS. 5D and 5E). 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, etc., and has two infusion lumens. Another object of the present invention is to provide a four-lumen catheter that has a structure suitable for efficiently performing blood purification and the like with less burden on the operator and patient when placing the catheter.

  As a result of intensive studies to solve the above problems, the present inventors made the catheter tip of the four-lumen catheter the same shape as the end-hole type tip of the double-lumen catheter, and shifted from the catheter tip to the base side. The special shape of providing the opening of the third lumen and the fourth lumen at the position prevents the blood vessel wall from sticking, and the insertion property equivalent to the end hole type double lumen can be obtained. And reached the present invention.

  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 the third lumen and the fourth lumen communicating with the outside through the third lumen and the fourth lumen opening provided in the narrow-diameter portion are side walls. The four-lumen catheter is characterized in that it is provided at the intersection of the septum and the septum. Preferably, the narrow-diameter portion is tapered so as to become narrower as it approaches the distal end of the catheter. Preferably, the cross-sectional shape of the catheter tip is circular, and preferably, the opening of the second lumen has an angle between the opening surface of the opening and the axis of the catheter. α is formed so as to be 15 to 90 °, and 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. It is what.

  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.

  Using the four-lumen catheter of the present invention, while performing extracorporeal circulation (blood access) for performing hemodialysis and blood purification, two infusion lumens are used for temporary infusion, drug administration, or CVP. Can be monitored with confidence at the same time.

  The four-lumen catheter of the present invention is generally composed of a first lumen that is used as a return lumen for extracorporeal circulation, a second lumen that is usually used as a blood removal lumen for extracorporeal circulation, an infusion solution, and a drug. 3rd and 4th lumens used for routes such as administration and CVP measurement, etc. Branch body (or extension) to connect to catheter body, bifurcation and extracorporeal circuit or infusion circuit CVP measuring machine etc. Tube). 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 four-lumen catheter of the present invention is characterized by the shape of the vicinity of the distal end portion of the catheter main body, and conventionally known branching portions, branch pipes, clamps, and connectors are preferably used.

  The four-lumen catheter of the present invention will be described with reference to the drawings. FIG. 1A shows an example of a four-lumen catheter 1 of the present invention. A branch tube 6 extends to the base side of the catheter body 2 via the branch portion 5, and a connector 7 is attached to the tip of the branch tube 6. FIG. 1B is an enlarged front view of the distal end side of the catheter body 2, FIG. 1C is an enlarged rear view of the distal end side of the catheter body 2, and FIG. It is an enlarged bottom view by the side of a front-end | tip part. The first lumen 11 extends from the base portion to the distal end portion of the catheter body 2 and communicates with the outside through the opening 15. In order to increase the return blood flow volume through the first lumen 11, 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 15.

  The second lumen 10 formed by separating the first lumen from the septum communicates with the outside through an end hole-type opening 14 provided at a position 1 to 11 cm away from the distal end to the base side. It penetrates to the base. The position where the opening 14 is provided is preferably 1 to 8 cm, more preferably 1.5 to 5 cm from the tip to the base. When this distance is shorter than 1 cm, the purified blood returned to the body through the opening 15 of the first lumen is sent again to the dialysis circuit. Conversely, when the distance is longer than 11 cm, the effective length of the catheter becomes longer and is placed. Cannot be adopted because blood vessels are limited.

  The angle α of the opening surface of the opening 14 of the second lumen 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 14 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 14 of the second lumen can be reduced and the amount of blood removal can be increased, it is preferable to provide the side hole 9 communicating with the outside on the side wall closer to the base than the opening 14. Even if the position of the side hole 9 is too much on the base side from the opening 14, it is not located in a sufficiently thick blood vessel, so it is preferably located 1mm to 50mm from the opening 14, more preferably 2 to 35mm 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 on the distal end side from the position where the opening 14 of the second lumen is located needs to be the narrow-diameter portion 4 having a small cross-sectional area. Openings 3a and 3b of the third lumen and the fourth lumen are provided at arbitrary positions of the narrow diameter portion 4, and the third lumen and the fourth lumen communicating with the outside through the opening 3 are provided. It is provided at the intersection of the side wall and the partition. The third lumen and the fourth lumen penetrate to the catheter body base. The position of the opening 3 of the third lumen and the fourth lumen may be between the opening 15 of the first lumen and the opening 14 of the second lumen, and 0.1 cm to 10.5 cm from the tip. Is preferable, 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 form of the opening of the third lumen and the fourth lumen is not particularly limited, but preferably an end hole type, a side hole type, or a slit type. The distance between the opening 3a of the third lumen and the opening 3b of the fourth lumen is preferably 0 to 7 cm, more preferably 0 to 2 cm.

  The cross-sectional area of the narrow-diameter portion 4 only needs to be smaller than the cross-sectional area of the catheter main body at the position where the opening 14 is located.

  FIGS. 1E, 1F, and 1G show the A-A ′, B-B ′, and C-C ′ sections shown in FIG. FIG. 1 (e) shows a second lumen 10 having a semicircular cross section, and two portions where the upper half of the partition is cut obliquely from the upper side of the semicircular shape toward the upper direction of the circumference. A first lumen 11 having a shape, a third lumen 12 and a fourth lumen 13 having a circular shape are shown. 1 (f) and 1 (g) are cross sections of the narrow-diameter portion 4. In FIG. 1 (f), a semicircle formed by the first lumen 11, the third lumen 12, and the fourth lumen 13 is shown. It has become a shape. The shape of the distal end portion of the narrow diameter portion 4 is not particularly limited, but preferably a circular shape, for example, a cross section as shown in FIG. FIG. 1 (h) is a right side view of FIG. 1 (b) in which the opening portions of the third lumen and the fourth lumen are in the form of end holes, and four lumens are opened in an end hole shape. FIG. 1 (i) is a cross-sectional view taken along the line DD 'shown in FIG. 1 (h) and shows only the narrow-diameter portion at the tip, and the third lumen and the fourth lumen are opened in an end hole shape at the tip. It shows a structure in which drug solution is discharged in the same direction as blood flow. 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. Thus, by making the opening part of the 3rd lumen and the 4th lumen into an end hole type, since medicine etc. are discharged in the same direction as the flow direction of a blood vessel, recirculation of medicine etc. can be prevented. .

  FIG. 2A is an enlarged front view of the distal end portion in which the opening portions of the third lumen and the fourth lumen are slit-shaped. FIG. 2B is a cross-sectional view taken along the line E-E ′ shown in FIG. 2A, and is opened at a slit-like opening. FIG. 2C is a right side view of FIG. 2A, and the third and fourth lumens are opened in a slit shape. FIG. 2D is a cross-sectional view taken along the line F-F ′ shown in FIG. The form of the slit is not particularly limited, but is preferably a one-way valve, a two-way valve, a notch or the like.

  FIG. 3A is a right side view in which the opening portions of the third lumen and the fourth lumen are in a side hole type, and the third lumen and the fourth lumen are opened in a side hole type. FIG. 3B is a sectional view taken along the line G-G ′ shown in FIG. The shape of the side hole is not particularly limited, but is preferably circular or elliptical.

  The four-lumen catheter of the present invention has an opening 14 for increasing the blood flow rate in at least the second lumen used as the blood removal lumen and the first lumen used as the blood return lumen because the blood return lumen is an endhole type. However, when the guide wire with a small diameter is used, a large gap is formed between the inner wall of the first lumen and the four-lumen catheter can be reduced with less resistance. There is a problem in the insertability such as being unable to follow the guide wire. In order to fill this gap, a stylet 19a 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 19a penetrates from the tip to the base. Further, a stylet 19b having a distal end closed 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 14. It is preferable in terms of operability that the stylet 19 is connected to the stylet connector 20 on the base side and can be fitted to the connector 7.

  In the four-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 16 may be formed by welding a softer material made of the same material as 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 4-lumen catheter of the present invention is placed in a patient and is not used in order to prevent the blood in the indwelling blood vessel from flowing back into the lumen and coagulating it, etc., the same as the volume in the lumen of the catheter. An amount of heparin can be charged or an obturator can be used. Applicable lumens can be applied to any of the first, second, third and fourth 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 lumens of the third and fourth lumens are small, it is preferable to use a flexible metal material such as a metal guide wire as an obturator rather than a plastic. Moreover, you may utilize the obturator which gave this metal material the antithrombotic process or the lubricity process.

  The four-lumen catheter of the present invention has been subjected to 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 four-lumen catheter of the present invention is one in which the surface of the base material is subjected to a biocompatible treatment such as an antithrombotic treatment in order to prevent a foreign body reaction from coming into contact with a bodily 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 four-lumen catheter of the present invention is obtained by coating the base catheter surface 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 as shown in FIG. 1 configured as described above, for example, when hemodialysis is performed, the guide wire previously inserted into the blood vessel is connected to the opening 15 of the first lumen 11 of the four-lumen catheter 1. The four-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 4-lumen catheter 1, the connector 7a connected to the first lumen branch pipe is connected to the blood return side of the dialysis circuit, and the connector 7d connected to the second lumen branch pipe 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. 4, for example, when performing hemodialysis, a guide wire previously inserted into the blood vessel is inserted into the first lumen of the four-lumen catheter 1. The stylet 19a is inserted into the stylet lumen from the distal end opening 21, and the four-lumen catheter 1 is inserted into the blood vessel using this guide wire or the like and placed. Next, the stylet is removed, and then the guide wire is removed from the 4-lumen catheter, and the connector 7a 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 7d 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 FIGS. 1 (a) to 1 (i), the angle α of the opening surface of the second lumen (blood removal lumen) is 4 in the polyurethane four-lumen catheter body 2 (outer diameter 4.0 mm, length 200 mm). It has an angle of 30 °, the position of the opening 14 (blood removal port) is 25 mm from the tip, and the tip side from the opening 14 (blood removal port) has a tapered structure, and the cross section of each part is as shown in FIG. It has a cross-sectional shape of (e) with an outer diameter of 4.0 mm, a tapered structure from the semicircular cross-sectional shape (f) with a radius of 2.0 mm toward the tip, and a cross-section with an outer diameter of 2.2 mm and an inner diameter of 1.6 mm (g Thus, a four-lumen catheter was produced in which the position of the end hole type opening 3 of the third lumen (infusion lumen 1) and the fourth lumen (infusion lumen 2) was 10 mm from the tip.

Example 2
As shown in FIGS. 1 (a) and 3 (a)-(b), a polyurethane four-lumen catheter body 2 (outer diameter: 4.0 mm, length: 200 mm) is opened with a second lumen (blood removal lumen). The angle α of the surface has an angle of 30 °, the position of the opening 14 (blood removal port) is 25 mm from the tip, and the tip side of the opening 14 (blood removal port) is a tapered structure, and the cross section of each part is shown in FIG. As shown in the figure, the outer diameter is 4.0 mm (e), and the tip side is tapered from the semicircular sectional shape (f) having a radius of 2.0 mm. The outer diameter of the tip is 2.2 mm and the inner diameter is 1.6. The side hole type opening 3a of the third lumen (infusion lumen 1) is 6 mm from the tip, and the side hole type of the fourth lumen (infusion lumen 2). A four-lumen catheter with the opening 3b positioned 10 mm from the tip was prepared.

Comparative Example 1
As shown in FIG. 6, a four-lumen catheter main body 28 (outer diameter: 4.0 mm, length: 200 mm) made of polyurethane has an opening surface of each lumen having an angle of 90 ° with respect to the axis. Are provided with branch pipes, connectors, etc. (not shown) communicating with the four lumens of the main body 28, respectively. The position of the blood removal port is 25 mm from the tip, and as shown in FIG. 6, the cross-section of each part is the cross-sectional shape of (e) with an outer diameter of 4.0 mm, the semicircular cross-sectional shape with a radius of 2.0 mm (f), (f) The cross-sectional shape (g) excluding the third lumen portion, and the cross-sectional shape (h) excluding the fourth lumen portion of (g), the position of the opening 3a of the third lumen (infusion lumen 1) are A 4-lumen catheter having a position 6 mm from the tip and an opening 3b of the fourth lumen (infusion lumen 2) being 10 mm from the tip was produced.

Comparative Example 2
As shown in FIG. 7, a polyurethane double-lumen catheter main body 29 (outer diameter 4.0 mm, length 200 mm) has an angle α of the opening surface of the blood removal lumen of 30 °. Are provided with branch pipes, connectors, etc. (not shown) communicating with the two lumens of the main body 29, respectively. The position of the blood removal port is 25 mm from the tip, the tip side from the blood removal port is a tapered structure, and the cross section of each part has a cross-sectional shape of (c) with an outer diameter of 4.0 mm as shown in FIG. A double-lumen catheter having a tapered structure from the semicircular cross-sectional shape (d) to the distal end side and a cross-section (e) 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. 8, a polyurethane double-lumen catheter body 30 (outer diameter: 4.0 mm, length: 200 mm) has a long diameter of 3 mm communicating from the blood return lumen to the outside at 9 mm and 15 mm from the distal end toward the base side. It has an elliptical return hole 31 with a minor axis of 1.2 mm, and a major axis of 3 mm and a minor axis of 1.2 mm with a minor axis of 1.2 mm communicating from the blood removal lumen to the outside at positions of 34 mm, 41 mm, and 48 mm from the tip to the base side. A blood vessel 32 is provided, and at the base of the main body 30, branch pipes, connectors, etc. (not shown) respectively communicating with the two lumens of the main body 30 are provided. As shown in FIG. A double-lumen catheter having a longitudinal cross-sectional view (b) and a cross-sectional shape (d) having a cross-sectional shape of (c) with an outer diameter of 4.0 mm and a semicircular filling filled in the distal end of the blood removal lumen is produced. did.

Test example 1 (catheter insertion resistance test)
Using the catheters produced in Example 1, Example 2, Comparative Example 1 and Comparative Example 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 clear from FIG. 10, in Comparative Example 1, since there are four end hole-like openings, four peaks of insertion resistance are observed. On the other hand, Example 1 and Example 2 have only relatively small two peaks and show substantially the same value as Comparative Example 2 which is an end-hole type double lumen catheter. In spite of the four lumens, the insertion resistance is structurally caused by the end hole type openings at two locations of the first and second lumens.

Test Example 2 (Bloodlet adsorption test on blood vessel wall)
Using the catheters produced in Example 1, Example 2, Comparative Example 1, Comparative Example 2 and Comparative Example 3, the blood removal port of the catheter was formed in a tube made of a film resembling a blood vessel. In the present test example, the same applies hereinafter) and the flow rate when adsorbing was measured. That is, as shown in FIG. 9, a cylindrical tube 34 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 34 to remove blood from the catheter. The device was assembled to be located underwater. The blood removal connector 7a and the blood return connector 7d 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, Example 2, 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 tube of the blood removal port was not confirmed. The end hole type (Example 1, Example 2, Comparative Example 1, Comparative Example 2) did not cause adsorption to the cylinder 38 even when the high flow rate, that is, the suction pressure applied to the blood removal port increased.

It is the schematic which shows an example of the 4 lumen catheter of this invention. (A) Schematic diagram showing an example of the overall shape (b) Front view of the catheter tip (c) Rear view of the catheter tip (d) Bottom view of the catheter tip (e) Catheter AA ′ sectional view (f ) Catheter BB 'cross section (g) Catheter CC' cross section (h) Right side view of catheter tip (i) Catheter DD 'cross section It is the schematic which shows an example of the front-end | tip part of the 4-lumen catheter of this invention. (A) Front view of distal end of catheter (b) Cross section of catheter E-E '(c) Right side view of distal end of catheter (d) Cross section of catheter F-F' It is the schematic which shows an example of the front-end | tip part of the 4-lumen catheter of this invention. (A) Right side view of the distal end of the catheter (d) Cross section of the catheter G-G ' It is the schematic which shows an example of the 4 lumen catheter of this invention. (A) Schematic diagram showing an example of the overall shape (b) Cross section of catheter H-H '(c) Cross section of catheter I-I' (d) Cross section of catheter J-J ' It is the schematic which shows an example of an end hole type tip structure. (A) Double lumen type (b), (c) Triple lumen type (d), (e) Four lumen type 3 is a schematic view of a catheter shape produced in Comparative Example 1. FIG. (A) Front view of the distal end of the catheter (b) Rear view of the distal end of the catheter (c) Bottom view of the distal end of the catheter (d) Plan view of the distal end of the catheter (e) Cross-sectional view of the catheter KK ′ (f) Catheter LL 'sectional view (g) Catheter MM' sectional view (g) Catheter NN 'sectional view Schematic diagram of catheter shape produced in Comparative Example 2 (a) Front view of catheter tip (b) Bottom view of catheter tip (c) Catheter OO ′ sectional view (d) Catheter PP ′ sectional view ( e) Catheter QQ 'cross section 10 is a schematic view of a catheter shape produced in Comparative Example 3. FIG. (A) Front view of the distal end of the catheter (b) Longitudinal sectional view of the distal end of the catheter (c) Cross sectional view of the catheter R-R '(d) Cross sectional view of the catheter S-S' It is the schematic which shows the model of the blood removal hole adsorption test to the blood vessel wall in this invention. Catheter insertion resistance diagram

Explanation of symbols

・ 4 lumen catheter ・ 4 lumen catheter body ・ Opening
3a End hole type opening of the third lumen
3b 4th lumen end-hole type opening, narrow diameter, branch
6a Branch (second lumen)
6b Branch pipe (third lumen)
6c Branch pipe (fourth lumen)
6d Branch (first lumen)
7a connector (second lumen)
7b connector (third lumen)
7c connector (fourth lumen)
7d connector (first lumen)
8a Clamp second lumen
8b Clamp third lumen
8c clamp 4th lumen
8d clamp 1st lumen 9 side hole
10 First lumen
11 Second lumen
12 Third lumen
13 Fourth lumen and second lumen opening (blood removal port)
・ Opening of the first lumen (blood transfusion opening)
・ Soft tip
17a Slit-like opening of the third lumen
17b Slit-like opening of the fourth lumen
18a Side hole opening of the third lumen
18b 4th lumen side hole opening
19a Stylet (for the first lumen)
19b Stylet (for second lumen)
20a Stylet connector (for second lumen)
20b stylet connector (for first lumen)
-Stylet tip opening-Stylet lumen (for first lumen)
Stylet lumen (for second lumen)
・ Double lumen catheter body ・ Terminal opening ・ Triple lumen catheter body ・ 4 lumen catheter body ・ 4 lumen catheter body (Comparative Example 1)
・ Double lumen catheter body (Comparative Example 2)
・ Double lumen catheter body (Comparative Example 3)
・ Blood return hole ・ Blood removal hole ・ Stuffing ・ Tube ・ Catheter ・ Blood circuit connector (blood removal side)
・ Blood circuit connector (return side)
・ Beaker ・ 37 ℃ water ・ Example 1
Example 2
Comparative example 1
Comparative example 2

Claims (8)

Comprising a first lumen and a second lumen formed by a partition wall provided in the longitudinal direction, further comprising a third and a fourth lumen;
A second lumen having a semicircular cross section is formed on one side of the partition wall, and a first, third, and fourth lumen are formed on the other side of the partition wall so as to have a semicircular cross section. And the cross section of the first lumen has a portion along the septum and a portion along the circumference of the catheter, at least on the base side from the opening of the second lumen,
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 in which the first, third, and fourth lumens 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, example Bei third and fourth lumen in communication with the outside through the opening of the third and fourth lumens provided in the narrow diameter portion at an intersection of the side walls and the partition wall,
The narrow-diameter part is tapered so that it narrows as it approaches the distal end of the catheter.   The four-lumen catheter according to claim 1, wherein the opening of the third and / or fourth lumen is an end-hole type opening.   The four-lumen catheter according to claim 1, wherein the opening of the third and / or fourth lumen is a slit-type opening.   The four-lumen catheter according to claim 1, wherein the opening of the third and / or fourth lumen is a side hole type opening. The four-lumen catheter according to any one of claims 1 to 4 , wherein a cross-sectional shape of the catheter tip is circular. The four-lumen catheter according to any one of claims 1 to 5 , wherein the opening of the second lumen is formed such that an angle α between the opening surface of the opening and the axis of the catheter is 15 to 90 °. . The four-lumen catheter according to any one of claims 1 to 6 , 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. The four-lumen catheter according to any one of claims 1 to 7 , wherein a side hole that communicates with the first lumen is provided in a distal narrow portion of the first lumen.