WO2022168719A1 - 経皮カテーテル - Google Patents

経皮カテーテル Download PDF

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Publication number
WO2022168719A1
WO2022168719A1 PCT/JP2022/003023 JP2022003023W WO2022168719A1 WO 2022168719 A1 WO2022168719 A1 WO 2022168719A1 JP 2022003023 W JP2022003023 W JP 2022003023W WO 2022168719 A1 WO2022168719 A1 WO 2022168719A1
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WO
WIPO (PCT)
Prior art keywords
catheter
blood
tube
stylet
reinforcing body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2022/003023
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English (en)
French (fr)
Japanese (ja)
Inventor
優 畑
研司 横山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2022579488A priority Critical patent/JPWO2022168719A1/ja
Publication of WO2022168719A1 publication Critical patent/WO2022168719A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the present invention relates to percutaneous catheters.
  • PCPS percutaneous cardiopulmonary support
  • ECMO extracorporeal membrane type oxygenator
  • the extracorporeal circulation device is equipped with an extracorporeal circulation circuit consisting of a centrifugal pump, an oxygenator, a blood removal channel, a blood delivery channel, etc., and performs gas exchange on the removed blood and sends the blood to the blood delivery channel.
  • an extracorporeal circulation circuit consisting of a centrifugal pump, an oxygenator, a blood removal channel, a blood delivery channel, etc., and performs gas exchange on the removed blood and sends the blood to the blood delivery channel.
  • a high-performance cannula disclosed in Patent Document 1 can be used for the blood removal channel and blood delivery channel of such an extracorporeal circulation circuit.
  • a high-performance cannula (catheter assembly) disclosed in Patent Document 1 is inserted into a living body with a mandrel (stylet) inserted into a cannula body (catheter).
  • a flexible material (reinforcing body) is arranged on the outer periphery of the cannula body disclosed in Patent Document 1.
  • the stylet After inserting the above catheter assembly into the body with the stylet attached to the catheter, the stylet is removed from the catheter to start extracorporeal circulation. After completing the extracorporeal circulation, the catheter (percutaneous catheter) is removed from the blood vessel.
  • the catheter When the catheter is removed from the blood vessel, the catheter may be unintentionally caught on the blood vessel, and the reinforcing body may be stretched and deformed as the catheter is stretched. If the reinforcing member is deformed in this way, for example, the strength of the catheter cannot be maintained, and there is a possibility that it will be difficult to remove it.
  • the present invention has been made to solve the above problems, and provides a percutaneous catheter that can prevent the percutaneous catheter from stretching even if the percutaneous catheter is unintentionally caught in a blood vessel. intended to provide
  • a percutaneous catheter for achieving the above object is a percutaneous catheter comprising a lumen through which blood flows, comprising: a tubular reinforcing body; a covering part covering at least a part of the reinforcing body; and a resin layer provided to cover the portion.
  • the covering portion since the covering portion covers at least a part of the reinforcing body, even if the percutaneous catheter is unintentionally caught in a blood vessel, the covering portion prevents the percutaneous catheter from stretching. Suppress. As described above, it is possible to provide a percutaneous catheter that can suppress stretching of the percutaneous catheter even if the percutaneous catheter is unintentionally caught in a blood vessel.
  • FIG. 1 is a system diagram showing an example of an extracorporeal circulation device to which a percutaneous catheter according to an embodiment of the present invention is applied;
  • FIG. FIG. 4 is a side view showing a state before the stylet is inserted through the catheter according to the present embodiment; It is a side cross-sectional view showing a catheter according to this embodiment.
  • Fig. 10 is a side view showing a state after the stylet has been inserted through the catheter according to the present embodiment. It is a figure for demonstrating the knitting angle of a 1st reinforcement. It is a figure for demonstrating the knitting angle of a 2nd reinforcement. It is a side sectional view showing a shaft part.
  • FIG. 4 is a plan view showing a state before the stylet is inserted through the double-lumen catheter;
  • Fig. 2 is a side cross-sectional view showing a double lumen catheter;
  • FIG. 4 is a plan view showing a state after the stylet has been inserted through the double-lumen catheter;
  • FIG. 8 is a diagram corresponding to FIG. 7 of a catheter according to modification 1;
  • FIG. 8 is a diagram corresponding to FIG. 7 of a catheter according to modification 2;
  • FIG. 8 is a diagram corresponding to FIG. 7 of a catheter according to modification 3;
  • FIG. 11 is a schematic diagram of a catheter according to Modification 4;
  • FIG. 1 shows that a percutaneous catheter according to an embodiment of the present invention is applied to temporarily assist and replace the functions of the heart and lungs until the heart function recovers when the patient's heart is weakened.
  • 1 is a system diagram showing an example of an extracorporeal circulation device used as percutaneous cardiopulmonary support (PCPS);
  • PCPS percutaneous cardiopulmonary support
  • the pump is operated to remove blood from the patient's vein (caval vein), oxygenate the blood by performing gas exchange in the blood with an artificial lung, and then re-inject the blood.
  • a Veno-Arterial (VA) procedure that returns to the patient's artery (aorta) can be performed.
  • This extracorporeal circulation device 1 is a device that assists the heart and lungs.
  • extracorporeal circulation a technique of removing blood from a patient, performing a predetermined treatment outside the body, and then reinjecting the blood into the patient's body.
  • the extracorporeal circulation device 1 has a circulation circuit that circulates blood.
  • the circulation circuit includes an oxygenator 2, a centrifugal pump 3, a drive motor 4 which is driving means for driving the centrifugal pump 3, a venous catheter (percutaneous catheter for blood removal) 5, and an arterial catheter ( It has a blood feeding catheter) 6 and a controller 10 as a control section.
  • the venous catheter (blood removal catheter) 5 is inserted from the femoral vein, and the tip of the venous catheter 5 is placed in the right atrium or the transition from the inferior vena cava to the right atrium via the inferior vena cava.
  • the venous catheter 5 is connected to the centrifugal pump 3 via a blood removal tube (blood removal line) 11 .
  • the blood removal tube 11 is a conduit for sending blood.
  • the arterial side catheter (blood feeding catheter) 6 is inserted from the femoral artery.
  • the centrifugal pump 3 removes blood from the blood removal tube 11 and passes the blood through the oxygenator 2, and then the blood supply tube (blood supply line). Blood can be returned to patient P via 12 .
  • the oxygenator 2 is arranged between the centrifugal pump 3 and the blood feeding tube 12.
  • the oxygenator 2 performs gas exchange (oxygenation and/or carbon dioxide removal) for the blood.
  • the oxygenator 2 is, for example, a membrane oxygenator, and preferably a hollow fiber membrane oxygenator.
  • Oxygen gas is supplied from an oxygen gas supply unit 13 to the oxygenator 2 through a tube 14 .
  • the blood supply tube 12 is a conduit connecting the oxygenator 2 and the arterial catheter 6 .
  • a highly transparent, elastically deformable flexible synthetic resin conduit such as vinyl chloride resin or silicone rubber can be used. Inside the blood removal tube 11, the liquid blood flows in the direction V1, and inside the blood supply tube 12, the blood flows in the direction V2.
  • an ultrasonic air bubble detection sensor 20 is arranged in the middle of the blood removal tube 11.
  • Fast clamp 17 is arranged in the middle of blood transfer tube 12 .
  • the ultrasonic air bubble detection sensor 20 detects air bubbles that have entered the circulation circuit due to erroneous operation of the three-way stopcock 18 or breakage of the tube during extracorporeal circulation.
  • the ultrasonic bubble detection sensor 20 detects that there are bubbles in the blood being sent into the blood removal tube 11 .
  • the ultrasonic bubble detection sensor 20 sends a detection signal to the controller 10 .
  • the controller 10 notifies an alarm and lowers the rotational speed of the centrifugal pump 3 or stops the centrifugal pump 3 .
  • the controller 10 commands the fast clamp 17 to immediately occlude the blood transfer tube 12 with the fast clamp 17 . This prevents air bubbles from being sent into the patient's P body.
  • the controller 10 controls the operation of the extracorporeal circulation device 1 to prevent air bubbles from entering the patient's P body.
  • a pressure sensor is provided in the tube 11 (12, 19) of the circulation circuit of the extracorporeal circulation device 1.
  • the pressure sensor is, for example, installed at any position A1 of the blood removal tube 11, A2 of the blood transfer tube 12 of the circulation circuit, or A3 of the connection tube 19 connecting between the centrifugal pump 3 and the oxygenator 2. or one or all of them.
  • the pressure in the tube 11 (12, 19) can be measured by the pressure sensor while the extracorporeal circulation is performed on the patient P by the extracorporeal circulation device 1.
  • the mounting positions of the pressure sensors are not limited to the mounting positions A1, A2, and A3, and an arbitrary number of pressure sensors can be mounted at arbitrary positions in the circulation circuit.
  • FIGS. 2 to 7 are diagrams for explaining the configuration of the catheter 30.
  • This catheter 30 is used as the venous side catheter (bleeding catheter) 5 in FIG.
  • the catheter 30 includes a catheter tube 31 having a first side hole 63 and a second side hole 46, a distal tip 41 disposed at the distal end of the catheter tube 31 and having a through hole 47, the catheter tube 31 , a catheter connector 35 for connecting the catheter tube 31 and the clamp tube 34 , and a lock connector 36 .
  • distal end means a fixed range including the distal end (most distal end) and its periphery
  • proximal end means a fixed range including the proximal end (most proximal end) and its periphery.
  • the catheter 30 has a lumen 30A penetrating from the distal end to the proximal end, as shown in FIG.
  • the through-hole 47 of the distal tip 41 and the first side hole 63 and the second side hole 46 of the catheter tube 31 are configured to be arranged in different blood removal targets in the living body so that blood removal can be performed efficiently. It is
  • a stylet 50 shown in FIG. 2 is used when inserting the catheter 30 into the living body.
  • the stylet 50 is inserted through the lumen 30A of the catheter 30, and the catheter 30 and the stylet 50 are integrated in advance and inserted into the living body.
  • the catheter tube 31 has, as shown in FIG.
  • the expansion part 32 is configured to have higher elasticity than the shaft part 33 . Further, the extension portion 32 is configured to have an outer diameter and an inner diameter larger than those of the shaft portion 33 .
  • the extension portion 32 and the shaft portion 33 have lengths necessary for arranging the through hole 47 of the distal tip 41 and the first side hole 63 and the second side hole 46 of the catheter tube 31 in the desired blood removal target. It is configured to be
  • the length of the extension portion 32 can be, for example, 20-40 cm, and the length of the shaft portion 33 can be, for example, 20-30 cm.
  • the catheter 30 is inserted into the living body so that the through hole 47 of the distal tip 41 and the second side hole 46 of the catheter tube 31 are arranged in the right atrium, and the first side hole 63 of the catheter tube 31 is arranged in the inferior vena cava. and detained.
  • the extension part 32 With the through hole 47, the second side hole 46, and the first side hole 63 arranged in the target of blood removal, the extension part 32 is arranged in the inferior vena cava, which is a relatively large blood vessel, and the shaft part 33 is relatively large. It is placed in the femoral vein, which is a small blood vessel.
  • the highly stretchable expansion portion 32 expands in the axial direction to reduce its outer diameter and inner diameter as shown in FIG.
  • the outer diameter of the extended portion 32 is substantially the same as the outer diameter of the shaft portion 33 . Since the catheter 30 is inserted into the living body in a state in which the expansion portion 32 is axially extended to reduce the outer diameter and the inner diameter, the catheter 30 can be inserted in a minimally invasive manner.
  • the expanded portion 32 shrinks from the axially expanded state, and the inner diameter increases.
  • the extension 32 is placed in the inferior vena cava, which is a relatively large blood vessel. Therefore, the outer diameter of the expanded portion 32 can be increased, and the inner diameter can be increased accordingly.
  • the pressure loss in the expanded portion 32 is the total length of the expanded portion 32 x (average) passage cross-sectional area. That is, by increasing the inner diameter of the expanded portion 32, the pressure loss in the expanded portion 32 is reduced.
  • the pressure loss in the expanded portion 32 is reduced, the flow rate of blood flowing through the circulation circuit increases without increasing the rotational speed of the centrifugal pump. Therefore, in order to obtain a sufficient amount of blood circulation, it is necessary to increase the inner diameter of the expanded portion 32 .
  • the inner diameter of the expansion portion 32 can be set to, for example, 9 to 11 mm, and the inner diameter of the shaft portion 33 can be set to, for example, 4 to 8 mm. Further, the thickness of the extension portion 32 and the shaft portion 33 is preferably 0.4 to 0.5 mm, for example.
  • the distal end portion of the extended portion 32 preferably forms a tapered portion that tapers gradually from the center of the extended portion 32 toward the distal end side in the axial direction.
  • the inner diameter of the distal end of the expanded portion 32 is continuous with the inner diameter of the distal tip 41 arranged on the distal end side.
  • the extension part 32 includes a first reinforcing body 321 made of wires W braided so as to intersect, a first resin layer 322 provided to cover the first reinforcing body 321, have
  • the shaft portion 33 covers a second reinforcing body (corresponding to a reinforcing body) 331 made of wires W braided so as to intersect, and a part of the second reinforcing body 331. It has a covering portion 332 and a second resin layer 333 provided so as to cover the second reinforcing body 331 and the covering portion 332 .
  • the first reinforcing body 321 is constructed by braiding wires W at a braiding angle ⁇ 1.
  • the second reinforcing body 331 is configured by braiding the wire W so as to have a braiding angle ⁇ 2.
  • the weaving angles ⁇ 1 and ⁇ 2 are defined as internal angles in the axial direction among the angles formed by the intersecting wires W, as shown in FIGS.
  • the weaving angle ⁇ 1 of the first reinforcing member 321 is smaller than the weaving angle ⁇ 2 of the second reinforcing member 331, as shown in FIGS. Therefore, the inclination angle of the wires W forming the first reinforcing body 321 with respect to the axial direction is smaller than when the weaving angle of the first reinforcing body 321 is larger than the weaving angle of the second reinforcing body 331 .
  • the weaving angle ⁇ 1 of the first reinforcing member 321 may be set larger than the weaving angle ⁇ 2 of the second reinforcing member 331 .
  • the extension portion 32 extends in the axial direction, the wire W forming the first reinforcing body 321 of the extension portion 32 is deformed such that the inclination angle with respect to the axial direction gradually decreases.
  • the angle of inclination of the wire W forming the first reinforcing member 321 of the extended portion 32 with respect to the axial direction becomes approximately zero, the extension of the extended portion 32 in the axial direction is restricted.
  • the weaving angle ⁇ 1 of the first reinforcing member 321 is smaller than the weaving angle ⁇ 2 of the second reinforcing member 331, the weaving angle of the first reinforcing member 321 is larger than the weaving angle of the second reinforcing member 331. In comparison, the axial extension of extension 32 associated with passing stylet 50 through catheter 30 is reduced.
  • the weaving angle ⁇ 1 of the first reinforcing member 321 is not particularly limited, but is 100 to 120 degrees. Further, the weaving angle ⁇ 2 of the second reinforcing member 331 is not particularly limited, but is 130 degrees to 150 degrees. By making the weaving angle ⁇ 2 of the second reinforcing member 331 larger than the weaving angle ⁇ 1 of the first reinforcing member 321 in this manner, the kink resistance of the second reinforcing member 331 can be improved. Therefore, the catheter 30 can be preferably inserted into the living body through the femoral vein, which has a complicated structure.
  • the first reinforcing body 321 of the extension part 32 is braided so as to be more sparse than the second reinforcing body 331 of the shaft part 33 .
  • the expansion portion 32 can be made softer than the shaft portion 33, and the stretchability can be enhanced.
  • the wire W is made of a shape memory material such as a known shape memory metal or shape memory resin.
  • a shape memory metal for example, titanium-based (Ni--Ti, Ti--Pd, Ti--Nb--Sn, etc.) and copper-based alloys can be used.
  • the shape memory resin for example, acrylic resin, trans-isoprene polymer, polynorbornene, styrene-butadiene copolymer, and polyurethane can be used.
  • the axial contraction distance of the extension 32 as the stylet 50 is withdrawn from the catheter 30 is the same as the extension 32 as the stylet 50 is passed through the catheter 30. 32 axial extension distance.
  • the wire diameter of the wire W is preferably 0.1 mm to 0.2 mm.
  • the function as a reinforcing body that improves strength can be suitably exhibited.
  • the wire W has a circular cross section, but is not limited to this, and may be rectangular, square, elliptical, or the like.
  • the first resin layer 322 of the extension part 32 may be made of a softer material with lower hardness than the second resin layer 333 of the shaft part 33 . According to this configuration, the expansion portion 32 can be made softer than the shaft portion 33, and the stretchability can be enhanced.
  • the first and second resin layers 322 and 333 can be formed using vinyl chloride, silicon, polyethylene, nylon, urethane, polyurethane, fluororesin, thermoplastic elastomer resin, or the like, or using composite materials thereof.
  • the silicone material is highly biocompatible and the material itself is soft, so it has the advantage of not damaging blood vessels.
  • the polyethylene material is soft and has hardness to withstand pressure.
  • polyethylene materials have biocompatibility comparable to silicon materials.
  • Polyethylene material is harder than silicon and has the advantage of being easy to insert into small blood vessels.
  • the polyurethane material has the advantage of becoming soft after insertion.
  • materials for the first and second resin layers 322 and 333 applicable materials can be used by taking advantage of the features of these materials.
  • a hydrophilic coating may be applied to the polyurethane material.
  • the surface of the tube is smooth, making it easy to insert into a blood vessel and less likely to damage the blood vessel wall. It is expected to prevent the formation of thrombus because it is difficult for blood and proteins to adhere to it.
  • the covering part 332 is arranged along the axial direction so as to cover part of the second reinforcing body 331 .
  • the covering part 332 covers a part of the second reinforcing body 331 means a layer configured by the second reinforcing body 331 so as to cover the wire W of the second reinforcing body 331. It shows that the covering portion 332 extends into the inside of the .
  • the covering portion 332 can use a heat-shrinkable tube.
  • the thickness of the covering portion 332 is not particularly limited, it is preferably 0.02 to 0.4 mm, for example.
  • the hardness of the covering portion 332 is not particularly limited, but preferably has a Shore A hardness of 60 to 8 degrees, for example.
  • the material constituting the covering portion 332 is not particularly limited, but olefin, nylon, vinyl chloride, silicon, urethane, EPDM (ethylene-propylene-diene copolymer), EPM (ethylene-propylene copolymer), etc. can be used. Specifically, Pebax (registered trademark), for example, can be used as the covering portion 332 .
  • the catheter when the catheter is removed from the blood vessel, the catheter may be unintentionally caught in the blood vessel, and the second reinforcing body 331 may be stretched as the catheter is stretched. There is a risk of deformation. If the reinforcing member is deformed in this manner, for example, the strength of the catheter cannot be maintained.
  • the covering portion 332 covers a part of the second reinforcing body 331. Therefore, even if the catheter 30 is unintentionally caught in a blood vessel, the covering portion 332 is Stretching of the catheter 30 is suppressed. Therefore, deformation of the second reinforcing body 331 can be suppressed.
  • the expansion portion 32 is axially extended and contracted radially inward.
  • the shaft portion positioned at the proximal end of the expanded portion 32 may also expand in the axial direction and contract radially inward.
  • the shaft portion contracts radially inward in this way, the frictional resistance against the stylet 50 increases, preventing the stylet 50 from being inserted to a desired position, and the expanded portion 32 contracts radially inwardly. do not have. If the expansion part 32 is not completely contracted radially inward and inserted into the living body, the degree of invasiveness to the patient's body increases, which is not preferable.
  • the covering portion 332 covers a part of the second reinforcing body 331. Therefore, when the stylet 50 is inserted into the catheter 30, the shaft portion 33 has a large diameter. Although the shaft portion 33 tries to contract inward, the covering portion 332 restricts the radially inward contraction of the shaft portion 33 . Accordingly, the stylet 50 can be inserted to a desired position, and the expanded portion 32 of the catheter 30 expands axially and preferably contracts radially inward.
  • extension part 32 is not particularly limited, it can be formed by, for example, dip coating (immersion method) or insert molding.
  • the method of forming the shaft portion 33 is also not particularly limited, but it can be formed, for example, as follows. That is, after the wires W are braided to form the second reinforcing body 331 , the covering portion 332 , which is a heat-shrinkable tube, is arranged around the outer periphery of the second reinforcing body 331 . Then, the covering portion 332 , which is a heat-shrinkable tube, is heated and shrunk to cover a part of the outer peripheral side of the second reinforcing body 331 with the covering portion 332 . Then, the second resin layer 333 is formed on the outer circumferences of the second reinforcing body 331 and the covering portion 332 by dip coating (immersion method) or insert molding.
  • dip coating immersion method
  • At least the outer surfaces of the reinforcing bodies 321 and 331 should be covered with the resin layers 322 and 333 .
  • the extension part 32 has a second side hole 46, as shown in FIG. As shown in FIG. 2, a plurality of (four in FIG. 2) second side holes 46 are provided along the axial direction. It is preferable that a plurality of the second side holes 46 are provided also in the circumferential direction.
  • the second side hole 46 functions as a blood removal hole.
  • the shaft portion 33 has a first side hole 63 as shown in FIG.
  • the first side hole 63 functions as a blood removal hole. It is preferable to have a plurality of first side holes 63 in the circumferential direction. In this embodiment, the shaft portion 33 is provided with four first side holes 63 in the circumferential direction. As a result, even if one of the first side holes 63 is blocked by the blood vessel wall due to blood removal, the other first side holes 63 can be used to remove blood, thereby stabilizing blood circulation. It can be carried out.
  • the distal tip 41 is arranged at the distal end of the extension portion 32, as shown in FIGS.
  • the distal tip 41 has a tapered shape whose diameter gradually decreases toward the distal end.
  • a flat receiving surface 48 is formed that contacts the flat surface 50a of the stylet 50 used prior to the insertion of the catheter 30 into the living body. ing.
  • the distal tip 41 is configured to accommodate the distal end of the wire W, as shown in FIG.
  • the distal tip 41 has a through hole 47 .
  • the through hole 47 functions as a blood removal hole.
  • Through hole 47 of distal tip 41 constitutes a portion of lumen 30A of catheter 30 .
  • the distal tip 41 can be made of urethane, for example.
  • the clamp tube 34 is provided on the proximal end side of the shaft portion 33, as shown in FIGS. A lumen through which the stylet 50 can be inserted is provided inside the clamp tube 34 .
  • the clamp tube 34 can be formed using the same material as the catheter tube 31 .
  • the catheter connector 35 connects the shaft portion 33 and the clamping tube 34, as shown in FIGS. A lumen through which the stylet 50 can be inserted is provided inside the catheter connector 35 .
  • the lock connector 36 is connected to the proximal end side of the clamp tube 34, as shown in FIGS.
  • a lumen through which the stylet 50 can be inserted is provided inside the lock connector 36 .
  • a male threaded portion 36A having a screw thread is provided on the outer surface of the lock connector 36 on the proximal end side.
  • the configuration of the stylet 50 is not limited to the following configuration.
  • the stylet 50 includes a stylet tube 51 extending in the axial direction, a stylet hub 52 to which the proximal end of the stylet tube 51 is fixed, and a distal end of the stylet hub 52. and a screw ring 53 provided on the .
  • the stylet tube 51 is an elongated body extending in the axial direction and having relatively high rigidity. The total axial length of the stylet tube 51 is longer than the axial length of the catheter 30 .
  • the stylet tube 51 has a guidewire lumen 54 through which a guidewire (not shown) can be inserted.
  • the stylet tube 51 is guided by a guide wire and inserted into the living body together with the catheter 30 .
  • the stylet tube 51 is removed from the catheter 30 by pulling out the stylet hub 52 to the proximal end side after the catheter 30 is left in the living body.
  • the distal end of the stylet tube 51 has a flat surface 50a with which the receiving surface 48 of the distal tip 41 abuts, as shown in FIG.
  • the stylet tube 51 has a relatively high rigidity, and is provided with a stiffness that enables transmission of pushing force toward the distal end side due to operation at hand to the distal tip 41 . Therefore, the stylet tube 51 plays a role of dilating a narrow blood vessel by bringing its flat surface 50a into contact with the receiving surface 48 of the distal tip 41 and pushing the distal tip 41 toward the distal side.
  • the threaded ring 53 has a female threaded portion (not shown) provided with a thread groove on the inner surface of the lumen.
  • the stylet 50 can be attached to the catheter 30 by screwing the female threaded portion of the screw ring 53 into the male threaded portion 36A of the lock connector 36 .
  • FIG. 2 shows the state before the stylet tube 51 of the stylet 50 is inserted through the lumen 30A of the catheter 30, and
  • FIG. 4 shows the state after the stylet tube 51 is inserted through the lumen 30A of the catheter 30.
  • the stylet tube 51 of the stylet 50 is inserted through the lumen 30A of the catheter 30, as shown in FIG.
  • the stylet tube 51 sequentially passes through the shaft portion 33 and the extension portion 32 , and the flat surface 50 a of the stylet tube 51 abuts the receiving surface 48 of the distal tip 41 .
  • the total length in the axial direction of the stylet tube 51 is longer than the total length in the axial direction of the catheter 30 before the expansion portion 32 expands. For this reason, the distal tip 41 is pressed to the distal side while the flat surface 50a of the stylet tube 51 is in contact with the receiving surface 48 of the distal tip 41 .
  • the catheter 30 receives an axially extending force, and the expanded portion 32 of the catheter 30, which has relatively high stretchability, is axially extended.
  • the shaft portion 33 tries to contract radially inwardly, but since the covering portion 332 covers a part of the second reinforcing body 331, the covering portion 332 causes the shaft portion 33 to contract radially inwardly. is regulated. Accordingly, the stylet 50 can be inserted to a desired position, and the expanded portion 32 of the catheter 30 expands axially and preferably contracts radially inward.
  • the stylet 50 is attached to the catheter 30 by screwing the female threaded portion of the screw ring 53 into the male threaded portion 36A provided on the lock connector 36 of the catheter 30 .
  • the catheter 30 through which the stylet 50 is inserted is inserted along a guide wire (not shown) that has been inserted into the target site in the living body in advance.
  • the outer diameter of the expanded portion 32 is substantially the same as the outer diameter of the shaft portion 33, so that the catheter 30 can be inserted into the living body in a minimally invasive manner. It is possible to suppress the burden on the patient's body.
  • the catheter 30 is moved until the through hole 47 of the distal tip 41 and the second side hole 46 of the catheter tube 31 are placed in or near the right atrium, and the first side hole 63 of the catheter tube 31 is placed in the inferior vena cava. It is inserted into the body and left in place.
  • the extended portion 32 is arranged in the inferior vena cava, which is a relatively large blood vessel, and the shaft portion 33 is relatively large. It is placed in the femoral vein, which is a small blood vessel.
  • the stylet 50 and the guidewire are removed from the catheter 30.
  • the stylet 50 and the guide wire are once withdrawn from the catheter 30 to the clamping tube 34 and clamped with forceps (not shown), and then completely removed from the catheter 30 .
  • the catheter 30 is relieved of the axially extending forces that the catheter 30 was subjected to from the stylet 50 . Therefore, the expanded portion 32 contracts in the axial direction, and the inner diameter of the expanded portion 32 increases. As a result, the pressure loss in the expanded portion 32 can be reduced and the required flow rate of the liquid can be ensured.
  • the catheter 30 After completing the extracorporeal circulation, the catheter 30 is removed from the blood vessel, and the insertion site is surgically repaired to stop bleeding as necessary. It should be noted that if there is a concern that the expanded portion 32 may cause a problem when the catheter 30 is removed, a new stylet 50 may be prepared and inserted into the catheter 30 to contract the expanded portion 32 before removal. good.
  • the covering part 332 covers a part of the second reinforcing body 331, so even if the catheter 30 is unintentionally caught in the blood vessel, the covering part 332 suppresses the stretching of the catheter 30. . Therefore, deformation of the second reinforcing body 331 can be suppressed, and the catheter 30 can be removed without any trouble.
  • the catheter 30 is a catheter 30 having a lumen 30A through which blood flows.
  • the catheter 30 includes a tubular second reinforcing body 331, a covering portion 332 covering a part of the second reinforcing body 331, and a second resin layer 333 provided so as to cover the second reinforcing body 331 and the covering portion 332.
  • the covering portion 332 covers a part of the second reinforcing body 331, so even if the catheter 30 is unintentionally caught in a blood vessel, the covering portion 332 will prevent the catheter 30 from being stretched. suppress As described above, it is possible to provide the catheter 30 that can suppress the stretching of the catheter 30 even if the catheter 30 is unintentionally caught in a blood vessel.
  • the covering portion 332 is a heat-shrinkable tube arranged on the outer circumference of the second reinforcing body 331 . According to the catheter 30 configured in this way, the catheter 30 having the covering portion 332 can be easily manufactured. Also, by selecting an arbitrary heat-shrinkable tube, the thickness of the covering portion 332 layer can be reduced.
  • a shaft portion 33 including a second reinforcing body 331, a covering portion 332, and a second resin layer 333, and an expansion portion 32 connected to the distal end of the shaft portion 33 and configured to be expandable in the axial direction by the stylet 50. and have According to the catheter 30 configured in this way, when the stylet 50 is inserted into the catheter 30 , the shaft portion 33 tends to contract radially inwardly, but the covering portion 332 prevents the shaft portion 33 from radially inwards. Contraction in the direction is regulated. Accordingly, the stylet 50 can be inserted to a desired position, and the expanded portion 32 of the catheter 30 expands axially and preferably contracts radially inward.
  • the catheter 60 is a so-called double-lumen catheter, capable of both blood feeding and blood withdrawal at the same time. Therefore, in this embodiment, in the extracorporeal circulation device of FIG. The procedure is performed using only the catheter 60 of .
  • the catheter 60 has a double-tube structure in which a third tube 161 having a first lumen 61 communicating with a blood feeding side hole 163 is arranged in the lumen of the shaft portion 33. have.
  • the pump of the extracorporeal circulation device is operated to remove blood from the patient's vein (caval vein), oxygenate the blood by performing gas exchange in the blood with an artificial lung, and then oxygenate the blood.
  • Veno-Venous (VV) oxygenated extracorporeal blood circulation can be performed by returning the blood to the patient's vein (caval vein).
  • the catheter 60 includes an extension portion 32, a shaft portion 33, a distal tip 41 arranged at the distal end of the extension portion 32, and a third tip 41 arranged in the lumen of the shaft portion 33. and a tube 161 .
  • the configurations of the extension portion 32, the shaft portion 33, and the distal tip 41 are the same as those of the catheter 30 of the first embodiment, so description thereof will be omitted.
  • the catheter 60 has a first lumen 61 functioning as a blood supply channel and a second lumen 62 functioning as a blood removal channel.
  • a first lumen 61 is formed in the lumen of the third tube 161 .
  • a second lumen 62 is formed in the inner lumen of the extension portion 32 and the shaft portion 33 and penetrates from the distal end to the proximal end.
  • the shaft portion 33 is provided with a blood feeding side hole 163 that communicates with the first lumen 61, which is a blood feeding path.
  • the shaft portion 33 has a blood removal side hole 164 that communicates with the second lumen 62, which is a blood removal path.
  • the shape of the blood supply side hole 163 and the blood removal side hole 164 is not limited, as an example, they are configured in an elliptical shape.
  • the third tube 161 is inserted into the second lumen 62 from the base end side of the shaft portion 33 and connected to the blood feeding side hole 163 .
  • the blood supply side hole 163 is arranged in a blood supply target in the living body, and the blood that has been oxygenated by the oxygenator is delivered into the living body through the blood supply side hole 163 .
  • the through hole 47 provided in the distal tip 41, the second side hole 46 provided in the extended portion 32, and the blood removal side hole 164 provided in the shaft portion 33 are arranged in different blood removal targets in vivo to efficiently remove blood. is configured to perform Further, even if the through hole 47, the second side hole 46, or the blood removal side hole 164 is blocked by adhesion to the blood vessel wall, blood can be removed from the hole that is not blocked. Extracorporeal circulation can be performed stably.
  • the catheter 60 is inserted from the internal jugular vein in the neck, and the tip is placed in the inferior vena cava via the superior vena cava and the right atrium.
  • the target for blood supply is the right atrium, and the targets for blood removal are the superior vena cava and the inferior vena cava.
  • the through-hole 47 of the distal tip 41, the second side hole 46 of the expanded portion 32 are connected to the inferior vena cava, and the shaft portion 33 is used to remove blood. It is inserted into the living body so that the side hole 164 is arranged in the internal jugular vein and left therein.
  • the expanded portion 32 is configured to have an inner diameter larger than that of the shaft portion 33 .
  • the extension part 32 With the through hole 47, the second side hole 46, and the blood removal side hole 164 arranged in the blood removal target, the extension part 32 is placed in the inferior vena cava, which is a relatively thick blood vessel, and the shaft part 33 is placed in the comparative It is placed in the superior vena cava, which is a very small blood vessel.
  • the lock connector 136 includes a first lock connector 137 communicating with the first lumen 61 and a second lock connector 137 provided in parallel with the first lock connector 137 and communicating with the second lumen 62 . 138 and .
  • the lock connector 136 is a Y-shaped Y connector formed by branching a first lock connector 137 from a second lock connector 138 .
  • the first lock connector 137 is connected to the proximal end of the third tube 161.
  • the second lock connector 138 is coaxially connected to the proximal end of the shaft portion 33 .
  • a blood supply tube (blood supply line) is connected to the first lock connector 137
  • a blood removal tube (blood removal line) is connected to the second lock connector 138 .
  • a single catheter can perform both functions of blood removal and blood supply.
  • FIG. 11 is a diagram corresponding to FIG. 7 of the catheter 230 according to Modification 1. As shown in FIG. The catheter 230 according to Modification 1 differs from the catheter 30 according to the embodiment in the configuration of the covering portion.
  • the covering portion 334 of the catheter 230 according to Modification 1 consists of a tube 334B having an adhesive layer 334A formed on its surface.
  • the covering portion 334 is arranged on the inner peripheral side of the second reinforcing body 331 .
  • 334 A of adhesion layers are comprised so that a part of 2nd reinforcement body 331 may be coat
  • Adhesives constituting the adhesive layer 334A include styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), and styrene/ethylene-butylene copolymer/styrene (SEBS).
  • SIS styrene-isoprene-styrene block copolymer
  • SBS styrene-butadiene-styrene block copolymer
  • SEBS styrene/ethylene-butylene copolymer/styrene
  • SEPS styrene/ethylene-propylene copolymer/styrene
  • SB styrene/butadiene
  • SI styrene/isoprene
  • SEB styrene/ethylene-butylene copolymer
  • SEP styrene/ethylene-propylene copolymer
  • SBR ethylene-vinyl acetate copolymer
  • EA ethylene-ethyl acrylate copolymer
  • ESA ethylene-ethyl acrylate copolymer
  • Thermoplastic elastomer adhesive Thermoplastic elastomer adhesive; Synthetic rubber such as isoprene rubber, polybutene rubber, butyl rubber, acrylic rubber, rubber adhesive such as natural rubber; One-component moisture-curing urethane resin adhesive, Two-component reactive urethane resin adhesive and urethane-based resin adhesives such as adhesives.
  • the strength of the shaft portion depends on the hardness of the adhesive when the tube 334B is higher than the adhesive layer 334A, and depends on the hardness of the tube 334B when the tube 334B is lower than the adhesive layer 334A. depends on
  • the method of forming the shaft portion of the catheter 230 according to Modification 1 is not particularly limited, it can be formed, for example, as follows. That is, after applying an adhesive to the outer surface of the tube 334B to form the adhesive layer 334A, the wire W is braided around the outer periphery to form the second reinforcing body 331. As shown in FIG. Then, the second resin layer 333 is formed by dip coating (immersion method) or insert molding.
  • the adhesive layer 334A easily enters the inside of the layers forming the second reinforcing body 331, so that the covering portion 334 can be easily formed.
  • the catheter 330 according to Modification 2 differs from the catheter 30 according to the embodiment in the configuration of the covering portion.
  • the covering portion 335 of the catheter 330 according to Modification 2 consists of a tube 335B with an adhesive layer 335A formed on the surface.
  • the covering portion 335 is arranged on the outer peripheral side of the second reinforcing body 331 .
  • 335 A of adhesion layers are comprised so that a part of 2nd reinforcement body 331 may be coat
  • the method of forming the shaft portion of the catheter 330 according to Modification 2 is not particularly limited, it can be formed, for example, as follows. That is, after the adhesive is applied to the inner surface of the tube 335B to form the adhesive layer 335A, the tube 335B is inflated with air. Then, the second reinforcing body 331 prepared in advance is placed inside the inflated tube 335B, and the air is released to shrink the tube 335B. Then, the second resin layer 333 is formed by dip coating (immersion method) or insert molding. Alternatively, a heat-shrinkable tube may be used as the tube 335B, and an adhesive may be applied to the inner surface of the tube 335B to cover the second reinforcing body 331. FIG. Alternatively, it can be formed by attaching a sheet coated with an adhesive to the second reinforcing member 331 .
  • the covering portion 335 of any shape can be easily formed at any position. be able to.
  • a catheter 430 according to Modification 3 differs from the catheter 30 according to the embodiment in the configuration of the covering portion.
  • the covering portion 336 of the catheter 430 according to Modification 3 is arranged so as to cover the entire second reinforcing body 331 .
  • the material that forms the coating portion 336 is not particularly limited, but silicon, rubber, urethane, or the like can be used.
  • the method of forming the shaft portion of the catheter 430 according to Modification 3 is not particularly limited, it can be formed, for example, as follows. That is, the wire W is braided around the outer periphery of the covering portion 336 with a strong force so that the wire W digs into the inside of the covering portion 336 to form the second reinforcing body 331 . Then, the second resin layer 333 is formed by dip coating (immersion method) or insert molding.
  • the covering portion 336 covers the entire second reinforcing body 331, so that the expansion and contraction of the catheter 430 can be more preferably suppressed.
  • the catheter 30 according to the embodiment described above is a so-called dilatation catheter in which the dilation portion 32 of the catheter 30 extends.
  • a catheter 530 according to Modification 4 is such that the stylet 50 and the catheter 530 are inserted along the guide wire GW so that the stylet 50 protrudes from the distal end of the catheter 530.
  • the tip of the stylet 50 may not have the flat surface 50a and may have an edgeless shape.
  • the catheter according to the present invention has been described above through the embodiments, the present invention is not limited to the configurations described in the embodiments and modifications, and can be appropriately modified based on the description of the claims. It is possible.
  • the material that constitutes the wire W is not limited to a shape-memory material as long as it has a restoring force to deform and return to its original shape and has a function to reinforce the resin layer. It can be constructed from an elastic material.
  • catheters percutaneous catheters
  • 30A catheter lumen 32 extensions, 33, 233 shaft portion, 331 second reinforcing body (reinforcing body), 332, 334, 335, 336 covering portion, 333 second resin layer (resin layer), 334A, 335A adhesive layer, 334B, 335B tubes, 50 Stylet.

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PCT/JP2022/003023 2021-02-03 2022-01-27 経皮カテーテル Ceased WO2022168719A1 (ja)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02102665A (ja) * 1988-10-11 1990-04-16 Terumo Corp カテーテル
WO2018193601A1 (ja) * 2017-04-20 2018-10-25 朝日インテック株式会社 カテーテル

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL9301642A (nl) * 1993-09-22 1995-04-18 Cordis Europ Microcatheter.
JP6876710B2 (ja) * 2016-09-14 2021-05-26 テルモ株式会社 カテーテル

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02102665A (ja) * 1988-10-11 1990-04-16 Terumo Corp カテーテル
WO2018193601A1 (ja) * 2017-04-20 2018-10-25 朝日インテック株式会社 カテーテル

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