WO2014006738A1

WO2014006738A1 - Treatment device for treating inside of organism lumen

Info

Publication number: WO2014006738A1
Application number: PCT/JP2012/067291
Authority: WO
Inventors: 石井直樹
Original assignee: テルモ株式会社
Priority date: 2012-07-06
Filing date: 2012-07-06
Publication date: 2014-01-09

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

Intraluminal therapy device

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) 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Furthermore, the surface of the deformation application part may be coated with a lubricating coating agent.

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.

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.

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.

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.

It is a perspective view which shows the whole structure of the treatment device which concerns on this Embodiment. 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 | frame of FIG. 1, and a deformation | transformation application part, FIG. 2D is a partial side view which shows the expansion | deployment state of the deformation | transformation application part in a thin blood vessel. 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, and 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, and 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. 5B is a second explanatory diagram showing an operation procedure of the treatment device following FIG. 5A, and FIG. It is the 3rd explanatory view showing the operation procedure of the treatment device following 5B. 6A is a first explanatory diagram showing another operation procedure using the treatment device of FIG. 1, and FIG. 6B is a second explanatory diagram showing another operation procedure of the treatment device following FIG. 6A. FIG. 6C is a third explanatory diagram illustrating another operation procedure of the treatment device subsequent to FIG. 6B.

Hereinafter, preferred embodiments of the intraluminal treatment device according to the present invention will be described in detail with reference to the accompanying drawings.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The treatment device 10 according to the present embodiment is basically configured as described above, and the operation and effect will be described below.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. ).

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.

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.

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.

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.

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

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. ).
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).
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.
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.
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.
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).
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).