WO2022208607A1 - ガイドエクステンションカテーテル - Google Patents

ガイドエクステンションカテーテル Download PDF

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Publication number
WO2022208607A1
WO2022208607A1 PCT/JP2021/013277 JP2021013277W WO2022208607A1 WO 2022208607 A1 WO2022208607 A1 WO 2022208607A1 JP 2021013277 W JP2021013277 W JP 2021013277W WO 2022208607 A1 WO2022208607 A1 WO 2022208607A1
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WO
WIPO (PCT)
Prior art keywords
resin
intermediate layer
layer
wire
reinforcing
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Application number
PCT/JP2021/013277
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English (en)
French (fr)
Japanese (ja)
Inventor
雄祐 速水
Original Assignee
日本ライフライン株式会社
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 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to PCT/JP2021/013277 priority Critical patent/WO2022208607A1/ja
Priority to JP2023509921A priority patent/JPWO2022208607A1/ja
Publication of WO2022208607A1 publication Critical patent/WO2022208607A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Definitions

  • the present invention relates to guide extension catheters.
  • a minimally invasive interventional treatment that treats diseases such as the heart and blood vessels by inserting a catheter into the blood vessel is widely practiced.
  • interventional therapy guiding catheters are used to guide catheter devices for treatment (eg, balloon catheters, stent delivery catheters, etc.) to lesions.
  • the guiding catheter supports the delivery of the catheter device by using the reaction force generated by being pressed against the wall of the blood vessel.
  • the guiding catheter alone does not provide sufficient back support, and in some cases, the catheter device cannot cross the stenosis and reach the lesion.
  • a guide extension catheter is used in addition to the guiding catheter to obtain additional back support.
  • the guide extension catheter is inserted into the guiding catheter and protrudes distally beyond the tip of the guiding catheter.
  • a guide extension catheter provides additional back support to the guide catheter. Additional back support allows the catheter device to be delivered across the stenosis to the lesion.
  • a catheter device (interventional coronary artery device) can be operated remotely by making the entrance port of a cylindrical distal shaft arranged on the distal side (tip side) of a guide extension catheter into a helical shape. It is designed for easy entry into the position shaft.
  • Patent Document 1 no consideration is given to improving the blood vessel followability of the distal shaft.
  • the present invention has been made in view of the circumstances described above, and aims to improve the blood vessel followability of a tubular portion disposed on the distal end side of a guide extension catheter.
  • the present invention provides a guide extension catheter having a tubular portion having a longitudinally penetrating lumen at its distal end in the longitudinal direction, wherein the tubular portion is located in the middle of the longitudinal direction.
  • a reinforcing portion having an inner layer that defines the inner surface of the lumen of the tubular portion, an intermediate layer that is disposed on the outer peripheral surface of the inner layer, and an outer layer that is disposed on the outer peripheral surface of the intermediate layer.
  • the intermediate layer comprises a cylindrical coil body in which a wire is spirally wound, or a cylindrical braided body in which a plurality of wires are intersected and braided, and the reinforcing body and a resin that is softer than the resin that constitutes the outer layer.
  • the vessel followability of the cylindrical portion arranged on the distal end side of the guide extension catheter is improved.
  • FIG. 4 is a vertical cross-sectional view schematically showing a detailed configuration of a guide portion according to one embodiment of the present invention; (a) to (d) are transverse cross-sectional views of respective parts in the longitudinal direction of the guide part.
  • FIG. 4A is a schematic plan view showing a longitudinal section of a part of the reinforcing part, and FIG. is a cross-sectional view taken along the line FF.
  • FIG. 1 (a) and (b) are diagrams for explaining the structure of an intermediate layer when the reinforcing body is a braided body, and are schematic plan views showing a part of the reinforcing portion in longitudinal section.
  • (a) to (d) are longitudinal cross-sectional views showing the internal state of the reinforcing portion. It is a longitudinal cross-sectional view which shows the internal state of the curved reinforcement part.
  • a catheter is inserted into a blood vessel to treat diseases of the heart, blood vessels, etc.
  • a guiding catheter is used to allow treatment catheters (eg, balloon catheters, stent delivery catheters, guidewires, etc.) to reach lesions.
  • treatment catheters eg, balloon catheters, stent delivery catheters, guidewires, etc.
  • the guiding catheter has a hollow tubular shape with a lumen through which the catheter for treatment is inserted. delivered to the lesion.
  • a guide extension catheter is used in addition to the guiding catheter.
  • FIGS. 1(a) and 1(b) are schematic diagrams showing an example of percutaneous coronary angioplasty treatment.
  • (a) shows a state in which a guiding catheter is placed
  • (b) shows a state in which a guide extension catheter is further placed.
  • PCI treatment percutaneous coronary angioplasty treatment
  • a distal end portion 311 of a guiding catheter 310 is placed at the coronary artery ostium 301 .
  • FIG. Insert the extension catheter 320 .
  • the distal end portion 321 of the guide extension catheter 320 is projected beyond the distal end of the guiding catheter 310 (toward the lesion 303).
  • a distal end portion of a treatment catheter (not shown) passed through the guide extension catheter 320 receives additional back support from the guide extension catheter 320 and is delivered toward the lesion 303 .
  • the guiding catheter can be pressed against the wall of the aorta on the opposite side of the ostium of the coronary artery even in cases where it is difficult for a treatment catheter or the like to pass through the affected area.
  • the back support necessary for delivering a treatment device or the like to the affected area is strengthened against the resistance caused by bending or calcification of the coronary artery.
  • the guide extension catheter can also be applied to the treatment of the lower extremity region.
  • FIG. 2 shows a guide extension catheter according to an embodiment of the present invention, where (a) is a plan view and (b) is a side view.
  • the guide extension catheter 1 includes a guide portion 100 on the distal end side in the longitudinal direction and a push rod 200 (push member) on the proximal end side in the longitudinal direction.
  • a distal end portion 200 a of the push rod 200 is joined to a joint portion 150 positioned at the proximal end portion of the guide portion 100 .
  • the guide part 100 and the push rod 200 have flexibility to curve following the curved shape of the blood vessel.
  • Ax in the drawing is the axis of the guide portion 100 .
  • the guide portion 100 takes an initial posture in which the axis Ax extends linearly and a curved posture in which the axis Ax curves.
  • FIG. 3 is a longitudinal sectional view schematically showing the detailed configuration of the guide portion according to one embodiment of the present invention.
  • FIGS. 4A to 4D are transverse cross-sectional views of respective portions in the longitudinal direction of the guide portion.
  • FIG. 3 shows a cross section of the guide section taken along the line AA in FIG. 2(a).
  • FIGS. 4(a) to 4(d) show cross sections of the guide section taken along lines BB to EE in FIG. 3, respectively.
  • the guide part 100 has a hollow cylindrical guide part (cylindrical part) 110 having a lumen 111 penetrating in the longitudinal direction on the distal end side in the longitudinal direction, and has a concave guide surface continuous with the inner surface 111a of the lumen 111.
  • a semi-cylindrical semi-cylindrical guide portion 155 having 157 is provided on the proximal longitudinal side. Lumen 111 and concave guide surface 157 guide a procedural catheter device.
  • the reinforcing portion 117 arranged in the longitudinally intermediate portion of the cylindrical guide portion 110 includes an inner layer 131 that defines the inner surface 111a of the lumen 111 of the cylindrical guide portion 110, and an outer peripheral surface of the inner layer 131.
  • An intermediate layer 140 is arranged, and an outer layer 133 is arranged on the outer peripheral surface of the intermediate layer 140 .
  • the intermediate layer 140 is, for example, a cylindrical coil body 141A in which a wire 143 is spirally wound as shown in FIG. and a resin 147 that enters a space 145 between wires 143 and 143 that constitute the reinforcing body 141 .
  • This embodiment is characterized in that the resin 147 is made of a material softer than the resin forming the outer layer 133 .
  • cylindrical guide portion 110 is generally cylindrical with a lumen 111 extending longitudinally therethrough.
  • the cylindrical guide portion 110 includes, in order from the distal end in the longitudinal direction toward the proximal end, a distal tip 113, a distal marker 115, a reinforcing portion 117 having a reinforcing body 141 embedded in its thickness, and a proximal marker. 119 and.
  • the cylindrical guide portion 110 includes an inner layer 131 that defines the inner surface 111a (the surface facing the lumen 111) of the cylindrical guide portion 110 over its entire longitudinal direction.
  • the inner diameter d1, the outer diameter, and the thickness t1 of the inner layer 131 are all substantially constant over the entire longitudinal direction.
  • the cylindrical guide portion 110 includes an outer layer 133 arranged radially outward of the inner layer 131 .
  • the distal tip 113 comprises an inner layer 131 and an outer layer 133 in intimate contact with the inner layer 131 .
  • Distal marker 115 and proximal marker 119 are radiopaque markers.
  • Distal marker 115 and proximal marker 119 are positioned between inner layer 131 and outer layer 133 .
  • Distal marker 115 and proximal marker 119 are ring-shaped.
  • the distal side marker 115 and the proximal side marker 119 are attached to the outer circumference of the tube forming the inner layer 131 by caulking.
  • the reinforcing portion 117 includes an inner layer 131 that defines the inner surface 111a of the cylindrical guide portion 110, an intermediate layer 140 arranged on the outer diameter side (peripheral surface) of the inner layer 131, and an outer diameter side (peripheral surface) of the intermediate layer 140. and an outer layer 133 disposed on the .
  • FIG. 5A and 5B are diagrams for explaining the configuration of an intermediate layer when the reinforcing body is a coil body
  • FIG. is a cross-sectional view taken along line FF of (a).
  • the left side of FIG. 5(a) shows the outer layer 133 of the reinforcing portion 117 in the GG cross section of FIG. 5(b), and corresponds to a view of the intermediate layer 140 observed from the H direction (from the outer diameter side).
  • the right side of FIG. 5(a) shows each layer of the reinforcing portion 117 in the GG cross section of FIG. 5(b), and corresponds to a view of the intermediate layer 140 observed from the J direction (from the inner diameter side).
  • FIGS. 6(a) and 6(b) are diagrams for explaining the configuration of the intermediate layer when the reinforcing body is a braided body, and are schematic plan views showing a part of the reinforcing portion in longitudinal section.
  • the outer layer and the intermediate layer are drawn by the same method as the left side of FIG. 5(a)
  • each layer and the intermediate layer are drawn by the same method as the right side of FIG. 5(a). It is
  • the intermediate layer 140 includes a flexible tubular reinforcing body 141 (141A, 141B) composed of one or more wires 143 and between the wires 143 constituting the reinforcing body 141 ( 5, between the portions 143a and 143b, and between the portions 143a to 143d in FIG. 6).
  • the reinforcing body 141 imparts kink resistance to the reinforcing portion 117 to prevent kink during bending. By providing the reinforcing body 141, the reinforcing portion 117 can freely bend in each direction without kinking.
  • the reinforcing body 141 shown in this example is formed so that the inner diameter and the outer diameter are constant in the longitudinal direction.
  • a tube forming the inner layer 131 is inserted through the hollow interior of the reinforcing body 141 .
  • a resin 147 that is softer (lower in hardness) than the resin forming the outer layer 133 is used for the intermediate layer 140 .
  • the resin 147 is in the space 145 between the wires in a plan view (within a plane defined by the longitudinal direction and the circumferential direction of the reinforcing portion 117). It should be fully filled.
  • the reinforcing body 141 can be composed of a cylindrical coil body 141A in which one wire rod 143 is spirally wound at a predetermined pitch.
  • the reinforcing body 141 is composed of a tubular coil body 141A in which a plurality of wire rods 143, 143, . can.
  • the coil body 141A has a spiral inter-wire space 145 (helical space) formed between portions 143a and 143b of the wire 143 adjacent along its longitudinal direction (axial direction).
  • the inter-wire space 145 penetrates the coil body 141A in the radially inner and outer directions.
  • the adjacent portions 143a and 143b may belong to the same wire 143 or may belong to different wires 143, 143, respectively.
  • the resin 147 has entered the space 145 between the wires.
  • the resin 147 may be arranged only in the spaces 145 between the wires, or may be arranged inside and outside the spaces 145 between the wires. In the former case, the resin 147 has a spiral shape within the intermediate layer 140, and in the latter case, the resin 147 has a cylindrical shape within the intermediate layer 140, for example.
  • the resin 147 contacts both the portion 143a and the portion 143b of the adjacent wire 143 over the entire length of the coil body 141A.
  • the reinforcing body 141 can be composed of a tubular braided body 141B in which a plurality of wire rods 143, 143, . . .
  • the braided body 141B includes a wire rod helically woven with a predetermined pitch in the clockwise direction and a wire rod helically woven with a predetermined pitch in the counterclockwise direction. That is, the wires 143, 143, .
  • the braided body 141B has mesh-shaped inter-wire spaces 145 formed between portions 143a to 143d of the wires 143, 143, .
  • the inter-wire space 145 has a substantially rhombic shape in plan view. Inter-wire spaces 145 are formed between different wires 143 , 143 . Adjacent portions (parts 143a and 143b, or portions 143c and 143d) in the wire rods inclined in the same direction may belong to the same wire rod 143 or to different wire rods 143, 143. may In this example, the inter-wire space 145 penetrates the braided body 141B in the radially inner and outer directions. The resin 147 has entered the space 145 between the wires. In the intermediate layer 140 , the resin 147 may be arranged only in the spaces 145 between the wires, or may be arranged inside and outside the spaces 145 between the wires.
  • the approximately diamond-shaped resin 147 is arranged in an oblique grid pattern in the intermediate layer 140 , and in the latter case, the resin 147 has a cylindrical shape in the intermediate layer 140 as an example. At least when the reinforcing portion 117 assumes the initial posture, the resin 147 contacts the portions 143a to 143d of the adjacent wire 143 over the entire length of the braided body 141B.
  • Wire rods 143 forming reinforcing bodies 141 may have various shapes such as a round wire with a circular cross-sectional shape and a square wire with a rectangular cross-sectional shape.
  • a rectangular wire having a substantially rectangular cross-sectional shape (a flattened rectangular shape) as the wire rod 143.
  • the rectangular wire is arranged so that its thickness direction (the direction of the short side of the cross section) coincides with the inner and outer radial directions of the reinforcing body 141 .
  • the wire shown as a single wire 143 in FIGS. 5 and 6 may be an aggregate of a plurality of wires, or a wire bundle in which a plurality of wires are bundled. That is, the coil body 141A may have a configuration in which a wire assembly or a wire bundle is spirally wound at a predetermined pitch. Further, the braided body 141B may have a structure in which a plurality of groups of wire rods or wire rod bundles are braided so as to intersect each other.
  • FIG. 7 corresponds to an enlarged view of a part of the reinforcing portion 117 shown in FIG.
  • the horizontal direction is the longitudinal direction
  • the vertical direction is the inner/outer diameter direction
  • the lower part is the inner diameter side
  • the upper part is the outer diameter side.
  • FIG. 7 shows a longitudinal sectional view when the reinforcing portion 117 assumes the initial posture shown in FIGS.
  • FIG. 7 shows an example in which the reinforcing body 141 is a coil body 141A, but the same is true when the reinforcing body 141 is a braided body 141B.
  • FIG. 7 shows an example using a rectangular wire as the wire, the same applies to the case of using a wire other than the rectangular wire.
  • side surfaces 144a and 144b are surfaces extending along the radially inner and outer directions (vertical direction in the drawing) of the reinforcing portion 117 .
  • Thicknesses t2 and t3 are the lengths of the wire rod 143 and the resin 147 in directions along the inner and outer radial directions of the reinforcing portion 117, respectively.
  • the resin 147 that constitutes the intermediate layer 140 is in contact with both wire rods (portions 143a and 143b of the wire rod 143) adjacent to each other via the space 145 between the wire rods, at least when the intermediate layer 140 assumes the initial posture. .
  • FIG. 7A shows an example in which the thickness t3 of the resin 147 is thinner than the thickness t2 of the reinforcing member 141 (thickness t2>thickness t3). Resin 147 is in contact with portions 143a and 143b of wire rod 143 at portions of side surfaces 144a and 144b (portions within a range corresponding to thickness t3).
  • FIG. 7A shows an example in which the thickness t3 of the resin 147 is thinner than the thickness t2 of the reinforcing member 141 (thickness t2>thickness t3). Resin 147 is in contact with portions 143a and 143b of
  • FIG. 7C shows an example in which the thickness t3 of the resin 147 is greater than the thickness t2 of the wire rod 143 (thickness t2 ⁇ thickness t3).
  • the resin 147 is in contact with the portions 143a, 143b of the wire rod 143 on the entire sides 144a, 144b. Furthermore, the resin 147 enters between the wire 143 (143a, 143b) and the outer layer 133. As shown in FIG. Therefore, wire 143 is not in contact with outer layer 133 .
  • FIG. 7D shows another example in which the thickness t3 of the resin 147 is thicker than the thickness t2 of the wire rod 143 (thickness t2 ⁇ thickness t3).
  • the resin 147 is in contact with the portions 143a, 143b of the wire rod 143 on the entire sides 144a, 144b. Furthermore, the resin 147 enters between the wire 143 and the inner layer 131 and between the wire 143 and the outer layer 133 . Therefore, the wire 143 is not in contact with both the inner layer 131 and the outer layer 133 .
  • the wire 143 may contact both the inner layer 131 and the outer layer 133. As shown in FIG. 7(c), the wire 143 may contact either the inner layer 131 or the outer layer 133 (the figure shows an example in which only the inner layer 131 is contacted). As shown in FIG. 7(d), the wire rod 143 does not have to contact both the inner layer 131 and the outer layer 133.
  • FIG. 7(c) the wire 143 may contact either the inner layer 131 or the outer layer 133 (the figure shows an example in which only the inner layer 131 is contacted).
  • the wire rod 143 does not have to contact both the inner layer 131 and the outer layer 133.
  • FIG. 8 is a vertical cross-sectional view showing the internal state of the curved reinforcing portion.
  • the inter-wire space 145 shrinks or extends in the longitudinal direction of the reinforcing portion 117 according to the curved shape of the reinforcing portion 117 .
  • the resin 147 deforms according to the deformation of the inter-wire space 145 .
  • the resin 147a positioned on the side (lower side in the figure) where the radius of curvature is smaller than the center axis Ax of the reinforcing portion 117 is moved in the direction of the arrow K in the figure by the portions 143a and 143b of the wire rod 143. Compressed.
  • the resin 147a maintains contact with both the portions 143a and 143b (side surfaces 144a and 144b) of the wire rod 143 .
  • the resin 147b positioned on the side (upper side in the figure) where the radius of curvature is larger than the center axis Ax of the reinforcing part 117 when the reinforcing part 117 is curved is elongated in the direction of the arrow L in the figure by the portions 143e and 143f of the wire rod 143. be done. At this time, it is desirable that the resin 147b maintain contact with both the portions 143e and 143f (side surfaces 144e and 144f) of the wire 143 .
  • the resin 147b may be separated from one or both of the portions 143e and 143f of the wire rod 143.
  • FIG. When the reinforcing portion 117 is bent and deformed, the wire rod 143 is displaced according to the bent shape. Since the resin 147 forming the intermediate layer 140 is softer (lower in hardness) than the resin forming the outer layer 133 , the wire 143 smoothly displaces while deforming the resin 147 . Therefore, even if the outer layer 133 is made of a resin having a strength and/or hardness that can prevent the guide section 100 from being damaged, the blood vessel followability of the reinforcement section 117 is improved.
  • the outer layer 133 may contact side surfaces 144a and 144b of the wire rod 143.
  • FIG. The length of contact of the outer layer 133 and the resin 147 with the side surfaces 144a and 144b of the wire rod 143 determines the mobility of the wire rod 143 in the intermediate layer 140 (easiness of displacement). ) is more dominantly controlled by the resin 147 forming the intermediate layer 140 than by the resin forming the outer layer 133 .
  • the hardness of the resin composing the outer layer 133 and the hardness of the resin 147 composing the intermediate layer 140 , or the difference in hardness between the two resins indicates that the mobility of the wire rod 143 in the intermediate layer 140 is greater than that of the resin composing the outer layer 133 . is also set to be predominantly controlled by the resin 147 forming the intermediate layer 140 .
  • the reinforcing portion 117 may be configured such that flexibility increases stepwise or steplessly from the base end side to the tip end side.
  • the reinforcing portion 117 shown in FIGS. 2 and 3 includes a distal reinforcing portion 117A (first reinforcing portion) disposed on the distal end side in the longitudinal direction, and a distal reinforcing portion 117A adjacent to the distal reinforcing portion 117A and further extending than the distal reinforcing portion 117A. and a proximal side reinforcing portion 117B (second reinforcing portion) arranged on the proximal side in the longitudinal direction.
  • the distal reinforcing portion 117A has higher flexibility than the proximal reinforcing portion 117B. That is, the distal reinforcing portion 117A is configured to follow the curved shape of the blood vessel more easily than the proximal reinforcing portion 117B.
  • the reinforcement part 117 may have three or more parts with different flexibility.
  • the resin 147 forming the intermediate layer 140 of the distal reinforcing portion 117A can be made of a resin that is softer than the resin 147 forming the intermediate layer 140 of the proximal reinforcing portion 117B. That is, the hardness of the resin 147 of the intermediate layer 140 can be set so as to gradually soften from the base end side of the reinforcing portion 117 toward the tip end side.
  • the interval between the wires 143, 143 (the pitch of the coiled body, the opening of the braided body) of the distal side reinforcing portion 117A can be set wider than that of the proximal side reinforcing portion 117B.
  • the cross-sectional area of the wire rods 143, 143 of the distal side reinforcing portion 117A may be smaller than that of the proximal side reinforcing portion 117B.
  • the cross-sectional area of the wire 143 here means the cross-sectional area in the direction perpendicular to the longitudinal direction of the wire 143 .
  • the joint portion 150 includes, in order from the distal end side in the longitudinal direction, a tubular joint portion 151 that constitutes the proximal end portion of the tubular guide portion 110, a lumen 111, and an external space. It has an inlet portion 153 open for communication and a semi-cylindrical guide portion 155 . As shown in FIG. 3 , the end face 153a of the entrance portion 153 is inclined with respect to the axis Ax of the cylindrical guide portion 110. As shown in FIG.
  • the inclination angle of the end surface 153a with respect to the axis Ax is appropriately set in consideration of the insertability of the catheter device into the lumen 111.
  • a longitudinal base end surface 155a of the semi-cylindrical guide portion 155 is inclined with respect to the axis Ax so that the base end side thereof is tapered.
  • the inclination angle of the base end surface 155a with respect to the axis Ax is appropriately set in consideration of the introducibility of the catheter device into the semi-cylindrical guide portion 155 and kink resistance (hardness change in the longitudinal direction).
  • the inlet portion 153 and the semi-cylindrical guide portion 155 are formed by forming the entire longitudinal direction of the guide portion 100 as a tubular body having a multi-layered structure, and then forming a portion of the tubular body in the circumferential direction (in the figure, It is produced by cutting and removing a cut region 161) indicated by a dotted line.
  • the outer layer 133 of the joint portion 150 may be made of resin that is harder than the outer layer 133 of the other tubular guide portion 110 .
  • the outer layer 133 (133A to 133C) of the guide portion 100 may be configured to become harder from the distal side toward the proximal side.
  • the change in hardness of the guide portion 100 in the longitudinal direction can be moderated.
  • the blood vessel followability of the distal end side of the guide portion 100 can be enhanced, and the change in hardness with the push rod 200 joined to the joint portion 150 can be moderated.
  • the push rod 200 is a linear member having a strength that allows the guide portion 100 to be pushed, pulled out, or rotated, and flexible enough to follow the shape of the blood vessel.
  • the flexibility of the push rod 200 is lower than that of the guide part 100 .
  • the distal end portion 200a of the push rod 200 is joined to the outer peripheral portion of the joint portion 150 using an adhesive or the like.
  • the tip portion 200a is joined to the cylindrical body having the multilayer structure before the cut region 161 is cut and removed by using a heat-shrinkable tube that functions as an adhesive. For this reason, an adhesive layer 159 is formed around the outer periphery of the joint portion 150 using the heat-shrinkable tube. Note that the adhesive layer 159 shown in FIG.
  • a tab 210 is attached to the proximal end of the push rod 200 to serve as a grip when the guide extension catheter 1 is operated.
  • Each member constituting the guide extension catheter 1 is integrated using adhesive, welding, welding, thermal bonding, brazing, bonding, mechanical bonding, or other suitable method.
  • the guide extension catheter 1 can be produced, for example, by the following procedure.
  • the mandrel is inserted into the hollow portion of the tube forming the inner layer 131 .
  • a reinforcing body 141 is arranged around the outer circumference of the tube. That is, the tube with the mandrel inserted is inserted into the hollow portion of the reinforcing body 141 .
  • a distal marker 115 and a proximal marker 119 are positioned on the outer circumference of the tube adjacent to the longitudinal ends of the stiffener 141, and the markers are crimped to integrate with the tube. Let this be the first tube assembly.
  • a tube made of the resin 147 forming the intermediate layer 140 and a tube forming the outer layer 133 are prepared.
  • a tube of resin 147 is inserted into the tube for outer layer 133 . This is called the second tube assembly.
  • a plurality of tubes of the resin 147 having different hardness are prepared.
  • Each tube of resin 147 is placed at a predetermined longitudinal position within the tube for outer layer 133 to form a second tube assembly.
  • the first tube assembly is inserted into the hollow portion of the second tube assembly so that the longitudinal positions of the resin 147 and the reinforcing body 141 are matched.
  • the entire outer peripheral portion of the second tube assembly is compressed in the inner diameter direction to bring the two tube assemblies into close contact and integrate them. Thereby, a cylindrical body having a multilayer structure is obtained.
  • the proximal end of the tubular body is covered with a heat-shrinkable tube forming an adhesive layer 159 .
  • the distal end portion 200a of the push rod 200 is inserted between the heat-shrinkable tube and the cylindrical body.
  • the heat-shrinkable tube is shrunk to join the tubular body and the push rod 200 .
  • the cut area 161 shown in FIG. 3 is cut and removed.
  • the guide extension catheter 1 is manufactured, for example, as follows. That is, as a tube forming the inner layer 131, a tube having a longitudinal length capable of forming the guide portion 100 is prepared. Using the tube, a first tube assembly is produced in the same manner as in the first production method. A tube of resin 147 is inserted into the tube for outer layer 133A to fabricate a second tube assembly in the same manner as in the first fabrication method.
  • the first and second tube assemblies are brought into close contact and integrated in the same manner as in the first manufacturing method so that the base ends of the tubes forming the inner layer 131 are exposed to the outside.
  • the base ends of the tubes forming the inner layer 131 are covered with a tube for the outer layer 133B and a tube for the outer layer 133C.
  • it is made into a tubular body having a multilayer structure.
  • the longitudinal base end portion of the outer layer 133A and the entire longitudinal direction of the outer layers 133B and 133C are covered with a heat-shrinkable tube forming an adhesive layer 159 .
  • a distal end portion 200a of a push rod 200 is inserted between the heat-shrinkable tube and the cylindrical body.
  • the heat-shrinkable tube is shrunk to join the tubular body and the push rod 200 .
  • the outer layers 133A-133C are longitudinally integrated with a heat-shrinkable tube. Finally, the cut area 161 shown in FIG. 3 is cut and removed.
  • Examples of dimensions of each part, examples of materials used for each part are set as follows.
  • the total length of the guide extension catheter 1 is 1000 mm to 2000 mm.
  • the longitudinal length of the tubular guide portion 110 is 100 mm to 500 mm
  • the longitudinal length of the semi-cylindrical guide portion 155 is 10 to 200 mm
  • the longitudinal length of the push rod 200 is 1000 mm to 1300 mm.
  • the inner diameter of the cylindrical guide portion 110 is 1.1 mm to 1.8 mm (Fr to Fr)
  • a biocompatible material having lubricity is used for the inner layer 131 of the guide part 100 .
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxyalkane
  • HDPA high density polyethylene
  • a material having manipulative compatibility is used for the wires constituting the reinforcing body 141 (the coil body 141A and the braided body 141B).
  • stainless steel SUS304WPB
  • other types of stainless steel, cobalt alloys, nickel-titanium alloys, tungsten, and the like can be used as metal materials for the wires constituting the reinforcing body 141 .
  • As the resin material polyamide, liquid crystal polymer (LCP), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), perfluoroalkoxyalkane (PFA), etc. can be used.
  • a biocompatible elastomer is used for the resin 147 forming the intermediate layer 140 of the reinforcing portion 117 .
  • a polyurethane-based thermoplastic elastomer is used.
  • polyether block amide, polyester elastomer, or the like can be used for the resin 147 .
  • the hardness of the resin 147 is 10 or more and less than 60 (Shore D hardness). By setting the Shore D hardness of the resin 147 in this manner, the mobility of the wire 143 within the intermediate layer 140 can be ensured.
  • the hardness of the resin 147 forming the intermediate layer 140 of the tip side reinforcing portion 117A is set to 10 or more and less than 40 (Shore D hardness).
  • the hardness of the resin 147 forming the intermediate layer 140 of the proximal side reinforcing portion 117B is set to 40 or more and less than 60 (Shore D hardness).
  • the difference in hardness between the resins 147, 147 of the distal reinforcing portion 117A and the proximal reinforcing portion 117B is preferably 20 (Shore D hardness) or more.
  • a biocompatible resin (elastomer) is used for the outer layer 133 .
  • a polyether block amide copolymer (PEBAX (registered trademark)
  • PEBAX polyether block amide copolymer
  • polyamide, polyamide elastomer, polyester, and polyethylene can be used for the outer layer 133 .
  • the hardness of the resin forming the outer layer 133 is 60 or more and less than 75 (Shore D hardness). By setting the hardness of the resin forming the outer layer 133 in this manner, it is possible to ensure strength enough to prevent the guide portion 100 from being damaged.
  • the difference in hardness between the resin forming the outer layer 133 and the resin 147 forming the intermediate layer 140 of the tip side reinforcing portion 117A is 20 or more and less than 65 (Shore D hardness).
  • An X-ray opaque material is used for the distal marker 115 and the proximal marker 119 .
  • platinum iridium 90Pt-10Ir
  • the distal marker 115 and the proximal marker 119 can be made of gold, platinum, palladium, tantalum, tungsten alloys, polymer materials containing X-ray opaque fillers (barium sulfate, bismuth subcarbonate, etc.).
  • a biocompatible material is used for the push rod 200 .
  • a cobalt alloy is used.
  • stainless steel, nickel-titanium alloys, cobalt, chromium, molybdenum, and nickel-based alloys can be used as metal materials for the push rod 200 .
  • the resin 147 forming the intermediate layer 140 is softer (lower in hardness) than the resin forming the outer layer 133 . Therefore, the resin 147 does not hinder the smooth displacement of the wire 143 forming the reinforcing body 141 . If the intermediate layer 140 were not provided with the resin 147 , the displacement of the wire 143 would be restricted by the hard outer layer 133 . Even if a resin having a hardness equivalent to that of the outer layer 133 enters the space 147 between the wires, the displacement of the wires 143 is limited by the hard resin. As described above, according to the present embodiment, the blood vessel followability of the reinforcing portion 117 is improved.
  • This embodiment is a guide extension catheter 1 having a tubular portion (tubular guide portion 110) having a lumen 111 penetrating in the longitudinal direction on the distal end side in the longitudinal direction, and the tubular portion is the intermediate portion in the longitudinal direction.
  • the reinforcing portion 117 has an inner layer 131 that defines the inner surface 111a of the lumen of the cylindrical portion, an intermediate layer 140 arranged on the outer peripheral surface of the inner layer, and an outer layer 133 arranged on the outer peripheral surface of the intermediate layer.
  • the intermediate layer is a cylindrical coil body 141A in which a wire 143 is spirally wound, or a cylindrical braided body 141B in which a plurality of wires are intersected. It is characterized in that it includes a resin 147 which is softer than the resin forming the outer layer and which enters into the inter-wire space 145 formed between the wires forming the reinforcing body.
  • the blood vessel followability of the cylindrical guide portion arranged on the distal side of the guide extension catheter is improved.
  • the intermediate layer is configured to include the reinforcing body and the resin that enters the space between the wire rods of the reinforcing body.
  • the resin forming the intermediate layer is softer (lower in hardness) than the resin forming the outer layer. Therefore, when the cylindrical portion is bent and deformed, the wire material constituting the reinforcing body can be smoothly displaced within the intermediate layer. Even if a resin having a strength or hardness capable of preventing damage is used for the outer layer, the blood vessel followability of the tubular portion is improved.
  • the guide extension catheter 1 is characterized in that the resin 147 forming the intermediate layer 140 is in contact with both adjacent wire rods 143 (portions 143a to 143f) via the space 145 between the wire rods. At least when the reinforcing portion 117 assumes the initial posture, the resin forming the intermediate layer fills the entire inter-wire space in plan view (within the plane defined by the longitudinal direction and the circumferential direction of the reinforcing portion). It is desirable to be The resin forming the intermediate layer may be thicker than the wire, may be as thick as the wire, or may be thinner than the wire.
  • the resin located on the side where the radius of curvature becomes smaller than the axis Ax when the cylindrical portion is curved is compressed by both adjacent wire rods. Since the resin forming the intermediate layer is softer (lower in hardness) than the resin forming the outer layer, it does not interfere with the movement of the reinforcing member.
  • the guide extension catheter 1 according to this aspect is characterized in that the Shore D hardness of the resin forming the outer layer 133 is 60 or more and less than 75. By setting the Shore D hardness of the resin forming the outer layer in this way, it is possible to secure strength that can prevent the guide portion 100 from being damaged.
  • the reinforcing section 117 includes a distal reinforcing section 117A arranged on the distal side in the longitudinal direction, and a proximal reinforcing section adjacent to the distal reinforcing section and extending in the longitudinal direction from the distal reinforcing section.
  • the resin 147 forming the intermediate layer 140 of the distal-side reinforcing portion is softer than the resin 147 forming the intermediate layer of the proximal-side reinforcing portion. and The flexibility of the reinforcing portion can be controlled according to the hardness of the resin.
  • the flexibility of the reinforcing portion will be high, and if a relatively hard resin is used for the intermediate layer, the flexibility of the reinforcing portion will be low.
  • the hardness of the resin along the longitudinal direction it is possible to obtain a reinforcing portion having different flexibility depending on the position in the longitudinal direction.
  • the flexibility of the distal end side of the reinforcing portion is relatively high, and the flexibility of the proximal end side of the reinforcing portion is relatively low. Therefore, the change in hardness with the push rod 200 arranged at the proximal end of the guide extension catheter can be moderated. According to this aspect, it is possible to prevent kink and breakage of the guide extension catheter due to sudden change in hardness in the longitudinal direction.
  • the hardness difference between the Shore D hardness of the resin forming the outer layer 133 and the Shore D hardness of the resin 147 forming the intermediate layer 140 of the tip reinforcing portion 117A is 20 or more. Characterized by By setting the hardness difference in this manner, the mobility of the wire rod 143 in the intermediate layer is controlled predominantly by the resin forming the intermediate layer rather than by the resin forming the outer layer.
  • the guide extension catheter 1 is characterized in that the Shore D hardness of the resin 147 forming the intermediate layer 140 of the tip reinforcing portion 117A is 10 or more and less than 40.
  • the Shore D hardness of the resin forming the intermediate layer is 10 or more and less than 40.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/JP2021/013277 2021-03-29 2021-03-29 ガイドエクステンションカテーテル WO2022208607A1 (ja)

Priority Applications (2)

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PCT/JP2021/013277 WO2022208607A1 (ja) 2021-03-29 2021-03-29 ガイドエクステンションカテーテル
JP2023509921A JPWO2022208607A1 (enrdf_load_stackoverflow) 2021-03-29 2021-03-29

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006263289A (ja) * 2005-03-25 2006-10-05 Kawasumi Lab Inc マイクロカテーテル
JP2007282678A (ja) * 2006-04-12 2007-11-01 Kaneka Corp カテーテルチューブ
JP2015526159A (ja) * 2012-07-17 2015-09-10 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． ガイド拡張カテーテル

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1839686B1 (en) * 2005-01-21 2011-07-20 Terumo Kabushiki Kaisha Catheter and process for producing the same
EP2919845B1 (en) * 2012-11-15 2018-08-29 Cardiac Pacemakers, Inc. Guide catheter occlusion balloon with active inflation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006263289A (ja) * 2005-03-25 2006-10-05 Kawasumi Lab Inc マイクロカテーテル
JP2007282678A (ja) * 2006-04-12 2007-11-01 Kaneka Corp カテーテルチューブ
JP2015526159A (ja) * 2012-07-17 2015-09-10 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． ガイド拡張カテーテル

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