WO2011108568A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2011108568A1
WO2011108568A1 PCT/JP2011/054708 JP2011054708W WO2011108568A1 WO 2011108568 A1 WO2011108568 A1 WO 2011108568A1 JP 2011054708 W JP2011054708 W JP 2011054708W WO 2011108568 A1 WO2011108568 A1 WO 2011108568A1
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WO
WIPO (PCT)
Prior art keywords
catheter
outer tube
end side
distal end
rigidity
Prior art date
Application number
PCT/JP2011/054708
Other languages
English (en)
Japanese (ja)
Inventor
北田徳幸
八木宏
多田裕一
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2012503202A priority Critical patent/JP5486675B2/ja
Publication of WO2011108568A1 publication Critical patent/WO2011108568A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • 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
    • 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
    • A61M2025/0183—Rapid exchange or monorail catheters
    • 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

Definitions

  • the present invention relates to a catheter provided with an opening for leading a guide wire in the middle of an outer tube.
  • a method in which a lesion (stenosis) of a coronary artery is expanded by a balloon provided at the distal end of the catheter, and other blood vessels, bile ducts, trachea, esophagus, urethra
  • the stenosis formed in a living organ such as another organ is improved in the same manner.
  • This type of catheter has a long shaft body, and a guide wire introduced in advance into the body is inserted into the shaft body, so that the catheter can be advanced into the body along the guide wire. it can.
  • Japanese Patent Laid-Open No. 2000-217923 discloses that a guide wire lead-out port is formed by providing an opening in the middle of an outer tube shaft composed of a single tube and joining the base end of the inner tube shaft to the opening.
  • a catheter of a structure called the so-called rapid exchange type is described.
  • the catheter is operated by a surgeon from the proximal end side to smoothly advance a long shaft in a tortuous blood vessel, and it is necessary to smoothly penetrate the distal end through a hard stenosis. Therefore, it is desirable that the pushing force by the operator from the proximal end side can be reliably transmitted to the distal end side.
  • peripheral blood vessels such as the above-mentioned cerebral blood vessels have a delicate structure and a thin blood vessel wall, so that when the tip of the catheter abuts against the blood vessel wall while guiding the catheter, the tissue in the blood vessel is damaged.
  • the possibility of perforating the blood vessel wall has been pointed out. Even in a normal blood vessel bifurcation, there is a possibility that the blood vessel wall may be perforated when the catheter is advanced with a strong force.
  • the operator gives a fine motion of about 1 mm to the distal end about 150 cm away from the base of the catheter that is the operation unit. If the load at hand is excessively transmitted to the tip, the tip may strongly press the blood vessel wall by a slight movement of the hand. That is, there is a demand for a structure capable of sufficiently buffering the pushing force from the proximal end side and transmitting it to the distal end side in the catheter used for cerebral endovascular treatment or the like.
  • the present invention has been made in consideration of such a conventional problem, and an object thereof is to provide a catheter in which the pushing force from the proximal end side is not easily transmitted to the distal end side.
  • the catheter according to the present invention is a catheter comprising an outer tube and an inner tube that is disposed in the outer tube and through which a guide wire is inserted through the distal end side opening and the proximal end side opening.
  • the tube has at least a first portion along the axial direction and a second portion having higher rigidity than the first portion, and the outer tube is an opening to which the proximal end side opening of the inner tube is connected. A portion is provided in the first part.
  • the outer tube in the catheter having a configuration in which an opening for guiding a guide wire is provided in the middle of the outer tube, the outer tube includes the flexible first portion and the second portion having high rigidity, and is flexible.
  • An opening is formed in the first part which is a difficult part.
  • the opening is formed in a portion having the lowest rigidity or a portion having a somewhat low rigidity among the plurality of portions having different rigidity.
  • the outer tube is provided between the first portion and the second portion, and has an outer tube having a transition portion including a portion having higher rigidity than the first portion and lower rigidity than the second portion.
  • the rigidity in the axial direction can be configured more smoothly.
  • the rigidity in the axial direction of the outer tube may be configured more smoothly. it can.
  • the distal end side can be configured to be somewhat rigid together with a structure in which a load from the hand is not easily transmitted to the distal end. Can be penetrated.
  • the distal end side can be configured to be somewhat rigid and the flexibility of the catheter distal end can be ensured.
  • the catheter when the first portion is provided on the distal end side with respect to the second portion, the catheter can be configured so that the rigidity of the catheter gradually becomes flexible from the proximal end side to the distal end side, and the catheter is bent. It can be further smoothly advanced into the blood vessel and the constricted portion having the uneven shape.
  • the first part and the second part are formed of resins having different rigidity, and the transition part is formed by mixing the resin of the first part and the resin of the second part, An outer tube having portions with different rigidity can be easily formed.
  • the first part, the second part, and the transition part may be integrally formed by extrusion molding using a resin switching mold. If it does so, the outer tube
  • the catheter When the catheter is configured as a balloon catheter including a balloon having a proximal end attached to the distal end side of the outer tube and a distal end attached to the distal end side of the inner tube, the balloon can be easily transferred to a constricted portion in the body. It is possible to easily obtain a balloon catheter that can be advanced and can be smoothly inserted even in a delicate blood vessel or the like.
  • the outer tube in a catheter having a configuration in which an opening for guiding a guide wire is provided in the middle of the outer tube, the outer tube includes the flexible first portion and the highly rigid second portion, and the flexible portion.
  • the opening in the first part By forming the opening in the first part, the pushing force from the base end side is sufficiently absorbed by the flexible first part and the opening formed in the first part. For this reason, it is difficult for the load from the hand to be transmitted to the distal end, and even when a large motion is given to the distal end, the distal end operates finely, and a catheter with little influence on the delicate blood vessel wall can be obtained.
  • FIG. 1 is an overall configuration diagram of a catheter according to a first embodiment of the present invention.
  • 2A is an enlarged plan view of the distal end side of the catheter shown in FIG. 1, and FIG. 2B is a side sectional view of the catheter shown in FIG. 2A.
  • 3A is a partially omitted plan view of the outer tube, and FIG. 3B is a graph showing an example of the relationship between the axial position of the outer tube and the resistance load shown in FIG. 3A.
  • FIG. 5A is a plan view of the first outer tube model simulating the outer tube
  • FIG. 5B is a plan view of the second outer tube model
  • FIG. 5C is a plan view of the third outer tube model. It is a block diagram of the measuring apparatus for measuring the transmissibility of the indentation load in the axial direction of an outer tube. It is a graph which shows the relationship between the indentation load and load transmission rate in each outer tube
  • FIG. 8A is a partially omitted plan view of an outer tube according to a modified example, and FIG. 8B is a graph showing an example of the relationship between the axial position of the outer tube and the resistance load shown in FIG. 8A.
  • FIG. 9A is an enlarged plan view of the distal end side of the catheter according to the second embodiment of the present invention, and FIG. 9B is a side sectional view of the catheter shown in FIG. 9A.
  • FIG. 10A is a partially omitted plan view showing a modification of the outer tube of the catheter shown in FIG. 9A
  • FIG. 10B is a graph showing an example of the relationship between the axial position of the outer tube shown in FIG. 10A and the resistance load. It is. It is a whole block diagram of the catheter which concerns on a modification. It is an enlarged view of the front end side of the catheter shown in FIG.
  • FIG. 1 is an overall configuration diagram of a catheter 10 according to a first embodiment of the present invention.
  • 2A is an enlarged plan view of the distal end side of the catheter 10 shown in FIG. 1
  • FIG. 2B is a side sectional view of the catheter 10 shown in FIG. 2A.
  • the long shaft body 12 is inserted into a living organ, for example, a cerebral blood vessel, and the balloon 14 provided on the distal end side thereof is expanded at the stenosis part (lesion part), thereby the stenosis part.
  • PTA Percutaneous Transluminal Angioplasty
  • the present invention can also be applied to uses other than such dilatation catheters, such as catheters for self-expandable stents.
  • the catheter 10 includes a thin and long shaft main body 12, a balloon 14 provided on the distal end side of the shaft main body 12, and a hub 18 provided on the proximal end side of the shaft main body 12. Is provided.
  • the catheter 10 is a so-called rapid exchange type in which an opening 22 through which the guide wire 20 is led out is provided slightly near the distal end side of the intermediate portion of the shaft body 12. 1 and 2, the right side (hub 18 side) of the shaft body 12 is referred to as the “base end (rear end)” side, and the left side (balloon 14 side) of the shaft body 12 is referred to as the “front end” side. The same applies to each figure.
  • the shaft main body 12 has an inner tube (inner tube shaft, guide wire tube) 24 that forms a wire lumen 24 a through which the guide wire 20 is inserted, and an expansion fluid for the balloon 14.
  • the shaft 27 is a concentric double tube from the tip to the opening 22.
  • the inner tube 24 extends inside the balloon 14 and the outer tube 26, the vicinity of the distal end is liquid-tightly joined to the distal end side of the balloon 14, and a proximal end side opening 24 c that opens at the proximal end is formed on the outer tube 26. It is liquid-tightly joined to the opening 22 formed in the middle by adhesion, heat fusion or the like. Therefore, the guide wire 20 inserted with the distal end side opening 24b of the inner tube 24 as the inlet is inserted through the wire lumen 24a of the inner tube 24 from the distal end side to the proximal end side, and the outlet 22 (base) is the outlet. It leads out to the exterior from the end side opening part 24c).
  • the outer tube 26 extends from the rear end of the balloon 14 to the joint portion 29 with the base shaft 27, and a portion from the distal end to the opening 22 forms a dilating tube 26 a between the inner tube 24 and the inner tube 24.
  • the distal end portion 31 of the base shaft 27 is inserted in a portion from the opening 22 to the joint portion 29, and an expansion lumen 26a continuous with the expansion lumen 27a of the base shaft 27 is formed.
  • the base shaft 27 has a distal end portion 31 formed in a hook shape that is inclined in the axial direction by cutting the tube in a direction along the axial direction and in a direction inclined from the axial direction.
  • a proximal end side from the portion 31 is formed as a tube extending to the hub 18.
  • the distal end portion 31 has a thin leading end portion 31a and an inclined portion 31b whose diameter is increased in an inclined manner from the proximal end side of the leading end portion 31a, and in order to gradually change the tube rigidity, A spiral slit 31c formed between the end portion and the vicinity of the joint portion 29 is provided.
  • tip part 31 is comprised so that the rigidity may become strong gradually toward a base end from a front-end
  • the base shaft 27 and the outer tube 26 are capable of feeding an expansion fluid pumped from a pressure application device such as an indeflator (not shown) to the balloon 14 by a luer taper 18 a provided on the hub 18.
  • a pressure application device such as an indeflator (not shown)
  • indeflator not shown
  • the outer tube 26 has a first portion R1 that is flexible on the distal end side that is joined to the balloon 14 and a first portion R1 that is more rigid than the first portion R1 on the proximal end side including the portion that is joined to the hub 18.
  • 2 parts R2 and a transition part R0 provided between the first part R1 and the second part R2 and changing in rigidity so as to connect between the two parts R2 and these are integrally formed in series in the axial direction. Tube.
  • the inner tube 24 has, for example, an outer diameter of about 0.1 mm to 1 mm, preferably about 0.3 mm to 0.7 mm, a wall thickness of about 10 ⁇ m to 150 ⁇ m, preferably about 20 ⁇ m to 100 ⁇ m, and a length.
  • the tube is about 10 mm to 2000 mm, preferably about 20 mm to 1500 mm, and may have different outer diameters and inner diameters on the distal end side and the proximal end side.
  • the outer tube 26 has, for example, an outer diameter of about 0.3 mm to 3 mm, preferably about 0.5 mm to 1.5 mm, a thickness of about 10 ⁇ m to 150 ⁇ m, preferably about 20 ⁇ m to 100 ⁇ m, and a length of 30 mm.
  • the length of the first part R1 is about 10 mm to 500 mm
  • the length of the transition part R0 is about 10 mm to 500 mm
  • the length of the second part R2 is about 10 mm to 1500 mm.
  • the base shaft 27 has, for example, an outer diameter of about 0.5 mm to 1.5 mm, preferably about 0.6 mm to 1.3 mm, and an inner diameter of about 0.3 mm to 1.4 mm, preferably 0.5 mm to 1.
  • the inner tube 24, the outer tube 26, and the base shaft 27 allow the operator to smoothly insert the long shaft body 12 into a living organ such as a blood vessel while grasping and operating the proximal end side.
  • a living organ such as a blood vessel
  • the base shaft 27 is preferably formed of a material having a relatively high rigidity, and examples thereof include Ni—Ti alloy, brass, SUS, and aluminum.
  • resins such as polyimide, vinyl chloride, and polycarbonate are used. May be used.
  • the outer tube 26 has three parts (first part R1, second part R2, and transition part R0) as described above, and therefore the first part R1 and the second part R2 are made of different materials.
  • the transition region R0 is formed of a material in which the mixing ratio of the materials of the first region R1 and the second region R2 is changed in the axial direction.
  • the outer tube 26 may be formed by other methods.
  • all parts of the outer tube 26 are formed of the same material, and the thickness or the like is changed structurally.
  • the first portion R1 may be configured to have a constant thin thickness
  • the second portion R2 may be configured to have a constant thickness
  • the transition portion R0 may be configured to gradually change in thickness.
  • FIG. 3A is a partially omitted plan view of the outer tube 26, and FIG. 3B is a graph showing an example of the relationship between the axial position of the outer tube 26 shown in FIG. 3A and the resistance load (gf).
  • the horizontal axis represents the axial position (distance) from the distal end to the proximal end of the outer tube 26 shown in FIG. 3A
  • the vertical axis represents the resistance load of the outer tube 26 at the corresponding axial position ( gf).
  • This resistance load (gf) is one index indicating the level of rigidity at each axial position of the outer tube 26.
  • the resistance load (gf) is at the center of a two-point support beam in which the distance between the two support points is set to 9 mm.
  • the resistance load of the flexible first portion R1 is about 15 gf
  • the resistance load of the highly rigid second portion R2 is about 35 gf
  • the transition portion connecting between them The resistance load of R0 can be changed between 15 gf and 35 gf.
  • the transition site R0 may be other than the configuration in which the load resistance changes in a proportional linear shape.
  • the transition site R0 may have a configuration in which the rigidity changes stepwise (stepwise).
  • the first portion R1 and the second portion R2 are configured such that the rigidity does not change suddenly, and the ratio of the resin having different rigidity before and after the transition portion R0 is 100: 0 and 0: 100. It is only necessary that the ratio of the resin having different rigidity gradually changes at the transition portion R0.
  • the opening 22 to which the proximal end opening 24c of the inner tube 24 is joined has the lowest rigidity and flexibility on the distal side from the transition region R0.
  • the first portion R1 is provided.
  • FIG. 4 is a configuration diagram of a manufacturing apparatus 30 that implements an example of a method for manufacturing the outer tube 26.
  • the manufacturing apparatus 30 includes a first extruder 32 that extrudes a predetermined resin A, and a second extrusion that extrudes another resin B that has higher rigidity (for example, resistance load) than the resin A.
  • a molding machine 34 and a resin switching mold 36 for kneading and molding while appropriately controlling the ratio of the resins A and B extruded from the first extrusion molding machine 32 and the second extrusion molding machine 34 are provided.
  • the resin switching mold 36 includes a switching valve 36a that can change the kneading ratio of the resin A from the first extrusion molding machine 32 and a switching valve 36b that can change the kneading ratio of the resin B from the second extrusion molding machine 34. And are provided.
  • the manufacturing apparatus 30 removes a cooling water tank 38 for cooling the tube after molding led out from the resin switching die 36, a take-up machine 40 for drawing the tube from the resin switching die 36, and a long tube after molding.
  • a fixed-size cutting machine 42 for cutting to a length corresponding to the pipe 26 and a tube accumulating machine 44 for accumulating the molded and cut tubes are provided.
  • the pellet of the resin A that forms the flexible first portion R1 of the outer tube 26 is charged into the first extruder 32, and the resin B that forms the second portion R2 having high rigidity is supplied.
  • the outer tube 26 formed integrally with each part having different rigidity is continuously formed as one tube.
  • the material of the resin A and the resin B include a nylon elastomer resin.
  • the resin A includes “PEBAX (registered trademark) No. 5533” and the resin B includes “PEBAX (registered). Trademark No. 7033 ".
  • the switching valve 36a when molding the first portion R1, only the switching valve 36a is opened and the switching valve 36b is closed, so that the tube is formed only by the resin A from the first extrusion molding machine 32. Subsequently, when the transition region R0 is formed, the opening amount of the switching valve 36b is gradually decreased and the opening amount of the switching valve 36b is gradually increased from the state where the switching valve 36a is opened and the switching valve 36b is closed. Finally, only the switching valve 36b is opened and the switching valve 36a is closed. Thereby, the ratio of the resin A from the first extruder 32 and the resin B from the second extruder 34 is, for example, 100: 0, 80:20, 60:40, 40:60, 20:80, The tube is formed while changing to 0: 100. Finally, when molding the second portion R2, only the switching valve 36b is opened and the switching valve 36a is closed, so that the tube is formed only with the resin B from the second extrusion molding machine 34.
  • the outer tube 26 whose rigidity changes can be integrally formed as one tube, and a joint portion in which the respective portions are joined. Therefore, it is possible to easily form a tube having no portion where the rigidity changes abruptly.
  • the outer tube 26 is formed with an opening 22 to which the proximal end side opening 24c of the inner tube 24 is joined, and since the opening 22 opens on the peripheral surface of the outer tube 26, It functions as a buffer portion that absorbs the pushing force in the axial direction applied to the outer tube 26 and affects the rigidity of the outer tube 26.
  • FIG. 5A is a plan view of the first outer tube model M1 simulating the outer tube 26
  • FIG. 5B is a plan view of the second outer tube model M2
  • FIG. 5C is a plan view of the third outer tube model M3.
  • Each of the outer tube models M1 to M3 is a tube having a shorter overall length of 200 mm and an outer diameter of 1 mm than the outer tube 26, and the distance from the tip of the tube to the tip of the opening 22 is set to 150 mm.
  • the first outer tube model M1 is provided with a flexible first portion R1 (length 175 mm) on the distal end side and a second portion R2 (length 10 mm) having high rigidity on the proximal end side, and a transition portion R0 ( The length is 15 mm).
  • the second outer tube model M2 is provided with a highly rigid second portion R2 (length 15 mm) on the distal end side, a flexible first portion R1 (length 170 mm) on the proximal end side, and a transition portion R0 (in the meantime) The length is 15 mm).
  • the third outer tube model M3 is provided with a flexible first part R1 (length: 95 mm) on the distal end side and a second part R2 (length: 90 mm) with high rigidity on the proximal end side, and a transition part R0 (in the meantime) The length is 15 mm).
  • an opening 22 is provided in the first portion R1, which is a flexible portion, and the third outer tube model M3. Then, the opening part 22 is provided in 2nd site
  • FIG. 6 is a configuration diagram of a measuring device 50 for measuring the transmission rate of the indentation load in the axial direction of the outer tube 26.
  • the outer tube model M1 (or M2, M3) imitating the outer tube 26 is shown.
  • the structure which has arranged is shown.
  • FIG. 7 is a graph showing the relationship between the indentation load (gf) and the load transfer rate (load transfer rate 100% is 1) in each of the outer tube models M1 to M3.
  • the horizontal axis represents the indentation load (gf) in the distal direction applied to the base end side of the outer tube models M1 to M3, and the vertical axis represents the load transmission rate at each indentation load.
  • the indentation load was set to three conditions of 30 gf, 60 gf, and 120 gf.
  • the measuring device 50 includes a first push-pull gauge 52 that measures loads on the distal end side and the proximal end side of the outer tube 26 (in this case, the outer tube model M1, M2, or M3), and A second push-pull gauge 54, a silicon tube 56 that slides and supports the outer tube 26 that moves to the distal end side in response to a load from the base end side between the two push-pull gauges 52, 54, A base end shaft 58 connected to the base end side of the outer tube 26 and a clamp mechanism 60 that clamps the base end side of the base end shaft 58 are provided.
  • a first push-pull gauge 52 that measures loads on the distal end side and the proximal end side of the outer tube 26 (in this case, the outer tube model M1, M2, or M3)
  • a second push-pull gauge 54 a silicon tube 56 that slides and supports the outer tube 26 that moves to the distal end side in response to a load from the base end side between the two push-pull gauges 52, 54
  • the proximal end shaft 58 is pushed toward the distal end side from the second push-pull gauge 54 side, thereby pressing the outer tube 26 (outer tube models M1 to M3) against the first push-pull gauge 52 side.
  • the transmission rate of the indentation load from the proximal end side to the distal end side is measured.
  • the inner tube 24 and the guide wire 20 are provided inside the outer tube models M1 to M3, that is, the load as the shaft body 12 in order to approach the actual use state of the catheter 10.
  • the transmission rate was measured.
  • the third outer tube model M3 in which the opening 22 is formed in the second portion R2 having high rigidity at any pressing load of 30 gf, 60 gf, and 120 gf (FIG. 7).
  • 5C and the one-dot chain line graph in FIG. 7) resulted in a high load transmission rate.
  • the first outer tube model M1 see the solid line graph in FIG. 5A and FIG. 7
  • the second outer tube model M2 FIG. 5B and FIG. 5
  • the load transmission rate tends to be low for any indentation load.
  • the tendency that the load transmission rate decreases as the indentation load increases is confirmed.
  • the pushing load in a general procedure is about 120 gf when it is strong.
  • a catheter for example, a microcatheter
  • the operator intends. Even when a strong pushing force is applied to the distal end, it is desired that the pushing force is absorbed in the middle of the catheter and the strong pushing force is not transmitted to the distal end.
  • the catheter 10 in order to achieve a structure in which the load at hand is difficult to be transmitted to the tip, it is effective to provide the opening 22 in the flexible first portion R1.
  • the first portion R1 forming the opening 22 is provided on the distal end side of the outer tube 26 (first outer tube model M1 in FIG. 5A), and the proximal end side (FIG. It was confirmed that a structure with a low load transmission rate can be obtained in substantially the same manner for any of the cases provided in the second outer tube model M2) of 5B.
  • the opening 22 is provided in the flexible first portion R1, but the catheter according to the second embodiment to be described later. 70 adopts a configuration in which the first part R1 in which the opening 22 is provided is arranged on the proximal side with respect to the second part R2 (see FIGS. 9A and 9B).
  • the distance from the base end of the transition region R0 to the center of the opening 22 is about 5 mm to 40 mm, for example, and the distance from the tip of the outer tube 26 to the tip of the opening 22 is 150 mm, for example. Although it may be set to about ⁇ 1500 mm, these dimensions may be optimized as appropriate according to the specifications and applications of the catheter 10.
  • the balloon 14 provided at the distal end of the catheter 10 can be folded and expanded by a change in internal pressure.
  • the balloon 14 is cylindrical (cylindrical) by an expansion fluid injected into the inside through the expansion lumen 26a.
  • the balloon 14 is provided with a cylindrical distal end non-expanded portion 14d provided on the distal end side of the distal tapered portion 14b in a liquid-tight manner on the outer peripheral surface of the inner tube 24, and is provided on the proximal end side of the proximal tapered portion 14c.
  • the cylindrical base-side non-expanded portion 14e is fixed to the shaft body 12 by being liquid-tightly joined to the distal end portion of the outer tube 26.
  • the inner diameter of the distal-side non-expanded portion 14 d substantially matches the outer diameter of the inner tube 24, and the outer diameter of the proximal-side non-expanded portion 14 e substantially matches the outer diameter of the outer tube 26.
  • the balloon 14 and the inner tube 24 and the outer tube 26 may be fixed in a liquid-tight manner, and are joined by, for example, adhesion or heat fusion.
  • the size of the balloon 14 when expanded is, for example, that the outer diameter of the cylindrical portion 14a is about 1 mm to 6 mm, preferably about 1 mm to 4 mm, and the length is about 5 mm to 50 mm, preferably about 5 mm to 40 mm. Further, the outer diameter of the distal side non-expanded portion 14d is about 0.5 mm to 1.5 mm, preferably about 0.6 mm to 1.3 mm, and the length is about 1 mm to 5 mm, preferably about 1 mm to 2 mm. is there.
  • the outer diameter of the proximal non-expanded portion 14e is about 0.5 mm to 1.6 mm, preferably about 0.7 mm to 1.5 mm, and the length is about 1 mm to 5 mm, preferably about 2 mm to 4 mm. Further, the lengths of the distal tapered portion 14b and the proximal tapered portion 14c are about 1 mm to 10 mm, preferably about 3 mm to 7 mm.
  • Such a balloon 14 is required to have an appropriate flexibility as in the case of the inner tube 24 and the outer tube 26, and to have a strength that can surely spread the narrowed portion.
  • it may be the same as that of the inner tube 24 and the outer tube 26 exemplified above, and other materials may be used.
  • the form of a stenosis part (lesion part) generated in a cerebral blood vessel or the like is specified by an intravascular imaging method or an intravascular ultrasonic diagnostic method.
  • the guide wire 20 is introduced in advance into the blood vessel percutaneously from the thigh or the like by, for example, the Seldinger method, and the guide wire 20 is used for the wire with the distal end side opening 24b of the inner tube 24 as the inlet.
  • the lumen 24a is inserted, and the catheter 10 is inserted into the cerebral blood vessel while being led out to the opening 22.
  • the guide wire 20 is advanced to the intended stenosis part, passed through the stenosis part and placed, and the catheter 10 is advanced along the guide wire 20 into the cerebral blood vessel. Then, the distal end of the catheter 10 reaches the stenosis and passes (penetrates) through the stenosis.
  • the balloon 14 can be disposed in the stenosis portion, and the balloon 14 is expanded and narrowed by pumping an expansion fluid (for example, contrast medium) from the hub 18 side into the expansion lumens 27a and 26a.
  • an expansion fluid for example, contrast medium
  • the catheter 10 of the present embodiment has a configuration in which the opening 22 is provided in the middle of the shaft body 12 (rapid exchange type), the guide wire 20 is led out to the proximal end side of the hub 18 (over-the- Compared to the wire type), the guide wire 20 can be configured to be short and easy to handle, and the catheter 10 can be easily replaced while the guide wire 20 is left in the body.
  • the outer tube 26 includes a flexible first portion R1, a second portion R2 having high rigidity, and a transition portion R0 whose rigidity has been changed so as to connect between the two, so that the proximal end side to the distal end side are provided.
  • the shaft rigidity can be gradually made flexible, and the catheter 10 can be smoothly advanced into a tortuous blood vessel or a constricted portion having an uneven shape.
  • the transmission rate of the pushing force from the proximal end side to the distal end side of the catheter 10 can be configured to be a low value. it can.
  • the strong pushing force is sufficiently absorbed by the outer tube 26, that is, the first portion R1 and the opening 22 formed in the outer tube 26. Therefore, the pushing force transmitted to the distal end of the catheter 10 can be sufficiently reduced. That is, the pushing force from the proximal end side by the operator is absorbed to some extent by the flexible first portion R1, but the first portion R1 is formed by forming the opening 22 in the flexible first portion R1.
  • R1 and the opening 22 formed in this function as a buffer part, and can fully absorb the transmitted pushing force. For this reason, it is difficult for the load from the hand to be transmitted to the distal end, and even when a relatively large motion is applied, the distal end operates finely, and a catheter with little influence on the delicate blood vessel wall can be easily obtained.
  • the outer tube 26 it is also effective to integrally form the first part R1, the second part R2, and the transition part R0 by the manufacturing apparatus 30 as described above. If it does so, a junction part will not be formed in the middle of outer pipe 26, and the rigidity of outer pipe 26 can be changed still more smoothly. For this reason, the outer pipe 26 does not have a portion where the rigidity changes suddenly, and the joint portion and the opening portion 22 become the rigidity changing point, and effectively avoids becoming the starting point of the kink or breakage due to the load of tension or bending. can do.
  • the entire configuration of the catheter 10 can be further simplified by using an outer tube 62 in which the transition portion R0 is omitted instead of the outer tube 26.
  • the outer tube 62 is also formed by integrally forming the first part R1 and the second part R2 by the manufacturing apparatus 30 or the like, or after forming the first part R1 and the second part R2 as separate bodies. Can be used.
  • FIG. 9A is an enlarged plan view of the distal end side of the catheter 70 according to the second embodiment of the present invention
  • FIG. 9B is a side sectional view of the catheter 70 shown in FIG. 9A.
  • the same reference numerals as those shown in FIG. 1 to FIG. 8 indicate the same or similar configurations, and therefore the detailed description is omitted because they have the same or similar functions and effects. The same applies to the following figures.
  • the catheter 70 according to the present embodiment is provided with the opening 22 in the flexible first region R1 and has a low load transmission property from the proximal end side to the distal end side.
  • the catheter 10 described above see FIG. 2A and the like) ), Except that the first portion R1 is provided with an outer tube 72 provided on the proximal end side of the second portion R2 and the transition portion R0.
  • the opening 22 is provided in the flexible first part R1, and the highly rigid second part R2 is provided on the distal end side, thereby obtaining a structure in which the load from the hand is hardly transmitted to the distal end.
  • the distal end side can be configured to be hard to some extent, there is an advantage that a somewhat hard constricted portion or the like can be smoothly penetrated.
  • a flexible distal end portion is provided in front of the second portion R2 on the distal end side. It is also effective to provide R3.
  • the distal end of the catheter can be configured to be somewhat hard while the distal end of the catheter can be configured more flexibly, so that the catheter 70 can be advanced more smoothly into the body, and invasion of the blood vessel wall and the like can also be reduced.
  • this balloon 14 can be substantially used as the front-end
  • the rigidity (resistance load) of the balloon 14 may be equal to or less than the rigidity of the flexible first portion R1.
  • the catheter 70 may have a configuration in which the transition portion R0 is not provided as in the case of the catheter 10.
  • the outer tube 26, 62, 72 is exemplified by a tube having a three-part structure in which the first part R1, the second part R2, and the transition part R0 are provided, or a two-part structure in which the transition part R0 is not provided.
  • the above-described configuration may be used.
  • the opening 22 is formed in a part having the lowest rigidity among the parts or a part having a somewhat low rigidity, the load is transmitted from the base end to the tip end. A difficultly structured catheter can be obtained.
  • the balloon 14 is not provided on the distal end side of the catheter 10, and it can be configured as a catheter 80 applicable to the above-described self-expandable stent catheter or the like.
  • Such a catheter 80 can be configured in substantially the same manner as the living organ dilator described in JP-A-2006-305335, for example. That is, the catheter 80 includes an inner tube 24 that forms a wire lumen 24a through which a guide wire is inserted, a stent housing tube 84 that houses a stent 82 disposed on the distal end side of the inner tube 24, and a distal end side.
  • the stent housing tube 84 has an outer tube 86 into which the proximal end side is inserted.
  • the stent storage tube 84 can be pulled by a pulling wire 92 that can be wound by a winding mechanism 90 mounted on an operation portion 88 provided on the proximal end side of the outer tube 86, whereby the stent 82 is pulled inside the body. Can be opened. Even in such a catheter 80, the proximal end is provided by providing the outer tube 86 with the first portion R1, the second portion R2 (and the transition portion R0), and forming the opening 22 in the first portion R1 having low rigidity. A structure in which the load is not easily transmitted from the tip to the tip can be obtained.

Abstract

La présente invention concerne un cathéter (10) utilisé comme un cathéter de dilation fileté, par exemple, dans des vaisseaux sanguins cérébraux, et qui comprend : un tube extérieur (26) ; et un tube intérieur (24) qui est disposé à l'intérieur du tube extérieur (26) et à travers lequel un fil-guide (20) est fileté via une ouverture (24b) dans l'extrémité formant la pointe et une ouverture (24c) dans l'extrémité formant la base. Le tube extérieur (26) a, dans le sens axial, au moins une première région (R1) et une seconde région (R2) qui est plus rigide que ladite première région (R1). Ledit tube extérieur (26) est configuré avec une ouverture (22), à laquelle se connecte l'ouverture (24c) dans l'extrémité formant la base du tube intérieur (24), fournie dans la première région (R1).
PCT/JP2011/054708 2010-03-05 2011-03-02 Cathéter WO2011108568A1 (fr)

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CN107206213A (zh) * 2015-03-06 2017-09-26 日本瑞翁株式会社 内窥镜用治疗器具
US11298043B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11497576B2 (en) 2017-07-17 2022-11-15 Voyager Therapeutics, Inc. Trajectory array guide system

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JP2003102841A (ja) * 2001-09-28 2003-04-08 Kanegafuchi Chem Ind Co Ltd バルーンカテーテル
JP2008264134A (ja) * 2007-04-18 2008-11-06 Kaneka Corp バルーンカテーテル

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JP4339940B2 (ja) * 1998-07-03 2009-10-07 清仁 石田 カテーテル及びその製造方法
JP3927735B2 (ja) * 1999-09-28 2007-06-13 テルモ株式会社 カテーテル
JP2001353225A (ja) * 2000-06-15 2001-12-25 Terumo Corp カテーテル
US6589207B1 (en) * 1999-12-21 2003-07-08 Advanced Cardiovascular Systems, Inc. Rapid exchange catheter having a support mandrel

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JP2003102841A (ja) * 2001-09-28 2003-04-08 Kanegafuchi Chem Ind Co Ltd バルーンカテーテル
JP2008264134A (ja) * 2007-04-18 2008-11-06 Kaneka Corp バルーンカテーテル

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107206213A (zh) * 2015-03-06 2017-09-26 日本瑞翁株式会社 内窥镜用治疗器具
CN107206213B (zh) * 2015-03-06 2020-09-15 日本瑞翁株式会社 内窥镜用治疗器具
US11298043B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11298041B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11497576B2 (en) 2017-07-17 2022-11-15 Voyager Therapeutics, Inc. Trajectory array guide system

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