WO2014006738A1 - Treatment device for treating inside of organism lumen - Google Patents
Treatment device for treating inside of organism lumen Download PDFInfo
- Publication number
- WO2014006738A1 WO2014006738A1 PCT/JP2012/067291 JP2012067291W WO2014006738A1 WO 2014006738 A1 WO2014006738 A1 WO 2014006738A1 JP 2012067291 W JP2012067291 W JP 2012067291W WO 2014006738 A1 WO2014006738 A1 WO 2014006738A1
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- WIPO (PCT)
- Prior art keywords
- substance
- treatment device
- deformation
- blood vessel
- coated
- Prior art date
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Classifications
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- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
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- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
- A61F2/945—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place hardenable, e.g. stents formed in situ
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- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
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.
- 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 is discharged only from the discharge port formed at a predetermined position of the catheter, it is likely to adhere unevenly to the blood vessel wall.
- the present invention has been made to solve the above-described problem, and can reliably apply a substance to be applied to a desired treatment target in a living body lumen, thereby favorably treating the living body lumen. It is an object of the present invention to provide a biological intraluminal treatment device that can be used.
- a treatment device for living body lumen includes a long shaft inserted into a living body lumen, a proximal end side supported by the shaft, and a distal end side supported by the shaft.
- a support part that can be expanded and contracted in a direction perpendicular to the axial direction of the support part, and is provided to be deformable on the distal end side of the support part.
- a deformable application part having a discharge port which is located in the vicinity of the inner surface of the living body lumen and can discharge the substance to be applied.
- the deformation application part having the discharge port for discharging the substance to be applied is provided at the distal end part of the support part that can be expanded and contracted in the direction orthogonal to the axial direction of the shaft, so that the living body lumen to be delivered
- the deformation application portion can be easily expanded / contracted in the radial direction. Therefore, it is possible to efficiently perform the operation of reducing the diameter of the deformation application portion and delivering the inside of the living body lumen, and expanding the deformation application portion to contact or approach the inner surface of the living body lumen.
- the discharge port is present in the vicinity of the inner surface of the biological lumen, applying the substance to be coated from this discharge port is hardly affected by the fluid flowing in the biological lumen, The substance to be coated can be reliably attached to the treatment target on the inner surface of the living body lumen.
- the deformation application part may be enlarged / reduced following the expansion / contraction of the support part.
- transformation application part can be easily expanded / contracted within a biological lumen.
- the support unit and the deformation application unit are accommodated, and the inside of the living body lumen can be delivered, and an outer tube that can move forward and backward with respect to the support unit and the deformation application unit is provided. It is preferable that the distal end side is contracted by being restricted by the outer tube while being accommodated in the outer tube, and is expanded by an elastic restoring force when exposed from the outer tube.
- the support portion contracts by the outer tube and is exposed from the outer tube, the support portion expands by the elastic restoring force, so that the outer diameter of the deformation application portion is easily switched based on the forward / backward movement of the outer tube. be able to. Then, the extension amount of the tip of the support portion is adjusted by the exposure amount from the outer tube, and regardless of the thickness of the biological lumen, the deformation application portion is appropriately pressed on the inner surface of the biological lumen. It can be contacted by pressure.
- the deformation application portion is formed in a flexible ring shape, and the discharge port is located on the distal end surface side and the radially outer side of the deformation application portion, and in the circumferential direction of the deformation application portion. It is good to provide a plurality along.
- the discharge port is positioned on the distal end surface side and the radially outer side of the deformation application portion, the discharge port is not blocked by the inner surface of the living body lumen, and a sufficient amount of the substance to be applied is applied. be able to.
- the substance to be applied can be uniformly discharged from the plurality of discharge ports and attached to the treatment target.
- the deformation application part has a coating substance passage that circulates in the interior and communicates with the discharge port, and has a coating substance supply path that communicates with the coating substance passage and can supply the coating substance. It is preferable that they are connected.
- the shaft has a coating substance distribution lumen extending in the axial direction inside, and the deformation coating section has a coating substance passage that circulates inside and communicates with the discharge port, and the support section.
- the coating substance passage of the deformation coating portion communicates with the coating substance distribution lumen of the shaft via the communication passage of the support portion, so that the deformation coating portion is coated through the coating substance distribution lumen inside the shaft.
- the coating material can be easily guided and the coating material can be discharged from the discharge port.
- the surface of the deformation application part may be coated with a lubricating coating agent.
- the surface of the deformation application portion is coated with the lubricity coating agent, so that the deformation application portion is arranged in the axial direction of the biological lumen in a state where the deformation application portion is in contact with the inner surface of the biological lumen. Can be slid smoothly.
- the deformation application portion has contrast, the operator can accurately grasp the position where the application of the substance to be applied is started.
- the substance to be coated can be reliably attached to a desired treatment target in the living body lumen, and thus the living body lumen can be favorably treated.
- FIG. 2A is a partial front view showing the unfolded state of the frame and deformation application portion of FIG. 1
- FIG. 2B is a partial side view showing the unfolded state of the frame and deformation application portion of FIG. 1, and FIG. It is a partial side view which shows the accommodation state of the flame
- FIG. 2D is a partial side view which shows the expansion
- FIG. 3A is a main part front view showing a treatment device according to a first configuration example
- FIG. 3A is a main part front view showing a treatment device according to a first configuration example
- FIG. 3B is a main part perspective view showing a treatment device according to a second configuration example
- FIG. 3C is a third configuration example. It is a principal part front view which shows the treatment device which concerns on FIG. 3
- FIG. 3D is a principal part front view which shows the treatment device which concerns on a 4th structural example.
- FIG. 4A is a main part side view showing a treatment device according to a fifth configuration example
- FIG. 4B is a main part side view showing a treatment device according to a sixth configuration example
- FIG. 4C is a seventh configuration example.
- FIG. 4D is a side view of an essential part showing a treatment device according to an eighth configuration example.
- FIG. 5A is a first explanatory diagram showing an operation procedure using the treatment device of FIG. 1, FIG.
- FIG. 1 is a perspective view showing an overall configuration of a treatment device 10 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 in combination with a treatment of a lesioned portion (a narrowed portion or a portion where a blood vessel wall is weakened) with a balloon catheter, a stent, or an atherectomy device, or a blood vessel treatment with an ablation device. Used to apply the substance to be applied to the later blood vessel wall.
- 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 a 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 the substance to be applied after removing the atheroma (treatment target X) generated in the blood vessel wall B in the blood vessel A will be described representatively (see FIGS. 5A to 5C).
- 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 includes a shaft 12, a support portion 16 connected to the distal end portion of the shaft 12, a deformation application portion 18 provided at the distal end portion of the support portion 16, the support portion 16 and the deformation. And a sheath 20 capable of accommodating the application portion 18 and delivering the inside of the blood vessel A.
- the support portion 16 is constituted by a plurality (six in FIG. 1) of frames 14.
- the deformation application unit 18 is provided with a plurality of discharge ports 22 through which the substance to be applied can be discharged onto the treatment target X in the blood vessel A.
- the shaft 12 is a solid rod member, is formed to have an outer diameter that can be accommodated in the sheath 20, and extends linearly with a sufficient length so that the deformation application portion 18 can reach the treatment target X.
- Six frames 14 are connected to the distal end portion of the shaft 12, and the shaft 12 and the frame 14 (and the deformation applying portion 18) can operate integrally with the blood vessel A.
- a hub 24 having a diameter larger than that of the shaft 12 is provided at the base end portion of the shaft 12 so as to be easily grasped by the operator.
- the hub 24 includes a movable portion 26 on the distal end side to which the shaft 12 is coupled, and a fixed portion 28 on the proximal end side that surrounds the movable portion 26 so that the movable portion 26 can be accommodated, and the movable portion 26 moves forward and backward with respect to the fixed portion 28.
- the shaft 12 can be moved forward and backward.
- the advance / retreat movement of the movable portion 26 can be performed by the actuator 30 in addition to the operator.
- this actuator 30 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.
- an applied substance supply port 32 is formed in the fixed portion 28, and the applied substance supply port 32 is connected to a tube 34 that passes inside and outside the hub 24. Further, the substance to be coated supply port 32 is connected to a syringe (not shown) that supplies the substance to be coated based on an operation of an operator or the like.
- the tube 34 is provided along the side surface of the shaft 12 from the hub 24 and extends in the distal direction of the treatment device 10.
- An application substance supply path 36 through which an application substance can flow is formed through the tube 34, and a base end side of the application substance supply path 36 is connected to a syringe via an application substance supply port 32. Yes.
- the tip of the tube 34 is branched into three small diameter tubes 34a at a position where the shaft 12 and the six frames 14 are connected.
- the three small-diameter tubes 34a extend in the distal direction, and their end portions are connected to the ring-shaped deformation application portion 18 at equal intervals (120 ° intervals).
- the substance to be coated supply path 36 extends through each small-diameter tube 34 a and communicates with the substance to be coated channel 38 of the deformation coating unit 18.
- the substance to be coated supplied from the syringe to the substance to be coated supply path 36 via the substance to be coated supply port 32 is guided from the substance to be coated supply path 36 to the substance path 38 to be coated on the tip side and is discharged from the discharge port 22. It is discharged into 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 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 deformation application part 18 having the discharge port 22 for discharging the substance to be applied is formed in a ring (ring) shape that can be expanded and contracted in a direction (radial direction) perpendicular to the axial direction of the shaft 12.
- the expansion / contraction of the deformation application portion 18 is realized by the six frames 14 that support the deformation application portion 18 on the base end side.
- FIG. 2A is a partial front view showing a developed state of the frame 14 and the deformation application unit 18 in FIG. 1
- FIG. 2B is a partial side view showing a development state of the frame 14 and the deformation application unit 18 in FIG.
- FIG. 2C is a partial side view showing a housing state of the frame 14 and the deformation application part 18 of FIG. 1
- FIG. 2D is a partial side view showing a developed state of the deformation application part 18 in the thin blood vessel A1.
- the six frames 14 extend from the connecting portion of the shaft 12 toward the distal end and radially outward in a natural state exposed from the sheath 20. These six frames 14 are provided at equal intervals (60 ° intervals in the front view) along the axis of the shaft 12 in the front view and extend so as to spread radially, and the distal ends of the six frames 14 are most spaced apart from each other. ing.
- the deformation application part 18 is attached so as to bridge the tip part of each frame 14.
- the six frames 14 are connected to the shaft 12 so as to have a predetermined elastic force, and the tip portions of the six frames 14 are elastically close to each other. Therefore, it is preferable that the connection part of the six frames 14 and the shaft 12 is integrated in a metallic manner by processing such as continuous connection by casting or cutting, or welding. Thereby, the frame 14 is elastically supported with respect to the shaft 12 so that the inclination angle (inclination with respect to the axial direction of the shaft 12) forms a predetermined angle in a natural state.
- the shaft 12 and the frame 14 are made of a metal having shape memory property.
- materials 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., all SUS varieties), cobalt alloys, noble metals such as gold and platinum, tungsten alloys, carbon materials (including piano wires), etc. Can be mentioned.
- the material is not particularly limited as long as the tip of the frame 14 can be elastically swung, and a resin such as a polymer material may be used.
- the polymer material include polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide. , Polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, and the like, or a mixture thereof, or a combination of the above two or more polymer materials.
- a shape memory resin that can change its shape (for example, increase its diameter) at body temperature may be used. In this case, it is possible to maintain the state in which the deformation application portion 18 is in contact with the lumen wall without further damaging the lumen wall, and to more reliably suppress damage to the blood vessel wall B and the like. Expected to be.
- the radial shape of the six frames 14 according to the present embodiment is maintained with a relatively weak elastic force, and is easily elastically deformed by coming into contact with the sheath 20.
- the tip portions of the six frames 14 act so as to be close to each other.
- the deformation application portion 18 is also radially contracted and accommodated together in the sheath 20.
- an elastic restoring force acts on each frame 14 so that the tip portions are separated from each other.
- transformation application part 18 is also expanded to radial direction outer side.
- the deformation application portion 18 is adjusted by adjusting the displacement amount of the sheath 20. It can be brought into contact with the blood vessel wall B1 with a predetermined pressing force. In this case, the deformation application unit 18 develops with a small outer diameter, but when the material to be applied is supplied, the deformation application unit 18 swells quickly and can discharge the material to be applied from the discharge port 22. Further, the sheath 20 and the shaft 12 may be provided with an adjustment mechanism capable of adjusting the displacement amount of the sheath 20 in a stepwise manner, that is, capable of changing the outer diameter of the deformation applying unit 18 in a stepwise manner.
Abstract
A treatment device (10) for treating the inside of an organism lumen is provided with: a long shaft (12) inserted into a blood vessel (A); a support section (16) having a proximal end side which is supported by the shaft (12) and also having a distal end side which is capable of expanding and contracting in the direction perpendicular to the axial direction of the shaft (12); and a deformable application section (18) provided on the distal end side of the support section (16). The deformable application section (18) is brought into contact with the wall (B) of the blood vessel by the expansion of the distal end side of the support section (16) and has a discharge opening (22) which, when the deformable application section (18) is in contact with the wall (B) of the blood vessel, is located near the wall (B) and can discharge a substance to be applied.
Description
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易い。
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. Further, since the adhesive substance is discharged only from the discharge port formed at a predetermined position of the catheter, it is likely to adhere unevenly 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 to solve the above-described problem, and can reliably apply a substance to be applied to a desired treatment target in a living body lumen, thereby favorably treating the living body lumen. It is an object of the present invention to provide a biological intraluminal treatment device that can be used.
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、生体管腔内に挿入される長尺なシャフトと、基端側が前記シャフトに支持されるとともに、先端側が前記シャフトの軸方向と直交する方向に拡縮自在な支持部と、前記支持部の先端側に変形可能に設けられ、変形作用下に前記生体管腔の内面に当接又は近接し、且つ当接又は近接状態で前記生体管腔の内面の近傍に位置して被塗布物質を吐出可能な吐出口を有する変形塗布部とを備えることを特徴とする。
In order to achieve the above-mentioned object, a treatment device for living body lumen according to the present invention includes a long shaft inserted into a living body lumen, a proximal end side supported by the shaft, and a distal end side supported by the shaft. A support part that can be expanded and contracted in a direction perpendicular to the axial direction of the support part, and is provided to be deformable on the distal end side of the support part. And a deformable application part having a discharge port which is located in the vicinity of the inner surface of the living body lumen and can discharge the substance to be applied.
上記によれば、被塗布物質を吐出する吐出口を有する変形塗布部が、シャフトの軸方向と直交する方向に拡縮可能な支持部の先端部に設けられることにより、送達される生体管腔の径方向に対して変形塗布部を簡単に拡縮することができる。よって、変形塗布部を縮径して生体管腔内を送達し、変形塗布部を展開して生体管腔の内面に当接又は近接させる動作を効率的に行うことができる。そして当接又は近接状態では、吐出口が生体管腔の内面の近傍位置に存在するため、この吐出口から被塗布物質を塗布すると、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、生体管腔の内面の処置対象に被塗布物質を確実に付着させることができる。
According to the above, the deformation application part having the discharge port for discharging the substance to be applied is provided at the distal end part of the support part that can be expanded and contracted in the direction orthogonal to the axial direction of the shaft, so that the living body lumen to be delivered The deformation application portion can be easily expanded / contracted in the radial direction. Therefore, it is possible to efficiently perform the operation of reducing the diameter of the deformation application portion and delivering the inside of the living body lumen, and expanding the deformation application portion to contact or approach the inner surface of the living body lumen. And in the contact or proximity state, since the discharge port is present in the vicinity of the inner surface of the biological lumen, applying the substance to be coated from this discharge port is hardly affected by the fluid flowing in the biological lumen, The substance to be coated can be reliably attached to the treatment target on the inner surface of the living body lumen.
また、前記変形塗布部は、前記支持部の拡縮に追従して拡縮するとよい。これにより、生体管腔内において変形塗布部を簡単に拡縮操作することができる。
Further, the deformation application part may be enlarged / reduced following the expansion / contraction of the support part. Thereby, a deformation | transformation application part can be easily expanded / contracted within a biological lumen.
この場合、前記支持部及び前記変形塗布部を収容して前記生体管腔内を送達可能であり、且つ前記支持部及び前記変形塗布部に対し進退移動自在な外管を備え、前記支持部の先端側は、前記外管内に収容された状態で、前記外管により拡張が規制されることにより収縮し、前記外管から露出された際に、弾性復元力によって拡張することが好ましい。
In this case, the support unit and the deformation application unit are accommodated, and the inside of the living body lumen can be delivered, and an outer tube that can move forward and backward with respect to the support unit and the deformation application unit is provided. It is preferable that the distal end side is contracted by being restricted by the outer tube while being accommodated in the outer tube, and is expanded by an elastic restoring force when exposed from the outer tube.
このように、外管により支持部が収縮し、外管から露出された際に弾性復元力によって支持部が拡張することで、変形塗布部の外径を外管の進退移動に基づき容易に切り替えることができる。そして、支持部は、外管からの露出量により先端部の拡張量が調整されることになり、生体管腔の太さに関わらず、該生体管腔の内面に変形塗布部を適度な押圧力で当接させることができる。
Thus, when the support portion contracts by the outer tube and is exposed from the outer tube, the support portion expands by the elastic restoring force, so that the outer diameter of the deformation application portion is easily switched based on the forward / backward movement of the outer tube. be able to. Then, the extension amount of the tip of the support portion is adjusted by the exposure amount from the outer tube, and regardless of the thickness of the biological lumen, the deformation application portion is appropriately pressed on the inner surface of the biological lumen. It can be contacted by pressure.
また、前記変形塗布部は、可撓性を有するリング状に形成されており、前記吐出口は、前記変形塗布部の先端面側且つ径方向外側に位置するとともに、前記変形塗布部の周方向に沿って複数設けられているとよい。
The deformation application portion is formed in a flexible ring shape, and the discharge port is located on the distal end surface side and the radially outer side of the deformation application portion, and in the circumferential direction of the deformation application portion. It is good to provide a plurality along.
このように、吐出口が変形塗布部の先端面側且つ径方向外側に位置することにより、吐出口が生体管腔の内面に遮断されることがなくなり、充分な量の被塗布物質を塗布することができる。また、吐出口が変形塗布部の周方向に沿って複数設けられていることで、複数の吐出口から被塗布物質を均一的に吐出して処置対象に付着させることができる。
As described above, since the discharge port is positioned on the distal end surface side and the radially outer side of the deformation application portion, the discharge port is not blocked by the inner surface of the living body lumen, and a sufficient amount of the substance to be applied is applied. be able to. In addition, since a plurality of discharge ports are provided along the circumferential direction of the deformation application portion, the substance to be applied can be uniformly discharged from the plurality of discharge ports and attached to the treatment target.
さらに、前記変形塗布部は、内部を周回し前記吐出口に連通する被塗布物質通路を有するとともに、前記被塗布物質通路に連通し被塗布物質を供給可能な被塗布物質供給路を有するチューブに接続されていることが好ましい。
Further, the deformation application part has a coating substance passage that circulates in the interior and communicates with the discharge port, and has a coating substance supply path that communicates with the coating substance passage and can supply the coating substance. It is preferable that they are connected.
このように、変形塗布部の被塗布物質通路がチューブの被塗布物質供給路に連通していることで、チューブを介して変形塗布部に被塗布物質を容易に導き、吐出口から被塗布物質を吐出することができる。
In this way, the coated substance passage of the deformation application part communicates with the coated substance supply path of the tube, so that the coated substance can be easily guided to the deformation application part via the tube, and the coated substance from the discharge port. Can be discharged.
或いは、前記シャフトは、内部を軸方向に延在する被塗布物質流通ルーメンを有し、前記変形塗布部は、内部を周回し前記吐出口に連通する被塗布物質通路を有し、前記支持部は、前記シャフトに連結され先端方向に放射状に延在する複数のフレームとして構成され、前記複数のフレームのうち少なくとも1つは、前記被塗布物質流通ルーメンと前記被塗布物質通路を連通させる連通路が形成された構成とすることもできる。
Alternatively, the shaft has a coating substance distribution lumen extending in the axial direction inside, and the deformation coating section has a coating substance passage that circulates inside and communicates with the discharge port, and the support section. Is configured as a plurality of frames that are connected to the shaft and extend radially in the distal direction, and at least one of the plurality of frames is a communication path that communicates the material to be coated flow passage and the material passage to be coated. It can also be set as the structure formed.
このように、変形塗布部の被塗布物質通路が支持部の連通路を介してシャフトの被塗布物質流通ルーメンに連通していることで、シャフト内部の被塗布物質流通ルーメンを通して変形塗布部に被塗布物質を容易に導き、吐出口から被塗布物質を吐出することができる。
In this way, the coating substance passage of the deformation coating portion communicates with the coating substance distribution lumen of the shaft via the communication passage of the support portion, so that the deformation coating portion is coated through the coating substance distribution lumen inside the shaft. The coating material can be easily guided and the coating material can be discharged from the discharge port.
さらに、前記変形塗布部の表面には、潤滑性コート剤がコーティングされているとよい。
Furthermore, the surface of the deformation application part may be coated with a lubricating coating agent.
このように、変形塗布部の表面に潤滑性コート剤がコーティングされていることで、生体管腔の内面に変形塗布部を当接させた状態で、生体管腔の軸方向に該変形塗布部を円滑に摺動させることができる。
As described above, the surface of the deformation application portion is coated with the lubricity coating agent, so that the deformation application portion is arranged in the axial direction of the biological lumen in a state where the deformation application portion is in contact with the inner surface of the biological lumen. Can be slid smoothly.
さらに、変形塗布部が造影性を有することで、被塗布物質の塗布を開始する位置を術者が正確に把握することができる。
Furthermore, since the deformation application portion has contrast, the operator can accurately grasp the position where the application of the substance to be applied is started.
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、生体管腔内に挿入される長尺なシャフトと、基端側が前記シャフトに支持されるとともに、先端側が前記シャフトの軸方向と直交する方向に拡縮自在な支持部と、前記支持部の先端側に設けられ、被塗布物質を吐出可能な吐出口を有する変形塗布部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、前記支持部及び前記変形塗布部を外管内に収容して縮径した状態で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、前記支持部及び前記変形塗布部を前記外管から露出して前記支持部の拡張により前記変形塗布部を前記生体管腔の内面に当接又は近接させる展開ステップと、前記展開ステップの後に、前記生体管腔の近傍に位置する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 to be inserted into a living body lumen, a proximal end side supported by the shaft, a distal end side being expandable / contractable in a direction perpendicular to the axial direction of the shaft, A treatment method using a living body intraluminal treatment device provided with a deformation application part having a discharge port capable of discharging a substance to be applied, provided on a distal end side, wherein the support part and the deformation application part are placed in an outer tube A delivery step of delivering to a position overlapping with a treatment target in the living body lumen in a state where the diameter is reduced, and after the delivery step, the support portion and the deformation application portion are exposed from the outer tube and the support is provided. An expansion step of bringing the deformation application portion into contact with or close to the inner surface of the biological lumen by expanding the portion; and after the expansion step, discharging the substance to be applied from the discharge port located in the vicinity of the biological lumen Before And having a coating step of applying the treatment target.
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 coated can be reliably attached to a desired treatment target in the living body lumen, and thus the living body lumen can be favorably treated.
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治療デバイス10の全体構成を示す斜視図である。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、バルーンカテーテル、ステント及び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 perspective view showing an overall configuration of a treatment device 10 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 in combination with a treatment of a lesioned portion (a narrowed portion or a portion where a blood vessel wall is weakened) with a balloon catheter, a stent, or an atherectomy device, or a blood vessel treatment with an ablation device. Used to apply the substance to be applied to the later blood vessel wall.
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を送達して処置箇所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 a 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、血管A内の血管壁Bに生じたアテローム(処置対象X)の除去後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(図5A~図5C参照)。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 the substance to be applied after removing the atheroma (treatment target X) generated in the blood vessel wall B in the blood vessel A will be described representatively (see FIGS. 5A to 5C). 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、シャフト12と、シャフト12の先端部に連結された支持部16と、支持部16の先端部に設けられた変形塗布部18と、支持部16及び変形塗布部18を収容して血管A内を送達可能なシース20とを有する。この場合、支持部16は、複数(図1中では6本)のフレーム14によって構成されている。また、変形塗布部18には、血管A内の処置対象Xに被塗布物質を吐出可能な吐出口22が複数設けられている。
The treatment device 10 according to the present embodiment includes a shaft 12, a support portion 16 connected to the distal end portion of the shaft 12, a deformation application portion 18 provided at the distal end portion of the support portion 16, the support portion 16 and the deformation. And a sheath 20 capable of accommodating the application portion 18 and delivering the inside of the blood vessel A. In this case, the support portion 16 is constituted by a plurality (six in FIG. 1) of frames 14. In addition, the deformation application unit 18 is provided with a plurality of discharge ports 22 through which the substance to be applied can be discharged onto the treatment target X in the blood vessel A.
シャフト12は、中実状の棒部材であり、シース20に収容可能な外径に形成され、変形塗布部18が処置対象Xに到達される充分な長さで直線状に延在している。シャフト12の先端部には6本のフレーム14が連結されており、シャフト12、フレーム14(及び変形塗布部18)は、血管Aに対し一体的に動作可能となっている。
The shaft 12 is a solid rod member, is formed to have an outer diameter that can be accommodated in the sheath 20, and extends linearly with a sufficient length so that the deformation application portion 18 can reach the treatment target X. Six frames 14 are connected to the distal end portion of the shaft 12, and the shaft 12 and the frame 14 (and the deformation applying portion 18) can operate integrally with the blood vessel A.
一方、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24が設けられている。ハブ24は、シャフト12が連結される先端側の可動部26と、可動部26を収容可能に囲う基端側の固定部28とを有し、固定部28に対し可動部26が進退移動することによりシャフト12が進退移動できるように構成されている。この可動部26の進退移動は、術者の他に、アクチュエータ30により実施可能となっている。このアクチュエータ30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。
On the other hand, a hub 24 having a diameter larger than that of the shaft 12 is provided at the base end portion of the shaft 12 so as to be easily grasped by the operator. The hub 24 includes a movable portion 26 on the distal end side to which the shaft 12 is coupled, and a fixed portion 28 on the proximal end side that surrounds the movable portion 26 so that the movable portion 26 can be accommodated, and the movable portion 26 moves forward and backward with respect to the fixed portion 28. Thus, the shaft 12 can be moved forward and backward. The advance / retreat movement of the movable portion 26 can be performed by the actuator 30 in addition to the operator. As this actuator 30, 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、固定部28には被塗布物質供給ポート32が形成されており、この被塗布物質供給ポート32は、ハブ24の内部及び外部を通るチューブ34に接続されている。また、被塗布物質供給ポート32は、術者等の操作に基づき被塗布物質を供給する図示しないシリンジに接続されている。
Further, an applied substance supply port 32 is formed in the fixed portion 28, and the applied substance supply port 32 is connected to a tube 34 that passes inside and outside the hub 24. Further, the substance to be coated supply port 32 is connected to a syringe (not shown) that supplies the substance to be coated based on an operation of an operator or the like.
チューブ34は、ハブ24からシャフト12の側面に沿うように設けられ、治療デバイス10の先端方向に延在している。チューブ34の内部には、被塗布物質を流通可能な被塗布物質供給路36が貫通形成され、被塗布物質供給路36の基端側は被塗布物質供給ポート32を介してシリンジに接続されている。
The tube 34 is provided along the side surface of the shaft 12 from the hub 24 and extends in the distal direction of the treatment device 10. An application substance supply path 36 through which an application substance can flow is formed through the tube 34, and a base end side of the application substance supply path 36 is connected to a syringe via an application substance supply port 32. Yes.
一方、チューブ34の先端部は、シャフト12と6本のフレーム14が連結する位置で、3本の細径チューブ34aに分岐されている。この3本の細径チューブ34aは、先端方向に延在し、その端部がリング状の変形塗布部18に対し等間隔(120°間隔)に接続されている。被塗布物質供給路36は、各細径チューブ34a内を延在して変形塗布部18の被塗布物質通路38に連通している。シリンジから被塗布物質供給ポート32を介して被塗布物質供給路36に供給された被塗布物質は、この被塗布物質供給路36から先端側の被塗布物質通路38に導かれて吐出口22から血管A内に吐出される。
On the other hand, the tip of the tube 34 is branched into three small diameter tubes 34a at a position where the shaft 12 and the six frames 14 are connected. The three small-diameter tubes 34a extend in the distal direction, and their end portions are connected to the ring-shaped deformation application portion 18 at equal intervals (120 ° intervals). The substance to be coated supply path 36 extends through each small-diameter tube 34 a and communicates with the substance to be coated channel 38 of the deformation coating unit 18. The substance to be coated supplied from the syringe to the substance to be coated supply path 36 via the substance to be coated supply port 32 is guided from the substance to be coated supply path 36 to the substance path 38 to be coated on the tip side and is discharged from the discharge port 22. It is discharged into 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 biological material include EGF (epidemal growth factor), VEGF (basic endowment growth factor), HGF (hepatocyte growth factor), and PDGF (platelet weight).
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22を有する変形塗布部18は、シャフト12の軸方向に直交する方向(径方向)に拡縮可能なリング(円環)状に形成されている。この変形塗布部18の拡縮は、基端側で変形塗布部18を支持している6本のフレーム14によって実現される。
The deformation application part 18 having the discharge port 22 for discharging the substance to be applied is formed in a ring (ring) shape that can be expanded and contracted in a direction (radial direction) perpendicular to the axial direction of the shaft 12. The expansion / contraction of the deformation application portion 18 is realized by the six frames 14 that support the deformation application portion 18 on the base end side.
以下、治療デバイス10の先端部に設けられるフレーム14及び変形塗布部18の構成ついて具体的に説明していく。図2Aは、図1のフレーム14及び変形塗布部18の展開状態を示す部分正面図であり、図2Bは、図1のフレーム14及び変形塗布部18の展開状態を示す部分側面図であり、図2Cは、図1のフレーム14及び変形塗布部18の収容状態を示す部分側面図であり、図2Dは、細い血管A1内での変形塗布部18の展開状態を示す部分側面図である。
Hereinafter, the configuration of the frame 14 and the deformation application unit 18 provided at the distal end portion of the treatment device 10 will be specifically described. 2A is a partial front view showing a developed state of the frame 14 and the deformation application unit 18 in FIG. 1, and FIG. 2B is a partial side view showing a development state of the frame 14 and the deformation application unit 18 in FIG. FIG. 2C is a partial side view showing a housing state of the frame 14 and the deformation application part 18 of FIG. 1, and FIG. 2D is a partial side view showing a developed state of the deformation application part 18 in the thin blood vessel A1.
6本のフレーム14は、図2A及び図2Bに示すように、シース20から露出された自然状態で、シャフト12の連結部分から先端方向且つ径方向外側に向かって延在している。これら6本のフレーム14は、正面視で、シャフト12の軸回りに沿って等間隔(正面視で60°間隔)に設けられ放射状に広がるように延びており、相互の先端部が最も離間している。変形塗布部18は、各フレーム14の先端部を架橋するように取り付けられる。
As shown in FIGS. 2A and 2B, the six frames 14 extend from the connecting portion of the shaft 12 toward the distal end and radially outward in a natural state exposed from the sheath 20. These six frames 14 are provided at equal intervals (60 ° intervals in the front view) along the axis of the shaft 12 in the front view and extend so as to spread radially, and the distal ends of the six frames 14 are most spaced apart from each other. ing. The deformation application part 18 is attached so as to bridge the tip part of each frame 14.
また、6本のフレーム14は、所定の弾性力を有するようにシャフト12に連結されており、相互の先端部は弾性的に近接自在となっている。そのため、6本のフレーム14とシャフト12の連結部分は、鋳造や切削により連設される、又は溶接接合される等の加工によって、金属的に一体化されていることが好ましい。これにより、フレーム14は、自然状態において、その傾斜角度(シャフト12の軸方向に対する傾き)が所定角度をなすようにシャフト12に対し弾性的に支持される。
Further, the six frames 14 are connected to the shaft 12 so as to have a predetermined elastic force, and the tip portions of the six frames 14 are elastically close to each other. Therefore, it is preferable that the connection part of the six frames 14 and the shaft 12 is integrated in a metallic manner by processing such as continuous connection by casting or cutting, or welding. Thereby, the frame 14 is elastically supported with respect to the shaft 12 so that the inclination angle (inclination with respect to the axial direction of the shaft 12) forms a predetermined angle in a natural state.
このため、シャフト12及びフレーム14は、特に、形状記憶性を有する金属によって構成されることが好ましい。このような材料としては、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。勿論、フレーム14の先端部が弾性的に揺動できれば、その材料は特に限定されるものではなく、高分子材料等の樹脂を用いてもよい。高分子材料としては、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2種以上の高分子材料を組み合わせたものが挙げられる。
Therefore, it is preferable that the shaft 12 and the frame 14 are made of a metal having shape memory property. Examples of such materials 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., all SUS varieties), cobalt alloys, noble metals such as gold and platinum, tungsten alloys, carbon materials (including piano wires), etc. Can be mentioned. Of course, the material is not particularly limited as long as the tip of the frame 14 can be elastically swung, and a resin such as a polymer material may be used. Examples of the polymer material include polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide. , Polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, and the like, or a mixture thereof, or a combination of the above two or more polymer materials.
また、体温で形状が変化(例えば、拡径)できるような形状記憶樹脂を用いてもよい。この場合、より管腔壁に損傷を与えることなく、該管腔壁に変形塗布部18が接触した状態を維持することが可能となり、血管壁B等への傷害を一層確実に抑止できるようになると期待される。
Alternatively, a shape memory resin that can change its shape (for example, increase its diameter) at body temperature may be used. In this case, it is possible to maintain the state in which the deformation application portion 18 is in contact with the lumen wall without further damaging the lumen wall, and to more reliably suppress damage to the blood vessel wall B and the like. Expected to be.
本実施の形態に係る6本のフレーム14の放射形状は、比較的弱い弾性力で維持されており、シース20に当接することにより容易に弾性変形がなされる。フレーム14をシース20に収容した状態では、図2Cに示すように、6本のフレーム14の先端部が互いに近接するように作用する。これにより、変形塗布部18も径方向内側に縮径してシース20内に一緒に収容される。そして、6本のフレーム14がシース20から露出されると、各フレーム14に弾性復元力が働き、先端部が互いに離間するように作用する。これにより、変形塗布部18も径方向外側に拡張される。
The radial shape of the six frames 14 according to the present embodiment is maintained with a relatively weak elastic force, and is easily elastically deformed by coming into contact with the sheath 20. In the state in which the frame 14 is accommodated in the sheath 20, as shown in FIG. 2C, the tip portions of the six frames 14 act so as to be close to each other. As a result, the deformation application portion 18 is also radially contracted and accommodated together in the sheath 20. When the six frames 14 are exposed from the sheath 20, an elastic restoring force acts on each frame 14 so that the tip portions are separated from each other. Thereby, the deformation | transformation application part 18 is also expanded to radial direction outer side.
変形塗布部18は、正面視(図2A参照)で、リング状に形成された無端状管体であり、側面視(図2B参照)では、無端状管体の先端面18aがシャフト12の軸方向と直交する。リング状に展開した変形塗布部18の外径は、例えば、処置対象Xが存在する血管Aの内径に一致する、又は血管Aの内径よりも若干大径となるように設定されることが望ましい。これにより、変形塗布部18を適度な押圧力で血管壁Bに当接させることができ、血管壁Bを不要に押圧して傷付けることを回避できる。
The deformation application unit 18 is an endless tubular body formed in a ring shape when viewed from the front (see FIG. 2A), and the distal end surface 18a of the endless tubular body is the axis of the shaft 12 when viewed from the side (see FIG. 2B). Orthogonal to the direction. It is desirable that the outer diameter of the deformation application unit 18 developed in a ring shape is set to be, for example, equal to the inner diameter of the blood vessel A where the treatment target X exists or slightly larger than the inner diameter of the blood vessel A. . Thereby, the deformation | transformation application part 18 can be made to contact | abut to the blood vessel wall B with moderate pressing force, and it can avoid damaging the blood vessel wall B unnecessary.
また、変形塗布部18の基端面18bには、周方向に沿って等間隔に6つの筒状部40が連設され、該6つの筒状部40は斜め後方に突出している。各筒状部40には、突出方向に孔(図示せず)が形成されており、この孔にはフレーム14の先端部が挿入固定される。すなわち、6つの筒状部40と6つのフレーム14が連結されることで、変形塗布部18が支持部16に拡縮可能に支持される。
Also, six cylindrical portions 40 are connected to the base end surface 18b of the deformation application portion 18 at regular intervals along the circumferential direction, and the six cylindrical portions 40 protrude obliquely rearward. Each tubular portion 40 is formed with a hole (not shown) in the protruding direction, and the distal end portion of the frame 14 is inserted and fixed in this hole. That is, by connecting the six cylindrical portions 40 and the six frames 14, the deformation application portion 18 is supported by the support portion 16 so as to be expandable / contractable.
変形塗布部18は、図2Cに示すように、シース20内に収容された状態では、リング状の管体が周方向に撓む(縮む)ことにより、変形塗布部18全体の外径が縮径される。そして、図2Dに示すように、フレーム14と変形塗布部18がシース20から露出されると、フレーム14の弾性復元力により、撓んでいた変形塗布部18の周長が延長されて、変形塗布部18全体の外径が拡径される。
As shown in FIG. 2C, the deformation application portion 18, when housed in the sheath 20, is bent (shrinks) in the circumferential direction by the ring-shaped tube body, thereby reducing the outer diameter of the deformation application portion 18 as a whole. Diameter. As shown in FIG. 2D, when the frame 14 and the deformation application portion 18 are exposed from the sheath 20, the circumferential length of the deformation application portion 18 that has been bent is extended by the elastic restoring force of the frame 14, and the deformation application portion 18 The outer diameter of the entire portion 18 is increased.
このため、変形塗布部18は、拡張状態でリング状を呈する復元性を有し、且つ径方向に縮径してシース20に収容される程度の可撓性を有する材料で構成されることが好ましい。このような材料としては、例えば、織物、編物、不織布、紙材のような繊維性多孔質膜、その他、非繊維性多孔質膜、高分子シートのような緻密膜等を挙げることができる。織物を構成する繊維としては、例えば、セルロース繊維、綿、リンター、カポック、亜麻、大麻、ラミー、絹、羊毛等の天然繊維、ナイロン(ポリアミド)、テトロン、レーヨン、キュプラ、アセテート、ビニロン、アクリル、ポリエチレンテレフタレート(ポリエステル)、ポリプロピレン等の化学繊維、又はこれら天然及び化学繊維のうちの2以上の組み合わせ(混紡等)等が挙げられる。また、変形塗布部18の内部に形状記憶性を有するリング状の芯材(図示せず)を設けて、この芯材の弾性復元力により変形塗布部18の拡張形状を誘導させてもよい。
For this reason, the deformation application part 18 has a resilience exhibiting a ring shape in the expanded state, and is made of a material having a degree of flexibility that is reduced in the radial direction and accommodated in the sheath 20. preferable. Examples of such materials include fibrous porous membranes such as woven fabrics, knitted fabrics, nonwoven fabrics, and paper materials, non-fibrous porous membranes, and dense membranes such as polymer sheets. Examples of fibers constituting the fabric include cellulose fibers, cotton, linter, kapok, flax, cannabis, ramie, silk, wool and other natural fibers, nylon (polyamide), tetron, rayon, cupra, acetate, vinylon, acrylic, Examples thereof include chemical fibers such as polyethylene terephthalate (polyester) and polypropylene, or combinations of two or more of these natural and chemical fibers (mixed spinning, etc.). Further, a ring-shaped core material (not shown) having shape memory property may be provided inside the deformation application portion 18 and the expanded shape of the deformation application portion 18 may be induced by the elastic restoring force of the core material.
変形塗布部18の基端面18bには、3つの筒状部40の隣接箇所に3本の細径チューブ34aがそれぞれ接続されている。変形塗布部18の内部には、リング状に沿って周回する被塗布物質通路38が形成されており、この被塗布物質通路38とチューブ34の被塗布物質供給路36が連通している。また、被塗布物質通路38は、変形塗布部18の周方向に沿って複数形成された吐出口22に連通している。従って、変形塗布部18は、細径チューブ34aを介して被塗布物質が供給されると、被塗布物質通路38に沿って被塗布物質を周方向に流動させ、吐出口22から被塗布物質を吐出させる。
The three small diameter tubes 34a are connected to the base end face 18b of the deformation applying portion 18 at the adjacent portions of the three cylindrical portions 40, respectively. An application substance passage 38 that circulates along a ring shape is formed inside the deformation application part 18, and the application substance passage 38 and the application substance supply path 36 of the tube 34 communicate with each other. Further, the substance passage 38 to be applied communicates with a plurality of discharge ports 22 formed along the circumferential direction of the deformation application part 18. Therefore, when the material to be coated is supplied via the small diameter tube 34 a, the deformation coating unit 18 causes the material to be coated to flow in the circumferential direction along the material passage 38 to be coated, and the material to be coated is discharged from the discharge port 22. Discharge.
複数の吐出口22は、リング状の変形塗布部18の先端面18a側且つ径方向外側に形成されている。より具体的には、図2Aに示すように、変形塗布部18がシース20から露出されて展開し外側の端部が血管壁Bに当接した状態で、吐出口22は血管壁Bの近傍位置にあって該血管壁Bを斜めに臨むように配置される。すなわち、吐出口22は、図2Bに示すように、血管壁Bに閉塞されることなく、その開口部分が血管A内に開口している。これにより、吐出口22は、血管壁Bに向けて充分な量の被塗布物質を吐出することができる。
The plurality of discharge ports 22 are formed on the distal end surface 18a side of the ring-shaped deformation application portion 18 and on the radially outer side. More specifically, as shown in FIG. 2A, the discharge port 22 is in the vicinity of the blood vessel wall B in a state in which the deformation applying portion 18 is exposed from the sheath 20 and deployed and the outer end is in contact with the blood vessel wall B. It is located so that the blood vessel wall B faces obliquely. That is, as shown in FIG. 2B, the opening portion of the discharge port 22 opens into the blood vessel A without being blocked by the blood vessel wall B. Accordingly, the discharge port 22 can discharge a sufficient amount of the substance to be applied toward the blood vessel wall B.
また、変形塗布部18の表面には、潤滑性コート剤18cがコーティングされていることが好ましい。潤滑性コート剤18cは、血管壁Bに変形塗布部18を当接させた状態で、変形塗布部18を血管Aの軸方向に円滑に移動させることができ、血管壁Bの炎症等を防ぐことができる。
Further, it is preferable that the surface of the deformation application portion 18 is coated with a lubricity coating agent 18c. The lubricant coating agent 18c can smoothly move the deformation application portion 18 in the axial direction of the blood vessel A in a state where the deformation application portion 18 is in contact with the blood vessel wall B, and prevents inflammation of the blood vessel wall B and the like. be able to.
シャフト12、フレーム14及び変形塗布部18を収容するシース20は、送達される血管Aの内径よりも小径な外径に形成され、その内部には、変形塗布部18を縮径して収容可能な貫通ルーメン42が形成されている。変形塗布部18は、貫通ルーメン42の先端開口42a付近に収容される。
The sheath 20, which accommodates the shaft 12, the frame 14, and the deformation application portion 18, is formed to have an outer diameter smaller than the inner diameter of the blood vessel A to be delivered, and the deformation application portion 18 can be accommodated by reducing the diameter in the inside thereof. A penetrating lumen 42 is formed. The deformation application unit 18 is accommodated in the vicinity of the distal end opening 42 a of the through lumen 42.
シース20を構成する材料は、変形塗布部18を縮径して収容可能な剛性を有するとともに、蛇行する血管Aに追従可能な柔軟性を有する材料によって構成されることが好ましい。このような材料としては、例えば、シャフト12及びフレーム14の説明で挙げた材料を好適に用いることができる。
The material constituting the sheath 20 is preferably constituted by a material having a rigidity capable of accommodating the deformed application portion 18 by reducing the diameter and having a flexibility capable of following the meandering blood vessel A. As such a material, the material quoted by description of the shaft 12 and the flame | frame 14 can be used suitably, for example.
シース20の基端部は、変形塗布部18が処置対象Xに送達された状態で、生体外部に露出するようになっており、該基端部には径方向外側に拡径した鍔部44(操作部)が形成されている。シース20は、鍔部44が操作されることで、フレーム14及び変形塗布部18と相対的な進退移動がなされる。
The proximal end portion of the sheath 20 is exposed to the outside of the living body in a state where the deformation application portion 18 is delivered to the treatment target X, and the flange portion 44 whose diameter is increased radially outward at the proximal end portion. (Operation part) is formed. The sheath 20 is moved forward and backward relative to the frame 14 and the deformation application portion 18 by operating the collar portion 44.
治療デバイス10のフレーム14は、貫通ルーメン42を構成するシース20の内壁20aによって拡張が規制される。シース20の後退移動時には、シース20の先端開口42aがフレーム14の胴部に当接することにより、その先端部が径方向外側に除々に展開していく。このため、治療デバイス10は、フレーム14に対するシース20の変位量により、フレーム14の先端部の拡張量(すなわち、変形塗布部18の外径)が変動する。
The expansion of the frame 14 of the treatment device 10 is restricted by the inner wall 20a of the sheath 20 constituting the penetration lumen 42. When the sheath 20 moves backward, the distal end opening 42a of the sheath 20 comes into contact with the body portion of the frame 14, so that the distal end portion gradually expands radially outward. For this reason, in the treatment device 10, the expansion amount of the distal end portion of the frame 14 (that is, the outer diameter of the deformation application portion 18) varies depending on the displacement amount of the sheath 20 with respect to the frame 14.
従って、図2Dに示すように、変形塗布部18が完全に拡張した状態の外径よりも小径の血管A1を治療する場合でも、シース20の変位量を調整することにより、変形塗布部18を血管壁B1に所定の押圧力で当接させることができる。この場合、変形塗布部18は小さな外径で展開するが、被塗布物質が供給されると速やかに膨らんで、吐出口22から被塗布物質を吐出することができる。また、シース20及びシャフト12には、シース20の変位量を段階的に調整可能、すなわち変形塗布部18の外径を段階的に変形可能な調整機構が設けられてもよい。
Therefore, as shown in FIG. 2D, even when treating a blood vessel A1 having a diameter smaller than the outer diameter in a state where the deformation application portion 18 is completely expanded, the deformation application portion 18 is adjusted by adjusting the displacement amount of the sheath 20. It can be brought into contact with the blood vessel wall B1 with a predetermined pressing force. In this case, the deformation application unit 18 develops with a small outer diameter, but when the material to be applied is supplied, the deformation application unit 18 swells quickly and can discharge the material to be applied from the discharge port 22. Further, the sheath 20 and the shaft 12 may be provided with an adjustment mechanism capable of adjusting the displacement amount of the sheath 20 in a stepwise manner, that is, capable of changing the outer diameter of the deformation applying unit 18 in a stepwise manner.
また、治療デバイス10の先端部を構成するフレーム14及び変形塗布部18(或いはシャフト12を含む)は、上述した構成に限定されるものではなく、種々の構成を取り得る。例えば、フレーム14の本数やチューブ34の先端部で分岐する細径チューブ34aの本数を適宜設定してよいことは勿論である。以下、治療デバイス10の先端部の他の構成例をいくつか説明していく。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。
Further, the frame 14 and the deformation application unit 18 (or including the shaft 12) constituting the distal end portion of the treatment device 10 are not limited to the above-described configurations, and can take various configurations. For example, the number of frames 14 and the number of small-diameter tubes 34a branched at the distal end of the tube 34 may be set as appropriate. Hereinafter, some other configuration examples of the distal end portion of the treatment device 10 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3Aに示す第1構成例に係る治療デバイス10Aは、被塗布物質を吐出する吐出口22aが小径の丸孔に形成されており、この吐出口22aが変形塗布部18の先端面18a且つ周方向に沿って複数設けられている。このように吐出口22aが形成されていると、被塗布物質通路38に供給された被塗布物質が周方向にスムーズに行き渡り、且つ複数の吐出口22aから被塗布物質を一層均等に吐出することができる。
In the treatment device 10A according to the first configuration example shown in FIG. 3A, a discharge port 22a for discharging a substance to be applied is formed in a small-diameter round hole, and the discharge port 22a is formed on the distal end surface 18a of the deformation application unit 18 and the periphery. A plurality are provided along the direction. When the discharge ports 22a are formed in this way, the material to be applied supplied to the material passage 38 to be applied is smoothly distributed in the circumferential direction, and the material to be coated is more evenly discharged from the plurality of discharge ports 22a. Can do.
また、図3Bに示す第2構成例に係る治療デバイス10Bは、被塗布物質を吐出する吐出口22bが変形塗布部18の周方向を一周する溝状に形成されている。さらに、図3Cに示す第3構成例に係る治療デバイス10Cは、被塗布物質を吐出する吐出口22cが長孔と丸孔に形成され、この長孔と丸孔が変形塗布部18の周方向に沿って交互に形成されている。このように、第2及び第3構成例に示す吐出口22b、22cでも血管壁Bに対し被塗布物質を塗布することができる。要するに、被塗布物質を吐出する吐出口は、形状や形成数について特に限定されるものではなく、例えば、塗布する物質の吐出量や粘度等に応じて適宜設計してよい。
Further, in the treatment device 10B according to the second configuration example shown in FIG. 3B, the discharge port 22b for discharging the substance to be applied is formed in a groove shape that goes around the circumferential direction of the deformable application portion 18. Furthermore, in the treatment device 10C according to the third configuration example shown in FIG. 3C, the discharge port 22c for discharging the substance to be coated is formed in a long hole and a round hole, and the long hole and the round hole are in the circumferential direction of the deformation application part 18. Are formed alternately. Thus, the substance to be coated can be applied to the blood vessel wall B also at the discharge ports 22b and 22c shown in the second and third configuration examples. In short, the discharge port for discharging the substance to be coated is not particularly limited in terms of shape and number of formation, and may be appropriately designed according to, for example, the discharge amount and viscosity of the substance to be applied.
図3Dに示す第4構成例に係る治療デバイス10Dは、6本のフレーム14それぞれに小型のバルーンからなる6つの変形塗布部19が接続されている。6つの変形塗布部19は、6つの細径チューブ34aからの被塗布物質の供給により膨張するように構成されており、膨張とともに変形塗布部19に形成された吐出口22から被塗布物質を吐出することが可能となっている。このように変形塗布部19がリング状に形成されていなくても、フレーム14により各変形塗布部19を変位させて、血管壁Bの近傍位置に吐出口22を配置することができる。
In the treatment device 10D according to the fourth configuration example illustrated in FIG. 3D, six deformation application portions 19 each including a small balloon are connected to each of the six frames 14. The six deformation application portions 19 are configured to expand by supplying the material to be applied from the six small diameter tubes 34a, and discharge the material to be applied from the discharge port 22 formed in the deformation application portion 19 along with the expansion. It is possible to do. Thus, even if the deformation application part 19 is not formed in a ring shape, each deformation application part 19 can be displaced by the frame 14 and the discharge port 22 can be arranged in the vicinity of the blood vessel wall B.
図4Aに示す第5構成例に係る治療デバイス10Eは、シャフト12a及びフレーム14aが中空状の部材として形成されている。すなわち、シャフト12aは、内部を軸方向に延在する被塗布物質流通ルーメン46(被塗布物質流通ルーメン)を有し、シャフト12aに連結される6本のフレーム14aの内部には、被塗布物質流通ルーメン46と被塗布物質通路38を連通する連通路48が形成されている。被塗布物質は、被塗布物質流通ルーメン46及び連通路48を介して被塗布物質通路38に供給され、吐出口22から吐出される。治療デバイス10Eは、このように構成されることにより、チューブ34を設ける必要がなくなるため、構造が簡単になり、変形塗布部18の拡張や被塗布物質の塗布を良好に行うことができる。
In the treatment device 10E according to the fifth configuration example shown in FIG. 4A, the shaft 12a and the frame 14a are formed as hollow members. That is, the shaft 12a has a coated material distribution lumen 46 (coating material distribution lumen) extending in the axial direction inside, and the coated material is disposed inside the six frames 14a connected to the shaft 12a. A communication passage 48 that connects the flow lumen 46 and the material passage 38 to be coated is formed. The substance to be coated is supplied to the substance passage 38 to be coated via the substance distribution lumen 46 and the communication path 48 and is discharged from the discharge port 22. Since the treatment device 10E is configured as described above, it is not necessary to provide the tube 34. Therefore, the structure is simplified, and the deformation application unit 18 can be expanded and the applied substance can be applied satisfactorily.
図4Bに示す第6構成例に係る治療デバイス10Fは、変形塗布部18を支持する支持部17がメッシュ状に形成されている。支持部17は、メッシュを構成する線材に形状記憶性を持たせており、個々の線材が弾性変形すると、菱形状の格子窓が潰れるように変形して先端部が縮径する。このため、支持部17の先端部に変形塗布部18を設けることにより、変形塗布部18を拡縮可能に支持することができる。すなわち、変形塗布部18を支持する支持部の構成も特に限定されるものではなく、種々の構成を取り得る。
In the treatment device 10F according to the sixth configuration example shown in FIG. 4B, the support portion 17 that supports the deformation application portion 18 is formed in a mesh shape. The support portion 17 has a shape memory property for the wire constituting the mesh, and when the individual wire is elastically deformed, the support 17 is deformed so that the rhombic lattice window is crushed and the tip portion is reduced in diameter. For this reason, by providing the deformation | transformation application part 18 in the front-end | tip part of the support part 17, the deformation | transformation application part 18 can be supported so that expansion / contraction is possible. That is, the structure of the support part that supports the deformation application part 18 is not particularly limited, and various structures can be taken.
図4Cに示す第7構成例に係る治療デバイス10Gは、シャフト12bとフレーム15が別体からなり、リング状の外装部材50によってフレーム15の基端部をシャフト12bの先端部に固定している。このように構成しても、シャフト12bとフレーム15を強固に連結することができ、フレーム15の弾性力により変形塗布部18を良好に拡縮することができる。この場合、シャフト12bの内部に挿通ルーメン52を形成して、変形塗布部18に接続される被塗布物質供給用のチューブ34を挿通させてもよい。このようにチューブ34をシャフト12b内に挿通させることで、シャフト12bの外部に沿わせた構造よりもチューブ34が邪魔とならず、シース20の進退移動をより良好に行うことができる。
In the treatment device 10G according to the seventh configuration example shown in FIG. 4C, the shaft 12b and the frame 15 are separate from each other, and the base end portion of the frame 15 is fixed to the distal end portion of the shaft 12b by the ring-shaped exterior member 50. . Even if comprised in this way, the shaft 12b and the flame | frame 15 can be connected firmly, and the deformation | transformation application part 18 can be expanded and contracted favorably with the elastic force of the flame | frame 15. In this case, the insertion lumen 52 may be formed inside the shaft 12b, and the tube 34 for supplying the substance to be applied connected to the deformation application unit 18 may be inserted. By inserting the tube 34 into the shaft 12b in this manner, the tube 34 does not get in the way compared to the structure along the outside of the shaft 12b, and the sheath 20 can be moved forward and backward.
図4Dに示す第8構成例に係る治療デバイス10Hは、6本のフレーム14の基端部に可動リング54が連設されるとともに、シャフト12の先端部に固定支点部56が設けられている。可動リング54は、基端方向に延設される摺動管58に接続されて、シャフト12に対し進退移動可能となっており、固定支点部56は、6本のフレーム14をスライド自在に支持している。摺動管58を後退移動させると、可動リング54が後退し、これに追従して6本のフレーム14も後退移動する。従って、固定支点部56によるフレーム14の支持位置が変位し、フレーム14の先端部の変形塗布部18が縮径する。一方、摺動管58を進出移動させると、可動リング54が進出し、これに追従して6本のフレーム14も進出移動する。従って、固定支点部56がフレーム14の基端側を支持するようになり、変形塗布部18が拡径する。治療デバイス10Hは、このような構成でも変形塗布部18を拡縮することができる。
In the treatment device 10H according to the eighth configuration example shown in FIG. 4D, a movable ring 54 is connected to the proximal end portions of the six frames 14, and a fixed fulcrum portion 56 is provided at the distal end portion of the shaft 12. . The movable ring 54 is connected to a sliding tube 58 extending in the proximal direction and can move forward and backward with respect to the shaft 12. The fixed fulcrum 56 supports the six frames 14 in a slidable manner. is doing. When the sliding tube 58 is moved backward, the movable ring 54 is moved backward, and the six frames 14 are also moved backward following this. Accordingly, the support position of the frame 14 by the fixed fulcrum 56 is displaced, and the deformation application portion 18 at the tip of the frame 14 is reduced in diameter. On the other hand, when the sliding tube 58 is moved forward, the movable ring 54 moves forward, and the six frames 14 also move forward following this. Therefore, the fixed fulcrum portion 56 comes to support the base end side of the frame 14 and the deformation application portion 18 is expanded in diameter. The treatment device 10H can expand and contract the deformation application unit 18 even with such a configuration.
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.
治療デバイス10は、アテレクトミーにおいて、血管A内に堆積された病変部であるアテロームや石灰化した病変を除去した後に、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内等に発生したアテロームや石灰化した病変をアテレクトミーデバイス(図示せず)により除去する手技が行われる。術者は、この手技において、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、アテレクトミーデバイスをこのガイドワイヤに沿って進行させる。そして、堆積されたアテロームをアテレクトミーデバイスにより除去(例えば、削り取る、粉砕する又は吸引する等)することで、処置対象Xの内面を血液が充分に流通可能な内径とする。所望の内径に形成した後は、アテレクトミーデバイスを血管A内から引き抜き、アテレクトミーが終了する。
The treatment device 10 is used to apply a substance to be applied to a treatment site (treatment target X) after removing an atheroma or a calcified lesion deposited in the blood vessel A in atherectomy. Therefore, before the treatment device 10 is used, a procedure for removing atheroma or calcified lesions in the blood vessel A or the like with an atherectomy device (not shown) is performed. In this procedure, the surgeon first specifies the form of the lesion by an intravascular imaging method or an intravascular ultrasound diagnostic method. Next, a guide wire is introduced into the blood vessel percutaneously from the thigh or the like by, for example, the Seldinger method, and the atherectomy device is advanced along the guide wire. Then, the accumulated atheroma is removed (for example, scraped, pulverized, or sucked) by an atherectomy device, so that the inner surface of the treatment target X has an inner diameter through which blood can sufficiently flow. After the desired inner diameter is formed, the atherectomy device is pulled out from the blood vessel A, and the atherectomy is completed.
その後、本治療デバイス10を血管A内に挿入して、アテロームが除去された処置対象Xに治療デバイス10の先端部を送達する送達ステップを実施する。なお、治療デバイス10は、生体への導入前に治療デバイス10の内部を被塗布物質で満たすプライミングが行われる。プライミングでは、シース20内に変形塗布部18を収容した状態で被塗布物質供給ポート32から被塗布物質を供給し、チューブ34の被塗布物質供給路36と変形塗布部18の被塗布物質通路38を被塗布物質により満たし、治療デバイス10の内部から空気を抜く作業が行われる。プライミング時には、変形塗布部18がシース20内に収容されているので、不用意に拡張することが防止される。
Thereafter, the present treatment device 10 is inserted into the blood vessel A, and a delivery step of delivering the distal end portion of the treatment device 10 to the treatment target X from which the atheroma has been removed is performed. The treatment device 10 is primed to fill the inside of the treatment device 10 with a substance to be coated before being introduced into the living body. In the priming, the substance to be coated is supplied from the substance to be coated supply port 32 in a state where the deformation coating part 18 is accommodated in the sheath 20, and the substance to be coated material supply path 36 of the tube 34 and the substance to be coated channel 38 of the deformation coating part 18. Is filled with the substance to be applied, and the air is extracted from the inside of the treatment device 10. At the time of priming, since the deformation application part 18 is accommodated in the sheath 20, it is prevented from being inadvertently expanded.
送達ステップでは、図5Aに示すように、シャフト12、フレーム14及び変形塗布部18がシース20の貫通ルーメン42に収容された治療デバイス10を、アテレクトミーデバイスと同じ挿入箇所から挿入する。血管A内の送達時には、先行して挿入されたガイドワイヤをシース20に挿通させることにより、治療デバイス10を処置対象Xにスムーズに送達することができる。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。
In the delivery step, as shown in FIG. 5A, the treatment device 10 in which the shaft 12, the frame 14, and the deformation application portion 18 are accommodated in the penetration lumen 42 of the sheath 20 is inserted from the same insertion location as the atherectomy device. At the time of delivery in the blood vessel A, the treatment device 10 can be smoothly delivered to the treatment target X by inserting the guide wire inserted in advance into the sheath 20. 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、図5Bに示すように、変形塗布部18を展開させる展開ステップを実施する。この展開ステップでは、シース20の基端部に設けられた鍔部44(図1参照)を後退操作することにより、シース20を後退移動させる。これにより、シース20の先端開口42aから変形塗布部18及びフレーム14が露出する。この際、縮径されていた変形塗布部18はフレーム14の弾性復元力により拡径し、外側の端部が血管壁Bに当接する。これにより、吐出口22が血管壁Bの近傍位置に配置される。なお、変形塗布部18は、吐出口22が血管壁Bの近傍位置に配置されれば、血管壁Bに必ずしも当接しなくてもよい。
After the delivery step, as shown in FIG. 5B, a deployment step for deploying the deformation application unit 18 is performed. In this deployment step, the sheath 20 is moved backward by retreating the collar portion 44 (see FIG. 1) provided at the proximal end portion of the sheath 20. Thereby, the deformation | transformation application part 18 and the flame | frame 14 are exposed from the front-end | tip opening 42a of the sheath 20. As shown in FIG. At this time, the deformed application portion 18 that has been reduced in diameter is expanded in diameter by the elastic restoring force of the frame 14, and the outer end abuts against the blood vessel wall B. As a result, the discharge port 22 is disposed in the vicinity of the blood vessel wall B. The deformation application unit 18 does not necessarily need to contact the blood vessel wall B as long as the discharge port 22 is disposed in the vicinity of the blood vessel wall B.
展開ステップの後は、図5Cに示すように、展開した変形塗布部18の吐出口22から被塗布物質を吐出して、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、被塗布物質供給ポート32を介して被塗布物質供給路36に被塗布物質を供給し、チューブ34を通して変形塗布部18に被塗布物質を導く。この被塗布物質は、変形塗布部18の被塗布物質通路38に流入されて、吐出口22から吐出される。
After the developing step, as shown in FIG. 5C, the applying step of applying the applying substance to the treatment target X is performed by discharging the applying substance from the discharge port 22 of the developed deformation applying unit 18. In the coating step, the substance to be coated is supplied to the substance to be coated supply path 36 via the substance to be coated supply port 32, and the substance to be coated is guided to the deformation coating unit 18 through the tube 34. The material to be coated flows into the material passage 38 to be coated of the deformation coating unit 18 and is discharged from the discharge port 22.
上述したように吐出口22は、処置対象Xの近傍位置にあり、さらに変形塗布部18の先端面18a且つ外径側に形成されている。このため、吐出口22から吐出された被塗布物質を処置対象Xに確実に付着させることができる。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付近の血流の方が緩やかになっている。このため、血管Aの軸心付近から被塗布物質を吐出するデバイス(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、所定の位置に被塗布物質をより精度良く塗布することができる。
As described above, the discharge port 22 is in the vicinity of the treatment target X, and is further formed on the distal end surface 18a and the outer diameter side of the deformation application unit 18. For this reason, the substance to be applied discharged from the discharge port 22 can be 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, the treatment device 10 according to the present embodiment has a predetermined position as compared with a device that discharges a substance to be applied from the vicinity of the axis of the blood vessel A (a device of US Patent Application Publication No. 2011/0077216). It is possible to apply the substance to be applied more accurately.
また、変形塗布部18の周方向に沿って複数の吐出口22が設けられているので、被塗布物質は、処置対象X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。
Further, since the plurality of discharge ports 22 are provided along the circumferential direction of the deformation application unit 18, the substance to be applied is uniformly applied to the entire inner surface of the treatment target X. Therefore, the treatment device 10 does not cause uneven application or coating failure of the substance to be applied.
また、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30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24に取り付けられたアクチュエータ30により、可動部26を固定部28に対し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変形塗布部18も等速度で後退移動し、この後退移動とともに吐出口22から被塗布物質を吐出することで、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。
Further, during the application step, a moving step is performed in which the treatment device 10 is moved by the actuator 30 while applying the substance to be applied. In the moving step, the movable part 26 is moved backward with respect to the fixed part 28 at a constant speed by the actuator 30 attached to the hub 24. Accordingly, the deformation application unit 18 at a position overlapping with the treatment target X also moves backward at a constant speed, and along with this backward movement, the substance to be applied is discharged from the discharge port 22, thereby applying the application along the axial direction of the treatment target X. The substance can be applied uniformly.
なお、移動ステップでは、変形塗布部18を後退移動させた後に、再び進出移動させて一層確実に被塗布物質を付着させてもよい。この場合、変形塗布部18の外側面により、被塗布物質を処置対象Xに塗り付けるように被塗布物質を広げることもできる。すなわち、治療デバイス10による手技では、血管A内における変形塗布部18の進退移動を何度行ってもよい。
In the moving step, after the deformation application unit 18 is moved backward, it may be moved forward again to adhere the substance to be applied more reliably. In this case, the substance to be coated can be spread so that the substance to be coated is applied to the treatment target X by the outer surface of the deformation application unit 18. That is, in the procedure using the treatment device 10, the deformation application unit 18 in the blood vessel A may be moved back and forth many times.
被塗布物質の塗布が終了した後は、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、シース20を進出移動させて、フレーム14及び変形塗布部18を貫通ルーメン42に再び収容して、変形塗布部18を縮径させる。従って、処置対象Xからフレーム14及び変形塗布部18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 application of the substance to be applied is completed, a backward movement step for moving the treatment device 10 backward from the blood vessel A is performed. In this backward movement step, the sheath 20 is moved forward, the frame 14 and the deformation application part 18 are again accommodated in the through lumen 42, and the deformation application part 18 is reduced in diameter. Accordingly, the treatment device 10 can be removed from the living body by smoothly moving the frame 14 and the deformation application unit 18 backward from the treatment target X.
ところで、血管Aの病変部として、プラークが血管壁B(内膜)の中膜側に入り込む形で形成(ポジティブリモデリング)されることがある(図6A等参照)。このようにプラークが中膜側に進行する形で形成されていった場合、血管壁Bは次第に薄くなり、わずかな物理的衝撃により血管壁Bが破れ易くなる“バルネラブルプラーク”の形成へとつながると言われている。この薄くなった血管壁Bが破れると、その周辺部に血小板が集まって急速に血栓を形成し、血管Aを完全に閉塞することになり、急性心筋梗塞を引き起こす。このため、このバルネラブルプラークを治療する場合には、プラークの発生箇所である処置対象X1に対し、治療デバイス10を接触させないようにして被塗布物質を塗布し、治療を施すことが望まれている。
By the way, as a lesioned part of the blood vessel A, a plaque may be formed (positive remodeling) in a form of entering the medial side of the blood vessel wall B (intima) (see FIG. 6A and the like). When the plaque is formed in such a way that it progresses toward the medial side, the blood vessel wall B becomes gradually thinner, and the formation of “bulnerable plaque” in which the blood vessel wall B is easily broken by a slight physical impact. It is said to be connected. When this thinned blood vessel wall B is torn, platelets gather around it and rapidly form a thrombus to completely occlude blood vessel A, causing acute myocardial infarction. For this reason, when treating this bulnerable plaque, it is desired to apply the substance to be treated so that the treatment device 10 is not brought into contact with the treatment target X1, which is the place where the plaque occurs, and to treat it. Yes.
本実施の形態に係る治療デバイス10は、上記のような処置対象X1に対しても良好に被塗布物質を塗布することが可能となっている。すなわち、送達ステップでは、図6Aに示すように、血管Aの上流側から処置対象X1に治療デバイス10を送達し、処置対象X1の上流側近傍位置に治療デバイス10の先端部(変形塗布部18)を位置決めする。
The therapeutic device 10 according to the present embodiment is capable of satisfactorily applying the substance to be applied to the treatment target X1 as described above. That is, in the delivery step, as shown in FIG. 6A, the therapeutic device 10 is delivered to the treatment target X1 from the upstream side of the blood vessel A, and the distal end portion (the deformation application unit 18) of the treatment device 10 is positioned near the upstream side of the treatment target X1. ).
次に、展開ステップでは、図6Bに示すように、シース20を後退移動させて処置対象X1の上流側近傍位置で変形塗布部18を展開する。そして、塗布ステップでは、図6Cに示すように、変形塗布部18の被塗布物質通路38に被塗布物質を供給して吐出口22から吐出させる。処置対象X1の上流側近傍位置に位置する吐出口22から被塗布物質を吐出すると、被塗布物質は下流に流れる血液によって一定距離搬送される。被塗布物質がアルギネート-カテコールの場合は、血液による搬送が比較的近距離に留まり、ちょうど処置対象X1を覆うように被塗布物質が付着される。このように、治療デバイス10を処置対象X1の上流側で展開して吐出口22から被塗布物質を吐出すれば、プラークを傷付けないで該プラークの治療を良好に行うことができる。
Next, in the deployment step, as shown in FIG. 6B, the sheath 20 is moved backward to deploy the deformation application portion 18 at a position near the upstream side of the treatment target X1. In the application step, as shown in FIG. 6C, the substance to be applied is supplied to the substance passage 38 to be applied in the deformation application unit 18 and discharged from the discharge port 22. When the substance to be coated is discharged from the discharge port 22 located in the vicinity of the upstream side of the treatment target X1, the substance to be coated is conveyed by a certain distance by the blood flowing downstream. When the substance to be coated is alginate-catechol, the conveyance by blood stays at a relatively short distance, and the substance to be coated is attached so as to cover the treatment object X1. Thus, if the treatment device 10 is deployed on the upstream side of the treatment target X1 and the substance to be applied is discharged from the discharge port 22, the plaque can be treated well without damaging the plaque.
以上のように、本実施の形態に係る治療デバイス10によれば、被塗布物質を吐出する吐出口22を有する変形塗布部18が、シャフト12の軸方向と直交する方向に拡縮可能なフレーム14の先端部に設けられることにより、送達される血管Aの径方向に対し変形塗布部18を簡単に拡縮することができる。よって、縮径状態の変形塗布部18を送達し、血管A内の処置対象Xで変形塗布部18を展開(拡径)して血管壁Bに当接又は近接させる動作を効率的に行うことができる。そして当接又は近接状態では、吐出口22が血管壁Bの近傍位置に存在するため、この吐出口22から被塗布物質を塗布すると、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、処置対象Xに被塗布物質を確実に付着させることができる。
As described above, according to the treatment device 10 according to the present embodiment, the deformable application part 18 having the discharge port 22 for discharging the substance to be applied can be expanded and contracted in the direction orthogonal to the axial direction of the shaft 12. By being provided at the distal end portion, the deformation applying portion 18 can be easily expanded and contracted with respect to the radial direction of the blood vessel A to be delivered. Therefore, the operation of delivering the deformed application portion 18 in a reduced diameter state and deploying (expanding the diameter) the deformable application portion 18 on the treatment target X in the blood vessel A so as to contact or approach the blood vessel wall B is efficiently performed. Can do. In the contact or proximity state, the discharge port 22 exists in the vicinity of the blood vessel wall B. Therefore, when the substance to be coated is applied from the discharge port 22, the treatment is hardly affected by the blood flowing in the blood vessel A. The substance to be coated can be reliably attached to the target X.
この場合、シース20により支持部16(フレーム14)が収縮し、シース20から露出された際に弾性復元力によって支持部16が拡張することで、変形塗布部18の外径をシース20の進退移動に基づき容易に切り替えることができる。そして、支持部16は、シース20からの露出量により先端部の拡張量が調整されるので、血管Aの太さに関わらず、変形塗布部18を適度な押圧力で血管壁Bに当接させることができる。また、吐出口22が変形塗布部18の先端面18a側且つ径方向外側に形成されているので、吐出口22が血管壁Bに遮断されずに、充分な量の被塗布物質を塗布することができる。
In this case, the support portion 16 (frame 14) is contracted by the sheath 20, and the support portion 16 is expanded by an elastic restoring force when exposed from the sheath 20, whereby the outer diameter of the deformation application portion 18 is increased or decreased. Easy switching based on movement. Then, since the extension amount of the distal end portion is adjusted by the exposure amount from the sheath 20, the support portion 16 abuts the deformation application portion 18 against the blood vessel wall B with an appropriate pressing force regardless of the thickness of the blood vessel A. Can be made. In addition, since the discharge port 22 is formed on the distal end surface 18a side and the radially outer side of the deformation application portion 18, the discharge port 22 is not blocked by the blood vessel wall B, and a sufficient amount of the substance to be applied is applied. Can do.
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(被塗布物質供給路36)がチューブ34により略直線状に延在して変形塗布部18の被塗布物質通路38に連通されているので、粘度の高い被塗布物質でも吐出口22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 (the coated substance supply path 36) of the coated substance extends substantially linearly by the tube 34, and the coated substance path of the deformation coating unit 18 is applied. 38, it is possible to smoothly guide even a high-viscosity material without clogging the discharge port 22.
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。例えば、変形塗布部18は、支持部16、17からの拡縮動作に関わらず、自己の弾性力等により自己拡張するように構成されてもよい。
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. For example, the deformation application unit 18 may be configured to self-expand by its own elastic force or the like regardless of the expansion / contraction operation from the support units 16 and 17.
Claims (7)
- 生体管腔内に挿入される長尺なシャフト(12、12a、12b)と、
基端側が前記シャフト(12、12a、12b)に支持されるとともに、先端側が前記シャフト(12、12a、12b)の軸方向と直交する方向に拡縮自在な支持部(16、17)と、
前記支持部(16、17)の先端側に変形可能に設けられ、変形作用下に前記生体管腔の内面に当接又は近接し、且つ当接又は近接状態で前記生体管腔の内面の近傍に位置して被塗布物質を吐出可能な吐出口(22、22a~22c)を有する変形塗布部(18、19)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~10H)。 A long shaft (12, 12a, 12b) to be inserted into the body lumen;
A support portion (16, 17) whose base end side is supported by the shaft (12, 12a, 12b) and whose distal end side is expandable / contractable in a direction perpendicular to the axial direction of the shaft (12, 12a, 12b);
Near the inner surface of the living body lumen in contact with or in close contact with the inner surface of the living body lumen under deformation and provided on the distal end side of the support portion (16, 17). And a deformable application part (18, 19) having a discharge port (22, 22a to 22c) which is located at a position where the target substance can be discharged. ). - 請求項1記載の生体管腔内治療デバイス(10、10A~10H)において、
前記変形塗布部(18、19)は、前記支持部(16、17)の拡縮に追従して拡縮する
ことを特徴とする生体管腔内治療デバイス(10、10A~10H) The intraluminal treatment device (10, 10A-10H) according to claim 1,
The intravascular treatment device (10, 10A to 10H), wherein the deformation application part (18, 19) expands / contracts following the expansion / contraction of the support part (16, 17). - 請求項1記載の生体管腔内治療デバイス(10、10A~10H)において、
前記支持部(16、17)及び前記変形塗布部(18、19)を収容して前記生体管腔内を送達可能であり、且つ前記支持部(16、17)及び前記変形塗布部(18、19)に対し進退移動自在な外管(20)を備え、
前記支持部(16、17)の先端側は、前記外管(20)内に収容された状態で、前記外管(20)により拡張が規制されることにより収縮し、前記外管(20)から露出された際に、弾性復元力によって拡張する
ことを特徴とする生体管腔内治療デバイス(10、10A~10H)。 The intraluminal treatment device (10, 10A-10H) according to claim 1,
The support part (16, 17) and the deformation application part (18, 19) can be accommodated and delivered through the living body lumen, and the support part (16, 17) and the deformation application part (18, 19) 19) with an outer tube (20) that can move forward and backward,
The distal end side of the support portion (16, 17) is contracted by being restricted by the outer tube (20) while being accommodated in the outer tube (20), and the outer tube (20). A biological intraluminal treatment device (10, 10A to 10H), which is expanded by an elastic restoring force when exposed from the body. - 請求項1記載の生体管腔内治療デバイス(10、10A、10C、10E~10H)において、
前記変形塗布部(18)は、可撓性を有するリング状に形成されており、
前記吐出口(22、22a、22c)は、前記変形塗布部(18)の先端面側且つ径方向外側に位置するとともに、前記変形塗布部(18)の周方向に沿って複数設けられている
ことを特徴とする生体管腔内治療デバイス(10、10A、10C、10E~10H)。 The biological endoluminal treatment device (10, 10A, 10C, 10E-10H) according to claim 1,
The deformation application part (18) is formed in a ring shape having flexibility,
The discharge ports (22, 22a, 22c) are located on the distal end surface side and the radially outer side of the deformation application portion (18), and are provided in a plurality along the circumferential direction of the deformation application portion (18). A biological intraluminal treatment device (10, 10A, 10C, 10E-10H) characterized by the above. - 請求項4記載の生体管腔内治療デバイス(10、10A~10D、10F~10H)において、
前記変形塗布部(18、19)は、内部を周回し前記吐出口(22)に連通する被塗布物質通路(38)を有するとともに、前記被塗布物質通路(38)に連通し被塗布物質を供給可能な被塗布物質供給路(36)を有するチューブ(34)に接続されている
ことを特徴とする生体管腔内治療デバイス(10、10A~10D、10F~10H)。 The biological endoluminal treatment device (10, 10A-10D, 10F-10H) according to claim 4,
The deformation application part (18, 19) has an application substance passage (38) that circulates in the interior and communicates with the discharge port (22), and communicates the application substance to the application substance passage (38). A biological intraluminal treatment device (10, 10A to 10D, 10F to 10H) characterized by being connected to a tube (34) having a supply substance supply path (36) that can be supplied. - 請求項4記載の生体管腔内治療デバイス(10E)において、
前記シャフト(12a)は、内部を軸方向に延在する被塗布物質流通ルーメン(46)を有し、
前記変形塗布部(18)は、内部を周回し前記吐出口(22)に連通する被塗布物質通路(38)を有し、
前記支持部(16)は、前記シャフト(12a)に連結され先端方向に放射状に延在する複数のフレーム(14a)として構成され、
前記複数のフレーム(14a)のうち少なくとも1つは、前記被塗布物質流通ルーメン(46)と前記被塗布物質通路(38)を連通させる連通路(48)が形成されている
ことを特徴とする生体管腔内治療デバイス(10E)。 The biological endoluminal treatment device (10E) according to claim 4,
The shaft (12a) has a coated substance distribution lumen (46) extending axially inside.
The deformation application part (18) has a substance passage (38) to be applied that circulates inside and communicates with the discharge port (22).
The support portion (16) is configured as a plurality of frames (14a) connected to the shaft (12a) and extending radially in the distal direction.
At least one of the plurality of frames (14a) is formed with a communication passage (48) for communicating the material to be coated circulation lumen (46) and the material to be coated passage (38). In vivo endoluminal therapy device (10E). - 請求項1記載の生体管腔内治療デバイス(10、10A~10H)において、
前記変形塗布部(18、19)の表面には、潤滑性コート剤(18c)がコーティングされている
ことを特徴とする生体管腔内治療デバイス(10、10A~10H)。 The intraluminal treatment device (10, 10A-10H) according to claim 1,
The living body intraluminal treatment device (10, 10A to 10H), wherein the surface of the deformation application part (18, 19) is coated with a lubricious coating agent (18c).
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PCT/JP2012/067291 WO2014006738A1 (en) | 2012-07-06 | 2012-07-06 | Treatment device for treating inside of organism lumen |
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PCT/JP2012/067291 WO2014006738A1 (en) | 2012-07-06 | 2012-07-06 | Treatment device for treating inside of organism lumen |
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