JP4790366B2 - Extracorporeal circulation catheter - Google Patents

Description

  The present invention relates to an extracorporeal circulation catheter used for medical purposes, and more particularly, after removing blood temporarily from the coronary sinus to remove the contrast agent locally administered to the coronary artery from the blood. The present invention relates to an extracorporeal circulation catheter that can return blood to the body.

  Conventionally, when a stenosis or occlusion occurs in a blood vessel such as a blood vessel, or a blood vessel is occluded by a thrombus, the blood vessel that improves the blood flow on the peripheral side of the blood vessel by dilating the stenosis or occlusion site with a balloon catheter Plastic surgery (PTA: Percutaneous Transluminal Angioplasty, PTCA: Percutaneous Transluminal Coronary Angioplasty) has many surgical cases in many medical institutions, and it has become a common treatment for this type of disease.

  With the evolution of devices such as DCA (Directional Coronary Atomology) and rotor vibrators, atherectomy therapy is also performed to excise the atheroma via a catheter. In addition, stents that are indwelled in order to maintain the patency state of the expanded stenosis site or the occlusion site are often used. These PTCA, atherectomy therapy, stenting, and the like are collectively referred to as percutaneous coronary intervention (PCI). In recent years, due to improvements in the skill level of surgeons and device performance, highly difficult cases such as left main coronary artery (LMT) lesions and chronic total occlusion (CTO) lesions have become PCI indications.

  A contrast agent is an indispensable agent at the time of coronary angiography (CAG) and PCI, and is widely used. On the other hand, contrast agents are known to have side effects such as renal dysfunction, skin disorders, cardiovascular disorders, respiratory disorders, and urinary disorders. Therefore, attempts have been made to suppress the amount of contrast medium used as much as possible by using an injector or the like.

  However, the number of contrast enhancements increases in complicated cases with high difficulty such as LMT lesions and CTO lesions, and the amount of contrast agent used inevitably increases. In addition, a drug eluting stent (DES) that dramatically reduces the occurrence of restenosis after stent placement has been developed in recent years, and has a high therapeutic effect. In the current situation, more contrast agents are used in order to accurately grasp the lesion properties such as the above and to position the DES with respect to the lesion.

  In recent years, it has been reported that patients undergoing PCI often have diabetes mellitus, and renal dysfunction is a problem among side effects caused by contrast agents. In order to suppress such renal dysfunction called contrast-induced nephropathy, especially for patients with renal insufficiency, fluid replacement before and after PCI operation, administration of N-acetylcysteine, etc., and contrast medium by dialysis after PCI operation Removal has been attempted.

  Above all, dialysis was considered to be an effective means for removing contrast medium in blood, but reports have been made to question its effect. As presented in Non-Patent Document 1, in patients with chronic renal failure, the incidence of contrast-induced nephropathy in the group that did dialysis after using the contrast medium (dialysis group) and in the group that did not (non-dialysis group) There is no difference. It is suggested that the time from administration of the contrast medium to dialysis is long, and blood containing the contrast medium continues to circulate in the body during this period, causing renal dysfunction. Against this background, there is a need for a treatment system that reduces the burden on the kidney caused by contrast agents during PCI, and related techniques are disclosed.

  In Patent Document 1, a balloon catheter comprising an expandable balloon, and a catheter body having a catheter lumen extending from the proximal end portion to the distal end portion and a balloon lumen extending from the proximal end portion to the balloon, There is disclosed a balloon catheter characterized in that a plurality of apertures penetrating the catheter lumen from the tip of the balloon of the catheter body are provided.

  A schematic cross-sectional view of the heart is shown in FIG. This catheter was placed at the coronary sinus 016, and the balloon was expanded almost simultaneously with the administration of the contrast agent to the coronary artery to block the blood flow from the coronary sinus 016 to the right atrium 015, and was administered to the coronary artery. The purpose is to collect blood containing a contrast agent from the catheter lumen. The contrast medium in the collected blood is removed by adsorption or filtration, and the removed blood is returned to the body again, thereby reducing the load on the kidney caused by the contrast medium. However, this catheter has the following problems.

  First, it is difficult to dilate the balloon at the coronary sinus 016 and block the blood flow to the right atrium 015. The coronary artery becomes an arteriole and circulates through the capillaries to the venule. Several venules join together to form a large heart vein, middle heart vein, small heart vein, etc., and together with the remaining venules join together into the coronary sinus and flow into the right atrium. Thus, a very large number of veins flow into the coronary sinus, and the inflow site covers a wide area up to the vicinity of the coronary sinus 016. That is, when the balloon is expanded inside the coronary sinus, the blood flow from the venule that merges in the vicinity of the coronary sinus opening 016 flows into the right atrium 015 without being blocked, and is introduced into the catheter lumen. It will be difficult to do.

  Also, the wall of the coronary sinus is very thin, and balloon expansion can cause wall damage and perforation. When injury or perforation occurs, blood flows out between the heart and the pericardium, increasing the risk of causing serious illnesses such as cardiac tamponade.

  On the other hand, it is extremely difficult to place the balloon accurately at a position that reliably covers the coronary sinus ostium 016 and to place the balloon in a fixed manner because of the influence of the heartbeat. Therefore, in the case of the balloon catheter according to the prior art, it becomes difficult to block the blood flow from the coronary sinus to the right atrium 015 and introduce it into the catheter lumen. As a result, the contrast agent administered to the coronary artery The recovery rate is low.

Furthermore, when blood containing a contrast medium administered to a coronary artery by such a catheter is removed during PCI, the catheter insertion site, the blood that has been removed, and the blood used for PCI are also used. It is necessary to introduce a blood access device such as a sheath introducer or an indwelling needle in at least three locations including the portion into which the insertion catheter is inserted. Thus, since the number of blood access devices introduced is larger than that of normal PCI, the degree of invasiveness to patients is also a problem.
Coronary Intervention, vol. 2, no. 4,2003,78-83 JP 7-303701 A

  Therefore, in view of the above problems, the present invention intends to solve the problem that blood flowing into the coronary sinus from the coronary artery via the coronary vein can be efficiently drained outside the body and used in the conventional PCI. It is an object of the present invention to provide an extracorporeal circulation catheter capable of reducing the number of introductions of blood access devices as much as possible and further reducing the burden on the patient, while maintaining the same operability as the catheters used.

  As a result of repeated studies to solve the above-mentioned problems, the distal end has a distal end and a rear end, the distal end is disposed in the coronary sinus of the heart, and blood is drained out of the body from the distal end and then returned to the body. A catheter for extracorporeal circulation, wherein the catheter has a blood removal lumen extending from the distal end to the rear end, and a blood return lumen extending from the rear end of the catheter to the distal end side of a predetermined length. The inventors have invented an extracorporeal circulation catheter.

  When the minimum cross-sectional area in the circumferential direction of the blood removal lumen is S1 and the immersion side length is L1, when D1 is an equivalent diameter defined by (4 × S1) / L1, D1 is 1.80 mm or more. When the minimum diameter in the circumferential direction of the blood return lumen is S2 and the immersion edge length is L2, D2 is 1.30 mm when the equivalent diameter defined by (4 × S2) / L2 is D2. As mentioned above, it is preferable that it is 2.00 mm or less.

  It is preferable that a side hole is provided on the distal end side of the extracorporeal circulation catheter, the side holes are preferably 2 or more and 10 or less, and the number of side holes existing on the same circumference is 1. preferable.

  Further, the side holes are preferably arranged in a spiral shape, and when the cross-sectional area of the side holes is S3 and the immersion side length is L3, the equivalent diameter defined by (4 × S3) / L3 is D3. In this case, D3 is preferably 1.80 mm or more.

  It is preferable that the extracorporeal circulation catheter is configured by a combination of a composite tube in which a metal and a resin are combined and a resin tube, and it is more preferable that the distal end side is configured by a resin tube.

  The resin preferably includes an elastomer having a Shore hardness of 25D or more and 75D or less or a blend of the elastomers, and the elastomer is more preferably a polyamide-based elastomer. Moreover, it is preferable that a radiopaque substance is mixed in the resin.

  It is preferable that a hydrophilic coating is applied to the outer surface of the extracorporeal circulation catheter.

  It is preferable to have a sub-catheter removably attached to the blood removal lumen, and it is more preferable that the sub-catheter is composed of a flexible resin tube.

  The resin is preferably either high-density polyethylene or low-density polyethylene, or the resin is polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / At least one selected from the group consisting of hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), and polychlorotrifluoroethylene (PCTFE) Preferably, the resin is a polyamide-based elastomer. More preferably, the resin is mixed with a radiopaque material.

  The resin tube is preferably provided with a radiopaque marker.

  A tip for suppressing coronary sinus damage is preferably attached to the distal end of the extracorporeal circulation catheter, and a tip for suppressing coronary sinus damage is attached to the distal end of the sub-catheter. It is preferable.

  It is preferable that the chip is made of a resin, and the resin has an Shore hardness of 25D or more and 40D or less, or a blend of the elastomer, and the resin further contains a radiopaque material. preferable.

  The present invention also relates to a method for operating an extracorporeal circulation catheter, wherein the catheter has a distal end and a rear end, and the catheter has a blood removal lumen extending from the front end to the rear end; A blood return lumen extending from the rear end of the catheter to the distal end side of a predetermined length, and blood is removed from the patient body from the distal end of the blood removal lumen disposed in the coronary sinus of the patient heart. Providing an operating method comprising returning the blood from the blood return lumen disposed within the patient body into the patient body.

  In this case, when the minimum cross-sectional area in the circumferential direction of the blood removal lumen is S1 and the immersion side length is L1, when D1 is an equivalent diameter defined by (4 × S1) / L1, D1 is 1. When the equivalent diameter defined by (4 × S2) / L2 is D2 where S2 is the minimum circumferential cross-sectional area of the blood return lumen and S2 and the immersion side length is L2, D2 is It is preferable that it is 1.30 mm or more and 2.00 mm or less.

  According to the present invention, blood flowing from the coronary artery into the coronary sinus via the coronary vein can be efficiently removed from the body. A drug such as a contrast agent administered to the coronary artery can be removed by extracorporeal circulation therapy such as adsorption and filtration, and diseases such as renal dysfunction such as contrast-induced nephropathy are effectively suppressed. In addition, the usability of the extracorporeal circulation catheter according to the present invention is not different from the catheters used in the conventional PCI, and therefore it is possible to safely remove blood outside the body without excessively extending the operation time. . Furthermore, it is not necessary to provide a separate blood access for returning the blood that has been removed, and the burden on the patient can be further reduced.

  Hereinafter, various embodiments of a blood removal catheter according to the present invention will be described in detail with reference to the drawings.

  As shown in FIG. 1, the catheter according to the present invention has a distal end and a rear end, and the distal end is disposed in the coronary sinus of the heart. After the blood is drained from the distal end to the outside of the body, the catheter is returned to the body. An extracorporeal circulation catheter capable of blooding, the catheter having a blood removal lumen extending from the distal end to the rear end, and a blood return lumen extending from the rear end of the catheter to the distal end side for a predetermined length It is characterized by.

  Since the extracorporeal circulation catheter according to the present invention has a blood removal lumen and a blood return lumen in one catheter, it is not necessary to separately provide a blood access for returning the blood after blood removal. Therefore, it is not necessary to provide a separate blood access, and the degree of invasiveness to the patient can be further reduced.

  On the other hand, since the outer diameter of the extracorporeal circulation catheter increases by providing a blood removal lumen and a blood return lumen in one catheter, the number of blood accesses decreases, but the degree of invasiveness to the patient increases as the outer diameter increases. There is concern.

  In the extracorporeal circulation catheter according to the present invention, the blood return lumen extends from the rear end of the extracorporeal circulation catheter to a distal end side of a predetermined length, and does not reach the distal end of the catheter. With this structure, an increase in the outer diameter of the catheter due to the addition of a blood return lumen can be suppressed. The total length (predetermined length) of the blood return lumen is preferably as short as possible as long as the tip of the blood return lumen can be inserted into the body. The total length of the blood return lumen (predetermined length) varies depending on the shape of the hub and the effective length of the extracorporeal circulation catheter (the length of the portion inserted into the body), but is preferably 100 or more and 700 mm or less.

  The extracorporeal circulation catheter according to the present invention has an equivalent diameter defined by (4 × S1) / L1 when D1 is defined as (4 × S1) / L1 when the circumferential cross-sectional area of the blood removal lumen is S1 and the immersion side length is L1. In addition, when D1 is 1.80 mm or more, the minimum cross-sectional area in the circumferential direction of the blood return lumen is S2, and the immersion edge length is L2, the equivalent diameter defined by (4 × S2) / L2 is D2. In this case, D2 is 1.30 mm or more and 2.00 mm or less.

  The circumferential minimum cross-section here refers to the cross-sectional area that is the smallest in the length direction of the extracorporeal circulation catheter among the exsanguination lumen extending to the extracorporeal circulation catheter or the circumferential cross-section area of the return blood lumen. Point to.

  The circumferential cross-sectional area is measured by cutting the extracorporeal circulation catheter in the circumferential direction and magnifying and observing the blood removal lumen or the blood return lumen on the cut surface with a micro high scope or the like. The minimum value obtained by performing the same measurement at a plurality of locations in the length direction of the extracorporeal circulation catheter is the circumferential minimum sectional area. The more measurement points in the length direction, the higher the accuracy of the minimum cross-sectional area in the circumferential direction. The evaluation value of the circumferential minimum cross-sectional area referred to in this specification is a value determined by evaluating every 10 mm in length.

  The term “immersion side length” as used herein refers to the total length of the perimeters that define each lumen in the circumferential cross section of the blood removal lumen extending to the extracorporeal circulation catheter or the blood return lumen. For example, when the blood removal lumen is a circle with a diameter R, the immersion side length is π × R. When the blood removal lumen has a donut shape defined by a circle having a diameter R and a circle having a diameter r (R> r) arranged concentrically, the immersion length is π × (R + r).

  The extracorporeal circulation catheter is cut in the circumferential direction, and the infiltration length is measured by magnifying the blood removal lumen or the blood return lumen on the cut surface with a micro high scope or the like.

The behavior when blood is deflated and returned via a catheter can be predicted hydrodynamically. When a fluid such as blood flows in a tube such as a catheter for extracorporeal circulation, the Reynolds number Re, which is a dimensionless amount representing the flow in the tube, is expressed as in Equation 1. Here, the circumferential minimum cross-sectional area of the blood removal lumen is S1, the blood flow velocity in the blood removal lumen is U1, the immersion side length is L1, the equivalent diameter is D1, the blood density is ρ, and the blood viscosity is μ. To do.
(Expression 1) Re = (D1 × U1 × ρ) / μ = [(4 × S1) / L1] × (ρ / μ)
Similarly, if the minimum cross-sectional area in the circumferential direction of the blood return lumen is S2, the blood flow velocity in the blood return lumen is U2, the immersion side length is L2, and the equivalent diameter is D2, the Reynolds number Re is expressed as shown in Equation 2. The
(Expression 2) Re = (D2 × U2 × ρ) / μ = [(4 × S2) / L2] × (ρ / μ)
It is known that when the Reynolds number is less than 2,100, it becomes laminar flow, and when it exceeds 4,000, it becomes turbulent flow. Assuming that the minimum cross-sectional shape in the circumferential direction of the blood removal lumen or the blood change lumen is a circle having a diameter of 3 mm, the Reynolds number is on the order of several tens. Therefore, the blood flow in the blood removal lumen and the return lumen is considered laminar.

For the laminar flow in the tube, the Hagen-Poiseuille equation shown in Equation 3 holds. Here, the equivalent diameter of the blood removal lumen is D1, the length of the blood removal lumen is Lu1, the absolute value of the pressure difference applied during blood removal (hereinafter referred to as blood removal pressure) is ΔP1, and the blood removal amount is Q1. The blood removal pressure in the present invention is a pressure difference P1− when the pressure when the blood removal amount is 0 mL / min is P0 mmHg, and the pressure when the blood removal amount is Q1 mL / min (Q1> 0) is P1 mmHg. This is the absolute value of P0.
(Formula 3) Q1 = [π × (D1 / 2) ^ 4 × ΔP1] / (8 × μ × Lu1)
Similarly, when the equivalent diameter of the blood return lumen is D2, the length of the blood return lumen is Lu2, the absolute value of the pressure difference (hereinafter referred to as return blood pressure) applied during blood return is ΔP2, and the blood removal amount is Q2. 4 is established. The return blood pressure in the present invention is a pressure difference P2- when the pressure when the return amount is 0 mL / min is P0 mmHg, and the pressure when the return amount is Q2 mL / min (Q2> 0) is P2 mmHg. This is the absolute value of P0. Regarding the blood removal amount and the blood return amount, Equation 5 is established from a continuous equation.
(Expression 4) Q2 = [π × (D2 / 2) ^ 4 × ΔP2] / (8 × μ × Lu2)
(Formula 5) Q1 = Q2
To remove blood containing a contrast medium administered to the coronary artery from the coronary sinus and return the blood from which the contrast medium has been removed by extracorporeal circulation therapy such as adsorption, to remove the contrast medium efficiently. For this, a higher blood removal amount is preferable. The adsorption efficiency is higher when the blood removal amount is lower, but if the blood removal amount is too low, it becomes difficult to remove all blood flowing from the coronary artery into the coronary sinus, resulting in a higher contrast agent removal efficiency. Lower. Accordingly, the blood removal amount is preferably at least 25 mL / min or more, more preferably 50 mL / min or more. More preferably, it is 80 mL / min or more. As a method for increasing the blood removal amount, there are a method for increasing blood removal pressure using a means such as a pump or a syringe, or a method for increasing the equivalent diameter of the blood removal lumen. With increasing blood removal volume, blood pressure becomes more negative. If the blood pressure is less than −200 mmHg, there is a very high possibility that the blood vessel may be crushed by negative pressure. Therefore, it is preferably −200 mmHg or more. From the viewpoint of preventing blood vessel flattening, the blood pressure removal is preferably −150 mmHg or more, more preferably −100 mmHg or more.

  In order for the blood removal amount to be 80 mL / min or more under the condition where the blood pressure is -100 mmHg or more, the equivalent diameter D1 of the blood removal lumen is preferably 1.80 mm or more. When D1 is less than 1.80 mm, it is difficult to stably obtain a blood removal amount of 80 mL / min or more under conditions where blood removal pressure is -100 mmHg or more. From the viewpoint of blood removal amount, D1 is preferably as large as possible. However, as D1 is large, the size of a blood access device such as a sheath introducer for inserting an extracorporeal circulation catheter is increased, and the degree of invasiveness to the patient is increased. Become. From such a viewpoint, D1 may be 3.00 mm or less.

  From formula 5, the blood return volume is preferably at least 25 mL / min or more, more preferably 50 mL / min or more. More preferably, it is 80 mL / min or more. As the amount of returned blood increases, the returned blood pressure becomes more positive. Since there is a high risk of hemolysis due to an increase in the return blood pressure, it is preferably 300 mmHg or less. More preferably, it is 200 mmHg or less, More preferably, it is 100 mmHg or less.

  In order to return blood pressure to less than 100 mmHg and to return blood to 80 mL / min or more, the equivalent diameter D2 of the blood return lumen is preferably 1.30 mm or more and 2.00 mm or less. When D2 is less than 1.30 mm, it is difficult to set the blood return rate to 80 mL / min or more. On the other hand, when D2 exceeds 2.00 mm, the outer diameter of the extracorporeal circulation catheter is remarkably increased and the degree of invasiveness to the patient is increased, which is not preferable.

  As described above, the extracorporeal circulation catheter according to the present invention is characterized by having both a blood removal lumen and a blood return lumen in one catheter, but the structure for providing these lumens is limited. Not. That is, as shown in FIGS. 2 and 3, a structure in which an outer tube is arranged in a double tubular shape outside the braided tube, a structure in which the braided tube is biaxial as shown in FIG. 4, and a braided tube as shown in FIG. The structure etc. which arrange | position an outer tube in parallel on the outer side, and fix with a covering tube are mentioned. In particular, in the case of the structure shown in FIGS. 2 and 3, in order to stably secure the blood removal amount, the lumen defined by the outer surface of the braided tube and the inner surface of the outer tube is defined as the blood removal lumen, and is defined by the inner surface of the braided tube. The lumen to be returned is preferably a blood return lumen.

  As shown in FIG. 8, it is preferable that a side hole is provided at the distal end side of the extracorporeal circulation catheter, preferably at the site inserted into the coronary sinus. When an extracorporeal circulation catheter is inserted and placed in a site surrounded by a very thin wall such as a coronary sinus, blood removal may cause the distal end of the catheter to be in close contact with the surrounding wall is there. Such close contact not only does not achieve the necessary blood removal volume, but also increases the risk of damage to surrounding walls and perforation. By setting the equivalent diameter of the catheter tip to 1.80 mm or more, the possibility of being in close contact with the surrounding wall is reduced. However, the provision of the side hole is preferable because the possibility is further reduced.

  In order to more effectively prevent close contact with the surrounding wall, it is preferable that there are two or more side holes. By providing a plurality of side holes, the safety of blood removal is further enhanced.

  On the other hand, since the intensity | strength of the part with which the side hole was equipped falls by the increase in the number of side holes, it is preferable that there are 10 or less side holes. Further, by providing the side hole, the flexibility of the extracorporeal circulation catheter in the portion is improved, but the kink resistance is lowered. Therefore, in order to maximize the merit of providing the side hole without causing kinking to the extracorporeal circulation catheter, the number of side holes existing on the same circumference is preferably one. Increasing the number of side holes on the same circumference is not preferable because the risk of kinking and further tearing of the extracorporeal circulation catheter increases.

  It is preferable that one or less patterns on which the side holes are arranged exist on the same circumference. That is, a pattern in which a plurality of side holes are arranged in a straight line in the axial direction, a pattern arranged in a spiral shape as shown in FIG. From the viewpoint of preventing close contact with the wall around the coronary sinus, it is preferably arranged in a spiral shape. Here, the number of side holes per unit helix, the inclination of the helix, and the like can be designed according to the dimensions of the extracorporeal circulation catheter and the shape of the distal end portion.

  The equivalent diameter D3 of the side hole is preferably 1.80 mm or more. When D3 is smaller than 1.80 mm, it is difficult to secure a blood removal amount of 80 mL / min or more under the condition that the blood pressure is -100 mmHg or more. From the viewpoint of the blood removal amount, D3 is preferably as large as possible, but when D3 is larger than D1, the strength of the portion where the side hole exists is significantly reduced. From such a viewpoint, D3 may be 3.00 mm or less.

  The shape of the side hole does not hinder the effect of the present invention, and it can be formed into an arbitrary shape in consideration of the flexibility, strength, etc. of the extracorporeal circulation catheter. That is, the shape may be a circle (FIG. 9), an ellipse (FIG. 10), a rectangle, or the like. In the case of an oval shape, the major axis direction may be the axial direction of the blood removal catheter or the circumferential direction. In the case of a rectangle, the long side direction may be the axial direction of the blood removal catheter or the circumferential direction. Furthermore, it is not necessary for all the side hole shapes to be the same shape, and shapes such as a circle, an ellipse, and a rectangle may be combined. Considering the ease of processing and the deformability of the side hole shape when the blood removal catheter is bent, the side hole shape is preferably circular or elliptical.

  The method for providing side holes does not limit the effects of the present invention. Laser processing with a YAG laser, excimer laser, femtosecond laser, etc., cutting with a punch, etc. are preferably used. Surface processing such as heat treatment or polishing treatment may be performed after the processing.

  The extracorporeal circulation catheter according to the present invention is used at the time of PCI, and is introduced percutaneously into the coronary sinus from the thigh, neck, arm, etc., so an effective length of 500 mm or more is preferable, and an effective length of 800 mm or more is preferable. Is more preferable. In order to introduce an extracorporeal circulation catheter having a relatively long effective length into the coronary sinus in this way, it is necessary to apply torque and perform operations such as rotation and pushing. Therefore, torque transmission is required for the extracorporeal circulation catheter according to the present invention. In addition, flexibility is required for introduction into the coronary sinus via a flexible and bent blood vessel.

  In order to realize a stable blood removal amount, even when an extracorporeal circulation catheter is placed at the bent portion of the coronary sinus, the catheter does not kink and a sufficient blood removal lumen must be secured. Furthermore, it is important to secure a return lumen to achieve a stable return volume. Therefore, the catheter is required to have sufficient kink resistance. As mentioned above, it is preferable that the blood removal catheter according to the present invention is constituted by a combination of a braided tube in which a metal and a resin are combined, and a resin tube. By using a braided tube, torque transmission, kink resistance, and flexibility are secured at the same time. The method of combination is not particularly limited, but from the viewpoint of making the distal end side flexible and the rear end side rigid, it is preferable to dispose a resin tube on the distal end side and a braided tube on the rear end side.

  The extracorporeal catheter is introduced into the coronary sinus via the vein. Since the vein has a thinner wall than the artery, it is preferable that the distal end side of the extracorporeal circulation catheter is composed of a resin tube. By using a resin tube on the distal end side, the flexibility is greatly improved as compared with the case where the entire extracorporeal circulation catheter is made of a braided tube, and it can be safely introduced into the coronary sinus. The length of the resin tube provided on the distal end side is selected according to the shape of the coronary sinus, but is preferably 50 mm or more and 200 mm or less. When the length is shorter than 50 mm, sufficient flexibility is not exhibited, which increases the risk of damaging the coronary sinus and is not preferable. On the other hand, when the length is longer than 200 mm, the torque transmission to the distal end side of the catheter becomes insufficient, and insertion into the coronary sinus becomes difficult.

  Further, in order to facilitate introduction into the coronary sinus, the distal end side of the blood removal catheter may be processed into an arbitrary shape in advance as shown in FIG. Although FIG. 6 shows an example in which three bent shapes are provided, the number and shape of the bends are not limited. Moreover, although the example of FIG. 6 gives the bending shape on the same plane, as shown in FIG. 7, you may show a bending shape so that it may cover not only the same plane but several planes.

  The bending shape imparting method does not limit the effect of the present invention, and any processing method can be used. As a preferred example, there is a method in which a core material for maintaining the shape of the blood removal lumen is inserted and a desired bent shape is given and the shape is memorized by heat treatment.

  The resin constituting the braided tube or the resin constituting the resin tube preferably contains an elastomer having a Shore hardness of 25D or more and 75D or less or a blend of the elastomers. Use of an elastomer makes it easy to achieve both strength and flexibility. In particular, in the case of a braided tube, flexibility can be easily realized by using the elastomer or a blend of the elastomer on the outer surface.

  When using only an elastomer having a Shore hardness lower than 25D, it is difficult to maintain the strength, which is not preferable. Moreover, when only an elastomer larger than 75D is used, the flexibility becomes low, which is not preferable. The elastomer may be blended in any ratio to achieve the desired strength and flexibility. The resin used for the braided tube and the resin tube may be the same elastomer or different elastomers, but it is preferable to use different elastomers in order to easily control the physical properties of the blood removal catheter. Further, it is not necessary to use the same resin over the entire length of the braided tube or the resin tube, and a plurality of resins may be used to incline the physical properties in the length direction of the tube. As a preferred example, the resin used for the braided tube has a Shore hardness of 40D or more and 75D or less, and the resin used for the resin tube has a Shore hardness of 25D or more and 63D or less.

  Here, in consideration of processability and the like, the elastomer is preferably a polyamide-based elastomer.

The Shore hardness referred to in this specification is a value measured by ISO868. When the elastomer is a polyetheresteramide elastomer, it can be said that the Shore D hardness of the polyetheresteramide elastomer material is proportional to the hard segment weight ratio of the polyetheresteramide elastomer material. The weight ratio of the hard segment was determined by measuring the weight of the polyamide portion, the weight of the ester portion, and the weight of the polyether portion by H ¹ -NMR, and the weight of the polyamide portion / (weight of the polyamide portion + weight of the ester portion + The shore hardness can be calculated by comparing the weight ratio of the hard segment with that of the standard product.

  The production method of the braided tube and the resin tube does not limit the effect of the present invention. In the case of the braided tube, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer Metal wire is braided or coiled on the outer surface of the tube with a fluorine resin such as coalescence (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), or a polyamide-based elastomer. It can be made by coating the outer surface with the elastomer or blend of elastomers. A stainless steel alloy, cobalt-chromium alloy, nickel-titanium alloy or the like can be used as the material of the metal element wire or coil, and the cross-sectional shape thereof may be any shape such as a circle, an ellipse, and a rectangle. The resin tube can be produced by an extrusion molding method, a dipping method, a wire coating method, or the like.

  The extracorporeal circulation catheter is introduced into the coronary sinus under fluoroscopy. Therefore, it is preferable that the extracorporeal circulation catheter has radiopacity. As a method of providing radiopacity, a method of providing a marker made of a material having radiopacity on the outer or inner surface of a catheter for extracorporeal circulation, an alloy containing a noble metal in a metal strand constituting the braided tube A method of mixing an X-ray-impermeable substance with the resin constituting at least one of the braided tube and the resin tube, etc., but the viewpoint of keeping the flexibility of the extracorporeal circulation catheter as high as possible A method of mixing an X-ray impermeable substance with a resin constituting at least one of the braided tube and the resin tube, and an X-ray impermeable material on the outer or inner surface of the extracorporeal circulation catheter A method of providing a marker is preferred. When the marker is provided, the number of markers provided is not limited. One may be provided only at the distal end of the blood removal catheter (FIG. 11), or may be provided around the side hole (FIG. 12).

  As a method of mixing the X-ray opaque material with the resin, a pellet of the resin kneaded with the X-ray opaque material is prepared in advance, the method using the pellet, the braided tube and / or the resin There is a method of mixing a resin and a radiopaque material when producing a tube, and any method may be used.

  The type of the radiopaque material is not particularly limited, and metal compounds such as barium and bismuth, and noble metal compounds such as gold and platinum are preferably used, but barium is used from the viewpoint of adaptability to the manufacturing method described above. Particularly preferred are oxides such as bismuth.

  The content of the radiopaque substance is preferably as high as possible within a range that does not greatly impair the physical properties of the resin and can be molded. When the barium or bismuth oxide described above is used, the amount is preferably 30% by weight or more.

  In order to improve the operability when introducing the extracorporeal circulation catheter into the coronary sinus and reduce the risk of damage accompanying the introduction, it is preferable that the outer surface of the catheter is provided with a hydrophilic coating. . It is possible to reduce the frictional resistance when introduced into the living body lumen by the hydrophilic coating. The kind of coating material is not limited and can be selected according to the physical properties of the braided tube or resin tube to be used. For example, hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyacrylamide, and polyvinylpyrrolidone can be used. You may adjust so that frictional resistance may be increased / decreased gradually by adjusting the kind of coating material and coating thickness in the length direction of this catheter.

  The extracorporeal circulation catheter may be guided over a guide wire for easier introduction into the coronary sinus. In this case, similarly to the case where the guide catheter is engaged with the coronary artery entrance during PCI, the guide catheter is inserted into the body with the guide wire disposed inside the extracorporeal circulation catheter. A lumen for inserting a guide wire independent of the blood removal lumen (guide wire lumen) may be provided inside the extracorporeal circulation catheter, but the guide wire is maintained without changing the equivalent diameter of the blood removal lumen in order to maintain the blood removal amount. Providing a lumen is not preferable because the outer diameter of the extracorporeal circulation catheter inevitably increases. Therefore, it is preferable to use a blood removal lumen as a guide wire lumen.

  When the guide wire is inserted from the hub of the extracorporeal circulation catheter according to the present invention, particularly when the distal end of the guide wire has a J-shaped curve, as shown in FIG. 13, from the side hole provided in the extracorporeal circulation catheter. The tip of the guide wire pops out, and the guide wire cannot be easily guided. In addition, when the guide wire is inserted into the extracorporeal circulation catheter once introduced into the living body lumen and the tip of the guide wire jumps out of the side hole as shown in FIG. 13, the guide wire is operated under fluoroscopy. The guide wire tip must be adjusted so that it comes out from the tip of the blood removal catheter. It is very time consuming to perform such adjustment under fluoroscopy, which not only increases the operator's stress but also increases the burden on the patient. Further, when the operation is continued without noticing that the guide wire is protruding from the side hole under fluoroscopy, there is a possibility that the extracorporeal circulation catheter may be broken due to the breakage of the side hole portion.

  From the above, as shown in FIG. 15, it is preferable to have a sub-catheter detachably attached to the blood removal lumen of the extracorporeal circulation catheter according to the present invention. As shown in FIG. 16, the use of the lumen of the sub-catheter as a guide wire lumen can prevent the guide wire from jumping out from the side hole of the extracorporeal circulation catheter. Placing the sub-catheter within the blood removal lumen reduces the circumferential minimum cross-sectional area of the blood removal lumen, but the sub-catheter is detachably attached. Blood loss can be maintained. If it is necessary to operate the blood removal catheter together with the guide wire after removing the sub catheter, the guide wire can be inserted after the sub catheter is placed in the blood removal lumen, allowing safe operation. It is.

  The sub-catheter shown in FIG. 14 is preferably made of a flexible tubular member, and preferably has a hub at the rear end. By comprising a flexible member, even when the blood removal catheter is provided with a bent shape, it can be easily detached. In addition, by providing a hub at the rear end, the inside of the sub-catheter can be flushed with physiological saline containing heparin or the like, and thrombus formation during use can be suppressed and used safely. The method for connecting the sub-catheter and the blood removal catheter is not limited, but as an example, as shown in FIGS. 14 and 15, the end of the hub is a male luer, thereby allowing the extracorporeal circulation. It is detachably connected to the rear end (female luer) of the hub provided at the rear end of the catheter.

  The tubular member is preferably composed of a resin tube, and the resin is either high-density polyethylene or low-density polyethylene, or polytetrafluoroethylene (PTFE), a tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer. (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), or polyamide-based It is preferable that it is either of these elastomers. By using any of the above-mentioned materials, it is possible to reduce not only the friction resistance when attaching / detaching the sub-catheter to the extracorporeal circulation catheter, but also the friction resistance between the sub-catheter and the guide wire, and good operability. Is feasible.

  Like the extracorporeal circulation catheter, the sub-catheter is preferably radiopaque. As a method for providing radiopacity, the subcatheter is made of a material having radiopacity on the outer surface or inner surface of the subcatheter from the viewpoint of maintaining the flexibility of the subcatheter as high as possible and realizing high radiopacity. A method of providing a marker to be used and a method of mixing a radiopaque substance with the resin constituting the sub-catheter are preferable.

  The material which comprises the said marker is not specifically limited, Noble metal compounds, such as metal compounds, such as barium and bismuth, gold | metal | money, platinum, are used suitably.

  As a method of mixing the radiopaque material with the resin, a pellet of the resin kneaded with the radiopaque material is prepared in advance, and the pellet is used. When the resin tube is manufactured There is a method of mixing a resin and a radiopaque material, and any method may be used.

  The kind of the radiopaque material mixed with the resin is not particularly limited, and metal compounds such as barium and bismuth, and noble metal compounds such as gold and platinum are preferably used. From the viewpoint of properties, oxides such as barium and bismuth are particularly preferable. Further, the content is preferably as high as possible within a range that does not greatly impair the physical properties of the resin and can be molded. When the barium or bismuth oxide described above is used, the amount is preferably 30% by weight or more.

  When the sub-catheter is attached to the extracorporeal circulation catheter, the relative positions of the catheters do not limit the effects of the present invention. That is, the distal end of the sub-catheter may be disposed on the distal end side with respect to the distal end of the blood removal catheter, or may be disposed on the rear end side with respect to the distal end of the extracorporeal circulation catheter. In any arrangement state, in order to prevent damage to the coronary sinus where the extracorporeal circulation catheter is arranged, it is preferable that a tip is provided at the most distal portion of the extracorporeal circulation catheter.

  Furthermore, when the distal end of the sub-catheter is disposed closer to the distal end than the distal end of the extracorporeal circulation catheter, it is preferable that the tip is provided at the distal end of the sub-catheter. Further, when the tip of the sub-catheter is disposed on the rear end side of the tip of the extracorporeal circulation catheter, it is preferable that the tip is provided at the tip of the extracorporeal circulation catheter. Thus, by providing the tip at the most distal portion with the sub-catheter and the extracorporeal circulation catheter attached, damage to the coronary sinus is suppressed.

  Since the tip is for suppressing damage to the coronary sinus as described above, it is preferable that the tip is flexible. That is, the chip is preferably made of a resin, and the resin has an Shore hardness of 25D or more and 40D or less, or a blend of the elastomers. When using only an elastomer having a Shore hardness lower than 25D, it is difficult to maintain the strength, which is not preferable. Moreover, when only an elastomer larger than 40D is used, flexibility is lowered, which is not preferable. The elastomer may be blended in any ratio to achieve the desired strength and flexibility. It is not necessary to use the same resin over the entire length of the chip, and a plurality of resins may be used to incline physical properties in the length direction of the chip.

  Since the tip is the most distal portion in a state where the sub-catheter and the extracorporeal circulation catheter are attached, it is necessary to accurately grasp the position under X-ray fluoroscopy. Therefore, it is preferable that a radiopaque material is mixed in the resin constituting the chip.

  As a method of mixing the radiopaque material with the resin, a pellet of the resin kneaded with the radiopaque material is prepared in advance, and the pellet is used. When the resin tube is manufactured There is a method of mixing a resin and a radiopaque material, and any method may be used.

  The kind of the radiopaque material mixed with the resin is not particularly limited, and metal compounds such as barium and bismuth, and noble metal compounds such as gold and platinum are preferably used. From the viewpoint of properties, oxides such as barium and bismuth are particularly preferable. Further, the content is preferably as high as possible within a range that does not greatly impair the physical properties of the resin and can be molded. When the barium or bismuth oxide described above is used, the amount is preferably 30% by weight or more.

  The method for producing an extracorporeal circulation catheter and sub-catheter according to the present invention does not limit the effects of the present invention. A typical structure of a blood removal catheter is shown in FIGS. 1 and 6 to 8. A tip and a resin tube, a resin tube and a braided tube, a braided tube and a hub are connected, and the braided tube and the hub are connected. A strain relief for preventing kinking or the like during use of the catheter is connected to the connecting portion. Further, a typical structure of the sub-catheter is shown in FIG. 14. A tip and a resin tube, a resin tube and a hub are connected, and a kink or the like at the time of catheter use is connected to a connection portion of the resin tube and the hub. A strain relief is connected to prevent it.

  The connection method in each connection part is not specifically limited, Methods, such as adhesion | attachment using an adhesive agent and heat welding, can be used.

  In the case of adhesion, the type of adhesive to be used is not limited, and cyanoacrylate, urethane, silicone, epoxy, and other adhesives can be suitably used. The effect type of the adhesive is not limited, and adhesives such as a two-component mixed type, a water absorption curable type, a heat curable type, and a UV curable type can be suitably used. It is preferable to use an adhesive having a hardness after curing such that the rigidity of the connection part does not change discontinuously before and after the connection part. The adhesive should be used in consideration of the material, dimensions, rigidity, etc. of the material to be bonded. You can choose. In order to reduce the diameter of the connection part, heat treatment, polishing treatment, etc. may be carried out before and after bonding. In the case of difficult-to-adhere materials such as polyolefin, surface treatment such as plasma treatment using oxygen gas or the like is performed. You may carry out.

  The material constituting the hub is not particularly limited, and a general-purpose resin that can be injection-molded is preferably used. Examples include polycarbonate, polyamide, polyurethane, polysulfone, polyarylate, styrene-butadiene copolymer, polyolefin and the like.

Specific examples according to the present invention are described in detail below, but the present invention is not limited to the following examples.
Example 1
A braided tube with an outer diameter of 2.69 mm, an inner diameter of 2.29 mm, and a length of 900 mm is produced using a metal braid made from SUS304 alloy and processed by holding a single 0.10 mm x 0.03 mm metal wire with 16 strokes. did. The inner layer is polytetrafluoroethylene (Polyflon F-207, Daikin Industries, Ltd.), and the outer layer is four types of polyamide elastomers (PEBAX7233SA01 (Shore hardness 72D), PEBAX6333SA01) containing barium sulfate at 40 wt% by a biaxial mixed extrusion method. (Shore Hardness 63D), PEBAX5533SA01 (Shore Hardness 55D), PEBAX4033SA01 (Shore Hardness 40D), and Elf Atochem Co.) were used for the switching extrusion method.

  Using a polyamide elastomer (PEBAX4033SA01 (Shore hardness 40D) elfatchem) containing barium sulfate at 40 wt% by a twin-screw continuous extrusion method, a tube having an outer diameter of 3.00 mm, an inner diameter of 2.25 mm, and a length of 150 mm is extruded. It was produced by molding. A pre-shaped SUS304 alloy core material with an outer diameter of 2.20 mm was inserted into the produced tube. A resin tube was prepared by heating in an oven at 180 ° C. for 45 minutes with a polyolefin heat-shrinkable tube covered and subjected to shaping as shown in FIG. In addition, a 5 mm long tip made of a polyamide elastomer (PEBAX3533SA01 (Shore hardness 35D) elfatchem) containing barium sulfate at 40 wt% was thermally welded to the tip of a resin tube by a biaxial mixed extrusion method.

  The braided tube and the resin tube were connected by heat welding to form a shaft. A braided tube with an outer diameter of 4.40 mm, an inner diameter of 4.00 mm, and a length of 100 mm is produced using a metal braid made of SUS304 alloy and processed by holding a single 0.10 mm x 0.03 mm metal wire with 16 strokes. did. The inner layer is polytetrafluoroethylene (Polyflon F-207, Daikin Industries, Ltd.), and the outer layer is a polyamide elastomer (PEBAX7233SA01 (Shore hardness 72D), elf atchem) containing 40 wt% of barium sulfate by the biaxial mixed extrusion method. Was produced by a switching extrusion method to obtain an outer tube. The outer tube was arranged in the form of a double tube outside the shaft, and the end of the outer tube protruded 10 mm from the end of the shaft on the side where the braided tube was connected. In this state, both ends of the outer tube and the braided tube were bonded with a two-component mixed urethane adhesive (UR0531, HB Fuller) to obtain a cross-sectional structure shown in FIG.

  A two-component mixed urethane-based adhesive (UR0531, a hub made of a strain relief made of polyamide elastomer (PEBAX5533SA01, elf atchem) and a hub made of polycarbonate (Makloron 2658, Bayer) at the end of the braided tube protruding 10 mm from the end of the shaft. H. B. Fuller) was used as an extracorporeal circulation catheter.

In Example 1, D1 is 2.25 mm and D2 is 1.31 mm.
(Example 2)
Using an excimer laser, an extracorporeal circulation catheter was prepared in the same manner as in Example 1 except that two circular side holes with a diameter of 1.85 mm were provided on the distal end side of the resin tube and the total length of the outer tube was 300 mm. . The phase difference between the side holes was 180 °, and the distance between the side holes in the length direction was 40 mm. An extracorporeal circulation catheter was prepared in the same manner as in Example 1 using the obtained braided tube and resin tube.

  A resin tube having an outer diameter of 1.60 mm, an inner diameter of 1.10 mm, and a length of 1,050 mm was produced by extrusion molding using low density polyethylene (LF480M, Nippon Polychem Co., Ltd.), and polycarbonate (Makloron 2658, Bayer) at one end. The hub produced in (1) was bonded with a two-component mixed urethane adhesive (UR0531, HB Fuller) to produce a sub-catheter. Prior to bonding, oxygen plasma treatment was performed.

In Example 2, D1 is 2.25 mm, D2 is 1.31 mm, and D3 is 1.85 mm.
(Example 3)
The outer diameter of the tip tube was 2.60 mm, the inner diameter was 1.80 mm, and the outer diameter of the core material used for shaping was 1.75 mm. Further, an extracorporeal circulation catheter was prepared in the same manner as in Example 2 except that the side hole diameter was 1.80 mm. The sub-catheter was produced in the same manner as in Example 2.

In Example 3, D1 is 1.80 mm, D2 is 1.31 mm, and D3 is 1.80 mm.
Example 4
The number of side holes provided in the tip tube was 10, the phase difference was 90 °, and the distance between the side holes in the length direction was 5 mm. Further, an extracorporeal circulation catheter was prepared in the same manner as in Example 2 except that the outer tube had an outer diameter of 5.00 mm, an inner diameter of 4.65 mm, and a length of 500 mm. The sub-catheter was produced in the same manner as in Example 2.

In Example 4, D1 is 2.25 mm, D2 is 1.96 mm, and D3 is 1.85 mm.
(Example 5)
A catheter for extracorporeal circulation was prepared in the same manner as in Example 2 except that a side hole having a diameter of 1.30 mm was provided, and the dimensions of the outer tube were an outer diameter of 4.00 mm, an inner diameter of 3.60 mm and a length of 300 mm. The sub-catheter was produced in the same manner as in Example 2.

In Example 5, D1 is 1.80 mm, D2 is 0.91 mm, and D3 is 1.30 mm.
(Evaluation)
A 15 Fr sheath introducer inserted into the right femoral vein under inhalation anesthesia was inserted into an LWD pig (body weight 57.7 kg). A blood removal catheter was placed in the coronary sinus under fluoroscopy. In both examples, a 0.035 "guide wire was used in combination. In Examples 2 to 4 and 5, the sub-catheter was placed in the coronary sinus in combination with the extracorporeal circulation catheter, and after placement The sub-catheter was removed.

Extension tubes with a length of 500 mm were connected to the blood removal lumen and blood return lumen of the extracorporeal circulation catheter, respectively, and blood removal and blood return were performed using the extracorporeal circulation device DX21 (Kaneka Corporation).
(result)
Any of Examples 1 to 4 and Example 5 according to the present invention could be placed in the coronary sinus. Further, in Examples 2 to 4 and Example 5, the guide wire did not jump out from the side hole of the blood removal catheter due to the effect of the sub-catheter, and it was possible to perform a satisfactory operation.

  In any of Examples 1 to 4, blood removal at 80 mL / min was possible, and blood return was possible without an extreme increase in blood pressure return. The blood pressure removal was -85 mmHg in Example 1, -86 mmHg in Example 2, -95 mmHg in Example 3, and -83 mmHg in Example 4. The return blood pressure was 50 mmHg in Example 1, 140 mmHg in Example 2, 137 mmHg in Example 3, and 46 mHg in Example 4. No hemolysis was observed during extracorporeal circulation. By using the extracorporeal circulation catheter according to the present invention, blood removal and blood return can be carried out without providing a separate blood access for returning blood that has been removed.

  On the other hand, in Example 5, the return blood pressure increased extremely, and the circulation at 80 mL / min could not be performed. Even when the return blood pressure is 200 mmHg, the blood removal rate is limited to about 30 mL / min, and the blood containing the contrast medium is removed by blood in Examples 1 to 4 and blood purification such as adsorption. From the viewpoint of application to a system in which blood from which a contrast medium has been removed by the method is returned to the body.

It is the schematic which shows an example of the catheter for extracorporeal circulation. It is sectional drawing which shows an example of the A-A 'cross section of the catheter for extracorporeal circulation. It is sectional drawing which shows an example from which the A-A 'cross section of the catheter for extracorporeal circulation differs. It is sectional drawing which shows an example from which the A-A 'cross section of the catheter for extracorporeal circulation differs. It is sectional drawing which shows an example from which the A-A 'cross section of the catheter for extracorporeal circulation differs. It is the schematic which shows a different example of the catheter for extracorporeal circulation. FIG. 7 is a side view showing an example of the extracorporeal circulation catheter shown in FIG. 6. It is the schematic which shows an example which has a side hole among the catheters for extracorporeal circulation. It is the schematic which shows an example of the front end side of the catheter for extracorporeal circulation. It is the schematic which shows an example from which the front end side of the catheter for extracorporeal circulation differs. It is the schematic which shows an example from which the front end side of the catheter for extracorporeal circulation differs. It is the schematic which shows an example from which the front end side of the catheter for extracorporeal circulation differs. It is the schematic which shows the state which the guide wire protruded from the side hole of the catheter for extracorporeal circulation. It is the schematic of a subcatheter. It is the schematic which shows the state which inserted the guide wire in the catheter for extracorporeal circulation provided with the subcatheter. It is an enlarged view of the front end side of the catheter for extracorporeal circulation shown in FIG. 1 is a cross-sectional view of a typical heart.

Explanation of symbols

001 Tip 002 Plastic tube 003 Braided tube 004 Strain relief 005 Hub 006 Blood removal lumen 007 Blood return lumen 008 Outer tube 009 Coated tube 010 Side hole 011 Marker 012 Guide wire 013 Blood removal catheter 014 Inferior vena cava 015 Venous sinus

Claims (22)

A distal end and a rear end, the distal end is disposed in the coronary sinus of the heart, and after removing blood containing the contrast medium from the distal end outside the body, the blood from which the contrast medium has been removed by a blood purification method An extracorporeal circulation catheter applied to an extracorporeal circulation system for returning blood to the blood vessel, wherein the catheter has a blood removal lumen extending from the distal end to the rear end, and a return extending from the rear end of the catheter to the distal end side for a predetermined length. With blood lumens ,
The catheter has a structure in which an outer tube is disposed in a double tubular shape outside the braided tube, and a lumen defined by the outer surface of the braided tube and the inner surface of the outer tube is a blood removal lumen, and is defined by the inner surface of the braided tube. An extracorporeal circulation catheter whose lumen is the return lumen . A distal end and a rear end, the distal end is disposed in the coronary sinus of the heart, and after removing blood containing the contrast medium from the distal end outside the body, the blood from which the contrast medium has been removed by a blood purification method An extracorporeal circulation catheter applied to an extracorporeal circulation system for returning blood to the blood vessel, wherein the catheter has a blood removal lumen extending from the distal end to the rear end, and a return extending from the rear end of the catheter to the distal end side for a predetermined length. With blood lumens,
The catheter has a structure in which a braided tube is biaxial,
An extracorporeal circulation catheter in which one lumen is a blood removal lumen and the other lumen is a blood return lumen. The catheter has a structure in which an outer tube is arranged in parallel outside the braided tube and fixed with a covering tube;
The extracorporeal circulation catheter according to claim 1, wherein the lumen defined by the inner surface of the braided tube is a blood removal lumen, and the lumen defined by the inner surface of the outer tube is a blood return lumen. A distal end and a rear end, the distal end is disposed in the coronary sinus of the heart, and after removing blood containing the contrast medium from the distal end outside the body, the blood from which the contrast medium has been removed by a blood purification method An extracorporeal circulation catheter applied to an extracorporeal circulation system for returning blood to the blood vessel, wherein the catheter has a blood removal lumen extending from the distal end to the rear end, and a return extending from the rear end of the catheter to the distal end side for a predetermined length. With blood lumens,
An extracorporeal circulation catheter, wherein the blood removal lumen has an equivalent diameter D1 of 1.80 mm or more and 3.00 mm or less, and the blood return lumen has an equivalent diameter D2 of 1.30 mm or more and 2.00 mm or less. . Claims wherein the phase equivalent diameter D1 of the blood removal lumen than 1.80 mm, or less 3.00 mm, a phase equivalent diameter D2 of the blood return lumen than 1.30 mm, and equal to or less than 2.00mm The catheter for extracorporeal circulation according to any one of 1 to 3 . The extracorporeal circulation catheter according to any one of claims 1 to 5 , further comprising a side hole on a distal end side of the extracorporeal circulation catheter. The extracorporeal circulation catheter according to claim 6 , wherein the number of the side holes is 2 or more and 10 or less. The extracorporeal circulation catheter according to claim 6 , wherein the number of side holes existing on the same circumference is one. The extracorporeal circulation catheter according to claim 7 or 8, wherein the side hole is disposed in a spiral shape. Extracorporeal circulation catheter according to any one of the from the side 6. phase equivalent diameter D3 of the hole is not less than 1.80 mm 9. The extracorporeal circulation catheter according to any one of claims 1 to 10 , wherein the extracorporeal circulation catheter is configured by a combination of a composite tube in which a metal and a resin are combined and a resin tube. The extracorporeal circulation catheter according to any one of claims 1 to 11 , wherein the distal end side is formed of a resin tube. The resin shore hardness 25D above, viewing contains a blend of the following elastomer or the elastomer together 75D,
The extracorporeal circulation catheter according to claim 11 or 12, wherein the elastomer is a polyamide-based elastomer . The extracorporeal circulation catheter according to claim 13, wherein the resin is mixed with a radiopaque substance. The catheter for extracorporeal circulation according to any one of claims 1 to 14 , wherein a hydrophilic coating is applied to an outer surface of the extracorporeal circulation catheter. The extracorporeal circulation catheter according to any one of claims 1 to 15 , further comprising a sub-catheter that is detachably attached to the blood removal lumen. The extracorporeal circulation catheter according to claim 16, wherein the sub-catheter is composed of a flexible resin tube. The extracorporeal circulation catheter according to claim 17 , wherein the resin is either high-density polyethylene or low-density polyethylene. The resin is polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE). ), polyvinylidene fluoride (PVDF), and polychlorotrifluoroethylene (at least 1 or more in extracorporeal circulation catheter of claim 17, wherein selected from the group consisting of PCTFE). The extracorporeal circulation catheter according to claim 17 , wherein the resin is a polyamide-based elastomer. The extracorporeal circulation catheter according to claim 17, wherein a radiopaque substance is mixed in the resin. The extracorporeal circulation catheter according to any one of claims 17 to 21 , wherein the resin tube is provided with a radiopaque marker.