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WO2014006737A1 - Treatment device for treating inside of organism lumen - Google Patents

Treatment device for treating inside of organism lumen Download PDF

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Publication number
WO2014006737A1
WO2014006737A1 PCT/JP2012/067290 JP2012067290W WO2014006737A1 WO 2014006737 A1 WO2014006737 A1 WO 2014006737A1 JP 2012067290 W JP2012067290 W JP 2012067290W WO 2014006737 A1 WO2014006737 A1 WO 2014006737A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
treatment device
lumen
rotating member
substance
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2012/067290
Other languages
French (fr)
Japanese (ja)
Inventor
西田香織
柴田秀彬
石井直樹
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Priority to PCT/JP2012/067290 priority Critical patent/WO2014006737A1/en
Publication of WO2014006737A1 publication Critical patent/WO2014006737A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069Tip not integral with tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • A61B2017/00893Material properties pharmaceutically effective
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Definitions

  • the present invention relates to a treatment device for a living body lumen that applies a substance to be coated on the inner surface of a living body lumen.
  • a technique for delivering a therapeutic device to a lesion in a living organ for example, a blood vessel, a bile duct, a trachea, an esophagus, a urethra, a nasal cavity, or other organs
  • a therapeutic device for treating a stenosis that is a lesion of a blood vessel includes a stent (including a drug eluting stent: DES), a drug eluting balloon catheter (DEB), or other prosthesis that pushes the blood vessel wall from the inside. Things are used.
  • an ablation device that can be delivered via a blood vessel is used as a therapeutic device, and a treatment for cutting (ablation) a nerve inside a blood vessel (for example, a renal artery) is sometimes performed.
  • the treatment device contacts or expands on the thickened blood vessel wall (intima), whereby the elastic plate in the intima is cracked or ruptured, or the blood vessel with the contact of the treatment device It has been confirmed that the walls are inflamed and damaged.
  • a thrombus is generated in the blood vessel to embolize the peripheral blood vessel, or restenosis occurs at the treatment site.
  • improvement of the treatment of lesions has been attempted by applying the composition disclosed in US Patent Application Publication No. 2011/0077216 to the treated blood vessel wall.
  • US Patent Application Publication No. 2011/0077216 discloses a gel adhesive called alginate-catechol.
  • the catechol group reacts with the blood vessel wall, and the alginate is cross-linked by Ca 2+ present at a high concentration at the inflammatory site. For this reason, an adhesive agent will gelatinize in a short time and can coat the blood vessel wall after a treatment favorably.
  • US Patent Application Publication No. 2011/0077216 discloses a tubular member (catheter) that can be delivered into a blood vessel.
  • This therapeutic device has a discharge port on the side surface of the distal end portion, and is configured to apply an adhesive to the blood vessel wall from the discharge port after being delivered to a treatment position in the blood vessel by an operator.
  • the treatment device disclosed in U.S. Patent Application Publication No. 2011/0077216 is configured to discharge adhesive from the side surface of a catheter formed in a long and thin shape, and the influence of blood flowing in the blood vessel is reduced. Receive a lot.
  • blood near the center flows faster than blood near the blood vessel wall, so when a solution containing an adhesive substance is discharged from the side of the treatment device located on the axis of the blood vessel, The solution containing the adhesive substance is poured, and it becomes difficult to attach a sufficient amount of the adhesive substance to the treatment target.
  • the adhesive substance since the adhesive substance is discharged only from the discharge port formed at a predetermined position of the catheter, it tends to adhere nonuniformly to the blood vessel wall.
  • the present invention has been made in order to solve the above-described problem, and can apply a substance to be applied to a desired treatment target in a living body lumen uniformly and reliably, thereby improving the living body lumen. It is an object of the present invention to provide a biological intraluminal treatment device capable of being treated.
  • an intraluminal treatment device is capable of rotating along a long shaft that is inserted into a living body lumen so as to advance and retreat, and about the axis of the shaft. And a rotating member having a discharge port provided on the shaft and capable of discharging a substance to be coated in a substantially centrifugal direction of rotation.
  • the rotating member provided on the shaft is rotatable along the shaft axis and has the discharge port capable of discharging the substance to be coated, thereby rotating the rotating member in the living body lumen.
  • the material to be coated can be discharged while the operation is performed. Therefore, the substance to be coated can be uniformly attached to the wall portion in the living body lumen.
  • the substance to be coated can be discharged at a position in the vicinity of the wall in the living body lumen by discharging the substance to be coated from the discharge port in the substantially centrifugal direction of rotation. For this reason, the discharged substance to be applied is substantially affected by the fluid flowing in the living body lumen in the substantially centrifugal direction, and is reliably attached to a desired location in the living body lumen.
  • the rotating member includes a first form in which the discharge port is positioned in the vicinity of the outer surface of the shaft, and the discharge port is spaced from the position in the vicinity of the outer surface of the shaft to cover the inner surface of the living body lumen. It is preferable to be able to be deformed to the second form that is faced.
  • the rotating member can be deformed into the first and second forms, when the treatment device in the living body lumen is delivered, the rotating member is used as the first form so that the inside of the living body lumen can be smoothly performed. Can be moved. Then, by deforming the rotating member into the second form at the position where the rotating member overlaps the treatment target in the living body lumen, the substance to be coated can be discharged with the discharge port facing the inner surface of the living body lumen. .
  • the rotating member has a plurality of wings that bend in the extending direction of the shaft in the first form and expand outward in the radial direction of the shaft in the second form.
  • the rotating member is formed around the axis of the shaft when the wing part in the second form receives the flow of fluid in the living body lumen. It can be set as the structure which rotates.
  • the wing portion of the rotating member in the second embodiment rotates by receiving the flow of fluid in the living body lumen, so that the delivered rotating member can be easily rotated in the living body lumen.
  • the substance to be coated can be satisfactorily applied from the discharge port formed on the radially outer side of the wing portion.
  • the wing portion may be configured as a balloon having an internal space, and the development fluid may be supplied to the internal space to shift from the first form to the second form.
  • the wing as a balloon having an internal space, the first and second forms of the wing can be easily deformed.
  • the rotating member may include a rotating body that surrounds the shaft and rotates integrally with the wing portion, and the rotating body may include a flow passage through which the deployment fluid can flow into the internal space. .
  • the rotating body that rotates integrally with the wing portion has the flow passage through which the deployment fluid flows, the deployment fluid can easily flow in or out of the internal space of the wing portion.
  • an outer tube that surrounds the shaft and is movable back and forth with respect to the shaft is disposed in the proximal direction of the rotating body, and the rotating body and the outer tube include the outer tube.
  • a connection mechanism may be provided that is connected to the rotating body as the advancing movement is performed and restricts the rotation of the rotating body, and is detached from the rotating body as the outer tube moves backward and allows the rotation of the rotating body.
  • connection mechanism that is connected to the rotating body to restrict the rotation of the rotating body and separates from the rotating body as the outer tube moves backward is provided. And the stop can be easily switched, and the substance to be coated can be efficiently applied.
  • the shaft has a lumen for a substance to be coated that extends in the axial direction and can flow the substance to be coated, and the rotating member rotates on a bearing portion provided in the lumen for the substance to be coated. It is good to have the rotating shaft part in which the hollow part which was supported freely and in which the said lumen
  • the hollow portion communicating with the lumen for the substance to be coated of the shaft is formed in the rotating shaft portion of the rotating member, so that the substance to be coated can be easily guided from the lumen for the substance to be coated to the discharge port. A sufficient amount of the substance to be coated can be discharged to the wall in the living body lumen.
  • the following method can be adopted as a treatment method for a biological intraluminal treatment device. That is, a long shaft that is inserted into a living body lumen so as to be movable back and forth, and a shaft that is provided on the shaft so as to be rotatable around the axis of the shaft, and a substance to be coated is applied in a substantially centrifugal direction of rotation.
  • the substance to be applied can be uniformly and reliably attached to a desired treatment target in the living body lumen, and thus the living body lumen can be treated well.
  • FIG. 2A is a partial side sectional view showing a distal end portion of the treatment device of FIG. 1
  • FIG. 2B is a sectional view taken along line IIB-IIB in FIG. 2A
  • FIG. 2C is a sectional view taken along line IIC-IIC in FIG. It is.
  • FIG. 3A is a first explanatory diagram showing an operation procedure using the treatment device of FIG. 1
  • FIG. 3B is a second explanatory diagram showing an operation procedure of the treatment device following FIG. 3A
  • FIG. 4A is a third explanatory diagram illustrating an operation procedure of the treatment device following FIG. 3B
  • FIG. 4B is a fourth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 4A.
  • FIG. 5A is a fifth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 4B
  • FIG. 5B is a sixth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 5A.
  • 6A is a main part front view showing a treatment device according to a first modification
  • FIG. 6B is a main part perspective view showing a treatment device according to a second modification
  • FIG. 6C is a third modification.
  • FIG. 6D is a side sectional view of an essential part showing a treatment device according to a fourth modified example.
  • FIG. 7A is a first explanatory diagram illustrating a treatment device according to a fifth modification
  • FIG. 7B is a second explanatory diagram illustrating a treatment device according to the fifth modification.
  • FIG. 1 is a partially omitted perspective view schematically showing a biological intraluminal treatment device according to the present embodiment.
  • This intraluminal treatment device 10 (hereinafter, also simply referred to as the treatment device 10) is used to treat a lesion in a blood vessel by a treatment method (intervention) in which a catheter is inserted into a blood vessel through a small hole opened in the skin.
  • the present therapeutic device 10 is used not only for single use, but also for treatment of a lesioned portion (a narrowed portion or a portion where a blood vessel wall is weakened) by a balloon catheter, a stent or an atherectomy device, or a blood vessel treatment by an ablation device, etc. It is used to apply a substance to be applied to a lesioned part or a blood vessel wall after treatment.
  • the treatment device 10 is delivered and the substance to be applied is applied to the treatment site.
  • the treatment device 10 is delivered to apply the substance to be coated around the placement site of the stent.
  • the therapeutic device 10 is delivered and the substance to be applied is applied to the treatment site.
  • the sympathetic ablation treatment after the treatment for cutting the sympathetic nerve passing through the inside of the blood vessel wall is performed, the therapeutic device 10 is delivered and the substance to be applied is applied to the blood vessel wall at the treatment site.
  • the treatment device 10 that applies a substance to be applied to the treatment target X in the blood vessel A (blood vessel wall B) that has been expanded by balloon angioplasty will be described as a representative example.
  • the treatment device 10 is not limited to the above procedure and can be used for various procedures, and various biological lumens (for example, bile duct, trachea, esophagus, urethra, nasal cavity, other organs, etc.). Of course, it can be applied to internal therapy.
  • the treatment device 10 surrounds the shaft 12 inserted into the blood vessel A, the rotating member 14 provided at the distal end portion of the shaft 12, and the outer surface of the shaft 12 on the proximal end side of the rotating member 14. And an outer tube 16.
  • the therapeutic device 10 is delivered from the discharge port 18 formed in the rotating member 14 while the rotating member 14 is rotated at a position (or a nearby position) that is delivered to the treatment target X by being delivered through the blood vessel A by the operator.
  • the material to be applied is attached to the treatment target X by discharging the material.
  • the shaft 12 is formed into a long tubular body having a sufficient length so that the distal end portion can be delivered to the treatment target X. Further, the outer shape of the shaft 12 is formed narrower than the inner surface of the blood vessel A to be delivered. Inside the shaft 12, a hollow coated material distribution lumen 20 (coated material lumen) extends along the axial direction.
  • the shaft 12 is preferably formed of a material having flexibility that can be deformed following the shape of the blood vessel A meandering in the living body and a rigidity that can support the rotation of the rotating member 14.
  • the material constituting the shaft 12 include metals and resins.
  • the metal include pseudoelastic alloys (including superelastic alloys) such as Ni—Ti alloys (naitinol), shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405).
  • the resin examples include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof
  • polyvinyl chloride for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof
  • polyvinyl chloride for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copoly
  • Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above-described two or more polymer materials.
  • the shaft 12 can also be applied to a composite of these metals and resins (for example, a multilayer tube in which a metal and a resin are laminated).
  • an X-ray impermeable marker that can be recognized under X-ray fluoroscopy may be provided near the tip of the shaft 12.
  • a hub 22 having a diameter larger than that of the shaft 12 is provided at the proximal end portion of the shaft 12 so that the operator can easily grasp it.
  • the hub 22 can be mounted on an actuator 24 (see FIG. 3A), and the treatment device 10 is configured to be moved forward and backward by the actuator 24 in addition to the operator.
  • an actuator 24 for example, an external drive device disclosed in Japanese Patent Application Laid-Open No. 2011-152274 filed earlier by the present applicant can be suitably applied.
  • a first port 26 is connected to the base end portion of the hub 22 so as to be able to supply physiological saline and the substance to be coated, communicating with the substance distribution lumen 20 (see FIG. 3A and the like).
  • a three-way stopcock (not shown) is attached to the proximal end of the first port 26, and a physiological saline syringe (not shown) is connected to one upstream side of the three-way stopcock to supply the substance to be coated.
  • a possible substance supply device (not shown) is connected to the other upstream side of the three-way cock.
  • physiological saline or a substance to be coated is selectively supplied to the substance to be coated circulation lumen 20 while air is prevented from being mixed therein.
  • the base end structure of the shaft 12 is not limited to the above-described configuration.
  • a plurality of ports are connected to the hub 22 to supply physiological saline and a substance to be coated separately. Also good.
  • the coated substance distribution lumen 20 is formed to have an inner diameter that allows the physiological saline and the coated substance supplied from the first port 26 to smoothly flow to the tip of the shaft 12.
  • the substance to be applied is guided to the discharge port 18 of the rotating member 14 via the material distribution lumen 20 and discharged from the discharge port 18 to the treatment target X in the blood vessel A.
  • the substance to be coated examples include alginate-catechol that exhibits a strong adhesive force to the blood vessel wall B.
  • the alginate-catechol gels in the blood vessel A in a short time, and well coats the blood vessel wall B after the treatment. For this reason, it is possible to prevent the restenosis and the thrombus from occurring in the treatment target X while protecting the inflammation and the like generated in the treatment target X.
  • the material to be applied is not limited to alginate-catechol, and examples thereof include polysaccharides such as heparin and hyaluronic acid, betaine-based polymers, and catechol-modified products of polyethylene glycol.
  • various drugs including biological and physiologically active substances can be applied simultaneously.
  • a biological physiologically active substance that suppresses restenosis by adhering to a treatment site in the blood vessel A may be applied.
  • biologically bioactive substances include anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergies.
  • 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, lipoprotein-related phospholipase inhibition Agents, biological materials, interferons, NO production promoting substances, and the like.
  • anticancer agent for example, vincristine sulfate, vinblastine sulfate, vindesine sulfate, irinotecan hydrochloride, paclitaxel, docetaxel hydrate, methotrexate, cyclophosphamide and the like are preferable.
  • immunosuppressive agent for example, sirolimus (rapamycin), tacrolimus hydrate, azathioprine, cyclosporine, mycophenolate mofetil, gusperimus hydrochloride, mizoribine and the like are preferable.
  • antibiotic for example, mitomycin C, doxorubicin hydrochloride, actinomycin D, daunorubicin hydrochloride, idarubicin hydrochloride, pirarubicin hydrochloride, aclarubicin hydrochloride, epirubicin hydrochloride, pepromycin sulfate, dinostatin styramer and the like are preferable.
  • antirheumatic agent for example, sodium gold thiomalate, penicillamine, lobenzalit disodium and the like are preferable.
  • antithrombotic agent for example, heparin, ticlopidine hydrochloride, hirudin and the like are preferable.
  • an HMG-CoA reductase inhibitor or probe is preferable.
  • the HMG-CoA reductase inhibitor 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. More specifically, for example, tranilast is preferable as the antiallergic agent.
  • the retinoid for example, all-trans retinoic acid is preferable.
  • the antioxidant for example, catechins, anthocyanins, proanthocyanidins, lycopene, ⁇ -carotene and the like are preferable.
  • catechins epigallocatechin gallate is particularly preferable.
  • the tyrosine kinase inhibitor for example, genistein, tyrphostin, arbustatin and the like are preferable.
  • the anti-inflammatory agent for example, steroids such as dexamethasone and prednisolone and aspirin are preferable.
  • the bio-derived material include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), PDGF (platelet gender, etc.).
  • the physiologically active substance may include only one type of the biologically physiologically active substances exemplified above, or may include two or more different biologically 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.
  • the discharge port 18 for discharging the substance to be coated is provided in the rotating member 14, and the substance to be coated is uniformly applied to the treatment target X (blood vessel wall B) by discharging the substance to be coated during rotation. It has become. For this reason, a bearing portion 30 that protrudes radially inward is provided near the tip of the inner surface of the shaft 12 that constitutes the coated substance distribution lumen 20, and the rotating member 14 is rotatably supported by the bearing portion 30.
  • FIG. 2A is a partial side sectional view showing the distal end portion of the treatment device 10 of FIG. 1
  • FIG. 2B is a sectional view taken along line IIB-IIB in FIG. 2A
  • FIG. 2C is a sectional view taken along line IIC-IIC in FIG. FIG.
  • the rotating member 14 includes a pair of wings 32 positioned at the distal end of the treatment device 10, a flow tube 34 extending inside each wing 32, and a roll shaft member 36 (to which the pair of flow tubes 34 are connected. (Rotating shaft portion) and a rotating body 38 connected to the base end face side of the wing portion 32.
  • the pair of wing portions 32 extend in opposite directions with the axis of the shaft 12 as a base point, and discharge ports 18 for discharging the substance to be coated are formed on the outer ends. Further, the pair of wing portions 32 are curved so as to be along the axial direction of the shaft 12, and the discharge port 18 is positioned in the vicinity of the rotating body 38 (see FIGS. 3A and 3B), and the discharge port. 18 is configured to be able to take a second form (see FIGS. 1 and 2A) that faces the blood vessel wall B away from the vicinity of the rotating body 38.
  • the interior of the wing part 32 is formed as a cavity 40 (internal space) having a predetermined volume, and a developing fluid (for example, physiological saline or contrast medium) can flow into the cavity 40. ing.
  • a developing fluid for example, physiological saline or contrast medium
  • the deformation of the first form and the second form is realized by supplying and discharging the development fluid. That is, the wing portion 32 is configured as a balloon that can be expanded and contracted, and in a state where the deployment fluid is not present in the cavity portion 40 (in a state where the fluid is discharged), the wing portion 32 is deflated and becomes the first form. Is in the cavity 40 (the supplied state), the wing 32 expands to the second form.
  • the wing portion 32 has a shape in which the body portion from the center portion toward the outer end portion is curved and contacts the outer surface of the rotating body 38. This shape is preferably stored in advance (shaped). As a result, after the wing portion 32 is deformed to the second configuration in response to the inflow of the deployment fluid, when the deployment fluid is discharged, the body portion is automatically restored to the first configuration in contact with the outer surface of the rotating body 38. Is done.
  • the wing portion 32 in the second embodiment has a predetermined thickness and is formed to have a distal end surface 32a and a proximal end surface 32b having a narrow end portion at the center and a wide outer end portion.
  • the distal end surface 32a and the proximal end surface 32b are formed as inclined surfaces that receive the blood flow in the blood vessel A from the front or rear and flow obliquely. Therefore, when the wing 32 receives a blood flow flowing in the blood vessel A (in the axial direction of the treatment device 10), the wing 32 rotates around the axis.
  • the degree of deployment of the wings 32 in the second embodiment can be adjusted according to the inflow amount of the deployment fluid. Thereby, blood vessels of various thicknesses can be treated with one therapeutic device 10.
  • a silicon rubber that can easily adjust the degree of expansion of the wing portion 32 in the blood vessel A can be suitably used.
  • the material is not particularly limited as long as it can be deformed into the first and second forms by supplying and discharging the development fluid, and can be rotated by the blood flow in the second form.
  • the pair of flow pipes 34 provided in the hollow portion 40 is configured as a tube body extending radially outward from the center portion.
  • Each flow pipe 34 has a flow passage 42 therein, and an outer end portion of the flow passage 42 communicates with the discharge port 18.
  • an end portion on the center side of the flow pipe 34 is connected to the roll shaft member 36.
  • the material which comprises the flow pipe 34 is not specifically limited, For example, the same material as the wing
  • the roll shaft member 36 is a substantially T-shaped tubular member, and extends in the proximal direction by connecting to a pair of branch portions 44 protruding radially outward at the distal end portion and an intermediate portion of the pair of branch portions 44.
  • Main shaft portion 46 Main shaft portion 46.
  • a guide path 48 (hollow part) is formed in the pair of branch parts 44 and the main shaft part 46 so that the flow path 42 and the material to be coated circulation lumen 20 can be conducted.
  • the pair of branch portions 44 are located on the distal end side of the distal end of the shaft 12, are inserted into the pair of wing portions 32 (hollow portion 40), and project in the same direction as the pair of wing portions 32. Further, the branch portion 44 is fitted and connected to the flow pipe 34, and the flow passage 42 and the guide passage 48 are communicated with each other.
  • the main shaft portion 46 connected to the branching portion 44 is inserted from the outside of the shaft 12 into the inside (the substance to be coated circulation lumen 20), and extends within the length of the coating substance circulation lumen 20 beyond the bearing portion 30. Yes. Further, the outer shape of the main shaft portion 46 is formed to have a thickness that is supported by the bearing portion 30. The axis of the main shaft portion 46 is disposed so as to coincide with the axis of the shaft 12.
  • a flange portion 50 having a diameter increased outward in the radial direction is formed.
  • the flange portion 50 is configured to be caught on the base end surface of the bearing portion 30, and prevents the roll shaft member 36 from falling off the shaft 12.
  • the roll shaft member 36 functions as a rotating shaft of the pair of wing portions 32 by being rotatable with respect to the bearing portion 30. Thereby, the rotating member 14 rotates around the axis of the shaft 12.
  • the rotating body 38 connected to the wing portion 32 is formed in a substantially bullet-shaped container having an accommodation space 52 in which the shaft 12 can be accommodated.
  • the wall 38a constituting the rotating body 38 has a distal end joined to the pair of wings 32, extends from the distal end in the proximal direction, and further axially extends from the curved portion toward the proximal direction. Extends in parallel with.
  • the inner surface of the curved portion of the wall portion 38 a is an abutting portion 54 that abuts on the curved portion of the tip portion of the shaft 12.
  • a pair of rotating body-side fluid passages 56 are formed in the wall portion 38a of the rotating body 38.
  • the rotating body-side fluid passages 56 are formed of elongated holes through which the developing fluid can flow.
  • the rotating body side fluid passage 56 extends from the distal end portion to the proximal end portion along the substantially bullet-shaped wall portion 38 a, and the distal end opening communicates with the cavity portion 40 of the pair of wing portions 32.
  • a valve body 58 that blocks outflow of the developing fluid is provided at the proximal end opening of the rotor-side fluid passage 56.
  • a connection mechanism 60 is provided on the base end surface of the rotating body 38 so that the rotating body 38 and the outer tube 16 can be easily connected. The connection mechanism 60 will be described later.
  • the rotating member 14 configured as described above is rotatable relative to the shaft 12.
  • the rotating member 14 according to the present embodiment automatically rotates when the wing portion 32 receives blood flow.
  • the rotation state (rotation and stop) of the rotation member 14 is switched by an outer tube 16 disposed on the base end side.
  • the outer tube 16 is a tubular body that extends along the axial direction of the shaft 12 and is slightly shorter than the shaft 12.
  • the outer tube 16 is exposed to the outside of the living body with the rotating member 14 delivered to the treatment target X.
  • a through lumen 62 having an inner diameter larger than the outer diameter of the shaft 12 is formed inside the outer tube 16, and the shaft 12 is inserted into the through lumen 62. That is, the shaft centers of the shaft 12 and the outer tube 16 are substantially coaxial.
  • a flange 64 (operation part) that expands radially outward is formed at the proximal end of the outer tube 16.
  • the flange portion 64 is located in front of the hub 22, and a fluid passage port 66 is formed at a predetermined position on the side surface thereof.
  • a second port 68 (see FIG. 3A and the like) is connected to the fluid passage port 66, and a developing fluid can be supplied by a pressure application device such as an indeflator (not shown).
  • the outer tube 16 is moved forward and backward relative to the shaft 12 and the rotating member 14 by the forward and backward movement of the collar portion 64.
  • An outer tube side fluid passage 70 extending from the distal end to the proximal end is formed inside the wall portion 16a constituting the outer tube 16.
  • the outer pipe side fluid passage 70 extends in a pair inside the outer pipe 16, joins at the flange 64 on the base end side, and communicates with the fluid passage port 66.
  • a projecting portion 72 that protrudes in the distal direction is formed at the distal end portion of the outer tube 16, and the outer tube side fluid passage 70 passes through the projecting portion 72.
  • the protrusion 72 is inserted into the valve body 58 in a state where the rotating member 14 and the outer tube 16 are connected, thereby realizing communication between the rotating body-side fluid passage 56 and the outer tube-side fluid passage 70.
  • connection mechanism 60 that connects the rotating member 14 and the outer tube 16 switches between a connection state and a detached state with the rotating member 14 as the outer tube 16 moves forward and backward. Yes.
  • the connection mechanism 60 includes the above-described valve body 58 of the rotating body 38 and the protrusion 72 of the outer tube 16, a magnet 74 (magnetic body) embedded in the rotating body 38, and a metal material 76 embedded in the outer tube 16. (For example, iron).
  • a pair of magnets 74 is provided on the base end surface of the rotating body 38 at a position shifted by 90 ° in the circumferential direction with respect to the pair of valve bodies 58.
  • a pair of metal members 76 are provided on the distal end surface of the outer tube 16 at positions shifted by 90 ° in the circumferential direction with respect to the pair of protrusions 72.
  • the magnet 74 acts to attract the metal material 76, and when the distal end surface of the outer tube 16 approaches the base end surface of the rotator 38, the rotator 38 is guided so that the magnet 74 and the metal material 76 coincide with each other in the circumferential direction.
  • the valve body 58 and the projection 72 are opposed to each other, and when the rotary body 38 and the outer tube 16 are to be connected, the projection 72 is easily inserted into the valve body 58 and the rotary body-side fluid passage 56 The pipe side fluid passage 70 is communicated. Further, since the magnet 74 and the metal material 76 are brought into close contact with each other by magnetic force, the rotating body 38 and the outer tube 16 are fixed, and the rotation of the rotating member 14 can be stopped.
  • the outer tube 16 is moved in the proximal direction beyond the magnetic force of the magnet 74 with the rotating body 38 and the outer tube 16 connected, the outer tube 16 is detached from the rotating member 14.
  • the protrusion 72 is removed from the valve body 58, and the valve body 58 is self-closed. Therefore, even if the developing fluid is present in the rotor-side fluid passage 56, the valve body 58 prevents leakage. Further, the rotating member 14 can be rotated by blood flow as the outer tube 16 is detached.
  • the treatment device 10 is preferably provided so as to cover the periphery with a sheath 78 in a state where the pair of wings 32 are folded inward (see FIG. 3A). .
  • blade part 32 does not expand
  • the treatment device 10 according to the present embodiment is basically configured as described above, and the operation and effect will be described below.
  • Priming is performed on the treatment device 10 according to the present embodiment to fill the inside of the treatment device 10 with physiological saline before introduction into the living body (priming step).
  • physiological saline is supplied through the first port 26 while the sheath 78 is attached to the distal end portion of the treatment device 10, and physiological saline is supplied through the substance distribution lumen 20. Lead to the tip side of the shaft 12.
  • the physiological saline flows into the guide path 48 of the roll shaft member 36 and is discharged from the discharge port 18 through the flow path 42 of the flow pipe 34.
  • air is extracted from the coated substance distribution lumen 20, the guide path 48, and the flow path 42 and filled with physiological saline.
  • a developing fluid (physiological saline) is supplied through the second port 68, and the developing fluid is supplied to the cavity 40 of the wing 32 through the outer tube side fluid passage 70 and the rotating body side fluid passage 56. Inflow. At this time, the rotating member 14 and the outer tube 16 are connected by the connection mechanism 60, and the developing fluid is easily guided to the cavity 40.
  • the supply amount of the deployment fluid at the time of priming is an amount sufficient to maintain the first form, and since the sheath 78 exists around the wing portion 32, the deployment of the wing portion 32 is restricted. In this way, by filling the wing 32 with the deployment fluid before insertion into the living body, the subsequent operation of the treatment device 10 (deployment of the wing 32) can be performed efficiently.
  • the primed treatment device 10 is used for applying a substance to be applied to a treatment site (treatment target X) in balloon angioplasty. Therefore, before the treatment device 10 is used, a treatment for expanding a stenosis, which is a lesion in the blood vessel A or the like, with a balloon catheter (not shown) is performed.
  • the surgeon first identifies the form of the lesion by an intravascular imaging method or an intravascular ultrasonic diagnostic method.
  • a guide wire is introduced into the blood vessel percutaneously from the thigh or the like, for example, by the Seldinger method, and the balloon catheter is advanced along the guide wire.
  • the stenosis is pushed outward in the radial direction of the blood vessel.
  • the balloon is deflated and the balloon catheter is withdrawn from the blood vessel. Thereby, the treatment by the balloon catheter is completed.
  • a delivery step of delivering the therapeutic device 10 to the treatment target X whose stenosis portion is pushed and expanded is performed.
  • this delivery step as shown in FIG. 3B, the sheath 78 attached to the distal end portion of the treatment device 10 is removed, and the treatment device 10 is inserted from the same insertion site as the balloon catheter.
  • the wing portion 32 of the treatment device 10 is maintained in the first form in contact with the rotating body 38, and the rotating member 14 is sufficiently thinner than the inner surface of the blood vessel A. Therefore, the treatment device 10 is smoothly delivered to the treatment target X without damaging the inner surface of the blood vessel A.
  • the delivery is stopped.
  • the wing 32 of the rotating member 14 is shifted to the second form. That is, the expansion
  • a deployment fluid is supplied to the outer tube side fluid passage 70 via the second port 68.
  • the developing fluid is guided to the rotating body side fluid passage 56 through the outer tube side fluid passage 70 and further flows into the cavity portion 40 of the wing portion 32.
  • blade part 32 transfers to a 2nd form from a 1st form.
  • the pair of wings 32 are expanded with a predetermined internal pressure to form the shape of the second form. Since the form of the treatment target X is specified before the treatment of the treatment device 10, the supply amount of the deployment fluid can be appropriately adjusted. That is, the supply amount is set so that the radial length of the pair of wings 32 is shorter than the diameter of the blood vessel wall B, and the pair of wings 32 is expanded.
  • the wings 32 are expanded so as to be orthogonal to the axis of the shaft 12.
  • the discharge port 18 is made to face the blood vessel wall B.
  • the pair of wing parts can be obtained by reducing the supply amount of the developing fluid. 32 is tilted and deployed, so that the discharge port 18 faces the blood vessel wall B. That is, the treatment device 10 can appropriately arrange the discharge port 18 in the vicinity of the treatment target X by adjusting the degree of expansion of the wing 32 according to the thickness of the blood vessel A.
  • the outer ends of the pair of wings 32 are brought into contact with the blood vessel wall B, and then the deployment fluid is somewhat removed from the cavity 40.
  • the work of adjusting the length of the wing portion 32 in the radial direction may be shortened.
  • the axial center of the shaft 12 can be easily matched (centered) with the axial center in the blood vessel A.
  • a rotating step for rotating the rotating member 14 is performed.
  • the outer tube 16 is moved in the proximal direction, and the outer tube 16 is detached from the rotating body 38.
  • the developing fluid supplied to the cavity 40 remains on the rotating member 14 side by closing the valve body 58.
  • blade part 32 is maintained in the state of a 2nd form. Then, when the pair of wing portions 32 receives blood flowing in the blood vessel A, the rotating member 14 automatically rotates.
  • an application step of applying a substance to be applied to the treatment target X is performed.
  • the material to be coated is supplied to the material circulation lumen 20 through the first port 26, and the material to be coated is guided to the tip of the shaft 12 through the material circulation lumen 20.
  • the material to be coated is discharged from the discharge port 18 through the guide path 48 of the rotating roll shaft member 36 and the flow path 42 of the flow pipe 34.
  • the treatment device 10 is a treatment target X It is possible to apply the substance to be applied more accurately.
  • the treatment device 10 does not cause uneven application or coating failure of the substance to be applied.
  • the rotating member 14 rotates, the blood in the blood vessel A acts in the centrifugal direction (radial direction) of the wing portion 32 based on the shape of the wing portion 32. Thereby, since the rotating member 14 is guided so as to be positioned at the axial center of the blood vessel A, the pair of wing portions 32 can be prevented from contacting the blood vessel wall B.
  • a moving step is performed in which the treatment device 10 is moved by the actuator 24 while applying the substance to be applied.
  • the treatment device 10 is moved backward at a constant speed by the actuator 24 connected to the hub 22. Therefore, the distal end portion of the shaft 12 and the rotating member 14 that are in a position overlapping the treatment target X also move backward at a constant speed.
  • the therapeutic device 10 can apply
  • the rotating member 14 In the moving step, after the rotating member 14 is moved backward, it can be moved again to apply the substance to be coated more reliably. That is, in the procedure using the treatment device 10, the rotation member 14 may move back and forth in the blood vessel A any number of times.
  • a backward movement step for contracting the pair of wings 32 and moving the treatment device 10 backward from the blood vessel A is performed as shown in FIG. 5B.
  • the rotation of the rotating member 14 is stopped by moving the outer tube 16 forward and reconnecting the rotating body 38 and the outer tube 16.
  • the magnet 74 and the metal material 76 of the connection mechanism 60 are attracted.
  • the valve body 58 of the rotating body 38 and the protruding portion 72 of the outer tube 16 face each other, and the protruding portion 72 is inserted into the valve body 58 as the rotating body 38 and the outer tube 16 are connected. Accordingly, the rotor-side fluid passage 56 and the outer tube-side fluid passage 70 communicate with each other.
  • the outer tube 16 After the outer tube 16 is connected to the rotating member 14, an operation of discharging the deployment fluid through the second port 68 is performed. As a result, the deployment fluid that has deployed the pair of wings 32 is discharged, and the pair of wings 32 contracts. As described above, since the pair of wing portions 32 is preliminarily stored in the first form, the pair of wing portions 32 can be easily bent so as to come into contact with the outer surface of the rotating body 38. Therefore, the treatment device 10 can be removed from the living body by smoothly moving the rotating member 14 backward from the blood vessel A.
  • the treatment device 10 is not limited to the above-described embodiment, and various modifications and application examples can be taken. Hereinafter, some modifications of the treatment device 10 according to the present invention will be described. In addition, in the following description, about the structure same as the treatment device 10 concerning this Embodiment, or the structure which has the same function, the same code
  • the treatment device 10 ⁇ / b> A according to the first modification is provided with eight wings 33 along the circumferential direction at the distal end portion of the rotation member 15, and the eight wings 33 allow the rotation member to rotate. 15 is configured to rotate.
  • the discharge port 18 for the substance to be coated may be provided in all the wing parts 33, or may be provided only in a part of the wing parts 33.
  • the number of the wings 32 and 33 provided on the rotating members 14 and 15 is not limited, and the shape of the wings 32 and 33 may be appropriately formed according to the number of sheets.
  • the number of wings 32 and 33 that can achieve both smooth delivery of the treatment device 10 (first form) and rotation of the rotating members 14 and 15 (second form) includes 2 to 8.
  • the treatment device 10 ⁇ / b> B according to the second modification includes a valley portion 80 in which the connection mechanism 61 is provided at the proximal end portion of the rotating body 38 and a mountain portion provided at the distal end portion of the outer tube 16. 82.
  • the valley portion 80 and the mountain portion 82 are connected to each other without any gap by engaging with each other. Therefore, the engagement state between the valley portion 80 and the mountain portion 82 can be switched in accordance with the forward / backward operation of the outer tube 16, and the rotation and rotation stop of the rotating member 14 can be switched.
  • the rotating body side fluid passage 56 and the outer tube side fluid passage 70 are provided in the valley portion 80 and the mountain portion 82, respectively, so that they can be easily communicated in the connected state. That is, the structure of the connection mechanism 61 can employ various structures that connect the rotating member 14 and the outer tube 16.
  • the guide path 48 of the roll shaft member 36 is in direct communication with the cavity 40 of the pair of wings 32, and the pair of coated devices is supplied by supplying the substance to be coated.
  • the wing portion 32 is expanded.
  • the discharge port 18 for discharging the substance to be coated is provided sufficiently small at the outer ends of the pair of wings 32 and communicates with the cavity 40, and is applied from the wings 32 expanded by a predetermined internal pressure.
  • the coating material can be discharged.
  • the treatment device 10 ⁇ / b> D includes an outer roll shaft member 84 coupled to the wing portion 32 and an inner roll shaft member 86 that passes through the inside of the outer roll shaft member 84.
  • a roll shaft member 37 having a double structure is provided.
  • the shaft 12 is comprised by the double tube body by which the inner tube
  • the outer roll shaft member 84 is formed therein with a fluid passage 90 through which a developing fluid can flow, and is rotatably supported by a bearing portion 30a provided in the shaft 12 (the developing fluid flow lumen 92). Is done.
  • the inner roll shaft member 86 is provided with a material flow passage 94 through which the material to be coated can flow, and this material flow passage 94 is connected to the material flow lumen 21 of the inner pipe 88 and discharged.
  • the outlet 18 is in communication.
  • the inner roll shaft member 86 is rotatably supported by a bearing portion 30b provided in the coated material distribution lumen 21.
  • the treatment device 10D according to the fourth modification can obtain the same effect as the treatment device 10 according to the present embodiment.
  • the treatment device 10E according to the fifth modification is configured to be inserted into the blood vessel A while being accommodated in the sheath 78.
  • the pair of wing portions 32 is formed in a shape (second form) extending in a direction orthogonal to the axial direction of the shaft 12 in a natural state, and is elastically deformed by being accommodated in the sheath 78. And it becomes the 1st form.
  • the treatment device 10 ⁇ / b> E may be configured to be positioned (centered) along the axis of the blood vessel A by being supported by the sheath 78 via the support member 96.
  • the rotating member 14 is automatically rotated by the blood flow in the state of transition to the second form, and discharges the substance to be coated from the discharge port 18. After the application, it is accommodated again in the sheath 78 and removed.
  • the rotating member 14 can be rotated by various means regardless of the blood flow.
  • the rotating member 14 may be rotated using the flow of the material to be coated.
  • the core material connected to the rotation member 14 is exposed at the proximal end portion of the treatment device 10, the core material is rotated by a driving source such as an operator's manual or a motor, and the rotation member 14 at the distal end portion is rotated. Also good.
  • the rotating member 14 provided on the shaft 12 is rotatable along the axis of the shaft 12 and is coated.
  • the discharge port 18 capable of discharging the substance
  • the substance to be coated can be discharged while rotating the rotating member 14 in the blood vessel A. Therefore, the substance to be coated can be uniformly attached to the treatment target X (blood vessel wall B).
  • the discharge port 18 is located in the substantially centrifugal direction of the wing part 32, the substance to be coated can be discharged near the treatment target X. For this reason, the discharged substance to be applied is directed substantially in the centrifugal direction without being substantially affected by the blood flowing in the blood vessel A, and is reliably attached to the treatment target X.
  • the rotating member 14 can be deformed into the first and second forms, when the therapeutic device 10 is delivered, the rotating member 14 can be smoothly moved in the blood vessel A as the first form. it can. And in the position which overlaps with the treatment target X, by deform
  • the pair of wings 32 is configured as a balloon, the radial length of the pair of wings 32 can be easily adjusted, and the contact between the wings 32 and the blood vessel wall B is suppressed and rotated. The member 14 can be rotated.
  • the coated substance can be easily transferred from the coated substance distribution lumen 20 to the discharge port 18. Therefore, a sufficient amount of the substance to be coated can be discharged to the treatment target X.
  • the substance to be coated has a high viscosity (a solution in which a high-molecular substance that expresses adhesiveness, such as sugars, betaine-based polymers, and polyethylene glycol) is dissolved) Is supplied, it is assumed that clogging is relatively easy in the flow path in the process of injecting the material to be coated.
  • the flow path of the substance to be applied extends substantially linearly to the roll shaft member 36, and the discharge port 18 is provided in the centrifugal direction in which the roll shaft member 36 rotates. Since it is formed, even a high-viscosity material can be smoothly guided to the discharge port 18 without clogging.

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Description

生体管腔内治療デバイスIntraluminal therapy device

 本発明は、生体管腔の内面に被塗布物質を塗布する生体管腔内治療デバイスに関する。 The present invention relates to a treatment device for a living body lumen that applies a substance to be coated on the inner surface of a living body lumen.

 生体器官(例えば、血管、胆管、気管、食道、尿道、鼻腔、或いはその他の臓器等)に生じた病変部に対しては、生体管腔内を通して治療デバイスを送達し、所定の治療を施す手技が行われている。例えば、血管の病変部である狭窄部を処置する治療デバイスとしては、血管壁を内側から押し広げるステント(薬剤溶出型ステント:DESを含む)や薬剤溶出型バルーンカテーテル(DEB)、或いは他の補綴物等が用いられる。また、近年では、治療デバイスとして血管内を介して送達可能なアブレーションデバイスを用い、血管(例えば、腎動脈)の内部の神経を切断(アブレーション)する処置等を行うこともある。 A technique for delivering a therapeutic device to a lesion in a living organ (for example, a blood vessel, a bile duct, a trachea, an esophagus, a urethra, a nasal cavity, or other organs) and delivering a predetermined treatment through the living body lumen. Has been done. For example, a therapeutic device for treating a stenosis that is a lesion of a blood vessel includes a stent (including a drug eluting stent: DES), a drug eluting balloon catheter (DEB), or other prosthesis that pushes the blood vessel wall from the inside. Things are used. In recent years, an ablation device that can be delivered via a blood vessel is used as a therapeutic device, and a treatment for cutting (ablation) a nerve inside a blood vessel (for example, a renal artery) is sometimes performed.

 ところで、上記の手技では、肥厚した血管壁(内膜)に治療デバイスが接触又は拡張することで内膜中の弾性板に亀裂が生じたり、断裂したりする、又は治療デバイスの接触にともない血管壁に炎症や損傷が生じることが確認されている。さらに、治療後に、血管内に血栓が発生して末梢血管を塞栓したり、処置箇所に再狭窄が生じたりする不都合も生じる。このため、近年では、米国特許出願公開第2011/0077216号明細書に開示されている組成物を処置した血管壁に塗布する等して、病変部の治療の改善が図られている。 By the way, in the above procedure, the treatment device contacts or expands on the thickened blood vessel wall (intima), whereby the elastic plate in the intima is cracked or ruptured, or the blood vessel with the contact of the treatment device It has been confirmed that the walls are inflamed and damaged. In addition, after treatment, a thrombus is generated in the blood vessel to embolize the peripheral blood vessel, or restenosis occurs at the treatment site. For this reason, in recent years, improvement of the treatment of lesions has been attempted by applying the composition disclosed in US Patent Application Publication No. 2011/0077216 to the treated blood vessel wall.

 米国特許出願公開第2011/0077216号明細書には、アルギネート-カテコールと呼ばれるゲル状の接着剤が開示されている。この接着剤は、血管壁に吐出されると、カテコール基が血管壁と反応し、且つ炎症部位に高濃度に存在するCa2+によりアルギネートが架橋される。このため、接着剤は短時間にゲル化することとなり、処置後の血管壁を良好にコーティングすることができる。 US Patent Application Publication No. 2011/0077216 discloses a gel adhesive called alginate-catechol. When this adhesive is discharged onto the blood vessel wall, the catechol group reacts with the blood vessel wall, and the alginate is cross-linked by Ca 2+ present at a high concentration at the inflammatory site. For this reason, an adhesive agent will gelatinize in a short time and can coat the blood vessel wall after a treatment favorably.

 また、上記の接着剤を塗布する治療デバイスとして、米国特許出願公開第2011/0077216号明細書には、血管内を送達可能な管状の部材(カテーテル)が開示されている。この治療デバイスは、先端部の側面に吐出口を有し、術者により血管内の処置位置に送達された後、吐出口から血管壁に接着剤を塗布するように構成されている。 Also, as a treatment device for applying the above adhesive, US Patent Application Publication No. 2011/0077216 discloses a tubular member (catheter) that can be delivered into a blood vessel. This therapeutic device has a discharge port on the side surface of the distal end portion, and is configured to apply an adhesive to the blood vessel wall from the discharge port after being delivered to a treatment position in the blood vessel by an operator.

 しかしながら、米国特許出願公開第2011/0077216号明細書に開示されている治療デバイスは、長細く形成されたカテーテルの側面から接着剤を吐出する構成となっており、血管内を流れる血液の影響を大きく受ける。特に、血管内では、血管壁付近の血液よりも中心部付近の血液の方が速く流れるため、血管の軸心上に位置する治療デバイスの側面から接着性物質を含む溶液を吐出すると、血液によって接着性物質を含む溶液が流され、充分な量の接着性物質を処置対象に付着させることが困難となる。また、接着性物質は、カテーテルの所定位置に形成された吐出口からのみ吐出されるため、血管壁に対し不均一に付着されやすい。 However, the treatment device disclosed in U.S. Patent Application Publication No. 2011/0077216 is configured to discharge adhesive from the side surface of a catheter formed in a long and thin shape, and the influence of blood flowing in the blood vessel is reduced. Receive a lot. In particular, in blood vessels, blood near the center flows faster than blood near the blood vessel wall, so when a solution containing an adhesive substance is discharged from the side of the treatment device located on the axis of the blood vessel, The solution containing the adhesive substance is poured, and it becomes difficult to attach a sufficient amount of the adhesive substance to the treatment target. In addition, since the adhesive substance is discharged only from the discharge port formed at a predetermined position of the catheter, it tends to adhere nonuniformly to the blood vessel wall.

 本発明は、上記の課題を解決するためになされたものであって、生体管腔内の所望の処置対象に被塗布物質を均一且つ確実に付着させることができ、これにより生体管腔を良好に治療することが可能な生体管腔内治療デバイスを提供することを目的とする。 The present invention has been made in order to solve the above-described problem, and can apply a substance to be applied to a desired treatment target in a living body lumen uniformly and reliably, thereby improving the living body lumen. It is an object of the present invention to provide a biological intraluminal treatment device capable of being treated.

 前記の目的を達成するために、本発明に係る生体管腔内治療デバイスは、生体管腔内に進退自在に挿入される長尺なシャフトと、前記シャフトの軸回りに沿って回転自在となるように該シャフトに設けられ、且つ回転の略遠心方向に被塗布物質を吐出可能な吐出口を有する回転部材とを備えることを特徴とする。 In order to achieve the above object, an intraluminal treatment device according to the present invention is capable of rotating along a long shaft that is inserted into a living body lumen so as to advance and retreat, and about the axis of the shaft. And a rotating member having a discharge port provided on the shaft and capable of discharging a substance to be coated in a substantially centrifugal direction of rotation.

 上記によれば、シャフトに設けられた回転部材が、シャフトの軸回りに沿って回転自在であり、且つ被塗布物質を吐出可能な吐出口を有することで、生体管腔内で回転部材を回転させながら被塗布物質を吐出することができる。従って、生体管腔内の壁部に被塗布物質を均一的に付着させることができる。また、回転の略遠心方向にある吐出口から被塗布物質を吐出することにより、生体管腔内の壁部の近傍位置で被塗布物質を吐出することができる。このため、吐出された被塗布物質は、生体管腔内を流れる流体の影響をほとんど受けることなく略遠心方向に向かい、生体管腔内の所望箇所に確実に付着される。 According to the above, the rotating member provided on the shaft is rotatable along the shaft axis and has the discharge port capable of discharging the substance to be coated, thereby rotating the rotating member in the living body lumen. The material to be coated can be discharged while the operation is performed. Therefore, the substance to be coated can be uniformly attached to the wall portion in the living body lumen. In addition, the substance to be coated can be discharged at a position in the vicinity of the wall in the living body lumen by discharging the substance to be coated from the discharge port in the substantially centrifugal direction of rotation. For this reason, the discharged substance to be applied is substantially affected by the fluid flowing in the living body lumen in the substantially centrifugal direction, and is reliably attached to a desired location in the living body lumen.

 また、前記回転部材は、前記シャフトの外側面の近傍位置に前記吐出口が位置する第1形態と、前記吐出口が前記シャフトの外側面の近傍位置から離間して前記生体管腔の内面を臨む第2形態とに変形自在であることが好ましい。 Further, the rotating member includes a first form in which the discharge port is positioned in the vicinity of the outer surface of the shaft, and the discharge port is spaced from the position in the vicinity of the outer surface of the shaft to cover the inner surface of the living body lumen. It is preferable to be able to be deformed to the second form that is faced.

 このように、回転部材が、第1及び第2形態に変形自在であることで、生体管腔内治療デバイスを送達する場合には、回転部材を第1形態として、生体管腔内を円滑に移動させることができる。そして、回転部材が生体管腔内の処置対象に重なる位置で、回転部材を第2形態に変形することにより、吐出口を生体管腔の内面に臨ませて被塗布物質を吐出することができる。 As described above, since the rotating member can be deformed into the first and second forms, when the treatment device in the living body lumen is delivered, the rotating member is used as the first form so that the inside of the living body lumen can be smoothly performed. Can be moved. Then, by deforming the rotating member into the second form at the position where the rotating member overlaps the treatment target in the living body lumen, the substance to be coated can be discharged with the discharge port facing the inner surface of the living body lumen. .

 さらに、前記回転部材は、前記第1形態で前記シャフトの延在方向に撓み、前記第2形態で前記シャフトの径方向外側に展開する複数の羽部を有し、前記吐出口は、前記第2形態における前記羽部の径方向外側に形成されており、前記回転部材は、前記第2形態における前記羽部が前記生体管腔内の流体の流れを受けることにより、前記シャフトの軸回りに回転する構成とすることができる。 Further, the rotating member has a plurality of wings that bend in the extending direction of the shaft in the first form and expand outward in the radial direction of the shaft in the second form. The rotating member is formed around the axis of the shaft when the wing part in the second form receives the flow of fluid in the living body lumen. It can be set as the structure which rotates.

 このように、第2形態における回転部材の羽部が、生体管腔内の流体の流れを受けることにより回転することで、生体管腔内において、送達した回転部材を簡単に回転させることができ、羽部の径方向外側に形成された吐出口から被塗布物質を良好に塗布することができる。 As described above, the wing portion of the rotating member in the second embodiment rotates by receiving the flow of fluid in the living body lumen, so that the delivered rotating member can be easily rotated in the living body lumen. The substance to be coated can be satisfactorily applied from the discharge port formed on the radially outer side of the wing portion.

 この場合、前記羽部は、内部空間を有するバルーンとして構成され、前記内部空間に展開用流体が供給されることにより前記第1形態から前記第2形態に移行するとよい。 In this case, the wing portion may be configured as a balloon having an internal space, and the development fluid may be supplied to the internal space to shift from the first form to the second form.

 このように、羽部が内部空間を有するバルーンとして構成されることで、羽部の第1及び第2形態の変形を容易に行うことができる。 Thus, by configuring the wing as a balloon having an internal space, the first and second forms of the wing can be easily deformed.

 また、前記回転部材は、前記シャフトの周囲を囲い、前記羽部と一体回転する回転体を有し、前記回転体は、前記内部空間に前記展開用流体を流入可能な流通路を有するとよい。 The rotating member may include a rotating body that surrounds the shaft and rotates integrally with the wing portion, and the rotating body may include a flow passage through which the deployment fluid can flow into the internal space. .

 このように、羽部と一体回転する回転体が展開用流体を流入させる流通路を有することで、羽部の内部空間に対し展開用流体を簡単に流入又は流出させることができる。 As described above, since the rotating body that rotates integrally with the wing portion has the flow passage through which the deployment fluid flows, the deployment fluid can easily flow in or out of the internal space of the wing portion.

 上記の構成に加えて、前記回転体の基端方向には、前記シャフトの周囲を囲い前記シャフトに対し進退自在な外管が配置され、前記回転体と前記外管には、前記外管の進出移動にともない前記回転体に接続されて該回転体の回転を規制し、前記外管の後退移動にともない前記回転体から離脱され該回転体の回転を許容する接続機構が設けられるとよい。 In addition to the above configuration, an outer tube that surrounds the shaft and is movable back and forth with respect to the shaft is disposed in the proximal direction of the rotating body, and the rotating body and the outer tube include the outer tube. A connection mechanism may be provided that is connected to the rotating body as the advancing movement is performed and restricts the rotation of the rotating body, and is detached from the rotating body as the outer tube moves backward and allows the rotation of the rotating body.

 このように、回転体に接続されて該回転体の回転を規制し、外管の後退移動にともない回転体から離脱する接続機構が設けられることで、外管の進退操作にともない回転部材の回転と停止を簡単に切り替えることができ、被塗布物質を効率的に塗布することができる。 As described above, the connection mechanism that is connected to the rotating body to restrict the rotation of the rotating body and separates from the rotating body as the outer tube moves backward is provided. And the stop can be easily switched, and the substance to be coated can be efficiently applied.

 ここで、前記シャフトは、軸方向に延在し前記被塗布物質を流通可能な被塗布物質用ルーメンを有し、前記回転部材は、前記被塗布物質用ルーメン内に設けられた軸受部に回転自在に支持され、且つ前記被塗布物質用ルーメンと前記吐出口を連通する中空部が形成された回転軸部を有するとよい。 Here, the shaft has a lumen for a substance to be coated that extends in the axial direction and can flow the substance to be coated, and the rotating member rotates on a bearing portion provided in the lumen for the substance to be coated. It is good to have the rotating shaft part in which the hollow part which was supported freely and in which the said lumen | rumen for to-be-coated material and the said discharge port were connected was formed.

 このように、シャフトの被塗布物質用ルーメンに連通する中空部が回転部材の回転軸部に形成されていることで、被塗布物質用ルーメンから吐出口に被塗布物質を容易に導くことができ、充分な量の被塗布物質を生体管腔内の壁部に吐出することができる。 Thus, the hollow portion communicating with the lumen for the substance to be coated of the shaft is formed in the rotating shaft portion of the rotating member, so that the substance to be coated can be easily guided from the lumen for the substance to be coated to the discharge port. A sufficient amount of the substance to be coated can be discharged to the wall in the living body lumen.

 また、前記の目的を達成するために、生体管腔内治療デバイスの治療方法として次の方法を採ることができる。すなわち、生体管腔内に進退自在に挿入される長尺なシャフトと、前記シャフトの軸回りに沿って回転自在となるように該シャフトに設けられ、且つ回転の略遠心方向に被塗布物質を吐出可能な吐出口を有する回転部材とを備える生体管腔内治療デバイスを用いた治療方法であって、前記シャフトの外側面の近傍位置に前記吐出口が位置する第1形態を呈する回転部材を、前記生体管腔内の処置対象に重なる位置に送達する送達ステップと、前記送達ステップの後に、前記吐出口が前記シャフトの外側面の近傍位置から離間して前記生体管腔の内面を臨む第2形態を呈するように、前記回転部材を変形させる展開ステップと、前記展開ステップの後に、前記回転部材を回転させつつ前記吐出口から被塗布物質を吐出して前記処置対象に塗布する塗布ステップとを有することを特徴とする。 Also, in order to achieve the above-mentioned object, the following method can be adopted as a treatment method for a biological intraluminal treatment device. That is, a long shaft that is inserted into a living body lumen so as to be movable back and forth, and a shaft that is provided on the shaft so as to be rotatable around the axis of the shaft, and a substance to be coated is applied in a substantially centrifugal direction of rotation. A rotating member having a first form in which the discharge port is located in the vicinity of the outer surface of the shaft. A delivery step for delivering to a position overlapping the treatment target in the biological lumen; and after the delivery step, the discharge port is spaced apart from a position near the outer surface of the shaft and faces the inner surface of the biological lumen. The unfolding step of deforming the rotating member so as to exhibit two forms, and after the unfolding step, the substance to be coated is discharged from the discharge port and applied to the treatment target while rotating the rotating member. And having a coating step.

 本発明によれば、生体管腔内の所望の処置対象に被塗布物質を均一且つ確実に付着させることができ、これにより生体管腔を良好に治療することができる。 According to the present invention, the substance to be applied can be uniformly and reliably attached to a desired treatment target in the living body lumen, and thus the living body lumen can be treated well.

本実施の形態に係る治療デバイスを概略的に示す一部省略斜視図である。It is a partially omitted perspective view schematically showing a treatment device according to the present embodiment. 図2Aは、図1の治療デバイスの先端部を示す部分側面断面図であり、図2Bは、図2AのIIB-IIB線断面図であり、図2Cは、図2AのIIC-IIC線断面図である。2A is a partial side sectional view showing a distal end portion of the treatment device of FIG. 1, FIG. 2B is a sectional view taken along line IIB-IIB in FIG. 2A, and FIG. 2C is a sectional view taken along line IIC-IIC in FIG. It is. 図3Aは、図1の治療デバイスを用いた動作手順を示す第1説明図であり、図3Bは、図3Aに続く治療デバイスの動作手順を示す第2説明図である。FIG. 3A is a first explanatory diagram showing an operation procedure using the treatment device of FIG. 1, and FIG. 3B is a second explanatory diagram showing an operation procedure of the treatment device following FIG. 3A. 図4Aは、図3Bに続く治療デバイスの動作手順を示す第3説明図であり、図4Bは、図4Aに続く治療デバイスの動作手順を示す第4説明図である。FIG. 4A is a third explanatory diagram illustrating an operation procedure of the treatment device following FIG. 3B, and FIG. 4B is a fourth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 4A. 図5Aは、図4Bに続く治療デバイスの動作手順を示す第5説明図であり、図5Bは、図5Aに続く治療デバイスの動作手順を示す第6説明図である。FIG. 5A is a fifth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 4B, and FIG. 5B is a sixth explanatory diagram illustrating an operation procedure of the treatment device following FIG. 5A. 図6Aは、第1変形例に係る治療デバイスを示す要部正面図であり、図6Bは、第2変形例に係る治療デバイスを示す要部斜視図であり、図6Cは、第3変形例に係る治療デバイスを示す要部側面断面図であり、図6Dは、第4変形例に係る治療デバイスを示す要部側面断面図である。6A is a main part front view showing a treatment device according to a first modification, FIG. 6B is a main part perspective view showing a treatment device according to a second modification, and FIG. 6C is a third modification. FIG. 6D is a side sectional view of an essential part showing a treatment device according to a fourth modified example. 図7Aは、第5変形例に係る治療デバイスを示す第1説明図であり、図7Bは、第5変形例に係る治療デバイスを示す第2説明図である。FIG. 7A is a first explanatory diagram illustrating a treatment device according to a fifth modification, and FIG. 7B is a second explanatory diagram illustrating a treatment device according to the fifth modification.

 以下、本発明に係る生体管腔内治療デバイスについて好適な実施の形態を挙げ、添付の図面を参照して詳細に説明する。 Hereinafter, preferred embodiments of the intraluminal treatment device according to the present invention will be described in detail with reference to the accompanying drawings.

 図1は、本実施の形態に係る生体管腔内治療デバイスを概略的に示す一部省略斜視図である。この生体管腔内治療デバイス10(以下、単に治療デバイス10ともいう)は、皮膚に開けた小さい孔からカテーテルを血管に挿入し治療を行う治療法(インターベンション)により、血管内の病変部を治療するためのデバイスである。特に、本治療デバイス10は単独使用に加え、バルーンカテーテル、ステント又はアテレクトミーデバイスによる病変部(狭窄部や血管壁が弱くなった部分)の治療、或いはアブレーションデバイスによる血管の処置等にも併用され、病変部や処置後の血管壁に被塗布物質を塗布するために用いられる。 FIG. 1 is a partially omitted perspective view schematically showing a biological intraluminal treatment device according to the present embodiment. This intraluminal treatment device 10 (hereinafter, also simply referred to as the treatment device 10) is used to treat a lesion in a blood vessel by a treatment method (intervention) in which a catheter is inserted into a blood vessel through a small hole opened in the skin. A device for treatment. In particular, the present therapeutic device 10 is used not only for single use, but also for treatment of a lesioned portion (a narrowed portion or a portion where a blood vessel wall is weakened) by a balloon catheter, a stent or an atherectomy device, or a blood vessel treatment by an ablation device, etc. It is used to apply a substance to be applied to a lesioned part or a blood vessel wall after treatment.

 例えば、バルーン血管形成術では、バルーンカテーテルにより狭窄部を押し広げる手技を行った後に、治療デバイス10を送達して治療部位に被塗布物質を塗布する。また、ステント留置術では、ステントを狭窄部に留置する手技を行った後に、治療デバイス10を送達してステントの留置部位周辺に被塗布物質を塗布する。さらに、アテレクトミーでは、アテレクトミーデバイスにより血管壁に堆積したアテローム(粥種)や石灰化病変の除去を行った後に、治療デバイス10を送達して治療部位に被塗布物質を塗布する。或いは、交感神経アブレーション治療では、血管壁の内部を通る交感神経を切断する処置を行った後に、治療デバイス10を送達して処置部位の血管壁に被塗布物質を塗布する。 For example, in balloon angioplasty, after performing a technique of expanding the stenosis with a balloon catheter, the treatment device 10 is delivered and the substance to be applied is applied to the treatment site. In stent placement, after performing a procedure of placing the stent in the stenosis, the treatment device 10 is delivered to apply the substance to be coated around the placement site of the stent. Furthermore, in atherectomy, after removing the atheroma (soot) and the calcified lesion deposited on the blood vessel wall by the atherectomy device, the therapeutic device 10 is delivered and the substance to be applied is applied to the treatment site. Alternatively, in the sympathetic ablation treatment, after the treatment for cutting the sympathetic nerve passing through the inside of the blood vessel wall is performed, the therapeutic device 10 is delivered and the substance to be applied is applied to the blood vessel wall at the treatment site.

 以下の説明では、バルーン血管形成術により押し広げられた血管A内(血管壁B)の処置対象Xに被塗布物質を塗布する治療デバイス10について代表的に説明していく。なお、この治療デバイス10は、上記の手技に限定されず様々な手技に用いることが可能であり、また種々の生体管腔(例えば、胆管、気管、食道、尿道、鼻腔、その他の臓器等)内の治療に応用できることは勿論である。 In the following description, the treatment device 10 that applies a substance to be applied to the treatment target X in the blood vessel A (blood vessel wall B) that has been expanded by balloon angioplasty will be described as a representative example. The treatment device 10 is not limited to the above procedure and can be used for various procedures, and various biological lumens (for example, bile duct, trachea, esophagus, urethra, nasal cavity, other organs, etc.). Of course, it can be applied to internal therapy.

 本実施の形態に係る治療デバイス10は、血管A内に挿入されるシャフト12と、シャフト12の先端部に設けられる回転部材14と、回転部材14の基端側でシャフト12の外側面を囲う外管16とを有する。この治療デバイス10は、術者により血管A内を送達されて、処置対象Xに重なる位置(又は近傍位置)で回転部材14を回転させつつ、回転部材14に形成された吐出口18から被塗布物質を吐出することで、処置対象Xに被塗布物質を付着させる構成となっている。 The treatment device 10 according to the present embodiment surrounds the shaft 12 inserted into the blood vessel A, the rotating member 14 provided at the distal end portion of the shaft 12, and the outer surface of the shaft 12 on the proximal end side of the rotating member 14. And an outer tube 16. The therapeutic device 10 is delivered from the discharge port 18 formed in the rotating member 14 while the rotating member 14 is rotated at a position (or a nearby position) that is delivered to the treatment target X by being delivered through the blood vessel A by the operator. The material to be applied is attached to the treatment target X by discharging the material.

 シャフト12は、先端部が処置対象Xに送達可能となるように充分な長さを有する長尺な管体に形成される。また、シャフト12の外形は、送達される血管Aの内面よりも細く形成される。シャフト12の内部には、空洞状の被塗布物質流通ルーメン20(被塗布物質用ルーメン)が軸方向に沿って延設される。 The shaft 12 is formed into a long tubular body having a sufficient length so that the distal end portion can be delivered to the treatment target X. Further, the outer shape of the shaft 12 is formed narrower than the inner surface of the blood vessel A to be delivered. Inside the shaft 12, a hollow coated material distribution lumen 20 (coated material lumen) extends along the axial direction.

 シャフト12は、生体内において蛇行している血管Aの形状に追従して変形可能な柔軟性と、回転部材14の回転を支持可能な程度の剛性を有する材料により形成されることが好ましい。この場合、シャフト12を構成する材料としては、金属や樹脂が挙げられる。金属としては、例えば、Ni-Ti系合金(ナイチノール)のような擬弾性合金(超弾性合金を含む)、形状記憶合金、ステンレス鋼(例えば、SUS304、SUS303、SUS316、SUS316L、SUS316J1、SUS316J1L、SUS405、SUS430、SUS434、SUS444、SUS429、SUS430F、SUS302等、SUSの全品種)、コバルト系合金、金、白金のような貴金属、タングステン系合金、炭素系材料(ピアノ線を含む)等が挙げられる。樹脂としては、例えば、ポリオレフィン(例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン-プロピレン共重合体、エチレン-酢酸ビニル共重合体、アイオノマー、或いはこれら二種以上の混合物等)、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、ポリイミド、フッ素樹脂等の高分子材料又はこれらの混合物、或いは上記ニ種以上の高分子材料が挙げられる。また、シャフト12は、これら金属や樹脂の複合物(例えば、金属と樹脂を積層した多層チューブ等)を適用することもできる。さらに、シャフト12の先端部付近には、X線透視下で認識可能なX線非透過性マーカが設けられてもよい。 The shaft 12 is preferably formed of a material having flexibility that can be deformed following the shape of the blood vessel A meandering in the living body and a rigidity that can support the rotation of the rotating member 14. In this case, examples of the material constituting the shaft 12 include metals and resins. Examples of the metal include pseudoelastic alloys (including superelastic alloys) such as Ni—Ti alloys (naitinol), shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405). SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt alloys, gold, noble metals such as platinum, tungsten alloys, carbon materials (including piano wires), and the like. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above-described two or more polymer materials. The shaft 12 can also be applied to a composite of these metals and resins (for example, a multilayer tube in which a metal and a resin are laminated). Furthermore, an X-ray impermeable marker that can be recognized under X-ray fluoroscopy may be provided near the tip of the shaft 12.

 シャフト12の基端部には、術者が把持し易いようにシャフト12よりも大径なハブ22が設けられている。このハブ22は、アクチュエータ24(図3A参照)に搭載可能となっており、治療デバイス10は、術者の他に、アクチュエータ24により進退移動が操作される構成となっている。このアクチュエータ24としては、例えば、本出願人が先に出願した特開2011-152274号公報に開示されている外部駆動装置等を好適に適用することができる。 A hub 22 having a diameter larger than that of the shaft 12 is provided at the proximal end portion of the shaft 12 so that the operator can easily grasp it. The hub 22 can be mounted on an actuator 24 (see FIG. 3A), and the treatment device 10 is configured to be moved forward and backward by the actuator 24 in addition to the operator. As this actuator 24, for example, an external drive device disclosed in Japanese Patent Application Laid-Open No. 2011-152274 filed earlier by the present applicant can be suitably applied.

 また、ハブ22の基端部には、被塗布物質流通ルーメン20に連通し生理食塩水及び被塗布物質を供給可能な第1ポート26が接続されている(図3A等参照)。第1ポート26の基端部には、例えば、図示しない三方活栓等が取り付けられ、生理食塩水用のシリンジ(図示せず)が三方活栓の一方の上流側に接続され、被塗布物質を供給可能な被塗布物質供給装置(図示せず)が三方活栓の他方の上流側に接続される。これにより、被塗布物質流通ルーメン20には、空気の混入が防止されつつ、生理食塩水又は被塗布物質が選択的に供給される。なお、シャフト12の基端構造は、上記の構成に限定されるものではなく、例えば、ハブ22に複数のポートが連設され、生理食塩水及び被塗布物質を別々に供給する構成であってもよい。 In addition, a first port 26 is connected to the base end portion of the hub 22 so as to be able to supply physiological saline and the substance to be coated, communicating with the substance distribution lumen 20 (see FIG. 3A and the like). For example, a three-way stopcock (not shown) is attached to the proximal end of the first port 26, and a physiological saline syringe (not shown) is connected to one upstream side of the three-way stopcock to supply the substance to be coated. A possible substance supply device (not shown) is connected to the other upstream side of the three-way cock. Thereby, physiological saline or a substance to be coated is selectively supplied to the substance to be coated circulation lumen 20 while air is prevented from being mixed therein. The base end structure of the shaft 12 is not limited to the above-described configuration. For example, a plurality of ports are connected to the hub 22 to supply physiological saline and a substance to be coated separately. Also good.

 被塗布物質流通ルーメン20は、第1ポート26から供給された生理食塩水や被塗布物質をシャフト12の先端部までスムーズに流通させることが可能な内径に形成されている。被塗布物質は、被塗布物質流通ルーメン20を介して、回転部材14の吐出口18に導かれて、吐出口18から血管A内の処置対象Xに吐出される。 The coated substance distribution lumen 20 is formed to have an inner diameter that allows the physiological saline and the coated substance supplied from the first port 26 to smoothly flow to the tip of the shaft 12. The substance to be applied is guided to the discharge port 18 of the rotating member 14 via the material distribution lumen 20 and discharged from the discharge port 18 to the treatment target X in the blood vessel A.

 被塗布物質としては、例えば、血管壁Bに対して強い接着力を発揮するアルギネート-カテコールが挙げられる。既述したように、アルギネート-カテコールは、血管A内で短時間にゲル化し、処置後の血管壁Bを良好にコーティングする。このため、処置対象Xに生じた炎症等を保護しつつ、処置対象Xの再狭窄や血栓の発生を抑止することができる。勿論、塗布される物質は、アルギネート-カテコールに限定されるものではなく、例えば、ヘパリン、ヒアルロン酸等の多糖類、ベタイン系の高分子、或いはポリエチレングリコールのカテコール修飾物等が挙げられる。また、被塗布物質に加えて、生物学的生理活性物質を含む種々の薬剤を同時に適用し得る。例えば、狭窄部の治療においては、血管A内の治療部位に付着させることで再狭窄を抑制する生物学的生理活性物質を適用するとよい。この場合、生物学的生理活性物質としては、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、リポタンパク関連ホスホリパーゼ阻害剤、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。 Examples of the substance to be coated include alginate-catechol that exhibits a strong adhesive force to the blood vessel wall B. As described above, the alginate-catechol gels in the blood vessel A in a short time, and well coats the blood vessel wall B after the treatment. For this reason, it is possible to prevent the restenosis and the thrombus from occurring in the treatment target X while protecting the inflammation and the like generated in the treatment target X. Of course, the material to be applied is not limited to alginate-catechol, and examples thereof include polysaccharides such as heparin and hyaluronic acid, betaine-based polymers, and catechol-modified products of polyethylene glycol. In addition to the substance to be coated, various drugs including biological and physiologically active substances can be applied simultaneously. For example, in the treatment of a stenosis, a biological physiologically active substance that suppresses restenosis by adhering to a treatment site in the blood vessel A may be applied. In this case, biologically bioactive substances include anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergies. 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, lipoprotein-related phospholipase inhibition Agents, biological materials, interferons, NO production promoting substances, and the like.

 抗癌剤としては、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、例えば、シロリムス(ラパマイシン)、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。 As the anticancer agent, for example, vincristine sulfate, vinblastine sulfate, vindesine sulfate, irinotecan hydrochloride, paclitaxel, docetaxel hydrate, methotrexate, cyclophosphamide and the like are preferable. As the immunosuppressive agent, for example, sirolimus (rapamycin), tacrolimus hydrate, azathioprine, cyclosporine, mycophenolate mofetil, gusperimus hydrochloride, mizoribine and the like are preferable.

 抗生物質としては、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、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、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, for example, mitomycin C, doxorubicin hydrochloride, actinomycin D, daunorubicin hydrochloride, idarubicin hydrochloride, pirarubicin hydrochloride, aclarubicin hydrochloride, epirubicin hydrochloride, pepromycin sulfate, dinostatin styramer and the like are preferable. As the antirheumatic agent, for example, sodium gold thiomalate, penicillamine, lobenzalit disodium and the like are preferable. As the antithrombotic agent, for example, heparin, ticlopidine hydrochloride, hirudin and the like are preferable.

 抗高脂血症薬としては、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、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。 As the antihyperlipidemic agent, an HMG-CoA reductase inhibitor or probe is preferable. As the HMG-CoA reductase inhibitor, 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、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、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。 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. 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、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、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、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、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。 生体由来材料としては、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。 As the retinoid, for example, all-trans retinoic acid is preferable. As the antioxidant, for example, catechins, anthocyanins, proanthocyanidins, lycopene, β-carotene and the like are preferable. Among catechins, epigallocatechin gallate is particularly preferable. As the tyrosine kinase inhibitor, for example, genistein, tyrphostin, arbustatin and the like are preferable. As the anti-inflammatory agent, for example, steroids such as dexamethasone and prednisolone and aspirin are preferable. Examples of the bio-derived material include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), PDGF (platelet gender, etc.).

 生理活性物質は、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。 The physiologically active substance may include only one type of the biologically physiologically active substances exemplified above, or may include two or more different biologically 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.

 上記の被塗布物質を吐出する吐出口18は、回転部材14に設けられ、回転中に被塗布物質を吐出することで、処置対象X(血管壁B)に満遍なく被塗布物質を塗布する構成となっている。このため、被塗布物質流通ルーメン20を構成するシャフト12内面の先端寄りには、径方向内側に突出する軸受部30が設けられ、回転部材14は、この軸受部30に対し回転自在に支持される。 The discharge port 18 for discharging the substance to be coated is provided in the rotating member 14, and the substance to be coated is uniformly applied to the treatment target X (blood vessel wall B) by discharging the substance to be coated during rotation. It has become. For this reason, a bearing portion 30 that protrudes radially inward is provided near the tip of the inner surface of the shaft 12 that constitutes the coated substance distribution lumen 20, and the rotating member 14 is rotatably supported by the bearing portion 30. The

 図2Aは、図1の治療デバイス10の先端部を示す部分側面断面図であり、図2Bは、図2AのIIB-IIB線断面図であり、図2Cは、図2AのIIC-IIC線断面図である。回転部材14は、治療デバイス10の先端に位置する一対の羽部32と、それぞれの羽部32の内部に延在する流通管34と、一対の流通管34が接続されるロール軸部材36(回転軸部)と、羽部32の基端面側に連なる回転体38とを備える。 2A is a partial side sectional view showing the distal end portion of the treatment device 10 of FIG. 1, FIG. 2B is a sectional view taken along line IIB-IIB in FIG. 2A, and FIG. 2C is a sectional view taken along line IIC-IIC in FIG. FIG. The rotating member 14 includes a pair of wings 32 positioned at the distal end of the treatment device 10, a flow tube 34 extending inside each wing 32, and a roll shaft member 36 (to which the pair of flow tubes 34 are connected. (Rotating shaft portion) and a rotating body 38 connected to the base end face side of the wing portion 32.

 一対の羽部32は、シャフト12の軸心を基点として互いに反対方向に延出し、外側の端部には被塗布物質を吐出する吐出口18がそれぞれ形成されている。また、一対の羽部32は、シャフト12の軸方向に沿うように湾曲して、吐出口18が回転体38の近傍位置に位置する第1形態(図3A及び図3B参照)と、吐出口18が回転体38の近傍位置から離間して血管壁Bを臨む第2形態(図1及び図2A参照)とを取り得るように構成されている。 The pair of wing portions 32 extend in opposite directions with the axis of the shaft 12 as a base point, and discharge ports 18 for discharging the substance to be coated are formed on the outer ends. Further, the pair of wing portions 32 are curved so as to be along the axial direction of the shaft 12, and the discharge port 18 is positioned in the vicinity of the rotating body 38 (see FIGS. 3A and 3B), and the discharge port. 18 is configured to be able to take a second form (see FIGS. 1 and 2A) that faces the blood vessel wall B away from the vicinity of the rotating body 38.

 羽部32の内部は、所定の容積を有する空洞部40(内部空間)として形成されており、この空洞部40には、展開用流体(例えば、生理食塩水や造影剤)が流入可能となっている。第1形態と第2形態の変形は、この展開用流体の供給と排出によって実現される。すなわち、羽部32は拡縮可能なバルーンとして構成されており、展開用流体が空洞部40に存在しない状態(排出されている状態)では、羽部32がしぼんで第1形態となり、展開用流体が空洞部40に存在する状態(供給されている状態)では、羽部32が展開して第2形態となる。 The interior of the wing part 32 is formed as a cavity 40 (internal space) having a predetermined volume, and a developing fluid (for example, physiological saline or contrast medium) can flow into the cavity 40. ing. The deformation of the first form and the second form is realized by supplying and discharging the development fluid. That is, the wing portion 32 is configured as a balloon that can be expanded and contracted, and in a state where the deployment fluid is not present in the cavity portion 40 (in a state where the fluid is discharged), the wing portion 32 is deflated and becomes the first form. Is in the cavity 40 (the supplied state), the wing 32 expands to the second form.

 羽部32は、第1形態において、中心部から外側の端部に向かう胴体部分が湾曲し、回転体38の外側面に接触する形状となる。この形状は予め記憶されている(形状付けされている)ことが好ましい。これにより、展開用流体の流入にともない羽部32が第2形態に変形した後に、この展開用流体を排出すると、胴体部分が回転体38の外側面に接触する第1形態に自動的に復元される。 In the first embodiment, the wing portion 32 has a shape in which the body portion from the center portion toward the outer end portion is curved and contacts the outer surface of the rotating body 38. This shape is preferably stored in advance (shaped). As a result, after the wing portion 32 is deformed to the second configuration in response to the inflow of the deployment fluid, when the deployment fluid is discharged, the body portion is automatically restored to the first configuration in contact with the outer surface of the rotating body 38. Is done.

 また、第2形態における羽部32は、所定の厚みを有するとともに、中心部の端部の幅が狭く外側の端部の幅が広い先端面32a及び基端面32bを有するように形成される。これら先端面32aと基端面32bは、血管A内の血流を前方又は後方から受けて斜めに流す傾斜面に形成される。そのため、羽部32は、血管A内(治療デバイス10の軸方向)を流れる血流を受けると、軸回りに回転するようになる。 Further, the wing portion 32 in the second embodiment has a predetermined thickness and is formed to have a distal end surface 32a and a proximal end surface 32b having a narrow end portion at the center and a wide outer end portion. The distal end surface 32a and the proximal end surface 32b are formed as inclined surfaces that receive the blood flow in the blood vessel A from the front or rear and flow obliquely. Therefore, when the wing 32 receives a blood flow flowing in the blood vessel A (in the axial direction of the treatment device 10), the wing 32 rotates around the axis.

 さらに、第2形態における羽部32の展開度合いは、展開用流体の流入量に応じて調整可能となっている。これにより、1つの治療デバイス10で様々な太さの血管を処置することができる。 Furthermore, the degree of deployment of the wings 32 in the second embodiment can be adjusted according to the inflow amount of the deployment fluid. Thereby, blood vessels of various thicknesses can be treated with one therapeutic device 10.

 羽部32を構成する材料としては、血管A内での羽部32の展開度合いを調整し易いシリコンラバーを好適に用いることができる。勿論、材料としては、展開用流体の供給及び排出により第1及び第2形態に変形自在であり、且つ第2形態において血流により回転可能であれば特に限定されず、例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン-プロピレン共重合体、エチレン-酢酸ビニル共重合体、アイオノマー、あるいはこれら二種以上の混合物等のポリオレフィンや、軟質ポリ塩化ビニル樹脂、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、フッ素樹脂等の熱可塑性樹脂、ラテックスゴム等が使用できる。 As a material constituting the wing portion 32, a silicon rubber that can easily adjust the degree of expansion of the wing portion 32 in the blood vessel A can be suitably used. Of course, the material is not particularly limited as long as it can be deformed into the first and second forms by supplying and discharging the development fluid, and can be rotated by the blood flow in the second form. For example, polyethylene, polypropylene, Polyolefins such as polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluorine A thermoplastic resin such as a resin, latex rubber, or the like can be used.

 また、空洞部40に設けられる一対の流通管34は、中心部から径方向外側に延在する管体として構成されている。各流通管34は、内部に流通路42を有しており、この流通路42の外側の端部が吐出口18と連通している。一方、流通管34の中心部側の端部は、ロール軸部材36に接続される。流通管34を構成する材料は特に限定されず、例えば、羽部32と同じ材料を用いることができる。従って、羽部32と流通管34は一体成形されていてもよい。 Further, the pair of flow pipes 34 provided in the hollow portion 40 is configured as a tube body extending radially outward from the center portion. Each flow pipe 34 has a flow passage 42 therein, and an outer end portion of the flow passage 42 communicates with the discharge port 18. On the other hand, an end portion on the center side of the flow pipe 34 is connected to the roll shaft member 36. The material which comprises the flow pipe 34 is not specifically limited, For example, the same material as the wing | blade part 32 can be used. Therefore, the wing part 32 and the flow pipe 34 may be integrally formed.

 ロール軸部材36は、略T字形状からなる管状の部材であり、先端部において径方向外側に突出する一対の分岐部44と、一対の分岐部44の中間部に連なり基端方向に延在する主軸部46とを有する。また、一対の分岐部44と主軸部46の内部には、流通路42と被塗布物質流通ルーメン20を導通可能な案内路48(中空部)が形成されている。 The roll shaft member 36 is a substantially T-shaped tubular member, and extends in the proximal direction by connecting to a pair of branch portions 44 protruding radially outward at the distal end portion and an intermediate portion of the pair of branch portions 44. Main shaft portion 46. Further, a guide path 48 (hollow part) is formed in the pair of branch parts 44 and the main shaft part 46 so that the flow path 42 and the material to be coated circulation lumen 20 can be conducted.

 一対の分岐部44は、シャフト12の先端よりも先端側に位置しており、一対の羽部32内(空洞部40)に挿入され、該一対の羽部32と同一方向に突出している。また、分岐部44は流通管34に嵌合接続されており、流通路42と案内路48を連通させている。 The pair of branch portions 44 are located on the distal end side of the distal end of the shaft 12, are inserted into the pair of wing portions 32 (hollow portion 40), and project in the same direction as the pair of wing portions 32. Further, the branch portion 44 is fitted and connected to the flow pipe 34, and the flow passage 42 and the guide passage 48 are communicated with each other.

 分岐部44に連なる主軸部46は、シャフト12の外部から内部(被塗布物質流通ルーメン20)に挿入されており、被塗布物質流通ルーメン20内では軸受部30を越える長さで延在している。また、主軸部46の外形は、軸受部30に軸支される太さに形成されている。この主軸部46の軸心は、シャフト12の軸心に一致するように配設される。 The main shaft portion 46 connected to the branching portion 44 is inserted from the outside of the shaft 12 into the inside (the substance to be coated circulation lumen 20), and extends within the length of the coating substance circulation lumen 20 beyond the bearing portion 30. Yes. Further, the outer shape of the main shaft portion 46 is formed to have a thickness that is supported by the bearing portion 30. The axis of the main shaft portion 46 is disposed so as to coincide with the axis of the shaft 12.

 主軸部46の基端には、径方向外側に拡径したフランジ部50が形成されている。このフランジ部50は、軸受部30の基端面に引っ掛かる構成となっており、ロール軸部材36がシャフト12から脱落することを防止する。 At the base end of the main shaft portion 46, a flange portion 50 having a diameter increased outward in the radial direction is formed. The flange portion 50 is configured to be caught on the base end surface of the bearing portion 30, and prevents the roll shaft member 36 from falling off the shaft 12.

 このように、ロール軸部材36は、軸受部30に対し回転自在となっていることで、一対の羽部32の回転軸として機能する。これにより、回転部材14はシャフト12の軸心を中心に回転する。 Thus, the roll shaft member 36 functions as a rotating shaft of the pair of wing portions 32 by being rotatable with respect to the bearing portion 30. Thereby, the rotating member 14 rotates around the axis of the shaft 12.

 羽部32に連設される回転体38は、シャフト12を収容可能な収容空間52を有する略砲弾状の器体に形成されている。回転体38を構成する壁部38aは、先端部が一対の羽部32に接合され、この先端部から湾曲しつつ基端方向に延在し、さらに湾曲部分から基端方向に向かって軸心と平行に延在している。 The rotating body 38 connected to the wing portion 32 is formed in a substantially bullet-shaped container having an accommodation space 52 in which the shaft 12 can be accommodated. The wall 38a constituting the rotating body 38 has a distal end joined to the pair of wings 32, extends from the distal end in the proximal direction, and further axially extends from the curved portion toward the proximal direction. Extends in parallel with.

 壁部38aの湾曲部分の内面は、シャフト12の先端部の湾曲部分に当接する当接部54となっている。回転体38は、一対の羽部32の回転に追従して回転する際に、当接部54がシャフト12の湾曲部分に摺接することで、より安定的に回転する。 The inner surface of the curved portion of the wall portion 38 a is an abutting portion 54 that abuts on the curved portion of the tip portion of the shaft 12. When the rotating body 38 rotates following the rotation of the pair of wing portions 32, the rotating portion 38 rotates more stably by the sliding contact of the contact portion 54 with the curved portion of the shaft 12.

 また、回転体38の壁部38a内には、展開用流体を流通可能な細長い孔からなる回転体側流体通路56が一対形成されている。回転体側流体通路56は、略砲弾状の壁部38aに沿って先端部から基端部にわたって延設されており、その先端開口は一対の羽部32の空洞部40に連通している。回転体側流体通路56の基端開口には、展開用流体の流出を遮断する弁体58が設けられている。さらに、回転体38の基端面には、回転体38と外管16が簡単に接続できるように接続機構60が設けられている。この接続機構60については後述する。 Also, a pair of rotating body-side fluid passages 56 are formed in the wall portion 38a of the rotating body 38. The rotating body-side fluid passages 56 are formed of elongated holes through which the developing fluid can flow. The rotating body side fluid passage 56 extends from the distal end portion to the proximal end portion along the substantially bullet-shaped wall portion 38 a, and the distal end opening communicates with the cavity portion 40 of the pair of wing portions 32. A valve body 58 that blocks outflow of the developing fluid is provided at the proximal end opening of the rotor-side fluid passage 56. Further, a connection mechanism 60 is provided on the base end surface of the rotating body 38 so that the rotating body 38 and the outer tube 16 can be easily connected. The connection mechanism 60 will be described later.

 以上のように構成される回転部材14は、シャフト12と相対的に回転自在となる。特に、本実施の形態に係る回転部材14は、羽部32が血流を受けることにより自動的に回転を行う。この場合、治療デバイス10の送達時に回転部材14が回転しないように構成することが好ましい。回転部材14の回転状態(回転と停止)の切り替えは、基端側に配置した外管16により操作する構成となっている。 The rotating member 14 configured as described above is rotatable relative to the shaft 12. In particular, the rotating member 14 according to the present embodiment automatically rotates when the wing portion 32 receives blood flow. In this case, it is preferable that the rotating member 14 is not rotated during delivery of the treatment device 10. The rotation state (rotation and stop) of the rotation member 14 is switched by an outer tube 16 disposed on the base end side.

 図1に示すように、外管16は、シャフト12の軸方向に沿って延在し、シャフト12よりも若干短く形成された管体である。外管16は、回転部材14が処置対象Xに送達された状態で、その基端部が生体の外部に露出される。外管16の内部には、シャフト12の外径よりも大きな内径をなす貫通ルーメン62が形成され、この貫通ルーメン62にシャフト12が挿通される。すなわち、シャフト12と外管16の軸心は略同軸上に位置している。 As shown in FIG. 1, the outer tube 16 is a tubular body that extends along the axial direction of the shaft 12 and is slightly shorter than the shaft 12. The outer tube 16 is exposed to the outside of the living body with the rotating member 14 delivered to the treatment target X. A through lumen 62 having an inner diameter larger than the outer diameter of the shaft 12 is formed inside the outer tube 16, and the shaft 12 is inserted into the through lumen 62. That is, the shaft centers of the shaft 12 and the outer tube 16 are substantially coaxial.

 また、外管16の基端部には、径方向外側に拡径する鍔部64(操作部)が形成されている。鍔部64は、ハブ22の前方に位置しており、その側面の所定位置には流体通路口66が形成されている。この流体通路口66には第2ポート68(図3A等参照)が接続され、図示しないインデフレータ等の圧力印加装置により展開用流体が供給可能となっている。外管16は、鍔部64が進退操作されることで、シャフト12及び回転部材14と相対的に進退移動がなされる。 Also, a flange 64 (operation part) that expands radially outward is formed at the proximal end of the outer tube 16. The flange portion 64 is located in front of the hub 22, and a fluid passage port 66 is formed at a predetermined position on the side surface thereof. A second port 68 (see FIG. 3A and the like) is connected to the fluid passage port 66, and a developing fluid can be supplied by a pressure application device such as an indeflator (not shown). The outer tube 16 is moved forward and backward relative to the shaft 12 and the rotating member 14 by the forward and backward movement of the collar portion 64.

 外管16を構成する壁部16aの内部には、先端から基端にわたって延在する外管側流体通路70が形成されている。外管側流体通路70は、外管16の内部において一対で延在し、基端側の鍔部64にて合流して流体通路口66に連通している。外管16の先端部には、先端方向に突出する突起部72が形成されており、外管側流体通路70はこの突起部72を貫通している。突起部72は、回転部材14と外管16が接続された状態において弁体58に挿入されることで、回転体側流体通路56と外管側流体通路70の連通を実現する。 An outer tube side fluid passage 70 extending from the distal end to the proximal end is formed inside the wall portion 16a constituting the outer tube 16. The outer pipe side fluid passage 70 extends in a pair inside the outer pipe 16, joins at the flange 64 on the base end side, and communicates with the fluid passage port 66. A projecting portion 72 that protrudes in the distal direction is formed at the distal end portion of the outer tube 16, and the outer tube side fluid passage 70 passes through the projecting portion 72. The protrusion 72 is inserted into the valve body 58 in a state where the rotating member 14 and the outer tube 16 are connected, thereby realizing communication between the rotating body-side fluid passage 56 and the outer tube-side fluid passage 70.

 図2A~図2Cに示すように、回転部材14と外管16を接続する接続機構60は、外管16の進退移動にともない、回転部材14との接続状態と離脱状態を切り替える構成となっている。この接続機構60は、上述した回転体38の弁体58及び外管16の突起部72と、回転体38に埋設された磁石74(磁性体)と、外管16に埋設された金属材76(例えば、鉄)とにより構成される。回転体38の基端面には、一対の弁体58に対し周方向に90°ずれる位置に一対の磁石74が設けられている。同様に、外管16の先端面には、一対の突起部72に対し周方向に90°ずれる位置に一対の金属材76が設けられている。磁石74は金属材76を引きつけるように作用し、外管16の先端面が回転体38の基端面に近接すると、磁石74と金属材76が周方向に一致するように回転体38が誘導される。その結果、弁体58と突起部72が対向することになり、回転体38と外管16を接続しようとすると、弁体58に突起部72が容易に挿入されて回転体側流体通路56と外管側流体通路70が連通される。また、磁石74と金属材76が磁力により密接し合うことで、回転体38と外管16が固定され、回転部材14の回転を停止することができる。 As shown in FIGS. 2A to 2C, the connection mechanism 60 that connects the rotating member 14 and the outer tube 16 switches between a connection state and a detached state with the rotating member 14 as the outer tube 16 moves forward and backward. Yes. The connection mechanism 60 includes the above-described valve body 58 of the rotating body 38 and the protrusion 72 of the outer tube 16, a magnet 74 (magnetic body) embedded in the rotating body 38, and a metal material 76 embedded in the outer tube 16. (For example, iron). A pair of magnets 74 is provided on the base end surface of the rotating body 38 at a position shifted by 90 ° in the circumferential direction with respect to the pair of valve bodies 58. Similarly, a pair of metal members 76 are provided on the distal end surface of the outer tube 16 at positions shifted by 90 ° in the circumferential direction with respect to the pair of protrusions 72. The magnet 74 acts to attract the metal material 76, and when the distal end surface of the outer tube 16 approaches the base end surface of the rotator 38, the rotator 38 is guided so that the magnet 74 and the metal material 76 coincide with each other in the circumferential direction. The As a result, the valve body 58 and the projection 72 are opposed to each other, and when the rotary body 38 and the outer tube 16 are to be connected, the projection 72 is easily inserted into the valve body 58 and the rotary body-side fluid passage 56 The pipe side fluid passage 70 is communicated. Further, since the magnet 74 and the metal material 76 are brought into close contact with each other by magnetic force, the rotating body 38 and the outer tube 16 are fixed, and the rotation of the rotating member 14 can be stopped.

 一方、回転体38と外管16の接続状態で、磁石74の磁力を超えて外管16を基端方向に移動させると、回転部材14から外管16が離脱する。離脱時には、突起部72が弁体58から抜け、弁体58が自己閉塞する。よって、回転体側流体通路56に展開用流体が存在しても弁体58により漏出が阻止される。また、回転部材14は、外管16の離脱にともない血流による回転が可能となる。 On the other hand, when the outer tube 16 is moved in the proximal direction beyond the magnetic force of the magnet 74 with the rotating body 38 and the outer tube 16 connected, the outer tube 16 is detached from the rotating member 14. At the time of detachment, the protrusion 72 is removed from the valve body 58, and the valve body 58 is self-closed. Therefore, even if the developing fluid is present in the rotor-side fluid passage 56, the valve body 58 prevents leakage. Further, the rotating member 14 can be rotated by blood flow as the outer tube 16 is detached.

 なお、治療デバイス10は、製品提供では、一対の羽部32が内側に折り畳まれる第1形態となった状態で、その周囲をシース78で覆うように提供されることが好ましい(図3A参照)。このように、シース78に収容されていることで、一対の羽部32が不用意に展開することがなくなり、また第1形態への形状記憶が安定的に維持される。 In the provision of the product, the treatment device 10 is preferably provided so as to cover the periphery with a sheath 78 in a state where the pair of wings 32 are folded inward (see FIG. 3A). . Thus, by accommodating in the sheath 78, a pair of wing | blade part 32 does not expand | deploy unintentionally, and the shape memory to a 1st form is maintained stably.

 本実施の形態に係る治療デバイス10は、基本的には以上のように構成されるものであり、以下、その作用及び効果について説明する。 The treatment device 10 according to the present embodiment is basically configured as described above, and the operation and effect will be described below.

 本実施の形態に係る治療デバイス10は、生体への導入前に治療デバイス10の内部を生理食塩水で満たすプライミングが行われる(プライミングステップ)。図3Aに示すように、プライミングステップでは、治療デバイス10の先端部にシース78を装着したまま、第1ポート26を介して生理食塩水を供給し、被塗布物質流通ルーメン20を通して生理食塩水をシャフト12の先端側に導く。この生理食塩水は、ロール軸部材36の案内路48に流入し、さらに流通管34の流通路42を通って吐出口18から吐出される。これにより、被塗布物質流通ルーメン20、案内路48及び流通路42から空気が抜かれ生理食塩水で満たされる。 Priming is performed on the treatment device 10 according to the present embodiment to fill the inside of the treatment device 10 with physiological saline before introduction into the living body (priming step). As shown in FIG. 3A, in the priming step, physiological saline is supplied through the first port 26 while the sheath 78 is attached to the distal end portion of the treatment device 10, and physiological saline is supplied through the substance distribution lumen 20. Lead to the tip side of the shaft 12. The physiological saline flows into the guide path 48 of the roll shaft member 36 and is discharged from the discharge port 18 through the flow path 42 of the flow pipe 34. As a result, air is extracted from the coated substance distribution lumen 20, the guide path 48, and the flow path 42 and filled with physiological saline.

 また、プライミングステップでは、第2ポート68を介して展開用流体(生理食塩水)を供給し、外管側流体通路70及び回転体側流体通路56を通して、羽部32の空洞部40に展開用流体を流入させる。この際、接続機構60により回転部材14と外管16が接続状態となっており、展開用流体は空洞部40に容易に導かれる。 In the priming step, a developing fluid (physiological saline) is supplied through the second port 68, and the developing fluid is supplied to the cavity 40 of the wing 32 through the outer tube side fluid passage 70 and the rotating body side fluid passage 56. Inflow. At this time, the rotating member 14 and the outer tube 16 are connected by the connection mechanism 60, and the developing fluid is easily guided to the cavity 40.

 プライミング時の展開用流体の供給量は、第1形態を維持する程度の量であり、また羽部32の周囲にシース78が存在することから、羽部32の展開が規制される。このように、生体への挿入前に羽部32についても展開用流体で満たしておくことで、以降の治療デバイス10の操作(羽部32の展開)を効率的に行うことができる。 The supply amount of the deployment fluid at the time of priming is an amount sufficient to maintain the first form, and since the sheath 78 exists around the wing portion 32, the deployment of the wing portion 32 is restricted. In this way, by filling the wing 32 with the deployment fluid before insertion into the living body, the subsequent operation of the treatment device 10 (deployment of the wing 32) can be performed efficiently.

 ここで、プライミングした治療デバイス10は、上述したように、バルーン血管形成術において、治療部位(処置対象X)に被塗布物質を塗布するために用いられる。従って、この治療デバイス10の使用前には、血管A内等に発生した病変部である狭窄部をバルーンカテーテル(図示せず)により押し広げる治療が行われる。術者は、この治療において、先ず、血管内造影法や血管内超音波診断法により病変部の形態を特定する。次に、例えばセルジンガー法によって、大腿部等から経皮的に血管内にガイドワイヤを導入し、バルーンカテーテルをこのガイドワイヤに沿って進行させる。そして、狭窄部の形成箇所でバルーンを拡張させることで、狭窄部を血管の径方向外側に押し広げる。狭窄部が押し広げられた後は、バルーンを収縮させて、バルーンカテーテルを血管内から引き抜く。これによりバルーンカテーテルによる処置が終了する。 Here, as described above, the primed treatment device 10 is used for applying a substance to be applied to a treatment site (treatment target X) in balloon angioplasty. Therefore, before the treatment device 10 is used, a treatment for expanding a stenosis, which is a lesion in the blood vessel A or the like, with a balloon catheter (not shown) is performed. In this treatment, the surgeon first identifies the form of the lesion by an intravascular imaging method or an intravascular ultrasonic diagnostic method. Next, a guide wire is introduced into the blood vessel percutaneously from the thigh or the like, for example, by the Seldinger method, and the balloon catheter is advanced along the guide wire. Then, by expanding the balloon at the formation site of the stenosis, the stenosis is pushed outward in the radial direction of the blood vessel. After the stenosis is expanded, the balloon is deflated and the balloon catheter is withdrawn from the blood vessel. Thereby, the treatment by the balloon catheter is completed.

 その後、狭窄部が押し広げられた処置対象Xに、治療デバイス10を送達する送達ステップを実施する。この送達ステップでは、図3Bに示すように、治療デバイス10の先端部に装着されていたシース78を取り外して、バルーンカテーテルと同じ挿入箇所から治療デバイス10を挿入する。この際、治療デバイス10の羽部32は、回転体38に接触した第1形態に維持されており、回転部材14は血管Aの内面よりも充分に細くなっている。そのため、治療デバイス10は、血管Aの内面を傷付けることなく、処置対象Xまでスムーズに送達される。術者は、X線造影下に、治療デバイス10の先端部が処置対象Xを越えたことを判別すると、送達を停止する。 Thereafter, a delivery step of delivering the therapeutic device 10 to the treatment target X whose stenosis portion is pushed and expanded is performed. In this delivery step, as shown in FIG. 3B, the sheath 78 attached to the distal end portion of the treatment device 10 is removed, and the treatment device 10 is inserted from the same insertion site as the balloon catheter. At this time, the wing portion 32 of the treatment device 10 is maintained in the first form in contact with the rotating body 38, and the rotating member 14 is sufficiently thinner than the inner surface of the blood vessel A. Therefore, the treatment device 10 is smoothly delivered to the treatment target X without damaging the inner surface of the blood vessel A. When the surgeon determines that the distal end portion of the treatment device 10 has exceeded the treatment target X under X-ray contrast, the delivery is stopped.

 送達ステップの後は、回転部材14の羽部32を第2形態に移行させる。すなわち羽部32を拡張させる展開ステップを実施する。この展開ステップでは、図4Aに示すように、第2ポート68を介して外管側流体通路70に展開用流体を供給する。この展開用流体は、外管側流体通路70を通って回転体側流体通路56に導かれ、さらに羽部32の空洞部40に流入される。これにより、羽部32は第1形態から第2形態に移行する。 After the delivery step, the wing 32 of the rotating member 14 is shifted to the second form. That is, the expansion | deployment step which expands the wing | blade part 32 is implemented. In this deployment step, as shown in FIG. 4A, a deployment fluid is supplied to the outer tube side fluid passage 70 via the second port 68. The developing fluid is guided to the rotating body side fluid passage 56 through the outer tube side fluid passage 70 and further flows into the cavity portion 40 of the wing portion 32. Thereby, the wing | blade part 32 transfers to a 2nd form from a 1st form.

 すなわち、所定量の展開用流体が空洞部40に流入されることで、一対の羽部32は所定の内圧で展開し第2形態の形状を形成する。治療デバイス10の処置前には処置対象Xの形態が特定されているので、展開用流体の供給量を適宜調整することができる。つまり、一対の羽部32の径方向長さが血管壁Bの直径よりも短くなるように供給量を設定して、一対の羽部32を拡張させる。 That is, when a predetermined amount of the developing fluid flows into the cavity 40, the pair of wings 32 are expanded with a predetermined internal pressure to form the shape of the second form. Since the form of the treatment target X is specified before the treatment of the treatment device 10, the supply amount of the deployment fluid can be appropriately adjusted. That is, the supply amount is set so that the radial length of the pair of wings 32 is shorter than the diameter of the blood vessel wall B, and the pair of wings 32 is expanded.

 例えば、処置対象X部分の血管Aが太く、一対の羽部32の径方向長さが血管壁Bの直径よりも短い場合は、シャフト12の軸心と直交するように羽部32を拡張させ、吐出口18を血管壁Bに対向させる。一方、処置対象X部分の血管Aが細く、一対の羽部32の径方向長さが血管壁Bの直径よりも長い場合は、展開用流体を少ない供給量とすることで、一対の羽部32を傾けて展開させ、吐出口18を血管壁Bに臨ませる。つまり、治療デバイス10は、血管Aの太さに応じて、羽部32の展開度合いを調整することにより、吐出口18を処置対象Xの近傍位置に適宜配置させることができる。 For example, when the blood vessel A of the treatment target X portion is thick and the radial length of the pair of wings 32 is shorter than the diameter of the blood vessel wall B, the wings 32 are expanded so as to be orthogonal to the axis of the shaft 12. The discharge port 18 is made to face the blood vessel wall B. On the other hand, when the blood vessel A of the treatment target X portion is thin and the radial length of the pair of wing parts 32 is longer than the diameter of the blood vessel wall B, the pair of wing parts can be obtained by reducing the supply amount of the developing fluid. 32 is tilted and deployed, so that the discharge port 18 faces the blood vessel wall B. That is, the treatment device 10 can appropriately arrange the discharge port 18 in the vicinity of the treatment target X by adjusting the degree of expansion of the wing 32 according to the thickness of the blood vessel A.

 なお、この展開ステップでは、一旦多量の展開用流体を供給することで、一対の羽部32の外側の端部を血管壁Bに当接させて、その後、展開用流体を空洞部40から多少排出することで、羽部32の径方向長さを短く調整する作業を行ってもよい。これにより、シャフト12の軸心を血管A内の軸心と容易に一致させる(センタリングさせる)ことができる。 In this deployment step, once a large amount of deployment fluid is supplied, the outer ends of the pair of wings 32 are brought into contact with the blood vessel wall B, and then the deployment fluid is somewhat removed from the cavity 40. By discharging, the work of adjusting the length of the wing portion 32 in the radial direction may be shortened. Thereby, the axial center of the shaft 12 can be easily matched (centered) with the axial center in the blood vessel A.

 展開ステップの後は、回転部材14を回転させる回転ステップを実施する。この回転ステップでは、図4Bに示すように、外管16を基端方向に移動させて回転体38から外管16を離脱させる。この離脱時には、弁体58が閉塞することにより空洞部40に供給された展開用流体が回転部材14側に残留する。このため、一対の羽部32は第2形態の状態で維持される。そして、一対の羽部32が血管A内を流れる血液を受けることで、回転部材14が自動的に回転する。 After the unfolding step, a rotating step for rotating the rotating member 14 is performed. In this rotation step, as shown in FIG. 4B, the outer tube 16 is moved in the proximal direction, and the outer tube 16 is detached from the rotating body 38. At the time of detachment, the developing fluid supplied to the cavity 40 remains on the rotating member 14 side by closing the valve body 58. For this reason, a pair of wing | blade part 32 is maintained in the state of a 2nd form. Then, when the pair of wing portions 32 receives blood flowing in the blood vessel A, the rotating member 14 automatically rotates.

 さらに、回転ステップの実施中には、図5Aに示すように、処置対象Xに被塗布物質を塗布する塗布ステップを実施する。塗布ステップでは、第1ポート26を介して被塗布物質流通ルーメン20に被塗布物質を供給し、被塗布物質流通ルーメン20を通してシャフト12の先端部に被塗布物質を導く。この被塗布物質は、回転しているロール軸部材36の案内路48及び流通管34の流通路42を介して、吐出口18から吐出される。 Further, during the rotation step, as shown in FIG. 5A, an application step of applying a substance to be applied to the treatment target X is performed. In the coating step, the material to be coated is supplied to the material circulation lumen 20 through the first port 26, and the material to be coated is guided to the tip of the shaft 12 through the material circulation lumen 20. The material to be coated is discharged from the discharge port 18 through the guide path 48 of the rotating roll shaft member 36 and the flow path 42 of the flow pipe 34.

 吐出口18は処置対象Xの近傍位置にあるので、吐出口18から吐出された被塗布物質は処置対象Xに確実に付着される。ここで、血管A内では、血管Aの軸心付近の血流よりも血管壁B付近の血流のほうが緩やかになっている。このため、血管Aの軸心付近から薬液を吐出するデバイス(例えば、米国特許出願公開第2011/0077216号明細書のデバイス)に比べて、本実施の形態に係る治療デバイス10は、処置対象Xに被塗布物質をより精度良く塗布することができる。 Since the discharge port 18 is in the vicinity of the treatment target X, the substance to be applied discharged from the discharge port 18 is reliably attached to the treatment target X. Here, in the blood vessel A, the blood flow near the blood vessel wall B is gentler than the blood flow near the axial center of the blood vessel A. For this reason, compared with a device (for example, a device disclosed in US Patent Application Publication No. 2011/0077216) that discharges a drug solution from the vicinity of the axis of the blood vessel A, the treatment device 10 according to the present embodiment is a treatment target X It is possible to apply the substance to be applied more accurately.

 また、一対の羽部32が回転し、吐出口18も一体的に回転しているので、被塗布物質は、処置対象X(血管壁B)の内面全体に均一的に塗布される。従って、治療デバイス10は、被塗布物質の塗布ムラや塗り損じ等を生じさせることがない。さらに、回転部材14の回転時には、羽部32の形状に基づき、血管A内の血液が羽部32の遠心方向(径方向)に向かうように作用する。これにより、回転部材14は血管Aの軸心に位置するように誘導されるので、一対の羽部32が血管壁Bに接触することを抑制できる。 In addition, since the pair of wings 32 rotate and the discharge port 18 also rotates integrally, the substance to be coated is uniformly applied to the entire inner surface of the treatment target X (blood vessel wall B). Therefore, the treatment device 10 does not cause uneven application or coating failure of the substance to be applied. Furthermore, when the rotating member 14 rotates, the blood in the blood vessel A acts in the centrifugal direction (radial direction) of the wing portion 32 based on the shape of the wing portion 32. Thereby, since the rotating member 14 is guided so as to be positioned at the axial center of the blood vessel A, the pair of wing portions 32 can be prevented from contacting the blood vessel wall B.

 塗布ステップ中には、被塗布物質を塗布しながら、アクチュエータ24により治療デバイス10を移動させる移動ステップを行う。移動ステップでは、ハブ22に接続したアクチュエータ24により、治療デバイス10を等速度で後退移動させる。従って、処置対象Xに重なる位置にあるシャフト12の先端部及び回転部材14も等速度で後退移動する。これにより治療デバイス10は、処置対象Xの軸方向に沿って被塗布物質を均一的に塗布することができる。 During the applying step, a moving step is performed in which the treatment device 10 is moved by the actuator 24 while applying the substance to be applied. In the moving step, the treatment device 10 is moved backward at a constant speed by the actuator 24 connected to the hub 22. Therefore, the distal end portion of the shaft 12 and the rotating member 14 that are in a position overlapping the treatment target X also move backward at a constant speed. Thereby, the therapeutic device 10 can apply | coat a to-be-coated substance uniformly along the axial direction of the treatment target X. FIG.

 なお、移動ステップでは、回転部材14の後退移動後に、再び進出移動させて被塗布物質を一層確実に塗布することも可能である。すなわち、治療デバイス10による手技では、血管A内における回転部材14の進退移動を何度行ってもよい。 In the moving step, after the rotating member 14 is moved backward, it can be moved again to apply the substance to be coated more reliably. That is, in the procedure using the treatment device 10, the rotation member 14 may move back and forth in the blood vessel A any number of times.

 被塗布物質の塗布が終了した後は、図5Bに示すように、一対の羽部32を収縮して治療デバイス10を血管A内から後退移動させる後退移動ステップを実施する。この後退移動ステップでは、外管16を進出移動させて、回転体38と外管16を再び接続することで、回転部材14の回転を停止させる。上述したように、回転体38に対し外管16を近接させると、接続機構60の磁石74と金属材76が引き寄せられる。これにより、回転体38の弁体58と外管16の突起部72とが対向し合い、回転体38と外管16の接続にともない、弁体58に突起部72が挿入される。従って、回転体側流体通路56と外管側流体通路70が連通する。 After the application of the substance to be applied is completed, a backward movement step for contracting the pair of wings 32 and moving the treatment device 10 backward from the blood vessel A is performed as shown in FIG. 5B. In this backward movement step, the rotation of the rotating member 14 is stopped by moving the outer tube 16 forward and reconnecting the rotating body 38 and the outer tube 16. As described above, when the outer tube 16 is brought close to the rotating body 38, the magnet 74 and the metal material 76 of the connection mechanism 60 are attracted. As a result, the valve body 58 of the rotating body 38 and the protruding portion 72 of the outer tube 16 face each other, and the protruding portion 72 is inserted into the valve body 58 as the rotating body 38 and the outer tube 16 are connected. Accordingly, the rotor-side fluid passage 56 and the outer tube-side fluid passage 70 communicate with each other.

 外管16が回転部材14に接続された後は、第2ポート68を介して展開用流体を排出する操作を行う。これにより、一対の羽部32を展開させていた展開用流体が排出され、一対の羽部32が収縮する。上述したように、一対の羽部32は第1形態に予め形状記憶されているため、回転体38の外側面に接触するように簡単に折り曲げられる。従って、血管A内から回転部材14をスムーズに後退移動させて、治療デバイス10を生体内から抜去することができる。 After the outer tube 16 is connected to the rotating member 14, an operation of discharging the deployment fluid through the second port 68 is performed. As a result, the deployment fluid that has deployed the pair of wings 32 is discharged, and the pair of wings 32 contracts. As described above, since the pair of wing portions 32 is preliminarily stored in the first form, the pair of wing portions 32 can be easily bent so as to come into contact with the outer surface of the rotating body 38. Therefore, the treatment device 10 can be removed from the living body by smoothly moving the rotating member 14 backward from the blood vessel A.

 なお、治療デバイス10は、上述した実施の形態に限定されず、種々の変形例や応用例をとり得ることができる。以下、本発明に係る治療デバイス10の変形例についていくつか説明を行う。なお、以下の説明において本実施の形態に係る治療デバイス10と同一の構成又は同一の機能を有する構成については、同じ符号を付しその詳細な説明については省略する。 The treatment device 10 is not limited to the above-described embodiment, and various modifications and application examples can be taken. Hereinafter, some modifications of the treatment device 10 according to the present invention will be described. In addition, in the following description, about the structure same as the treatment device 10 concerning this Embodiment, or the structure which has the same function, the same code | symbol is attached | subjected and the detailed description is abbreviate | omitted.

 図6Aに示すように、第1変形例に係る治療デバイス10Aは、回転部材15の先端部に周方向に沿って8つの羽部33が設けられており、この8つの羽部33により回転部材15を回転させる構成となっている。このように羽部33を8つ設けても、本実施の形態に係る治療デバイス10と同じ効果を得ることができる。この場合、被塗布物質の吐出口18は、図6A中に示すように、全ての羽部33に設けられてもよく、一部の羽部33にだけ設けられてもよい。 As shown in FIG. 6A, the treatment device 10 </ b> A according to the first modification is provided with eight wings 33 along the circumferential direction at the distal end portion of the rotation member 15, and the eight wings 33 allow the rotation member to rotate. 15 is configured to rotate. Thus, even if eight wings 33 are provided, the same effect as the treatment device 10 according to the present embodiment can be obtained. In this case, as shown in FIG. 6A, the discharge port 18 for the substance to be coated may be provided in all the wing parts 33, or may be provided only in a part of the wing parts 33.

 要するに、回転部材14、15に設けられる羽部32、33の数は限定されるものではなく、羽部32、33の形状も枚数等に応じて適宜形成してよい。特に、治療デバイス10のスムーズな送達(第1形態)と、回転部材14、15の回転(第2形態)とを両立し得る羽部32、33の枚数としては2~8枚が挙げられる。 In short, the number of the wings 32 and 33 provided on the rotating members 14 and 15 is not limited, and the shape of the wings 32 and 33 may be appropriately formed according to the number of sheets. In particular, the number of wings 32 and 33 that can achieve both smooth delivery of the treatment device 10 (first form) and rotation of the rotating members 14 and 15 (second form) includes 2 to 8.

 図6Bに示すように、第2変形例に係る治療デバイス10Bは、接続機構61が回転体38の基端部に設けられた谷部80と、外管16の先端部に設けられた山部82とからなる。谷部80と山部82は互いに係合することで隙間なく接続される。よって、外管16の進退操作にともない谷部80と山部82の係合状態を切り替え、回転部材14の回転と回転停止を切り替えることができる。この場合、回転体側流体通路56と外管側流体通路70は、谷部80と山部82にそれぞれ設けられることで、接続状態において容易に連通させることができる。すなわち、接続機構61の構成も回転部材14と外管16の接続をなす種々の構造を採用することができる。 As shown in FIG. 6B, the treatment device 10 </ b> B according to the second modification includes a valley portion 80 in which the connection mechanism 61 is provided at the proximal end portion of the rotating body 38 and a mountain portion provided at the distal end portion of the outer tube 16. 82. The valley portion 80 and the mountain portion 82 are connected to each other without any gap by engaging with each other. Therefore, the engagement state between the valley portion 80 and the mountain portion 82 can be switched in accordance with the forward / backward operation of the outer tube 16, and the rotation and rotation stop of the rotating member 14 can be switched. In this case, the rotating body side fluid passage 56 and the outer tube side fluid passage 70 are provided in the valley portion 80 and the mountain portion 82, respectively, so that they can be easily communicated in the connected state. That is, the structure of the connection mechanism 61 can employ various structures that connect the rotating member 14 and the outer tube 16.

 図6Cに示すように、第3変形例に係る治療デバイス10Cは、一対の羽部32の空洞部40にロール軸部材36の案内路48が直接連通しており、被塗布物質の供給により一対の羽部32を展開する構成となっている。また、被塗布物質を吐出する吐出口18は、一対の羽部32の外側の端部に充分に小さく設けられて空洞部40に連通しており、所定の内圧で拡張した羽部32から被塗布物質を吐出することができる。このように構成することで、羽部32を拡張させる動作と被塗布物質を吐出させる動作を1つのルーメン(被塗布物質流通ルーメン20)により行うことができるので、治療デバイス10Cを簡単に構成することができる。 As shown in FIG. 6C, in the treatment device 10C according to the third modified example, the guide path 48 of the roll shaft member 36 is in direct communication with the cavity 40 of the pair of wings 32, and the pair of coated devices is supplied by supplying the substance to be coated. The wing portion 32 is expanded. Further, the discharge port 18 for discharging the substance to be coated is provided sufficiently small at the outer ends of the pair of wings 32 and communicates with the cavity 40, and is applied from the wings 32 expanded by a predetermined internal pressure. The coating material can be discharged. With this configuration, the operation of expanding the wing 32 and the operation of discharging the substance to be coated can be performed by one lumen (the substance to be coated circulation lumen 20), and thus the treatment device 10C is simply configured. be able to.

 図6Dに示すように、第4変形例に係る治療デバイス10Dは、羽部32に連結される外側ロール軸部材84と、外側ロール軸部材84の内部を挿通する内側ロール軸部材86とを有する二重構造のロール軸部材37を備える。また、シャフト12は、内部に内管88が挿通された二重管体に構成されている。外側ロール軸部材84は、展開用流体を流通可能な流体通路90が内部に形成されており、シャフト12の内部(展開用流体流通ルーメン92)に設けられた軸受部30aに回転自在に軸支される。一方、内側ロール軸部材86は、被塗布物質を流通可能な被塗布物質流通路94が内部に設けられており、この被塗布物質流通路94は内管88の被塗布物質流通ルーメン21と吐出口18を連通させている。また、内側ロール軸部材86は、被塗布物質流通ルーメン21に設けられた軸受部30bに回転自在に軸支される。 As illustrated in FIG. 6D, the treatment device 10 </ b> D according to the fourth modification includes an outer roll shaft member 84 coupled to the wing portion 32 and an inner roll shaft member 86 that passes through the inside of the outer roll shaft member 84. A roll shaft member 37 having a double structure is provided. Moreover, the shaft 12 is comprised by the double tube body by which the inner tube | pipe 88 was penetrated inside. The outer roll shaft member 84 is formed therein with a fluid passage 90 through which a developing fluid can flow, and is rotatably supported by a bearing portion 30a provided in the shaft 12 (the developing fluid flow lumen 92). Is done. On the other hand, the inner roll shaft member 86 is provided with a material flow passage 94 through which the material to be coated can flow, and this material flow passage 94 is connected to the material flow lumen 21 of the inner pipe 88 and discharged. The outlet 18 is in communication. Further, the inner roll shaft member 86 is rotatably supported by a bearing portion 30b provided in the coated material distribution lumen 21.

 このように構成することで、一対の羽部32を拡張する場合は、展開用流体流通ルーメン92、流体通路90を介して空洞部40に展開用流体を供給し、被塗布物質を塗布する場合は、被塗布物質流通ルーメン21、被塗布物質流通路94を介して吐出口18から被塗布物質を吐出することができる。従って、第4変形例に係る治療デバイス10Dでも、本実施の形態に係る治療デバイス10と同じ効果を得ることができる。 With this configuration, when expanding the pair of wing parts 32, the developing fluid is supplied to the cavity 40 via the developing fluid flow lumen 92 and the fluid passage 90, and the substance to be applied is applied. Can discharge the coated material from the discharge port 18 through the coated material flow lumen 21 and the coated material flow passage 94. Therefore, the treatment device 10D according to the fourth modification can obtain the same effect as the treatment device 10 according to the present embodiment.

 図7A及び図7Bに示すように、第5変形例に係る治療デバイス10Eは、シース78に収容された状態で血管A内に挿入される構成になっている。この場合、一対の羽部32は、自然状態で、シャフト12の軸方向に対し直交方向に延出する形状(第2形態)に形成されており、シース78内に収容されることで弾性変形して第1形態となっている。 7A and 7B, the treatment device 10E according to the fifth modification is configured to be inserted into the blood vessel A while being accommodated in the sheath 78. In this case, the pair of wing portions 32 is formed in a shape (second form) extending in a direction orthogonal to the axial direction of the shaft 12 in a natural state, and is elastically deformed by being accommodated in the sheath 78. And it becomes the 1st form.

 従って、治療デバイス10Eと相対的にシース78を後退移動させて回転部材14を露出させると、弾性的に復元して第2形態に移行し、吐出口18を血管壁Bの近傍位置に配置させる。また、治療デバイス10Eは、支持部材96を介してシース78に支持されることにより、血管Aの軸心に沿うように位置決め(センタリング)される構成であってもよい。回転部材14は、第2形態に移行した状態で、血流により自動的に回転し、吐出口18から被塗布物質を吐出する。塗布後は、シース78に再び収容されて抜去される。 Therefore, when the sheath 78 is moved backward relative to the treatment device 10E to expose the rotating member 14, it is elastically restored to the second form, and the discharge port 18 is disposed in the vicinity of the blood vessel wall B. . The treatment device 10 </ b> E may be configured to be positioned (centered) along the axis of the blood vessel A by being supported by the sheath 78 via the support member 96. The rotating member 14 is automatically rotated by the blood flow in the state of transition to the second form, and discharges the substance to be coated from the discharge port 18. After the application, it is accommodated again in the sheath 78 and removed.

 また、治療デバイスの他の変形例としては、回転部材14を血流に依らず種々の手段で回転させることもできる。例えば、被塗布物質流通ルーメン20や案内路48に被塗布物質を流通させる際に、被塗布物質の流動を利用して回転部材14を回転させる構成とすることもできる。また、治療デバイス10の基端部に回転部材14に連なる芯材を露出させて、術者の手動やモータ等の駆動源により芯材を回転させ、先端部の回転部材14を回転させる構成としてもよい。 As another modification of the treatment device, the rotating member 14 can be rotated by various means regardless of the blood flow. For example, when the material to be coated is circulated through the material to be coated circulation lumen 20 or the guide path 48, the rotating member 14 may be rotated using the flow of the material to be coated. In addition, the core material connected to the rotation member 14 is exposed at the proximal end portion of the treatment device 10, the core material is rotated by a driving source such as an operator's manual or a motor, and the rotation member 14 at the distal end portion is rotated. Also good.

 以上のように、本発明に係る治療デバイス10、10A~10E及び治療方法によれば、シャフト12に設けられた回転部材14が、シャフト12の軸回りに沿って回転自在であり、且つ被塗布物質を吐出可能な吐出口18を有することで、血管A内で回転部材14を回転させながら被塗布物質を吐出することができる。従って、処置対象X(血管壁B)に被塗布物質を均一的に付着させることができる。また、吐出口18が羽部32の略遠心方向に位置するので、処置対象Xの近くで被塗布物質を吐出することができる。このため、吐出された被塗布物質は、血管A内を流れる血液の影響をほとんど受けることなく略遠心方向に向かい、処置対象Xに確実に付着される。 As described above, according to the treatment devices 10, 10A to 10E and the treatment method according to the present invention, the rotating member 14 provided on the shaft 12 is rotatable along the axis of the shaft 12 and is coated. By having the discharge port 18 capable of discharging the substance, the substance to be coated can be discharged while rotating the rotating member 14 in the blood vessel A. Therefore, the substance to be coated can be uniformly attached to the treatment target X (blood vessel wall B). Moreover, since the discharge port 18 is located in the substantially centrifugal direction of the wing part 32, the substance to be coated can be discharged near the treatment target X. For this reason, the discharged substance to be applied is directed substantially in the centrifugal direction without being substantially affected by the blood flowing in the blood vessel A, and is reliably attached to the treatment target X.

 また、回転部材14が、第1及び第2形態に変形自在であることで、治療デバイス10を送達する場合には、回転部材14を第1形態として、血管A内を円滑に移動させることができる。そして、処置対象Xに重なる位置では、第2形態に変形することにより吐出口18を処置対象Xの近傍位置に位置させて被塗布物質を吐出することができる。この場合、一対の羽部32がバルーンとして構成されていることで、一対の羽部32の半径長を容易に調整することができ、羽部32と血管壁Bの接触を抑止して、回転部材14を回転させることができる。 In addition, since the rotating member 14 can be deformed into the first and second forms, when the therapeutic device 10 is delivered, the rotating member 14 can be smoothly moved in the blood vessel A as the first form. it can. And in the position which overlaps with the treatment target X, by deform | transforming into a 2nd form, the discharge port 18 can be located in the vicinity position of the treatment target X, and a to-be-coated substance can be discharged. In this case, since the pair of wings 32 is configured as a balloon, the radial length of the pair of wings 32 can be easily adjusted, and the contact between the wings 32 and the blood vessel wall B is suppressed and rotated. The member 14 can be rotated.

 さらに、シャフト12の被塗布物質流通ルーメン20に連通する案内路48が回転部材14のロール軸部材36に形成されていることで、被塗布物質流通ルーメン20から吐出口18に被塗布物質を容易に導くことができ、充分な量の被塗布物質を処置対象Xに吐出することができる。 Further, since the guide path 48 communicating with the coated substance distribution lumen 20 of the shaft 12 is formed in the roll shaft member 36 of the rotating member 14, the coated substance can be easily transferred from the coated substance distribution lumen 20 to the discharge port 18. Therefore, a sufficient amount of the substance to be coated can be discharged to the treatment target X.

 また、従来の治療デバイスを使用した場合は、被塗布物質として粘度の高いもの(糖類、ベタイン系高分子、ポリエチレングリコール等の変性物である接着性を発現する高分子物質を溶解させた溶液)を供給すると、被塗布物質を注入している過程で流通路内で比較的容易に詰まってしまうことが想定される。これに対し、本実施の形態に係る治療デバイス10は、被塗布物質の流通路がロール軸部材36まで略直線状に延在し、さらにロール軸部材36が回転する遠心方向に吐出口18が形成されているので、粘度の高い被塗布物質でも吐出口18まで詰まることなくスムーズに導くことが可能である。 In addition, when a conventional treatment device is used, the substance to be coated has a high viscosity (a solution in which a high-molecular substance that expresses adhesiveness, such as sugars, betaine-based polymers, and polyethylene glycol) is dissolved) Is supplied, it is assumed that clogging is relatively easy in the flow path in the process of injecting the material to be coated. On the other hand, in the treatment device 10 according to the present embodiment, the flow path of the substance to be applied extends substantially linearly to the roll shaft member 36, and the discharge port 18 is provided in the centrifugal direction in which the roll shaft member 36 rotates. Since it is formed, even a high-viscosity material can be smoothly guided to the discharge port 18 without clogging.

 上記において、本発明について好適な実施の形態を挙げて説明したが、本発明は前記実施の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. Needless to say.

Claims (7)

 生体管腔内に進退自在に挿入される長尺なシャフト(12)と、
 前記シャフト(12)の軸回りに沿って回転自在となるように該シャフト(12)に設けられ、且つ回転の略遠心方向に被塗布物質を吐出可能な吐出口(18)を有する回転部材(14、15)とを備える
 ことを特徴とする生体管腔内治療デバイス(10、10A~10E)。
A long shaft (12) which is inserted into a living body lumen so as to freely advance and retract;
A rotating member () provided on the shaft (12) so as to be rotatable along the axis of the shaft (12) and having a discharge port (18) capable of discharging a substance to be coated in a substantially centrifugal direction of rotation. 14, 15). A biological intraluminal treatment device (10, 10A to 10E).
 請求項1記載の生体管腔内治療デバイス(10、10A~10E)において、
 前記回転部材(14、15)は、前記シャフト(12)の外側面の近傍位置に前記吐出口(18)が位置する第1形態と、
 前記吐出口(18)が前記シャフト(12)の外側面の近傍位置から離間して前記生体管腔の内面を臨む第2形態とに変形自在である
 ことを特徴とする生体管腔内治療デバイス(10、10A~10E)。
The intraluminal treatment device (10, 10A-10E) according to claim 1,
The rotating member (14, 15) has a first form in which the discharge port (18) is positioned in the vicinity of the outer surface of the shaft (12);
The in-vivo treatment device characterized in that the discharge port (18) can be deformed to a second configuration in which the discharge port (18) faces away from a position near the outer surface of the shaft (12) and faces the inner surface of the living body lumen. (10, 10A-10E).
 請求項2記載の生体管腔内治療デバイス(10、10A~10E)において、
 前記回転部材(14、15)は、前記第1形態で前記シャフト(12)の延在方向に撓み、前記第2形態で前記シャフト(12)の径方向外側に展開する複数の羽部(32、33)を有し、
 前記吐出口(18)は、前記第2形態における前記羽部(32、33)の径方向外側に形成されており、
 前記回転部材(14、15)は、前記第2形態における前記羽部(32、33)が前記生体管腔内の流体の流れを受けることにより、前記シャフト(12)の軸回りに回転する
 ことを特徴とする生体管腔内治療デバイス(10、10A~10E)。
The intraluminal treatment device (10, 10A-10E) according to claim 2,
The rotating member (14, 15) is bent in the extending direction of the shaft (12) in the first form, and a plurality of wing parts (32) deployed outward in the radial direction of the shaft (12) in the second form. 33)
The discharge port (18) is formed on the radially outer side of the wings (32, 33) in the second form,
The rotating member (14, 15) rotates around the axis of the shaft (12) when the wings (32, 33) in the second form receive a flow of fluid in the living body lumen. A biological intraluminal treatment device (10, 10A to 10E) characterized by:
 請求項3記載の生体管腔内治療デバイス(10、10A~10D)において、
 前記羽部(32、33)は、内部空間(40)を有するバルーンとして構成され、前記内部空間(40)に展開用流体が供給されることにより前記第1形態から前記第2形態に移行する
 ことを特徴とする生体管腔内治療デバイス(10、10A~10D)。
The intraluminal treatment device (10, 10A-10D) according to claim 3,
The wings (32, 33) are configured as balloons having an internal space (40), and the deployment fluid is supplied to the internal space (40), thereby shifting from the first form to the second form. A biological endoluminal treatment device (10, 10A to 10D) characterized by the above.
 請求項4記載の生体管腔内治療デバイス(10、10A、10B、10E)において、
 前記回転部材(14、15)は、前記シャフト(12)の周囲を囲い、前記羽部(32、33)と一体回転する回転体(38)を有し、
 前記回転体(38)は、前記内部空間(40)に前記展開用流体を流入可能な流通路(56)を有する
 ことを特徴とする生体管腔内治療デバイス(10、10A、10B、10E)。
The intraluminal treatment device (10, 10A, 10B, 10E) according to claim 4,
The rotating member (14, 15) has a rotating body (38) that surrounds the shaft (12) and rotates integrally with the wings (32, 33).
The rotator (38) has a flow path (56) through which the deployment fluid can flow into the internal space (40). Intraluminal treatment device (10, 10A, 10B, 10E) .
 請求項5記載の生体管腔内治療デバイス(10、10A、10B)において、
 前記回転体(38)の基端方向には、前記シャフト(12)の周囲を囲い前記シャフト(12)に対し進退自在な外管(16)が配置され、
 前記回転体(38)と前記外管(16)には、前記外管(16)の進出移動にともない前記回転体(38)に接続されて該回転体(38)の回転を規制し、前記外管(16)の後退移動にともない前記回転体(38)から離脱され該回転体(38)の回転を許容する接続機構(60、61)が設けられる
 ことを特徴とする生体管腔内治療デバイス(10、10A、10B)。
The intraluminal treatment device (10, 10A, 10B) according to claim 5,
In the proximal direction of the rotating body (38), an outer tube (16) surrounding the shaft (12) and being movable forward and backward with respect to the shaft (12) is disposed.
The rotating body (38) and the outer tube (16) are connected to the rotating body (38) as the outer tube (16) moves forward to restrict the rotation of the rotating body (38), and A living body intraluminal treatment characterized in that a connection mechanism (60, 61) is provided that is detached from the rotating body (38) and allows the rotating body (38) to rotate as the outer tube (16) moves backward. Device (10, 10A, 10B).
 請求項1記載の生体管腔内治療デバイス(10、10A~10E)において、
 前記シャフト(12)は、軸方向に延在し前記被塗布物質を流通可能な被塗布物質用ルーメン(20、21)を有し、
 前記回転部材(14、15)は、前記被塗布物質用ルーメン(20、21)内に設けられた軸受部(30)に回転自在に支持され、且つ前記被塗布物質用ルーメン(20、21)と前記吐出口(18)を連通する中空部(48、94)が形成された回転軸部(36、37)を有する
 ことを特徴とする生体管腔内治療デバイス(10、10A~10E)。
The intraluminal treatment device (10, 10A-10E) according to claim 1,
The shaft (12) has a lumen for coated material (20, 21) extending in the axial direction and capable of circulating the coated material,
The rotating member (14, 15) is rotatably supported by a bearing portion (30) provided in the lumen for coated material (20, 21), and the lumen for coated material (20, 21). And a rotating shaft portion (36, 37) formed with hollow portions (48, 94) communicating with the discharge port (18). A biological intraluminal treatment device (10, 10A to 10E).
PCT/JP2012/067290 2012-07-06 2012-07-06 Treatment device for treating inside of organism lumen Ceased WO2014006737A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000501632A (en) * 1995-12-13 2000-02-15 ニーコメド・アルツナイミッテル・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Instruments for the use of surgical tools
JP2004500175A (en) * 1999-12-14 2004-01-08 リンバテック・コーポレーション Fixation systems and methods
JP2009082727A (en) * 2004-10-18 2009-04-23 Tyco Healthcare Group Lp Structure for applying sprayable wound treatment material

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000501632A (en) * 1995-12-13 2000-02-15 ニーコメド・アルツナイミッテル・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Instruments for the use of surgical tools
JP2004500175A (en) * 1999-12-14 2004-01-08 リンバテック・コーポレーション Fixation systems and methods
JP2009082727A (en) * 2004-10-18 2009-04-23 Tyco Healthcare Group Lp Structure for applying sprayable wound treatment material

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