WO2013015025A1 - 治療デバイス - Google Patents
治療デバイス Download PDFInfo
- Publication number
- WO2013015025A1 WO2013015025A1 PCT/JP2012/064567 JP2012064567W WO2013015025A1 WO 2013015025 A1 WO2013015025 A1 WO 2013015025A1 JP 2012064567 W JP2012064567 W JP 2012064567W WO 2013015025 A1 WO2013015025 A1 WO 2013015025A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- protective sleeve
- treatment device
- active substance
- physiologically active
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
Definitions
- the present invention relates to a treatment device for causing a distal end portion to reach a lesion in a living body lumen and performing a predetermined treatment.
- a balloon catheter is generally configured to include a long shaft and a balloon that is provided on the distal end side of the shaft and expands in the radial direction, and a stenosis portion in the body is formed by inserting a preceding guide wire. Sent to.
- the present invention has been made in view of such problems, and provides a treatment device that can prevent a drug or the like applied to the outer surface of a balloon from peeling before contacting a lesioned part. With the goal.
- a treatment device is a device body having a shaft, an expandable balloon provided on the distal end side of the shaft, applied to the outer surface of the balloon, and at least one kind.
- An intervening member disposed between the sleeve and surrounding the balloon and displaceable in a proximal direction with respect to the device body, and having a self-expanding function, and the protective sleeve is disposed in the proximal direction When displaced, the intervening member expands at a position surrounding the balloon.
- the physiologically active substance portion applied to the outer surface of the balloon is covered with the protective sleeve, the living body lumen inner wall and the physiological Contact with the active substance part can be prevented or suppressed, and peeling of the physiologically active substance part is prevented.
- the interposition member is disposed between the protective sleeve and the balloon, the physiologically active substance portion applied to the outer surface of the balloon is not in contact with the inner surface of the protective sleeve, so that the protective sleeve is in the proximal direction. When the balloon is exposed by being moved to, the physiologically active substance portion can be prevented from being scraped off and peeled off by the protective sleeve.
- the intervening member automatically expands by the self-expanding function when the protective sleeve moves in the proximal direction, when the intervening member is moved in the proximal direction thereafter, the physiologically active substance portion is moved by the intervening member. It is scraped off and does not peel off.
- the proximal end of the intervention member is provided with an operation mechanism extending along the shaft to at least the proximal end side of the device body, and the operation mechanism extends the protective sleeve in the proximal direction.
- the interposition member is prevented from moving in the proximal direction when moving to the proximal end, and the intermediate member is displaced in the proximal direction by operating on the proximal end side of the device body. Good. With this configuration, it is possible to reliably prevent the interposition member from moving along with the movement of the protective sleeve in the proximal direction, and it is possible to easily perform the operation of moving the interposition member in the proximal direction on the hand side, Excellent operability.
- the operation mechanism includes a linear member disposed along the shaft, so that flexibility of the treatment device can be secured.
- the intervening member is securely disposed between the protective sheath and the balloon until the fixing is intentionally released. Can be placed.
- the fixing mechanism when the fixing mechanism is provided on the base end side of the device body, the fixing of the operation mechanism by the fixing mechanism can be easily released, and the operability is excellent.
- the fixing mechanism includes a first holding part provided on the device body side, and a second holding part that can be attached to and detached from the device body, and the first holding part and the device When the operating mechanism is clamped between the second clamping unit and the operating mechanism is fixed, the fixing and releasing thereof can be performed reliably and simply.
- the interposition member moves in accordance with the movement of the protective sleeve in the proximal direction. Can be prevented more reliably.
- the following treatment method can be implemented. That is, the treatment method has a self-expanding function between a balloon in which a physiologically active substance part containing at least one biological physiologically active substance is applied to the outer surface and a protective sleeve surrounding the balloon.
- a step of disposing the balloon of the treatment device having a structure in which the interposition member is disposed in a lesion site, which is a treatment target site in a living body lumen, and the state in which the interposition member is disposed outside the balloon Moving the protective sleeve in the proximal direction and expanding the interposed member; moving the expanded interposed member in a proximal direction to a position where the expanded interposed member is retracted from the outside of the balloon; and Expanding and expanding the lesioned part from the inside, and attaching at least a part of the physiologically active substance part to the lesioned part.
- FIG. 2 is a cross-sectional view taken along line II-II in FIG. It is an expanded sectional view which shows a part of treatment device shown in FIG. 4A is a cross-sectional view of the fixing mechanism in the locked state
- FIG. 4B is a cross-sectional view of the fixing mechanism in the unlocked state.
- FIG. 5A is a diagram of a first state explaining the operation of the treatment device shown in FIG. 1
- FIG. 5D is a diagram of a fourth state for explaining the operation of the treatment device shown in FIG. It is a partially omitted side view showing a treatment device according to a second embodiment of the present invention.
- FIG. 1 is a partially omitted side view showing a treatment device 10A according to a first embodiment of the present invention.
- a part of the distal end side of the treatment device 10 ⁇ / b> A is shown in cross section and a middle portion thereof is omitted, the distal end side of the treatment device 10 ⁇ / b> A is on the upper side of FIG. The side is shown in the lower part of FIG.
- the front end side of 10 A of treatment devices is expanded and shown rather than the base end side.
- the treatment device 10A is used to reach a lesioned part in a living body lumen (blood vessel or the like) and perform a predetermined treatment on the lesioned part. It is configured as a so-called PTCA (Percutaneous Transluminal Coronary Angioplasty) balloon catheter that expands the stenosis part from the inside by expanding the balloon 16 provided in the stenosis part, which is a lesioned part. ing.
- the present invention is other than such PTCA balloon catheters, for example, catheters for improving lesions formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity and other organs. It is also applicable to.
- a treatment device 10A includes a thin and long shaft 12, a hub 15 provided on the proximal end side of the shaft 12, a distal tip 14 fixed to the tip of the shaft 12, A balloon 16 provided in the vicinity of the distal end portion of the shaft 12 on the proximal end side of the distal tip 14, a physiologically active substance portion 18 applied to the outer surface of the balloon 16, and a protective sleeve 21 covering the physiologically active substance portion 18; An interposed member 23 disposed between the balloon 16 and the protective sleeve 21 and an operation mechanism 25 provided on the proximal end side of the interposed member 23 are provided.
- the shaft 12 and the hub 15 constitute a device body 11.
- the shaft 12 is a double tube having an inner tube 24 in which a lumen 19 into which a guide wire (not shown) is inserted is formed, and an outer tube 26 arranged so as to surround the inner tube 24, and the treatment device 10A. It is a part which comprises the main body (catheter tube).
- the inner tube 24 extends through the balloon 16 and the outer tube 26, and its base end is bent, and is joined in a liquid-tight manner to an opening 27 formed in the middle portion of the outer tube 26 in the longitudinal direction (see FIG. (See also 3). Therefore, in this treatment device 10A, the guide wire inserted with the distal end opening portion 14a of the distal tip 14 as the inlet is inserted through the lumen 19 of the inner tube 24 from the distal end side to the proximal end side and led out from the opening portion 27. It is configured as a “rapid exchange type” catheter.
- the treatment device 10 ⁇ / b> A may be configured as an “over-the-wire type” catheter in which a guide wire opening is provided in the hub 15 on the proximal end side of the shaft 12.
- the outer tube 26 is a flexible tubular member extending in the axial direction so as to connect the rear end of the balloon 16 and the tip of the hub 15, and a lumen is formed in the axial direction inside the outer tube 26. Yes.
- the inner tube 24 protrudes from the tip of the outer tube 26.
- a gap 28 is formed between the inner tube 24 and the outer tube 26 so as to extend in the axial direction in a hollow cylindrical shape and communicate with the inside of the balloon 16.
- the gap 28 functions as a flow path for supplying the expansion fluid for the balloon 16.
- the hub 15 is provided with a balloon expansion port 17.
- the balloon expansion port 17 communicates with the gap 28 described above via the hub 15 and the lumen of the outer tube 26.
- the constituent material of the hub 15 is not particularly limited, but a relatively hard resin material such as polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, Examples include acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).
- the balloon expansion port 17 can be connected to an expansion fluid supply means such as an indeflator (not shown).
- an expansion fluid supply means such as an indeflator (not shown).
- the expansion fluid for example, contrast medium
- the liquid can be fed to the balloon 16 through the lumen (including the gap 28).
- the inner tube 24 has, for example, an outer diameter of about 0.1 to 1.0 mm, preferably about 0.3 to 0.7 mm, a wall thickness of about 10 to 150 ⁇ m, preferably about 20 to 100 ⁇ m, and is long.
- the tube has a length of about 100 to 2000 mm, preferably about 150 to 1500 mm, and may have different outer diameters and inner diameters on the distal end side and the proximal end side.
- the outer tube 26 has, for example, an outer diameter of about 0.3 to 3.0 mm, preferably about 0.5 to 1.5 mm, a thickness of about 10 to 150 ⁇ m, preferably about 20 to 100 ⁇ m, and a length. Is a tube of about 300 to 2000 mm, preferably about 700 to 1600 mm, and may have different outer diameters and inner diameters on the distal end side and the proximal end side.
- the inner tube 24 and the outer tube 26 allow the operator to smoothly insert the long shaft 12 into a living body lumen such as a blood vessel while grasping and operating the proximal end side.
- a structure having flexibility and moderate rigidity is preferable. Therefore, the inner tube 24 and the outer tube 26 are made of, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these).
- It may be formed of a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.
- a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.
- the balloon 16 is configured to be foldable (deflated) and expanded by a change in internal pressure.
- the balloon 16 in a deflated state is indicated by a solid line
- the balloon 16 in an expanded state is indicated by a virtual line (two-point difference line).
- the balloon 16 includes a cylindrical portion (straight portion) 30 that expands into a cylindrical shape (cylindrical shape) by an expansion fluid injected therein, a distal tapered portion 32 that gradually decreases in diameter on the distal end side of the cylindrical portion 30, and a cylindrical portion. 30 and a proximal end taper portion 34 that gradually decreases in diameter on the proximal end side.
- a cylindrical distal-side non-expanded portion 36 provided on the distal end side of the distal tapered portion 32 is liquid-tightly joined to the outer peripheral surface of the inner tube 24, and is provided on the proximal end side of the proximal tapered portion 34.
- the cylindrical base-side non-expanded portion 38 is fixed to the shaft 12 by being liquid-tightly joined to the distal end portion of the outer tube 26.
- the inner diameter of the distal-side non-expanded portion 36 substantially matches the outer diameter of the inner tube 24, and the outer diameter of the proximal-side non-expanded portion 38 substantially matches the outer diameter of the outer tube 26.
- the balloon 16 and the inner tube 24 and the outer tube 26 may be fixed in a liquid-tight manner, and are joined by, for example, adhesion or heat fusion.
- the size of the balloon 16 when expanded is, for example, that the outer diameter of the cylindrical portion 30 is about 1 to 10 mm, preferably about 1 to 7 mm, and the length is about 5 to 350 mm, preferably about 5 to 300 mm.
- the outer diameter of the distal non-expanded portion 36 is about 0.5 to 1.5 mm, preferably about 0.6 to 1.3 mm, and is substantially the same as the outer diameter of the distal tip 14.
- the thickness is about 1 to 5 mm, preferably about 1 to 2 mm.
- the outer diameter of the proximal non-expanded portion 38 is about 0.5 to 1.6 mm, preferably about 0.7 to 1.5 mm, and the length is about 1 to 5 mm, preferably about 2 to 4 mm.
- the lengths of the distal end taper portion 32 and the proximal end taper portion 34 are about 1 to 10 mm, preferably about 3 to 7 mm.
- Such a balloon 16 is required to have an appropriate flexibility as in the case of the inner tube 24 and the outer tube 26, and needs to have a strength that can surely spread the narrowed portion.
- it may be the same as the constituent material of the inner tube 24 and the outer tube 26 exemplified above, or may be another material.
- the distal tip 14 is a short tube whose outer diameter is substantially the same as the distal non-expanded portion 36 of the balloon 16, and whose inner diameter is substantially the same as the outer diameter of the inner tube 24.
- the length is about 0.5 to 10 mm.
- the distal tip 14 is externally fitted and liquid-tightly joined to the distal end portion of the inner tube 24 and protrudes to the distal end side from the distal end opening portion of the lumen 19, and its proximal end surface is the distal end side non-expanded portion 36 of the balloon 16. It is joined to the tip surface.
- the tip opening portion 14a of the tip tip 14 communicates with the lumen 19 of the inner tube 24 and serves as an inlet for the guide wire.
- the tip 14 is configured more flexibly than at least the inner tube 24 or the outer tube 26 by appropriately setting the material and shape thereof.
- polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, Ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof
- a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or the above It is good to form with the multilayer tube etc. of 2 or more types of polymeric materials.
- Such a tip 14 as a leading edge of the treatment device 10A flexibly proceeds through a curved portion or a concavo-convex portion in a living body lumen, penetrates through a stenosis portion (lesioned portion), and smoothes the treatment device 10A. It is a part for leading insertion.
- the distal tip 14 may be omitted.
- a configuration in which the distal end position of the inner tube 24 and the distal end position of the distal end side non-expanded portion 36 of the balloon 16 are matched, A configuration in which the most advanced position of the inner tube 24 protrudes somewhat from the most advanced position of the extended portion 36 is preferable.
- FIG. 2 is a sectional view taken along line II-II in FIG.
- the physiologically active substance portion 18 applied to the outer surface of the balloon 16 contains at least one biological physiologically active substance.
- the physiologically active substance portion 18 is preferably applied to the entire circumference (range of 360 degrees) of the outer peripheral surface of the balloon 16 in order to ensure adhesion (detention) to the lesioned portion (stenosis portion). And applied over at least the entire length of the cylindrical portion 30. Therefore, for example, the physiologically active substance portion 18 is preferably applied in the range indicated by A in FIG. 1 (the range from the middle of the distal tapered portion 32 to the middle of the proximal tapered portion 34).
- the thickness (application thickness) of the physiologically active substance portion 18 is preferably 3 to 100 ⁇ m, more preferably 5 to 50 ⁇ m. Note that the physiologically active substance portion 18 may be formed on the entire outer surface of the balloon 16 or may be formed on a part of the outer surface of the balloon 16.
- the biological physiologically active substance contained in the physiologically active substance part 18 is not particularly limited as long as it has an effect of suppressing restenosis by attaching the stenosis part in the living body lumen to the treated site.
- anticancer agents for example, anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergic agents, antioxidants, GPIIbIIIa Antagonists, retinoids, flavonoids, carotenoids, lipid improvers, DNA synthesis inhibitors, tyrosine kinase inhibitors, antiplatelet agents, vascular smooth muscle growth inhibitors, anti-inflammatory agents, biomaterials, interferons, NO production promoters, etc. Can be mentioned.
- anticancer agent for example, vincristine sulfate, vinblastine sulfate, vindesine sulfate, irinotecan hydrochloride, paclitaxel, docetaxel hydrate, methotrexate, cyclophosphamide and the like are preferable.
- an immunosuppressant for example, sirolimus, tacrolimus hydrate, azathioprine, cyclosporine, mycophenolate mofetil, gusperimus hydrochloride, mizoribine and the like are preferable.
- the antibiotic more specifically, for example, mitomycin C, doxorubicin hydrochloride, actinomycin D, daunorubicin hydrochloride, idarubicin hydrochloride, pirarubicin hydrochloride, aclarubicin hydrochloride, epirubicin hydrochloride, pepromycin sulfate, dinostatin stimaramer and the like are preferable.
- the antirheumatic agent is preferably, for example, sodium gold thiomalate, penicillamine, lobenzalit disodium or the like.
- an antithrombotic agent for example, heparin, ticlopidine hydrochloride, hirudin and the like are preferable.
- the antihyperlipidemic drug is preferably an HMG-CoA reductase inhibitor or probe.
- HMG-CoA reductase inhibitor more specifically, for example, cerivastatin sodium, atorvastatin, nisvastatin, pitavastatin, fluvastatin sodium, simvastatin, lovastatin, pravastatin sodium and the like are preferable.
- ACE inhibitor for example, quinapril hydrochloride, perindopril erbumine, trandolapril, cilazapril, temocapril hydrochloride, delapril hydrochloride, enalapril maleate, lisinopril, captopril and the like are preferable.
- calcium antagonist for example, nifedipine, nilvadipine, diltiazem hydrochloride, benidipine hydrochloride, nisoldipine and the like are preferable.
- tranilast is preferable as the antiallergic agent.
- all-trans retinoic acid is preferable as the retinoid.
- an antioxidant for example, catechins, anthocyanins, proanthocyanidins, lycopene, ⁇ - carotene and the like are preferable.
- catechins epigallocatechin gallate is particularly preferable.
- a tyrosine kinase inhibitor for example, genistein, tyrphostin, arbustatin and the like are preferable.
- steroids such as dexamethasone and prednisolone and aspirin are preferable.
- bio-derived material examples include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), and PDGF (platelet weight GF). Etc.) are preferred.
- the physiologically active substance portion 18 may include only one type of the above-exemplified biological physiologically active substances, or may include two or more different biological physiologically active substances. When two or more kinds of biological physiologically active substances are included, the combination may be appropriately selected from the biologically physiologically active substances exemplified above as necessary.
- the protective sleeve 21 is a long and flexible tubular member surrounding the shaft 12, covers the physiologically active substance portion 18, and extends along the shaft 12 to the proximal end side of the shaft 12.
- the protective sleeve 21 is configured to cover at least the entire physiologically active substance part 18 with respect to the physiologically active substance part 18 formed on a part or the whole of the balloon 16.
- the protective sleeve 21 can be displaced (slid) in the proximal direction with respect to the device body 11, and at least the distance between the distal end of the protective sleeve 21 and the proximal end of the balloon 16 is equal to or greater than the axial length of the interposition member 23. It is possible to move back to the position.
- the distal end of the protective sleeve 21 is closer to the distal end than the distal end of the physiologically active substance portion 18 applied to the outer surface of the balloon 16. That is, in the initial state, the physiologically active substance portion 18 is completely covered with the protective sleeve 21 and does not come into contact with the outside of the protective sleeve 21. Therefore, the physiologically active substance portion 18 applied to the outer surface of the balloon 16 is appropriately protected.
- FIG. 3 is an enlarged cross-sectional view of the opening 27 for leading out the guide wire and the peripheral portion thereof.
- the protective sleeve 21 is provided with a long hole 31 for guiding a guide wire inserted through the lumen 19 along the axis of the protective sleeve 21. Regardless of the position of the protective sleeve 21 within the movable range, the position and range of the long hole 31 are set so that the guide wire lead-out opening 27 provided on the side surface of the shaft 12 is exposed to the outside. ing.
- the constituent material of the protective sleeve 21 is not particularly limited, for example, at least one material selected from those exemplified as the constituent materials of the inner tube 24 and the outer tube 26 described above may be employed. It is desirable that the protective sleeve 21 has a strength capable of restraining an interposed member 23 described later in a compressed state, and has an inner surface having lubricity with respect to the interposed member 23. Thereby, when sliding the protective sleeve 21 to the base end side, the frictional resistance by the interposition member 23 can be suppressed small.
- a hub 40 is provided at the proximal end of the protective sleeve 21.
- the hub 40 has a hollow shape (hollow cylindrical shape) through which the shaft 12 is inserted.
- the hub 40 has an appropriate length and is protected so that an operator can easily grasp the finger 12 and pull it in the proximal direction. It has a moderate outer diameter larger than the outer diameter of the sleeve 21. The operator can easily slide the protective sleeve 21 by gripping the hub 40 with fingers.
- the interposition member 23 has a hollow cylindrical shape as a whole, and has a self-expanding function.
- expansion is prevented by the inner surface of the protective sleeve 21 and the contracted state is obtained.
- the protective sleeve 21 is released, it is elastically expanded (expanded diameter) by its self-expanding function.
- the interposition member 23 is disposed outside the physiologically active substance part 18 in the protective sleeve 21, thereby preventing the physiologically active substance part 18 from contacting the inner surface of the protective sleeve 21. Therefore, the length of the intervening member 23 in the axial direction should be at least equal to or longer than the application range of the physiologically active substance portion 18 (the range indicated by A in FIG. 1).
- the interposition member 23 in the illustrated configuration example is formed in a coil shape in which an elastic wire is spirally wound.
- a mesh shape in which elastic wires are interwoven and a tubular shape as a whole are configured.
- a plurality of rings made of elastic wire are connected to each other to form a tubular shape, or a plurality of ring-shaped cells bent in a Z-shape or S-shape are connected to each other to form a tubular shape as a whole. It may be.
- the constituent material of the interposing member 23 is not particularly limited as long as it can provide a self-expanding function, but a superelastic alloy (shape memory alloy) or shape memory resin can be adopted.
- superelastic alloys include Ti—Ni alloys, Ti—Ni—Fe alloys, Cu—Zn alloys, Cu—Zn—Al alloys, Cu—Al—Ni alloys, and Cu—Au—Zn alloys.
- a metal or alloy having normal elasticity such as stainless steel, tantalum, or cobalt alloy can be adopted.
- An operation mechanism 25 is provided on the proximal end side of the interposed member 23.
- the operation mechanism 25 is constituted by a linear member 29.
- the linear member 29 is inserted and disposed between the protective sleeve 21 and the shaft 12 and is disposed along the shaft 12.
- the distal end of the linear member 29 is coupled to the proximal end of the interposed member 23, and the proximal end side of the linear member 29 is protected. Projecting in the proximal direction from between the shaft 21 and the shaft 12 is drawn out.
- the linear member 29 prevents the interposition member 23 from moving in the base end direction when the protective sleeve 21 is moved in the base end direction, while operating on the base end side of the device body 11 to operate the interposition member 23. Is a member for displacing the base plate in the proximal direction. Therefore, the thickness (outer diameter) and the constituent material of the linear member 29 are set so that the linear member 29 has an appropriate rigidity that does not bend greatly when receiving a load in the proximal direction from the interposed member 23. Is done.
- the constituent material of the linear member 29 may be selected from those exemplified as the constituent material of the interposed member 23, for example.
- the interposition member 23 and the linear member 29 may be comprised with the same material, and may be comprised with a different material.
- the interposition member 23 and the linear member 29 are comprised with the same material, both may be comprised integrally as a single member, Thereby, a number of parts can be reduced and a structure can be simplified.
- the treatment device 10A is provided with a fixing mechanism 44 for releasably fixing the linear member 29, which is the operation mechanism 25, to the device body 11.
- the fixing mechanism 44 in the illustrated example is provided on the proximal end side of the device main body 11, specifically, on the hub 15.
- the fixing mechanism 44 includes a first holding part 46 provided in the hub 15 and a second holding part 48 that can be attached to and detached from the first holding part 46.
- a first protrusion 50 is provided on the first clamping part 46.
- Two second protrusions 52 are provided apart from each other in the second clamping portion 48.
- the proximal end of the linear member 29 is more than the linear member 29.
- a large-diameter grip portion may be provided.
- the fixing mechanism 44 is not limited to the configuration in which the linear member 29 is clamped by the first clamping unit 46 and the second clamping unit 48, and the fixing mechanism 44 has a function of detachably fixing the linear member 29 to the device body 11.
- the configuration may be adopted.
- adhesion, heat fusion, physical engagement, or a combination thereof may be employed.
- the fixing strength by adhesion, thermal fusion, or physical engagement is set to such an extent that the linear member 29 and the device main body 11 are released from being fixed by the operator pulling the linear member 29.
- the treatment device 10A according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
- the form of the stenosis which is a lesion
- a guide wire is introduced into the blood vessel percutaneously from the thigh or the like by, for example, the Seldinger method, and the lumen 19 of the inner tube 24 is passed from the distal end opening portion 14a of the distal end tip 14 to the guide wire. Insert the treatment device 10A into the blood vessel.
- the guide wire is advanced to the target lesion (stenosis), placed through the lesion, and the treatment device 10A is placed in the blood vessel (for example, coronary artery) along the guide wire.
- the physiologically active substance portion 18 applied to the outer surface of the balloon 16 is covered with the protective sleeve 21, so that the inner wall of the blood vessel and the physiology are in the middle of delivering the balloon 16 to the lesion. Contact with the active substance portion 18 can be prevented or suppressed, and peeling of the physiologically active substance portion 18 is effectively prevented.
- the distal tip 14 at the distal end of the treatment device 10A eventually passes (penetrates) through the lesioned portion (stenosis portion) 56 and the protective sleeve.
- the balloon 16 surrounded by 21 is placed in the lesioned part 56.
- the balloon 16 and the interposition member 23 are exposed in the blood vessel 54 by pulling the protective sleeve 21 in the proximal direction as shown in FIG. 5B.
- the interposition member 23 is fixed by the fixing mechanism 44 via the linear member 29, even if the protective sleeve 21 is moved in the proximal direction, it moves in the proximal direction in accordance with the movement.
- the balloon 16 is expanded by the self-expanding function.
- a moderate gap is formed between the interposed member 23 and the physiologically active substance portion 18.
- the outer diameter of the interposed member 23 in the natural state (expanded state) is preferably larger than the inner diameter of the protective sleeve 21 and smaller than the inner diameter of the blood vessel 54 to be applied.
- the intervening member 23 and the physiologically active substance portion 18 are in contact with each other before the intervening member 23 is expanded, when the intervening member 23 is expanded, the diameter is increased to increase the surface of the physiologically active substance portion 18. Therefore, the physiologically active substance portion 18 is not scraped off by the intervening member 23.
- the fixing of the linear member 29 and the device body 11 by the fixing mechanism 44 is released.
- the 1st clamping part 46 is removed from the 2nd clamping part 48, and the base end side of the linear member 29 is released from the fixing mechanism 44.
- the fixing mechanism 44 is adhesion, heat fusion, or the like, the fixing is released by pulling the proximal end side of the linear member 29.
- the linear member 29 When the fixing of the linear member 29 by the fixing mechanism 44 is released, the linear member 29 is pulled in the proximal direction, and the interposition member 23 is moved in the proximal direction to surround the balloon 16 as shown in FIG. 5C. Evacuate from. In this case, since a moderate gap is formed between the intervening member 23 and the physiologically active substance portion 18, it is applied to the outer surface of the balloon 16 when the intervening member 23 moves in the proximal direction. The physiologically active substance portion 18 is not scraped off by the intervening member 23 and peeled off. As a result of the intervening member 23 retracting from the outside of the balloon 16, the physiologically active substance portion 18 is completely exposed in the blood vessel 54.
- the balloon 16 When the physiologically active substance portion 18 is exposed in the blood vessel 54 in this way, the balloon 16 is expanded under the action of an expansion fluid supply means (not shown) to expand the lesioned portion 56 from the inside, and the portion where the lesioned portion 56 is generated is normal. (See FIG. 5D). At this time, the physiologically active substance portion 18 applied to the outer surface of the balloon 16 is pressed against the expanded lesioned portion 56 and adheres to the lesioned portion 56. As described above, the physiologically active substance portion 18 contains a biologically physiologically active substance having an effect of suppressing restenosis. Accordingly, restenosis of the treated site can be suppressed.
- the balloon 16 reaches the lesioned portion 56. Can prevent peeling of the physiologically active substance part 18, but then, when the sleeve is shifted in the proximal direction to expose the physiologically active substance part 18, the physiologically active substance part 18 is scraped and peeled off by the sleeve. .
- the interposed member 23 is disposed between the protective sleeve 21 and the balloon 16, thereby protecting the physiologically active substance portion 18 applied to the outer surface of the balloon 16. Since the inner surface of the sleeve 21 is not in contact, when the balloon 16 is exposed by moving the protective sleeve 21 in the proximal direction, the protective sleeve 21 can prevent the physiologically active substance portion 18 from being scraped off and peeled off. .
- the intervening member 23 is automatically expanded by the self-expanding function. Therefore, when the intervening member 23 is moved in the proximal direction thereafter, the physiologically active substance portion 18 is expanded. Will not rub off and peel off.
- the operation mechanism 25 (linear member 29) prevents the interposition member 23 from moving in the proximal direction when the protective sleeve 21 is moved in the proximal direction, while the device body 11 Since the interposition member 23 is configured to be displaced in the base end direction by operating on the base end side, it is ensured that the interposition member 23 moves as the protective sleeve 21 moves in the base end direction. In addition to being able to block, the operation of moving the interposition member 23 in the proximal direction can be easily performed on the hand side, and the operability is excellent.
- the treatment device 10A is provided with a fixing mechanism 44 that removably fixes the operation mechanism 25 to the device body 11, the treatment device 10A is provided between the protective sleeve 21 and the balloon 16 until the fixation is intentionally released.
- the interposition member 23 can be reliably arranged in the.
- the fixing mechanism 44 is provided on the base end side of the device body 11, the fixing of the linear member 29 by the fixing mechanism 44 can be easily released, and the operability is excellent.
- the fixing mechanism 44 includes a first clamping unit 46 provided on the device body 11 side and a second clamping unit 48 that can be attached to and detached from the device body 11, and the first clamping unit 46. Since the operation mechanism 25 is clamped between the second clamping unit 48 and the second clamping unit 48, the operation mechanism 25 is fixed, so that the fixing and releasing thereof can be performed reliably and easily.
- FIG. 6 is a partially omitted side view of the treatment device 10B according to the second embodiment of the present invention.
- symbol is attached
- an operation mechanism 25 a is provided at the proximal end of the interposed member 23.
- the operating mechanism 25 a includes a traction tube 62 disposed between the shaft 12 and the protective sleeve 21, and a hub 64 provided at the proximal end of the traction tube 62.
- the pulling tube 62 is a long and thin tubular member (circular tubular member) having flexibility, and is disposed so as to be slidable in the axial direction with respect to the shaft 12, and the tip is coupled to the interposition member 23.
- the end side protrudes from a hub 40 provided at the proximal end of the protective sleeve 21.
- the traction tube 62 is provided with a long hole (not shown) for guiding a guide wire inserted into the lumen 19 (long hole similar to the long hole 31 shown in FIG. 3) along the axis of the traction tube 62. Yes. Regardless of the position of the traction tube 62 within the movable range, the long hole has a position and a range so that the guide wire lead-out opening 27 provided on the side surface of the shaft 12 is exposed to the outside. Yes.
- the constituent material of the traction tube 62 is not particularly limited, but for example, at least one or more materials selected from those exemplified as the constituent materials of the inner tube 24 and the outer tube 26 described above may be employed.
- the hub 64 provided at the proximal end of the traction tube 62 is a hollow shape (hollow cylindrical shape) through which the shaft 12 is inserted, so that the operator can easily grasp the finger and pull it in the proximal direction. It has a moderate length and a moderate outer diameter that is larger than the outer diameter of the traction tube 62.
- the protective sleeve 21 is fixed to the proximal end while the position of the traction tube 62 with respect to the shaft 12 is maintained. Slide in the direction. As a result, the protective sleeve 21 can be retracted from the outside of the balloon 16 while maintaining the state where the interposition member 23 is disposed outside the balloon 16. Thereby, the balloon 16 and the interposition member 23 are exposed in the blood vessel 54.
- the operation mechanism 25a is configured in a tube shape extending to the proximal end side of the shaft 12 along the shaft 12, and has higher rigidity than the linear member 29 shown in FIG. Further, it is possible to more reliably prevent the interposition member 23 from moving as the protective sleeve 21 moves in the proximal direction.
- the interposition member 23 is moved in the proximal direction and retracted from the position surrounding the balloon 16 in the same manner as described with reference to FIG. 5C. .
- the balloon 16 is expanded under the action of an unillustrated expansion fluid supply means to expand the lesioned portion 56 from the inside, and the portion where the lesioned portion 56 is generated is normally treated.
- the bioactive substance portion 18 is attached to the lesioned portion 56 while being brought close to a suitable blood vessel diameter.
- the protective sleeve 21 is displaced in the proximal direction to the position where the entire interposed member 23 expands, the protective sleeve 21 is further moved in the proximal direction. It is good also as a structure which can also move the interposition member 23 to a base end direction with the protective sleeve 21 when it is moved to.
- a configuration for example, when the protective sleeve 21 and the interposition member 23 are coupled in advance with a linear member having a predetermined slack, or when the protective sleeve 21 is retracted to a predetermined position.
- a configuration in which the interposition member 23 is caught on the protective sleeve 21 may be employed.
Abstract
Description
Claims (8)
- シャフト(12)を有するデバイス本体(11)と、
前記シャフト(12)の先端側に設けられた拡張可能なバルーン(16)と、
前記バルーン(16)の外表面に塗布され、少なくとも1種以上の生物学的生理活性物質を含む生理活性物質部(18)と、
前記生理活性物質部(18)を覆い、前記デバイス本体(11)に対して基端方向に変位可能に配置された保護スリーブ(21)と、
前記バルーン(16)と、前記保護スリーブ(21)との間に、前記バルーン(16)を囲んで配置されるとともに、前記デバイス本体(11)に対して基端方向に変位可能であり、自己拡張機能を有する介在部材(23)とを備え、
前記保護スリーブ(21)が基端方向に変位したとき、前記介在部材(23)が前記バルーン(16)を包囲した位置で拡張する、
ことを特徴とする治療デバイス(10A、10B)。 - 請求項1記載の治療デバイス(10A、10B)において、
前記介在部材(23)の基端には、前記シャフト(12)に沿って少なくとも前記デバイス本体(11)の基端側まで延在する操作機構(25、25a)が設けられ、
前記操作機構(25、25a)は、前記保護スリーブ(21)を基端方向に移動させる際に前記介在部材(23)が基端方向に移動することを阻止する一方、前記デバイス本体(11)の基端側で操作することにより前記介在部材(23)を基端方向に変位させるように構成されている、
ことを特徴とする治療デバイス(10A、10B)。 - 請求項2記載の治療デバイス(10A)において、
前記操作機構(25)は、前記シャフト(12)に沿って配設された線状部材(29)を含む、
ことを特徴とする治療デバイス(10A)。 - 請求項2記載の治療デバイス(10A)において、
前記操作機構(25)を前記デバイス本体(11)に対して離脱可能に固定する固定機構(44)が設けられる、
ことを特徴とする治療デバイス(10A)。 - 請求項4記載の治療デバイス(10A)において、
前記固定機構(44)は、前記デバイス本体(11)の基端側に設けられる、
ことを特徴とする治療デバイス(10A)。 - 請求項5記載の治療デバイス(10A)において、
前記固定機構(44)は、前記デバイス本体(11)側に設けられた第1挟持部(46)と、前記デバイス本体(11)に対して着脱可能な第2挟持部(48)とを有し、
前記第1挟持部(46)と前記第2挟持部(48)との間に前記操作機構(25)が挟持されることで、前記操作機構(25)が固定される、
ことを特徴とする治療デバイス(10A)。 - 請求項2記載の治療デバイス(10A、10B)において、
前記介在部材(23)と前記操作機構(25、25a)とは、同一部材により一体的に構成される、
ことを特徴とする治療デバイス(10A、10B)。 - 請求項2記載の治療デバイス(10B)において、
前記操作機構(25a)は、前記シャフト(12)に沿って前記シャフト(12)の基端側まで延在するチューブ状に構成される、
ことを特徴とする治療デバイス(10B)。
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US14/063,576 US9616202B2 (en) | 2011-07-25 | 2013-10-25 | Self-expanding interposed member spacing protective sleeve from restenosis restraining agent coated balloon catheter |
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US20140052104A1 (en) | 2014-02-20 |
US9616202B2 (en) | 2017-04-11 |
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