WO2014076776A1 - Catheter assembly, and balloon folding and holding method - Google Patents

Catheter assembly, and balloon folding and holding method Download PDF

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Publication number
WO2014076776A1
WO2014076776A1 PCT/JP2012/079491 JP2012079491W WO2014076776A1 WO 2014076776 A1 WO2014076776 A1 WO 2014076776A1 JP 2012079491 W JP2012079491 W JP 2012079491W WO 2014076776 A1 WO2014076776 A1 WO 2014076776A1
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WO
WIPO (PCT)
Prior art keywords
balloon
linear
catheter assembly
shaft
ring
Prior art date
Application number
PCT/JP2012/079491
Other languages
French (fr)
Japanese (ja)
Inventor
柴田秀彬
石井直樹
篠田さやか
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 JP2014546768A priority Critical patent/JP5848463B2/en
Priority to PCT/JP2012/079491 priority patent/WO2014076776A1/en
Publication of WO2014076776A1 publication Critical patent/WO2014076776A1/en

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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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1038—Wrapping or folding devices for use with 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
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty

Definitions

  • the present invention relates to a catheter assembly including a balloon catheter and a balloon folding holder, and a balloon folding holding method for folding and holding a balloon of the balloon catheter.
  • the coronary artery lesion (stenosis) is spread by a balloon catheter, and other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity, and other organs are used.
  • the stenosis part formed in a living organ such as the same may be improved in the same manner.
  • a balloon catheter generally includes a long shaft and a balloon that is provided on the distal end side of the shaft and expands in the radial direction.
  • the balloon catheter is inserted into a narrowed portion in the body. Sent.
  • the balloon travels inside the blood vessel or the like in a state where the balloon is folded so that the diameter is reduced, and expands the diameter by reaching the constriction and injecting an expansion fluid into the balloon. Therefore, the balloon catheter is generally held in a state in which the balloon is folded until the balloon catheter is shipped and used for the treatment.
  • Japanese Patent Publication No. 2004-525704 discloses a folding device for folding a balloon.
  • the folding device includes a plurality of folding molds that contact the outer surface of the balloon along the entire length of the balloon, and rotates the folding molds relative to the balloon while pushing the folding molds toward the radial center of the balloon. Fold the balloon by
  • the outer surface of the balloon is covered with a metal net-like tube formed so as to be shrinkable in the radial direction, and the outer surface of the balloon is interposed through the tube. It is conceivable to bring the folding mold into contact with the surface.
  • the peripheral surface of the rotating roller is pressed against the outer surface of the balloon, so that, for example, the medicine applied to the outer surface of the DEB adheres to the peripheral surface of the rotating roller.
  • the drug is peeled off from the balloon and the function as the DEB is remarkably deteriorated, or the work of cleaning the peripheral surface of the rotating roller to which the drug is attached becomes a problem. From the viewpoint of sex, it is not preferable.
  • the drug applied to the outer surface of the DEB adheres to the inner surface of the tube, not only causing a significant decrease in the amount of drug on the balloon, but also uneven distribution of the drug on the balloon. Therefore, there is a concern that the function as the DEB is deteriorated.
  • a tube having a shape that takes into consideration the diameter of the balloon is used for each balloon to be folded, it is necessary to remove the metal-type mesh tube after the diameter reduction. The problem is that the amount is reduced and the drug distribution on the balloon is non-uniform.
  • An object of the present invention is to provide a catheter assembly and a balloon folding and holding method that can be held in a folded state.
  • the present invention provides a catheter assembly including a balloon catheter having a balloon and a balloon folding holder that holds the balloon in a folded state
  • the balloon folding holder includes: At least one linear member forming a plurality of rings surrounding the outer periphery of the balloon at a plurality of locations in the longitudinal direction of the balloon in a state where the balloon is folded, and extending along the longitudinal direction of the balloon and the balloon
  • a shaft member capable of fixing the ring that is held in a folded state.
  • the balloon can be folded with a reduced diameter by surrounding the outer periphery of the balloon with a ring formed of a linear member and contracting the diameter of the ring. That is, the balloon can be folded with only the linear member in contact with the outer surface of the balloon. For this reason, for example, compared with the case of using a folding type that contacts the entire outer surface of the balloon, the balloon can be folded with a simple configuration and the area that generates friction by contacting the outer surface of the balloon is reduced. be able to. Accordingly, the balloon can be easily folded while suppressing damage to the outer surface of the balloon.
  • the reduced diameter ring can be fixed to the shaft member, the balloon can be easily held in a folded state using the configuration used when the balloon is folded.
  • the linear member is spirally wound around an outer periphery of the balloon to form a plurality of rings, and the shaft member is wound with the balloon along with the linear member.
  • a plurality of first guide grooves along the circumferential direction are formed at intervals in the longitudinal direction and a second guide groove extending in the longitudinal direction is formed on the outer surface of the shaft member.
  • a locking portion capable of locking the linear member is formed at both ends of the shaft member, and the linear member wound around the shaft member passes through the first and second guide grooves.
  • a single linear member is spirally wound around the balloon and the shaft member, whereby a plurality of rings can be easily formed. Further, the position of the ring with respect to the balloon can be determined by the linear member passing through the first guide groove and the second guide groove. Therefore, the position where the balloon can be efficiently folded can be set by adjusting the arrangement of the first guide groove and the second guide groove.
  • the diameter of the ring is fixed by engaging the portions on both ends of the portion of the linear member that forms the ring with the locking portions of the shaft member. Accordingly, by fixing at least one of the portions locked to the locking portion of the linear member from the locking portion, the fixing of the diameters of the plurality of rings can be continuously released. For this reason, it becomes possible to easily release the balloon from the folded state.
  • the catheter assembly further includes a rod-shaped detachable member that is detachably attached to the shaft member, and the linear member surrounds the shaft member to which the detachable member is attached and the balloon.
  • the shaft member is formed in a rod shape extending along the balloon, and the detachable member is detachable on the peripheral surface of the shaft member.
  • a fitting groove that fits into the shaft member is formed over the longitudinal direction of the shaft member, and the linear member can be latched, and the latch extends from the fitting groove along the circumferential direction of the shaft member.
  • a plurality of grooves are formed at predetermined intervals along the longitudinal direction of the shaft member, and the linear member passes through the detaching member fitted in the fitting groove and is locked in the locking groove. The diameter of the ring is fixed, and the detaching member is removed from the fitting groove. At least a portion of the linear member with the bringing apart is good the balloon by desorbed from the engaging groove is released from the annulus.
  • the catheter assembly further includes a rod-shaped pressing member that is detachably attached to the shaft member, and the linear member independently forms a plurality of the rings that surround the shaft member and the balloon.
  • the shaft member is formed in a rod shape extending along the balloon, and a fitting groove into which the pressing member is detachably fitted is formed on the outer peripheral surface of the shaft member. It is formed so as to extend along the longitudinal direction of the member, and the diameter of the ring is reduced by fitting the pressing member into the fitting groove so as to press the linear member into the fitting groove. It is preferable that the fixing of the diameter of the ring is released by fixing and releasing the pressing member from the fitting groove.
  • the pressing member is disposed in the fitting groove in a state where the start point and the end point that form the ring are both disposed on the fitting groove.
  • the diameters of the plurality of rings can be fixed.
  • the diameter of the ring can be fixed by removing the pressing member from the fitting groove.
  • the fixing of the diameters of the plurality of wheels can be easily and quickly released. That is, it is possible to easily and quickly release the balloon that is folded and held.
  • the linear member includes a plurality of independently forming the plurality of rings, and the shaft member is surrounded by the ring together with the balloon, and the position of the ring with respect to the balloon is determined.
  • insertion grooves into which each of the plurality of linear members can be inserted are formed at predetermined intervals along the longitudinal direction of the fixing member so that a part of the ring crosses the hollow interior. Then, the cutting member moves along the longitudinal direction in the fixing member, so that the linear member inside the hollow is cut, and the balloon is released from the ring.
  • the linear member includes a plurality of independently forming the plurality of rings, and the shaft member includes a plurality of winding grooves each wound on one end side of the linear member.
  • a cylindrical member is formed, and the cylindrical member is formed with a slit facing the opening and extending along a longitudinal direction of the cylindrical member, and the other end side of the linear member is formed of the linear member.
  • the said ring member is formed so that the said other end side of the said linear member may extend outside the said cylindrical member through the said slit, forming the said ring
  • one end side of the linear member is wound around the winding groove, and the other end side of the linear member forms a ring surrounding the outer periphery of the balloon.
  • one end side of the linear member is further wound around the winding groove, and by rotating the shaft body in the other direction, The winding on one end side is released.
  • the ring on the other end side of the linear member is reduced in diameter as the one end side of the linear member is wound, and the diameter is increased as the winding on the one end side of the linear member is released. . Therefore, by rotating the shaft body, it is possible to adjust the diameters of a plurality of rings formed from a plurality of linear members at a time.
  • the rotational position of the shaft main body with respect to the linear member is fixed by mounting the cylindrical member on the shaft main body with the balloon folded. That is, the diameter of the ring can be fixed and the balloon can be held in a folded state.
  • the shaft main body is rotated in the other direction to expand the diameter of the plurality of rings, whereby the holding of the balloon by the plurality of rings can be easily and quickly released. That is, it is possible to easily and quickly release the balloon that is folded and held.
  • a chemical part may be formed on the outer surface of the balloon.
  • the chemical substance part may be a drug for preventing restenosis.
  • the chemical substance part can be suitably used for a balloon which is a drug for preventing restenosis, and damage to the drug on the outer surface of the balloon can be sufficiently suppressed.
  • the present invention also relates to a balloon folding and holding method for folding and holding a balloon of a balloon catheter, wherein the balloon is surrounded by a plurality of rings made of linear members, and the plurality of the rings are reduced in diameter. And a step of holding the balloon in a folded state by fixing the diameters of the plurality of reduced diameter rings.
  • the balloon can be folded with a simple configuration as compared to, for example, a folding type that contacts the entire outer surface of the balloon. And the area of contact with the outer surface of the balloon to cause friction can be reduced. Therefore, the balloon can be easily folded while suppressing damage to the outer surface of the balloon. Further, by fixing the diameter of the reduced diameter ring, the balloon can be easily held in a folded state using the configuration used when the balloon is folded.
  • the catheter assembly and the balloon folding and holding method of the present invention it is possible to fold the balloon with a simple configuration while sufficiently suppressing the occurrence of damage to the outer surface of the balloon, and easily in the folded state of the balloon. Can be held.
  • FIG. 2 is a partially enlarged perspective view in which a distal end side of the balloon catheter shown in FIG. 1 is enlarged. It is a partial expansion perspective view which shows the state where the diameter of the ring
  • FIG. 4 is a partially enlarged perspective view showing a state where a diameter of a ring of the catheter assembly shown in FIG. 3 is fixed.
  • 5A is a partial cross-sectional end view of the catheter assembly shown in FIG. 3 cut along the second guide groove, and FIG. 5B shows the catheter assembly shown in FIG. 4 cut along the second guide groove.
  • FIG. 7 is a partially enlarged perspective view showing a state where the fixation of the diameter of the ring of the catheter assembly shown in FIG. 6 is released.
  • 8A is a cross-sectional view when the catheter assembly shown in FIG. 6 is cut along the locking groove
  • FIG. 8B is a cross-sectional view when the catheter assembly shown in FIG. 7 is cut along the locking groove.
  • FIG. 9A is a partially enlarged perspective view showing a state in which the diameter of the ring is fixed in a modified example of the catheter assembly shown in FIG. 6, and FIG. 9B shows the catheter assembly shown in FIG.
  • FIG. 9A is a cross-sectional view when the catheter assembly shown in FIG. 10 is cut along the circumferential direction of the shaft member
  • FIG. 11B is a state where the fixation of the diameter of the ring of the catheter assembly of FIG. 11A is released.
  • FIG. 12A is a cross-sectional view showing a modification of the shaft member in the catheter assembly shown in FIG. 11A
  • FIG. 12B is a cross-sectional view showing a state in which the fixation of the diameter of the catheter assembly shown in FIG.
  • FIG. 12A It is released. . It is a partial expansion perspective view which shows the state by which the diameter of the ring
  • FIG. 19A is a partially enlarged perspective view showing a state in which the diameter of the ring of the catheter assembly according to the fifth embodiment is not fixed
  • FIG. 19B shows the catheter assembly shown in FIG. 19A along the winding groove.
  • 20A is a partially enlarged perspective view showing a state where the diameter of the ring of the catheter assembly shown in FIG. 19A is fixed
  • FIG. 20B is a view of the catheter assembly shown in FIG. 20A cut along the radial direction of the ring. It is sectional drawing in the case.
  • the catheter assembly according to the present invention includes a balloon catheter and a balloon folding holder that can be attached to the balloon of the balloon catheter.
  • a configuration example of the balloon catheter 10 according to the present embodiment will be described with reference to FIGS. 1 and 2.
  • FIG. 1 is a diagram showing a configuration example of a balloon catheter 10 provided in a catheter assembly according to the present invention.
  • the left side in FIG. 1 is referred to as “tip (front)”, and the right side is referred to as “base (rear end, rear)”.
  • FIG. 2 is a partially enlarged perspective view in which the distal end side of the balloon catheter 10 shown in FIG. 1 is enlarged.
  • the balloon catheter 10 is used to reach a lesioned part in a living body lumen (blood vessel or the like) and perform a predetermined treatment on the lesioned part, and a balloon provided at the distal part. It is configured as a so-called PTCA (Percutaneous Transluminal Coronary Angioplasty) balloon catheter that expands the stenosis part 12 from the inside by expanding the stenosis part 12 as a lesion part.
  • the present invention is other than such PTCA balloon catheters, for example, catheters for improving lesions formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity and other organs. It is also applicable to.
  • the balloon catheter 10 includes a thin and long shaft 14, a hub 16 provided on the proximal end side of the shaft 14, a distal end tip 18 fixed to the most distal end of the shaft 14, A balloon 12 provided in the vicinity of the distal end portion of the shaft 14 on the proximal end side of the distal end tip 18 and a chemical substance portion 20 formed on the outer surface of the balloon 12 are provided.
  • the shaft 14 is a concentric double tube having an outer tube 22 and an inner tube 23 (see FIG. 5A), and an opening 26 through which a guide wire 24 is inserted is slightly closer to the distal end side of the intermediate portion of the outer tube 22. Is provided.
  • the inner tube 23 extends through the balloon 12 and the outer tube 22 and is joined to the opening 26 in a liquid-tight manner. That is, the inner tube 23 forms a lumen through which the guide wire 24 is inserted through the opening 26. Therefore, in this balloon catheter 10, the guide wire 24 inserted with the distal end opening 18 ⁇ / b> A of the distal end tip 18 as the entrance is inserted through the lumen of the inner tube 23 from the distal end side to the proximal end side, and is led out from the opening portion 26. It is configured as a “rapid exchange type” catheter.
  • the balloon catheter 10 may be configured as an “over-the-wire type” catheter in which an opening for a guide wire is provided in the hub 16 on the proximal end side of the shaft 14.
  • the outer tube 22 is a flexible tubular member extending in the axial direction so as to connect the rear end of the balloon 12 and the tip of the hub 16. Between the outer tube 22 and the inner tube 23, a gap extending in the axial direction in the shape of a hollow cylinder and communicating with the inside of the balloon 12 is formed. This gap supplies the balloon 12 with an expansion fluid. It functions as a flow channel (expansion fluid flow channel).
  • the hub 16 is provided with a balloon expansion port 28 that communicates with the expansion fluid flow path via the hub 16 and the outer tube 22.
  • the balloon expansion port 28 can be connected to expansion fluid supply means such as an indeflator (not shown).
  • expansion fluid supply means such as an indeflator (not shown).
  • the balloon 12 contracts and expands due to changes in internal pressure. 1 shows the balloon 12 in an expanded state, and FIG. 2 shows the balloon 12 in a deflated state before being folded.
  • the balloon 12 is fixed to the shaft 14 by bonding the distal end side thereof to the outer peripheral surface of the inner tube 23 in a liquid-tight manner and bonding the proximal end side thereof to the distal end portion of the outer tube 22 by, for example, adhesion or heat fusion. Has been.
  • the chemical substance portion 20 is formed by applying a chemical substance on the outer surface of the balloon 12, for example.
  • the chemical substance include a physiologically physiologically active substance and a lubricious substance that have an effect of suppressing restenosis by attaching a stenosis portion in a living body lumen to a treated site.
  • physiological physiologically active substances include anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergic agents. , Antioxidants, GPIIbIIIa antagonists, retinoids, flavonoids, carotenoids, lipid improvers, DNA synthesis inhibitors, tyrosine kinase inhibitors, antiplatelet agents, vascular smooth muscle growth inhibitors, anti-inflammatory agents, biological materials, interferons, Examples include NO production promoting substances.
  • anticancer agent for example, vincristine sulfate, vinblastine sulfate, vindesine sulfate, irinotecan hydrochloride, paclitaxel, docetaxel hydrate, methotrexate, cyclophosphamide and the like are preferable.
  • an immunosuppressant for example, sirolimus, tacrolimus hydrate, azathioprine, cyclosporine, mycophenolate mofetil, gusperimus hydrochloride, mizoribine and the like are preferable.
  • the antibiotic more specifically, for example, mitomycin C, doxorubicin hydrochloride, actinomycin D, daunorubicin hydrochloride, idarubicin hydrochloride, pirarubicin hydrochloride, aclarubicin hydrochloride, epirubicin hydrochloride, pepromycin sulfate, dinostatin stimaramer and the like are preferable.
  • the antirheumatic agent is preferably, for example, sodium gold thiomalate, penicillamine, lobenzalit disodium or the like.
  • an antithrombotic agent for example, heparin, ticlopidine hydrochloride, hirudin and the like are preferable.
  • the antihyperlipidemic drug is preferably an HMG-CoA reductase inhibitor or probe.
  • HMG-CoA reductase inhibitor more specifically, for example, cerivastatin sodium, atorvastatin, nisvastatin, pitavastatin, fluvastatin sodium, simvastatin, lovastatin, pravastatin sodium and the like are preferable.
  • ACE inhibitor for example, quinapril hydrochloride, perindopril erbumine, trandolapril, cilazapril, temocapril hydrochloride, delapril hydrochloride, enalapril maleate, lisinopril, captopril and the like are preferable.
  • calcium antagonist for example, nifedipine, nilvadipine, diltiazem hydrochloride, benidipine hydrochloride, nisoldipine and the like are preferable.
  • tranilast is preferable as the antiallergic agent.
  • all-trans retinoic acid is preferable as the retinoid.
  • an antioxidant for example, catechins, anthocyanins, proanthocyanidins, lycopene, ⁇ -carotene and the like are preferable.
  • catechins epigallocatechin gallate is particularly preferable.
  • a tyrosine kinase inhibitor for example, genistein, tyrphostin, arbustatin and the like are preferable.
  • steroids such as dexamethasone and prednisolone and aspirin are preferable.
  • bio-derived material examples include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), and PDGF (platelet weight GF). Etc.) are preferred.
  • the chemical substance unit 20 may include only one type of the biological physiologically active substances exemplified above, or may include two or more different biological physiologically active substances. When two or more kinds of biological physiologically active substances are included, the combination may be appropriately selected from the biologically physiologically active substances exemplified above as necessary. Furthermore, in order to more efficiently transfer the biological physiologically active substance from the balloon to the treatment target site, a biological physiologically active substance layer in the form of an additive added to the biological physiologically active substance is formed. It may be.
  • the lubricating substance include, for example, fluorine resin, silicone resin, silicone oil, olive oil, glycerin, cellulose polymer substance, polyethylene oxide polymer substance, maleic anhydride polymer substance (for example, methyl vinyl ether).
  • -Maleic anhydride copolymers such as maleic anhydride copolymers
  • acrylamide polymer materials eg polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymers
  • water-soluble nylon Polyvinyl alcohol, polyvinyl pyrrolidone, and the like.
  • a catheter assembly according to the present invention includes a balloon catheter 10 formed as described above, a balloon folding holder for folding the deflated balloon 12 so as to further reduce the diameter, and holding the balloon 12 in a folded state. It has.
  • a catheter assembly 32 including the balloon catheter 10 and the balloon folding holder 30 according to the first embodiment will be described with reference to FIGS. 3, 4, 5A and 5B.
  • the balloon folding holder 30 extends along the longitudinal direction of the balloon 12 and a linear member 36 that forms a plurality of rings 34 surrounding the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12.
  • a shaft member 38 that can fix the ring 34 that holds the balloon 12 in a folded state is provided.
  • the linear member 36 is spirally wound around the outer circumference of the balloon 12 to form a plurality of rings 34.
  • Examples of the constituent material of the linear member 36 include cotton, resin, metal, and the like, but are not particularly limited thereto.
  • the shaft member 38 has a rod shape around which the linear member 36 is wound together with the balloon 12.
  • Examples of the constituent material of the shaft member 38 include resins and metals, but are not particularly limited thereto.
  • a plurality of first guide grooves 40 along the circumferential direction are formed on the outer surface of the shaft member 38 at intervals in the longitudinal direction.
  • a second guide groove 42 is formed on the outer surface of the shaft member 38 so as to cross the first guide groove 40 and extend in the longitudinal direction of the shaft member 38 and to face both end surfaces of the shaft member 38.
  • the corners are formed.
  • a chamfering process is performed on a connecting portion, which is a portion where the linear member 36 comes into contact, and thereby, a curved surface portion 43 is formed.
  • a linear member 36 is passed through the first guide groove 40 and the second guide groove 42.
  • the first guide groove 40 guides the linear member 36 in the circumferential direction of the shaft member 38
  • the second guide groove 42 guides the linear member 36 in the longitudinal direction of the shaft member 38.
  • the linear member 36 passes through the first guide groove 40 and the second guide groove 42 while contacting the curved surface portion 43, the linear member 36 is smoothly guided in the circumferential direction and the longitudinal direction. Is possible.
  • the curved surface portion 43 is formed at a location where the linear member 36 comes into contact. What is necessary is just to be provided.
  • the method of forming the curved surface portion 43 is not limited to chamfering the corner portion.
  • a molding die having a shape in which the curved surface portion 43 is formed may be used.
  • the first guide groove 40 extends from the second guide groove 42 over the entire circumferential direction of the shaft member 38.
  • the first guide groove 40 is not particularly limited to this, and the first guide groove 40 extends along the circumferential direction of the shaft member 38 to the extent that the linear member 36 can be guided in the circumferential direction. It only needs to extend on both sides.
  • a locking portion 44 that can lock the linear member 36 is formed inside the second guide groove 42 at both ends of the shaft member 38.
  • the locking portion 44 may be configured as a groove having a width slightly smaller than the diameter of the linear member 36, and the linear member 36 may be inserted into or removed from the groove.
  • the balloon 12 When the balloon 12 is folded by the balloon folding holder 30 configured as described above, first, as shown in FIGS. 3 and 5A, the contracted balloon 12 and the shaft member 38 are aligned in the longitudinal direction. After the arrangement, the linear member 36 is wound around the outer periphery from one end side to the other end side in the longitudinal direction of the balloon 12 and the shaft member 38 to form a plurality of rings 34.
  • the linear member 36 is guided in the circumferential direction by passing through the first guide groove 40, and is guided in the longitudinal direction by passing through the second guide groove 42.
  • the position of the ring 34 with respect to the balloon 12 is determined.
  • the locations (intervals) and the number of the first guide grooves 40 of the shaft member 38 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the diameter is reduced, so that the balloon 12 can be efficiently folded. Each may be adjusted so as to be possible.
  • the diameters of the plurality of rings 34 are reduced by applying tension to the both ends of the linear member 36 wound around the balloon 12 and the shaft member 38 in the direction indicated by the arrow in FIG.
  • the balloon 12 disposed inside the ring 34 can be reduced in diameter and folded.
  • the balloon 12 folded by bringing only the linear member 36 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
  • the plurality of rings 34 can be easily formed by winding one linear member 36 around the balloon 12 and the shaft member 38 in a spiral manner. Furthermore, since the position of the ring 34 with respect to the balloon 12 can be determined by the linear member 36 passing through the first guide groove 40 and the second guide groove 42, the position and number of the balloon 12 to be reduced in diameter can be selected. is there. Thereby, the balloon 12 can be efficiently folded.
  • Diameter fixation can be released continuously. For this reason, it is possible to easily release the balloon 12 from the folded and held state.
  • the balloon folding holder 46 includes a plurality of linear members 52 that independently form a plurality of rings 50 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12.
  • a shaft member 54 that can be fixed to a ring 50 that extends along the balloon 12 and that holds the balloon 12 in a folded state, and a rod-shaped detachable member 56 that is detachably attached to the shaft member 54.
  • the linear member 52 forms a ring 50 that surrounds the shaft member 54 to which the detaching member 56 is attached and the balloon 12.
  • Examples of the constituent material of the linear member 52 include those similar to the linear member 36. Hereinafter, the same material is mentioned as an example of a constituent material also about the linear members 70, 92, and 118 mentioned later.
  • the shaft member 54 has a rod shape extending along the balloon 12.
  • Examples of the constituent material of the shaft member 54 include the same materials as the shaft member 38. Hereinafter, the same material is mentioned as an example of a constituent material also about shaft members 72, 94, 120, and 126 mentioned below.
  • a fitting groove 58 into which the detachable member 56 is detachably fitted and a locking groove 62 capable of locking the linear member 52 are formed.
  • the fitting groove 58 extends in the longitudinal direction of the shaft member 54.
  • a plurality of locking grooves 62 are formed on one side in the circumferential direction of the shaft member 54 with respect to the fitting groove 58 at a predetermined interval in the longitudinal direction of the shaft member 54.
  • the predetermined interval between the plurality of sets of locking grooves 62 and the number of the locking grooves 62 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the balloon 12 is reduced in diameter, the balloon 12 is efficiently folded. It may be adjusted so that it is possible.
  • the locking groove 62 may be formed to have a width slightly smaller than the diameter of the linear member 52 so that the linear member 52 is detachably locked.
  • the deflated balloon 12 and the shaft member 54 to which the detachable member 56 is attached are arranged with their longitudinal directions aligned, and the outer periphery of the balloon 12 and the shaft member 54 is surrounded by a linear member 52.
  • both ends of the linear member 52 are fixed to the locking grooves 62.
  • the balloon 12 can be held in a folded state by forming the plurality of rings 50 by the plurality of linear members 52 and reducing the diameters of the rings 50 and fixing them.
  • the balloon 12 folded by bringing only the linear member 52 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
  • the linear member 52 locked to the locking groove 62 is detached. That is, when the detaching member 56 is detached from the fitting groove 58, the linear member 52 passing over the detaching member 56 is pushed up by the detaching member 56. Accordingly, only one of the linear members 52 locked in the locking groove 62 can be detached and the other can be kept locked in the locking groove 62.
  • the fixing of the diameters of the plurality of rings 50 can be easily and quickly released, and the balloon 12 in a folded and held state can be easily and quickly released. Furthermore, even if the fixing of the diameters of the plurality of rings 50 formed independently of each other is released, the plurality of linear members 52 can be kept fixed to the shaft member 54. That is, the plurality of linear members 52 can be prevented from dropping independently from the catheter assembly 48.
  • a plurality of the locking grooves 62 are formed in the shaft member 54.
  • the present invention is not limited to this.
  • the balloon folding holder 46 may include a locking groove 60 instead of the locking groove 62.
  • the locking groove 60 extends from the fitting groove 58 along the circumferential direction of the shaft member 54, and has a predetermined length in the longitudinal direction of the shaft member 54 on both sides in the circumferential direction of the shaft member 54 with respect to the fitting groove 58. A plurality are formed at intervals. Specifically, a set of locking grooves 60 a and 60 b provided at positions slightly shifted in the longitudinal direction of the shaft member 54 on both sides of the fitting groove 58, and a plurality of sets are spaced in the longitudinal direction of the shaft member 54. Is formed.
  • both end sides of the linear member 52 pass over the detaching member 56, and then one end side is engaged. Only the locking groove 60a is locked, and the other end is locked only to the locking groove 60b.
  • each of the linear members 52 locked to the locking groove 60 can be easily detached from the locking groove 60. That is, it is possible to easily and quickly release the fixed diameters of the plurality of rings 50 and to easily and quickly release the balloon 12 that is folded and held.
  • the balloon folding holder 112 includes a plurality of linear members 118 that independently form a plurality of rings 116 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12.
  • a shaft member 120 that can be fixed to a ring 116 that extends along the balloon 12 and that holds the balloon 12 in a folded state, and a rod-shaped pressing member 122 that is detachably attached to the shaft member 120.
  • the linear member 118 forms a ring 116 that surrounds the shaft member 120 to which the pressing member 122 is not attached and the balloon 12.
  • the shaft member 120 has a rod shape extending along the balloon 12.
  • a fitting groove 124 into which the pressing member 122 is detachably fitted is formed on the peripheral surface of the shaft member 120 so as to extend along the longitudinal direction of the shaft member 120.
  • the balloon 12 is folded and held by the balloon folding holder 112 configured as described above will be described with reference to FIGS. 10 and 11A.
  • the outer periphery of the balloon 12 and the shaft member 120 is surrounded by a linear member 118. 116 is formed.
  • the diameter of the ring 116 is then reduced until the balloon 12 is folded within the ring 116.
  • a plurality of rings 116 are formed at predetermined intervals in the longitudinal direction of the shaft member 120 to reduce the diameter of the rings 116.
  • the pressing member 122 is fitted into the fitting groove 124 in a state where the start point portion and the end point portion forming the respective rings 116 are both arranged on the fitting groove 124. Accordingly, the diameters of the plurality of rings 116 can be fixed and the balloon 12 can be held in a folded state.
  • the balloon 12 folded by bringing only the linear member 118 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
  • the fixing of the diameters of the plurality of rings 116 can be released by removing the pressing member 122 from the fitting groove 124. For this reason, it becomes possible to release the balloon 12 easily and quickly from the folded and held state.
  • the balloon folding holder 112 includes the shaft member 120.
  • the present invention is not limited to this.
  • the balloon folding holder 112 may include a shaft member 126 instead of the shaft member 120.
  • the shaft member 126 has a locking groove extending from the fitting groove 124 along the circumferential direction on one side of the shaft member 126 in the circumferential direction with respect to the fitting groove 124. 128 is formed. Note that the locking grooves 128 may be formed at locations surrounded by the plurality of rings 116 of the shaft member 126, respectively.
  • the ring 116 is formed in a state where one end side of the linear member 118 is locked in the locking groove 128.
  • the diameter of the ring 116 is fixed by fitting the pressing member 122 into the fitting groove 124 in a state where one end side of the linear member 118 is fixed to the shaft member 126. Can do. Therefore, as shown in FIG. 12B, even if the pressing member 122 is detached from the fitting groove 124 and the fixing of the diameters of the plurality of rings 116 is released, only one end side of the plurality of linear members 118 is a shaft member. 126 can be kept fixed. That is, the plurality of linear members 118 can be prevented from dropping independently from the catheter assembly 114.
  • FIG. 1 A catheter assembly 88 including the balloon catheter 10 and the balloon folding holder 86 according to the fourth embodiment will be described with reference to FIGS. 13 to 16, FIGS. 17A, 17B, and 18.
  • FIG. The balloon folding holder 86 includes a plurality of linear members 92 that independently form a plurality of rings 90 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. And a shaft member 94 that can be fixed to a ring 90 that extends along the balloon 12 and holds the balloon 12 in a folded state.
  • both ends of the linear member 92 are connected by a knot (not shown) or bonding with an adhesive, and the diameter of the ring 90 is fixed.
  • the shaft member 94 includes a hollow cylindrical fixing member 96 that is surrounded by the ring 90 together with the balloon 12 and fixes the position of the ring 90 with respect to the balloon 12, and a cutting member 98 that can be inserted into the fixing member 96. .
  • the fixing member 96 communicates between the hollow interior and the exterior, and a plurality of insertion grooves 100 that can be inserted so that a part of the ring 90 crosses the hollow interior have a predetermined interval along the longitudinal direction of the fixing member 96. Is formed.
  • the predetermined interval between the plurality of insertion grooves 100 and the number of the insertion grooves 100 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the diameter is reduced, the balloon 12 is efficiently folded. It is only necessary to adjust so as to be possible.
  • the cutting member 98 has a bar shape in which a notch 102 is formed at one end, as shown in FIG.
  • a set of cutting blades 104 capable of cutting the linear member 92 is provided inside the notch 102.
  • Each of the pair of cutting blades 104 is disposed such that the cutting edge faces in the insertion direction of the cutting member 98 with respect to the fixing member 96. Further, when the cutting member 98 is inserted through the fixing member 96, the cutting edge contacts a linear member 92 (a part of the ring 90) that traverses the inside of the fixing member 96 through the insertion groove 100.
  • the cutting blade 104 by providing the cutting blade 104 inside the notch 102, it is possible to prevent the cutting blade 104 from contacting other than the linear member 92.
  • the deflated balloon 12 and the fixing member 96 are arranged with their longitudinal directions aligned, and then the outer periphery of the balloon 12 and the fixing member 96 is surrounded by a linear member 92 to form a ring 90.
  • the ring 90 is formed so that the linear member 92 passes through the insertion groove 100. Then, after the diameter of the ring 90 is reduced until the balloon 12 is folded in the ring 90, both ends of the linear member 92 are joined to fix the diameter of the ring 90.
  • the balloon 12 can be held in a folded state by forming a plurality of rings 90 with the plurality of linear members 92 and reducing the diameters of the rings 90 and fixing them.
  • the balloon 12 folded by bringing only the linear member 92 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
  • the ring 90 inserted into the insertion groove 100 traverses the hollow interior of the fixing member 96. For this reason, when the cutting member 98 is inserted into the inside of the fixed member 96 from the side where the notch 102 is provided, the cutting blade 104 comes into contact with the linear member 92, thereby cutting the linear member 92. be able to.
  • the fixing of the diameters of the plurality of rings 90 can be easily and quickly released, and the balloon 12 in a folded and held state can be easily and quickly released.
  • the cutting member 98 is inserted from the proximal end side of the fixing member 96 attached to the balloon 12, but the cutting member 98 may be inserted from the distal end side of the fixing member 96.
  • the shaft member 94 includes the cutting member 98 having the pair of cutting blades 104 provided in the notch 102, but the present invention is particularly limited thereto. Is not to be done.
  • the shaft member 94 may include a cutting member 106 shown in FIG. 16 instead of the cutting member 98.
  • the cutting member 98 is inserted into the fixing member 96 when releasing the fixing of the diameter of the ring 90.
  • the cutting member 106 is surrounded by the ring 90 together with the balloon 12 while being accommodated in advance in the fixing member 96. Then, when releasing the fixing of the diameter of the ring 90, the ring 90 is pulled out from the inside of the fixing member 96.
  • the cutting member 106 has a rod shape longer than the length of the fixing member 96 in the longitudinal direction, and a cutting blade holding portion 110 that holds the cutting blade 108 that cuts the linear member 92 is formed on one end side.
  • the extending portion 111 extends from the cutting edge holding portion 110 toward the other end side.
  • the cutting blade 108 is arranged so as to extend from the cutting blade holding portion 110 toward the other end side of the cutting member 106 with the cutting edge directed.
  • the length of the extending portion 111 in the radial direction is configured to be shorter than the length of the insertion groove 100 in the radial direction. This prevents the extension 111 from contacting the wheel 90 when the cutting member 106 is accommodated in the fixing member 96.
  • the cutting member 106 is inserted into the fixed member 96 from the extending portion 111 side.
  • the cutting blade 108 contacts the most proximal end ring 90 in the fixing member 96.
  • the cutting member 106 and the fixing member 96 are fixed by, for example, an adhesive tape (not shown) at a position where the extending portion 111 protrudes from the opening on the distal end side of the fixing member 96.
  • the cutting member 106 may be inserted through the opening on the distal end side of the fixing member 96.
  • the cutting blade 108 is not in contact with the most distal end ring 90 in the fixing member 96 and the extending portion 111 protrudes from the opening on the proximal end side of the fixing member 96 as in the above case.
  • the cutting member 106 and the fixing member 96 may be fixed.
  • the shape of the insertion groove 100 may be formed as shown in FIG. That is, the insertion groove 100 has a groove width that decreases from one side to the other side in the transverse direction of the ring 90 in the fixing member 96 so that the minimum groove width is slightly smaller than the diameter of the linear member 92. May be formed.
  • the linear member 92 can be locked to the groove width portion where the insertion groove 100 is the smallest, so that the plurality of linear members 92 are cut in order to release the fixing of the diameters of the plurality of rings 90.
  • the one end side of the cut linear member 92 can be kept fixed to the fixing member 96. That is, the plurality of linear members 92 can be prevented from dropping independently from the catheter assembly 88.
  • the balloon folding holder 64 includes a plurality of linear members 70 that independently form a plurality of rings 68 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. And a shaft member 72 that can be fixed to a ring 68 that extends along the balloon 12 and holds the balloon 12 in a folded state.
  • the shaft member 72 has a shaft main body 74 and a cylindrical member 76 that is detachably attached to the shaft main body 74.
  • a plurality of winding grooves 78 around which one end sides of the plurality of linear members 70 are respectively wound are formed on the peripheral surface of the shaft main body 74 along the longitudinal direction of the shaft member 72 at a predetermined interval.
  • the predetermined interval between the plurality of winding grooves 78 and the number of the winding grooves 78 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the balloon 12 is reduced in diameter, the balloon 12 can be efficiently used. What is necessary is just to adjust so that it can fold.
  • the cylindrical member 76 has an opening 80 into which the shaft main body 74 can be inserted at one end in the longitudinal direction, and a slit 82 that faces the opening 80 and extends along the longitudinal direction of the cylindrical member 76.
  • One end side of the linear member 70 is wound around the winding groove 78, and the other end side of the linear member 70 forms a ring 68 that surrounds the outer periphery of the balloon 12.
  • the shaft body 74 By rotating the shaft body 74 in one direction (winding direction of the linear member 70), one end side of the linear member 70 is further wound around the winding groove 78.
  • the shaft main body 74 By rotating the shaft main body 74 in the other direction, the winding on the one end side of the linear member 70 is released.
  • the ring 68 on the other end side of the linear member 70 is reduced in diameter as the one end side of the linear member 70 is wound, and the winding on the one end side of the linear member 70 is released.
  • an insertion ring 84 through which the linear member 70 itself is inserted is formed at the other end of the linear member 70. After one end of the linear member 70 is inserted through the insertion wheel 84 in advance, one end side of the linear member 70 is wound around the winding groove 78.
  • a ring 68 is formed on the other end side of the linear member 70.
  • the diameter of the ring 68 can be adjusted by moving one end side of the linear member 70 with respect to the insertion wheel 84, that is, by rotating the shaft main body 74. .
  • FIGS. 19A and 19B by adjusting the amount by which the linear member 70 is wound around the winding groove 78, the diameter of the ring 68 is adjusted, and the inside of the ring 68 is adjusted.
  • the balloon 12 deflated is inserted.
  • the shaft body 74 is rotated in one direction (the arrow direction in FIG. 19B) to reduce the diameter of the ring 68, and the balloon 12 is folded.
  • the balloon 12 folded by bringing only the linear member 70 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
  • the plurality of rings 68 can be reduced in diameter by rotating the shaft body 74 in one direction. For this reason, the balloon 12 can be efficiently folded. Furthermore, by attaching the cylindrical member 76 to the shaft main body 74 in a state where the balloon 12 is folded, the diameters of the plurality of rings 68 can be fixed and the balloon 12 can be held in a folded state.
  • the cylindrical member 76 attached to the shaft main body 74 is detached from the shaft main body 74, and then the shaft main body 74 is rotated in the other direction, thereby expanding the plurality of rings 68. Can do. Thereby, the holding of the balloon 12 by the plurality of rings 68 can be easily and quickly released. That is, the balloon 12 in a folded and held state can be easily and quickly released.
  • the balloon folding holding method according to the present embodiment can be carried out using the balloon folding holding tools 30, 46, 64, 86, and 112 configured as described above.
  • the process of folding the balloon 12 of the balloon catheter 10 and holding the balloon 12 in a folded state using the balloon folding holder 30 will be described as an example.
  • the balloon folding and holding method according to the present embodiment can be suitably applied not only to the balloon 12 of the balloon catheter 10 but also to balloons of various balloon catheters.
  • the outer periphery of the balloon 12 is surrounded by a plurality of rings 34 made of a linear member 36, the diameter of the plurality of rings 34 is reduced to fold the balloon 12, and the plurality of reduced diameter rings 34. And fixing the balloon 12 in a folded state.
  • the balloon 12 is folded by bringing only the linear member 36 into contact with the outer surface of the balloon 12, for example, compared to the case of using a folding type that contacts the entire outer surface of the balloon 12, etc.
  • the area where the balloon 12 can be folded and brought into contact with the outer surface of the balloon 12 to generate friction can be reduced. Therefore, the balloon 12 can be easily folded while suppressing damage to the outer surface of the balloon 12.
  • the ring 34 having a reduced diameter can be fixed to the shaft member 38, the balloon 12 can be easily held in a folded state using the configuration used when the balloon 12 is folded.
  • the chemical substance portion 20 made of a physiologically physiologically active substance having an effect of suppressing restenosis by attaching the stenosis portion in the ecological lumen to the treated site on the outer surface of the balloon 12.
  • the present invention is not particularly limited to this, and even a balloon in which the chemical substance portion 20 is not formed on the outer surface can be folded and held while sufficiently preventing damage to the outer surface of the balloon. Is possible.

Abstract

The present invention relates to a catheter assembly (32, 48, 66, 88, 114) and a balloon folding and holding method. This catheter assembly (32, 48, 66, 88, 114) is provided with a balloon catheter (10) having a balloon (12) and also with a balloon folding and holding device (30, 46, 64, 86, 112). The balloon folding and holding device (30, 46, 64, 86, 112) has: at least one linear member (36, 52, 70, 92, 118) for forming rings (34, 50, 68, 90, 116) which, with the balloon (12) folded, surround the outer periphery of the balloon (12) at multiple positions in the longitudinal direction of the balloon (12); and a shaft member (38, 54, 72, 94, 120, 126) extending in the longitudinal direction of the balloon (12) and enabling the rings (34, 50, 68, 90, 116) which hold the balloon (12) in the folded state to be affixed thereto.

Description

カテーテル組立体及びバルーン折り畳み保持方法Catheter assembly and balloon folding and holding method
　本発明は、バルーンカテーテルとバルーン折り畳み保持具とを備えたカテーテル組立体及びバルーンカテーテルのバルーンを折り畳んで保持するバルーン折り畳み保持方法に関する。 The present invention relates to a catheter assembly including a balloon catheter and a balloon folding holder, and a balloon folding holding method for folding and holding a balloon of the balloon catheter.
　例えば、心筋梗塞や狭心症の治療では、冠動脈の病変部（狭窄部）をバルーンカテーテルによって押し広げる方法が行われており、他の血管、胆管、気管、食道、尿道、鼻腔、その他の臓器等の生体器官内に形成された狭窄部の改善についても同様に行われることがある。 For example, in the treatment of myocardial infarction and angina, the coronary artery lesion (stenosis) is spread by a balloon catheter, and other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity, and other organs are used. The stenosis part formed in a living organ such as the same may be improved in the same manner.
　バルーンカテーテルは、一般的に長尺なシャフトと、このシャフトの先端側に設けられて径方向に拡張するバルーンとを備えて構成され、先行するガイドワイヤが挿通されることで体内の狭窄部へと送られる。この際、バルーンは、径が縮小するように折り畳まれた状態で血管等の内部を走行し、狭窄部に到達した後にバルーンの内部に拡張用流体が注入されることによって径を拡張させる。従って、バルーンカテーテルは、例えば出荷されて施術に使用されるまでの間、バルーンを折り畳んだ状態で保持されることが一般的である。 A balloon catheter generally includes a long shaft and a balloon that is provided on the distal end side of the shaft and expands in the radial direction. By inserting a preceding guide wire, the balloon catheter is inserted into a narrowed portion in the body. Sent. At this time, the balloon travels inside the blood vessel or the like in a state where the balloon is folded so that the diameter is reduced, and expands the diameter by reaching the constriction and injecting an expansion fluid into the balloon. Therefore, the balloon catheter is generally held in a state in which the balloon is folded until the balloon catheter is shipped and used for the treatment.
　特表２００４－５２５７０４号公報には、バルーンを折り畳むための折り畳み装置が開示されている。この折り畳み装置は、バルーンの全長に沿って、該バルーンの外表面に接触する複数の折り畳み型を備え、該折り畳み型をそれぞれバルーンの径方向の中心に向かって押し込みつつ、バルーンに対して回転させることによってバルーンを折り畳む。 Japanese Patent Publication No. 2004-525704 discloses a folding device for folding a balloon. The folding device includes a plurality of folding molds that contact the outer surface of the balloon along the entire length of the balloon, and rotates the folding molds relative to the balloon while pushing the folding molds toward the radial center of the balloon. Fold the balloon by
　しかしながら、このようにバルーンの外表面に対して折り畳み型を接触させた状態で回転させると、バルーンの外表面と折り畳み型との間に生じる摩擦によって、バルーンの外表面が損傷する懸念がある。 However, if the folding mold is rotated in contact with the outer surface of the balloon as described above, there is a concern that the outer surface of the balloon is damaged due to friction generated between the outer surface of the balloon and the folding mold.
　特に、再狭窄を予防する効果のある薬剤が外表面にコーティングされた、薬剤溶出性バルーン（ＤＥＢ：Ｄｒｕｇ　Ｅｌｕｔｉｎｇ　Ｂａｌｌｏｏｎ）等を上記の折り畳み装置を用いて折り畳む場合、バルーンの外表面と折り畳み型との間に生じる摩擦によって、薬剤のコーティングが剥がれてしまう懸念がある。 In particular, when a drug-eluting balloon (DEB: Drug Eluting Ballon) or the like coated on the outer surface with a drug that has the effect of preventing restenosis is folded using the above folding device, the outer surface of the balloon and the folding type There is a concern that the drug coating may be peeled off due to friction generated during
　そこで、バルーンの外表面に生じる摩擦を低減させるため、例えば特開２００６－２７１６７８号公報にて提案されたように、バルーンの外表面に回転ローラを押し当ててバルーンを折り畳むことが考えられる。 Therefore, in order to reduce the friction generated on the outer surface of the balloon, for example, as proposed in Japanese Patent Laid-Open No. 2006-271678, it is conceivable to fold the balloon by pressing a rotating roller against the outer surface of the balloon.
　また、折り畳み型とバルーンの外表面との接触面積を縮小させるため、例えば径方向に収縮可能に形成された金属製の網状のチューブでバルーンの外表面を覆い、該チューブを介してバルーンの外表面に折り畳み型を接触させることが考えられる。 Further, in order to reduce the contact area between the folding mold and the outer surface of the balloon, for example, the outer surface of the balloon is covered with a metal net-like tube formed so as to be shrinkable in the radial direction, and the outer surface of the balloon is interposed through the tube. It is conceivable to bring the folding mold into contact with the surface.
　ところが、上記の特開２００６－２７１６７８号公報記載の構成では、バルーンの外表面に回転ローラの周面が押し当てられるため、例えばＤＥＢの外表面に塗布された薬剤が回転ローラの周面に付着する可能性がある。この場合、例えば、薬剤がバルーンから剥離し、ＤＥＢとしての機能が著しく低下することや、薬剤の付着した回転ローラの周面を清掃する作業等が余分に必要になること等が問題となり、安全性の観点からも好ましくない。 However, in the configuration described in Japanese Patent Application Laid-Open No. 2006-271678, the peripheral surface of the rotating roller is pressed against the outer surface of the balloon, so that, for example, the medicine applied to the outer surface of the DEB adheres to the peripheral surface of the rotating roller. there's a possibility that. In this case, for example, the drug is peeled off from the balloon and the function as the DEB is remarkably deteriorated, or the work of cleaning the peripheral surface of the rotating roller to which the drug is attached becomes a problem. From the viewpoint of sex, it is not preferable.
　また、上記のチューブを用いる場合、ＤＥＢの外表面に塗布された薬剤がチューブの内面に付着してしまい、バルーン上の薬剤量の著しい減少を招くだけでなく、バルーン上の薬剤分布も不均一となることからＤＥＢとしての機能が低下してしまうことが懸念される。また、折り畳むバルーンごとに、バルーンの径等を考慮した形状のチューブを用いる場合には、縮径した後の金属型の網状チューブを取り外す必要があり、その際、上記したようなバルーン上の薬剤量の減少、バルーン上の薬剤分布が不均一になるといったことが問題となる。 In addition, when the above tube is used, the drug applied to the outer surface of the DEB adheres to the inner surface of the tube, not only causing a significant decrease in the amount of drug on the balloon, but also uneven distribution of the drug on the balloon. Therefore, there is a concern that the function as the DEB is deteriorated. In addition, when a tube having a shape that takes into consideration the diameter of the balloon is used for each balloon to be folded, it is necessary to remove the metal-type mesh tube after the diameter reduction. The problem is that the amount is reduced and the drug distribution on the balloon is non-uniform.
　本発明は、このような課題を考慮してなされたものであり、バルーンの外表面や、該外表面に形成された化学物質部に損傷が生じることを十分に抑制しつつ簡易な構成で折り畳むことができ、且つバルーンを折り畳んだ状態で容易に保持することが可能なカテーテル組立体及びバルーン折り畳み保持方法を提供することを目的とする。 The present invention has been made in consideration of such problems, and can be folded with a simple configuration while sufficiently suppressing the occurrence of damage to the outer surface of the balloon and the chemical substance portion formed on the outer surface. An object of the present invention is to provide a catheter assembly and a balloon folding and holding method that can be held in a folded state.
　上記の目的を達成するため、本発明は、バルーンを有するバルーンカテーテルと、前記バルーンを折り畳んだ状態で保持するバルーン折り畳み保持具とを備えたカテーテル組立体であって、前記バルーン折り畳み保持具は、前記バルーンを折り畳んだ状態で前記バルーンの長手方向の複数箇所で前記バルーンの外周を囲む複数の輪を形成する少なくとも１つの線状部材と、前記バルーンの長手方向に沿って延在し且つ前記バルーンを折り畳み状態に保持した前記輪を固定可能な軸部材と、を有することを特徴とする。 In order to achieve the above object, the present invention provides a catheter assembly including a balloon catheter having a balloon and a balloon folding holder that holds the balloon in a folded state, and the balloon folding holder includes: At least one linear member forming a plurality of rings surrounding the outer periphery of the balloon at a plurality of locations in the longitudinal direction of the balloon in a state where the balloon is folded, and extending along the longitudinal direction of the balloon and the balloon And a shaft member capable of fixing the ring that is held in a folded state.
　本発明の構成によれば、バルーンの外周を線状部材で形成した輪で囲み、該輪の径を収縮させることによって、バルーンを縮径させて折り畳むことができる。すなわち、線状部材のみをバルーンの外表面に接触させてバルーンを折り畳むことができる。このため、例えばバルーンの外表面全体に接触する折り畳み型等を用いる場合に比して、簡易な構成でバルーンを折り畳むことができ且つバルーンの外表面に接触して摩擦を生じさせる面積を縮小することができる。従って、バルーンの外表面が損傷することを抑制しつつ、容易にバルーンを折り畳むことができる。 According to the configuration of the present invention, the balloon can be folded with a reduced diameter by surrounding the outer periphery of the balloon with a ring formed of a linear member and contracting the diameter of the ring. That is, the balloon can be folded with only the linear member in contact with the outer surface of the balloon. For this reason, for example, compared with the case of using a folding type that contacts the entire outer surface of the balloon, the balloon can be folded with a simple configuration and the area that generates friction by contacting the outer surface of the balloon is reduced. be able to. Accordingly, the balloon can be easily folded while suppressing damage to the outer surface of the balloon.
　また、縮径させた輪を軸部材に固定することができるため、バルーンを折り畳む際に使用した構成を用いてバルーンを折り畳んだ状態で容易に保持することができる。 In addition, since the reduced diameter ring can be fixed to the shaft member, the balloon can be easily held in a folded state using the configuration used when the balloon is folded.
　上記のカテーテル組立体において、前記線状部材は、前記バルーンの外周に螺旋状に巻回されることで複数の前記輪を形成し、前記軸部材は、前記バルーンとともに前記線状部材が巻回される棒形状であり、前記軸部材の外面には周方向に沿う複数の第１案内溝が長手方向に間隔をおいて形成されるとともに、該長手方向に延在する第２案内溝が形成され、前記軸部材の両端部には前記線状部材を係止可能な係止部が形成され、前記軸部材に巻回された前記線状部材は、前記第１及び第２案内溝を通ることで前記バルーンに対する前記輪の位置が定められ、且つ前記線状部材のうち複数の前記輪を形成する部分よりも両端側の部分がそれぞれ前記係止部に係止されることで前記輪の径が固定されるとよい。 In the catheter assembly, the linear member is spirally wound around an outer periphery of the balloon to form a plurality of rings, and the shaft member is wound with the balloon along with the linear member. A plurality of first guide grooves along the circumferential direction are formed at intervals in the longitudinal direction and a second guide groove extending in the longitudinal direction is formed on the outer surface of the shaft member. A locking portion capable of locking the linear member is formed at both ends of the shaft member, and the linear member wound around the shaft member passes through the first and second guide grooves. Thus, the position of the ring with respect to the balloon is determined, and the portions of the linear member that are on both ends of the plurality of the ring forming portions are locked to the locking portions. The diameter should be fixed.
　上記の構成によれば、１つの線状部材がバルーン及び軸部材に螺旋状に巻回されることによって、複数の輪を容易に形成することが可能となる。また、線状部材が第１案内溝及び第２案内溝を通ることによって、バルーンに対する輪の位置を定めることができる。従って、第１案内溝及び第２案内溝の配置を調整することによって、バルーンを効率的に折り畳むことが可能な位置を設定することができる。 According to the above configuration, a single linear member is spirally wound around the balloon and the shaft member, whereby a plurality of rings can be easily formed. Further, the position of the ring with respect to the balloon can be determined by the linear member passing through the first guide groove and the second guide groove. Therefore, the position where the balloon can be efficiently folded can be set by adjusting the arrangement of the first guide groove and the second guide groove.
　さらに、１つの線状部材の輪を形成する部分よりも両端側の部分がそれぞれ軸部材の係止部に係止されて、輪の径が固定されている。従って、線状部材の係止部に係止された部分のうち、少なくとも一方を係止部から脱離させることによって、複数の輪の径の固定を連続的に解放することができる。このため、バルーンを折り畳まれて保持された状態から容易に解放することが可能となる。 Furthermore, the diameter of the ring is fixed by engaging the portions on both ends of the portion of the linear member that forms the ring with the locking portions of the shaft member. Accordingly, by fixing at least one of the portions locked to the locking portion of the linear member from the locking portion, the fixing of the diameters of the plurality of rings can be continuously released. For this reason, it becomes possible to easily release the balloon from the folded state.
　上記のカテーテル組立体において、前記軸部材に着脱自在に装着される棒形状の脱離部材をさらに備え、前記線状部材は、前記脱離部材が装着された前記軸部材と前記バルーンとを囲む複数の前記輪をそれぞれ独立に形成する複数から構成され、前記軸部材は、前記バルーンに沿って延在する棒形状に形成され、前記軸部材の周面には、前記脱離部材が着脱自在に嵌合する嵌合溝が前記軸部材の長手方向に亘って形成され、且つ前記線状部材を係止可能であり前記嵌合溝から前記軸部材の周方向に沿って延在する係止溝が前記軸部材の長手方向に沿って所定の間隔をおいて複数形成され、前記線状部材が、前記嵌合溝に嵌合した前記脱離部材上を通って前記係止溝に係止されることで前記輪の径が固定され、前記脱離部材を前記嵌合溝から脱離させることに伴って前記線状部材の少なくとも一部が前記係止溝から脱離することで前記バルーンが前記輪内から解放されるとよい。 The catheter assembly further includes a rod-shaped detachable member that is detachably attached to the shaft member, and the linear member surrounds the shaft member to which the detachable member is attached and the balloon. The shaft member is formed in a rod shape extending along the balloon, and the detachable member is detachable on the peripheral surface of the shaft member. A fitting groove that fits into the shaft member is formed over the longitudinal direction of the shaft member, and the linear member can be latched, and the latch extends from the fitting groove along the circumferential direction of the shaft member. A plurality of grooves are formed at predetermined intervals along the longitudinal direction of the shaft member, and the linear member passes through the detaching member fitted in the fitting groove and is locked in the locking groove. The diameter of the ring is fixed, and the detaching member is removed from the fitting groove. At least a portion of the linear member with the bringing apart is good the balloon by desorbed from the engaging groove is released from the annulus.
　上記の構成によれば、嵌合溝から脱離部材を脱離させる際、脱離部材上を通る線状部材が脱離部材によって押し上げられる。これによって、係止溝に係止された線状部材のそれぞれを、係止溝から脱離させることができるため、複数の輪の径の固定を容易且つ速やかに解放することができる。すなわち、折り畳まれて保持された状態のバルーンを容易且つ速やかに解放することが可能となる。 According to the above configuration, when the detaching member is detached from the fitting groove, the linear member passing over the detaching member is pushed up by the detaching member. Accordingly, each of the linear members locked in the locking grooves can be detached from the locking grooves, so that the fixing of the diameters of the plurality of rings can be easily and quickly released. That is, it is possible to easily and quickly release the balloon that is folded and held.
　上記のカテーテル組立体において、前記軸部材に着脱自在に装着される棒形状の押圧部材をさらに備え、前記線状部材は、前記軸部材と前記バルーンとを囲む複数の前記輪をそれぞれ独立に形成する複数から構成され、前記軸部材は、前記バルーンに沿って延在する棒形状に形成され、前記軸部材の外周面には、前記押圧部材が着脱自在に嵌合する嵌合溝が前記軸部材の長手方向に沿って延在するように形成され、前記線状部材を前記嵌合溝内に押圧するように前記押圧部材が前記嵌合溝に嵌合することで、前記輪の径を固定し、前記押圧部材が前記嵌合溝から脱離することで、前記輪の径の固定が解放されるとよい。 The catheter assembly further includes a rod-shaped pressing member that is detachably attached to the shaft member, and the linear member independently forms a plurality of the rings that surround the shaft member and the balloon. The shaft member is formed in a rod shape extending along the balloon, and a fitting groove into which the pressing member is detachably fitted is formed on the outer peripheral surface of the shaft member. It is formed so as to extend along the longitudinal direction of the member, and the diameter of the ring is reduced by fitting the pressing member into the fitting groove so as to press the linear member into the fitting groove. It is preferable that the fixing of the diameter of the ring is released by fixing and releasing the pressing member from the fitting groove.
　上記の構成によれば、複数の輪を独立に形成する複数の線状部材それぞれについて、輪を形成する始点と終点とがともに嵌合溝上に配置された状態で、嵌合溝に押圧部材を嵌合することで、複数の輪の径をそれぞれ固定することができる。 According to the above configuration, for each of the plurality of linear members that independently form the plurality of rings, the pressing member is disposed in the fitting groove in a state where the start point and the end point that form the ring are both disposed on the fitting groove. By fitting, the diameters of the plurality of rings can be fixed.
　また、嵌合溝から押圧部材を脱離することで、輪の径の固定を解放することができる。これによって、複数の輪の径の固定を容易且つ速やかに解放することができる。すなわち、折り畳まれて保持された状態のバルーンを容易且つ速やかに解放することが可能となる。 Also, the diameter of the ring can be fixed by removing the pressing member from the fitting groove. As a result, the fixing of the diameters of the plurality of wheels can be easily and quickly released. That is, it is possible to easily and quickly release the balloon that is folded and held.
　上記のカテーテル組立体において、前記線状部材は、複数の前記輪をそれぞれ独立に形成する複数から構成され、前記軸部材は、前記バルーンとともに前記輪に囲まれ且つ前記バルーンに対する前記輪の位置を固定する中空筒形状の固定部材と、前記線状部材を切断可能な切刃を有し且つ前記固定部材の内部に挿通可能な切断部材とを備え、前記固定部材は、中空の内部と外部とを連通し、前記輪の一部が前記中空の内部を横断するように複数の前記線状部材の各々を挿入可能な挿入溝が前記固定部材の長手方向に沿って所定の間隔をおいて形成され、前記固定部材内を長手方向に沿って前記切断部材が移動することで、前記中空の内部の前記線状部材が切断されて、前記バルーンが前記輪内から解放されるとよい。 In the above catheter assembly, the linear member includes a plurality of independently forming the plurality of rings, and the shaft member is surrounded by the ring together with the balloon, and the position of the ring with respect to the balloon is determined. A fixing member having a hollow cylindrical shape to be fixed, and a cutting member having a cutting blade capable of cutting the linear member and capable of being inserted into the fixing member; and the fixing member includes a hollow interior and an exterior. And insertion grooves into which each of the plurality of linear members can be inserted are formed at predetermined intervals along the longitudinal direction of the fixing member so that a part of the ring crosses the hollow interior. Then, the cutting member moves along the longitudinal direction in the fixing member, so that the linear member inside the hollow is cut, and the balloon is released from the ring.
　上記の構成によれば、複数の線状部材によって形成された複数の輪がそれぞれ縮径した状態で、該輪の一部が中空筒形状の固定部材の挿入溝に挿入され、固定部材の中空の内部を横断する。これによって、固定部材の内部に切断部材を挿通すると、該切断部材に備えられる切刃が線状部材に当接するため、線状部材を切断することができる。すなわち、固定部材の中空内に、切断部材を挿通することによって、複数の輪の径の固定を容易且つ速やかに解放することができる。このため、折り畳まれて保持された状態のバルーンを容易且つ速やかに解放することが可能となる。 According to the above configuration, in a state in which the plurality of rings formed by the plurality of linear members are respectively reduced in diameter, a part of the ring is inserted into the insertion groove of the hollow cylindrical fixing member, and the fixing member is hollow. Cross the inside of. Accordingly, when the cutting member is inserted into the fixing member, the cutting blade provided in the cutting member comes into contact with the linear member, so that the linear member can be cut. In other words, by inserting the cutting member into the hollow of the fixing member, the fixing of the diameters of the plurality of rings can be easily and quickly released. For this reason, it becomes possible to release the balloon in a folded and held state easily and quickly.
　上記のカテーテル組立体において、前記線状部材は、複数の前記輪をそれぞれ独立に形成する複数から構成され、前記軸部材は、前記線状部材の一端側がそれぞれ巻回される複数の巻回溝が前記軸部材の長手方向に沿って所定の間隔をおいて形成された軸本体と、長手方向の一端に前記軸本体が挿入可能な開口部を有し、前記軸本体に着脱可能に装着される筒部材とを備え、前記筒部材は、前記開口部に臨み且つ前記筒部材の長手方向に沿って延在するスリットが形成され、前記線状部材の他端側は、前記線状部材の一端側を前記軸部材に巻回することで縮径する前記輪を形成し、前記スリットを介して前記線状部材の他端側が前記筒部材の外部へ延出するように前記筒部材を前記軸本体に装着することで、前記線状部材の他端側に形成される前記輪の径を固定するとよい。 In the catheter assembly, the linear member includes a plurality of independently forming the plurality of rings, and the shaft member includes a plurality of winding grooves each wound on one end side of the linear member. Has a shaft body formed at a predetermined interval along the longitudinal direction of the shaft member, and has an opening into which the shaft body can be inserted at one end in the longitudinal direction, and is detachably attached to the shaft body. A cylindrical member is formed, and the cylindrical member is formed with a slit facing the opening and extending along a longitudinal direction of the cylindrical member, and the other end side of the linear member is formed of the linear member. The said ring member is formed so that the said other end side of the said linear member may extend outside the said cylindrical member through the said slit, forming the said ring | wheel which is diameter-reduced by winding one end side around the said shaft member. By attaching to the shaft body, it is formed on the other end side of the linear member. It may fix the diameter of the wheel that.
　上記の構成によれば、線状部材の一端側が巻回溝に巻回されており、該線状部材の他端側がバルーンの外周を囲む輪を形成している。そして、軸本体を一方の方向（巻回方向）に回転させることで、線状部材の一端側が巻回溝にさらに巻回され、軸本体を他方の方向に回転させることで、線状部材の一端側の巻回が解かれる。また、線状部材の他端側の輪は、線状部材の一端側が巻回されることに伴って縮径し、線状部材の一端側の巻回が解かれることに伴って拡径する。従って、軸本体を回転させることによって、複数の線状部材から形成された複数の輪の径を一度に調節することが可能となる。 According to the above configuration, one end side of the linear member is wound around the winding groove, and the other end side of the linear member forms a ring surrounding the outer periphery of the balloon. And by rotating the shaft body in one direction (winding direction), one end side of the linear member is further wound around the winding groove, and by rotating the shaft body in the other direction, The winding on one end side is released. Further, the ring on the other end side of the linear member is reduced in diameter as the one end side of the linear member is wound, and the diameter is increased as the winding on the one end side of the linear member is released. . Therefore, by rotating the shaft body, it is possible to adjust the diameters of a plurality of rings formed from a plurality of linear members at a time.
　このため、軸本体を一方の方向に回転させて、複数の輪を縮径させることによって、効率的にバルーンを折り畳むことが可能となる。さらに、バルーンを折り畳んだ状態で、軸本体に筒部材を装着することによって、線状部材に対する軸本体の回転位置が固定される。すなわち、輪の径を固定し、バルーンを折り畳んだ状態で保持することができる。 Therefore, it is possible to efficiently fold the balloon by rotating the shaft body in one direction and reducing the diameter of the plurality of rings. Furthermore, the rotational position of the shaft main body with respect to the linear member is fixed by mounting the cylindrical member on the shaft main body with the balloon folded. That is, the diameter of the ring can be fixed and the balloon can be held in a folded state.
　また、軸本体から筒部材を取り外した後、軸本体を他方向に回転させて、複数の輪を拡径させることによって、複数の輪によるバルーンの保持を容易且つ速やかに解放することができる。すなわち、折り畳まれて保持された状態のバルーンを容易且つ速やかに解放することが可能となる。 In addition, after removing the cylindrical member from the shaft main body, the shaft main body is rotated in the other direction to expand the diameter of the plurality of rings, whereby the holding of the balloon by the plurality of rings can be easily and quickly released. That is, it is possible to easily and quickly release the balloon that is folded and held.
　上記のカテーテル組立体において、前記バルーンの外表面に化学物質部が形成されていてもよい。また、前記化学物質部は、再狭窄を予防する薬剤であってもよい。 In the above catheter assembly, a chemical part may be formed on the outer surface of the balloon. The chemical substance part may be a drug for preventing restenosis.
　上記の構成によれば、バルーンを折り畳む際に、バルーンの外表面に接触して摩擦を生じさせる面積を縮小することができる。従って、バルーンの外表面に化学物質部が形成されている場合であっても、化学物質部を損傷することによるバルーン上の化学物質量の減少、分布の不均一性が生じることを十分に抑制できる。このため、例えば、化学物質部が再狭窄を予防する薬剤であるバルーンに対しても好適に用いることができ、バルーン外表面の薬剤が損傷することを十分に抑制可能である。 According to the above configuration, when the balloon is folded, the area that contacts the outer surface of the balloon and causes friction can be reduced. Therefore, even when the chemical substance part is formed on the outer surface of the balloon, the amount of chemical substance on the balloon due to damage to the chemical substance part and the uneven distribution are sufficiently suppressed. it can. Therefore, for example, the chemical substance part can be suitably used for a balloon which is a drug for preventing restenosis, and damage to the drug on the outer surface of the balloon can be sufficiently suppressed.
　また、本発明は、バルーンカテーテルのバルーンを折り畳んで保持するバルーン折り畳み保持方法であって、前記バルーンの外周を線状部材からなる複数の輪で囲み、複数の前記輪を縮径させて前記バルーンを折り畳む工程と、縮径させた複数の前記輪の径を固定して前記バルーンを折り畳んだ状態で保持する工程と、を備えることを特徴とする。 The present invention also relates to a balloon folding and holding method for folding and holding a balloon of a balloon catheter, wherein the balloon is surrounded by a plurality of rings made of linear members, and the plurality of the rings are reduced in diameter. And a step of holding the balloon in a folded state by fixing the diameters of the plurality of reduced diameter rings.
　このように、線状部材のみをバルーンの外表面に接触させてバルーンを折り畳むため、例えばバルーンの外表面全体に接触する折り畳み型等を用いる場合に比して、簡易な構成でバルーンを折り畳むことができ且つバルーンの外表面に接触して摩擦を生じさせる面積を縮小することができる。従って、バルーンの外表面が損傷することを抑制しつつ容易にバルーンを折り畳むことができる。また、縮径させた輪の径を固定することによって、バルーンを折り畳む際に使用した構成を用いてバルーンを折り畳んだ状態で容易に保持することができる。 In this way, only the linear member is brought into contact with the outer surface of the balloon to fold the balloon, so that the balloon can be folded with a simple configuration as compared to, for example, a folding type that contacts the entire outer surface of the balloon. And the area of contact with the outer surface of the balloon to cause friction can be reduced. Therefore, the balloon can be easily folded while suppressing damage to the outer surface of the balloon. Further, by fixing the diameter of the reduced diameter ring, the balloon can be easily held in a folded state using the configuration used when the balloon is folded.
　本発明のカテーテル組立体及びバルーン折り畳み保持方法によれば、バルーンの外表面に損傷が生じることを十分に抑制しつつ簡易な構成でバルーンを折り畳むことができ、且つバルーンを折り畳んだ状態で容易に保持することができる。 According to the catheter assembly and the balloon folding and holding method of the present invention, it is possible to fold the balloon with a simple configuration while sufficiently suppressing the occurrence of damage to the outer surface of the balloon, and easily in the folded state of the balloon. Can be held.
本発明に係るカテーテル組立体に備えられるバルーンカテーテルの構成例を示す図である。It is a figure which shows the structural example of the balloon catheter with which the catheter assembly which concerns on this invention is equipped. 図１に示すバルーンカテーテルの先端側を拡大した部分拡大斜視図である。FIG. 2 is a partially enlarged perspective view in which a distal end side of the balloon catheter shown in FIG. 1 is enlarged. 第１の実施形態に係るカテーテル組立体の輪の径が固定されていない状態を示す部分拡大斜視図である。It is a partial expansion perspective view which shows the state where the diameter of the ring | wheel of the catheter assembly which concerns on 1st Embodiment is not being fixed. 図３に示すカテーテル組立体の輪の径が固定された状態を示す部分拡大斜視図である。FIG. 4 is a partially enlarged perspective view showing a state where a diameter of a ring of the catheter assembly shown in FIG. 3 is fixed. 図５Ａは、図３に示すカテーテル組立体を第２案内溝に沿って切断した場合の部分断面端面図であり、図５Ｂは、図４に示すカテーテル組立体を第２案内溝に沿って切断した場合の部分断面端面図である。5A is a partial cross-sectional end view of the catheter assembly shown in FIG. 3 cut along the second guide groove, and FIG. 5B shows the catheter assembly shown in FIG. 4 cut along the second guide groove. FIG. 第２の実施形態に係るカテーテル組立体の輪の径が固定された状態を示す部分拡大斜視図である。It is a partial expansion perspective view which shows the state by which the diameter of the ring | wheel of the catheter assembly which concerns on 2nd Embodiment was fixed. 図６に示すカテーテル組立体の輪の径の固定が解放された状態を示す部分拡大斜視図である。FIG. 7 is a partially enlarged perspective view showing a state where the fixation of the diameter of the ring of the catheter assembly shown in FIG. 6 is released. 図８Ａは、図６に示すカテーテル組立体を係止溝に沿って切断した場合の断面図であり、図８Ｂは、図７に示すカテーテル組立体を係止溝に沿って切断した場合の断面図である。8A is a cross-sectional view when the catheter assembly shown in FIG. 6 is cut along the locking groove, and FIG. 8B is a cross-sectional view when the catheter assembly shown in FIG. 7 is cut along the locking groove. FIG. 図９Ａは、図６に示すカテーテル組立体の変形例について輪の径が固定された状態を示す部分拡大斜視図であり、図９Ｂは、図９Ａに示すカテーテル組立体を係止溝に沿って切断した場合の断面図である。FIG. 9A is a partially enlarged perspective view showing a state in which the diameter of the ring is fixed in a modified example of the catheter assembly shown in FIG. 6, and FIG. 9B shows the catheter assembly shown in FIG. 9A along the locking groove. It is sectional drawing at the time of cut | disconnecting. 第３の実施形態に係るカテーテル組立体の輪の径が固定された状態を示す部分拡大斜視図である。It is a partial expansion perspective view which shows the state by which the diameter of the ring | wheel of the catheter assembly which concerns on 3rd Embodiment was fixed. 図１１Ａは、図１０に示すカテーテル組立体を軸部材の周方向に沿って切断した場合の断面図であり、図１１Ｂは、図１１Ａのカテーテル組立体の輪の径の固定が解放された状態を示す断面図である。11A is a cross-sectional view when the catheter assembly shown in FIG. 10 is cut along the circumferential direction of the shaft member, and FIG. 11B is a state where the fixation of the diameter of the ring of the catheter assembly of FIG. 11A is released. FIG. 図１２Ａは、図１１Ａに示すカテーテル組立体における軸部材の変形例を示す断面図であり、図１２Ｂは、図１２Ａに示すカテーテル組立体の径の固定が解放された状態を示す断面図である。12A is a cross-sectional view showing a modification of the shaft member in the catheter assembly shown in FIG. 11A, and FIG. 12B is a cross-sectional view showing a state in which the fixation of the diameter of the catheter assembly shown in FIG. 12A is released. . 第４の実施形態に係るカテーテル組立体の輪の径が固定された状態を示す部分拡大斜視図である。It is a partial expansion perspective view which shows the state by which the diameter of the ring | wheel of the catheter assembly which concerns on 4th Embodiment was fixed. 図１３に示すカテーテル組立体の切断部材の部分拡大斜視図である。It is a partial expansion perspective view of the cutting member of the catheter assembly shown in FIG. 図１３に示すカテーテル組立体の輪の径の固定を解放する様子を示す部分拡大斜視図である。It is a partial expansion perspective view which shows a mode that the fixation of the diameter of the ring | wheel of the catheter assembly shown in FIG. 13 is released. 図１３に示すカテーテル組立体における切断部材の変形例を示す斜視図である。It is a perspective view which shows the modification of the cutting member in the catheter assembly shown in FIG. 図１７Ａは、図１６に示す切断部材を固定部材の内部に収容した状態を示す斜視図であり、図１７Ｂは、図１６に示す切断部材によって、輪の径の固定を解放する様子を示す部分拡大斜視図である。17A is a perspective view showing a state in which the cutting member shown in FIG. 16 is housed in the fixing member, and FIG. 17B is a part showing a state in which fixing of the diameter of the ring is released by the cutting member shown in FIG. It is an expansion perspective view. 図１３に示すカテーテル組立体における固定部材の変形例を示す部分平面図である。It is a partial top view which shows the modification of the fixing member in the catheter assembly shown in FIG. 図１９Ａは、第５の実施形態に係るカテーテル組立体の輪の径が固定されていない状態を示す部分拡大斜視図であり、図１９Ｂは、図１９Ａに示すカテーテル組立体を巻回溝に沿って切断した場合の筒部材を除く断面図である。FIG. 19A is a partially enlarged perspective view showing a state in which the diameter of the ring of the catheter assembly according to the fifth embodiment is not fixed, and FIG. 19B shows the catheter assembly shown in FIG. 19A along the winding groove. It is sectional drawing except a cylindrical member at the time of cut | disconnecting. 図２０Ａは、図１９Ａに示すカテーテル組立体の輪の径が固定された状態を示す部分拡大斜視図であり、図２０Ｂは、図２０Ａに示すカテーテル組立体を輪の径方向に沿って切断した場合の断面図である。20A is a partially enlarged perspective view showing a state where the diameter of the ring of the catheter assembly shown in FIG. 19A is fixed, and FIG. 20B is a view of the catheter assembly shown in FIG. 20A cut along the radial direction of the ring. It is sectional drawing in the case.
　以下、本発明に係るカテーテル組立体及びバルーン折り畳み保持方法について好適な実施形態を挙げ、添付の図面を参照しながら説明する。 Hereinafter, preferred embodiments of the catheter assembly and the balloon folding and holding method according to the present invention will be described with reference to the accompanying drawings.
　本発明に係るカテーテル組立体は、バルーンカテーテルと、バルーンカテーテルのバルーンに装着可能なバルーン折り畳み保持具とを備えている。そこで、先ず、図１及び図２を参照しつつ、本実施形態に係るバルーンカテーテル１０の構成例について説明する。 The catheter assembly according to the present invention includes a balloon catheter and a balloon folding holder that can be attached to the balloon of the balloon catheter. First, a configuration example of the balloon catheter 10 according to the present embodiment will be described with reference to FIGS. 1 and 2.
　図１は、本発明に係るカテーテル組立体に備えられるバルーンカテーテル１０の構成例を示す図である。なお、以下の説明では、バルーンカテーテル１０並びにそれらの構成要素に関し、図１中の左側を「先端（前方）」、右側を「基端（後端、後方）」という。また、図２は、図１に示すバルーンカテーテル１０の先端側を拡大した部分拡大斜視図である。 FIG. 1 is a diagram showing a configuration example of a balloon catheter 10 provided in a catheter assembly according to the present invention. In the following description, regarding the balloon catheter 10 and components thereof, the left side in FIG. 1 is referred to as “tip (front)”, and the right side is referred to as “base (rear end, rear)”. FIG. 2 is a partially enlarged perspective view in which the distal end side of the balloon catheter 10 shown in FIG. 1 is enlarged.
　バルーンカテーテル１０は、生体管腔（血管等）内の病変部に先端部を到達させ、当該病変部に対して所定の処置を施すために使用されるものであり、先端部に設けられたバルーン１２を病変部である狭窄部で拡張させることで当該狭窄部を内側から押し広げて治療する、いわゆるＰＴＣＡ（Ｐｅｒｃｕｔａｎｅｏｕｓ　Ｔｒａｎｓｌｕｍｉｎａｌ　Ｃｏｒｏｎａｒｙ　Ａｎｇｉｏｐｌａｓｔｙ：経皮経管冠動脈形成術）バルーンカテーテルとして構成されている。本発明は、このようなＰＴＣＡバルーンカテーテル以外のもの、例えば、他の血管、胆管、気管、食道、尿道、鼻腔、その他の臓器等の生体器官内に形成された病変部の改善のためのカテーテルにも適用可能である。 The balloon catheter 10 is used to reach a lesioned part in a living body lumen (blood vessel or the like) and perform a predetermined treatment on the lesioned part, and a balloon provided at the distal part. It is configured as a so-called PTCA (Percutaneous Transluminal Coronary Angioplasty) balloon catheter that expands the stenosis part 12 from the inside by expanding the stenosis part 12 as a lesion part. The present invention is other than such PTCA balloon catheters, for example, catheters for improving lesions formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity and other organs. It is also applicable to.
　図１に示すように、バルーンカテーテル１０は、細径で長尺なシャフト１４と、シャフト１４の基端側に設けられたハブ１６と、シャフト１４の最先端に固着された先端チップ１８と、先端チップ１８の基端側でシャフト１４の先端部近傍に設けられたバルーン１２と、バルーン１２の外表面に形成された化学物質部２０とを備える。 As shown in FIG. 1, the balloon catheter 10 includes a thin and long shaft 14, a hub 16 provided on the proximal end side of the shaft 14, a distal end tip 18 fixed to the most distal end of the shaft 14, A balloon 12 provided in the vicinity of the distal end portion of the shaft 14 on the proximal end side of the distal end tip 18 and a chemical substance portion 20 formed on the outer surface of the balloon 12 are provided.
　シャフト１４は、外管２２と内管２３（図５Ａ参照）とを有する同心二重管であり、外管２２の中間部のやや先端側寄りには、ガイドワイヤ２４が挿通される開口部２６が設けられている。 The shaft 14 is a concentric double tube having an outer tube 22 and an inner tube 23 (see FIG. 5A), and an opening 26 through which a guide wire 24 is inserted is slightly closer to the distal end side of the intermediate portion of the outer tube 22. Is provided.
　内管２３は、バルーン１２及び外管２２内を延在し、開口部２６に液密に接合されている。すなわち、内管２３は、開口部２６を介して内部にガイドワイヤ２４が挿通されるルーメンを形成する。従って、このバルーンカテーテル１０では、先端チップ１８の先端開口部１８Ａを入口として挿入されたガイドワイヤ２４が、内管２３のルーメンを先端側から基端側へと挿通され、開口部２６から導出される「ラピッドエクスチェンジタイプ」のカテーテルとして構成されている。 The inner tube 23 extends through the balloon 12 and the outer tube 22 and is joined to the opening 26 in a liquid-tight manner. That is, the inner tube 23 forms a lumen through which the guide wire 24 is inserted through the opening 26. Therefore, in this balloon catheter 10, the guide wire 24 inserted with the distal end opening 18 </ b> A of the distal end tip 18 as the entrance is inserted through the lumen of the inner tube 23 from the distal end side to the proximal end side, and is led out from the opening portion 26. It is configured as a “rapid exchange type” catheter.
　なお、バルーンカテーテル１０は、シャフト１４の基端側のハブ１６にガイドワイヤ用の開口部を設けた「オーバーザワイヤタイプ」のカテーテルとして構成されてもよい。 The balloon catheter 10 may be configured as an “over-the-wire type” catheter in which an opening for a guide wire is provided in the hub 16 on the proximal end side of the shaft 14.
　外管２２は、バルーン１２の後端とハブ１６の先端とを連結するように軸方向に延在する可撓性を有する管状部材である。外管２２と内管２３との間には、中空円筒状に軸方向に延在し、バルーン１２の内部と連通する隙間が形成され、この隙間が、バルーン１２に拡張用流体を供給するための流路（拡張用流体流路）として機能する。 The outer tube 22 is a flexible tubular member extending in the axial direction so as to connect the rear end of the balloon 12 and the tip of the hub 16. Between the outer tube 22 and the inner tube 23, a gap extending in the axial direction in the shape of a hollow cylinder and communicating with the inside of the balloon 12 is formed. This gap supplies the balloon 12 with an expansion fluid. It functions as a flow channel (expansion fluid flow channel).
　ハブ１６には、該ハブ１６及び外管２２を介して、前記拡張用流体流路に連通するバルーン拡張用ポート２８が設けられている。バルーン拡張用ポート２８は、図示しないインデフレータ等の拡張用流体供給手段を接続することが可能である。バルーン拡張用ポート２８に拡張用流体供給手段を接続して該手段を作動させることで、ハブ１６及び外管２２内を介してバルーン１２まで拡張用流体（例えば生理食塩水）を送液することが可能になっている。 The hub 16 is provided with a balloon expansion port 28 that communicates with the expansion fluid flow path via the hub 16 and the outer tube 22. The balloon expansion port 28 can be connected to expansion fluid supply means such as an indeflator (not shown). By connecting an expansion fluid supply means to the balloon expansion port 28 and operating the means, the expansion fluid (for example, physiological saline) is sent to the balloon 12 through the hub 16 and the outer tube 22. Is possible.
　バルーン１２は、内圧の変化により収縮及び拡張する。なお、図１では、拡張状態のバルーン１２を示し、図２では、折り畳む前の収縮状態のバルーン１２を示す。バルーン１２は、例えば接着や熱融着によって、先端側が内管２３の外周面に液密に接合され、基端側が外管２２の先端部に液密に接合されることで、シャフト１４に固着されている。 The balloon 12 contracts and expands due to changes in internal pressure. 1 shows the balloon 12 in an expanded state, and FIG. 2 shows the balloon 12 in a deflated state before being folded. The balloon 12 is fixed to the shaft 14 by bonding the distal end side thereof to the outer peripheral surface of the inner tube 23 in a liquid-tight manner and bonding the proximal end side thereof to the distal end portion of the outer tube 22 by, for example, adhesion or heat fusion. Has been.
　化学物質部２０は、例えばバルーン１２の外表面に化学物質が塗布されることで形成される。化学物質としては、生体管腔内の狭窄部を治療した部位に付着させることで再狭窄を抑制する効果を有する生理学的生理活性物質や潤滑性物質が挙げられる。 The chemical substance portion 20 is formed by applying a chemical substance on the outer surface of the balloon 12, for example. Examples of the chemical substance include a physiologically physiologically active substance and a lubricious substance that have an effect of suppressing restenosis by attaching a stenosis portion in a living body lumen to a treated site.
　生理学的生理活性物質の具体例としては、抗癌剤、免疫抑制剤、抗生物質、抗リウマチ剤、抗血栓薬、抗高脂血症薬、ＡＣＥ阻害剤、カルシウム拮抗剤、インテグリン阻害薬、抗アレルギー剤、抗酸化剤、ＧＰIIｂIIIａ拮抗薬、レチノイド、フラボノイド、カロチノイド、脂質改善薬、ＤＮＡ合成阻害剤、チロシンキナーゼ阻害剤、抗血小板薬、血管平滑筋増殖抑制薬、抗炎症剤、生体由来材料、インターフェロン、ＮＯ産生促進物質等が挙げられる。 Specific examples of physiological physiologically active substances include anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergic agents. , Antioxidants, GPIIbIIIa antagonists, retinoids, flavonoids, carotenoids, lipid improvers, DNA synthesis inhibitors, tyrosine kinase inhibitors, antiplatelet agents, vascular smooth muscle growth inhibitors, anti-inflammatory agents, biological materials, interferons, Examples include NO production promoting substances.
　抗癌剤としては、より具体的には、例えば硫酸ビンクリスチン、硫酸ビンブラスチン、硫酸ビンデシン、塩酸イリノテカン、パクリタキセル、ドセタキセル水和物、メトトレキサート、シクロフォスファミド等が好ましい。免疫抑制剤としては、より具体的には、例えば、シロリムス、タクロリムス水和物、アザチオプリン、シクロスポリン、ミコフェノール酸モフェチル、塩酸グスペリムス、ミゾリビン等が好ましい。 More specifically, as the anticancer agent, for example, vincristine sulfate, vinblastine sulfate, vindesine sulfate, irinotecan hydrochloride, paclitaxel, docetaxel hydrate, methotrexate, cyclophosphamide and the like are preferable. More specifically, as an immunosuppressant, for example, sirolimus, tacrolimus hydrate, azathioprine, cyclosporine, mycophenolate mofetil, gusperimus hydrochloride, mizoribine and the like are preferable.
　抗生物質としては、より具体的には、例えば、マイトマイシンＣ、塩酸ドキソルビシン、アクチノマイシンＤ、塩酸ダウノルビシン、塩酸イダルビシン、塩酸ピラルビシン、塩酸アクラルビシン、塩酸エピルビシン、硫酸ペプロマイシン、ジノスタチンスチマラマー等が好ましい。抗リウマチ剤としては、より具体的には、例えば、金チオリンゴ酸ナトリウム、ペニシラミン、ロベンザリット二ナトリウム等が好ましい。抗血栓薬としては、より具体的には、例えば、へパリン、塩酸チクロピジン、ヒルジン等が好ましい。 As the antibiotic, more specifically, for example, mitomycin C, doxorubicin hydrochloride, actinomycin D, daunorubicin hydrochloride, idarubicin hydrochloride, pirarubicin hydrochloride, aclarubicin hydrochloride, epirubicin hydrochloride, pepromycin sulfate, dinostatin stimaramer and the like are preferable. More specifically, the antirheumatic agent is preferably, for example, sodium gold thiomalate, penicillamine, lobenzalit disodium or the like. More specifically, as an antithrombotic agent, for example, heparin, ticlopidine hydrochloride, hirudin and the like are preferable.
　抗高脂血症薬としては、より具体的にはＨＭＧ－ＣｏＡ還元酵素阻害剤やプロブユールが好ましい。そして、ＨＭＧ－ＣｏＡ還元酵素阻害剤としては、より具体的には、例えば、セリバスタチンナトリウム、アトルバスタチン、ニスバスタチン、ピタバスタチン、フルバスタチンナトリウム、シンバスタチン、ロバスタチン、プラバスタチンナトリウム等が好ましい。 More specifically, the antihyperlipidemic drug is preferably an HMG-CoA reductase inhibitor or probe. As the HMG-CoA reductase inhibitor, more specifically, for example, cerivastatin sodium, atorvastatin, nisvastatin, pitavastatin, fluvastatin sodium, simvastatin, lovastatin, pravastatin sodium and the like are preferable.
　ＡＣＥ阻害剤としては、より具体的には、例えば、塩酸キナプリル、ペリンドプリルエルブミン、トランドラプリル、シラザプリル、塩酸テモカプリル、塩酸デラプリル、マレイン酸エナラプリル、リシノプリル、カプトプリル等が好ましい。カルシウム拮抗剤としては、より具体的には、例えば、ニフェジピン、ニルバジピン、塩酸ジルチアゼム、塩酸ベニジピン、ニソルジピン等が好ましい。抗アレルギー剤としては、より具体的には、例えば、トラニラストが好ましい。 More specifically, as the ACE inhibitor, for example, quinapril hydrochloride, perindopril erbumine, trandolapril, cilazapril, temocapril hydrochloride, delapril hydrochloride, enalapril maleate, lisinopril, captopril and the like are preferable. More specifically, as the calcium antagonist, for example, nifedipine, nilvadipine, diltiazem hydrochloride, benidipine hydrochloride, nisoldipine and the like are preferable. More specifically, for example, tranilast is preferable as the antiallergic agent.
　レチノイドとしては、より具体的には、例えば、オールトランスレチノイン酸が好ましい。抗酸化剤としては、より具体的には、例えば、カテキン類、アントシアニン、プロアントシアニジン、リコピン、β－カロチン等が好ましい。カテキン類の中では、エピガロカテキンガレートが特に好ましい。チロシンキナーゼ阻害剤としては、より具体的には、例えば、ゲニステイン、チルフォスチン、アーブスタチン等が好ましい。抗炎症剤としては、より具体的には、例えば、デキサメタゾン、プレドニゾロン等のステロイドやアスピリンが好ましい。 More specifically, for example, all-trans retinoic acid is preferable as the retinoid. More specifically, as an antioxidant, for example, catechins, anthocyanins, proanthocyanidins, lycopene, β-carotene and the like are preferable. Among catechins, epigallocatechin gallate is particularly preferable. More specifically, as a tyrosine kinase inhibitor, for example, genistein, tyrphostin, arbustatin and the like are preferable. More specifically, as an anti-inflammatory agent, for example, steroids such as dexamethasone and prednisolone and aspirin are preferable.
　生体由来材料としては、より具体的には、例えば、ＥＧＦ（ｅｐｉｄｅｒｍａｌ　ｇｒｏｗｔｈ　ｆａｃｔｏｒ）、ＶＥＧＦ（ｖａｓｃｕｌａｒ　ｅｎｄｏｔｈｅｌｉａｌ　ｇｒｏｗｔｈ　ｆａｃｔｏｒ）、ＨＧＦ(ｈｅｐａｔｏｃｙｔｅ　ｇｒｏｗｔｈ　ｆａｃｔｏｒ)、ＰＤＧＦ（ｐｌａｔｅｌｅｔ　ｄｅｒｉｖｅｄ　ｇｒｏｗｔｈ　ｆａｃｔｏｒ）、ＢＦＧＦ（ｂａｓｉｃ　ｆｉｂｒｏｂｌａｓｔ　ｇｒｏｗｔｈ　ｆａｃｔｏｒ）等が好ましい。 More specifically, examples of the bio-derived material include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), and PDGF (platelet weight GF). Etc.) are preferred.
　化学物質部２０は、上記例示した生物学的生理活性物質のうち、一種類のみを含んでもよく、又は二種類以上の異なる生物学的生理活性物質を含んでもよい。二種類以上の生物学的生理活性物質を含む場合、その組み合わせは上記例示した生物学的生理活性物質から必要に応じて適宜選択すればよい。さらに、生物学的生理活性物質をより効率的にバルーン上から治療対象部位へと移行させるため、生物学的生理活性物質に添加物が加えられた形態の生物学的生理活性物質層を形成していてもよい。 The chemical substance unit 20 may include only one type of the biological physiologically active substances exemplified above, or may include two or more different biological physiologically active substances. When two or more kinds of biological physiologically active substances are included, the combination may be appropriately selected from the biologically physiologically active substances exemplified above as necessary. Furthermore, in order to more efficiently transfer the biological physiologically active substance from the balloon to the treatment target site, a biological physiologically active substance layer in the form of an additive added to the biological physiologically active substance is formed. It may be.
　潤滑性物質の具体例としては、例えば、フッ素樹脂やシリコーン樹脂、シリコーンオイル、オリーブオイル、グリセリン、セルロース系高分子物質、ポリエチレンオキサイド系高分子物質、無水マレイン酸系高分子物質（例えば、メチルビニルエーテル－無水マレイン酸共重合体のような無水マレイン酸共重合体）、アクリルアミド系高分子物質（例えば、ポリアクリルアミド、ポリグリシジルメタクリレート－ジメチルアクリルアミド（ＰＧＭＡ－ＤＭＡＡ）のブロック共重合体）、水溶性ナイロン、ポリビニルアルコール、ポリビニルピロリドン、等が挙げられる。 Specific examples of the lubricating substance include, for example, fluorine resin, silicone resin, silicone oil, olive oil, glycerin, cellulose polymer substance, polyethylene oxide polymer substance, maleic anhydride polymer substance (for example, methyl vinyl ether). -Maleic anhydride copolymers such as maleic anhydride copolymers), acrylamide polymer materials (eg polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymers), water-soluble nylon , Polyvinyl alcohol, polyvinyl pyrrolidone, and the like.
　本発明に係るカテーテル組立体は、上記のように形成されたバルーンカテーテル１０と、収縮させたバルーン１２をさらに縮径させるように折り畳み、且つバルーン１２を折り畳んだ状態で保持するバルーン折り畳み保持具とを備えている。 A catheter assembly according to the present invention includes a balloon catheter 10 formed as described above, a balloon folding holder for folding the deflated balloon 12 so as to further reduce the diameter, and holding the balloon 12 in a folded state. It has.
＜第１の実施形態＞
　図３、図４、図５Ａ及び図５Ｂを参照しつつ、上記のバルーンカテーテル１０と、第１の実施形態に係るバルーン折り畳み保持具３０とを備えるカテーテル組立体３２について説明する。バルーン折り畳み保持具３０は、収縮したバルーン１２の外周を、該バルーン１２の長手方向の複数箇所で囲む複数の輪３４を形成する線状部材３６と、バルーン１２の長手方向に沿って延在し且つバルーン１２を折り畳んだ状態に保持した輪３４を固定可能な軸部材３８とを有している。 <First Embodiment>
A catheter assembly 32 including the balloon catheter 10 and the balloon folding holder 30 according to the first embodiment will be described with reference to FIGS. 3, 4, 5A and 5B. The balloon folding holder 30 extends along the longitudinal direction of the balloon 12 and a linear member 36 that forms a plurality of rings 34 surrounding the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12. A shaft member 38 that can fix the ring 34 that holds the balloon 12 in a folded state is provided.
　線状部材３６は、バルーン１２の外周に螺旋状に巻回されることで複数の輪３４を形成する。線状部材３６の構成材料としては、木綿、樹脂、金属等が挙げられるが、特にこれらに限定されるものではない。 The linear member 36 is spirally wound around the outer circumference of the balloon 12 to form a plurality of rings 34. Examples of the constituent material of the linear member 36 include cotton, resin, metal, and the like, but are not particularly limited thereto.
　軸部材３８は、バルーン１２とともに線状部材３６が巻回される棒形状である。軸部材３８の構成材料としては、樹脂、金属等が挙げられるが、特にこれらに限定されるものではない。軸部材３８の外面には周方向に沿う複数の第１案内溝４０が長手方向に間隔をおいて形成されている。また、軸部材３８の外面には、第１案内溝４０と交わって軸部材３８の長手方向に延在し、且つ該軸部材３８の両端面に臨む第２案内溝４２が形成されている。 The shaft member 38 has a rod shape around which the linear member 36 is wound together with the balloon 12. Examples of the constituent material of the shaft member 38 include resins and metals, but are not particularly limited thereto. A plurality of first guide grooves 40 along the circumferential direction are formed on the outer surface of the shaft member 38 at intervals in the longitudinal direction. A second guide groove 42 is formed on the outer surface of the shaft member 38 so as to cross the first guide groove 40 and extend in the longitudinal direction of the shaft member 38 and to face both end surfaces of the shaft member 38.
　軸部材３８の外面のうち、第１案内溝４０及び第２案内溝４２が交差することによって形成される角部（第１案内溝４０の内側面と、第２案内溝４２の内側面とをつなぐ部分であって、線状部材３６が接触する部分）は、例えば面取り加工され、これによって、曲面部４３が形成されている。後述するように、第１案内溝４０及び第２案内溝４２の内部には線状部材３６が通される。これによって、第１案内溝４０は、線状部材３６を軸部材３８の周方向に案内し、第２案内溝４２は、線状部材３６を軸部材３８の長手方向に案内する。この際、線状部材３６は曲面部４３に接触しつつ、第１案内溝４０及び第２案内溝４２内を通るため、線状部材３６を上記の周方向及び長手方向に円滑に案内することが可能となる。 Of the outer surface of the shaft member 38, the corners (the inner surface of the first guide groove 40 and the inner surface of the second guide groove 42 formed by the first guide groove 40 and the second guide groove 42 intersecting each other) are formed. For example, a chamfering process is performed on a connecting portion, which is a portion where the linear member 36 comes into contact, and thereby, a curved surface portion 43 is formed. As will be described later, a linear member 36 is passed through the first guide groove 40 and the second guide groove 42. Thus, the first guide groove 40 guides the linear member 36 in the circumferential direction of the shaft member 38, and the second guide groove 42 guides the linear member 36 in the longitudinal direction of the shaft member 38. At this time, since the linear member 36 passes through the first guide groove 40 and the second guide groove 42 while contacting the curved surface portion 43, the linear member 36 is smoothly guided in the circumferential direction and the longitudinal direction. Is possible.
　なお、上記の角部がすべて面取り加工される必要はなく、軸部材３８に線状部材３６を巻回する際に、該線状部材３６が接触することとなる箇所に対して曲面部４３が設けられればよい。また、曲面部４３を形成する方法は、上記の角部を面取り加工することに限定されない。例えば、樹脂を射出成形して軸部材３８を形成する場合には、曲面部４３が形成されるような形状の成形型を用いてもよい。 In addition, it is not necessary to chamfer all the corners described above, and when the linear member 36 is wound around the shaft member 38, the curved surface portion 43 is formed at a location where the linear member 36 comes into contact. What is necessary is just to be provided. The method of forming the curved surface portion 43 is not limited to chamfering the corner portion. For example, when the shaft member 38 is formed by injection molding of a resin, a molding die having a shape in which the curved surface portion 43 is formed may be used.
　また、図３～図５Ａ及び図５Ｂの例示では、第１案内溝４０が、第２案内溝４２から、軸部材３８の周方向全体に亘って延在している。しかしながら、特にこれに限定されるものではなく、第１案内溝４０は、線状部材３６を周方向に案内することが可能な程度、軸部材３８の周方向に沿って、第２案内溝４２の両側に延在していればよい。 3 to 5A and 5B, the first guide groove 40 extends from the second guide groove 42 over the entire circumferential direction of the shaft member 38. However, the first guide groove 40 is not particularly limited to this, and the first guide groove 40 extends along the circumferential direction of the shaft member 38 to the extent that the linear member 36 can be guided in the circumferential direction. It only needs to extend on both sides.
　また、軸部材３８の両端の第２案内溝４２の内部には、線状部材３６を係止可能な係止部４４が形成されている。係止部４４は、例えば、線状部材３６の径よりもわずかに小さい幅の溝として構成され、この溝に対して線状部材３６を挿入又は脱離可能であることとしてもよい。 In addition, a locking portion 44 that can lock the linear member 36 is formed inside the second guide groove 42 at both ends of the shaft member 38. For example, the locking portion 44 may be configured as a groove having a width slightly smaller than the diameter of the linear member 36, and the linear member 36 may be inserted into or removed from the groove.
　上記のように構成されたバルーン折り畳み保持具３０によって、バルーン１２を折り畳む場合、先ず、図３及び図５Ａに示すように、収縮させたバルーン１２と軸部材３８とを互いの長手方向を揃えて並べた後、該バルーン１２及び軸部材３８の長手方向の一端側から他端側にかけて外周に線状部材３６を巻回し、複数の輪３４を形成する。 When the balloon 12 is folded by the balloon folding holder 30 configured as described above, first, as shown in FIGS. 3 and 5A, the contracted balloon 12 and the shaft member 38 are aligned in the longitudinal direction. After the arrangement, the linear member 36 is wound around the outer periphery from one end side to the other end side in the longitudinal direction of the balloon 12 and the shaft member 38 to form a plurality of rings 34.
　この際、線状部材３６は、第１案内溝４０を通ることによって周方向に案内され、第２案内溝４２を通ることによって長手方向に案内される。これによって、バルーン１２に対する輪３４の位置がそれぞれ定められる。従って、軸部材３８の第１案内溝４０を形成する箇所（間隔）及び個数は、バルーン１２を縮径させる位置及び縮径させる箇所の個数に対応するため、バルーン１２を効率的に折り畳むことが可能となるようにそれぞれ調整されればよい。 At this time, the linear member 36 is guided in the circumferential direction by passing through the first guide groove 40, and is guided in the longitudinal direction by passing through the second guide groove 42. As a result, the position of the ring 34 with respect to the balloon 12 is determined. Accordingly, the locations (intervals) and the number of the first guide grooves 40 of the shaft member 38 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the diameter is reduced, so that the balloon 12 can be efficiently folded. Each may be adjusted so as to be possible.
　次に、バルーン１２及び軸部材３８に巻回した線状部材３６の両端側に対して、例えば図３の矢印で示す方向に張力を加えることで、複数の輪３４の径を縮小させる。これによって、輪３４の内部に配置されたバルーン１２を縮径させて折り畳むことができる。 Next, the diameters of the plurality of rings 34 are reduced by applying tension to the both ends of the linear member 36 wound around the balloon 12 and the shaft member 38 in the direction indicated by the arrow in FIG. As a result, the balloon 12 disposed inside the ring 34 can be reduced in diameter and folded.
　そして、輪３４の内部でバルーン１２が折り畳まれた状態となるまで、輪３４の径を縮小させた後、図４及び図５Ｂに示すように、線状部材３６の輪３４を形成する部分よりも両端側の部分を、それぞれ係止部４４に係止する。これによって、輪３４の径を固定することができる。すなわち、バルーン１２を折り畳まれた状態で保持することができる。 Then, after reducing the diameter of the ring 34 until the balloon 12 is folded inside the ring 34, as shown in FIGS. 4 and 5B, from the portion of the linear member 36 that forms the ring 34. Also, both end portions are locked to the locking portions 44, respectively. As a result, the diameter of the ring 34 can be fixed. That is, the balloon 12 can be held in a folded state.
　よって、カテーテル組立体３２では、線状部材３６のみをバルーン１２の外表面に接触させて折り畳まれたバルーン１２を、そのままの状態で保持することができる。このため、バルーン１２の外表面に接触して摩擦を生じさせる面積を最小限に抑制しつつ、簡易な構成によってバルーン１２を折り畳んで保持することが可能である。すなわち、化学物質部２０が損傷することを十分に抑制しつつ、容易にバルーン１２を折り畳んで保持することができる。 Therefore, in the catheter assembly 32, the balloon 12 folded by bringing only the linear member 36 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
　また、バルーン折り畳み保持具３０では、１つの線状部材３６をバルーン１２及び軸部材３８に螺旋状に巻回することによって、複数の輪３４を容易に形成することができる。さらに、線状部材３６が第１案内溝４０及び第２案内溝４２を通ることによって、バルーン１２に対する輪３４の位置を定めることができるため、バルーン１２の縮径させる位置や個数を選択可能である。これによって、バルーン１２を効率的に折り畳むことが可能となる。 Moreover, in the balloon folding holder 30, the plurality of rings 34 can be easily formed by winding one linear member 36 around the balloon 12 and the shaft member 38 in a spiral manner. Furthermore, since the position of the ring 34 with respect to the balloon 12 can be determined by the linear member 36 passing through the first guide groove 40 and the second guide groove 42, the position and number of the balloon 12 to be reduced in diameter can be selected. is there. Thereby, the balloon 12 can be efficiently folded.
　さらにまた、線状部材３６の係止部４４に係止された部分のうち、少なくとも一方を係止部４４から脱離させ、線状部材３６による巻回を解くことによって、複数の輪３４の径の固定を連続的に解放することができる。このため、バルーン１２を折り畳まれて保持された状態から容易に解放することが可能である。 Furthermore, by removing at least one of the portions of the linear member 36 that are locked to the locking portion 44 from the locking portion 44 and unwinding the linear member 36, Diameter fixation can be released continuously. For this reason, it is possible to easily release the balloon 12 from the folded and held state.
＜第２の実施形態＞
　図６、図７、図８Ａ及び図８Ｂ、図９Ａ及び図９Ｂを参照しつつ、上記のバルーンカテーテル１０と、第２の実施形態に係るバルーン折り畳み保持具４６とを備えるカテーテル組立体４８について説明する。バルーン折り畳み保持具４６は、収縮したバルーン１２の外周を、該バルーン１２の長手方向の複数箇所で囲む複数の輪５０をそれぞれ独立に形成する複数の線状部材５２と、バルーン１２の長手方向に沿って延在し、且つバルーン１２を折り畳んだ状態に保持した輪５０を固定可能な軸部材５４と、軸部材５４に着脱自在に装着される棒形状の脱離部材５６とを有している。 <Second Embodiment>
A catheter assembly 48 including the balloon catheter 10 described above and the balloon folding holder 46 according to the second embodiment will be described with reference to FIGS. 6, 7, 8A and 8B, 9A and 9B. To do. The balloon folding holder 46 includes a plurality of linear members 52 that independently form a plurality of rings 50 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. A shaft member 54 that can be fixed to a ring 50 that extends along the balloon 12 and that holds the balloon 12 in a folded state, and a rod-shaped detachable member 56 that is detachably attached to the shaft member 54. .
　線状部材５２は、脱離部材５６が装着された軸部材５４とバルーン１２とを囲む輪５０を形成する。線状部材５２の構成材料例としては、前記線状部材３６と同様のものが挙げられる。以下、後述する線状部材７０、９２、１１８についても、同様の材料が構成材料例として挙げられる。 The linear member 52 forms a ring 50 that surrounds the shaft member 54 to which the detaching member 56 is attached and the balloon 12. Examples of the constituent material of the linear member 52 include those similar to the linear member 36. Hereinafter, the same material is mentioned as an example of a constituent material also about the linear members 70, 92, and 118 mentioned later.
　軸部材５４は、バルーン１２に沿って延在する棒形状である。軸部材５４の構成材料例としては、前記軸部材３８と同様のものが挙げられる。以下、後述する軸部材７２、９４、１２０、１２６についても、同様の材料が構成材料例として挙げられる。 The shaft member 54 has a rod shape extending along the balloon 12. Examples of the constituent material of the shaft member 54 include the same materials as the shaft member 38. Hereinafter, the same material is mentioned as an example of a constituent material also about shaft members 72, 94, 120, and 126 mentioned below.
　軸部材５４の周面には、脱離部材５６が着脱自在に嵌合する嵌合溝５８と、線状部材５２を係止可能な係止溝６２とが形成されている。嵌合溝５８は、軸部材５４の長手方向に延在する。 On the peripheral surface of the shaft member 54, a fitting groove 58 into which the detachable member 56 is detachably fitted and a locking groove 62 capable of locking the linear member 52 are formed. The fitting groove 58 extends in the longitudinal direction of the shaft member 54.
　係止溝６２は、嵌合溝５８に対して軸部材５４の周方向の片側に、軸部材５４の長手方向に所定の間隔をおいて複数形成されている。ここで、複数組の係止溝６２同士の所定の間隔及び係止溝６２の個数は、バルーン１２を縮径させる位置及び縮径させる箇所の個数に対応するため、バルーン１２を効率的に折り畳むことが可能となるように調整されればよい。また、例えば、係止溝６２は、線状部材５２の径よりもわずかに小さい幅に形成されることで、線状部材５２が着脱自在に係止される構成としてもよい。 A plurality of locking grooves 62 are formed on one side in the circumferential direction of the shaft member 54 with respect to the fitting groove 58 at a predetermined interval in the longitudinal direction of the shaft member 54. Here, since the predetermined interval between the plurality of sets of locking grooves 62 and the number of the locking grooves 62 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the balloon 12 is reduced in diameter, the balloon 12 is efficiently folded. It may be adjusted so that it is possible. Further, for example, the locking groove 62 may be formed to have a width slightly smaller than the diameter of the linear member 52 so that the linear member 52 is detachably locked.
　上記のように構成されたバルーン折り畳み保持具４６によって、バルーン１２を折り畳んで保持する場合について、図６及び図８Ａを参照しつつ説明する。先ず、収縮させたバルーン１２と、脱離部材５６を装着した軸部材５４とを互いの長手方向を揃えて並べた後、該バルーン１２及び軸部材５４の外周を線状部材５２で囲み輪５０を形成する。 The case where the balloon 12 is folded and held by the balloon folding holder 46 configured as described above will be described with reference to FIGS. 6 and 8A. First, the deflated balloon 12 and the shaft member 54 to which the detachable member 56 is attached are arranged with their longitudinal directions aligned, and the outer periphery of the balloon 12 and the shaft member 54 is surrounded by a linear member 52. Form.
　そして、輪５０の径を、該輪５０内においてバルーン１２が折り畳まれるまで縮小させた後、線状部材５２の両端側をともに係止溝６２に係止することで固定する。 Then, after the diameter of the ring 50 is reduced until the balloon 12 is folded in the ring 50, both ends of the linear member 52 are fixed to the locking grooves 62.
　このように、複数の線状部材５２によってそれぞれ複数の輪５０を形成し、該輪５０の径をそれぞれ縮径させて固定することによって、バルーン１２を折り畳まれた状態で保持することができる。 Thus, the balloon 12 can be held in a folded state by forming the plurality of rings 50 by the plurality of linear members 52 and reducing the diameters of the rings 50 and fixing them.
　よって、カテーテル組立体４８では、線状部材５２のみをバルーン１２の外表面に接触させて折り畳まれたバルーン１２を、そのままの状態で保持することができる。このため、バルーン１２の外表面に接触して摩擦を生じさせる面積を最小限に抑制しつつ、簡易な構成によってバルーン１２を折り畳んで保持することが可能である。すなわち、化学物質部２０が損傷することを十分に抑制しつつ、容易にバルーン１２を折り畳んで保持することができる。 Therefore, in the catheter assembly 48, the balloon 12 folded by bringing only the linear member 52 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
　また、カテーテル組立体４８では、図７に示すように、嵌合溝５８から脱離部材５６を脱離することで、係止溝６２に係止された線状部材５２が脱離する。すなわち、嵌合溝５８から脱離部材５６を脱離させる際、脱離部材５６上を通る線状部材５２が脱離部材５６によって押し上げられる。これによって、係止溝６２に係止された線状部材５２の一方のみを脱離させ、他方を係止溝６２に係止されたままの状態とすることができる。 Further, in the catheter assembly 48, as shown in FIG. 7, by removing the detaching member 56 from the fitting groove 58, the linear member 52 locked to the locking groove 62 is detached. That is, when the detaching member 56 is detached from the fitting groove 58, the linear member 52 passing over the detaching member 56 is pushed up by the detaching member 56. Accordingly, only one of the linear members 52 locked in the locking groove 62 can be detached and the other can be kept locked in the locking groove 62.
　よって、複数の輪５０の径の固定を容易且つ速やかに解放して、折り畳まれて保持された状態のバルーン１２を容易且つ速やかに解放することが可能となる。さらに、それぞれ独立に形成された複数の輪５０の径の固定を解放しても、複数の線状部材５２を軸部材５４に固定した状態に保つことができる。すなわち、複数の線状部材５２がカテーテル組立体４８から独立して落下すること等を防止できる。 Therefore, the fixing of the diameters of the plurality of rings 50 can be easily and quickly released, and the balloon 12 in a folded and held state can be easily and quickly released. Furthermore, even if the fixing of the diameters of the plurality of rings 50 formed independently of each other is released, the plurality of linear members 52 can be kept fixed to the shaft member 54. That is, the plurality of linear members 52 can be prevented from dropping independently from the catheter assembly 48.
　なお、本実施形態に係るカテーテル組立体４８では、軸部材５４に係止溝６２が複数形成されることとしたが、特にこれに限定されるものではない。例えば、図９Ａ及び図９Ｂに示すように、バルーン折り畳み保持具４６は、前記係止溝６２に代えて、係止溝６０を備えていてもよい。 In the catheter assembly 48 according to the present embodiment, a plurality of the locking grooves 62 are formed in the shaft member 54. However, the present invention is not limited to this. For example, as shown in FIGS. 9A and 9B, the balloon folding holder 46 may include a locking groove 60 instead of the locking groove 62.
　係止溝６０は、嵌合溝５８から軸部材５４の周方向に沿って延在し、嵌合溝５８に対して軸部材５４の周方向の両側に、軸部材５４の長手方向に所定の間隔をおいて複数形成されている。具体的には、嵌合溝５８の両側で軸部材５４の長手方向に若干だけずれた位置に設けられた係止溝６０ａ、６０ｂを一組として、複数組が軸部材５４の長手方向に間隔をおいて形成されている。 The locking groove 60 extends from the fitting groove 58 along the circumferential direction of the shaft member 54, and has a predetermined length in the longitudinal direction of the shaft member 54 on both sides in the circumferential direction of the shaft member 54 with respect to the fitting groove 58. A plurality are formed at intervals. Specifically, a set of locking grooves 60 a and 60 b provided at positions slightly shifted in the longitudinal direction of the shaft member 54 on both sides of the fitting groove 58, and a plurality of sets are spaced in the longitudinal direction of the shaft member 54. Is formed.
　このように、一組の係止溝６０は、互いに軸部材５４の周方向に対する位置がずれているため、線状部材５２の両端側はともに脱離部材５６上を通った後、一端側が係止溝６０ａにのみ係止され且つ他端側が係止溝６０ｂにのみ係止される。 As described above, since the pair of locking grooves 60 are displaced from each other in the circumferential direction of the shaft member 54, both end sides of the linear member 52 pass over the detaching member 56, and then one end side is engaged. Only the locking groove 60a is locked, and the other end is locked only to the locking groove 60b.
　これによって、嵌合溝５８から脱離部材５６を脱離させることで、係止溝６０に係止された線状部材５２のそれぞれを容易に係止溝６０から脱離させることができる。すなわち、複数の輪５０の径の固定を容易且つ速やかに解放して、折り畳まれて保持された状態のバルーン１２を容易且つ速やかに解放することが可能となる。 Thus, by detaching the detaching member 56 from the fitting groove 58, each of the linear members 52 locked to the locking groove 60 can be easily detached from the locking groove 60. That is, it is possible to easily and quickly release the fixed diameters of the plurality of rings 50 and to easily and quickly release the balloon 12 that is folded and held.
＜第３の実施形態＞
　図１０、図１１Ａ、図１１Ｂ、図１２Ａ及び図１２Ｂを参照しつつ、上記のバルーンカテーテル１０と、第３の実施形態に係るバルーン折り畳み保持具１１２とを備えるカテーテル組立体１１４について説明する。バルーン折り畳み保持具１１２は、収縮したバルーン１２の外周を、該バルーン１２の長手方向の複数箇所で囲む複数の輪１１６をそれぞれ独立に形成する複数の線状部材１１８と、バルーン１２の長手方向に沿って延在し、且つバルーン１２を折り畳んだ状態に保持した輪１１６を固定可能な軸部材１２０と、軸部材１２０に着脱自在に装着される棒形状の押圧部材１２２とを有している。 <Third Embodiment>
A catheter assembly 114 including the balloon catheter 10 and the balloon folding holder 112 according to the third embodiment will be described with reference to FIGS. 10, 11A, 11B, 12A, and 12B. The balloon folding holder 112 includes a plurality of linear members 118 that independently form a plurality of rings 116 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. A shaft member 120 that can be fixed to a ring 116 that extends along the balloon 12 and that holds the balloon 12 in a folded state, and a rod-shaped pressing member 122 that is detachably attached to the shaft member 120.
　線状部材１１８は、押圧部材１２２が装着されていない軸部材１２０とバルーン１２とを囲む輪１１６を形成する。 The linear member 118 forms a ring 116 that surrounds the shaft member 120 to which the pressing member 122 is not attached and the balloon 12.
　軸部材１２０は、バルーン１２に沿って延在する棒形状である。軸部材１２０の周面には、押圧部材１２２が着脱自在に嵌合する嵌合溝１２４が、軸部材１２０の長手方向に沿って延在するように形成されている。 The shaft member 120 has a rod shape extending along the balloon 12. A fitting groove 124 into which the pressing member 122 is detachably fitted is formed on the peripheral surface of the shaft member 120 so as to extend along the longitudinal direction of the shaft member 120.
　上記のように構成されたバルーン折り畳み保持具１１２によって、バルーン１２を折り畳んで保持する場合について、図１０及び図１１Ａを参照しつつ説明する。先ず、収縮させたバルーン１２と、押圧部材１２２を装着していない軸部材１２０とを互いの長手方向を揃えて並べた後、該バルーン１２及び軸部材１２０の外周を線状部材１１８で囲み輪１１６を形成する。次いで、輪１１６の径を、該輪１１６内においてバルーン１２が折り畳まれるまで縮小させる。 The case where the balloon 12 is folded and held by the balloon folding holder 112 configured as described above will be described with reference to FIGS. 10 and 11A. First, after the deflated balloon 12 and the shaft member 120 to which the pressing member 122 is not mounted are arranged with their longitudinal directions aligned, the outer periphery of the balloon 12 and the shaft member 120 is surrounded by a linear member 118. 116 is formed. The diameter of the ring 116 is then reduced until the balloon 12 is folded within the ring 116.
　複数の線状部材１１８についてそれぞれ同様に、複数の輪１１６を、軸部材１２０の長手方向に所定の間隔をおいて形成して該輪１１６の径を縮小させる。 Similarly, for each of the plurality of linear members 118, a plurality of rings 116 are formed at predetermined intervals in the longitudinal direction of the shaft member 120 to reduce the diameter of the rings 116.
　そして、複数の線状部材１１８について、それぞれの輪１１６を形成する始点部分と終点部分とがともに嵌合溝１２４上に配置された状態で、嵌合溝１２４に押圧部材１２２を嵌合させる。これによって、複数の輪１１６の径をそれぞれ固定して、バルーン１２を折り畳まれた状態で保持することができる。 Then, with respect to the plurality of linear members 118, the pressing member 122 is fitted into the fitting groove 124 in a state where the start point portion and the end point portion forming the respective rings 116 are both arranged on the fitting groove 124. Accordingly, the diameters of the plurality of rings 116 can be fixed and the balloon 12 can be held in a folded state.
　よって、カテーテル組立体１１４では、線状部材１１８のみをバルーン１２の外表面に接触させて折り畳まれたバルーン１２を、そのままの状態で保持することができる。このため、バルーン１２の外表面に接触して摩擦を生じさせる面積を最小限に抑制しつつ、簡易な構成によってバルーン１２を折り畳んで保持することが可能である。すなわち、化学物質部２０が損傷することを十分に抑制しつつ、容易にバルーン１２を折り畳んで保持することができる。 Therefore, in the catheter assembly 114, the balloon 12 folded by bringing only the linear member 118 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
　また、カテーテル組立体１１４では、図１１Ｂに示すように、嵌合溝１２４から押圧部材１２２を脱離することで、複数の輪１１６の径の固定を解放することができる。このため、バルーン１２を折り畳まれて保持された状態から容易且つ速やかに解放することが可能となる。 Moreover, in the catheter assembly 114, as shown in FIG. 11B, the fixing of the diameters of the plurality of rings 116 can be released by removing the pressing member 122 from the fitting groove 124. For this reason, it becomes possible to release the balloon 12 easily and quickly from the folded and held state.
　なお、本実施形態に係るカテーテル組立体１１４では、バルーン折り畳み保持具１１２が軸部材１２０を備えていることとしたが、特にこれに限定されるものではない。例えば、バルーン折り畳み保持具１１２は、軸部材１２０に代えて、軸部材１２６を備えていてもよい。 In the catheter assembly 114 according to the present embodiment, the balloon folding holder 112 includes the shaft member 120. However, the present invention is not limited to this. For example, the balloon folding holder 112 may include a shaft member 126 instead of the shaft member 120.
　軸部材１２６は、図１２Ａ及び図１２Ｂに示すように、嵌合溝１２４に対して軸部材１２６の周方向の片側に、該周方向に沿って該嵌合溝１２４から延在する係止溝１２８が形成されている。なお、係止溝１２８は、軸部材１２６の複数の輪１１６によって囲まれる箇所にそれぞれ形成されればよい。 As shown in FIGS. 12A and 12B, the shaft member 126 has a locking groove extending from the fitting groove 124 along the circumferential direction on one side of the shaft member 126 in the circumferential direction with respect to the fitting groove 124. 128 is formed. Note that the locking grooves 128 may be formed at locations surrounded by the plurality of rings 116 of the shaft member 126, respectively.
　この係止溝１２８に線状部材１１８の一端側を係止した状態で、輪１１６を形成する。これによって、図１２Ａに示すように、線状部材１１８の一端側が軸部材１２６に固定された状態で、押圧部材１２２を嵌合溝１２４に勘合させることで、輪１１６の径をそれぞれ固定することができる。従って、図１２Ｂに示すように、押圧部材１２２を嵌合溝１２４から脱離させて、複数の輪１１６の径の固定を解放しても、複数の線状部材１１８の一端側のみを軸部材１２６に固定した状態に保つことができる。すなわち、複数の線状部材１１８がカテーテル組立体１１４から独立して落下すること等を防止できる。 The ring 116 is formed in a state where one end side of the linear member 118 is locked in the locking groove 128. Thus, as shown in FIG. 12A, the diameter of the ring 116 is fixed by fitting the pressing member 122 into the fitting groove 124 in a state where one end side of the linear member 118 is fixed to the shaft member 126. Can do. Therefore, as shown in FIG. 12B, even if the pressing member 122 is detached from the fitting groove 124 and the fixing of the diameters of the plurality of rings 116 is released, only one end side of the plurality of linear members 118 is a shaft member. 126 can be kept fixed. That is, the plurality of linear members 118 can be prevented from dropping independently from the catheter assembly 114.
＜第４の実施形態＞
　図１３～図１６、図１７Ａ、図１７Ｂ及び図１８を参照しつつ、上記のバルーンカテーテル１０と、第４の実施形態に係るバルーン折り畳み保持具８６とを備えるカテーテル組立体８８について説明する。バルーン折り畳み保持具８６は、収縮したバルーン１２の外周を、該バルーン１２の長手方向の複数箇所で囲む複数の輪９０をそれぞれ独立に形成する複数の線状部材９２と、バルーン１２の長手方向に沿って延在し、且つバルーン１２を折り畳んだ状態に保持した輪９０を固定可能な軸部材９４とを有している。 <Fourth Embodiment>
A catheter assembly 88 including the balloon catheter 10 and the balloon folding holder 86 according to the fourth embodiment will be described with reference to FIGS. 13 to 16, FIGS. 17A, 17B, and 18. FIG. The balloon folding holder 86 includes a plurality of linear members 92 that independently form a plurality of rings 90 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. And a shaft member 94 that can be fixed to a ring 90 that extends along the balloon 12 and holds the balloon 12 in a folded state.
　線状部材９２は、例えば、両端部が不図示の結び目や接着剤による接合等によって接続され、これによって、輪９０の径が固定されている。 For example, both ends of the linear member 92 are connected by a knot (not shown) or bonding with an adhesive, and the diameter of the ring 90 is fixed.
　軸部材９４は、バルーン１２とともに輪９０に囲まれ且つバルーン１２に対する輪９０の位置を固定する中空円筒形状の固定部材９６と、固定部材９６の内部に挿通可能な切断部材９８とを備えている。 The shaft member 94 includes a hollow cylindrical fixing member 96 that is surrounded by the ring 90 together with the balloon 12 and fixes the position of the ring 90 with respect to the balloon 12, and a cutting member 98 that can be inserted into the fixing member 96. .
　固定部材９６は、中空の内部と外部とを連通し、輪９０の一部が中空の内部を横断するように挿入可能な複数の挿入溝１００が固定部材９６の長手方向に沿って所定の間隔をおいて形成されている。ここで、複数の挿入溝１００同士の間の所定の間隔及び挿入溝１００の個数は、バルーン１２を縮径させる位置及び縮径させる箇所の個数に対応するため、バルーン１２を効率的に折り畳むことが可能となるように調整されればよい。 The fixing member 96 communicates between the hollow interior and the exterior, and a plurality of insertion grooves 100 that can be inserted so that a part of the ring 90 crosses the hollow interior have a predetermined interval along the longitudinal direction of the fixing member 96. Is formed. Here, since the predetermined interval between the plurality of insertion grooves 100 and the number of the insertion grooves 100 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the diameter is reduced, the balloon 12 is efficiently folded. It is only necessary to adjust so as to be possible.
　切断部材９８は、図１４に示すように、一端に切欠部１０２が形成された棒形状である。切欠部１０２の内部には、線状部材９２を切断可能な一組の切刃１０４が設けられている。一組の切刃１０４はそれぞれ、固定部材９６に対する切断部材９８の挿通方向に刃先が向くように配置されている。さらに、この刃先は、切断部材９８を固定部材９６に挿通したとき、挿入溝１００を介して固定部材９６の内部を横断する線状部材９２（輪９０の一部）に接触する。なお、切欠部１０２の内部に切刃１０４が設けられることで、切刃１０４が線状部材９２以外に接触することを防止できる。 The cutting member 98 has a bar shape in which a notch 102 is formed at one end, as shown in FIG. A set of cutting blades 104 capable of cutting the linear member 92 is provided inside the notch 102. Each of the pair of cutting blades 104 is disposed such that the cutting edge faces in the insertion direction of the cutting member 98 with respect to the fixing member 96. Further, when the cutting member 98 is inserted through the fixing member 96, the cutting edge contacts a linear member 92 (a part of the ring 90) that traverses the inside of the fixing member 96 through the insertion groove 100. In addition, by providing the cutting blade 104 inside the notch 102, it is possible to prevent the cutting blade 104 from contacting other than the linear member 92.
　上記のように構成されたバルーン折り畳み保持具８６によって、バルーン１２を折り畳んで保持する場合について、図１３を参照しつつ説明する。先ず、収縮させたバルーン１２と固定部材９６とを互いの長手方向を揃えて並べた後、該バルーン１２及び固定部材９６の外周を線状部材９２で囲み輪９０を形成する。この際、線状部材９２が挿入溝１００内を通過するように輪９０を形成する。そして、輪９０の径を、該輪９０内においてバルーン１２が折り畳まれるまで縮小させた後、線状部材９２の両端部を接合し、輪９０の径を固定する。 The case where the balloon 12 is folded and held by the balloon folding holder 86 configured as described above will be described with reference to FIG. First, the deflated balloon 12 and the fixing member 96 are arranged with their longitudinal directions aligned, and then the outer periphery of the balloon 12 and the fixing member 96 is surrounded by a linear member 92 to form a ring 90. At this time, the ring 90 is formed so that the linear member 92 passes through the insertion groove 100. Then, after the diameter of the ring 90 is reduced until the balloon 12 is folded in the ring 90, both ends of the linear member 92 are joined to fix the diameter of the ring 90.
　このように、複数の線状部材９２によってそれぞれ複数の輪９０を形成し、該輪９０の径をそれぞれ縮径させて固定することによって、バルーン１２を折り畳まれた状態で保持することができる。 Thus, the balloon 12 can be held in a folded state by forming a plurality of rings 90 with the plurality of linear members 92 and reducing the diameters of the rings 90 and fixing them.
　よって、カテーテル組立体８８では、線状部材９２のみをバルーン１２の外表面に接触させて折り畳まれたバルーン１２を、そのままの状態で保持することができる。このため、バルーン１２の外表面に接触して摩擦を生じさせる面積を最小限に抑制しつつ、簡易な構成によってバルーン１２を折り畳んで保持することが可能である。すなわち、化学物質部２０が損傷することを十分に抑制しつつ、容易にバルーン１２を折り畳んで保持することができる。 Therefore, in the catheter assembly 88, the balloon 12 folded by bringing only the linear member 92 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
　また、カテーテル組立体８８では、図１５に示すように、挿入溝１００に挿入された輪９０が、固定部材９６の中空の内部を横断する。このため、固定部材９６の内部に対して、切断部材９８を切欠部１０２が設けられた側から挿通すると、切刃１０４が線状部材９２に当接し、これによって、線状部材９２を切断することができる。 Further, in the catheter assembly 88, as shown in FIG. 15, the ring 90 inserted into the insertion groove 100 traverses the hollow interior of the fixing member 96. For this reason, when the cutting member 98 is inserted into the inside of the fixed member 96 from the side where the notch 102 is provided, the cutting blade 104 comes into contact with the linear member 92, thereby cutting the linear member 92. be able to.
　すなわち、複数の輪９０の径の固定を容易且つ速やかに解放することができ、折り畳まれて保持された状態のバルーン１２を容易且つ速やかに解放することが可能となる。 That is, the fixing of the diameters of the plurality of rings 90 can be easily and quickly released, and the balloon 12 in a folded and held state can be easily and quickly released.
　なお、図１３の例示では、バルーン１２に取り付けられた固定部材９６の基端側から切断部材９８が挿通されているが、該固定部材９６の先端側から切断部材９８が挿通されてもよい。 In the illustration of FIG. 13, the cutting member 98 is inserted from the proximal end side of the fixing member 96 attached to the balloon 12, but the cutting member 98 may be inserted from the distal end side of the fixing member 96.
　なお、本実施形態に係るカテーテル組立体８８では、軸部材９４が、切欠部１０２内に設けられた一組の切刃１０４を有する切断部材９８を備えていることとしたが、特にこれに限定されるものではない。軸部材９４は、前記切断部材９８に代えて、例えば、図１６に示す切断部材１０６を備えていてもよい。 In the catheter assembly 88 according to the present embodiment, the shaft member 94 includes the cutting member 98 having the pair of cutting blades 104 provided in the notch 102, but the present invention is particularly limited thereto. Is not to be done. For example, the shaft member 94 may include a cutting member 106 shown in FIG. 16 instead of the cutting member 98.
　上記の通り、切断部材９８は、輪９０の径の固定を解放する際に、固定部材９６の内部に挿通される。これに対して、切断部材１０６は、図１７Ａに示すように、予め固定部材９６の内部に収容された状態で、バルーン１２とともに輪９０に囲まれる。そして、輪９０の径の固定を解放する際に、固定部材９６の内部から引き抜かれる。 As described above, the cutting member 98 is inserted into the fixing member 96 when releasing the fixing of the diameter of the ring 90. On the other hand, as shown in FIG. 17A, the cutting member 106 is surrounded by the ring 90 together with the balloon 12 while being accommodated in advance in the fixing member 96. Then, when releasing the fixing of the diameter of the ring 90, the ring 90 is pulled out from the inside of the fixing member 96.
　具体的には、切断部材１０６は、固定部材９６の長手方向の長さよりも長い棒形状であり、一端側に、線状部材９２を切断する切刃１０８を保持する切刃保持部１１０が形成され、該切刃保持部１１０から他端側に向かって延在部１１１が延在している。切刃１０８は、切刃保持部１１０から、切断部材１０６の他端側に刃先を向けて延在するように配置されている。 Specifically, the cutting member 106 has a rod shape longer than the length of the fixing member 96 in the longitudinal direction, and a cutting blade holding portion 110 that holds the cutting blade 108 that cuts the linear member 92 is formed on one end side. The extending portion 111 extends from the cutting edge holding portion 110 toward the other end side. The cutting blade 108 is arranged so as to extend from the cutting blade holding portion 110 toward the other end side of the cutting member 106 with the cutting edge directed.
　延在部１１１の径方向の長さは、挿入溝１００の径方向の長さよりも短くなるように構成されている。これによって、切断部材１０６を固定部材９６内に収容した際に、延在部１１１が輪９０に接触しないようになっている。 The length of the extending portion 111 in the radial direction is configured to be shorter than the length of the insertion groove 100 in the radial direction. This prevents the extension 111 from contacting the wheel 90 when the cutting member 106 is accommodated in the fixing member 96.
　切断部材１０６は、固定部材９６の内部に延在部１１１側から挿通される。例えば、図１７Ａに示すように、切断部材１０６が、固定部材９６の基端側の開口を介して挿通された場合、切刃１０８が固定部材９６内の最も基端側の輪９０に接触せず、且つ延在部１１１が固定部材９６の先端側の開口から突出する位置で、例えば不図示の粘着テープ等によって切断部材１０６と固定部材９６とが固定される。 The cutting member 106 is inserted into the fixed member 96 from the extending portion 111 side. For example, as shown in FIG. 17A, when the cutting member 106 is inserted through the opening on the proximal end side of the fixing member 96, the cutting blade 108 contacts the most proximal end ring 90 in the fixing member 96. In addition, the cutting member 106 and the fixing member 96 are fixed by, for example, an adhesive tape (not shown) at a position where the extending portion 111 protrudes from the opening on the distal end side of the fixing member 96.
　なお、切断部材１０６は、固定部材９６の先端側の開口を介して挿通されてもよい。この場合、切刃１０８が固定部材９６内の最も先端側の輪９０に接触せず、且つ延在部１１１が固定部材９６の基端側の開口から突出する状態で、上記の場合と同様に切断部材１０６と固定部材９６とが固定されればよい。 Note that the cutting member 106 may be inserted through the opening on the distal end side of the fixing member 96. In this case, the cutting blade 108 is not in contact with the most distal end ring 90 in the fixing member 96 and the extending portion 111 protrudes from the opening on the proximal end side of the fixing member 96 as in the above case. The cutting member 106 and the fixing member 96 may be fixed.
　そして、バルーン１２の保持を解放する際には、上記の粘着テープを取り外し、固定部材９６から突出する延在部１１１を把持して切断部材１０６を引き抜く。これによって、図１７Ｂに示すように、切刃１０８の刃先が線状部材９２に当接するため、線状部材９２を切断して、輪９０の径の固定を解放することができる。 Then, when releasing the holding of the balloon 12, the adhesive tape is removed, the extending part 111 protruding from the fixing member 96 is gripped, and the cutting member 106 is pulled out. As a result, as shown in FIG. 17B, the cutting edge of the cutting blade 108 comes into contact with the linear member 92, so that the linear member 92 can be cut and the fixing of the diameter of the ring 90 can be released.
　また、本実施形態に係るカテーテル組立体８８では、挿入溝１００の形状を、図１８に示す形状に形成してもよい。すなわち、挿入溝１００は、固定部材９６内の輪９０の横断方向の一方側から他方側にかけて、溝幅が縮小し、最小となる溝幅が線状部材９２の径よりもわずかに小さくなるように形成されてもよい。これによって、挿入溝１００の最小となる溝幅部分に線状部材９２を係止することができるため、複数の輪９０の径の固定を解放するべく、複数の線状部材９２を切断しても、切断された線状部材９２の一端側を固定部材９６に固定した状態に保つことができる。すなわち、複数の線状部材９２がカテーテル組立体８８から独立して落下すること等を防止できる。 Further, in the catheter assembly 88 according to the present embodiment, the shape of the insertion groove 100 may be formed as shown in FIG. That is, the insertion groove 100 has a groove width that decreases from one side to the other side in the transverse direction of the ring 90 in the fixing member 96 so that the minimum groove width is slightly smaller than the diameter of the linear member 92. May be formed. As a result, the linear member 92 can be locked to the groove width portion where the insertion groove 100 is the smallest, so that the plurality of linear members 92 are cut in order to release the fixing of the diameters of the plurality of rings 90. Also, the one end side of the cut linear member 92 can be kept fixed to the fixing member 96. That is, the plurality of linear members 92 can be prevented from dropping independently from the catheter assembly 88.
＜第５の実施形態＞
　図１９Ａ、図１９Ｂ、図２０Ａ及び図２０Ｂを参照しつつ、上記のバルーンカテーテル１０と、第５の実施形態に係るバルーン折り畳み保持具６４とを備えるカテーテル組立体６６について説明する。バルーン折り畳み保持具６４は、収縮したバルーン１２の外周を、該バルーン１２の長手方向の複数箇所で囲む複数の輪６８をそれぞれ独立に形成する複数の線状部材７０と、バルーン１２の長手方向に沿って延在し、且つバルーン１２を折り畳んだ状態に保持した輪６８を固定可能な軸部材７２とを有している。 <Fifth Embodiment>
A catheter assembly 66 including the balloon catheter 10 described above and the balloon folding holder 64 according to the fifth embodiment will be described with reference to FIGS. 19A, 19B, 20A, and 20B. The balloon folding holder 64 includes a plurality of linear members 70 that independently form a plurality of rings 68 that surround the outer periphery of the deflated balloon 12 at a plurality of locations in the longitudinal direction of the balloon 12, and a longitudinal direction of the balloon 12. And a shaft member 72 that can be fixed to a ring 68 that extends along the balloon 12 and holds the balloon 12 in a folded state.
　軸部材７２は、軸本体７４と、該軸本体７４に着脱自在に装着される筒部材７６とを有している。軸本体７４の周面には、複数の線状部材７０の一端側がそれぞれ巻回される複数の巻回溝７８が軸部材７２の長手方向に沿って所定の間隔をおいて形成されている。ここで、複数の巻回溝７８同士の間の所定の間隔及び巻回溝７８の個数は、バルーン１２を縮径させる位置及び縮径させる箇所の個数に対応するため、バルーン１２を効率的に折り畳むことが可能となるように調整されればよい。 The shaft member 72 has a shaft main body 74 and a cylindrical member 76 that is detachably attached to the shaft main body 74. A plurality of winding grooves 78 around which one end sides of the plurality of linear members 70 are respectively wound are formed on the peripheral surface of the shaft main body 74 along the longitudinal direction of the shaft member 72 at a predetermined interval. Here, since the predetermined interval between the plurality of winding grooves 78 and the number of the winding grooves 78 correspond to the positions at which the balloon 12 is reduced in diameter and the number of locations at which the balloon 12 is reduced in diameter, the balloon 12 can be efficiently used. What is necessary is just to adjust so that it can fold.
　筒部材７６は、長手方向の一端に軸本体７４を挿入可能な開口部８０と、該開口部８０に臨み且つ筒部材７６の長手方向に沿って延在するスリット８２とが形成されている。 The cylindrical member 76 has an opening 80 into which the shaft main body 74 can be inserted at one end in the longitudinal direction, and a slit 82 that faces the opening 80 and extends along the longitudinal direction of the cylindrical member 76.
　線状部材７０の一端側が巻回溝７８に巻回されており、線状部材７０の他端側がバルーン１２の外周を囲む輪６８を形成している。軸本体７４を一方の方向（線状部材７０の巻回方向）に回転させることで、線状部材７０の一端側が巻回溝７８にさらに巻回される。軸本体７４を他方の方向に回転させることで、線状部材７０の一端側の巻回が解かれる。 One end side of the linear member 70 is wound around the winding groove 78, and the other end side of the linear member 70 forms a ring 68 that surrounds the outer periphery of the balloon 12. By rotating the shaft body 74 in one direction (winding direction of the linear member 70), one end side of the linear member 70 is further wound around the winding groove 78. By rotating the shaft main body 74 in the other direction, the winding on the one end side of the linear member 70 is released.
　また、線状部材７０の他端側の輪６８は、線状部材７０の一端側が巻回されることに伴って縮径し、線状部材７０の一端側の巻回が解かれることに伴って拡径する。詳細には、線状部材７０の他端には、線状部材７０自体が挿通される挿通輪８４が形成されている。この挿通輪８４に予め線状部材７０の一端を挿通させた後、該線状部材７０の一端側が巻回溝７８に巻回されている。 Further, the ring 68 on the other end side of the linear member 70 is reduced in diameter as the one end side of the linear member 70 is wound, and the winding on the one end side of the linear member 70 is released. To expand the diameter. Specifically, an insertion ring 84 through which the linear member 70 itself is inserted is formed at the other end of the linear member 70. After one end of the linear member 70 is inserted through the insertion wheel 84 in advance, one end side of the linear member 70 is wound around the winding groove 78.
　これによって、線状部材７０の他端側に輪６８が形成される。そして、挿通輪８４内に対して線状部材７０の一端側を移動させることによって、すなわち、軸本体７４を回転させることによって、輪６８の径の大きさを調節することが可能となっている。 Thereby, a ring 68 is formed on the other end side of the linear member 70. The diameter of the ring 68 can be adjusted by moving one end side of the linear member 70 with respect to the insertion wheel 84, that is, by rotating the shaft main body 74. .
　上記のように構成されたバルーン折り畳み保持具６４によって、バルーン１２を折り畳んで保持する場合について説明する。先ず、図１９Ａ及び図１９Ｂに示すように、巻回溝７８に対して線状部材７０を巻回する量を調整することで、輪６８の径の大きさを調整し、該輪６８の内部に収縮したバルーン１２を挿通する。次いで、軸本体７４を一方の方向（図１９Ｂの矢印方向）に回転させることで輪６８の径を縮小させて、バルーン１２を折り畳む。 A case will be described in which the balloon 12 is folded and held by the balloon folding holder 64 configured as described above. First, as shown in FIGS. 19A and 19B, by adjusting the amount by which the linear member 70 is wound around the winding groove 78, the diameter of the ring 68 is adjusted, and the inside of the ring 68 is adjusted. The balloon 12 deflated is inserted. Next, the shaft body 74 is rotated in one direction (the arrow direction in FIG. 19B) to reduce the diameter of the ring 68, and the balloon 12 is folded.
　このように、輪６８内部でバルーン１２が折り畳まれるまで輪６８の径を縮小させたところで、軸本体７４の回転を停止し、該軸本体７４に筒部材７６を装着する。すなわち、図２０Ａ及び図２０Ｂに示すように、筒部材７６の開口部８０を介して、筒部材７６の内部に軸本体７４を収容する。この際、筒部材７６のスリット８２を介して、線状部材７０の他端側を筒部材７６の外部に延出させることができる。これによって、線状部材７０に対する軸本体７４の回転位置が固定される。すなわち、輪６８の径を固定し、バルーン１２を折り畳んだ状態で保持することができる。 Thus, when the diameter of the ring 68 is reduced until the balloon 12 is folded inside the ring 68, the rotation of the shaft body 74 is stopped, and the cylindrical member 76 is attached to the shaft body 74. That is, as shown in FIGS. 20A and 20B, the shaft main body 74 is accommodated inside the cylindrical member 76 through the opening 80 of the cylindrical member 76. At this time, the other end side of the linear member 70 can be extended to the outside of the cylindrical member 76 through the slit 82 of the cylindrical member 76. Thereby, the rotational position of the shaft main body 74 with respect to the linear member 70 is fixed. That is, the diameter of the ring 68 can be fixed and the balloon 12 can be held in a folded state.
　よって、カテーテル組立体６６では、線状部材７０のみをバルーン１２の外表面に接触させて折り畳まれたバルーン１２を、そのままの状態で保持することができる。このため、バルーン１２の外表面に接触して摩擦を生じさせる面積を最小限に抑制しつつ、簡易な構成によってバルーン１２を折り畳んで保持することが可能である。すなわち、化学物質部２０が損傷することを十分に抑制しつつ、容易にバルーン１２を折り畳んで保持することができる。 Therefore, in the catheter assembly 66, the balloon 12 folded by bringing only the linear member 70 into contact with the outer surface of the balloon 12 can be held as it is. For this reason, it is possible to fold and hold the balloon 12 with a simple configuration while minimizing the area that contacts the outer surface of the balloon 12 and causes friction. That is, the balloon 12 can be easily folded and held while sufficiently suppressing the chemical substance portion 20 from being damaged.
　また、バルーン折り畳み保持具６４では、上記の通り、軸本体７４を一方の方向に回転させることで、複数の輪６８を縮径させることができる。このため、効率的にバルーン１２を折り畳むことが可能となる。さらに、バルーン１２を折り畳んだ状態で、軸本体７４に筒部材７６を装着することによって、複数の輪６８の径を固定し、バルーン１２を折り畳んだ状態で保持することができる。 In the balloon folding holder 64, as described above, the plurality of rings 68 can be reduced in diameter by rotating the shaft body 74 in one direction. For this reason, the balloon 12 can be efficiently folded. Furthermore, by attaching the cylindrical member 76 to the shaft main body 74 in a state where the balloon 12 is folded, the diameters of the plurality of rings 68 can be fixed and the balloon 12 can be held in a folded state.
　さらに、カテーテル組立体６６では、軸本体７４に装着した筒部材７６を該軸本体７４から脱離させた後、軸本体７４を他方向に回転させることで、複数の輪６８を拡径させることができる。これによって、複数の輪６８によるバルーン１２の保持を容易且つ速やかに解放することができる。すなわち、折り畳まれて保持された状態のバルーン１２を容易且つ速やかに解放することが可能となる。 Further, in the catheter assembly 66, the cylindrical member 76 attached to the shaft main body 74 is detached from the shaft main body 74, and then the shaft main body 74 is rotated in the other direction, thereby expanding the plurality of rings 68. Can do. Thereby, the holding of the balloon 12 by the plurality of rings 68 can be easily and quickly released. That is, the balloon 12 in a folded and held state can be easily and quickly released.
　次に、本実施形態に係るバルーン折り畳み保持方法は、上記のように構成されるバルーン折り畳み保持具３０、４６、６４、８６、１１２を用いて実施することができる。ここで、バルーン折り畳み保持具３０を用いて、バルーンカテーテル１０のバルーン１２を折り畳み、且つバルーン１２を折り畳んだ状態で保持する工程を例に挙げて説明する。勿論、本実施形態に係るバルーン折り畳み保持方法は、バルーンカテーテル１０のバルーン１２に限らず、種々のバルーンカテーテルのバルーンに対して好適に適用することができる。 Next, the balloon folding holding method according to the present embodiment can be carried out using the balloon folding holding tools 30, 46, 64, 86, and 112 configured as described above. Here, the process of folding the balloon 12 of the balloon catheter 10 and holding the balloon 12 in a folded state using the balloon folding holder 30 will be described as an example. Of course, the balloon folding and holding method according to the present embodiment can be suitably applied not only to the balloon 12 of the balloon catheter 10 but also to balloons of various balloon catheters.
　このバルーン折り畳み保持方法では、バルーン１２の外周を線状部材３６からなる複数の輪３４で囲み、この複数の輪３４を縮径させてバルーン１２を折り畳む工程と、縮径させた複数の輪３４の径を固定してバルーン１２を折り畳んだ状態で保持する工程とを備える。 In this balloon folding and holding method, the outer periphery of the balloon 12 is surrounded by a plurality of rings 34 made of a linear member 36, the diameter of the plurality of rings 34 is reduced to fold the balloon 12, and the plurality of reduced diameter rings 34. And fixing the balloon 12 in a folded state.
　このように、線状部材３６のみをバルーン１２の外表面に接触させてバルーン１２を折り畳むため、例えばバルーン１２の外表面全体に接触する折り畳み型等を用いる場合に比して、簡易な構成でバルーン１２を折り畳むことができ且つバルーン１２の外表面に接触して摩擦を生じさせる面積を縮小することができる。従って、バルーン１２の外表面が損傷することを抑制しつつ容易にバルーン１２を折り畳むことができる。また、縮径させた輪３４を軸部材３８に対して固定することができるため、バルーン１２を折り畳む際に使用した構成を用いてバルーン１２を折り畳んだ状態で容易に保持することができる。 In this way, since the balloon 12 is folded by bringing only the linear member 36 into contact with the outer surface of the balloon 12, for example, compared to the case of using a folding type that contacts the entire outer surface of the balloon 12, etc. The area where the balloon 12 can be folded and brought into contact with the outer surface of the balloon 12 to generate friction can be reduced. Therefore, the balloon 12 can be easily folded while suppressing damage to the outer surface of the balloon 12. Further, since the ring 34 having a reduced diameter can be fixed to the shaft member 38, the balloon 12 can be easily held in a folded state using the configuration used when the balloon 12 is folded.
　上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.
　上記した実施形態では、バルーン１２の外表面に、例えば、生態管腔内の狭窄部を治療した部位に付着させることで再狭窄を抑制する効果を有する生理学的生理活性物質からなる化学物質部２０が形成されていることとした。しかしながら、特にこれに限定されるものではなく、外表面に化学物質部２０が形成されていないバルーンであっても、該バルーンの外表面に損傷が生じることを十分に抑制しつつ折り畳み保持することが可能である。 In the above-described embodiment, for example, the chemical substance portion 20 made of a physiologically physiologically active substance having an effect of suppressing restenosis by attaching the stenosis portion in the ecological lumen to the treated site on the outer surface of the balloon 12. Has been formed. However, the present invention is not particularly limited to this, and even a balloon in which the chemical substance portion 20 is not formed on the outer surface can be folded and held while sufficiently preventing damage to the outer surface of the balloon. Is possible.

Claims (9)

  1. 　バルーン（１２）を有するバルーンカテーテル（１０）と、前記バルーン（１２）を折り畳んだ状態で保持するバルーン折り畳み保持具（３０、４６、６４、８６、１１２）とを備えたカテーテル組立体（３２、４８、６６、８８、１１４）であって、
    　前記バルーン折り畳み保持具（３０、４６、６４、８６、１１２）は、
    　前記バルーン（１２）を折り畳んだ状態で前記バルーン（１２）の長手方向の複数箇所で前記バルーン（１２）の外周を囲む複数の輪（３４、５０、６８、９０、１１６）を形成する少なくとも１つの線状部材（３６、５２、７０、９２、１１８）と、
    　前記バルーン（１２）の長手方向に沿って延在し且つ前記バルーン（１２）を折り畳み状態に保持した前記輪（３４、５０、６８、９０、１１６）を固定可能な軸部材（３８、５４、７２、９４、１２０、１２６）と、
    　を有することを特徴とするカテーテル組立体（３２、４８、６６、８８、１１４）。     A catheter assembly (32,) comprising a balloon catheter (10) having a balloon (12) and a balloon folding holder (30, 46, 64, 86, 112) for holding the balloon (12) in a folded state. 48, 66, 88, 114),
    The balloon folding holder (30, 46, 64, 86, 112)
    Forming a plurality of rings (34, 50, 68, 90, 116) surrounding the outer periphery of the balloon (12) at a plurality of locations in the longitudinal direction of the balloon (12) with the balloon (12) folded. Two linear members (36, 52, 70, 92, 118);
    A shaft member (38, 54,) capable of fixing the ring (34, 50, 68, 90, 116) extending along the longitudinal direction of the balloon (12) and holding the balloon (12) in a folded state. 72, 94, 120, 126),
    Catheter assembly (32, 48, 66, 88, 114) characterized by comprising:
  2. 　請求項１記載のカテーテル組立体（３２）において、
    　前記線状部材（３６）は、前記バルーン（１２）の外周に螺旋状に巻回されることで複数の前記輪（３４）を形成し、
    　前記軸部材（３８）は、前記バルーン（１２）とともに前記線状部材（３６）が巻回される棒形状であり、前記軸部材（３８）の外面には周方向に沿う複数の第１案内溝（４０）が長手方向に間隔をおいて形成されるとともに、該長手方向に延在する第２案内溝（４２）が形成され、前記軸部材（３８）の両端部には前記線状部材（３６）を係止可能な係止部（４４）が形成され、
    　前記軸部材（３８）に巻回された前記線状部材（３６）は、前記第１及び第２案内溝（４０、４２）を通ることで前記バルーン（１２）に対する前記輪（３４）の位置が定められ、且つ前記線状部材（３６）のうち複数の前記輪（３４）を形成する部分よりも両端側の部分がそれぞれ前記係止部（４４）に係止されることで前記輪（３４）の径が固定されること、を特徴とするカテーテル組立体（３２）。     The catheter assembly (32) of claim 1,
    The linear member (36) is spirally wound around the outer circumference of the balloon (12) to form a plurality of the rings (34),
    The shaft member (38) has a rod shape around which the linear member (36) is wound together with the balloon (12), and a plurality of first guides along the circumferential direction are formed on the outer surface of the shaft member (38). Grooves (40) are formed at intervals in the longitudinal direction, and second guide grooves (42) extending in the longitudinal direction are formed, and the linear members are formed at both ends of the shaft member (38). A locking portion (44) capable of locking (36) is formed,
    The linear member (36) wound around the shaft member (38) passes through the first and second guide grooves (40, 42) so that the position of the ring (34) with respect to the balloon (12). And the portions of both ends of the linear member (36) that are closer to both ends than the portions that form the plurality of rings (34) are engaged with the engagement portions (44), respectively. 34) a catheter assembly (32) characterized in that the diameter of 34) is fixed.
  3. 　請求項１記載のカテーテル組立体（４８）において、
    　前記軸部材（５４）に着脱自在に装着される棒形状の脱離部材（５６）をさらに備え、
    　前記線状部材（５２）は、前記脱離部材（５６）が装着された前記軸部材（５４）と前記バルーン（１２）とを囲む複数の前記輪（５０）をそれぞれ独立に形成する複数から構成され、
    　前記軸部材（５４）は、前記バルーン（１２）に沿って延在する棒形状に形成され、
    　前記軸部材（５４）の周面には、前記脱離部材（５６）が着脱自在に嵌合する嵌合溝（５８）が前記軸部材（５４）の長手方向に亘って形成され、且つ前記線状部材（５２）を係止可能であり前記嵌合溝（５８）から前記軸部材（５４）の周方向に沿って延在する係止溝（６０、６０ａ、６０ｂ、６２）が前記軸部材（５４）の長手方向に沿って所定の間隔をおいて複数形成され、
    　前記線状部材（５２）が、前記嵌合溝（５８）に嵌合した前記脱離部材（５６）上を通って前記係止溝（６０、６０ａ、６０ｂ、６２）に係止されることで前記輪（５０）の径が固定され、前記脱離部材（５６）を前記嵌合溝（５８）から脱離させることに伴って前記線状部材（５２）の少なくとも一部が前記係止溝（６０、６０ａ、６０ｂ、６２）から脱離することで前記バルーン（１２）が前記輪（５０）内から解放されること、を特徴とするカテーテル組立体（４８）。     The catheter assembly (48) of claim 1,
    A rod-shaped detachable member (56) that is detachably attached to the shaft member (54);
    The linear member (52) includes a plurality of the rings (50) surrounding the shaft member (54) and the balloon (12), to which the detaching member (56) is mounted, respectively. Configured,
    The shaft member (54) is formed in a rod shape extending along the balloon (12),
    A fitting groove (58) into which the detachable member (56) is detachably fitted is formed in the circumferential surface of the shaft member (54) over the longitudinal direction of the shaft member (54), and Locking grooves (60, 60a, 60b, 62) that can lock the linear member (52) and extend from the fitting groove (58) along the circumferential direction of the shaft member (54) are the shafts. A plurality of members (54) are formed at predetermined intervals along the longitudinal direction,
    The linear member (52) passes over the detachable member (56) fitted in the fitting groove (58) and is locked to the locking groove (60, 60a, 60b, 62). And the diameter of the ring (50) is fixed, and at least a part of the linear member (52) is engaged with the engagement when the detaching member (56) is detached from the fitting groove (58). Catheter assembly (48), wherein the balloon (12) is released from within the annulus (50) by detaching from the groove (60, 60a, 60b, 62).
  4. 　請求項１記載のカテーテル組立体（１１４）において、
    　前記軸部材（１２０、１２６）に着脱自在に装着される棒形状の押圧部材（１２２）をさらに備え、
    　前記線状部材（１１８）は、前記軸部材（１２０、１２６）と前記バルーン（１２）とを囲む複数の前記輪（１１６）をそれぞれ独立に形成する複数から構成され、
    　前記軸部材（１２０、１２６）は、前記バルーン（１２）に沿って延在する棒形状に形成され、
    　前記軸部材（１２０、１２６）の外周面には、前記押圧部材（１２２）が着脱自在に嵌合する嵌合溝（１２４）が前記軸部材（１２０、１２６）の長手方向に沿って延在するように形成され、
    　前記線状部材（１１８）を前記嵌合溝（１２４）内に押圧するように前記押圧部材（１２２）が前記嵌合溝（１２４）に嵌合することで、前記輪（１１６）の径を固定し、前記押圧部材（１２２）が前記嵌合溝（１２４）から脱離することで、前記輪（１１６）の径の固定が解放されること、を特徴とするカテーテル組立体（１１４）。     The catheter assembly (114) of claim 1,
    A rod-shaped pressing member (122) that is detachably attached to the shaft member (120, 126);
    The linear member (118) is composed of a plurality of independently forming a plurality of the rings (116) surrounding the shaft member (120, 126) and the balloon (12),
    The shaft member (120, 126) is formed in a rod shape extending along the balloon (12),
    On the outer peripheral surface of the shaft member (120, 126), a fitting groove (124) into which the pressing member (122) is detachably fitted extends along the longitudinal direction of the shaft member (120, 126). Formed to
    By fitting the pressing member (122) into the fitting groove (124) so as to press the linear member (118) into the fitting groove (124), the diameter of the ring (116) is reduced. The catheter assembly (114) is characterized in that the fixing of the diameter of the ring (116) is released by fixing and releasing the pressing member (122) from the fitting groove (124).
  5. 　請求項１記載のカテーテル組立体（８８）において、
    　前記線状部材（９２）は、複数の前記輪（９０）をそれぞれ独立に形成する複数から構成され、
    　前記軸部材（９４）は、前記バルーン（１２）とともに前記輪（９０）に囲まれ且つ前記バルーン（１２）に対する前記輪（９０）の位置を固定する中空筒形状の固定部材（９６）と、前記線状部材（９２）を切断可能な切刃（１０４、１０８）を有し且つ前記固定部材（９６）の内部に挿通可能な切断部材（９８、１０６）とを備え、
    　前記固定部材（９６）は、中空の内部と外部とを連通し、前記輪（９０）の一部が前記中空の内部を横断するように複数の前記線状部材（９２）の各々を挿入可能な挿入溝（１００）が互いに前記固定部材（９６）の長手方向に沿って所定の間隔をおいて形成され、
    　前記固定部材（９６）内を長手方向に沿って前記切断部材（９８、１０６）が移動することで、前記中空の内部の前記線状部材（９２）が切断されて、前記バルーン（１２）が前記輪（９０）内から解放されること、を特徴とするカテーテル組立体（８８）。     The catheter assembly (88) of claim 1,
    The linear member (92) is composed of a plurality of independently forming a plurality of the rings (90),
    The shaft member (94) is surrounded by the ring (90) together with the balloon (12) and a hollow cylindrical fixing member (96) for fixing the position of the ring (90) with respect to the balloon (12); A cutting member (98, 106) having a cutting edge (104, 108) capable of cutting the linear member (92) and capable of being inserted into the fixing member (96);
    The fixing member (96) allows a hollow interior and an exterior to communicate with each other, and each of the plurality of linear members (92) can be inserted so that a part of the ring (90) crosses the hollow interior. Insertion grooves (100) are formed at predetermined intervals along the longitudinal direction of the fixing member (96).
    When the cutting members (98, 106) move along the longitudinal direction in the fixing member (96), the linear member (92) inside the hollow is cut, and the balloon (12) becomes A catheter assembly (88), characterized in that it is released from within the annulus (90).
  6. 　請求項１記載のカテーテル組立体（６６）において、
    　前記線状部材（７０）は、複数の前記輪（６８）をそれぞれ独立に形成する複数から構成され、
    　前記軸部材（７２）は、前記線状部材（７０）の一端側がそれぞれ巻回される複数の巻回溝（７８）が前記軸部材（７２）の長手方向に沿って所定の間隔をおいて形成された軸本体（７４）と、長手方向の一端に前記軸本体（７４）が挿入可能な開口部（８０）を有し、前記軸本体（７４）に着脱可能に装着される筒部材（７６）とを備え、
    　前記筒部材（７６）は、前記開口部（８０）に臨み且つ前記筒部材（７６）の長手方向に沿って延在するスリット（８２）が形成され、
    　前記線状部材（７０）の他端側は、前記線状部材（７０）の一端側を前記軸部材（７２）に巻回することで縮径する前記輪（６８）を形成し、
    　前記スリット（８２）を介して前記線状部材（７０）の他端側が前記筒部材（７６）の外部へ延出するように前記筒部材（７６）を前記軸本体（７４）に装着することで、前記線状部材（７０）の他端側に形成される前記輪（６８）の径を固定すること、を特徴とするカテーテル組立体（６６）。     The catheter assembly (66) of claim 1,
    The linear member (70) is composed of a plurality of independently forming a plurality of the rings (68),
    The shaft member (72) has a plurality of winding grooves (78) around which one end side of the linear member (70) is wound with a predetermined interval along the longitudinal direction of the shaft member (72). The formed shaft main body (74), and a cylindrical member that has an opening (80) into which the shaft main body (74) can be inserted at one end in the longitudinal direction, and is detachably attached to the shaft main body (74). 76)
    The cylindrical member (76) is formed with a slit (82) that faces the opening (80) and extends along the longitudinal direction of the cylindrical member (76).
    The other end side of the linear member (70) forms the ring (68) whose diameter is reduced by winding one end side of the linear member (70) around the shaft member (72),
    The cylindrical member (76) is attached to the shaft main body (74) so that the other end side of the linear member (70) extends to the outside of the cylindrical member (76) through the slit (82). The catheter assembly (66), wherein the diameter of the ring (68) formed on the other end of the linear member (70) is fixed.
  7. 　請求項１～６のいずれか１項に記載のカテーテル組立体（３２、４８、６６、８８、１１４）において、
    　前記バルーン（１２）の外表面に化学物質部（２０）が形成されていること、を特徴とするカテーテル組立体（３２、４８、６６、８８、１１４）。     The catheter assembly (32, 48, 66, 88, 114) according to any one of the preceding claims,
    A catheter assembly (32, 48, 66, 88, 114), characterized in that a chemical part (20) is formed on the outer surface of the balloon (12).
  8. 　請求項７記載のカテーテル組立体（３２、４８、６６、８８、１１４）において、
    　前記化学物質部（２０）は、再狭窄を予防する薬剤であること、を特徴とするカテーテル組立体（３２、４８、６６、８８、１１４）。     The catheter assembly (32, 48, 66, 88, 114) according to claim 7,
    A catheter assembly (32, 48, 66, 88, 114), wherein the chemical part (20) is a drug for preventing restenosis.
  9. 　バルーンカテーテル（１０）のバルーン（１２）を折り畳んで保持するバルーン折り畳み保持方法であって、
    　前記バルーン（１２）の外周を線状部材（３６、５２、７０、９２、１１８）からなる複数の輪（３４、５０、６８、９０、１１６）で囲み、複数の前記輪（３４、５０、６８、９０、１１６）を縮径させて前記バルーン（１２）を折り畳む工程と、
    　縮径させた複数の前記輪（３４、５０、６８、９０、１１６）の径を固定して前記バルーン（１２）を折り畳んだ状態で保持する工程と、
    　を備えることを特徴とするバルーン折り畳み保持方法。     A balloon folded holding method for folding and holding a balloon (12) of a balloon catheter (10), comprising:
    The outer periphery of the balloon (12) is surrounded by a plurality of rings (34, 50, 68, 90, 116) made of linear members (36, 52, 70, 92, 118), and a plurality of the rings (34, 50, 68, 90, 116) to fold the balloon (12) by reducing its diameter;
    Fixing the diameters of the plurality of reduced diameter rings (34, 50, 68, 90, 116) and holding the balloon (12) in a folded state;
    A balloon folding and holding method comprising:
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US20180207855A1 (en) * 2015-09-25 2018-07-26 Terumo Kabushiki Kaisha Balloon wrapping apparatus and balloon wrapping method
US20180207410A1 (en) * 2015-09-25 2018-07-26 Terumo Kabushiki Kaisha Balloon wrapping apparatus and balloon wrapping method
US10869995B2 (en) * 2015-09-25 2020-12-22 Terumo Kabushiki Kaisha Balloon wrapping apparatus and balloon wrapping method
JP2021041270A (en) * 2015-09-25 2021-03-18 テルモ株式会社 Balloon folding machine and balloon folding method
US11104056B2 (en) * 2015-09-25 2021-08-31 Terumo Kabushiki Kaisha Balloon wrapping apparatus and balloon wrapping method
JP6999016B2 (en) 2015-09-25 2022-01-18 テルモ株式会社 Balloon folding machine and balloon folding method

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