JP6249843B2 - Medical tube, method for manufacturing medical tube, and catheter - Google Patents

Description

  The present invention relates to a medical tube used for diagnosis of a biological lumen such as a blood vessel, a method for manufacturing the medical tube, and a catheter including the medical tube.

  Ultrasound for observing the nature of the stenosis, or for observing the condition after treatment, during percutaneous treatment of a stenosis that causes myocardial infarction that occurs in a body lumen such as blood vessels and vessels Alternatively, a diagnostic catheter that acquires an image of a living body lumen using a test wave such as light is used.

  An ultrasonic catheter is used for intravascular ultrasound (IVUS). The ultrasonic catheter is provided with an ultrasonic transducer or an ultrasonic reflection mirror rotatably at the distal end of the insertion portion, inserted into a body cavity, and then rotated via a drive shaft or the like extending from the drive portion on the hand side. Scanning (radial scanning) is common. These configurations are contained within a medical tube to form a catheter.

  Since the medical tube on the insertion tip side of the catheter is inserted into a coronary artery or the like and scanned for image acquisition, a flexible resin (for example, polyethylene (PE)) is used. On the other hand, in order to improve the pushability of the medical tube on the base side of the catheter, a hard resin (for example, polyetheretherketone (PEEK), polyimide (PI), polyamide (PA), etc.) or metal (for example, Stainless steel) is used.

  Patent Document 1 discloses a medical tube whose rigidity gradually decreases from the proximal end side toward the distal end side.

International Publication No. 2013/077275

  However, in general, the resin used for the medical tube on the insertion distal end side and the resin used for the medical tube on the proximal end side have different melting points, and joining by fusion is difficult. Therefore, although bonding by pressure bonding or adhesion is usually performed, there is a problem of insufficient strength in the case of pressure bonding, and there is a problem that the diameter of the bonded portion becomes large in the case of bonding.

  The present invention has been made in view of the above problems, and in a medical tube composed of a plurality of resins, a technique for joining so that the joint portion maintains sufficient strength and the diameter of the joint portion does not increase. The purpose is to provide.

In order to achieve the above object, a medical tube according to the present invention has the following configuration. That is,
A medical tube,
A first tube;
A second tube in which the material of the tube is polyetheretherketone (PEEK) ;
A third tube covering a part of the first tube and a part of the second tube;
The second tube has a notch;
The distal end portion of the first tube is inserted into the second tube, and is fused to the third tube through the notch portion.

  ADVANTAGE OF THE INVENTION According to this invention, in the medical tube comprised with several resin, it becomes possible to join so that a joining location keeps sufficient intensity | strength and the diameter of a joining location does not become thick.

It is a figure which shows the structure of the catheter 10 which concerns on one Embodiment of this invention. It is a figure which shows an example of the internal structure of the area | region A of the catheter 10 which concerns on one Embodiment of this invention. It is a figure which shows an example of the internal structure of the area | region B of the catheter 10 which concerns on one Embodiment of this invention. It is a figure showing an example of appearance composition of field B of catheter 10 concerning one embodiment of the present invention. It is a flowchart which shows the manufacture procedure of the medical tube which concerns on one Embodiment of this invention.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. Throughout the drawings, the same reference numerals refer to the same components.

1. Configuration of Catheter FIG. 1 is a diagram showing a configuration of a catheter 10 according to an embodiment of the present invention. In the following, an ultrasonic catheter will be described as an example of a catheter. However, the embodiment of the present invention is not limited to an ultrasonic catheter, but can be applied to other types of catheters such as an OCT catheter.

  As shown in FIG. 1, a catheter 10 includes a long medical tube 101 that is inserted into a blood vessel, and a connector 102 that is not inserted into the blood vessel to be operated by the user and is disposed on the user's hand side. including. The medical tube 101 includes a first tube 101a and a second tube 101b.

  Since the first medical tube 101a on the insertion tip side of the catheter 10 is inserted into the coronary artery and scanned for image acquisition, a flexible resin (for example, polyethylene (PE)) is used. . For the second medical tube 101b on the base side of the catheter 10, in order to improve pushability, hard resin (for example, polyether ether ketone (PEEK), polyimide (PI), polyamide (PA), etc.) or metal ( For example, stainless steel is used. The first tube 101a and the second tube 101b are fused by a method described later.

  A guide wire lumen 103 is formed at the distal end of the medical tube 101, and the medical tube 101 is formed as a continuous lumen from a connection portion with the guide wire lumen 103 to a connection portion with the connector 102.

  The connector 102 includes a tube connector 102a configured integrally with a proximal end of the medical tube 101 and a drive shaft connector 102b configured integrally with a proximal end of a drive shaft (a drive shaft 202 described later). An anti-kink protector 1021 is provided at the boundary between the tube connector 102a and the medical tube 101. Thereby, a predetermined rigidity is maintained, and bending (kink) due to a rapid change can be prevented. The drive shaft connector 102b is provided with an injection port 1022 to which a syringe (not shown) or the like can be attached in order to fill the entire lumen of the medical tube 101 with the ultrasonic transmission liquid. The base end of the drive shaft connector 102b is configured to be connectable to a scanner / pullback unit (not shown), and is movable in the direction of the arrow 104.

  Next, the configuration of the distal end portion (region A in FIG. 1) of the catheter 10 will be described with reference to FIG. In FIG. 2, inside the lumen of the medical tube 101, there are an ultrasonic transducer unit 201 that transmits and receives ultrasonic waves, and a drive shaft 202 that transmits a driving force for rotating the ultrasonic transducer unit 201. The imaging core 203 can be accommodated, and is inserted through almost the entire length of the medical tube 101. The ultrasonic transducer unit 201 includes an ultrasonic transducer 201a and a housing 201b that holds the ultrasonic transducer 201a, and ultrasonic waves are transmitted from the ultrasonic transducer 201a toward the body cavity tissue. The ultrasonic transducer 201a receives a reflected wave from the body cavity tissue.

  The drive shaft 202 is formed in a coil shape, and a signal line is disposed therein, and extends from the ultrasonic transducer 201a to the connector 102. The ultrasonic transducer 201a has a rectangular or circular shape, and is formed by vapor-depositing electrodes on both sides of a piezoelectric material made of PZT or the like. The ultrasonic transducer 201a is installed so as to be positioned near the center in the rotation axis direction so that the drive shaft 202 does not cause rotation unevenness.

  The housing 201b has a shape having a notch in a part of a short cylindrical metal pipe, and is formed by cutting out from a metal lump, MIM (metal powder injection molding) or the like. The housing 201 b has an ultrasonic transducer 201 a inside, and the base end side is connected to the drive shaft 202. Further, a short coil-shaped elastic member 204 may be provided on the distal end side. By doing so, the stability during rotation of the imaging core 203 is improved.

  The drive shaft 202 can be rotated and slid with respect to the medical tube 101, has flexibility and can transmit the rotation well, for example, a multi-layered close contact coil made of a metal wire such as stainless steel, etc. It is comprised by.

  The inside of the lumen can be observed and photographed by rotating the drive shaft 202, but in order to observe and photograph a wider range, the drive shaft 202 is slid in the axial direction relative to the medical tube 101. You can do it.

  Specifically, with the tube connector 102a fixed, the drive shaft connector 102b is slid toward the proximal end side (in the direction of arrow 104 in FIG. 1), so that the ultrasonic vibration fixed to the internal drive shaft 202 or the distal end thereof is fixed. The child unit 201 slides in the axial direction (that is, in the direction of the arrow 205 in FIG. 2). This sliding in the axial direction may be performed manually by the user or electrically.

2. Structure of Medical Tube Next, with reference to FIG. 3 and FIG. 4, the structure of the medical tube 101 according to one embodiment of the present invention (region B in FIG. 1) will be described. FIG. 3 is a diagram illustrating an example of the internal configuration of the region B of the catheter 10 according to the embodiment of the present invention. FIG. 4 is a diagram illustrating an example of an external configuration of the region B of the catheter 10 according to the embodiment of the present invention.

  As shown in FIGS. 3 and 4, the tip portion 1011a of the first tube 101a is inserted into the tip portion 1011b of the second tube 101b. A notch 301 is provided at the tip 1011b of the second tube 101b. The number and shape of the notches 301 are arbitrary, but at least one of a spiral, a rectangle, a circle, and an ellipse can be used. In this embodiment, it is a spiral shape.

  The distal end portion 1011a of the first tube 101a is further covered with the third tube 101c while being inserted into the distal end portion 1011b of the second tube 101b. The third tube 101c is an outer layer tube that covers a part of the first tube 101a and a part of the second tube 101b.

  The third tube 101c is made of a material that is fused with the first tube 101a and is not fused with the second tube 101b. The third tube 101c may be made of the same material as the first tube 101a or a material having a melting point close to that of the first tube 101a. The distal end portion 1011a of the first tube 101a is inserted into the second tube 101b and is fused to the third tube 101c via the notch portion 301. In this case, the material of the second tube 101b is obviously a material having a higher melting point than the materials of the first tube 101a and the third tube 101c.

  As a result, two tubes having different melting points and usually difficult to be fused can be joined so that the joined portion maintains sufficient strength and the diameter of the joined portion does not increase. In the case of bonding, the thickness of the adhesive is increased and the diameter of the joining portion is increased. However, according to the medical tube of the present invention, no adhesive is required and the diameter can be reduced.

  Further, as shown in FIG. 3, a tapered portion 302 is provided inside the first tube 101a so as to be smoothly connected to the second tube 101b in the pipeline. By providing the tapered portion 302, it is possible to suppress / prevent the occurrence of turning due to the flow pressure of the ultrasonic transmission liquid flowing from the injection port 1022 when the catheter 10 is primed or flushed.

  In this embodiment, the case where the first tube 101a is inserted into the second tube 101b has been described as an example. However, the second tube 101b may be inserted into the first tube 101a. . In that case, the third tube 101c is made of a material that is fused to the second tube 101b and is not fused to the first tube 101a. The third tube 101c may be made of the same material as the second tube 101b or a material having a melting point close to that of the second tube 101b. Moreover, a notch part is formed in the front-end | tip part of the 1st tube 101a. Furthermore, in this embodiment, the case where the first tube 101a is inserted into the second tube 101b and the second tube 101b is sandwiched between the inner first tube 101a and the outer third tube 101c is taken as an example. Although described, the first tube 101a may be on the outside, and the third tube 101c may be on the inside. In this case, the second tube 101b is inserted into the first tube 101a, and the second tube 101b is sandwiched between the outer first tube 101a and the inner third tube 101c.

  In the present embodiment, polyethylene (PE) is described as an example of the material of the first tube 101a. However, the material is not limited to polyethylene (PE) as long as it has flexibility. Absent. For example, polyolefin such as polypropylene can be used. This is because polyolefin has a relatively small bending rigidity. Similarly, the polyether ether ketone (PEEK) having a relatively high bending rigidity has been described as an example of the material of the second tube 101b, but the material is not limited. In the present embodiment, the first tube 101a is configured on the distal end side of the medical tube 101 and the second tube 101b is configured on the proximal end side. However, the second tube 101b on the proximal end side is It is preferable that it is bladeless, and it is preferable that the second tube 101b constitutes the outer surface of the medical tube 101. By doing so, the outer diameter does not increase due to the thickness of the blade, and the thickness of the proximal end side of the medical tube 101 can be reduced as a whole due to the absence of the coating layer.

3. Manufacturing Procedure for Medical Tube Further, a manufacturing procedure for the medical tube 101 according to an embodiment of the present invention will be described with reference to the flowchart of FIG.

  In S501, the tip portion 1011a of the first tube 101a is inserted into the tip portion 1011b of the second tube 101b.

  In S502, the third tube 101c covers a part of the first tube 101a and a part of the second tube 101b having the cutout portion 301.

  In S503, the first tube 101a and the second tube 101b are heated to perform the fusion process. In this embodiment, the first tube 101a is heated by a heating device (not shown) with the melting point of the first tube 101a as a target temperature, and the first tube 101a and the third tube 101c are fused via the notch 301.

  According to the above procedure, the medical tube 101 according to the embodiment of the present invention is manufactured. In addition, as a pre-process of the manufacturing procedure, there is a process of providing a notch 301 at the tip of the second tube 101b (not shown). In this case, means for providing the notch 301 include cutting with a cutting blade and cutting with a laser.

  10: catheter, 101: medical tube, 101a: first tube, 101b: second tube, 101c: third tube, 102: connector, 102a: tube connector, 102b: drive shaft connector, 103: guide wire Lumen, 201: Ultrasonic transducer unit, 201a: Ultrasonic transducer, 201b: Housing, 202: Drive shaft, 203: Imaging core, 204: Elastic member, Notch 301, Taper 302, 1021: Anti-kink protector 1022: Injection port

Claims (9)

A medical tube,
A first tube;
A second tube in which the material of the tube is polyetheretherketone (PEEK) ;
A third tube covering a part of the first tube and a part of the second tube;
The second tube has a notch;
The medical tube, wherein a distal end portion of the first tube is inserted into the second tube and is fused to the third tube through the notch portion.   The medical tube according to claim 1, wherein a portion of the first tube that is not inserted into the second tube and the third tube are further fused.   The medical tube according to claim 1 or 2, wherein the notch is at least one of a spiral, a rectangle, a circle, and an ellipse.   The medical tube according to any one of claims 1 to 3, wherein the third tube is fused to the first tube and is not fused to the second tube.   The medical tube according to any one of claims 1 to 4, wherein the bending rigidity of the first tube is smaller than the bending rigidity of the second tube.   The medical tube according to any one of claims 1 to 5, wherein a material of the first tube is polyethylene (PE). A catheter comprising the medical tube according to any one of claims 1 to 6 . A method of manufacturing a medical tube,
Inserting the tip of the first tube into a second tube having a notch;
Covering a part of the first tube and a part of the second tube with a third tube;
The distal end portion of said first tube, possess a step of fusing said third tube via the notch,
The material of the second tube, method for manufacturing a medical tube according to claim polyether ether ketone (PEEK) der Rukoto. A medical tube,
A first tube;
A second tube in which the material of the tube is polyetheretherketone (PEEK) ;
A third tube covered with a part of the first tube and a part of the second tube;
The second tube has a notch;
A medical tube, wherein a distal end portion of the second tube is inserted into the first tube and is fused to the third tube through the notch portion.

Images