WO2017175530A1 - Cathéter percutané - Google Patents

Cathéter percutané Download PDF

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Publication number
WO2017175530A1
WO2017175530A1 PCT/JP2017/008826 JP2017008826W WO2017175530A1 WO 2017175530 A1 WO2017175530 A1 WO 2017175530A1 JP 2017008826 W JP2017008826 W JP 2017008826W WO 2017175530 A1 WO2017175530 A1 WO 2017175530A1
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WO
WIPO (PCT)
Prior art keywords
tube
catheter
blood
dilator
axial direction
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PCT/JP2017/008826
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English (en)
Japanese (ja)
Inventor
研司 横山
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2018510276A priority Critical patent/JP6813570B2/ja
Publication of WO2017175530A1 publication Critical patent/WO2017175530A1/fr

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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 a percutaneous catheter.
  • PCPS percutaneous cardiopulmonary support
  • the extracorporeal circulation apparatus includes an extracorporeal circulation circuit including a centrifugal pump, an artificial lung, a blood removal path, a blood transmission path, and the like, and performs gas exchange on the removed blood to send blood to the blood transmission path.
  • Patent Document 1 discloses a high-performance cannula that can expand or contract the diameter by extending or contracting the cannula body (catheter) in the axial direction by a mandrel (dilator). It is disclosed. According to the high-performance cannula configured in this manner, the mandrel is inserted into the living body in a state where the diameter (outer diameter) is reduced by extending the cannula body in the axial direction, thereby preventing invasiveness to the patient's body. The degree becomes smaller. Further, by removing the mandrel after inserting the high performance cannula into the living body, the main body of the cannula contracts in the axial direction and the diameter (inner diameter) increases. For this reason, the pressure loss in the catheter is reduced, and the required liquid flow rate can be ensured.
  • the distal end position of the catheter may be shifted due to contraction in the axial direction of the catheter.
  • blood removal or the like may not be suitably performed. Therefore, after the catheter is placed in the living body, it is required to suppress the shift of the tip position of the catheter. .
  • the present invention suppresses the burden on the patient's body, reduces the pressure loss of the liquid circulating in the circulation circuit, secures the necessary liquid flow rate, and after placing the catheter in the living body, It aims at providing the percutaneous catheter which can suppress that a tip position shifts
  • the percutaneous catheter that achieves the above object is a percutaneous catheter that extends in the axial direction and allows blood to pass therethrough, and is a first tube and a second tube that is provided on the proximal end side in the insertion direction of the first tube. And having.
  • the first tube has a thicker inner diameter than the second tube, and is configured to be more stretchable than the second tube.
  • the first tube has a first reinforcing body made of wires braided so as to cross each other.
  • the second tube has a second reinforcing body made of the wires braided so as to cross each other.
  • the first reinforcing body is configured such that a knitting angle, which is an inner angle in the axial direction, among angles formed by the intersecting wires is smaller than that of the second reinforcing body.
  • the percutaneous catheter is inserted into the living body in a state where the first tube extends in the axial direction and the outer diameter becomes small, so that the burden on the patient's body is suppressed. can do.
  • the first tube contracts in the axial direction and returns to its original state.
  • the first tube has an inner diameter larger than that of the second tube, the pressure loss in the first tube is reduced, and the required liquid flow rate can be ensured.
  • the wire constituting the first reinforcing body of the first tube is deformed so that the inclination angle with respect to the axial direction becomes gradually smaller.
  • the first reinforcing body is configured such that the knitting angle, which is the inner angle in the axial direction, of the angles formed by the intersecting wires is smaller than that of the second reinforcing body, the knitting angle of the first reinforcing body is the second.
  • the inclination angle with respect to the axial direction of the wire constituting the first reinforcing body becomes smaller, so The extension distance along the axial direction of the first tube accompanying the insertion of the tractor is shortened. Therefore, the contraction distance along the axial direction of the first tube when the dilator is removed from the percutaneous catheter is also shortened. Therefore, it is possible to prevent the distal end position of the catheter from shifting after the catheter is placed in the living body.
  • FIG. 5A is a schematic view of a portion indicated by reference numeral 5A in FIG. 2
  • FIG. 5B is a schematic view of a portion indicated by reference numeral 5B in FIG.
  • FIG. 5A is a schematic view of a portion indicated by reference numeral 5A in FIG. 2
  • FIG. 5B is a schematic view of a portion indicated by reference numeral 5B in FIG.
  • FIG. 5A is a schematic view of a portion indicated by reference numeral 5A in FIG. 2
  • FIG. 5B is a schematic view of a portion indicated by reference numeral 5B in FIG.
  • FIG. 9A and 9B are views for explaining the effect of the catheter according to the first embodiment, in which FIG. 9A shows the first tube before the dilator is inserted, and FIG. 9B shows the dilator. It is a figure which shows the 1st tube after inserting. It is a top view which shows the mode before inserting a dilator into the catheter which concerns on 2nd Embodiment. It is side surface sectional drawing which shows the catheter which concerns on 2nd Embodiment. It is a top view which shows the mode after inserting the dilator into the catheter which concerns on 2nd Embodiment.
  • FIG. 1 shows a case where a percutaneous catheter according to an embodiment of the present invention is applied, and when the heart of a patient is weak, the function of the heart and lungs is temporarily assisted and substituted until the heart function is restored.
  • PCPS percutaneous cardiopulmonary assist method
  • the extracorporeal circulation apparatus 1 blood is removed from a patient's vein (vena cava) by operating a pump, and blood is oxygenated by exchanging gas in the blood using an artificial lung.
  • a venous-arterial (VA) procedure to return to the patient's artery (aorta) can be performed.
  • the extracorporeal circulation device 1 is a device that assists the heart and lungs.
  • extracorporeal circulation a procedure for removing blood from a patient and performing a predetermined treatment outside the body and then sending blood again into the patient's body is referred to as “extracorporeal circulation”.
  • the extracorporeal circulation device 1 has a circulation circuit for circulating blood.
  • the circulation circuit includes an artificial lung 2, a centrifugal pump 3, a drive motor 4 which is a driving means for driving the centrifugal pump 3, a venous catheter (percutaneous catheter for blood removal) 5, and an arterial catheter ( And a controller 10 as a control unit.
  • the venous catheter (blood removal catheter) 5 is inserted from the femoral vein, and the distal end of the venous catheter 5 is placed in 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 artery 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 artificial lung 2, and then a blood supply tube (blood supply line). The blood can be returned to the patient P via 12.
  • the artificial lung 2 is disposed between the centrifugal pump 3 and the blood feeding tube 12.
  • the oxygenator 2 performs gas exchange (oxygenation and / or carbon dioxide removal) with respect to blood.
  • the oxygenator 2 is, for example, a membrane oxygenator, and a hollow fiber membrane oxygenator is particularly preferably used.
  • Oxygen gas is supplied from the oxygen gas supply unit 13 to the artificial lung 2 through the tube 14.
  • the blood supply tube 12 is a conduit connecting the artificial lung 2 and the artery side catheter 6.
  • a highly transparent and flexible synthetic resin flexible conduit such as vinyl chloride resin or silicone rubber can be used.
  • V1 direction blood that is liquid flows in the V1 direction
  • the blood supply tube 12 blood flows in the V2 direction.
  • the ultrasonic bubble detection sensor 20 is arranged in the middle of the blood removal tube 11.
  • the fast clamp 17 is disposed in the middle of the blood supply tube 12.
  • the ultrasonic bubble detection sensor 20 detects the mixed bubbles when bubbles are mixed in the circulation circuit due to erroneous operation of the three-way cock 18 or breakage of the tube during extracorporeal circulation.
  • the ultrasonic bubble detection sensor 20 detects that there is a bubble in the blood 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 by an alarm and lowers the rotational speed of the centrifugal pump 3 or stops the centrifugal pump 3.
  • the controller 10 instructs the fast clamp 17 to immediately close the blood feeding tube 12 by the fast clamp 17. This prevents bubbles from being sent into the patient P's body.
  • the controller 10 controls the operation of the extracorporeal circulation device 1 to prevent bubbles from entering the patient P's body.
  • the tube 11 (12, 19) of the circulation circuit of the extracorporeal circulation device 1 is provided with a pressure sensor.
  • the pressure sensor is, for example, any one of the attachment position A1 of the blood removal tube 11, the attachment position A2 of the blood supply tube 12 of the circulation circuit, or the attachment position A3 of the connection tube 19 that connects the centrifugal pump 3 and the artificial lung 2. Or one or all of them.
  • the pressure in the tube 11 (12, 19) can be measured by the pressure sensor.
  • the mounting position of the pressure sensor is not limited to the mounting positions A1, A2, and A3, and can be mounted at any position of the circulation circuit.
  • FIGS. 2 to 8 are views for explaining the configuration of the catheter 30 according to the first embodiment.
  • This catheter 30 is used as the venous catheter (blood removal catheter) 5 of FIG.
  • the catheter 30 includes a catheter tube 31, a connector 45 having a side hole 63, a distal end tip 41 having through holes 46 and 47 disposed at the distal end of the catheter tube 31, A clamp tube 34 disposed on the proximal end side of the catheter tube 31, a catheter connector 35 connecting the catheter tube 31 and the clamp tube 34, and a lock connector 36 are provided.
  • the side inserted into the living body is referred to as “tip” or “tip side”
  • the proximal side operated by the operator is referred to as “base end” or “base end side”.
  • the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof
  • the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof.
  • the catheter 30 has a lumen 30A that penetrates from the distal end to the proximal end.
  • the through holes 46 and 47 provided in the distal tip 41 and the side holes 63 provided in the connector 45 are arranged in different blood removal targets in the living body so that blood can be efficiently removed.
  • a dilator 50 shown in FIG. 2 is used.
  • the dilator 50 is inserted into the lumen 30A of the catheter 30, and the catheter 30 and the dilator 50 are inserted into the living body in a state of being integrated in advance.
  • the method for using the catheter 30 will be described in detail later.
  • the catheter tube 31 includes a first tube 32 and a second tube 33 connected to the proximal end side of the first tube 32 via a connector 45.
  • the first tube 32 is configured to be more stretchable than the second tube 33.
  • the first tube 32 is configured to have an outer diameter and an inner diameter larger than those of the second tube 33.
  • the lengths of the first tube 32 and the second tube 33 are configured to be necessary for arranging the through holes 46 and 47 of the tip tip 41 and the side hole 63 of the connector 45 on a desired blood removal target.
  • the length of the first tube 32 can be, for example, 20 to 40 cm
  • the length of the second tube 33 can be, for example, 20 to 30 cm.
  • blood removal targets are the right atrium and the inferior vena cava.
  • the catheter 30 is inserted and placed in the living body so that the through holes 46 and 47 of the distal tip 41 are disposed in the right atrium and the side hole 63 of the connector 45 is disposed in the inferior vena cava.
  • the first tube 32 is arranged in the inferior vena cava which is a relatively thick blood vessel, and the second tube 33 is a thigh which is a relatively thin blood vessel. Placed in the vein.
  • the catheter 30 when the dilator 50 is inserted into the lumen 30A of the catheter 30, the first tube 32 having high stretchability is elongated in the axial direction and the outer diameter and inner diameter are reduced as shown in FIG. At this time, the outer diameter of the first tube 32 is substantially the same as the outer diameter of the second tube 33. Since the catheter 30 is inserted into the living body in a state where the first tube 32 is extended in the axial direction and the outer diameter and inner diameter are reduced, the catheter 30 can be inserted with minimal invasiveness.
  • the first tube 32 contracts from the axially extended state, and the inner diameter increases.
  • the first tube 32 is disposed in the inferior vena cava which is a relatively thick blood vessel. Therefore, the outer diameter of the first tube 32 can be increased, and the inner diameter can be increased accordingly.
  • the pressure loss in the first tube 32 is the total length of the first tube 32 ⁇ (average) passage cross-sectional area, respectively. That is, by increasing the inner diameter of the first tube 32, the pressure loss in the first tube 32 is reduced. When the pressure loss in the first tube 32 is reduced, the flow rate of blood flowing through the circulation circuit increases. For this reason, in order to obtain a sufficient blood circulation amount, it is necessary to increase the inner diameter of the first tube 32.
  • the inner diameter of the first tube 32 can be, for example, 9 to 11 mm
  • the inner diameter of the second tube 33 can be, for example, 4 to 8 mm.
  • the thickness of the first tube 32 and the second tube 33 can be set to 0.4 to 0.5 mm, for example.
  • the distal end portion and the proximal end portion of the first tube 32 form a tapered portion that gradually decreases from the center of the first tube 32 toward the outer side in the axial direction.
  • the inner diameters of the distal end and the proximal end of the first tube 32 are continuous with the inner diameter of the distal end tip 41 disposed on the distal end side and the inner diameter of the second tube 33 disposed on the proximal end side, respectively.
  • the first tube 32 is provided so as to cover the first reinforcement body 321 composed of the wires W braided so as to cross each other, and the first reinforcement body 321.
  • the second tube 33 is provided so as to cover the second reinforcing body 331 composed of the wires W braided so as to cross each other, and the second reinforcing body 331.
  • a second resin layer 332 is provided so as to cover the second reinforcing body 331 composed of the wires W braided so as to cross each other, and the second reinforcing body 331.
  • the first reinforcing body 321 is formed by braiding wires W so as to have a knitting angle ⁇ 1. Further, as shown in FIG. 5B, the second reinforcing body 331 is configured by braiding the wire W so that the knitting angle ⁇ 2 is obtained.
  • the knitting angles ⁇ 1 and ⁇ 2 are defined as inner angles in the axial direction among the angles formed by the intersecting wires W, as shown in FIGS. 5 (A) and 5 (B).
  • the knitting angle ⁇ 1 of the first reinforcing body 321 is configured to be smaller than the knitting angle ⁇ 2 of the second reinforcing body 331 as shown in FIGS. 5 (A) and 5 (B). For this reason, the inclination angle with respect to the axial direction of the wire W constituting the first reinforcing body 321 is smaller than the case where the knitting angle of the first reinforcing body 321 is larger than the knitting angle of the second reinforcing body 331.
  • the wire W constituting the first reinforcing body 321 of the first tube 32 is deformed so that the inclination angle with respect to the axial direction gradually decreases. And when the inclination-angle with respect to the axial direction of the wire W which comprises the 1st reinforcement body 321 of the 1st tube 32 becomes about zero, the expansion
  • the knitting angle ⁇ 1 of the first reinforcing body 321 is smaller than the knitting angle ⁇ 2 of the second reinforcing body 331, the knitting angle of the first reinforcing body 321 is larger than the knitting angle of the second reinforcing body 331, and In comparison, the extension distance along the axial direction of the first tube 32 accompanying the insertion of the dilator 50 into the catheter 30 is shortened.
  • 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, a titanium-based (Ni—Ti, Ti—Pd, Ti—Nb—Sn, etc.) or a copper-based alloy can be used.
  • the shape memory resin for example, acrylic resin, transisoprene polymer, polynorbornene, styrene-butadiene copolymer, and polyurethane can be used.
  • the contraction distance along the axial direction of the first tube 32 associated with the removal of the dilator 50 from the catheter 30 is the first as the dilator 50 is inserted through the catheter 30. It becomes the same as the extension distance along the axial direction of one tube 32.
  • the contraction along the axial direction of the first tube 32 accompanying the removal of the dilator 50 from the catheter 30. It is necessary to shorten the distance, and the first reinforcing body 321 constituting the first tube 32 is shortened so that the extension distance along the axial direction of the first tube 32 when the dilator 50 is inserted into the catheter 30 is shortened. It is necessary to set the knitting angle ⁇ 1.
  • the following shows the results of an extension test using three tubes with different knitting angles. Specifically, using a tube with a length of 100 mm, an outer diameter of 10 mm, and a knitting angle of 72 degrees, 90 degrees, and 120 degrees, it extends in the axial direction until the outer diameter changes from 10 mm to 7 mm. The extension distance when measured was measured.
  • the extension distance was 14 mm when the knitting angle was 72 degrees.
  • the extension distance was 40 mm.
  • the extension distance was 60 mm.
  • the upper limit of the knitting angle ⁇ 1 of the first reinforcing body 321 is preferably 90 degrees.
  • the upper limit of the knitting angle ⁇ 1 of the first reinforcing body 321 is 75 degrees.
  • the lower limit of the knitting angle ⁇ 1 of the first reinforcing body 321 can reduce the outer diameter of the first tube 32 to about the outer diameter of the second tube 33 when the dilator 50 is inserted through the catheter 30.
  • the catheter 30 is preferably 70 degrees from the viewpoint of suppressing the burden on the patient's body and suppressing the decrease in kink resistance. That is, when the knitting angle ⁇ 1 of the first reinforcing body 321 is less than 70 degrees, when the kink resistance is lowered or the dilator 50 is inserted through the catheter 30, the outer diameter of the first tube 32 is set to a desired outer diameter. It may not be possible to make it smaller.
  • the knitting angle ⁇ 1 is at least 70 degrees or more, the first tube 32 can be suitably reduced in diameter.
  • the knitting angle ⁇ 2 of the second reinforcing body 331 is not limited as long as it is larger than the knitting angle ⁇ 1 of the first reinforcing body 321. For example, it is preferably 90 to 120 degrees. Thus, by making the knitting angle ⁇ 2 of the second reinforcing body 331 larger than the knitting angle ⁇ 1 of the first reinforcing body 321, the kink resistance of the second reinforcing body 331 can be improved. For this reason, the catheter 30 can be preferably inserted into the living body in the femoral vein having an intricate configuration.
  • the first reinforcing body 321 of the first tube 32 is configured to be braided so as to be sparser than the second reinforcing body 331 of the second tube 33. Yes. According to this structure, compared with the 2nd tube 33, the 1st tube 32 can be made soft and a stretching property can be improved.
  • the wire diameter of the wire W is preferably 0.1 mm to 0.2 mm.
  • the wire W has a wire diameter of 0.1 mm or more, the function as a reinforcing body for improving the strength can be suitably exhibited.
  • the thickness of the first tube 32 can be 0.5 mm or less, and the inner diameter can be increased while reducing the outer diameter.
  • the burden on the patient's body when the catheter 30 is inserted can be reduced and the pressure loss can be reduced. Further, at this time, it is possible to prevent the wire W from being exposed from the first resin layer 322 even in a portion where the wire W is braided to form two layers.
  • the cross section of the wire W is circular, but is not limited thereto, and may be rectangular, square, elliptical, or the like.
  • the first resin layer 322 of the first tube 32 is made of a soft material having a lower hardness than the second resin layer 332 of the second tube 33. According to this structure, compared with the 2nd tube 33, the 1st tube 32 can be made soft and a stretching property can be improved.
  • the first and second resin layers 322 and 332 can be formed using vinyl chloride, silicon, polyethylene, nylon, urethane, polyurethane, fluorine resin, thermoplastic elastomer resin, or a composite material thereof.
  • Silicon material has high biocompatibility and the material itself is soft.
  • the polyethylene material is soft and has a hardness that can withstand pressure.
  • polyethylene materials have biocompatibility comparable to silicon materials.
  • Polyethylene material is harder than silicon and has the advantage of being easily inserted into thin blood vessels.
  • Polyurethane material has a feature that it becomes soft after insertion.
  • materials for the first and second resin layers 322 and 332 applicable materials can be used taking advantage of the characteristics of these materials.
  • a hydrophilic coating may be applied to the polyurethane material.
  • the tube surface is smooth, blood vessel insertion is easy, and the blood vessel wall is not easily damaged. Blood and protein are less likely to adhere, and it can be expected to prevent thrombus formation.
  • the method of forming the tubes 32 and 33 is not particularly limited, but can be formed by, for example, dip coating (immersion method) or insert molding. Note that at least the outer surfaces of the reinforcing bodies 321 and 331 may be covered with the resin layers 322 and 332.
  • the connector 45 is a joint member that connects the first tube 32 and the second tube 33 as shown in FIGS.
  • the connector 45 is a cylindrical body as a whole, and is formed of, for example, hard plastic.
  • the connector 45 has connecting portions 42 and 43 which are reduced diameter portions at both ends of the cylindrical body.
  • the connection portions 42 and 43 are inserted into the first and second tubes 32 and 33, so that the liquid passage 64 provided inside communicates with the first and second tubes 32 and 33.
  • the connector 45 has a side hole 63 opened on a side surface.
  • the side hole 63 functions as a blood removal hole. It is preferable to have a plurality of side holes 63 in the circumferential direction. In the present embodiment, the connector 45 is provided with four side holes 63 in the circumferential direction. As a result, even if one side hole 63 is adsorbed and blocked by the blood vessel wall due to blood removal, blood removal can be performed by the other side hole 63, so that blood circulation can be performed stably. .
  • the tip 41 is disposed at the tip of the first tube 32 as shown in FIG.
  • the tip 41 has a shape with a narrow tip that is gradually reduced in diameter toward the tip.
  • a flat receiving surface 48 is formed on the inner side of the tip 41 to come into contact with the flat surface 50a of the dilator 50 used prior to insertion of the catheter 30 into the living body.
  • the tip tip 41 includes a base 49 that is inserted into the tip of the first tube 32, a plurality of through holes 46 provided on the side surface, and a through hole 47 provided at the tip of the tip tip 41. And have.
  • the through holes 46 and 47 function as blood removal holes.
  • the through hole 47 of the distal tip 41 constitutes a part of the lumen 30A of the catheter 30.
  • the tip 41 can be made of hard plastic, for example.
  • the clamping tube 34 is provided on the proximal end side of the second tube 33 as shown in FIGS. A lumen through which the dilator 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 second tube 33 and the clamp tube 34 as shown in FIGS.
  • a lumen through which the dilator 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 dilator 50 can be inserted is provided inside the lock connector 36.
  • a male screw portion 36A provided with a screw thread is provided on the outer surface of the base end side of the lock connector 36.
  • the dilator 50 includes a dilator tube 51 that extends in the axial direction, a dilator hub 52 to which the base end of the dilator tube 51 is fixed, and a tip of the dilator hub 52. And a screw ring 53 provided on the head.
  • the dilator tube 51 is an elongated body extending in the axial direction and having relatively high rigidity.
  • the total length along the axial direction of the dilator tube 51 is configured to be longer than the total length along the axial direction of the catheter 30.
  • the dilator tube 51 includes a guide wire lumen 54 through which a guide wire (not shown) can be inserted.
  • the dilator tube 51 is guided by the guide wire and inserted into the living body together with the catheter 30.
  • the dilator tube 51 is extracted from the catheter 30 by pulling out the dilator hub 52 toward the proximal end after the catheter 30 is placed in the living body.
  • the tip of the dilator tube 51 has a flat surface 50a with which the receiving surface 48 of the tip tip 41 abuts.
  • the dilator tube 51 has relatively high rigidity, and is provided with a stiffness that enables the pushing force toward the distal end side by a hand operation to be transmitted to the distal end tip 41. For this reason, the dilator tube 51 plays the role of expanding a narrow blood vessel by bringing the flat surface 50a into contact with the receiving surface 48 of the tip 41 and pushing the tip 41 toward the tip.
  • the screw ring 53 has a female screw portion (not shown) provided with a screw groove on the inner surface of the lumen.
  • the dilator 50 can be attached to the catheter 30 by screwing the female screw portion of the screw ring 53 into the male screw portion 36 ⁇ / b> A of the lock connector 36.
  • FIG. 2 shows a state before the dilator tube 51 of the dilator 50 is inserted through the lumen 30A of the catheter 30, and
  • FIG. 4 shows a state after the dilator tube 51 is inserted through the lumen 30A of the catheter 30.
  • the dilator tube 51 of the dilator 50 is inserted into the lumen 30 ⁇ / b> A of the catheter 30.
  • the dilator tube 51 passes through the inside of the second tube 33 and the first tube 32 in order, and the flat surface 50a of the dilator tube 51 contacts the receiving surface 48 of the tip tip 41.
  • the total length of the dilator tube 51 in the axial direction is longer than the total length of the catheter 30 in the axial direction.
  • the tip 41 is pressed to the tip side in a state where the flat surface 50 a of the dilator tube 51 is in contact with the receiving surface 48 of the tip 41.
  • the distal end of the first tube 32 fixed to the distal tip 41 is pulled toward the distal end side.
  • the catheter 30 receives a force extending in the axial direction, and the first tube 32 having a relatively high elasticity in the catheter 30 extends in the axial direction.
  • the proximal end of the catheter 30 is fixed to the dilator hub 52.
  • the first tube 32 changes from the state shown in FIG. 9A to the state shown in FIG. 9B. That is, the first tube 32 extends in the axial direction by the extension distance L, and the outer diameter of the first tube is reduced to be substantially the same as the outer diameter of the second tube 33 (see FIG. 4).
  • the wire W constituting the first reinforcing body 321 of the first tube 32 is deformed so that the inclination angle with respect to the axial direction gradually decreases as the first tube 32 extends in the axial direction.
  • the knitting angle ⁇ 1 of the first reinforcing body 321 is configured to be smaller than the knitting angle ⁇ 2 of the second reinforcing body 331, as described above, the knitting angle of the first reinforcing body 321 is the second. Compared with the case where the knitting angle of the reinforcing body 331 is larger, the extension distance L can be shortened.
  • the catheter 30 through which the dilator 50 is inserted is inserted along a guide wire (not shown) that has been previously inserted into the target site in the living body.
  • a guide wire not shown
  • the outer diameter of the first tube 32 is substantially the same as the outer diameter of the second tube 33, and insertion of the catheter 30 into the living body is minimally invasive. It can be carried out at the same time, and the burden on the patient's body can be suppressed.
  • the catheter 30 is inserted into the living body until the through holes 46 and 47 of the distal tip 41 are disposed in the right atrium and the side hole 63 of the connector 45 is disposed in the inferior vena cava.
  • the first tube 32 is arranged in the inferior vena cava which is a relatively thick blood vessel
  • the second tube 33 is a thigh which is a relatively thin blood vessel. Placed in the vein.
  • the dilator tube 51 and the guide wire are removed from the catheter 30.
  • the dilator tube 51 and the guide wire are once pulled out to the location of the clamping tube 34 of the catheter 30 and clamped with forceps (not shown), and then completely removed from the catheter 30.
  • the catheter 30 is released from the axially extending force that the catheter 30 received from the dilator 50.
  • the first tube 32 contracts in the axial direction, and the inner diameter of the first tube 32 increases. Thereby, the pressure loss in the 1st tube 32 can be reduced and the required flow volume of the liquid can be ensured.
  • the catheter 30 is configured so that the knitting angle ⁇ 1 of the first reinforcing body 321 is smaller than the knitting angle ⁇ 2 of the second reinforcing body 331.
  • the extension distance L along the axial direction of the first tube 32 when the dilator 50 is inserted through the catheter 30 is shorter than when the knitting angle is larger than the knitting angle of the second reinforcing body 331.
  • the wire W is made of a shape memory material, the contraction distance along the axial direction of the first tube 32 when the dilator 50 is removed from the catheter 30 is inserted through the catheter 30. It becomes the same as the extension distance along the axial direction of the 1st tube 32 in connection with doing.
  • the contraction distance along the axial direction of the first tube 32 when the dilator 50 is removed from the catheter 30 is also compared with the case where the knitting angle of the first reinforcing body 321 is larger than the knitting angle of the second reinforcing body 331. And get shorter. Therefore, it is possible to prevent the distal end position of the catheter 30 from shifting after the catheter 30 is placed in the living body.
  • the lock connector 36 of the catheter 30 is connected to the blood removal tube 11 of the extracorporeal circulation apparatus of FIG. After confirming that the connection of the catheter on the blood supply side is completed, the forceps of the clamp tube 34 are released, and extracorporeal circulation is started.
  • the catheter 30 is removed from the blood vessel, and hemostasis is repaired by a surgical technique as necessary at the insertion site.
  • the catheter 30 is a catheter 30 that extends in the axial direction and allows blood to pass therethrough.
  • the catheter 30 includes a first tube 32 and a second tube 33 provided on the proximal end side in the insertion direction of the first tube 32.
  • the first tube 32 has an inner diameter larger than that of the second tube 33 and is configured to be more stretchable than the second tube 33.
  • the 1st tube 32 has the 1st reinforcement body 321 which consists of the wire W braided so that it may cross, and the 2nd tube 33 has the 2nd reinforcement body 331 which consists of the wire W braided so that it may intersect.
  • the first reinforcing body 321 is configured such that the knitting angle, which is the inner angle in the axial direction, of the angles formed by the intersecting wires W is smaller than that of the second reinforcing body 331.
  • the first tube 32 is higher in elasticity than the second tube 33, and therefore the first tube 32 extends in the axial direction by inserting the dilator 50 through the catheter 30. Since the first tube 32 is extended in the axial direction, the outer diameter of the first tube 32 is reduced. Since the catheter 30 is inserted into the living body in this state, the burden on the patient's body can be suppressed.
  • the first tube 32 contracts from the axially extended state and returns to its original state.
  • the first tube 32 has an inner diameter larger than that of the second tube 33, the pressure loss in the first tube 32 is reduced, and the necessary liquid flow rate can be ensured.
  • the first tube 32 extends in the axial direction as described above.
  • the wire W constituting the first reinforcing body 321 of the first tube 32 is deformed so that the inclination angle with respect to the axial direction gradually decreases as the first tube 32 extends in the axial direction.
  • the first reinforcing body 321 is configured such that the knitting angle, which is the inner angle in the axial direction, among the angles formed by the intersecting wires W is smaller than that of the second reinforcing body 331.
  • the inclination angle of W with respect to the axial direction becomes small.
  • the contraction distance along the axial direction of the first tube 32 when the dilator 50 is removed from the catheter 30 is also compared with the case where the knitting angle of the first reinforcing body 321 is larger than the knitting angle of the second reinforcing body 331. And get shorter. Therefore, it is possible to prevent the distal end position of the catheter 30 from shifting after the catheter 30 is placed in the living body.
  • the pressure loss of the liquid circulating in the circulation circuit is reduced and the necessary liquid flow rate is secured, and the catheter 30 is placed in the living body, and then the catheter is placed.
  • the catheter 30 which can suppress that the front-end
  • the knitting angle ⁇ 1 of the first reinforcing body 321 is 70 degrees to 90 degrees.
  • the outer diameter of the first tube 32 can be reduced to a desired size when the dilator 50 is inserted into the catheter 30.
  • the burden on the patient's body can be suppressed.
  • the fall of kink resistance can be suppressed by making the knitting angle (theta) 1 of the 1st reinforcement body 321 70 degrees or more.
  • the knitting angle ⁇ 1 of the first reinforcing body 321 is set to 90 degrees or less, when the dilator 50 is removed from the catheter 30 after the catheter 30 is left in the living body, the distal end position of the catheter 30 is displaced. It is possible to suppress the increase.
  • the wire W has a wire diameter of 0.1 mm to 0.2 mm.
  • the diameter of the wire W By setting the diameter of the wire W to 0.1 mm or more, the functions as the first reinforcing body 321 and the second reinforcing body 331 that improve the strength can be suitably exhibited.
  • the thickness of the first tube 32 can be 0.5 mm or less, and the inner diameter can be increased while reducing the outer diameter. The burden on the patient's body when the catheter 30 is inserted can be reduced and the pressure loss can be reduced. Further, at this time, it is possible to prevent the wire W from being exposed from the first resin layer 322 even in a portion where the wire W is braided to form two layers.
  • the wire W is made of a shape memory material. For this reason, when the dilator 50 is removed from the catheter 30, it contracts in the axial direction and preferably returns to its original shape. Therefore, the pressure loss can be more suitably reduced.
  • the catheter 30 is disposed at the distal end of the first tube 32, and connects the distal tip 41 having the through holes 46 and 47, the first tube 32 and the second tube 33, and a side hole opened to the side surface. And a connector 45 having 63. For this reason, blood removal can be performed via the tip 41 and the connector 45. Therefore, blood circulation can be performed stably.
  • FIGS. 10 to 12 are views for explaining the configuration of the catheter 60 according to the second embodiment.
  • the catheter 60 is a so-called double lumen catheter and can perform both blood feeding and blood removal at the same time. Therefore, in this embodiment, the extracorporeal circulation apparatus of FIG. 1 does not use two catheters, ie, a venous catheter (blood removal catheter) 5 and an artery side catheter (blood feeding catheter) 6. The procedure is performed using only the catheter 60.
  • the catheter 60 includes a third tube 161 including a first lumen 61 communicating with the blood supply side hole 163 of the connector 145, and the lumen of the second tube 133. It differs from the catheter 30 which concerns on 1st Embodiment by the point which has the double tube
  • the pump of the extracorporeal circulation device is operated to remove blood from the vein (vena cava) of the patient, and after blood oxygenation is performed by exchanging blood in the blood using an artificial lung, this blood Venous-venous (VV-Venous, VV) extracorporeal blood circulation can be performed.
  • VV-Venous, VV Venous-venous
  • the catheter 60 is disposed at the distal end of the first tube 32, the second tube 133, the connector 145 connecting the first tube 32 and the second tube 133, and the first tube 32. And a third tube 161 disposed in the lumen of the second tube 133. Since the structure of the 1st tube 32 and the front-end
  • the catheter 60 has a first lumen 61 that functions as a blood supply path and a second lumen 62 that functions as a blood removal path.
  • the first lumen 61 is formed in the lumen of the third tube 161.
  • the second lumen 62 is formed in the lumen of the first tube 32, the second tube 133, and the connector 145, and penetrates from the distal end to the proximal end.
  • the connector 145 includes a blood supply side hole 163 communicating with the first lumen 61 which is a blood supply path.
  • the second tube 133 includes a blood removal side hole 164 communicating with the second lumen 62 which is a blood removal path.
  • the blood supply side hole 163 and the blood removal side hole 164 are configured in an elliptical shape.
  • the third tube 161 is inserted into the second lumen 62 from the base end side of the second tube 133 and connected to the blood feeding side hole 163.
  • the blood-feeding side hole 163 is arranged in a living body and the blood oxygenated by the artificial lung is delivered into the living body through the blood-feeding side hole 163.
  • the through holes 46 and 47 provided in the distal tip 41 and the blood removal side holes 164 provided in the second tube 133 are arranged in different blood removal targets in the living body and are configured to perform blood removal efficiently.
  • the through holes 46 and 47 or the blood removal side hole 164 are adsorbed to the blood vessel wall and blocked, blood removal can be performed from the hole that is not blocked, thus stabilizing the extracorporeal circulation. Can be done.
  • the catheter 60 is inserted from the internal jugular vein of the neck, and the distal end is placed in the inferior vena cava via the superior vena cava and the right atrium.
  • the blood supply target is the right atrium, and the blood removal targets are the superior vena cava and the inferior vena cava.
  • the catheter 60 has the dilator 50 inserted therein, the through holes 46 and 47 of the tip 41 are in the inferior vena cava, and the blood removal side hole 164 of the second tube 133 is in the internal neck. It is inserted and placed in the living body so as to be placed in a vein.
  • the first tube 32 is configured to have a larger inner diameter than the second tube 133.
  • the first tube 32 is arranged in the inferior vena cava which is a relatively thick blood vessel, and the second tube 133 is a relatively thin blood vessel. Placed in the femoral vein.
  • the lock connector 136 includes a first lock connector 137 that communicates with the first lumen 61 and a second lock connector that is provided in parallel to the first lock connector 137 and communicates with the second lumen 62. 138.
  • the lock connector 136 is a Y-shaped Y connector formed by branching the first lock connector 137 from the second lock connector 138.
  • the first lock connector 137 is connected to the proximal end portion of the third tube 161.
  • the second lock connector 138 is coaxially connected to the proximal end portion of the second tube 133.
  • a blood supply tube (blood supply line) is connected to the first lock connector 137, and a blood removal tube (blood removal line) is connected to the second lock connector 138.
  • the first tube 32 exhibits the same function as the first embodiment, and has the same function and effect.
  • both functions of blood removal and blood feeding can be achieved with a single catheter.
  • the first reinforcing body 321 is braided so as to be sparser than the second reinforcing body 331, so that the first tube 32 is compared with the second tube 33. Softened to increase elasticity.
  • the wire diameter of the wire W constituting the first reinforcement body 321 of the first tube 32 is made larger than the wire diameter of the wire W constituting the second reinforcement body 331 of the second tube 33. By making it smaller, the first tube 32 may be made softer than the second tube 33 to enhance the stretchability.
  • the material constituting the wire W is not limited to the configuration that allows the shape memory material to be used as long as the material has a restoring force that deforms and returns to the original shape, and has a function of reinforcing the resin layer. It can be made of a known elastic material.
  • the catheter 30 was used as the venous catheter (blood removal catheter) 5 of FIG.
  • the catheter 30 may be used as the artery side catheter (blood feeding catheter) 6 of FIG.
  • the through holes 46 and 47 and the blood removal side hole 164 are used for blood removal, and the blood supply side hole 163 is used for blood supply.
  • the through holes 46 and 47 and the side holes 164 may be used for blood feeding, and the side holes 163 may be used for blood removal.
  • the first tube 32 includes the first resin layer 322.
  • the present invention is not limited to this configuration, and the first resin layer 322 may not include the first resin layer.

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  • Anesthesiology (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

Le problème décrit par la présente invention est de fournir un cathéter percutané qui est apte : à réduire la perte de pression d'un liquide circulant dans un circuit de circulation ; à assurer le débit requis du liquide, sans augmenter le caractère effractif ou la charge sur le corps d'un patient ; et à empêcher le déplacement de la position de la pointe du cathéter percutané après que le cathéter percutané ait été inséré dans un organisme vivant. La solution selon l'invention porte sur un cathéter percutané (30) comprend : un premier tube (32) ; et un second tube (33) qui est disposé sur le côté d'extrémité de base du premier tube dans le sens d'insertion, est doté d'un diamètre interne inférieur à celui du premier tube, et a une extensibilité inférieure à celle du premier tube. Le premier tube est pourvu d'un premier corps de renforcement (321) comprenant des fils (W) qui sont tressés de façon à se croiser mutuellement. Le second tube est pourvu d'un second corps de renforcement (331) comprenant des fils qui sont tressés de façon à se croiser mutuellement. Le premier corps de renforcement est formé de telle sorte que les angles de tressage, c'est-à-dire les angles internes dans la direction axiale parmi les angles formés par les fils d'intersection, sont plus petits que ceux du second corps de renforcement.
PCT/JP2017/008826 2016-04-05 2017-03-06 Cathéter percutané WO2017175530A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2018510276A JP6813570B2 (ja) 2016-04-05 2017-03-06 経皮カテーテル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016-076098 2016-04-05
JP2016076098 2016-04-05

Publications (1)

Publication Number Publication Date
WO2017175530A1 true WO2017175530A1 (fr) 2017-10-12

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Application Number Title Priority Date Filing Date
PCT/JP2017/008826 WO2017175530A1 (fr) 2016-04-05 2017-03-06 Cathéter percutané

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JP (1) JP6813570B2 (fr)
WO (1) WO2017175530A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021172155A1 (fr) * 2020-02-25 2021-09-02 テルモ株式会社 Cathéter percutané

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001518325A (ja) * 1997-09-30 2001-10-16 ボストン サイエンティフィック リミテッド 軟先端高性能編組カテーテル
JP2009148602A (ja) * 1999-11-11 2009-07-09 Edwards Lifesciences Corp 増大したドレナージを有する静脈還流カニューレ
JP5059305B2 (ja) * 2000-01-18 2012-10-24 コラフロ リミテッド ライアビリティ カンパニー 高性能カニューレ

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001518325A (ja) * 1997-09-30 2001-10-16 ボストン サイエンティフィック リミテッド 軟先端高性能編組カテーテル
JP2009148602A (ja) * 1999-11-11 2009-07-09 Edwards Lifesciences Corp 増大したドレナージを有する静脈還流カニューレ
JP5059305B2 (ja) * 2000-01-18 2012-10-24 コラフロ リミテッド ライアビリティ カンパニー 高性能カニューレ

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021172155A1 (fr) * 2020-02-25 2021-09-02 テルモ株式会社 Cathéter percutané

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JP6813570B2 (ja) 2021-01-13

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