WO2016031071A1 - Medical catheter - Google Patents

Medical catheter Download PDF

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Publication number
WO2016031071A1
WO2016031071A1 PCT/JP2014/072825 JP2014072825W WO2016031071A1 WO 2016031071 A1 WO2016031071 A1 WO 2016031071A1 JP 2014072825 W JP2014072825 W JP 2014072825W WO 2016031071 A1 WO2016031071 A1 WO 2016031071A1
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WO
WIPO (PCT)
Prior art keywords
catheter tube
groove
catheter
medical
medical catheter
Prior art date
Application number
PCT/JP2014/072825
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French (fr)
Japanese (ja)
Inventor
前田 真法
清隆 森
秋山 省一
Original Assignee
Usciジャパン株式会社
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.)
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Publication date
Application filed by Usciジャパン株式会社 filed Critical Usciジャパン株式会社
Priority to PCT/JP2014/072825 priority Critical patent/WO2016031071A1/en
Priority to JP2016545211A priority patent/JPWO2016031071A1/en
Publication of WO2016031071A1 publication Critical patent/WO2016031071A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters

Definitions

  • the present invention relates to a medical catheter that is inserted into a blood vessel, liver, bile duct, or other luminal tissue or organ in a living body for use, and in particular, relatively without adversely affecting the living body.
  • shunt PTA percutaneous angioplasty
  • Such a shunt PTA uses a medical catheter provided with a balloon on the distal end side of the catheter tube.
  • the catheter tube is inserted into a blood vessel under the guidance of a guide wire, and the balloon is allowed to reach a shunt stenosis or the like.
  • the balloon is inflated and deformed, and the constricted portion of the shunt blood vessel is expanded from the inside to expand, thereby allowing blood in the shunt to flow smoothly.
  • a contrast medium is used using an angiography apparatus.
  • an X-ray opaque marker portion provided at the balloon placement portion of the catheter tube was guided.
  • Non-Patent Document 1 discloses a catheter tube to be inserted into a blood vessel, and a shadow tube that is the same length as the catheter tube and is fixed to the proximal end of the catheter tube.
  • a method using a medical catheter having the following has been proposed.
  • the shadow catheter on the outer surface is moved along the marking indicating the blood vessel running.
  • the balloon of the catheter tube that moves in the blood vessel following the shadow catheter is made to reach the target site, and as a result, “the balloon tip is guided to the target site easily and accurately”.
  • Non-Patent Document 1 it is assumed that the catheter tube in the blood vessel moves following the movement of the shadow catheter, and the tip of the shadow catheter reaches the outer surface side of the target site. As a result, it is indirectly considered that the tip of the catheter tube has reached the target site, but since the catheter tube in the blood vessel cannot actually be confirmed directly, the position of the catheter tube is sufficiently accurate. It is hard to say that it can be grasped.
  • this method requires a time-consuming and time-consuming and quick and easy operation because it is necessary to mark the blood vessel traveling route along the shadow catheter on the outer surface of the blood vessel into which the catheter tube is inserted. The treatment could not be realized.
  • An object of the present invention is to solve such problems of the prior art, and an object of the present invention is to provide an X-ray angiography apparatus and an X-ray contrast medium that may adversely affect a living body.
  • a medical catheter that can accurately reach a predetermined site of a catheter tube inserted into a luminal organ in a living body without using an agent under a relatively simple facility There is to do.
  • the medical catheter according to the present invention is a medical catheter that is used by being inserted into a luminal tissue or organ in a living body, and reaches the medical catheter through the living tissue at least at one of the medical catheters.
  • An elastic wave marker portion that reflects an elastic wave in a manner different from other portions is provided.
  • the medical catheter may include a tubular catheter tube inserted into a luminal tissue or organ, and the elastic wave marker portion may be provided in at least one place in the extending direction of the catheter tube.
  • the elastic wave marker portion is an ultrasonic marker portion that reflects ultrasonic waves in a manner different from other portions.
  • At least one of the elastic wave marker portions is formed by one or more grooves recessed from the outer peripheral surface of the catheter tube and / or one or more protrusions protruding from the outer peripheral surface. It is preferable to configure.
  • the inner surface of the groove and / or the outer surface of the protrusion is formed as a flat surface or a curved surface.
  • the groove wall surface of the groove and / or the protrusion side surface of the protrusion is a tapered surface inclined with respect to the outer peripheral surface of the catheter tube in a cross section orthogonal to the extending direction of the groove and / or protrusion. It is preferable to do.
  • the groove and / or the protrusion extend in a direction inclined with respect to the extending direction of the catheter tube or in a direction perpendicular to the extending direction.
  • such a groove and / or the protrusion is provided on at least a part of a half-circumferential region on one side of the outer peripheral surface of the catheter tube and a half-circular portion on the other side located behind the half-circular region on the one side. It is preferable to form each at least part of the region. Further, here, a plurality of the groove portions and / or the plurality of protrusion portions are arranged adjacent to each other, and a dense region is formed, and the plurality of groove portions and / or the plurality of protrusion portions are spaced from each other. It is preferable to provide a dispersion region formed side by side.
  • the said elastic wave marker part of at least one place can also be comprised by including the material from which an elastic modulus and / or density differ from the said other part.
  • at least one portion of the elastic wave marker portion may be made of a material having a different elastic modulus and / or density from the other portion in the extending direction of the catheter tube itself.
  • the other portion is made of a material having a different elastic modulus and / or density, and is formed of a coating portion that covers at least a portion of the outer peripheral surface of the catheter tube in the circumferential direction.
  • the medical catheter described above has an inflatable deformable balloon disposed at least one place in the longitudinal direction of the catheter tube so as to surround the catheter tube from the outer peripheral side, Alternatively, the elastic wave marker portion is arranged at a close location at a certain distance along the extending direction of the catheter tube from the arrangement location, and the elastic wave marker portion is used as a luminal organ in a living body. It is preferable that the position display portion of the balloon inserted into the.
  • the balloon is more preferably configured to include microbubbles.
  • the medical catheter further includes a guide wire that is inserted into a luminal organ in a living body and guides the catheter tube in the luminal organ.
  • the medical catheter is preferably an intravascular treatment catheter in which the catheter tube is inserted into a blood vessel in a living body.
  • an elastic wave that reflects an elastic wave such as an ultrasonic wave that reaches the medical catheter through a living tissue in at least one place among the medical catheters in a manner different from the other parts By providing a marker portion for use, it is easy to use an ultrasonic diagnostic apparatus, etc., which is cheaper and smaller than an X-ray angiography apparatus.
  • the position can be grasped directly. Accordingly, a predetermined portion of the catheter tube to be inserted into a luminal organ in a living body can be accurately obtained under relatively simple equipment without using an X-ray angiography apparatus and an X-ray contrast medium.
  • the target part can be reached.
  • FIG. 2 is a partially enlarged side view schematically showing a part of a balloon placement portion of a catheter tube included in the medical catheter of FIG. 1.
  • FIG. 3 is a side view schematically showing a part of FIG. 2 further enlarged. It is the photograph which shows the image which displayed the medical catheter of FIG. 1 on the display using an ultrasonic diagnostic apparatus, and its schema.
  • FIG. 4 is a longitudinal sectional view taken along line IV-IV in FIG. 3. It is a longitudinal cross-sectional view which shows the modification of a groove part and a projection part.
  • FIG. 4 is a transverse sectional view taken along line VI-VI in FIG. 3.
  • a medical catheter 1 is mainly a catheter tube 2 such as a circular tube that can be bent and formed of, for example, polyethylene, nylon, or polyethylene terephthalate (PET), as illustrated in FIG.
  • the catheter tube 2 is inserted into a vascular tissue or organ in the form of a blood vessel, a liver, a bile duct or other tubular or bag-like body in the living body, for example, under the guidance of a known guide wire (not shown) during the operation. It is what is done.
  • the medical catheter 1 shown in the figure has a balloon 3 that is inflated and deformed at a predetermined location in the luminal organ in the vicinity of the distal end portion of the catheter tube 2 to be inserted into the luminal tissue or organ.
  • a Y-shaped connector 4 that branches in a Y-shape from the base end portion is provided at the base end portion disposed outside the living body on the opposite side of the base plate.
  • the balloon 3 is shown in an inflated and deformed state.
  • the cylindrical portion 4 a on one side of the Y-shaped connector 4 is used for supplying a fluid to the balloon 3 for inflating and deforming the balloon 3, and the cylindrical portion 4 b on the other side is used for the catheter tube 2.
  • a guide wire inserted into a luminal tissue or organ passes therethrough.
  • these balloon 3 and Y-shaped connector 4 are not essential components for the present invention.
  • the catheter tube 2 when the catheter tube 2 is inserted into a luminal tissue or organ in a living body, the position of the predetermined portion of the catheter tube 2 in the luminal tissue or organ is determined.
  • the catheter tube passes through the living tissue from the ultrasonic diagnostic apparatus or the like outside the living body in at least one place in the extending direction of the catheter tube 2.
  • An ultrasonic marker portion 5 for reflecting the ultrasonic wave reaching 2 in a different manner from the other portions is provided.
  • the ultrasonic marker portion 5 is provided with a groove 6 recessed from the outer peripheral surface 2 a of the catheter tube 2, and It is composed of a protrusion 7 protruding from the outer peripheral surface 2 a of the catheter tube 2 adjacent to the groove 6.
  • the ultrasonic marker portion 5 provided with the groove portion 6 and the protrusion portion 7 reflects in a different direction from the other outer peripheral surface portion of the catheter tube 2 that does not have an uneven shape, and is thus reflected as such.
  • the ultrasonic marker portion 5 including, for example, the groove portion 6 and the projection portion 7 can be displayed darker than the other portions, as illustrated in FIG. .
  • the medical catheter 1 can be used for patients and medical personnel. There is a risk of radiation exposure to the person, and it is not necessary to use an expensive and large-sized X-ray imaging apparatus or an X-ray contrast agent that may cause side effects.
  • the medical catheter 1 can be manufactured very easily simply by forming the groove 6 and the protrusion 7 in the catheter tube 2 by, for example, laser processing, cutting with a cutter or a drill, sandblasting, or rolling. Therefore, the medical catheter 1 to be manufactured in the future can be used as the medical catheter 1 as well as the medical catheter 1 by performing simple processing on the existing medical catheter.
  • the ultrasonic marker portion is a protrusion portion. It is also possible to have only one or more groove portions without, or only one or more protrusion portions without the groove portion. Therefore, the protrusion 7 in the illustrated embodiment is not necessarily provided.
  • each groove 6 is inclined with respect to the outer peripheral surface 2a of the catheter tube 2 and faces each other as shown in a cross-sectional view across the groove 6 and the protrusion 7 in FIG. It can have an inner surface constituted by a pair of groove wall surfaces 6a and a groove bottom portion 6b located at the deepest position continuously to the groove wall surfaces 6a.
  • each protrusion 7 is composed of a protrusion side surface 7a that is inclined with respect to the outer peripheral surface 2a of the catheter tube 2, and a protrusion top portion 7b that connects the protrusion side surfaces 7a to each other. It may have an outer surface.
  • the groove wall surface 6 a forming the inner surface of the groove portion 6 and the protrusion side surface 7 a and the protrusion top portion 7 b forming the outer surface of the protrusion portion 7 are both tapered surfaces formed as flat surfaces.
  • Both the inner surface of the groove portion 6 and the outer surface of the projection portion 7 can be tapered surfaces having a curved surface that is concave or convex in the radial direction of the catheter tube 2 as shown in FIG.
  • the inner surface of the groove 6 can be a curved surface
  • the outer surface of the projection 7 can be a flat surface.
  • the inner surface of the groove 6 can be a flat surface
  • the outer surface of the projection 7 can be a curved surface.
  • the groove bottom portion 6b of the groove 6 is a corner where the opposing groove wall surfaces 6a and 6b intersect, but as shown in FIG. 6 (d).
  • the groove wall surfaces 6a and 6b that are separated from each other at the groove bottom position may be formed in a flat surface shape that connects the mutual surfaces.
  • the projection top part 7b of the projection part 7 can also have a flat surface shape as shown in FIGS. 5 and 6B or a corner part shape not shown.
  • the groove wall surface 6a of the groove portion 6 is formed so that the groove wall surfaces 6a facing each other as they approach the groove bottom are mutually effective for the purpose of effectively reflecting ultrasonic waves irradiated from outside the living body in different directions from other parts. It is preferable to incline in the approaching direction, and the inclination angle ⁇ 1 is 30 ° to 90 ° with respect to the extending direction of the catheter tube 2 (the left-right direction in FIGS. 5 and 6).
  • the projection side surface 7a of the projection portion 7 is inclined so that the projection side surface 7a approaches each other as it approaches the projection top portion 7b, and the inclination angle ⁇ 2 is inclined in the extending direction of the catheter tube 2. On the other hand, it is preferably 30 ° to 90 °.
  • the maximum depth Dg of the groove 6 is preferably 20 ⁇ m to 200 ⁇ m as measured along the radial direction of the catheter tube 2 from the position of the outer peripheral surface of the catheter tube 2.
  • the maximum depth Dg of the groove 6 is preferably 10% to 70% with respect to the thickness of the tubular catheter tube 2 from the viewpoint of securing the required tensile strength of the catheter tube 2.
  • the width Wg of the opening at the position of the outer peripheral surface of the groove 6 is preferably 50 ⁇ m to 500 ⁇ m when measured in the direction perpendicular to the groove 6.
  • the width Wp of the protrusion 7 at the position of the outer peripheral surface is preferably 10 ⁇ m to 100 ⁇ m as measured in the direction orthogonal to the protrusion 7, and the maximum protrusion height Hp of the protrusion 7 Is preferably 0 ⁇ m to 100 ⁇ m as measured along the radial direction of the catheter tube 2 from the position of the outer peripheral surface of the catheter tube 2.
  • the maximum depth Dg and the opening width Wg of the groove 6 described above the width Wp of the protrusion 7 and the maximum protrusion height Hp are too small, the visibility of the groove 6 or the protrusion 7 due to ultrasonic waves is reduced. When an image is displayed using an ultrasonic diagnostic apparatus, there is a possibility that it cannot be confirmed sufficiently clearly.
  • the groove 6 and / or the protrusion 7 are inclined with respect to the extending direction of the catheter tube 2 (left and right direction in FIG. 3), or with respect to the extending direction as shown in FIG. It can extend in a vertical direction.
  • the respective groove portions 6 and / or protrusions 7 may be continuously extended around the entire outer periphery 2a of the catheter tube 2; 7, the outer peripheral surface 2a of the catheter tube 2 is arranged on the one side (for example, front side) half circumference region Ah1 located on the upper side of FIG. 7 and on the other side located on the lower side. It is preferable that the groove 6 and / or the protrusion 7 are formed in at least a part of each of the half-circumferential regions Ah1 and Ah2 on one side and the other side thereof. .
  • each catheter tube of a plurality of medical catheters can be In a state where they are arranged side by side, all of a plurality of medical catheters can be collectively processed by laser processing in a direction crossing the catheter tube from each of the front side and the back side. Can do. Therefore, the groove 6 and / or the protrusion 7 can be easily formed as compared with the case where the groove 6 or the protrusion 7 is formed over the entire circumference.
  • the observation from outside the living body by the ultrasonic diagnostic apparatus does not require that the groove 6 and the protrusion 7 are formed over the entire circumference of the catheter tube 2, and as described above, the circumference of the outer circumferential surface 2a. It is possible to carry out sufficiently effectively by being formed at positions opposite to each other in the direction.
  • the groove 6 and / or the protrusion 7 is formed in each of the half-circumferential region Ah1 on one side (for example, the front side) and the half-circular region Ah2 on the other side (for example, the back side), these grooves 6
  • the length of the protrusion 7 along the circumferential direction of the outer circumferential surface 2a of the catheter tube 2 is preferably 10% to 100% with respect to the total circumferential length of the outer circumferential surface 2a of the catheter tube 2.
  • the length of the groove 6 to the protrusion 7 is preferably set to 300 ⁇ m to 4500 ⁇ m.
  • the circumferential length of the groove 6 and / or the protrusion 7 is about 0.3 mm as 10% of the tube diameter of 1.0 mm in the shortest case. In the longest case, the entire circumference can be 1.5 mm in tube diameter. Even when the circumferential length of the groove 6 and / or the protrusion 7 is short, the surface on which the groove 6 and / or the protrusion 7 is processed is always directed toward the side irradiated with the ultrasonic waves. By doing so, the groove 6 and / or the protrusion 7 can effectively function as the ultrasonic marker portion 5.
  • the circumferential length of the groove 6 and / or the protrusion 7 is too long, there is a concern that the strength of the catheter tube may locally decrease or increase at the location where the ultrasonic marker portion 5 is provided. On the other hand, if the circumferential length of the groove 6 and / or the protrusion 7 is too short, the visibility of the groove 6 and / or the protrusion 7 as the ultrasonic marker portion 5 may be reduced.
  • the plurality of grooves 6 and / or the plurality of protrusions 7 are adjacent to each other as illustrated in FIGS. It is preferable to provide a dense region Fd that is aligned with each other and a dispersion region Fs in which the plurality of groove portions 6 and / or the plurality of protrusions 7 are spaced apart from each other at a predetermined interval.
  • the formation position of the groove 6 and / or the protrusion 7 can have different meanings in the dense region Fd and the dispersion region Fs.
  • an ultrasonic marker portion 15 including a material having a different elastic modulus and / or density from other portions can be provided.
  • the outer peripheral surface of the catheter tube 12 is coated with a material having a larger or smaller elastic modulus than other tube portions by spraying, painting, or other processing methods, and the outer periphery thereof.
  • a coating portion 16 is formed to cover at least a part of the circumferential direction of the surface, in FIG.
  • the ultrasonic waves are reflected in different directions by the ultrasonic marker portions 15 made of materials having different elastic moduli and / or densities, the portion provided with the ultrasonic marker portions 15 in the living body The position in can be effectively grasped.
  • the elastic modulus means volume elastic modulus or Young's modulus. This can be calculated from the result of a tensile test.
  • the elastic modulus of the catheter tube 12 corresponding to “other portion” here is generally about 0.2 MPa to 7 MPa, whereas the elastic modulus of a portion made of a material having a different elastic modulus is different from that of the other portion.
  • the elastic modulus is made large or small in the range of 0.01% to 1%, more preferably in the range of 0.1% to 0.5%. More specifically, the portion made of a material having a different elastic modulus can be set to 0.01 MPa to 0.1 MPa, specifically assuming that the elastic modulus of the other portion is different from that described above. Is 0.03 MPa to 0.05 MPa.
  • the material of the catheter tube 12 corresponding to the “other part” is generally PTEE, polyethylene, polypropylene, nylon or the like, whereas the elasticity constituting the ultrasonic marker part 15 is used.
  • the material having a different modulus and / or density can be a rubber material having a smaller elastic modulus than other portions, a metal material having a larger elastic modulus than other portions, or the like.
  • the ultrasonic marker portion 15 made of a material having a different elastic modulus can have a larger or smaller elastic modulus than the other portions.
  • the ultrasonic marker portion 15 having a low elastic modulus is displayed as a black streak on the catheter tube 12 displayed in white when viewed with an ultrasonic diagnostic apparatus. Since the sonic marker portion 15 is displayed as white stripes, it may be slightly inferior in visibility. Further, since the ultrasonic marker portion 15 having a large elastic modulus hardens the portion where the catheter tube 12 is provided, the bendability and kink resistance (hardness to buckle) may be impaired.
  • the ultrasonic marker portion 15 containing a material having a different elastic modulus is provided on the outer peripheral surface of the catheter tube 12 by coating a material having a different elastic modulus, but the illustration is omitted.
  • the ultrasonic marker portion 15 can also be provided by coating the inner peripheral surface of the catheter tube 12, and a part of the catheter tube 12 itself is replaced with a material having a different elasticity and / or density ratio. By doing so, the ultrasonic marker portion 15 including materials having different elastic moduli and / or densities can be provided.
  • a tube made of a material having different elastic modulus and / or density can be joined and provided in the middle of the catheter tube 12.
  • the medical catheters 1 and 11 as described above are provided with the ultrasonic marker portions 5 and 15 in at least one place of the catheter tubes 2 and 12, thereby inserting the catheter tubes 2 and 12 into the luminal organ.
  • an ultrasonic wave is radiated from outside the living body using an ultrasonic diagnostic apparatus, it is possible to accurately determine where the portion provided with the ultrasonic marker portions 5 and 15 is currently located in the luminal tissue or organ. Can be confirmed.
  • ultrasonic marker portions 5 and 15 are applied to the medical catheters 1 and 11 provided with the balloon 3 as shown in the drawing, it is generally impossible to grasp the position in the luminal tissue or organ. This is very advantageous because the position of the balloon 3 can be accurately confirmed with the display function of the ultrasonic marker portions 5 and 15.
  • the ultrasonic marker portions 5 and 15 described above for example, the catheter tube portion inside the flexible thin film balloon 3 provided at the distal end portion of the catheter tube 2 or the like.
  • the ultrasonic marker portion 5 is provided at a location close to the balloon 3 by a predetermined distance Ls1, Ls2. 15 can function as a position display portion of the balloon 3 in the living body.
  • the ultrasonic marker portions 5 and 15 are provided in the catheter tube portion inside the balloon 3, it is a portion that widens the actually narrowed blood vessel portion. It is preferable to provide the ultrasonic marker portions 5 and 15 over the entire length of the balloon length Lb, which has a constant diameter. Thereby, it can be reliably displayed by the ultrasonic diagnostic apparatus. Further, in order to emphasize and display the both end positions of the balloon length Lb of the balloon 3, for example, an area in the vicinity of the both end positions, for example, 0.5 mm to 2 mm from each of the both end positions toward the center in the longitudinal direction.
  • the grooves and the like are densely or to dispose a material that absorbs more ultrasonic waves.
  • the distance Ls1 and the distance Ls2 can be equal to each other, or can be different from each other. it can.
  • an ultrasonic marker portion 5 in which grooves and / or protrusions are densely provided is provided in the vicinity of the balloon 3.
  • the medical catheter 1 provided with such a balloon 3 although the illustration is omitted, it is possible to provide the above-described groove and / or protrusion on the balloon 3 itself.
  • the medical catheters 1 and 11 according to the embodiments of the present invention are particularly used as an intravascular treatment catheter for performing a shunt PTA or the like in which the catheter tubes 2 and 12 are inserted into blood vessels in the living body. It is valid.
  • the balloon 3 itself has a groove and / or protrusion. Ultrasonic marker portions 5 and 15 such as can be provided.
  • a guide wire (not shown) is passed through the blood vessel of the arm of an artificial dialysis patient who has shunted due to diabetic nephropathy or the like, and the tip is positioned beyond the stenosis of the shunt.
  • the medical catheters 1 and 11 are inserted into the blood vessel under the guidance of the guide wire.
  • the position of the balloon 3 at the distal end of the catheter tube 2 inserted into the blood vessel cannot normally be confirmed from outside the human body.
  • the location of the balloon 3 or By providing the ultrasonic marker portions 5 and 15 in the vicinity thereof by irradiating ultrasonic waves from outside the human body using an ultrasonic diagnostic apparatus or the like, for example, ultrasonic waves are displayed on an image displayed outside the human body.
  • the marker portions 5 and 15 can be clearly displayed, and the position of the balloon 3 can be confirmed accurately. Therefore, here, the balloon 3 can be sent to the shunt stenosis portion with high accuracy and placed there under visual recognition from the outside.
  • the fluid is sent from the cylindrical part 4a of the Y-shaped connector 4 of the medical catheters 1 and 11 to the balloon 3, and the balloon 3 is inflated and deformed to expand and expand the shunt stenosis part from the inside. Can be made.
  • the fluid supplied to such a balloon 3 is a liquid containing microbubbles.
  • the microbubbles when supplied into the living body, the microbubbles reflect the ultrasonic wave by the irradiation of ultrasonic waves from outside the living body, and the part where the microbubbles exist is Since it can be displayed on the ultrasonic diagnostic apparatus, for example, when the balloon 3 positioned in the shunt stenosis is inflated and deformed, it can be confirmed whether the balloon 3 is inflated and deformed as expected. . Thereby, it is possible to quickly cope with an unintended situation such as leakage of liquid from the balloon 3.
  • Such microbubbles are fine particles having a diameter of about 2 ⁇ m to 3 ⁇ m, in which a gas such as air is contained in a phospholipid film together with a stabilizer such as perflubutane, and those already known should be used.
  • a gas such as air
  • a stabilizer such as perflubutane
  • the liquid containing this include a contrast agent for ultrasonic diagnosis, specifically, sonazoid (registered trademark, manufactured by Daiichi Sankyo Co., Ltd.), levovist (registered trademark, manufactured by Bayer Yakuhin Co., Ltd.), and the like. it can.
  • transformation as mentioned above can be acquired by forming balloon 3 itself with the material containing a microbubble.
  • the balloon 3 can be manufactured by coating the surface with a drug containing microbubbles.
  • the ultrasonic marker portions 5 and 15 described above may also reflect elastic waves other than ultrasonic waves in a manner different from other portions, and depending on the diagnostic device used, the ultrasonic waves may be reflected. It is also possible to use an elastic wave marker portion that targets an elastic wave other than the above and has a reflection mode of the elastic wave different from other portions.

Abstract

This medical catheter (1, 11) is used by being inserted into luminal tissue and an organ inside a living organism, and is obtained by providing, to at least one portion of the medical catheter (1, 11), an elastic-wave marker section (5, 15) for causing elastic waves, which pass through living tissue and reach the medical catheter (1, 11), to be reflected in a different way to other sections.

Description

医療用カテーテルMedical catheter
 この発明は、生体内の血管、肝臓、胆管その他の管腔組織や臓器に挿入されて使用に供される医療用カテーテルに関するものであり、特には、生体に悪影響を及ぼすことなしに、比較的簡易な設備の下で医療行為を行い得るものとする技術を提案するものである。 The present invention relates to a medical catheter that is inserted into a blood vessel, liver, bile duct, or other luminal tissue or organ in a living body for use, and in particular, relatively without adversely affecting the living body. We propose a technology that enables medical practice under simple equipment.
 たとえば、糖尿病性腎症による人工透析患者に対しては、腕の静脈と動脈とをバイパスさせるべく吻合したシャントが狭くなり、または詰まった場合に、いわゆるシャントPTA(経皮的血管形成術)を実施することがある。 For example, for dialysis patients with diabetic nephropathy, so-called shunt PTA (percutaneous angioplasty) is performed when the shunt that is anastomosed to bypass the arm vein and artery is narrowed or clogged May be implemented.
 かかるシャントPTAは、カテーテルチューブの先端側にバルーンを設けた医療用カテーテルを用いることとし、このカテーテルチューブを、ガイドワイヤーによる案内の下で血管に挿入するとともに、バルーンをシャント狭窄部等に到達させた後、たとえばバルーンへ流体を送り込むことで、バルーンを膨張変形させ、シャント血管の狭窄部を内側から押し広げて拡張させることにより、シャント内の血液を円滑に通流させるものである。 Such a shunt PTA uses a medical catheter provided with a balloon on the distal end side of the catheter tube. The catheter tube is inserted into a blood vessel under the guidance of a guide wire, and the balloon is allowed to reach a shunt stenosis or the like. After that, for example, by sending a fluid into the balloon, the balloon is inflated and deformed, and the constricted portion of the shunt blood vessel is expanded from the inside to expand, thereby allowing blood in the shunt to flow smoothly.
 ここで、医療用カテーテルのカテーテルチューブを血管内に挿入して、その先端側のバルーンを、シャント狭窄部等の目的部位に到達させるに当り、従来は、血管撮影装置を用いて、造影剤を使用したX線透視下で、カテーテルチューブのバルーン配設箇所に設けたX線不透過のマーカー部分を誘導することとしていた。 Here, when a catheter tube of a medical catheter is inserted into a blood vessel and the balloon on the tip side reaches a target site such as a shunt stenosis, conventionally, a contrast medium is used using an angiography apparatus. Under the X-ray fluoroscope used, an X-ray opaque marker portion provided at the balloon placement portion of the catheter tube was guided.
 しかるに、このような血管撮影装置は大型であり、しかも極めて高価なものであることから、血管撮影装置を有する医療機関は限られており、それ故に、上記のシャントPTAを、場所を問わず容易に行うことができなかった。
 またこの方法では、X線造影剤を使用することから、それによる副作用の発症のおそれを確実に取り除くことができない他、治療を受ける患者だけでなく、治療を行う医療従事者への放射線被爆が問題になっている。
However, since such an angiographic apparatus is large and extremely expensive, medical institutions having the angiographic apparatus are limited. Therefore, the above shunt PTA can be easily used regardless of location. Could not be done.
In addition, since this method uses an X-ray contrast medium, the risk of side effects caused by the X-ray contrast medium cannot be surely removed, and radiation exposure to not only patients receiving medical treatment but also medical staff performing treatment is not possible. It is a problem.
 血管撮影装置を用いる場合のこのような問題に対し、非特許文献1には、血管に挿入するカテーテルチューブと、該カテーテルチューブと等長で、そのカテーテルチューブの基端側に固定されるシャドウチューブとを有する医療用カテーテルを用いる方法が提案されている。
 この非特許文献1では、先に血管に挿入したガイドワイヤーによる案内下で、カテーテルチューブを血管に挿入する際に、外表にあるシャドウカテーテルを、血管走行が示されたマーキングに沿わせて移動させていくことにより、シャドウカテーテルに追従して血管内を移動するカテーテルチューブのバルーンを目的部位に到達させ、これにより、「容易かつ正確にバルーン先端を目的部位に誘導する」としている。
To deal with such problems when using an angiographic device, Non-Patent Document 1 discloses a catheter tube to be inserted into a blood vessel, and a shadow tube that is the same length as the catheter tube and is fixed to the proximal end of the catheter tube. A method using a medical catheter having the following has been proposed.
In this non-patent document 1, when a catheter tube is inserted into a blood vessel under the guidance of a guide wire previously inserted into the blood vessel, the shadow catheter on the outer surface is moved along the marking indicating the blood vessel running. Thus, the balloon of the catheter tube that moves in the blood vessel following the shadow catheter is made to reach the target site, and as a result, “the balloon tip is guided to the target site easily and accurately”.
 しかしながら、上記の非特許文献1に開示された方法では、血管内のカテーテルチューブがシャドウカテーテルの動きに追従して移動することを前提とし、シャドウカテーテルの先端部が目的部位の外表側に到達したことをもって、カテーテルチューブの先端部が目的部位に達したと間接的に見なしているが、実際に血管内のカテーテルチューブを直接的に確認することができないことから、カテーテルチューブの位置を十分正確に把握できるとは言い難い。 However, in the method disclosed in Non-Patent Document 1 above, it is assumed that the catheter tube in the blood vessel moves following the movement of the shadow catheter, and the tip of the shadow catheter reaches the outer surface side of the target site. As a result, it is indirectly considered that the tip of the catheter tube has reached the target site, but since the catheter tube in the blood vessel cannot actually be confirmed directly, the position of the catheter tube is sufficiently accurate. It is hard to say that it can be grasped.
 また、この方法では、カテーテルチューブを挿入する血管の外表に、シャドウカテーテルを沿わせる血管走行経路を事前にマーキングしておくことが必要となることにより、手間と時間がかかって、迅速かつ容易な治療を実現することができなかった。
 しかもここでは、カテーテルチューブとは別個にシャドウカテーテルを設けることを要するので、部材点数の増加による大幅な製造コストの増大が否めない。
In addition, this method requires a time-consuming and time-consuming and quick and easy operation because it is necessary to mark the blood vessel traveling route along the shadow catheter on the outer surface of the blood vessel into which the catheter tube is inserted. The treatment could not be realized.
In addition, since it is necessary to provide a shadow catheter separately from the catheter tube, a significant increase in manufacturing cost due to an increase in the number of members cannot be denied.
 この発明は、従来技術が抱えるこのような問題を解決することを課題とするものであり、それの目的とするところは、生体に悪影響を及ぼす可能性のあるX線血管撮影装置およびX線造影剤を使用することなしに、比較的簡易な設備の下で、生体内の管腔臓器に挿入されるカテーテルチューブの所定の箇所を、目的部位に正確に到達させることのできる医療用カテーテルを提供することにある。 An object of the present invention is to solve such problems of the prior art, and an object of the present invention is to provide an X-ray angiography apparatus and an X-ray contrast medium that may adversely affect a living body. Provided a medical catheter that can accurately reach a predetermined site of a catheter tube inserted into a luminal organ in a living body without using an agent under a relatively simple facility There is to do.
 この発明の医療用カテーテルは、生体内の管腔組織や臓器に挿入されて用いられる医療用カテーテルであって、前記医療用カテーテルのうちの少なくとも一箇所に、生体組織を通じて医療用カテーテルに到達する弾性波を、他の部分とは異なる態様で反射させる弾性波用マーカー部分を設けてなるものである。 The medical catheter according to the present invention is a medical catheter that is used by being inserted into a luminal tissue or organ in a living body, and reaches the medical catheter through the living tissue at least at one of the medical catheters. An elastic wave marker portion that reflects an elastic wave in a manner different from other portions is provided.
 ここで、上記の医療用カテーテルは、管腔組織や臓器に挿入される管状のカテーテルチューブを有し、該カテーテルチューブの延在方向の少なくとも一箇所に、前記弾性波用マーカー部分を設けることが好ましい。
 またここで、前記弾性波用マーカー部分を、超音波を他の部分とは異なる態様で反射させる超音波用マーカー部分とすることが好ましい。
Here, the medical catheter may include a tubular catheter tube inserted into a luminal tissue or organ, and the elastic wave marker portion may be provided in at least one place in the extending direction of the catheter tube. preferable.
Here, it is preferable that the elastic wave marker portion is an ultrasonic marker portion that reflects ultrasonic waves in a manner different from other portions.
 この発明の医療用カテーテルでは、少なくとも一箇所の前記弾性波用マーカー部分を、カテーテルチューブの外周面から窪む一本以上の溝部、および/または、該外周面から突出する一個以上の突起部で構成することが好ましい。 In the medical catheter according to the present invention, at least one of the elastic wave marker portions is formed by one or more grooves recessed from the outer peripheral surface of the catheter tube and / or one or more protrusions protruding from the outer peripheral surface. It is preferable to configure.
 この場合、前記溝部の内面および/または前記突起部の外面を、平坦面または湾曲面で形成することが好ましい。
 またこの場合、前記溝部の溝壁面および/または前記突起部の突起側面を、該溝部および/または突起部の延在方向に直交する断面で、カテーテルチューブの外周面に対して傾斜するテーパ面とすることが好ましい。
 そしてまたこの場合、前記溝部および/または前記突起部を、カテーテルチューブの延在方向に対して傾斜する方向、または、該延在方向に対して垂直な方向に延びるものとすることが好ましい。
In this case, it is preferable that the inner surface of the groove and / or the outer surface of the protrusion is formed as a flat surface or a curved surface.
In this case, the groove wall surface of the groove and / or the protrusion side surface of the protrusion is a tapered surface inclined with respect to the outer peripheral surface of the catheter tube in a cross section orthogonal to the extending direction of the groove and / or protrusion. It is preferable to do.
In this case, it is preferable that the groove and / or the protrusion extend in a direction inclined with respect to the extending direction of the catheter tube or in a direction perpendicular to the extending direction.
 なお、このような溝部および/または前記突起部は、カテーテルチューブの外周面の一方側の半周分領域の少なくとも一部、および、前記一方側の半周分領域の裏側に位置する他方側の半周分領域の少なくとも一部のそれぞれに形成することが好ましい。
 またここでは、複数本の前記溝部および/または複数個の前記突起部を、互いに隣接させて並べて形成した密集領域と、複数本の前記溝部および/または複数個の前記突起部を、互いに間隔をおいて並べて形成した分散領域とを設けることが好ましい。
Note that such a groove and / or the protrusion is provided on at least a part of a half-circumferential region on one side of the outer peripheral surface of the catheter tube and a half-circular portion on the other side located behind the half-circular region on the one side. It is preferable to form each at least part of the region.
Further, here, a plurality of the groove portions and / or the plurality of protrusion portions are arranged adjacent to each other, and a dense region is formed, and the plurality of groove portions and / or the plurality of protrusion portions are spaced from each other. It is preferable to provide a dispersion region formed side by side.
 また、少なくとも一箇所の前記弾性波用マーカー部分は、前記他の部分とは弾性率および/または密度の異なる材料を含むものとすることにより構成することもできる。
 この場合、少なくとも一箇所の前記弾性波用マーカー部分は、カテーテルチューブの延在方向の一部自体を、他の部分とは弾性率および/または密度の異なる材料からなるものとすることも可能であるが、好ましくは、前記他の部分とは弾性率および/または密度の異なる材料からなり、カテーテルチューブの外周面の周方向の少なくとも一部を被覆するコーティング部分で構成する。
Moreover, the said elastic wave marker part of at least one place can also be comprised by including the material from which an elastic modulus and / or density differ from the said other part.
In this case, at least one portion of the elastic wave marker portion may be made of a material having a different elastic modulus and / or density from the other portion in the extending direction of the catheter tube itself. Preferably, however, the other portion is made of a material having a different elastic modulus and / or density, and is formed of a coating portion that covers at least a portion of the outer peripheral surface of the catheter tube in the circumferential direction.
 以上に述べた医療用カテーテルは、前記カテーテルチューブの長手方向の少なくとも一箇所に、該カテーテルチューブを外周側から取り囲んで配置される膨張変形可能なバルーンを有し、前記バルーンの配設箇所に、または、該配設箇所からカテーテルチューブの延在方向に沿って一定の距離をおいた近接箇所に、前記弾性波用マーカー部分を配置し、該弾性波用マーカー部分を、生体内の管腔臓器に挿入されるバルーンの位置表示部分とすることが好適である。
 このバルーンは、マイクロバブルを含んで構成されるものであることがより好ましい。
The medical catheter described above has an inflatable deformable balloon disposed at least one place in the longitudinal direction of the catheter tube so as to surround the catheter tube from the outer peripheral side, Alternatively, the elastic wave marker portion is arranged at a close location at a certain distance along the extending direction of the catheter tube from the arrangement location, and the elastic wave marker portion is used as a luminal organ in a living body. It is preferable that the position display portion of the balloon inserted into the.
The balloon is more preferably configured to include microbubbles.
 なおここで、上記の医療用カテーテルは、生体内の管腔臓器に挿入されて該管腔臓器内でカテーテルチューブを案内するガイドワイヤーをさらに有することが好ましい。
 また、上記の医療用カテーテルは、前記カテーテルチューブが生体内の血管に挿入される血管内治療用カテーテルとすることが好ましい。
Here, it is preferable that the medical catheter further includes a guide wire that is inserted into a luminal organ in a living body and guides the catheter tube in the luminal organ.
The medical catheter is preferably an intravascular treatment catheter in which the catheter tube is inserted into a blood vessel in a living body.
 この発明の医療用カテーテルによれば、医療用カテーテルのうちの少なくとも一箇所に、生体組織を通じて医療用カテーテルに到達する超音波等の弾性波を、他の部分とは異なる態様で反射させる弾性波用マーカー部分を設けたことにより、X線血管撮影装置に比して安価で小型な超音波診断装置等を用いて容易に、たとえば管腔組織や臓器内のカテーテルチューブ等の所定箇所の正確な位置を直接的に把握することができる。
 それにより、X線血管撮影装置およびX線造影剤を使用することなしに、比較的簡易な設備の下で、生体内の管腔臓器に挿入されるカテーテルチューブの所定の箇所を、高い精度で目的部位に到達させることができる。
According to the medical catheter of the present invention, an elastic wave that reflects an elastic wave such as an ultrasonic wave that reaches the medical catheter through a living tissue in at least one place among the medical catheters in a manner different from the other parts. By providing a marker portion for use, it is easy to use an ultrasonic diagnostic apparatus, etc., which is cheaper and smaller than an X-ray angiography apparatus. The position can be grasped directly.
Accordingly, a predetermined portion of the catheter tube to be inserted into a luminal organ in a living body can be accurately obtained under relatively simple equipment without using an X-ray angiography apparatus and an X-ray contrast medium. The target part can be reached.
この発明の一の実施形態に係る医療用カテーテルの全体を示す側面図である。It is a side view showing the whole medical catheter concerning one embodiment of this invention. 図1の医療用カテーテルが有するカテーテルチューブのバルーン配設箇所の一部を概略的に示す部分拡大側面図である。FIG. 2 is a partially enlarged side view schematically showing a part of a balloon placement portion of a catheter tube included in the medical catheter of FIG. 1. 図2の一部をさらに拡大して概略的に示す側面図である。FIG. 3 is a side view schematically showing a part of FIG. 2 further enlarged. 超音波診断装置を用いて、図1の医療用カテーテルをディスプレー上に表示した画像を示す写真および、そのシェーマである。It is the photograph which shows the image which displayed the medical catheter of FIG. 1 on the display using an ultrasonic diagnostic apparatus, and its schema. 図3のIV―IV線に沿う縦断面図である。FIG. 4 is a longitudinal sectional view taken along line IV-IV in FIG. 3. 溝部および突起部の変形例を示す縦断面図である。It is a longitudinal cross-sectional view which shows the modification of a groove part and a projection part. 図3のVI―VI線に沿う横断面図である。FIG. 4 is a transverse sectional view taken along line VI-VI in FIG. 3. この発明の他の実施形態に係る医療用カテーテルを示す、カテーテルチューブのバルーン配設箇所の部分拡大側面図である。It is a partial expanded side view of the balloon arrangement | positioning location of a catheter tube which shows the medical catheter which concerns on other embodiment of this invention. カテーテルチューブへの超音波用マーカー部分の配設例を示す、カテーテルチューブの部分拡大側面図である。It is the partial enlarged side view of a catheter tube which shows the example of arrangement | positioning of the marker part for ultrasonic waves to a catheter tube.
 以下に図面に示すところに基き、この発明の実施の形態について詳細に説明する。
 この発明の一の実施形態に係る医療用カテーテル1は、主として、図1に例示するように、たとえば、ポリエチレン、ナイロンまたはポリエチレンテレフタレート(PET)等からなる屈曲変形可能な円管状等のカテーテルチューブ2を有し、このカテーテルチューブ2は、施術に際し、たとえば図示しない公知の任意のガイドワイヤーによる案内の下、生体内の血管、肝臓、胆管その他の管状もしくは袋状をなす管腔組織や臓器に挿入されるものである。
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
A medical catheter 1 according to an embodiment of the present invention is mainly a catheter tube 2 such as a circular tube that can be bent and formed of, for example, polyethylene, nylon, or polyethylene terephthalate (PET), as illustrated in FIG. The catheter tube 2 is inserted into a vascular tissue or organ in the form of a blood vessel, a liver, a bile duct or other tubular or bag-like body in the living body, for example, under the guidance of a known guide wire (not shown) during the operation. It is what is done.
 なお、図示のこの医療用カテーテル1は、管腔組織や臓器に挿入されるカテーテルチューブ2の先端部の近傍に、管腔臓器内の所定箇所で膨張変形させるバルーン3を有するとともに、その先端部とは逆側の、生体外に配置される基端部に、該基端部からY字状に分岐するY字コネクタ4を有する。なお、図1では、バルーン3は膨張変形した状態で示している。
 このY字コネクタ4の一方側の筒状部4aは、バルーン3を膨張変形させるためのバルーン3への流体の供給に用いられるものであり、他方側の筒状部4bは、カテーテルチューブ2の挿入に先立って管腔組織や臓器に挿入されるガイドワイヤーが通過するものである。
 但し、これらのバルーン3およびY字コネクタ4は、この発明に必須の構成ではない。
The medical catheter 1 shown in the figure has a balloon 3 that is inflated and deformed at a predetermined location in the luminal organ in the vicinity of the distal end portion of the catheter tube 2 to be inserted into the luminal tissue or organ. A Y-shaped connector 4 that branches in a Y-shape from the base end portion is provided at the base end portion disposed outside the living body on the opposite side of the base plate. In FIG. 1, the balloon 3 is shown in an inflated and deformed state.
The cylindrical portion 4 a on one side of the Y-shaped connector 4 is used for supplying a fluid to the balloon 3 for inflating and deforming the balloon 3, and the cylindrical portion 4 b on the other side is used for the catheter tube 2. Prior to insertion, a guide wire inserted into a luminal tissue or organ passes therethrough.
However, these balloon 3 and Y-shaped connector 4 are not essential components for the present invention.
 ここで、この発明の医療用カテーテル1では、カテーテルチューブ2を生体内の管腔組織や臓器に挿入した際に、そのカテーテルチューブ2の所定の箇所の、管腔組織や臓器内での位置を、超音波診断装置を用いて外部から把握可能にするため、図2に示すように、カテーテルチューブ2の延在方向の少なくとも一箇所に、生体外の超音波診断装置等から生体組織を通じてカテーテルチューブ2に到達する超音波を、他の部分とは異なる態様で反射させる超音波用マーカー部分5を設ける。 Here, in the medical catheter 1 of the present invention, when the catheter tube 2 is inserted into a luminal tissue or organ in a living body, the position of the predetermined portion of the catheter tube 2 in the luminal tissue or organ is determined. In order to be able to grasp from the outside using the ultrasonic diagnostic apparatus, as shown in FIG. 2, the catheter tube passes through the living tissue from the ultrasonic diagnostic apparatus or the like outside the living body in at least one place in the extending direction of the catheter tube 2. An ultrasonic marker portion 5 for reflecting the ultrasonic wave reaching 2 in a different manner from the other portions is provided.
 図1および2に示すこの実施形態では、図3に更なる拡大図で示すところから解かるように、超音波用マーカー部分5を、カテーテルチューブ2の外周面2aから窪む溝部6、および、該溝部6に隣接してカテーテルチューブ2の外周面2aから突出する突起部7で構成している。 In this embodiment shown in FIGS. 1 and 2, as can be seen from the further enlarged view shown in FIG. 3, the ultrasonic marker portion 5 is provided with a groove 6 recessed from the outer peripheral surface 2 a of the catheter tube 2, and It is composed of a protrusion 7 protruding from the outer peripheral surface 2 a of the catheter tube 2 adjacent to the groove 6.
 このことによれば、カテーテルチューブ2を管腔組織や臓器に挿入した状態で、超音波診断装置を用いて生体外から照射された超音波としての平面波等は、生体組織を伝搬した後、上記の溝部6および突起部7を設けた超音波用マーカー部分5で、カテーテルチューブ2の凹凸形状のない他の外周面部分とは異なる向きに反射することになり、それにより、そのように反射される超音波を受信して処理された画像データでは、図4に例示するように、たとえば溝部6と突起部7からなる超音波用マーカー部分5が、他の部分とは異なって暗く表示され得る。
 その結果として、超音波診断装置を用いて、管腔臓器内のカテーテルチューブ2の超音波用マーカー部分5を正確に把握することができるので、この医療用カテーテル1によれば、患者や医療従事者への放射線被爆のおそれがあるとともに高価で大型のX線撮影装置や、副作用の可能性があるX線造影剤の使用を要しない。
According to this, in a state where the catheter tube 2 is inserted into a luminal tissue or organ, a plane wave or the like as an ultrasonic wave irradiated from outside the living body using an ultrasonic diagnostic apparatus propagates through the living tissue, The ultrasonic marker portion 5 provided with the groove portion 6 and the protrusion portion 7 reflects in a different direction from the other outer peripheral surface portion of the catheter tube 2 that does not have an uneven shape, and is thus reflected as such. In the image data processed by receiving the ultrasonic wave, the ultrasonic marker portion 5 including, for example, the groove portion 6 and the projection portion 7 can be displayed darker than the other portions, as illustrated in FIG. .
As a result, since the ultrasonic marker portion 5 of the catheter tube 2 in the luminal organ can be accurately grasped using the ultrasonic diagnostic apparatus, the medical catheter 1 can be used for patients and medical personnel. There is a risk of radiation exposure to the person, and it is not necessary to use an expensive and large-sized X-ray imaging apparatus or an X-ray contrast agent that may cause side effects.
 しかもこの医療用カテーテル1は、たとえばレーザー加工、カッターやドリルによる切削加工またはサンドブラスト加工や転造加工によって、カテーテルチューブ2に溝部6および突起部7を形成するだけで極めて容易に製造することができるので、今後製造する医療用カテーテルを、この医療用カテーテル1とすることは勿論、既存の医療用カテーテルに対し、簡単な加工を施して、この医療用カテーテル1とすることも可能である。 Moreover, the medical catheter 1 can be manufactured very easily simply by forming the groove 6 and the protrusion 7 in the catheter tube 2 by, for example, laser processing, cutting with a cutter or a drill, sandblasting, or rolling. Therefore, the medical catheter 1 to be manufactured in the future can be used as the medical catheter 1 as well as the medical catheter 1 by performing simple processing on the existing medical catheter.
 このような超音波用マーカー部分5では、少なくとも一本の溝部6または、少なくとも一個の突起部7を設けていれば、超音波診断装置による視認が可能になるも、図示の実施形態のように、複数本の溝部6および/または複数個の突起部7を設けたほうが、画像データにより確実に表示させることができるので好ましい。
 なお、図示の実施形態では、レーザー加工で溝部6を形成した結果として、各溝部6の両側に突起部7が形成されているが、図示は省略するが、超音波用マーカー部分は、突起部なしで一本以上の溝部だけからなるもの、または、溝部なしで一個以上の突起部だけからなるものとすることも可能である。従って、図示の実施形態における突起部7は、必ずしも設けることを要しない。
In such an ultrasonic marker portion 5, if at least one groove 6 or at least one protrusion 7 is provided, it is possible to visually recognize the ultrasonic diagnostic apparatus, but as in the illustrated embodiment. It is preferable to provide a plurality of groove portions 6 and / or a plurality of projection portions 7 because the image data can be surely displayed.
In the illustrated embodiment, as a result of forming the groove portions 6 by laser processing, the protrusion portions 7 are formed on both sides of each groove portion 6. However, although not illustrated, the ultrasonic marker portion is a protrusion portion. It is also possible to have only one or more groove portions without, or only one or more protrusion portions without the groove portion. Therefore, the protrusion 7 in the illustrated embodiment is not necessarily provided.
 ここで、より詳細には、各溝部6は、図5に溝部6および突起部7を横断する断面図で示すように、いずれもカテーテルチューブ2の外周面2aに対して傾斜して互いに対向する一対の溝壁面6aと、それらの溝壁面6aに連続して最も深い位置にある溝底部分6bとで構成される内面を有するものとすることができる。
 また、各突起部7は、図5に示すように、いずれもカテーテルチューブ2の外周面2aに対して傾斜する突起側面7aと、それらの突起側面7aの相互を繋ぐ突起頂部7bとで構成される外面を有するものとすることができる。
Here, more specifically, each groove 6 is inclined with respect to the outer peripheral surface 2a of the catheter tube 2 and faces each other as shown in a cross-sectional view across the groove 6 and the protrusion 7 in FIG. It can have an inner surface constituted by a pair of groove wall surfaces 6a and a groove bottom portion 6b located at the deepest position continuously to the groove wall surfaces 6a.
Further, as shown in FIG. 5, each protrusion 7 is composed of a protrusion side surface 7a that is inclined with respect to the outer peripheral surface 2a of the catheter tube 2, and a protrusion top portion 7b that connects the protrusion side surfaces 7a to each other. It may have an outer surface.
 図5に示すところでは、溝部6の内面をなす溝壁面6aならびに、突起部7の外面をなす突起側面7aおよび突起頂部7bはいずれも、平坦面にて形成されるテーパ面をなすが、これらの溝部6の内面および突起部7の外面はともに、図6(a)に示すように、カテーテルチューブ2の半径方向に凹状または凸状の湾曲面によるテーパ面とすることができる。
 あるいは、図6(b)に示すように、溝部6の内面を湾曲面とするとともに、突起部7の外面を平坦面とすることができる他、これとは逆に、図6(c)に示すように、溝部6の内面を平坦面とするとともに、突起部7の外面を湾曲面とすることもできる。
In FIG. 5, the groove wall surface 6 a forming the inner surface of the groove portion 6 and the protrusion side surface 7 a and the protrusion top portion 7 b forming the outer surface of the protrusion portion 7 are both tapered surfaces formed as flat surfaces. Both the inner surface of the groove portion 6 and the outer surface of the projection portion 7 can be tapered surfaces having a curved surface that is concave or convex in the radial direction of the catheter tube 2 as shown in FIG.
Alternatively, as shown in FIG. 6 (b), the inner surface of the groove 6 can be a curved surface, and the outer surface of the projection 7 can be a flat surface. As shown, the inner surface of the groove 6 can be a flat surface, and the outer surface of the projection 7 can be a curved surface.
 また、図5および図6(c)に示すところでは、溝部6の溝底部分6bを、対向する溝壁面6aおよび6bの相互が交わる角部としているが、図6(d)に示すように、溝底位置で互いに離隔する溝壁面6aおよび6bの相互を連結する平坦面状に形成することもできる。突起部7の突起頂部7bもまた同様に、図5および図6(b)に示すような平坦面状、または、図示しない角部形状とすることができる。 5 and 6 (c), the groove bottom portion 6b of the groove 6 is a corner where the opposing groove wall surfaces 6a and 6b intersect, but as shown in FIG. 6 (d). The groove wall surfaces 6a and 6b that are separated from each other at the groove bottom position may be formed in a flat surface shape that connects the mutual surfaces. Similarly, the projection top part 7b of the projection part 7 can also have a flat surface shape as shown in FIGS. 5 and 6B or a corner part shape not shown.
 このような溝部6の溝壁面6aは、生体外から照射される超音波を、他の部分とは異なる向きに有効に反射させることを目的として、溝底に近付くに従って対向する溝壁面6aが互いに接近する向きに傾斜させるとともに、その傾斜角度θ1を、カテーテルチューブ2の延在方向(図5および6の左右方向)に対し、30°~90°とすることが好ましい。
 また、突起部7の突起側面7aは、同様の目的で、突起頂部7bに近付くに従って突起側面7aが相互に接近する向きに傾斜させるとともに、その傾斜角度θ2を、カテーテルチューブ2の延在方向に対し、30°~90°とすることが好ましい。
The groove wall surface 6a of the groove portion 6 is formed so that the groove wall surfaces 6a facing each other as they approach the groove bottom are mutually effective for the purpose of effectively reflecting ultrasonic waves irradiated from outside the living body in different directions from other parts. It is preferable to incline in the approaching direction, and the inclination angle θ1 is 30 ° to 90 ° with respect to the extending direction of the catheter tube 2 (the left-right direction in FIGS. 5 and 6).
For the same purpose, the projection side surface 7a of the projection portion 7 is inclined so that the projection side surface 7a approaches each other as it approaches the projection top portion 7b, and the inclination angle θ2 is inclined in the extending direction of the catheter tube 2. On the other hand, it is preferably 30 ° to 90 °.
 なお、溝部6の最大深さDgは、カテーテルチューブ2の外周面位置から該カテーテルチューブ2の半径方向に沿って測って、20μm~200μmとすることが好ましい。溝部6のこの最大深さDgは、管状のカテーテルチューブ2の厚みに対して、10%~70%であることが、カテーテルチューブ2の所要の引張強度を確保するとの観点から好ましい。
 また、溝部6の、前記外周面位置での開口部の幅Wgは、溝部6を直交する向きに測って、50μm~500μmとすることが好ましい。
The maximum depth Dg of the groove 6 is preferably 20 μm to 200 μm as measured along the radial direction of the catheter tube 2 from the position of the outer peripheral surface of the catheter tube 2. The maximum depth Dg of the groove 6 is preferably 10% to 70% with respect to the thickness of the tubular catheter tube 2 from the viewpoint of securing the required tensile strength of the catheter tube 2.
Further, the width Wg of the opening at the position of the outer peripheral surface of the groove 6 is preferably 50 μm to 500 μm when measured in the direction perpendicular to the groove 6.
 またここで、突起部7の、前記外周面位置での幅Wpは、突起部7を直交する向きに測って、10μm~100μmとすることが好ましく、また、突起部7の最大突出高さHpは、カテーテルチューブ2の外周面位置から該カテーテルチューブ2の半径方向に沿って測って、0μm~100μmとすることが好ましい。
 上述した溝部6の最大深さDg、開口幅Wgや、突起部7の幅Wp、最大突出高さHpが小さすぎる場合は、超音波による溝部6ないし突起部7の視認性が低下して、超音波診断装置を用いて画像表示した際に、十分明確に確認し得なくなるおそれがある。また、溝部6の最大深さDgが大きすぎる場合は、引張強度が低下したり、耐キンク性が低下して座屈しやすくなったりすることがある。そしてまた、突起部7の幅Wpが大きすぎる場合は、柔軟性の低下や、病変部の通過性の低下の可能性があり、また、突起部7の最大突出高さHpが大きすぎる場合は、外径の増加によって病変部の通過性が低下することが懸念される。
Here, the width Wp of the protrusion 7 at the position of the outer peripheral surface is preferably 10 μm to 100 μm as measured in the direction orthogonal to the protrusion 7, and the maximum protrusion height Hp of the protrusion 7 Is preferably 0 μm to 100 μm as measured along the radial direction of the catheter tube 2 from the position of the outer peripheral surface of the catheter tube 2.
When the maximum depth Dg and the opening width Wg of the groove 6 described above, the width Wp of the protrusion 7 and the maximum protrusion height Hp are too small, the visibility of the groove 6 or the protrusion 7 due to ultrasonic waves is reduced. When an image is displayed using an ultrasonic diagnostic apparatus, there is a possibility that it cannot be confirmed sufficiently clearly. Moreover, when the maximum depth Dg of the groove part 6 is too large, tensile strength may fall, or kink resistance may fall and it may become easy to buckle. In addition, when the width Wp of the protrusion 7 is too large, there is a possibility that the flexibility and the passability of the lesioned area may be decreased, and when the maximum protrusion height Hp of the protrusion 7 is too large. There is a concern that the passage of the lesioned part may decrease due to the increase in the outer diameter.
 そしてまた、溝部6および/または突起部7は、カテーテルチューブ2の延在方向(図3の左右方向)に対して傾斜する方向、または、図3に示すように、その延在方向に対して垂直な方向に延びるものとすることができる。 Further, the groove 6 and / or the protrusion 7 are inclined with respect to the extending direction of the catheter tube 2 (left and right direction in FIG. 3), or with respect to the extending direction as shown in FIG. It can extend in a vertical direction.
 この場合、それぞれの溝部6および/または突起部7は、図示は省略するが、カテーテルチューブ2の外周面2aの全周にわたって連続して一周して延びるものとすることも可能であるが、図7にカテーテルチューブ2の横断面図で示すように、カテーテルチューブ2の外周面2aを、図7の上側に位置する一方側(たとえば表側)の半周分領域Ah1と、下側に位置する他方側(たとえば裏側)の半周分領域Ah2とに区分けし、溝部6および/または突起部7を、それらの一方側および他方側のそれぞれの半周分領域Ah1およびAh2の少なくとも一部に形成することが好ましい。 In this case, although not shown in the drawings, the respective groove portions 6 and / or protrusions 7 may be continuously extended around the entire outer periphery 2a of the catheter tube 2; 7, the outer peripheral surface 2a of the catheter tube 2 is arranged on the one side (for example, front side) half circumference region Ah1 located on the upper side of FIG. 7 and on the other side located on the lower side. It is preferable that the groove 6 and / or the protrusion 7 are formed in at least a part of each of the half-circumferential regions Ah1 and Ah2 on one side and the other side thereof. .
 このようにカテーテルチューブ2の外周面2aの周方向で互いに反対側の位置のそれぞれに、溝部6および/または突起部7を形成することにより、たとえば、複数本の医療用カテーテルの各カテーテルチューブを並べて配置した状態で、それらの表側および裏側のそれぞれから、それらのカテーテルチューブを横断する向きで、レーザー加工を施すことで、複数本の医療用カテーテルの全てに対して一括的に加工を施すことができる。そのため、このような溝部6および/または突起部7は、全周にわたる溝部6ないし突起部7を形成する場合に比して容易に形成することができる。
 しかも、超音波診断装置による生体外からの観察は、溝部6や突起部7が、カテーテルチューブ2の全周にわたって形成されていることを要せず、上記のように、その外周面2aの周方向で互いに反対側の位置のそれぞれに形成されていることで十分有効に行うことが可能である。
In this way, by forming the groove 6 and / or the protrusion 7 at positions opposite to each other in the circumferential direction of the outer peripheral surface 2a of the catheter tube 2, for example, each catheter tube of a plurality of medical catheters can be In a state where they are arranged side by side, all of a plurality of medical catheters can be collectively processed by laser processing in a direction crossing the catheter tube from each of the front side and the back side. Can do. Therefore, the groove 6 and / or the protrusion 7 can be easily formed as compared with the case where the groove 6 or the protrusion 7 is formed over the entire circumference.
Moreover, the observation from outside the living body by the ultrasonic diagnostic apparatus does not require that the groove 6 and the protrusion 7 are formed over the entire circumference of the catheter tube 2, and as described above, the circumference of the outer circumferential surface 2a. It is possible to carry out sufficiently effectively by being formed at positions opposite to each other in the direction.
 上述したように、一方側(たとえば表側)の半周分領域Ah1および、他方側(たとえば裏側)の半周分領域Ah2のそれぞれに、溝部6および/または突起部7を形成した場合、それらの溝部6ないし突起部7の、カテーテルチューブ2の外周面2aの周方向に沿う長さは、カテーテルチューブ2の外周面2aの全周長さに対し、10%~100%とすることが好ましく、具体的には、溝部6ないし突起部7の上記の長さは、300μm~4500μmとすることが好適である。たとえば、直径が1.0mm~1.5mmのカテーテルチューブ2では、溝部6および/または突起部7の周方向長さは、最も短い場合で、チューブ直径1.0mmの10%として約0.3mmとすることができ、また最も長い場合で、チューブ直径1.5mmの全周とすることができる。
 なお、溝部6および/または突起部7の周方向長さが短い場合であっても、その溝部6および/または突起部7を加工した面を常に、超音波が照射される側に向けて使用されるようにすることで、かかる溝部6および/または突起部7を、超音波用マーカー部分5として有効に機能させることができる。
As described above, when the groove 6 and / or the protrusion 7 is formed in each of the half-circumferential region Ah1 on one side (for example, the front side) and the half-circular region Ah2 on the other side (for example, the back side), these grooves 6 The length of the protrusion 7 along the circumferential direction of the outer circumferential surface 2a of the catheter tube 2 is preferably 10% to 100% with respect to the total circumferential length of the outer circumferential surface 2a of the catheter tube 2. For this, the length of the groove 6 to the protrusion 7 is preferably set to 300 μm to 4500 μm. For example, in the catheter tube 2 having a diameter of 1.0 mm to 1.5 mm, the circumferential length of the groove 6 and / or the protrusion 7 is about 0.3 mm as 10% of the tube diameter of 1.0 mm in the shortest case. In the longest case, the entire circumference can be 1.5 mm in tube diameter.
Even when the circumferential length of the groove 6 and / or the protrusion 7 is short, the surface on which the groove 6 and / or the protrusion 7 is processed is always directed toward the side irradiated with the ultrasonic waves. By doing so, the groove 6 and / or the protrusion 7 can effectively function as the ultrasonic marker portion 5.
 溝部6および/または突起部7の周方向長さが長すぎる場合は、その超音波用マーカー部分5を設けた箇所で、カテーテルチューブの強度が局所的に低下ないし増加することが懸念される。この一方で、溝部6および/または突起部7の周方向長さが短すぎる場合は、超音波用マーカー部分5としての溝部6および/または突起部7の視認性の低下のおそれがある。 If the circumferential length of the groove 6 and / or the protrusion 7 is too long, there is a concern that the strength of the catheter tube may locally decrease or increase at the location where the ultrasonic marker portion 5 is provided. On the other hand, if the circumferential length of the groove 6 and / or the protrusion 7 is too short, the visibility of the groove 6 and / or the protrusion 7 as the ultrasonic marker portion 5 may be reduced.
 なお、複数本の溝部6および/または複数個の突起部7を設ける場合は、図2、3に例示するように、複数本の溝部6および/または複数個の突起部7が、互いに隣接して整列する密集領域Fdと、複数本の溝部6および/または複数個の突起部7が、互いに所定の間隔をおいて離隔して整列する分散領域Fsとを設けることが好ましく、これにより、超音波診断装置による観察時に、溝部6および/または突起部7の形成位置を、密集領域Fdと分散領域Fsとで異なる意味を持たせることができる。 In the case where a plurality of grooves 6 and / or a plurality of protrusions 7 are provided, the plurality of grooves 6 and / or the plurality of protrusions 7 are adjacent to each other as illustrated in FIGS. It is preferable to provide a dense region Fd that is aligned with each other and a dispersion region Fs in which the plurality of groove portions 6 and / or the plurality of protrusions 7 are spaced apart from each other at a predetermined interval. At the time of observation by the ultrasonic diagnostic apparatus, the formation position of the groove 6 and / or the protrusion 7 can have different meanings in the dense region Fd and the dispersion region Fs.
 ところで、この発明では、上述した溝部6および/または突起部7からなる超音波用マーカー部分5とともに、または、該超音波用マーカー部分5に代えて、図8に部分拡大側面図で示す他の実施形態のように、他の部分とは異なる弾性率および/または密度を有する材料を含む超音波用マーカー部分15を設けることができる。 By the way, in this invention, it replaces with the marker part 5 for ultrasonic waves which consists of the groove part 6 and / or the projection part 7 mentioned above, or it replaces with this marker part 5 for ultrasonic waves, and the other part shown by a partial expanded side view in FIG. As in the embodiment, an ultrasonic marker portion 15 including a material having a different elastic modulus and / or density from other portions can be provided.
 図8に示すところでは、カテーテルチューブ12の外周面に、他のチューブ部分に比して、弾性率の大きい、または小さい材料を、吹付けまたは塗装その他の処理方法にてコーティングして、その外周面の周方向の少なくとも一部、図8では全周を被覆するコーティング部分16を形成している。
 このように弾性率および/または密度の異なる材料で超音波用マーカー部分15を構成することにより、生体内の管腔組織や臓器に挿入されたカテーテルチューブ12に対し、生体外から超音波を照射した場合、その弾性率および/または密度の異なる材料からなる超音波用マーカー部分15で、超音波が異なる向きに反射することになるので、超音波用マーカー部分15を設けた部分の、生体内における位置を有効に把握することができる。
In the place shown in FIG. 8, the outer peripheral surface of the catheter tube 12 is coated with a material having a larger or smaller elastic modulus than other tube portions by spraying, painting, or other processing methods, and the outer periphery thereof. A coating portion 16 is formed to cover at least a part of the circumferential direction of the surface, in FIG.
By configuring the ultrasonic marker portion 15 with materials having different elastic moduli and / or densities in this way, ultrasonic waves are irradiated from outside the living body to the catheter tube 12 inserted into the luminal tissue or organ in the living body. In this case, since the ultrasonic waves are reflected in different directions by the ultrasonic marker portions 15 made of materials having different elastic moduli and / or densities, the portion provided with the ultrasonic marker portions 15 in the living body The position in can be effectively grasped.
 ここで弾性率は、体積弾性率ないしヤング率を意味する。これは、引張試験の結果から算出することができる。
 なお、ここでいう「他の部分」に相当するカテーテルチューブ12の弾性率は一般に、0.2MPa~7MPa程度であるのに対し、弾性率の異なる材料からなる部分の弾性率は、他の部分の弾性率に対して、0.01%~1%の範囲、より好ましくは0.1%~0.5%の範囲で大きいものとするか、または小さいものとする。
 より具体的には、弾性率の異なる材料からなる部分は具体的には、上記の他の部分の弾性率とは異なることを前提として、0.01MPa~0.1MPaとすることができ、好ましくは、0.03MPa~0.05MPaとする。
 このような材料の例として、「他の部分」に相当するカテーテルチューブ12の材料が一般的に、PTEE、ポリエチレン、ポリプロピレン、ナイロン等であるのに対し、超音波用マーカー部分15を構成する弾性率および/または密度の異なる材料を、他の部分よりも弾性率の小さいゴム材料または、他の部分より弾性率の大きい金属材料等とすることができる。
Here, the elastic modulus means volume elastic modulus or Young's modulus. This can be calculated from the result of a tensile test.
The elastic modulus of the catheter tube 12 corresponding to “other portion” here is generally about 0.2 MPa to 7 MPa, whereas the elastic modulus of a portion made of a material having a different elastic modulus is different from that of the other portion. The elastic modulus is made large or small in the range of 0.01% to 1%, more preferably in the range of 0.1% to 0.5%.
More specifically, the portion made of a material having a different elastic modulus can be set to 0.01 MPa to 0.1 MPa, specifically assuming that the elastic modulus of the other portion is different from that described above. Is 0.03 MPa to 0.05 MPa.
As an example of such a material, the material of the catheter tube 12 corresponding to the “other part” is generally PTEE, polyethylene, polypropylene, nylon or the like, whereas the elasticity constituting the ultrasonic marker part 15 is used. The material having a different modulus and / or density can be a rubber material having a smaller elastic modulus than other portions, a metal material having a larger elastic modulus than other portions, or the like.
 たとえば、弾性率の異なる材料からなる超音波用マーカー部分15は、他の部分よりも弾性率を大きくすることができ、または小さくすることができるが、超音波診断装置での見え方ならびに、カテーテルチューブ12の曲げ性および耐キンク性の観点からは、超音波用マーカー部分15の弾性率を小さくすることが好ましい。
 これはすなわち、弾性率の小さい超音波用マーカー部分15は、超音波診断装置で見ると、白く表示されるカテーテルチューブ12に対して黒い筋として表示されて確認しやすいが、弾性率の大きい超音波用マーカー部分15は、白い筋として表示されるので若干視認性に劣る可能性がある。また、弾性率の大きい超音波用マーカー部分15は、カテーテルチューブ12のそれを設けた箇所を硬くするので、曲げ性や耐キンク性(座屈のしにくさ)が損なわれる可能性がある。
For example, the ultrasonic marker portion 15 made of a material having a different elastic modulus can have a larger or smaller elastic modulus than the other portions. From the viewpoint of the bendability and kink resistance of the tube 12, it is preferable to reduce the elastic modulus of the ultrasonic marker portion 15.
That is, the ultrasonic marker portion 15 having a low elastic modulus is displayed as a black streak on the catheter tube 12 displayed in white when viewed with an ultrasonic diagnostic apparatus. Since the sonic marker portion 15 is displayed as white stripes, it may be slightly inferior in visibility. Further, since the ultrasonic marker portion 15 having a large elastic modulus hardens the portion where the catheter tube 12 is provided, the bendability and kink resistance (hardness to buckle) may be impaired.
 図8に示す実施形態では、カテーテルチューブ12の外周面に、弾性率の異なる材料をコーティングすることにより、弾性率の異なる材料を含む超音波用マーカー部分15を設けているが、図示は省略するが、カテーテルチューブ12の内周面へのコーティングによっても超音波用マーカー部分15を設けることができる他、カテーテルチューブ12の一部それ自体を、弾性および/または密度率の異なる材料で置き換えて形成することにより、弾性率および/または密度の異なる材料を含む超音波用マーカー部分15を設けることができる。たとえば、超音波用マーカー部分15として、異なる弾性率および/または密度の材料からなるチューブを、カテーテルチューブ12の途中に接合して設けることが可能である。 In the embodiment shown in FIG. 8, the ultrasonic marker portion 15 containing a material having a different elastic modulus is provided on the outer peripheral surface of the catheter tube 12 by coating a material having a different elastic modulus, but the illustration is omitted. However, the ultrasonic marker portion 15 can also be provided by coating the inner peripheral surface of the catheter tube 12, and a part of the catheter tube 12 itself is replaced with a material having a different elasticity and / or density ratio. By doing so, the ultrasonic marker portion 15 including materials having different elastic moduli and / or densities can be provided. For example, as the ultrasonic marker portion 15, a tube made of a material having different elastic modulus and / or density can be joined and provided in the middle of the catheter tube 12.
 以上に述べたような医療用カテーテル1、11は、カテーテルチューブ2、12の少なくとも一箇所に、超音波用マーカー部分5、15を設けたことにより、カテーテルチューブ2、12を管腔臓器に挿入した際に、生体外から超音波診断装置を用いて超音波を照射すると、その超音波用マーカー部分5、15を設けた部分が現在、管腔組織や臓器のどの位置にあるかを正確に確認することができる。
 このような超音波用マーカー部分5、15を、図示のようなバルーン3を設けた医療用カテーテル1、11に適用した場合は、一般に管腔組織や臓器内での位置を把握することのできないバルーン3の位置を、超音波用マーカー部分5、15による表示機能をもって正確に確認することができるので非常に有利である。
The medical catheters 1 and 11 as described above are provided with the ultrasonic marker portions 5 and 15 in at least one place of the catheter tubes 2 and 12, thereby inserting the catheter tubes 2 and 12 into the luminal organ. When an ultrasonic wave is radiated from outside the living body using an ultrasonic diagnostic apparatus, it is possible to accurately determine where the portion provided with the ultrasonic marker portions 5 and 15 is currently located in the luminal tissue or organ. Can be confirmed.
When such ultrasonic marker portions 5 and 15 are applied to the medical catheters 1 and 11 provided with the balloon 3 as shown in the drawing, it is generally impossible to grasp the position in the luminal tissue or organ. This is very advantageous because the position of the balloon 3 can be accurately confirmed with the display function of the ultrasonic marker portions 5 and 15.
 すなわち、上述した超音波用マーカー部分5、15を、図9(a)に示すように、たとえばカテーテルチューブ2の先端部等に設けられる可撓性の薄膜状のバルーン3の内側のカテーテルチューブ部分に設け、または、図9(b)に示すように、そのバルーン3の配設箇所から予め決められた一定の距離Ls1、Ls2で離隔した近接箇所に設けることにより、超音波用マーカー部分5、15を、生体内でのバルーン3の位置表示部分として機能させることができる。 That is, as shown in FIG. 9A, the ultrasonic marker portions 5 and 15 described above, for example, the catheter tube portion inside the flexible thin film balloon 3 provided at the distal end portion of the catheter tube 2 or the like. 9B, or as shown in FIG. 9 (b), the ultrasonic marker portion 5 is provided at a location close to the balloon 3 by a predetermined distance Ls1, Ls2. 15 can function as a position display portion of the balloon 3 in the living body.
 なお、図9(a)に示すように、バルーン3の内側のカテーテルチューブ部分に超音波用マーカー部分5、15を設ける場合は、実際に狭窄した血管部位を押し広げる部位であり、そのバルーン3の径が一定の長さであるバルーン長さLbの全長にわたって、超音波用マーカー部分5、15を設けることが好ましい。これにより、超音波診断装置により確実に表示させることができる。さらに、バルーン3のバルーン長さLbの両端位置をより強調して表示させるため、それらの両端位置の近傍の領域、たとえば、両端位置のそれぞれから長手方向中央側に向かって0.5mm~2mmの範囲の領域で、溝部等をより密に配置し、または、超音波をより吸収する材料を配置することが好適である。
 図9(b)に示すように、バルーン3の近接箇所に超音波用マーカー部分5を設ける場合、距離Ls1と距離Ls2とは互いに等しい長さとすることができる他、互いに異なる長さとすることもできる。図9(b)に示すところでは、バルーン3の近接箇所に、溝部および/または突起部を密集させた超音波用マーカー部分5を設けている。
 このようなバルーン3を設けた医療用カテーテル1では、図示は省略するが、バルーン3自体に、上述した溝部および/または突起部を設けることも可能である。
As shown in FIG. 9A, when the ultrasonic marker portions 5 and 15 are provided in the catheter tube portion inside the balloon 3, it is a portion that widens the actually narrowed blood vessel portion. It is preferable to provide the ultrasonic marker portions 5 and 15 over the entire length of the balloon length Lb, which has a constant diameter. Thereby, it can be reliably displayed by the ultrasonic diagnostic apparatus. Further, in order to emphasize and display the both end positions of the balloon length Lb of the balloon 3, for example, an area in the vicinity of the both end positions, for example, 0.5 mm to 2 mm from each of the both end positions toward the center in the longitudinal direction. In the range region, it is preferable to arrange the grooves and the like more densely or to dispose a material that absorbs more ultrasonic waves.
As shown in FIG. 9B, when the ultrasonic marker portion 5 is provided in the vicinity of the balloon 3, the distance Ls1 and the distance Ls2 can be equal to each other, or can be different from each other. it can. As shown in FIG. 9B, an ultrasonic marker portion 5 in which grooves and / or protrusions are densely provided is provided in the vicinity of the balloon 3.
In the medical catheter 1 provided with such a balloon 3, although the illustration is omitted, it is possible to provide the above-described groove and / or protrusion on the balloon 3 itself.
 このことによれば、X線撮影装置のような大型の装置ではなく、比較的小型で安価な超音波診断装置をもって、生体内のバルーン3の位置を正確に確認することができるので、たとえばシャントPTAを、より多くの施設で容易かつ安全に、しかも高い精度にて実施することが可能になる。しかもこの場合、X線撮影の際の造影剤の使用を要しない。
 従って、この発明の実施形態に係る医療用カテーテル1、11は、カテーテルチューブ2、12が生体内の血管に挿入される、シャントPTA等を実施するための血管内治療用カテーテルとして用いることが特に有効である。
 なお、上述したようにカテーテルチューブ2、12に超音波用マーカー部分5、15を設けることに加えて、または、それに代えて、図示は省略するが、バルーン3自体に、溝部および/または突起部等の超音波用マーカー部分5、15を設けることができる。
According to this, since the position of the balloon 3 in the living body can be accurately confirmed with a relatively small and inexpensive ultrasonic diagnostic apparatus rather than a large apparatus such as an X-ray imaging apparatus, for example, a shunt PTA can be carried out easily and safely in more facilities with high accuracy. Moreover, in this case, it is not necessary to use a contrast agent for X-ray imaging.
Therefore, the medical catheters 1 and 11 according to the embodiments of the present invention are particularly used as an intravascular treatment catheter for performing a shunt PTA or the like in which the catheter tubes 2 and 12 are inserted into blood vessels in the living body. It is valid.
In addition to or in place of providing the ultrasonic marker portions 5 and 15 on the catheter tubes 2 and 12 as described above, although not shown, the balloon 3 itself has a groove and / or protrusion. Ultrasonic marker portions 5 and 15 such as can be provided.
 上記の実施形態の医療用カテーテル1、11を用いて、シャントPTAを実施するには、たとえば、以下の手順にて行うことができる。
 はじめに、糖尿病性腎症等に起因してシャントを行った人工透析患者の腕の血管内に、図示しないガイドワイヤーを先行させて通し、その先端をシャントの狭窄部を超えて位置させる。
To perform the shunt PTA using the medical catheters 1 and 11 of the above-described embodiment, for example, the following procedure can be used.
First, a guide wire (not shown) is passed through the blood vessel of the arm of an artificial dialysis patient who has shunted due to diabetic nephropathy or the like, and the tip is positioned beyond the stenosis of the shunt.
 次いで、上記のガイドワイヤーによる案内の下、医療用カテーテル1、11を血管に挿入する。
 このとき、血管に挿入されたカテーテルチューブ2の先端部のバルーン3の位置は、通常は人体外から確認することができないが、この医療用カテーテル1、11では、そのバルーン3の配設箇所またはその近接箇所に、超音波用マーカー部分5、15を設けたことにより、超音波診断装置等を用いて人体外から超音波を照射することで、たとえば、人体外で表示させる画像に、超音波用マーカー部分5、15を鮮明に表示することができて、バルーン3の位置を正確に確認することができる。
 そのため、ここでは、外部からの視認の下、バルーン3を、高い精度でシャント狭窄部に送り、そこに配置することができる。
Next, the medical catheters 1 and 11 are inserted into the blood vessel under the guidance of the guide wire.
At this time, the position of the balloon 3 at the distal end of the catheter tube 2 inserted into the blood vessel cannot normally be confirmed from outside the human body. However, in the medical catheters 1 and 11, the location of the balloon 3 or By providing the ultrasonic marker portions 5 and 15 in the vicinity thereof, by irradiating ultrasonic waves from outside the human body using an ultrasonic diagnostic apparatus or the like, for example, ultrasonic waves are displayed on an image displayed outside the human body. The marker portions 5 and 15 can be clearly displayed, and the position of the balloon 3 can be confirmed accurately.
Therefore, here, the balloon 3 can be sent to the shunt stenosis portion with high accuracy and placed there under visual recognition from the outside.
 しかる後は、医療用カテーテル1、11のY字コネクタ4の筒状部4aから、バルーン3へと流体を送り込んで、バルーン3を膨張変形させることにより、シャント狭窄部を内部から押し広げて拡張させることができる。 After that, the fluid is sent from the cylindrical part 4a of the Y-shaped connector 4 of the medical catheters 1 and 11 to the balloon 3, and the balloon 3 is inflated and deformed to expand and expand the shunt stenosis part from the inside. Can be made.
 なお、このようなバルーン3に供給する流体は、マイクロバブルを含む液体であることが好ましい。
 かかるマイクロバブルを含む液体を用いた場合、生体内に供給された際に、生体外からの超音波の照射により、マイクロバブルが超音波を反射して、そのマイクロバブルが存在する部分を、超音波診断装置に表示させることができるので、たとえば、シャント狭窄部に位置させたバルーン3を膨張変形させるに際し、所期した通りにバルーン3が膨張変形しているかどうかを確認することが可能になる。それにより、バルーン3からの液体の漏洩等の意図しない事態に対して迅速に対処することができる。
In addition, it is preferable that the fluid supplied to such a balloon 3 is a liquid containing microbubbles.
When a liquid containing such microbubbles is used, when supplied into the living body, the microbubbles reflect the ultrasonic wave by the irradiation of ultrasonic waves from outside the living body, and the part where the microbubbles exist is Since it can be displayed on the ultrasonic diagnostic apparatus, for example, when the balloon 3 positioned in the shunt stenosis is inflated and deformed, it can be confirmed whether the balloon 3 is inflated and deformed as expected. . Thereby, it is possible to quickly cope with an unintended situation such as leakage of liquid from the balloon 3.
 このようなマイクロバブルは、リン脂質の被膜の中にペルフルブタンなどの安定化剤とともに空気などの気体を封じ込めてなる直径2μm~3μm程度の微細な粒子であり、既に知られているものを用いることができる。これを含む液体としては、たとえば、超音波診断用造影剤、具体的にはソナゾイド(第一三共株式会社製、登録商標)、レボビスト(バイエル薬品株式会社製、登録商標)等を挙げることができる。 Such microbubbles are fine particles having a diameter of about 2 μm to 3 μm, in which a gas such as air is contained in a phospholipid film together with a stabilizer such as perflubutane, and those already known should be used. Can do. Examples of the liquid containing this include a contrast agent for ultrasonic diagnosis, specifically, sonazoid (registered trademark, manufactured by Daiichi Sankyo Co., Ltd.), levovist (registered trademark, manufactured by Bayer Yakuhin Co., Ltd.), and the like. it can.
 また、バルーン3それ自体を、マイクロバブルを含む材料にて形成することで、上述したような膨張変形を確認できる効果を得ることができる。
 この場合、バルーン3は、表面にマイクロバブルを含有する薬剤をコーティングして製造することができる。
Moreover, the effect which can confirm expansion | swelling deformation | transformation as mentioned above can be acquired by forming balloon 3 itself with the material containing a microbubble.
In this case, the balloon 3 can be manufactured by coating the surface with a drug containing microbubbles.
 なお、以上に述べた超音波用マーカー部分5、15は、超音波以外の弾性波もまた、他の部分と異なる態様で反射させ得る場合もあり、使用する診断装置等に応じて、超音波以外の弾性波を対象とし、その弾性波の反射態様を他の部分とは異なるものとする弾性波用マーカー部分とすることも可能である。 Note that the ultrasonic marker portions 5 and 15 described above may also reflect elastic waves other than ultrasonic waves in a manner different from other portions, and depending on the diagnostic device used, the ultrasonic waves may be reflected. It is also possible to use an elastic wave marker portion that targets an elastic wave other than the above and has a reflection mode of the elastic wave different from other portions.
 1、11 医療用カテーテル
 2、12 カテーテルチューブ
 2a 外周面
 3、13 バルーン
 4 Y字コネクタ
 4a、4b 筒状部
 5、15 超音波用マーカー部分
 6 溝部
 6a 溝壁面
 6b 溝底部分
 7 突起部
 7a 突起側面
 7b 突起頂部
 16 コーティング部分
 Fd 密集領域
 Fs 分散領域
 θ1 溝壁面の傾斜角度
 θ2 突起側面の傾斜角度
 Ah1、Ah2 半周分領域
 Ls1、Ls2 超音波用マーカー部分とバルーン配設箇所との距離
DESCRIPTION OF SYMBOLS 1, 11 Medical catheter 2, 12 Catheter tube 2a Outer peripheral surface 3, 13 Balloon 4 Y connector 4a, 4b Tubular part 5, 15 Ultrasound marker part 6 Groove part 6a Groove wall surface 6b Groove bottom part 7 Protrusion part 7a Protrusion Side surface 7b Projection top portion 16 Coating portion Fd Dense region Fs Dispersion region θ1 Inclination angle of groove wall surface θ2 Inclination angle of projection side surface Ah1, Ah2 Half circumference region Ls1, Ls2 Distance between ultrasonic marker portion and balloon placement location

Claims (15)

  1.  生体内の管腔組織や臓器に挿入されて用いられる医療用カテーテルであって、前記医療用カテーテルのうちの少なくとも一箇所に、生体組織を通じて医療用カテーテルに到達する弾性波を、他の部分とは異なる態様で反射させる弾性波用マーカー部分を設けてなる医療用カテーテル。 A medical catheter used by being inserted into a luminal tissue or organ in a living body, wherein an elastic wave that reaches the medical catheter through the biological tissue is transmitted to at least one of the medical catheters with another portion. Is a medical catheter provided with an elastic wave marker portion that reflects in a different manner.
  2.  管腔組織や臓器に挿入される管状のカテーテルチューブを有し、該カテーテルチューブの延在方向の少なくとも一箇所に、前記弾性波用マーカー部分を設けてなる請求項1に記載の医療用カテーテル。 The medical catheter according to claim 1, further comprising a tubular catheter tube inserted into a luminal tissue or organ, wherein the elastic wave marker portion is provided in at least one place in the extending direction of the catheter tube.
  3.  前記弾性波用マーカー部分を、超音波を他の部分とは異なる態様で反射させる超音波用マーカー部分としてなる請求項1または2に記載の医療用カテーテル。 The medical catheter according to claim 1 or 2, wherein the elastic wave marker portion is an ultrasonic marker portion that reflects ultrasonic waves in a manner different from other portions.
  4.  少なくとも一箇所の前記弾性波用マーカー部分を、カテーテルチューブの外周面から窪む一本以上の溝部、および/または、該外周面から突出する一個以上の突起部で構成してなる請求項2または3に記載の医療用カテーテル。 The at least one elastic wave marker portion is constituted by one or more grooves recessed from the outer peripheral surface of the catheter tube and / or one or more protrusions protruding from the outer peripheral surface. 3. The medical catheter according to 3.
  5.  前記溝部の内面および/または前記突起部の外面を、平坦面または湾曲面で形成してなる請求項4に記載の医療用カテーテル。 The medical catheter according to claim 4, wherein the inner surface of the groove and / or the outer surface of the protrusion is formed as a flat surface or a curved surface.
  6.  前記溝部の溝壁面および/または前記突起部の突起側面を、該溝部および/または突起部の延在方向に直交する断面で、カテーテルチューブの外周面に対して傾斜するテーパ面としてなる請求項4または5に記載の医療用カテーテル。 The groove wall surface of the groove and / or the protrusion side surface of the protrusion is a tapered surface inclined with respect to the outer peripheral surface of the catheter tube in a cross section orthogonal to the extending direction of the groove and / or protrusion. Or the medical catheter of 5.
  7.  前記溝部および/または前記突起部を、カテーテルチューブの延在方向に対して傾斜する方向、または、該延在方向に対して垂直な方向に延びるものとしてなる請求項4~6のいずれか一項に記載の医療用カテーテル。 The groove portion and / or the protrusion portion extends in a direction inclined with respect to the extending direction of the catheter tube or in a direction perpendicular to the extending direction. The medical catheter according to 1.
  8.  前記溝部および/または前記突起部を、カテーテルチューブの外周面の一方側の半周分領域の少なくとも一部、および、前記一方側の半周分領域の裏側に位置する他方側の半周分領域の少なくとも一部のそれぞれに形成してなる請求項7に記載の医療用カテーテル。 The groove and / or the protrusion is provided at least a part of one half circumference region on one side of the outer peripheral surface of the catheter tube and at least one of the other half circumference regions located on the back side of the one half circumference region. The medical catheter according to claim 7, wherein the medical catheter is formed on each of the portions.
  9.  複数本の前記溝部および/または複数個の前記突起部を、互いに隣接させて並べて形成した密集領域と、複数本の前記溝部および/または複数個の前記突起部を、互いに間隔をおいて並べて形成した分散領域とを設けてなる請求項7または8に記載の医療用カテーテル。 A dense region formed by arranging a plurality of the groove portions and / or the plurality of projection portions adjacent to each other, and a plurality of the groove portions and / or the plurality of projection portions arranged at intervals from each other. The medical catheter according to claim 7 or 8, wherein a dispersed region is provided.
  10.  少なくとも一箇所の前記弾性波用マーカー部分が、前記他の部分とは弾性率および/または密度の異なる材料を含んで構成されてなる請求項2~9のいずれか一項に記載の医療用カテーテル。 The medical catheter according to any one of claims 2 to 9, wherein at least one of the elastic wave marker portions includes a material having a modulus of elasticity and / or a density different from that of the other portions. .
  11.  少なくとも一箇所の前記弾性波用マーカー部分が、前記他の部分とは弾性率および/または密度の異なる材料からなり、カテーテルチューブの外周面の周方向の少なくとも一部を被覆するコーティング部分で構成されてなる請求項10に記載の医療用カテーテル。 At least one of the elastic wave marker portions is made of a material having a different elastic modulus and / or density from the other portions, and is formed of a coating portion that covers at least a portion of the outer peripheral surface of the catheter tube in the circumferential direction. The medical catheter according to claim 10.
  12.  前記カテーテルチューブの長手方向の少なくとも一箇所に、該カテーテルチューブを外周側から取り囲んで配置される膨張変形可能なバルーンを有し、
     前記バルーンの配設箇所に、または、該配設箇所からカテーテルチューブの延在方向に沿って一定の距離をおいた近接箇所に、前記弾性波用マーカー部分を配置し、該弾性波用マーカー部分を、生体内の管腔臓器に挿入されるバルーンの位置表示部分としてなる請求項2~11のいずれか一項に記載の医療用カテーテル。
    Having at least one place in the longitudinal direction of the catheter tube having an inflatable deformable balloon disposed so as to surround the catheter tube from the outer peripheral side;
    The elastic wave marker portion is arranged at a location where the balloon is arranged or at a location close to the arrangement location along the extending direction of the catheter tube from the arrangement location. The medical catheter according to any one of claims 2 to 11, which is a position display portion of a balloon inserted into a luminal organ in a living body.
  13.  前記バルーンがマイクロバブルを含んで構成されてなる請求項12に記載の医療用カテーテル。 The medical catheter according to claim 12, wherein the balloon includes a microbubble.
  14.  生体内の管腔臓器に挿入されて該管腔臓器内でカテーテルチューブを案内するガイドワイヤーをさらに有してなる請求項2~13のいずれか一項に記載の医療用カテーテル。 The medical catheter according to any one of claims 2 to 13, further comprising a guide wire that is inserted into a luminal organ in a living body and guides the catheter tube within the luminal organ.
  15.  前記カテーテルチューブが生体内の血管に挿入される血管内治療用カテーテルとしてなる請求項2~14のいずれか一項に記載の医療用カテーテル。 The medical catheter according to any one of claims 2 to 14, wherein the catheter tube is an intravascular treatment catheter inserted into a blood vessel in a living body.
PCT/JP2014/072825 2014-08-29 2014-08-29 Medical catheter WO2016031071A1 (en)

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JP2020130883A (en) * 2019-02-25 2020-08-31 日本ゼオン株式会社 Balloon catheter for IABP
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