Classifications

• • 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
  • A61M25/10—Balloon catheters
  • A61M25/1006—Balloons formed between concentric tubes
• • 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
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
• • 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
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
• • 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
  • A61M25/10—Balloon catheters
  • A61M25/1027—Making of balloon catheters
  • A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
• • 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
  • A61M25/10—Balloon catheters
  • A61M25/104—Balloon catheters used for angioplasty
• • 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
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
• • 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
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon

Definitions

• the present invention relates to an inner tube, a catheter, and a method for manufacturing an inner tube.
• a large amount of blood from an artificial dialysis patient is taken out of the body into a dialyzer, and as a vascular access for efficient hemodialysis, the arteries and veins are directly connected to allow a large amount of blood to pass through.
• a dedicated blood vessel (shunt) is known.
• hemodialysis a large amount of blood can be extracted from the shunt and a large amount of blood can be dialyzed in a short time by removing waste products, excess water and electrolytes from the extracted blood.
• stenosis may occur due to neointimal proliferation or thrombus.
• PTA percutaneous angioplasty, Percutaneous Angioplasty, Percutaneous Angioplasty
• PTA percutaneous angioplasty
• a force catheter with a balloon at the tip is kneaded into the narrowed part of the blood vessel in or near the shunt, and the narrowed part is expanded by inflating the balloon at the narrowed part.
• ultrasonic guide PTA A method called ultrasonic guide PTA may be adopted instead of TA.
• the balloon is inserted into the narrowed part of the shunt and then the balloon is expanded to expand the narrowed part.
• Ultrasonic Guide PTA ⁇ 0 2020/175462 2 ⁇ (: 171? 2020 /007419
• the ultrasonic guide can be operated only by using a relatively inexpensive ultrasonic diagnostic device, and an expensive X-ray diagnostic device and a dedicated operating room to shield X-rays are installed, and it is heavy and stuffy. It also has the advantage of not having to wear X-ray protective clothing.
• Patent Document 1 International Publication No. 2 0 1 6/0 3 1 0 7 1 Summary of Invention
• the marker portion since the marker portion is formed by laser processing or cutting processing, the marker portion becomes relatively thin as compared with a portion not provided with other marker portions, and Strength tends to decrease.
• the outer diameter of the catheter is increased by increasing the wall thickness to ensure the mechanical strength of the marker, the flexibility of the catheter will be impaired.
• the shunt stenosis cannot be squeezed and treatment cannot be performed.
• the present invention has been made in view of the above circumstances, and an object thereof is to provide an inner tube that can detect a position in the body by ultrasonic irradiation and is not easily damaged. ..
• one embodiment of the present invention is an inner tube used for a medical catheter, wherein the outer surface of the inner tube is superior to the other parts of the outer surface described above.
• a marker portion having a relatively reduced amount of regular reflection of sound waves is provided, and the marker portion includes a first marker portion provided on one half circumferential surface of the outer peripheral surface and a half circumferential portion on the other side of the outer peripheral surface.
• a second marker portion provided on the surface, wherein the marker portion has a plurality of arc-shaped grooves extending around the central axis of the inner tube, and the groove included in the first marker portion,
• an inner tube including a portion which is discontinuous with the groove included in the second marker portion.
• the inner peripheral surface of the inner tube is provided with a ridge portion that overlaps with the groove in a field of view along a direction perpendicular to a central axis along the groove,
• the ridge portion that overlaps the groove of the marker portion and the ridge portion that overlaps the groove of the second force part may be discontinuous.
• the ridge on the inner peripheral surface side of the first marker portion and the ridge on the inner peripheral surface side of the second marker portion are It may be configured so that they do not overlap in the field of view from the direction orthogonal to the central axis of the lens.
• the marker portion has a first region in which the plurality of grooves are adjacent to each other, and a second region in which a plurality of the grooves are wider than the first region.
• the groove may extend in a circumferential direction of the outer peripheral surface.
• a pattern formed by the plurality of grooves included in the first marker portion and a pattern formed by the plurality of grooves included in the second marker portion are mutually It may be configured.
• a pattern formed by a plurality of the grooves included in the first marker section and a plurality of the grooves formed in a second marker section are formed. ⁇ 0 2020/175462 4 ⁇ (: 171? 2020 /007419
• the patterns to be performed may be different from each other.
• one aspect of the present invention includes the above inner tube, an outer tube through which the inner tube is passed, and a balloon provided at an end of the outer tube.
• the inner tube provides a catheter having the marker portion in a portion overlapping with the balloon.
• the inner tube may have a guide wire that is passed through the inner tube.
• a first mold that complementarily corresponds to the first marker part and a second mold that complementarily corresponds to the second marker part are used.
• a method for manufacturing an inner tube which comprises a step of forming a plurality of grooves corresponding to the first marker portion and the second merging portion by hot pressing on the outer peripheral surface of the manufactured tube.
• a manufacturing method may include a step of kneading a metal core into the tube prior to the step of forming the groove.
• the present invention includes the following embodiments.
• An inner tube used for a medical catheter wherein the outer peripheral surface of the inner tube has a reduced amount of regular reflection of ultrasonic waves as compared with other portions of the outer peripheral surface.
• a marker portion is provided, and the marker portion includes a first marker portion provided on one half circumferential surface of the outer circumferential surface and a second marker portion provided on the other half circumferential surface of the outer circumferential surface.
• the marker portion has a plurality of arcuate grooves extending around the central axis of the inner tube, the groove included in the first marker part and the groove included in the second marker part.
• An inner tube that includes the part where and are not connected.
• the marker portion has a first region in which the plurality of grooves are adjacent to each other and a second region in which the plurality of grooves are wider than the first region [1] to [3 ]
• the inner tube according to any one of [1].
• the balloon has a cylindrical portion and a pair of conical portions provided on both sides of the cylindrical portion, and the inner tube has the marker portion at a position overlapping with the pair of conical portions. catheter.
• [0030] [10] The inner tube according to any one of [1] to [7], an outer tube through which the inner tube is threaded, and an outer tube provided at an end of the outer tube.
• [0034] The method for manufacturing an inner tube according to any one of [1] to [7], comprising: a first mold having unevenness corresponding to the first marker portion in a complementary manner. Using a second mold having irregularities corresponding to the second marker portion, and corresponding to the first marker portion and the second marker portion by hot pressing on the outer peripheral surface of the resin tube. A method of manufacturing an inner tube having a step of forming a plurality of grooves.
• an inner tube that can detect a position in the body by irradiating ultrasonic waves and is not easily damaged. Further, it is possible to provide a catheter provided with such an inner tube, and a method for manufacturing an inner tube that enables easy manufacture of the inner tube.
• Fig. 1 is a schematic view showing a catheter 18 of a first embodiment.
• FIG. 2 is a schematic sectional view of the catheter tube 2.
• FIG. 3 is a schematic cross-sectional view showing the peripheral structure of the balloon 3. ⁇ 0 2020/175 462 7 ⁇ (: 171? 2020 /007419
• FIG. 4 A plan view of the inner tube 22.
• FIG. 5 is a side view of the inner tube 22.
• FIG. 6 is a sectional view of the inner tube 22.
• FIG. 7 is a sectional view of the inner tube 22.
• FIG. 8 is a sectional view of the inner tube 23.
• Fig. 9 is a schematic view showing a method for manufacturing an inner tube.
• FIG. 10 is a schematic view showing a modified example of the inner tube.
• FIG. 11 is a schematic view showing a modified example of the inner tube.
• FIG. 12 is a schematic cross-sectional view of a catheter tube 5 included in the catheter 1 of the second embodiment.
• FIG. 13 is a schematic cross-sectional view showing the peripheral structure of the balloon 3.
• FIG. 14 is a schematic cross-sectional view showing a peripheral structure of a balloon 3 having a catheter 1 ⁇ 3 according to a third embodiment.
• FIG. 15 is a schematic enlarged view of a portion indicated by a symbol in FIG.
• FIGS. 1 to 11 a method of manufacturing an inner tube, a catheter, and an inner tube according to the first embodiment of the present invention will be described with reference to FIGS. 1 to 11.
• the dimensions and ratios of the respective constituent elements are appropriately different from each other in order to make the drawings easy to see.
• FIG. 1 is a schematic diagram showing a catheter 18 of this embodiment.
• the catheter 18 has a catheter tube 2, a balloon 3 and a connector 4.
• the catheter 18 is a medical catheter used for treatment.
• FIG. 2 is a schematic cross-sectional view of the catheter tube 2.
• the force catheter tube 2 has an outer tube 21 and an inner tube 22 that is passed through the outer tube 21.
• the outer tube 21 and the inner tube 22 form a double tube structure. ⁇ 0 2020/175462 8 ⁇ (: 171? 2020 /007419
• the catheter 18 is a guide wire that is threaded inside the inner tube 22. Guide the catheter tube 2 when using the catheter 18.
• the outer tube 21 and the inner tube 22 are cylindrical members made of a flexible resin material as a forming material.
• the material for forming the outer tube 21 and the inner tube 22 include thermoplastic resins such as polyamide, polyester, polyolefin, polyurethane and polyvinyl chloride.
• polyamide is preferable as a material for forming the outer tube 21 and the inner tube 22 because it is safe and has high strength.
• polyamid 11 1, polyamid 12, polyamid 6, polyamid 6 6 can be used, and among them, polyamid 11 has a good balance between safety, strength and material cost. Is preferred.
• the “safe” material means a material that has biological safety and does not show toxicity to the human body even if it is rubbed into the body.
• the inner peripheral surfaces of the outer tube 21 and the inner tube 22 slide with the guide wire ⁇ , so that they are preferably coated with a low friction material such as silicone resin or fluororesin.
• the outer peripheral surface of the outer tube 21 may be covered with a hydrophilic resin such as polyvinylpyrrolidone or 2-hydroxyethylmethacrylate.
• FIG. 3 is a schematic cross-sectional view showing the peripheral structure of the balloon 3.
• the balloon 3 is provided at the end of the outer tube 21 that constitutes the catheter tube 2.
• the inner tube 22 has its tip connected to the tip 29, and is penetrated through the inside of the balloon 3.
• the balloon 3 is attached to the outer tube 21 and the inner tube 22 in a liquid-tight manner.
• Tip 29 is a guidewire on the distal end of catheter tube 2. A hole that can be passed through 2 ⁇ 0 2020/175462 9 ⁇ (: 171? 2020 /007419
• the tip 29 is a protective member having a taper on the tip side, and is made of a flexible material such as silicone resin or fluororesin or a low friction material.
• the tip 29 has flexibility so as not to damage the inner wall of the blood vessel when the catheter tube 2 is inserted into the blood vessel, and is easily slippery with the inner wall of the blood vessel.
• the balloon 3 a balloon used for ordinary treatment can be used.
• the balloon 3 is made of a resin material.
• silicone rubber or latex rubber can be used as a material for forming the balloon 3.
• the balloon 3 can be expanded and deformed by supplying an expansion liquid containing physiological saline as a main component to the internal space 3X. 1 and 3, the balloon 3 is shown in a state of being expanded and deformed.
• the expanded and deformed balloon 3 has a cylindrical portion 33 and conical portions 3 and 3 provided on both sides of the cylindrical portion 33.
• the length of the cylindrical portion 33 is indicated by the symbol !_ 1.
• the length 1_ 1 is the expandable width of the stricture in the treatment.
• the diameter of the cylindrical portion 33 corresponds to the diameter that can be expanded in the treatment.
• the connector 4 is provided on the other end side of the catheter tube 2.
• the connector 4 has a first port 4 that communicates with the outer tube 21 and a second port 4 that communicates with the inner tube 22.
• the inner tube 22 will be described in more detail below.
• the inner tube 2 2 has, for example, an outer diameter of 1.
• a portion of the outer peripheral surface of the inner tube 22 which overlaps the balloon 3 has a force equal to that of the regular reflection amount of ultrasonic waves, which is relatively reduced as compared with other portions.
• Part 1 ⁇ /1 is provided.
• the marker part 1 ⁇ /1 is provided with a plurality of grooves 2 21.
• the depth of the groove 2 21 is, for example, 50 to 300. Further, the width of the groove 2221 is, for example, 500 to 300.
• the edges of the groove 2 21 may be raised in a convex shape. When the edge of the groove 2 2 1 is convexly raised, the depth of the groove refers to the difference in height from the deepest part of the groove to the top of the convexly raised portion. It is preferable that the groove 2 2 1 is deep if the strength required by the inner tube 2 2 can be secured and there is no manufacturing demerit.
• the groove 2 2 1 diffusely reflects the ultrasonic wave, the specular reflection amount of the ultrasonic wave is relatively reduced as compared with the portion where the groove 2 2 1 is not provided.
• the amount of ultrasonic waves reaching the probe that receives the reflected ultrasonic waves decreases after the ultrasonic waves emitted toward the catheter are reflected. Therefore, in the echo image using ultrasonic waves, the portion corresponding to the groove 2 2 1 is displayed dark and the marker portion 1 ⁇ /1 is detected as a striped pattern.
• the distance (pitch) between the plurality of grooves 2 21 is ⁇ . Is preferred.
• the pitch is ⁇ . If it is above, it will become easy to distinguish with a living tissue in an echo image. Pitch is 20 If it is below,
• the groove spacing becomes appropriate compared to the length of the balloon that is commonly used, and it becomes easier to place the groove 2 2 1 at a position overlapping the balloon.
• the pitch of the groove 2 2 1 is 2 Is preferred.
• the marker part 1 ⁇ /1 is the first part where the plurality of grooves 2 2 1 are close to each other.
• the first region 8 [has a second region 8 2 in which a plurality of grooves 2 2 1 are wider than each other.
• the marker part 1 ⁇ /1 shown in the figure is And the first area 8 [3 ⁇ 4 1, the second area 8 2, Arranged in order of ⁇ 0 2020/175462 1 1 ⁇ (: 171? 2020 /007419
• the appearance in the echo image is different. Therefore, in the echo image, the position where the two first areas 8 1 are recognized is a mark for the conical portion 3 of the balloon 3, and the position where the second area 8 2 is recognized is the cylindrical portion 3 3 of the balloon 3. Will be a mark of.
• FIGs. 4 and 5 are schematic views of the inner tube 22 around the marker IV!. 4 and 5 are schematic views in the field of view orthogonal to the central axis !_ of the inner tube 22.
• FIG. 4 is a plan view of the inner tube 22.
• FIG. 5 is a side view of the inner tube 22 in the visual field inclined 90° in the circumferential direction of the inner tube 22.
• a plurality of grooves 2 are formed on the outer peripheral surface of the inner tube 22.
• the groove 2 21 is provided on the outer peripheral surface of the cylindrical inner tube 22 so as to extend in the circumferential direction.
• a plurality of grooves 2 21 are arranged at regular intervals (interval 1).
• a plurality of grooves 2 21 are arranged at regular intervals (interval 2, where 2> 1).
• the groove 2 21 is not connected to the entire outer peripheral surface of the inner tube 2 2 and the central axis! -It has an arc shape extending around.
• the groove 2 2 1 is the central axis in the field of view in Fig. 5! It is formed in the circumferential direction of the outer peripheral surface of the inner tube 22 so as to be orthogonal to -. Therefore, the plurality of grooves 2 21 do not overlap each other in the field of view from the direction orthogonal to the central axis !_ of the inner tube 2 2.
• the marker portion 1 ⁇ /1 is the first marker portion IV! 1 provided on the half circumferential surface (indicated by reference numeral 8) on one side of the outer circumferential surface of the inner tube 22. And a second marker part IV! 2 provided on the other half of the outer peripheral surface (indicated by the reference numeral).
• the groove 2 2 1 swallowed includes a discontinuous portion.
• the groove 2 2 1 3 included in the first marker part IV! 1 and the groove 2 21 1 included in the second marker part IV! 2 are all discontinuous.
• a part of the plurality of grooves 2 2 1 3 and the grooves 2 2 1 may be continuous.
• discontinuity means the end portion 1 of the groove 2 2 1 3 and the end portion X of the groove 2 2 1
• the portion of the inner tube 22 where the groove is formed has a relatively lower strength than the portion where the groove is not formed.
• the inner tube 22 of the present embodiment is “discontinuous” because the groove 2 21 is not formed over the entire circumference of the outer peripheral surface.
• Such an inner tube 22 has higher strength than a tube in which grooves are formed over the entire circumference of the outer peripheral surface, and is relatively unlikely to be damaged.
• the pattern formed by the plurality of grooves 2 2 1 3 included in the first marker portion IV! 1 and the plurality of grooves 2 2 included in the second marker portion ! ⁇ /! 1 The pattern formed by the swallow is in agreement with each other.
• FIG. 6 is a cross-sectional view of the inner tube 22 and is a cross-sectional view taken along the line segment V 1 -V 1 in FIG.
• a ridge portion 2 22 which overlaps the groove 2 2 1 is provided. If the groove 2 2 1 3 of the first marker IV! 1 and the groove 2 2 1 of the second marker IV! 2 are discontinuous, the ridges 2 2 overlapping the groove 2 2 1 3 2 and the ridge 2 2 2 overlapping the groove 2 2 1 are also discontinuous.
• a projection 2 23 may be provided at the end of the groove 2 21.
• the ridges 22 22 and the protrusions 22 3 are formed as a result of performing the manufacturing method of the present embodiment described later.
• Fig. 7 is a cross-sectional view of the inner tube 22 and shows the line segment V ⁇ I-VI
• FIG. 3 is a schematic sectional view taken along the line I of FIG. ⁇ 0 2020/175462 13 ⁇ (: 171? 2020 /007419
• the plurality of grooves 2 21 are formed so as not to overlap each other in the field of view from the direction orthogonal to the central axis !_ of the inner tube 22. Therefore, the ridges 2 2 2 formed on the inner peripheral surface of the inner tube 22 overlapping with the grooves 2 21 are also the ridges 2 2 2 3 on the side of the first marker IV! 2 Marker section IV! The ridge on the 2nd side 2 2 2 -Does not overlap in the field of view from the direction orthogonal to-.
• the ridges 2 2 2 are located on the inner peripheral surface side of the inner tube 2 2 and
• the inner diameter 1 of the inner tube 2 2 will not become excessively narrow at the location where the ridge 2 2 2 is formed.
• Fig. 8 is a cross-sectional view of a modified example of the inner tube, and is a diagram corresponding to Fig. 7.
• the ridges 2 3 2 will be formed.
• the inner diameter 3 of the inner tube 23 at the location where it exists is even smaller than the inner diameter ⁇ / 1 in Fig. 7.
• the inner tube 22 having the configuration shown in Fig. 7 can be made thinner than the inner tube 23, and is an inner tube with high versatility.
• FIG. 9 is a schematic diagram showing a method for manufacturing an inner tube.
• the metal core 30 is passed through the tube 2 28, which is a raw material for the inner tube.
• the tube 22 8 is a cylindrical member made of the same material as that of the inner tube 22 described above.
• Tube 2 28 is made by hot pressing. ⁇ 0 2020/175462 14 ⁇ (: 171? 2020 /007419
• the core 30 is a wire made of metal.
• brass or copper can be used, and copper is preferable. Since copper has a high thermal conductivity, it is easy to heat the tube 22 8 during hot pressing. Also, since copper is softer than the metal generally used for molds, it is difficult to damage the mold during press working.
• the diameter of the core 30 is smaller than the inner diameter of the tube 22 and the catheter is
• first mold IV! 0 1 and the second mold IV! 0 2 have semi-cylindrical grooves IV! 0 1 1 and IV! 0 2 1, respectively.
• Semi-cylindrical groove of first mold IV! 0 1 IV! Mouth 1 Has a semi-cylindrical groove
• the two molds form a cylindrical through hole that penetrates the aggregated body.
• the formed through hole has a diameter equivalent to the outer diameter of the tube 2 28.
• the above-mentioned uneven portion IV! 0 1 2 of the first die IV! 0 1 has the central axis of the semi-cylindrical groove 11 1 of the first die IV! 0 1, that is, Extends around the central axis of the through hole Semi-cylindrical groove of the second mold IV! 02 It extends around the central axis of 2 1, that is, the central axis of the through hole described above.
• FIG. IV! 0 2 2 shows that multiple irregularities are arranged at equal intervals.
• the composition of the above shall be formed according to the first marker part IV! 1 and the second marker part IV! 2 to be formed.
• the materials of the first mold IV! 0 1 and the second mold IV! 02 various materials can be used as long as they are metals generally known as materials for molds. Among them, the mold shape is easy to process and has high thermal conductivity. As the material of the second mold IV! 02, brass or aluminum alloy is preferable.
• the inner peripheral surface side of the tube 22 8 projects in accordance with the stress from the outer peripheral surface of the tube 2 28, and the above-mentioned ridge portion is formed on the inner peripheral surface of the tube 2 28. 2 2 2 is formed.
• Various processing conditions can be adopted for the hot pressing as long as they can be thermally deformed so that the tube 22 8 can have irregularities.
• the processing conditions it is possible to select conditions such as a mold temperature of 1300 ° , a surface pressure of 0.041/13, and a pressing time of 30 seconds.
• the protrusion 2223 may be formed at a position corresponding to the interface between the first mold IV!01 and the second mold IV!02.
• the protrusions 2 23 have a function of irregularly reflecting ultrasonic waves. Therefore, the projections 2 23 diffusely reflect the ultrasonic waves, so that the regular reflection amount of the ultrasonic waves is relatively reduced. As a result, in the echo image using ultrasonic waves, the part corresponding to the protrusions 2 2 3 is displayed dark, and the effect of making the marker part IV! clear can be expected.
• the pattern formed by the plurality of grooves 2 2 1 3 included in the first marker portion 1 ⁇ /1 1 and the plurality of grooves included in the second marker portion ! ⁇ /! 2 are formed.
• the pattern formed by the 2 2 1 swallows corresponds to each other. Therefore, the groove of the first metal mold and the groove of the second metal mold IV!
• the groove included in the first marker portion IV! When forming a part that is discontinuous with the groove included in the marker part, ⁇ 0 2020/175462 16 ⁇ (: 171? 2020 /007419
• the marker portion is formed by hot pressing. Therefore, the design of the first mold IV! 0 1 and the second mold IV! 0 2 and the relative positions of the first mold IV! 0 1 and the second mold IV! 0 2 can be easily adjusted. It is possible to easily form, with high reproducibility, a portion where the groove included in the first marker portion IV! 1 and the groove included in the second marker portion are discontinuous.
• the inner peripheral surface side projects in accordance with the stress from the outer peripheral surface of the tube 22 8 and a ridge is formed on the inner peripheral surface of the tube 22 8. Therefore, the inner tube manufactured by hot pressing is less likely to have a smaller wall thickness than the inner tube manufactured by laser processing or cutting.
• the tube 2 28 is passed through the core 30 and then hot pressed.
• the core 30 supports the tube 22 8 from the inner peripheral side during hot pressing, which facilitates press working.
• the diameter of the core 30 is larger than the diameter of the guide wire ⁇ / ⁇ / used in the catheter 18. Therefore, the guide wire should be attached to the obtained inner tube 22. It is possible to ensure that the guide wire can be passed through, and it is possible to suppress the occurrence of defective products in which the guide wire cannot be passed through.
• the desired inner tube can be manufactured as described above.
• the catheter having the above-mentioned configuration it is possible to detect the position inside the body by ultrasonic irradiation, and it is difficult for the position to be damaged.
• the inner tube described above can be easily manufactured.
• the pattern of the marker portion formed on the outer peripheral surface of the inner tube is not limited to the above configuration.
• the groove 2 2 1 has the central axis! It is formed in the circumferential direction of the outer peripheral surface of the inner tube 22 so as to be orthogonal to -, but is not limited to this.
• Fig. 10 is a schematic diagram showing a modified example of the inner tube, and is a diagram corresponding to Fig. 4.
• the groove 241 formed on the outer peripheral surface has a central axis! -It may be installed so as to cross at an angle.
• the groove 2 4 1 is formed in an arc shape on the outer peripheral surface of the inner tube 2 4.
• the pattern formed by the plurality of grooves 2 2 1 3 included in the first marker portion 1 ⁇ /1 1 and the second marker portion 1 ⁇ / match with each other, but may differ from each other.
• Fig. 11 is a schematic diagram showing a modified example of the inner tube, and is a diagram corresponding to Fig. 5.
• the intervals between the plural grooves 2 52 of the second marker portion IV! 2 are widened with respect to the intervals between the plural grooves 2 5 1 of the first marker portion IV! 1. You may. Also, as indicated by reference numerals 5 and 6, the intervals between the plurality of grooves 2 52 of the second marker section IV! 2 are narrowed with respect to the intervals between the plurality of grooves 2 5 1 of the first marker section IV! 1. Also ⁇ 0 2020/175462 18 ⁇ (: 171? 2020 /007419
• the echo image is displayed according to the posture of the marker section IV!. The way it changes. Therefore, the echo screen can be easily distinguished from the noise, and the operability is improved.
• the marker portion 1 ⁇ /1 has the first area 8 [3 ⁇ 4 1 and the second area 8 2; however, the present invention is not limited to this, and the groove 2 2 1 It may be configured to have multiple regions, such as further having a third region in which the interval is different from the first region 8 [
• the marker portion 1 ⁇ /1 has the groove, but the structure of the marker portion is not limited to the groove.
• the marker portion may have a plurality of protrusions or a roughened area. Such protrusions and roughened regions can also be easily formed by hot pressing.
• FIGS. 12 and 13 are explanatory views of an inner tube and a catheter according to the second embodiment of the present invention.
• the inner tube and catheter of this embodiment are partially common to the inner tube and catheter of the first embodiment. Therefore, in this embodiment, the same components as those in the first embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.
• FIG. 12 shows the catheter tube 5 of the catheter 1 of the present embodiment. ⁇ 0 2020/175 462 19 ⁇ (: 171? 2020 /007419
• FIG. 3 is a schematic sectional view and corresponds to FIG. 2.
• the catheter tube 5 has an outer tube 51 and an inner tube 52 that is passed through the outer tube 51.
• the outer tube 51 and the inner tube 52 form a double tube structure.
• the same material as the material for forming the outer tube 21 described above can be used.
• a partition wall 5 19 is provided inside the outer tube 5 1 along the longitudinal direction of the outer tube 5 1.
• the inner space of the outer tube 5 1 is controlled by the partition wall 5 1 9 It is divided into a space 5 13 for passing through and a space 5 13 for flowing an expansion liquid for expanding a balloon (not shown).
• Space 5 1 8 and Space 5 1 Are formed along the longitudinal direction of the outer tube 51.
• the outer peripheral surface of the end portion 5 2 3 of the inner tube 5 second connector side is welded and fixed to the inner wall 5 1 X end of Autachi cube 5 1 balloon side.
• the inner peripheral surfaces of the outer tube 51 and the inner tube 52 slide with the guide wire ⁇ , and are therefore preferably covered with a low friction material such as silicone resin or fluororesin.
• the outer peripheral surface of the outer tube 51 may be covered with a hydrophilic resin such as polyvinylpyrrolidone or 2-hydroxyethylmethacrylate.
• Fig. 13 is a schematic cross-sectional view showing the peripheral structure of the balloon 3, and is a view corresponding to Fig. 3.
• a marker portion 1 ⁇ /1 is provided on the outer peripheral surface of the inner tube 52 and on the portion overlapping the conical portion 3 of the balloon 3.
• the marker part 1 ⁇ /1 is provided with a plurality of grooves 2 21.
• the marker portion IV! of the inner tube 52 shown in FIG. 13 is not provided on the outer peripheral surface of the inner tube 52 and on the portion overlapping the cylindrical portion 38 of the balloon 3.
• the amount of resin forming the cylindrical portion 33 is larger than the amount of resin forming the conical portion 3. Therefore, in the balloon 3 wound around the inner tube 52, the cylindrical portion 33 is wound thicker than the conical portion 3 swath.
• a catheter having an inner tube as described above it is possible to detect the position inside the body by irradiating ultrasonic waves, and it is less likely to be damaged.
• FIG. 14 and 15 are explanatory views of an inner tube and a catheter according to the third embodiment of the present invention.
• the inner tube and catheter of this embodiment are partially common to the inner tube and catheter of the first and second embodiments. Shi ⁇ 0 2020/175462 21 ⁇ (: 171? 2020 /007419
• Fig. 14 is a schematic cross-sectional view showing the peripheral structure of the balloon 3 of the catheter 10 and is a diagram corresponding to Figs.
• the inner tube 5 6 is exposed between the tip 29 and the balloon 3 on the distal side of the catheter 10.
• the portion of the inner tube 56 that does not overlap the balloon (exposed portion) is indicated by the symbol ⁇ .
• the exposed portion ⁇ is provided with the marker portion 1 ⁇ /1.
• the marker part 1 ⁇ /1 shown in Fig. 14 is provided from the conical part 3 to the exposed part ⁇ .
• FIG. 15 is a schematic enlarged view of a portion indicated by a symbol in FIG.
• the outer tube 55 is an outer tube marker in which the amount of specular reflection of ultrasonic waves is relatively reduced on the outer peripheral surface of the outer tube 51 shown in the second embodiment compared to the other outer peripheral surfaces of the outer tube 55.
• Part ⁇ IV! The outer tube marker section IV! has multiple grooves 5 51.
• the outer tube marker part ⁇ 1 ⁇ /1 is provided at a position adjacent to the balloon 3. "Adjacent" means the distance from the end of the balloon 3 to the groove 5 51 on the balloon 3 side of the outer tube mer part ⁇ IV!.
• the groove 5 51 can be formed by the same method as the marker portion IV! of the inner tube 22 of the first embodiment.
• the depth of the groove 5 51 is, for example, 50 to 300. Further, the width of the groove 5 51 is, for example, 500 1 to 300.
• the edges of the groove 5 51 may be convexly raised. When the edge of the groove 5 51 is convexly raised, the depth of the groove refers to the difference in height from the deepest part of the groove to the top of the convexly raised portion. It is preferable that the groove 5 5 1 is deep if the strength required by the outer tube 5 5 can be secured and there is no manufacturing demerit.
• a catheter having an inner tube as described above it is possible to detect the position inside the body by irradiating ultrasonic waves, and it is less likely to be damaged.
• both the marker (marker section IV!) on the distal side of the catheter 10 and the marker (outer tube marker section 001 ⁇ / ⁇ ) on the connector 4 side of the balloon 3 are It is provided at a position that does not overlap with balloon 1 ⁇ /1, but it is not limited to this.
• the distal end side of the catheter 10 has the same configuration as that of the first embodiment or the second embodiment, the marker portion IV! is provided at the position overlapping the balloon 3, and the connector 4 side is the first portion.
• the outer tube marker section IV! shown in the third embodiment may be provided.
• the exposed portion shown in the third embodiment is used. ⁇ 02020/175462 23 ⁇ (: 17 2020 /007419
• the marker part IV! may be provided on the inner tube of the connector 4 side as shown in the first or second embodiment.

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• Heart & Thoracic Surgery (AREA)
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Citations (7)

• 2020
  • 2020-02-25 JP JP2021502262A patent/JPWO2020175462A1/ja active Pending
  • 2020-02-25 WO PCT/JP2020/007419 patent/WO2020175462A1/ja not_active Ceased
  • 2020-02-26 TW TW109106226A patent/TW202039024A/zh unknown

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