JP5242979B2 - In vivo indwelling stent and biological organ dilator - Google Patents

Description

  The present invention relates to an in-vivo indwelling stent and a biological organ dilator used to improve a stenosis or occlusion in a biological lumen such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra.

In-vivo stents are used to expand the stenosis or occlusion site and secure the lumen to treat various diseases caused by stenosis or occlusion of blood vessels or other in-vivo lumens. In general, it is a tubular medical device.
Since the stent is inserted into the body from outside the body, the diameter is small at that time. The stent is expanded at the target stenosis or occlusion site to increase the diameter, and the lumen is held as it is.

As the stent, a metal wire or a cylindrical shape obtained by processing a metal tube is generally used. It is attached to a catheter or the like in a thin state, inserted into a living body, expanded by a certain method at a target site, and tightly fixed to the inner wall of the lumen to maintain the lumen shape. Stents are classified into self-expandable stents and balloon expandable stents according to function and placement method. The balloon expandable stent has no expansion function in the stent itself. After inserting the stent into the target site, the balloon is positioned in the stent to expand the balloon, and the stent is expanded (plastic deformation) by the expansion force of the balloon. Fix it in close contact with the inner surface of the lumen. This type of stent requires the above-described stent expansion operation.
The purpose of stent placement is to prevent and reduce restenosis that occurs after a procedure such as PTCA. And in recent years, a bioactive substance is carried on the stent so that the bioactive substance can be locally released over a long period of time at the indwelling site of the lumen to reduce the restenosis rate. .
For example, Japanese Patent Application Laid-Open No. 8-33718 (Patent Document 1) discloses a stent in which the surface of a stent body is coated with a mixture of a substance for treatment and a polymer, and Japanese Patent Application Laid-Open No. 9-56807 (Patent Document). In 2), a stent is proposed in which a drug layer is provided on the surface of the stent body, and a biodegradable polymer layer is provided on the surface of the drug layer.
As a result of intensive studies by the inventor of the present application, it has been found that there may be a cause of restenosis in the vasodilation retention strength (strength) possessed by the stent. However, a stent having a low vascular expansion retention force cannot sufficiently improve the vascular stenosis at the time of placement.

JP-A-8-33718 JP-A-9-56807

  The object of the present invention is to provide a sufficient vasodilation retention force at the time of stent placement, to satisfactorily improve the stenosis, and to become flexible after a predetermined period of time and to have high followability to vascular deformation. An in-vivo indwelling stent and a living organ dilator having the same are provided.

What achieves the above object is as follows.
(1) A stent for in-vivo indwelling that is composed of linear components and is in close contact with the in-vivo tissue by being deformed during in-dwelling operation in the living body, wherein the stent is a non-biodegradable metal linear configuration A metal stent base formed in a substantially cylindrical shape by an element, and a plurality of biodegradable material-made linear components joined at one end and the other end to the metal linear component, and The metal stent substrate is formed of a plurality of metal linear spirals formed in a zigzag-shaped non-biodegradable metal linear component spirally and substantially parallel to the axial direction of the stent ; One end side metal wavy annular portion connected to one end of each metal linear spiral body, and the other end side metal wavy annular portion connected to the other end of each metal linear spiral body Formed of the biodegradable material linear configuration The element connects the plurality of metal linear spiral bodies and has a zigzag shape, and the plurality of biodegradable material linear components are all of the metal linear spiral bodies. The stent extends in a direction different from the spiral direction, and after the disappearance of the linear component made of biodegradable material, the stent has the one end side metal wavy annular portion and the other end side metal wavy wire. And the plurality of metal linear spirals connected to the one end side metal wavy annular portion and the other end side metal wavy annular portion, and a gap on the side surface of the stent is formed. Stent for in- vivo placement with increased flexibility and improved flexibility .

(2) The metal linear spiral body includes a joint portion with the biodegradable material-made linear component, and the joint portion is the metal of the biodegradable material-made linear component. The stent for indwelling in a living body according to the above (1), comprising detachment suppressing means for suppressing detachment from the stent substrate.

(3) A notch portion is formed in a side portion of the free end portion of the joint portion of the metallic linear spiral body, and a part of the biodegradable material-made linear component is the joint portion. The in-vivo indwelling stent according to (2), which has entered the notch portion of the free end portion of the portion.

(4) The stent includes a joint between the metal linear spiral body and the biodegradable material-made linear component, and the biodegradable material-made linear component at the joint. The stent for indwelling in a living body according to the above (1), which covers the outer surface and the inner surface of the metallic linear component.
(5) The in-vivo stent according to any one of (1) to (4), wherein the biodegradable material is a biodegradable metal or a biodegradable polymer.
(6) The in-vivo stent according to (5), wherein the biodegradable metal is pure magnesium or a magnesium alloy.
(7) The magnesium alloy contains at least one element selected from a biocompatible element group consisting of Zr, Y, Ti, Ta, Nd, Nb, Zn, Ca, Al, Li, and Mn. The stent for indwelling according to (6) above.

( 8 ) The biodegradable polymer is at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, polyhydroxybutyric acid, cellulose, polyhydroxybutyrate valeric acid, and polyorthoester, or The indwelling stent according to ( 5 ), which is a copolymer, mixture, or composite of these.
( 9 ) The non-biodegradable metal linear component is an easily plastic deformable metal linear component, and the stent is formed in a substantially tubular body and is inserted into a living body lumen. The in vivo indwelling stent according to any one of the above (1) to ( 8 ), which has a diameter and expands when a force spreading in the radial direction from the inside of the stent is applied.
( 10 ) The non-biodegradable metal linear component is a superelastic metal linear component, and the stent is formed in a substantially cylindrical shape, and is compressed in the direction of the central axis when inserted into a living body. The stent for in-vivo indwelling in any one of said (1) thru | or ( 9 ) which expands outside at the time of in-vivo indwelling, and restores the shape before compression.

Moreover, what achieves the said objective is as follows.
( 11 ) A tube-shaped shaft main body, a foldable and expandable balloon provided at the distal end of the shaft main body, and a balloon mounted on the balloon so as to enclose the balloon in a folded state. A living organ dilator comprising the stent according to ( 9 ), which is expanded by expansion.
( 12 ) A sheath, the stent of ( 10 ) housed in the distal end portion of the sheath, and an inner tube for slidably passing through the sheath and pushing out the stent from the distal end of the sheath. Biological organ dilator.

The in vivo indwelling stent of the present invention is composed of linear components, and is an in vivo indwelling stent that is in close contact with the in vivo tissue by being deformed during the indwelling operation. A metal stent base formed in a substantially cylindrical shape by a degradable metal linear component, and a plurality of biodegradable material linear components in which one end and the other end are joined to the metal linear component; It is formed by.
For this reason, at the time of stent placement, a metal stent base formed in a substantially cylindrical shape by a non-biodegradable metal linear component, and a plurality of living bodies in which one end and the other end are joined to the metal linear component. With a linear component made of a degradable material, sufficient vasodilation retention force is exhibited. Then, the biodegradable material-made linear component is biodegraded with the passage of a predetermined period, so that the expansion maintenance force developing portion of the stent is formed in a substantially cylindrical shape by the non-biodegradable metal-made linear component. Since only the metal stent substrate is used, the stent becomes flexible and has good followability to the deformation of blood vessels.

The in-vivo indwelling stent of the present invention will be described using the following preferred embodiments.
FIG. 1 is a front view of an in-vivo stent according to an embodiment of the present invention. FIG. 2 is a development view of the in-vivo stent of FIG. FIG. 3 is an explanatory diagram for explaining the operation of the in-dwelling stent of FIG. FIG. 4 is a partially enlarged view of FIG. FIG. 5 is an enlarged sectional view taken along line AA in FIG.
The in-vivo stent 1 of the present invention is an in-vivo stent that is composed of linear components and is in close contact with the in-vivo tissue by being deformed during the in-vivo operation. The stent 1 includes a metallic stent base 2 formed in a substantially cylindrical shape by non-biodegradable metallic linear components 21, 22, 23, and 24, and one end and the other end joined to the metallic linear component. And a plurality of biodegradable material-made linear components 3.

The stent 1 according to this embodiment is a self-expanding stent that is compressed in the direction of the central axis when inserted into a living body, and expands outward when placed in the living body to restore a shape before compression. The stent of the present invention is not limited to a self-expanding stent, is formed in a substantially tubular body, has a diameter for insertion into a lumen in a living body, and extends radially from the inside of the tubular body. It may be a stent that is expandable when a spreading force is applied, a so-called balloon expandable stent.
As shown in FIGS. 1 to 3, the stent 1 of this embodiment has a metal stent base 2 formed in a substantially cylindrical shape by non-biodegradable metal linear components 21, 22, 23, and 24. And a plurality of biodegradable material-made linear components 3 having one end and the other end joined to a metal linear component. Note that FIG. 3 shows a state in which the biodegradable material-made linear component 3 has disappeared from the in-vivo stent of FIG. 1, in other words, only the non-biodegradable metal stent base 2. .
In the stent of the present invention, the basic skeleton portion of the stent is formed of a non-biodegradable metallic linear component, and retains the stent shape even after the disappearance of the biodegradable material linear component. In addition, in the stent 1 of this example, when the linear component made of biodegradable material disappears, nearly half of the entire linear component disappears. As shown in FIG. The distance between the linear components of the holding is increased, in other words, the gap on the side surface of the stent is considerably increased, and the expansion maintenance force is reduced and the flexibility is improved.

The metal stent base 2 is composed of a plurality of linear spiral bodies 21 and 22 that are spirally formed in the axial direction of the stent by zigzag metal linear components. The linear component 3 made of a conductive material connects a plurality of linear spiral bodies and has a zigzag shape. In the stent 1 of this embodiment, the zigzag shape of the biodegradable material-made linear component 3 (all biodegradable material-made linear component 3 shown in FIG. 2) is a metal linear spiral. It extends in a direction different from the spiral direction of the body. Further, in this stent 1, the metal stent base 2 includes metal wavy annular portions 23 and 24 formed endlessly at portions located at both ends of the metal stent base. Thus, by providing the metal wavy annular portions 23 and 24 at both ends of the metal stent base, the blood vessel expansion maintaining force at both ends of the stent becomes high.

The metal stent base 2 of the stent 1 of this embodiment is formed by partially removing the metal pipe, and as shown in FIGS. 1 to 3 (particularly FIG. 3), it is zigzag and spiral. A plurality of (specifically, two) linear spiral bodies 21 and 22 are arranged substantially in parallel. The individual linear spiral bodies 21 and 22 have a zigzag structure, so that the diameter can be surely expanded at the time of restoration after compression. By the spiral shape, the deformability at the curved narrowed portion is high.
As shown in FIG. 3, the metal stent substrate 2 of this embodiment includes two linear spiral bodies 21 and 22 arranged in parallel, and two metal stent substrates 2 positioned on one end side of the metal stent substrate. One end side metallic wavy annular portion 23 to which one ends of the linear spiral bodies 21 and 22 are connected, and the two linear spiral bodies 21 and 22 located on the other end side of the metal stent base. The other end is formed by a metal wavy annular portion 24 connected to the other end. And in metal wavy linear annular parts 23 and 24, the height (depth) of the trough part and peak part of a connection part part with the linear spiral bodies 21 and 22 becomes larger than another part. Yes. Note that the number of linear spiral bodies may be three or more.

The pitch between the bent portions of the linear spiral body (in other words, the distance between the apexes of the bent portions in one linear spiral body) is preferably 2.0 to 8.0 mm. Further, the angle (inner angle) of the bent portion in the linear spiral body is preferably 30 to 70 °. In one linear spiral body, the pitch between the bent portions, that is, the angles (inner angles) of the bent portions may all be the same or may be partially different. For example, the pitch between the bent portions of the linear spiral body in the portion located at the center of the stent 1 may be shorter than the pitch between the bent portions of the linear spiral bodies located in the both ends.
Further, as a whole, in the stent 1 of this embodiment, the plurality of linear spiral bodies are substantially spaced apart from each other. That is, the spiral pitch is the same in all the linear spiral bodies as the entire stent 1. However, the present invention is not limited to this, and the spiral pitch of the linear spiral body may be partially different. For example, the helical pitch of the portion of the linear spiral itself located at the center of the stent 1 may be shorter than the pitch of the portions of the linear spiral located at both ends. By doing in this way, as the stent 1, the expansion force of a center part can be made higher than both ends. Furthermore, as a whole of the stent 1, the pitch between the bent portions of the linear spiral body in the portion located in the central portion of the stent 1 is shorter than the pitch between the bent portions of the linear spiral bodies in the portions located at both ends. It is good.

In the case of this embodiment, which is a self-expanding stent, a superelastic metal is suitable as a material for forming the metallic stent substrate 2. As the superelastic metal, a superelastic alloy is preferably used. The superelastic alloy here is generally called a shape memory alloy, and exhibits superelasticity at least at a living body temperature (around 37 ° C.). Particularly preferably, a Ti—Ni alloy of 49 to 53 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, and a Cu—Zn—X alloy of 1 to 10 wt% X (X = Be, A super elastic metal body such as Si, Sn, Al, Ga), Ni-Al alloy of 36-38 atomic% Al is preferably used. Particularly preferred is the Ti—Ni alloy described above. Further, a Ti—Ni—X alloy in which a part of the Ti—Ni alloy is substituted with 0.01 to 10.0% X (X = Co, Fe, Mn, Cr, V, Al, Nb, W, B, etc.) Or a Ti—Ni—X alloy (X = Cu, Pb, Zr) in which a part of the Ti—Ni alloy is substituted by 0.01 to 30.0% atoms, and the cold work rate Alternatively, mechanical properties can be appropriately changed by selecting conditions for the final heat treatment. Further, the mechanical characteristics can be appropriately changed by selecting the cold work rate and / or the final heat treatment conditions using the Ti—Ni—X alloy. The buckling strength (yield stress during loading) of the superelastic alloy used is 5 to 200 kg / mm ² (22 ° C.), more preferably 8 to 150 kg / mm ^2. Restoring stress (yield stress during unloading) ) Is 3 to 180 kg / mm ² (22 ° C.), more preferably 5 to 130 kg / mm ² . Superelasticity here means that even if it is deformed (bending, pulling, compressing) to a region where normal metal is plastically deformed at the operating temperature, it will recover to its almost uncompressed shape without the need for heating after the deformation is released. It means to do.

In this stent 1, the biodegradable material-made linear component 3 has a zigzag shape while connecting the plurality of metal linear spiral bodies 21, 22. Further, the zigzag shape of the biodegradable material-made linear component 3 extends in a direction different from the spiral direction of the metal linear spiral body. Specifically, the zigzag line made of biodegradable material that is short at substantially equal intervals and extends in a direction different from the helix direction of the metal line helix is formed between the metal line helixes 21 and 22. The components 3 are connected. The plurality of zigzag-shaped biodegradable material-made linear components 3 have a spiral shape in which the arrangement positions thereof also extend in the axial direction. The number of apexes of the zigzag-shaped biodegradable material-made linear component 3 is preferably about 3 to 8.
A biodegradable metal or a biodegradable polymer is preferably used as the biodegradable material used for the linear component made of the biodegradable material. In addition, the biodegradable material preferably has adhesiveness with the stent forming material.

As the biodegradable metal, pure magnesium or a magnesium alloy, calcium, zinc, lithium or the like is used. Preferred is pure magnesium or a magnesium alloy. The magnesium alloy contains magnesium as a main component and contains at least one element selected from a biocompatible element group consisting of Zr, Y, Ti, Ta, Nd, Nb, Zn, Ca, Al, Li, and Mn. Those that do are preferred.
As a magnesium alloy, for example, magnesium is 50 to 98%, lithium (Li) is 0 to 40%, iron is 0 to 5%, and other metals or rare earth elements (cerium, lanthanum, neodymium, praseodymium, etc.) are 0 to 0%. Mention may be made of 5%. Further, for example, magnesium is 79 to 97%, aluminum is 2 to 5%, lithium (Li) is 0 to 12%, and rare earth elements (cerium, lanthanum, neodymium, praseodymium, etc.) are 1 to 4%. be able to. Moreover, for example, magnesium is 85 to 91%, aluminum is 2%, lithium (Li) is 6 to 12%, and rare earth elements (cerium, lanthanum, neodymium, praseodymium, etc.) are 1%. Also, for example, magnesium is 86 to 97%, aluminum is 2 to 4%, lithium (Li) is 0 to 8%, and rare earth elements (cerium, lanthanum, neodymium, praseodymium, etc.) are 1 to 2%. be able to. Also, for example, aluminum is 8.5 to 9.5%, manganese (Mn) is 0.15 to 0.4%, zinc is 0.45 to 0.9%, and the remainder is magnesium. it can. Moreover, for example, aluminum is 4.5 to 5.3%, manganese (Mn) is 0.28 to 0.5%, and the remainder is magnesium. For example, magnesium is 55 to 65%, lithium (Li) is 30 to 40%, and other metals and / or rare earth elements (cerium, lanthanum, neodymium, praseodymium, etc.) are 0 to 5%. Can do.

  The biodegradable polymer is not particularly limited as long as it is enzymatically and non-enzymatically degraded in vivo and the degradation product does not exhibit toxicity. For example, polylactic acid, polyglycolic acid, polylactic acid- Polyglycolic acid copolymer, polycaprolactone, polylactic acid-polycaprolactone copolymer, polyorthoester, polyphosphazene, polyphosphoric acid ester, polyhydroxybutyric acid, polymalic acid, polyalpha-amino acid, collagen, gelatin, laminin, heparan sulfate Fibronectin, vitronectin, chondroitin sulfate, hyaluronic acid, polypeptide, chitin, chitosan and the like can be used.

  In addition, the joint part of the non-biodegradable metal linear spiral that is bonded to the biodegradable material linear component is to increase the adhesion with the biodegradable material linear component forming material. The whole or a part may be surface-treated. As the surface treatment, a method of coating the surface with a material having high affinity as a primer is preferable. Although various materials can be used as the primer material, the most preferable one is a silane coupling agent having a hydrolyzable group and an organic functional group. The silanol group generated by the decomposition of the hydrolyzable group (for example, alkoxy group) of the silane coupling agent is bonded to the surface of the joining portion (free end portion) of the metal easily deformable portion by a covalent bond or the like. These organic functional groups (for example, epoxy group, amino group, mercapto group, vinyl group, methacryloxy group) can be bonded to the polymer in the resin adhesive layer by chemical bonding. Specific examples of the silane coupling agent include γ-aminopropylethoxysilane and γ-glycidoxypropylmethyldimethoxysilane. Examples of primer materials other than silane coupling agents include organic titanium coupling agents, aluminum coupling agents, chromium coupling agents, organic phosphoric acid coupling agents, organic vapor deposition films such as polyparaxylene, and cyanoacrylates. Adhesives, polyurethane-based paste resins, and the like.

In addition, a bioactive substance may be contained in the forming material of the biodegradable material-made linear component.
Physiologically active substances include agents that suppress intimal thickening, anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, HMG-CoA reductase inhibitors, ACE inhibitors, calcium antagonists, anti-high fats Antihypertensive agent, anti-inflammatory agent, integrin inhibitor, antiallergic agent, antioxidant, GPIIbIIIa antagonist, retinoid, flavonoid and carotenoid, lipid improver, DNA synthesis inhibitor, tyrosine kinase inhibitor, antiplatelet agent, vascular smoothing Muscle growth inhibitors, anti-inflammatory drugs, biological materials, interferons and epithelial cells generated by genetic engineering are used. And you may use 2 or more types of mixtures, such as said chemical | medical agent.

  As the anticancer agent, for example, vincristine, vinblastine, vindesine, irinotecan, pirarubicin, paclitaxel, docetaxel, methotrexate and the like are preferable. As the immunosuppressant, for example, sirolimus, tacrolimus, azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, gusperimus, mizoribine and the like are preferable. As the antibiotic, for example, mitomycin, adriamycin, doxorubicin, actinomycin, daunorubicin, idarubicin, pirarubicin, aclarubicin, epirubicin, pepromycin, dinostatin styramer and the like are preferable. As the anti-rheumatic agent, for example, methotrexate, sodium thiomalate, penicillamine, lobenzalit and the like are preferable. As the antithrombotic drug, for example, heparin, aspirin, antithrombin preparation, ticlopidine, hirudin and the like are preferable. As the HMG-CoA reductase inhibitor, for example, cerivastatin, cerivastatin sodium, atorvastatin, nisvastatin, itavastatin, fluvastatin, fluvastatin sodium, simvastatin, lovastatin, pravastatin and the like are preferable. As the ACE inhibitor, for example, quinapril, perindopril erbumine, trandolapril, cilazapril, temocapril, delapril, enalapril maleate, lisinopril, captopril and the like are preferable. As the calcium antagonist, for example, nifedipine, nilvadipine, diltiazem, benidipine, nisoldipine and the like are preferable. As the antihyperlipidemic agent, for example, probucol is preferable. As the antiallergic agent, for example, tranilast is preferable. As the retinoid, for example, as the all-trans retinoic acid flavonoid and carotenoid, for example, catechins, particularly epigallocatechin gallate, anthocyanin, proanthocyanidins, lycopene, β-carotene and the like are 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 are preferable. As the biological material, for example, EGF (epidermal growth factor), VEGF (vascular endothelial growth factor), HGF (hepatocyte growth factor), PDGF (platelet derived growth factor), bFGF (basic fibroblast growth factor) and the like are preferable.

  And in the stent 1 of this Example, as shown in FIG.4 and FIG.5, the biodegradable-material linear component 3 is joined in the side part of the metal linear spiral bodies 21 and 22. As shown in FIG. . Specifically, as shown in FIG. 4, the distal end portion of the biodegradable material-made linear component 3 facing the one end of the stent is a linear portion of one of the metal linear spiral bodies 21, 22. The side part 31 is joined. The biodegradable material-made linear component 3 extends in a zigzag manner in the circumferential direction of the stent by a predetermined distance and reaches the other metal linear spiral bodies 21 and 22. And the rear-end part which faces the other end direction of the stent of the biodegradable material-made linear component 3 is joined to the side part 32 of the linear part of the other metal-made linear spiral bodies 21, 22. . In this stent, what is called end face bonding is used, but the bonding form is not limited to this, and may be as shown in FIGS. 6 and 7.

FIG. 6 is a partially enlarged view of an in-vivo stent according to another embodiment of the present invention. FIG. 7 is an enlarged sectional view taken along line BB in FIG.
In the stent of this embodiment, the metal linear spiral bodies 21 and 22 are provided with joint portions 31a and 32a that partially protrude from the zigzag shape. One end of the biodegradable material-made linear component 3 is joined to the joint portion 31a, and the other end of the biodegradable material-made linear component 3 is joined to the joint portion 32a. And in the stent of this Example, as shown in FIG. 6, the corners of the free ends of the joint portions 31a and 32a are rounded. Further, the joint portions 31a and 32a are provided with means for suppressing the separation of the biodegradable material-made linear component 3 from the metal stent base 2. In the stent of this embodiment, as shown in FIG. 6, the end portion of the biodegradable material-made linear component 3 encloses only the free end portions of the joint portions 31a and 32a. The zigzag-shaped portions of the metal linear spiral bodies 21 and 22 have their surfaces exposed.
And in this stent, as shown in FIG. 6, the notch part is formed in the side part of the free end part of the junction parts 31a and 32a of the metal linear spiral bodies 21 and 22, and it is biodegradable. A part of the linear component 3 made of material penetrates into the notch portions of the free end portions of the joint portions 31a and 32a. Separation of both is suppressed by the notch part of the free end part of joining part 31a, 32a, and the part of the linear component made from a biodegradable material which penetrate | invaded it.

In addition, the form of a connection part is not limited to the above-mentioned thing, As shown in FIG. 8 and FIG.
FIG. 8 is a partially enlarged view of an in-vivo stent according to another embodiment of the present invention. FIG. 9 is an enlarged sectional view taken along the line CC of FIG.
In the stent of this embodiment, the biodegradable material-made linear component 3 covers the outer surface and the inner surface of the metal linear spiral bodies 21, 22 at the joint portion 33. By doing so, the outer surface and the inner surface of the stent are smooth without a stepped portion. Note that the biodegradable material-made linear component may cover only one of the outer surface and the inner surface of the metal linear spiral body.
In all of the above-described embodiments, the joint portion of the metal linear spiral body to be joined to the biodegradable material-made linear component is bonded to the biodegradable material-made linear component forming material. In order to increase the surface, the whole or a part may be surface-treated. As the surface treatment, a method of coating the surface with a material having high affinity as a primer is preferable. As the surface treatment method, those described above can be preferably used.

Further, the form of the stent is not limited to that described above. For example, it may be as shown in FIGS.
FIG. 10 is a front view of an in-vivo stent according to another embodiment of the present invention. FIG. 11 is a developed view of the in-vivo stent of FIG. FIG. 12 is an explanatory diagram for explaining the operation of the in-dwelling stent of FIG. FIG. 12 shows a state where the biodegradable material-made linear component 43 has disappeared from the in-vivo indwelling stent of FIG. 10, in other words, only the metal stent base 41. Therefore, in this stent, the basic skeleton portion of the stent is formed of a metal linear component, and maintains the stent shape even after the disappearance of the biodegradable material linear component.
In the stent 40 of this embodiment, an annular body formed in an annular shape by linear components is arranged in a plurality of axial directions, and adjacent annular bodies are connected by connecting portions 44, and are attached to both ends of the stent. The annular bodies 45 and 46 positioned are metal wavy linear annular bodies, and the connecting portion 44 is formed of a metal linear component.

  In the stent 40 of this embodiment, the annular bodies 45 and 46 located at both ends of the stent are metallic wavy linear annular bodies, but the other annular bodies are formed with the metallic linear components 42a and 42b. Both the decomposable material-made linear components 43 are provided. And in this stent 40, the state which only the metallic stent base | substrate 41 was shown in the state which the biodegradable-material linear component 43 lose | disappeared from the stent for in-vivo of FIG. As shown, like the stent 1 described above, two metal spirals 42a and 42b are provided. The metal linear spiral bodies 42a and 42b are connected by a zigzag-shaped biodegradable material linear component 43 that is short at substantially equal intervals and extends in the circumferential direction of the stent. A plurality of zigzag-shaped biodegradable material-made linear components 43 are arranged in a spiral shape extending in the axial direction. And also in the stent of this Example, as a joining form of the metal linear spiral bodies 42a, 42b and the biodegradable material-made linear component 43, any of the joining forms described above may be used.

For example, it may be as shown in FIG. 13 and FIG.
13 is a partially enlarged view of the in-vivo stent of FIG. FIG. 14 is an enlarged sectional view taken along the line DD of FIG.
In the stent of this embodiment, the metal linear spiral body 42 includes a joint portion 42 c that extends from the connecting portion 44 toward the biodegradable material-made linear component 43. And the edge part of the linear component 43 made from biodegradable material is joined to the junction part 42c. And in this stent, as shown in FIG. 13, the corner | angular part is rounded at the free end of the junction part 42c. Furthermore, the joining part 42c is provided with a means for suppressing the separation of the linear component 43 made of the biodegradable material from the metal stent base 41. Specifically, as shown in FIG. 13, the end portion of the biodegradable material-made linear component 43 encloses only the free end portion of the joint portion 42c, and the metal linear spiral The surface of the connecting portion 44 portion of the shaped body 42 is exposed. And as shown in FIG. 13, the notch part 42d is formed in the side part of the free end part of the junction part 42c of the metal linear spiral body 42, and the linear component 43 made from biodegradable material is formed. A part of has penetrated into the notch part 42d of the free end part of the junction part 42c. Separation of both is suppressed by the notch part 42d of the free end part of the junction part 42c, and the part of the linear component 43 made from a biodegradable material which penetrate | invaded it.
In the stent 40 of this embodiment, the number of wavy annular bodies forming the stent 40 is 12 in the examples shown in FIGS. 10 and 11. The number of wavy annular bodies varies depending on the length of the stent, but is preferably 4 to 50, and more preferably 8 to 35.
In addition, the stent of the present invention is formed in a substantially tubular body, has a diameter for insertion into a lumen in a living body, and is expandable when a force spreading in the radial direction from the inside of the tubular body is applied. It may be a stent, a so-called balloon expandable stent.

  FIG. 15 is a front view of an in-vivo stent according to another embodiment of the present invention. 16 is a development view of the in-vivo indwelling stent of FIG. 15 at the time of expansion. FIG. 17 is an explanatory diagram for explaining the operation of the in-vivo stent in FIG. 15. FIG. 17 shows a state in which the biodegradable material-made linear components have disappeared from the in vivo indwelling stent of FIG. 16, in other words, only the metal stent substrate. FIG. 18 is a partially enlarged view of FIG. Therefore, in this stent, the basic skeleton portion of the stent is formed of a metal linear component, and maintains the stent shape even after the disappearance of the biodegradable material linear component.

The stent 50 of this embodiment is a so-called balloon expandable stent, and a crushed annular component 52 that is long in the axial direction of the stent and has an opening in the center is arranged so as to surround the central axis of the plurality of stents, and The adjacent annular component 52 includes an annular body 54 connected by a connection portion 53, and a plurality of annular bodies 54 are arranged in the axial direction of the stent, and are adjacent to the connection portion 53 of the annular body 54. The connecting portion 53 of the body 54 is connected to at least one place by the connecting portion 55.
The connecting portion 53 and the connecting portion 55 are formed of metal linear components, and all or a part of the annular component 52 is a part of a portion not connected to the connecting portion 53 of the annular component 52. However, it is formed by the linear component made from a biodegradable material, and the other part is formed by the metal linear component.

In the stent 50 according to this embodiment, the annular component 52 is configured such that one end side portion 51 of the stent 50 is formed of a metal linear component from the connection portion 53, and the other end side of the stent 50 from the connection portion 53. Almost the entire portion 57 is formed by a linear component made of biodegradable material.
The stent of this embodiment is a balloon-expandable stent as described above, and the material for forming the metal linear component 51 is preferably one having easy plastic deformation. The material for forming the metallic linear component 51 is preferably a material having a certain degree of biocompatibility, such as stainless steel, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, cobalt base alloy, cobalt chrome. An alloy, a titanium alloy, a niobium alloy, etc. can be considered. Moreover, after producing the stent shape, precious metal plating (gold, platinum) may be performed. As stainless steel, SUS316L having the most corrosion resistance is suitable.

A biodegradable metal or a biodegradable polymer is preferably used as the biodegradable material used for the linear component made of the biodegradable material. In addition, the biodegradable material preferably has adhesiveness to the metal linear component forming material. As the biodegradable metal and biodegradable polymer, those described above can be preferably used.
In addition, in order to improve the adhesion to the biodegradable material-made linear component forming material, the joint portion of the metal linear component to be joined with the biodegradable material-made linear component is wholly or partially. May be surface treated. As the surface treatment, those described above can be preferably used.
In addition, a bioactive substance may be contained in the forming material of the biodegradable material-made linear component. As the physiologically active substance, those described above can be preferably used.

As shown in FIG. 18, in the stent 50 of this embodiment, the metal linear component 51 includes joint portions 58 a and 59 a for joining with the biodegradable material linear component 57. Yes. And the edge part of the linear component 57 made from biodegradable material is joined to joining part 58a, 59a. In this stent, as shown in FIG. 18, the free ends of the joint portions 58a and 59a have rounded corners. Further, the joint portions 58a and 59a are provided with means for suppressing the separation of the linear component 57 made of biodegradable material from the metal stent substrate. Specifically, as shown in FIG. 18, notches are formed in the side portions of the free ends of the joint portions 58a and 59a of the metal linear component 51, and the biodegradable material linear shape is formed. A part of the component 57 has penetrated into the notch part of the free end part of the junction parts 58a and 59a. Separation of both is suppressed by the notch part of the free end part of joining part 58a, 59a, and the part of the linear component 57 made from a biodegradable material which penetrate | invaded it.
The diameter of the stent when not expanded is preferably about 0.8 to 1.8 mm, and more preferably 0.9 to 1.6 mm. The length of the stent when not expanded is preferably about 8 to 40 mm. The length of one annular body 54 is preferably about 1.0 to 2.5 mm.

In this embodiment, the stent 50 is arranged such that a crushed annular component 52 that is long in the axial direction of the stent and has an opening in the central portion surrounds the central axis of the plurality of stents 50, and adjacent annular components 52. (56a, 56b) is composed of an annular body 54 connected at the connection portion 53, and a plurality of annular bodies 54 (54a, 54b, 54c, 54d, 54e, 54f) are arranged in the axial direction of the stent, The connecting portion 53 of the annular body 54 and the connecting portion 53 of the adjacent annular body 54 are connected to at least one place by the connecting portion 55.
Further, the annular component 52 in each annular body 54 (54a, 54b, 54c, 54d, 54e, 54f) is such that one annular component 56b adjacent to the other annular component 56a is proximal to the axial direction of the stent 50. The end portions of each annular body 54 project in a zigzag shape, and the end portions of each annular body 54 projecting in a zigzag shape enter into the adjacent annular bodies. Further, the connection portion 53 of each annular body 54 is substantially parallel to the central axis of the stent 50 (when not expanded).

  In the stent 50 of this embodiment, as shown in FIG. 17, the one end side portion 51 of the stent 50 from the connecting portion 53, the connecting portion 55 and the connecting portion 53 of all the annular components 52 is a metal linear component. It is formed by. Therefore, in this stent, the basic skeleton portion of the stent is formed of a metal linear component, and maintains the stent shape even after the disappearance of the biodegradable material linear component. Further, almost the entire other end portion 57 of the stent 50 is formed by the biodegradable material-made linear components from the connection portions 53 of all the annular components 52. In the stent 50 of this embodiment, when the linear component made of biodegradable material disappears, almost half of each annular component 52 disappears, and the stent shape is maintained as shown in FIG. However, the distance between the linear components is increased, in other words, the gap on the side surface of the stent is considerably increased, and the expansion maintenance force is reduced and the flexibility is improved.

  In the stent 50 of this embodiment, in each annular component in one annular body 54, one adjacent annular component 56b is positioned closer to the proximal end side in the axial direction of the stent 50 than the other annular component 56a. It has become a thing. That is, the end of one annular body 54 protrudes in a zigzag shape. Specifically, one annular body 54 includes a plurality of annular components 56a whose end portions protrude toward the front end side, and annular component elements 56a whose end portions protrude toward the rear end side and each protrude toward the front end side. And a plurality of annular components 56b. In the stent 50 of this embodiment, each annular body 54 includes an even number of annular components, so that all the adjacent annular components 56a and 56b are shifted in the axial direction. In order to stabilize such a zigzag shape, it is preferable to provide an even number of annular components.

Further, in each annular body 54, adjacent annular components 52 (52a, 52b) are connected by a short connection portion 53 in the vicinity of the center of the side portion of each annular element. That is, the connection part 53 connects each cyclic | annular component 52 (52a, 52b) in the circumferential direction, and forms the cyclic | annular body. Since the connection portion 53 does not substantially change even when the stent 50 is expanded, a force during expansion is easily applied to the center of each annular component, and each annular component can be expanded (deformed) uniformly. The connecting portion is a portion with a small amount of deformation when the stent is compressed or expanded.
Further, in this stent 50, the connecting portion 53 is substantially parallel to the central axis of the stent 50. For this reason, when the stent 50 is compressed, there is little restriction on reducing the diameter of the connection portion, and the stent 50 can be made to have a small diameter.

The number of annular components 52 is not limited to 12 and is preferably 4 or more. In particular, the number of annular components 52 is preferably 6-20. The number of annular components 52 is preferably an even number. In addition, the shape of the annular component is preferably an approximately elliptical or approximately rhomboid shape when expanded, but other polygonal shapes, for example, an axially long rectangle, hexagon, octagon, etc. It may be.
The connecting portion 53 of the annular body 54 and the connecting portion 53 of the adjacent annular body 54 are connected by a relatively long connecting portion 55 (longer than the connecting portion). Specifically, the annular body 54 a and the adjacent annular body 54 b are connected by a connecting portion 55 that connects the connecting portions 53. The annular body 54 b and the adjacent annular body 54 c are connected by a connecting portion 55 that connects the connecting portions 53. The annular body 54 c and the adjacent annular body 54 d are connected by a connecting portion 55 that connects the connecting portions 53. The annular body 54d and the adjacent annular body 54e are connected by a connecting portion 55 that connects the connecting portions 53 together. The annular body 54e and the adjacent annular body 54f are connected by a connecting portion 55 that connects the connecting portions 53 together. In the stent of this embodiment, the connecting portion 55 is provided so as to connect the adjacent annular bodies 54 at a plurality of locations. Moreover, a connection part is good also as what connects only one place. The number of connecting portions provided between adjacent annular bodies is preferably 1 to 5, and particularly preferably 1 to 3.

Further, in the stent 50 of this embodiment, each annular component 52 is aligned so as to be substantially linear with respect to the axial direction of the stent 50 when viewed in the axial direction. Specifically, in the stent 50 of this embodiment, all the annular components adjacent in the axial direction are aligned so as to be substantially linear with respect to the axial direction. All the connecting portions 55 are also substantially parallel to the axial direction of the stent 50. For this reason, the connecting portion 55 is hardly twisted. Further, all the connecting portions 53 are parallel to the axial direction of the stent 50 when not expanded. For this reason, even in the connecting portion 55, twisting is unlikely to occur.
The diameter of the stent when not expanded is preferably about 0.8 to 1.8 mm, more preferably 0.9 to 1.6 mm. The length of the stent when not expanded is preferably about 8 to 40 mm. The length of one annular body in the axial direction is preferably about 1.0 to 2.5 mm.

Next, an in-vivo stent 60 according to another embodiment of the present invention will be described.
FIG. 19 is a front view of an in-vivo stent according to another embodiment of the present invention. 20 is a development view of the in-vivo indwelling stent of FIG. FIG. 21 is an explanatory diagram for explaining the action of the in-vivo stent in FIG. (FIG. 21 shows a state where the biodegradable material-made linear components have disappeared from the in-vivo indwelling stent of FIG. 20, in other words, only the metal stent substrate).
The stent 60 of this embodiment is composed of linear components, and is an in-vivo indwelling stent that is in close contact with the in-vivo tissue by being deformed during in-vivo indwelling operation. The stent 60 is a linear component. The annular bodies 62 formed in an annular shape are arranged in a plurality of axial directions, and adjacent annular bodies are connected by a connecting portion 63. The annular body 62 is formed of a non-biodegradable metal linear component, and the connecting portion 63 is formed of a biodegradable material linear component.

The stent 60 of this embodiment is a self-expanding stent that is compressed in the direction of the central axis when inserted into a living body and that expands outward when in vivo to restore the shape before compression. The stent of the present invention is not limited to a self-expanding stent, is formed in a substantially tubular body, has a diameter for insertion into a lumen in a living body, and extends radially from the inside of the tubular body. It may be a stent that is expandable when a spreading force is applied, a so-called balloon expandable stent. Further, the form of the stent is not limited to this type.
And in the stent 60 of this Example, as shown in FIG. 21, in the state which the biodegradable-material linear component (connection part) 63 lose | disappeared, the some annular body 62 is not connected, but is isolated. Therefore, although each annular body exhibits an expansion holding force, the expansion holding force between the annular bodies disappears, so that the entire stent becomes flexible.

And also in the stent of this Example, as a joining form of the non-biodegradable metal linear component 62 and the biodegradable material linear component 63, any of the above-described joining forms may be used. . For example, it may be as shown in FIG. 22 and FIG. FIG. 22 is a partially enlarged view of FIG. 23 is an enlarged cross-sectional view taken along line EE in FIG.
In the stent 60 of this embodiment, the connecting portion 63 is formed so as to connect adjacent bent portions of the adjacent annular bodies 62. A part of the biodegradable material-made linear component constituting the connecting portion 63 is a part of the metal linear component 62, specifically, the apex portion of the adjacent bent portion of the adjacent annular body 62 Is encapsulated. Then, the apex portion of the bent portion of the annular body 62 encapsulated by the biodegradable material-made linear component is formed on the surface in order to improve the adhesion with the biodegradable material-made linear component joint forming material. Preferably it has been treated. As the surface treatment, a method of coating the surface with a material having high affinity as a primer is preferable. As the surface treatment method, those described above can be preferably used.

In the stent 60 of this embodiment, the number of wavy annular bodies forming the stent 60 is 12 in the examples shown in FIGS. 19 and 20. The number of wavy annular bodies varies depending on the length of the stent, but is preferably 4 to 50, and more preferably 8 to 35.
In the case of this embodiment, which is a self-expanding stent, a superelastic metal is suitable as a material for forming the non-biodegradable metal linear component (annular body). As the superelastic metal, those described above are preferably used.
A biodegradable metal or a biodegradable polymer is preferably used as the biodegradable material used for the linear component made of the biodegradable material. In addition, the biodegradable material preferably has adhesiveness to the metal linear component forming material. As the biodegradable metal and biodegradable polymer, those described above can be preferably used.
In addition, a bioactive substance may be contained in the forming material of the biodegradable material-made linear component. As the physiologically active substance, those described above can be preferably used.

In addition, the stent of the present invention is formed in a substantially tubular body, has a diameter for insertion into a lumen in a living body, and is expandable when a force spreading in the radial direction from the inside of the tubular body is applied. It may be a stent, a so-called balloon expandable stent.
In the case of a balloon expandable stent, the material for forming the metallic linear component is preferably one having easy plastic deformation. As a material for forming a metal linear component (annular body), a material having a certain degree of biocompatibility is preferable. For example, stainless steel, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, cobalt base alloy Cobalt chromium alloy, titanium alloy, niobium alloy, etc. are conceivable. Moreover, after producing the stent shape, precious metal plating (gold, platinum) may be performed. As stainless steel, SUS316L having the most corrosion resistance is suitable.

Next, the vasodilator of the present invention will be described with reference to the embodiments shown in the drawings.
FIG. 24 is a partially omitted front view of the living organ dilator according to the embodiment of the present invention. FIG. 25 is an enlarged partial cross-sectional view of the distal end portion of the biological organ dilator shown in FIG. FIG. 26 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention.
The vasodilator 100 of the present invention encloses a tubular shaft body 102, a foldable and expandable balloon 103 provided at the distal end of the shaft body 102, and a balloon 103 in a folded state. And a stent 101 that is expanded by expansion of the balloon 103.

  As the stent 101, a balloon expandable stent is used among the above-described stents. The stent used here is a so-called balloon expandable stent that has a diameter for insertion into a lumen in a living body and is expandable when a force that expands radially from the inside of the tubular body is applied. Used. As the stent, it is preferable that the area occupied by the linear component portion of the stent in a state where it is attached to the balloon 103 is 60% to 80% of the area of the outer peripheral surface including the void portion of the stent. Further, in the vasodilator 100 of the present invention, the shaft main body 102 includes a balloon dilating lumen whose one end communicates with the inside of the balloon 103. The biological organ dilator 100 is fixed to the outer surface of the shaft main body at a position corresponding to both ends of a predetermined length of the X-ray contrast member or the central portion of the stent fixed to the outer surface of the shaft main body at the position to be the central portion of the stent. Two X-ray contrast members.

In the living organ dilator 100 of this embodiment, as shown in FIG. 25, one end of the shaft main body 102 opens at the tip of the shaft main body 102 and the other end of the rear end of the shaft main body 102. An opening guide wire lumen 115 is provided.
The living organ dilating instrument 100 includes a shaft main body 102, a stent expansion balloon 103 fixed to the distal end of the shaft main body 102, and a stent 101 mounted on the balloon 103. The shaft body 102 includes an inner tube 112, an outer tube 113, and a branch hub 110.

As shown in FIG. 25, the inner tube 112 is a tube body including a guide wire lumen 115 for inserting a guide wire therein. The inner tube 112 has a length of 100 to 2500 mm, more preferably 250 to 2000 mm, and an outer diameter of 0.1 to 1.0 mm, more preferably 0.3 to 0.7 mm, and a wall thickness of 10 to 10. It is 250 micrometers, More preferably, it is 20-100 micrometers. The inner tube 112 is inserted into the outer tube 113, and the tip of the inner tube 112 protrudes from the outer tube 113. A balloon expanding lumen 116 is formed by the outer surface of the inner tube 112 and the inner surface of the outer tube 113, and has a sufficient volume. The outer tube 113 is a tube body in which the inner tube 112 is inserted and the tip is located at a portion slightly retracted from the tip of the inner tube 112.
The outer tube 113 has a length of 100 to 2500 mm, more preferably 200 to 2000 mm, and an outer diameter of 0.5 to 1.5 mm, more preferably 0.7 to 1.1 mm, and a wall thickness of 25 to 25 mm. It is 200 μm, more preferably 50 to 100 μm.

In the living organ dilator 100 of this embodiment, the outer tube 113 is formed by the distal end side outer tube 113a and the main body side outer tube 113b, and both are joined. The distal end side outer tube 113a has a tapered diameter at a portion closer to the distal end than the joint portion with the main body side outer tube 113b, and the distal end side has a smaller diameter than the tapered portion.
The outer diameter at the small diameter portion of the distal end side outer tube 113a is 0.50 to 1.5 mm, preferably 0.60 to 1.1 mm. Further, the base end portion of the distal end side outer tube 113a and the outer diameter of the main body side outer tube 113b are 0.75 to 1.5 mm, preferably 0.9 to 1.1 mm.

The balloon 103 has a front end side joint portion 103a and a rear end side joint portion 103b. The front end side joint portion 103a is fixed at a position slightly rear end side from the front end of the inner tube 112, and the rear end side joint portion 103b. Is fixed to the tip of the outer tube. The balloon 103 communicates with the balloon expansion lumen 116 in the vicinity of the proximal end portion.
As a material for forming the inner tube 112 and the outer tube 113, a material having a certain degree of flexibility is preferable. For example, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.) Further, thermoplastic resins such as polyvinyl chloride, polyamide elastomer and polyurethane, silicone rubber, latex rubber and the like can be used, preferably the above-mentioned thermoplastic resin, more preferably polyolefin.

The balloon 103 is foldable as shown in FIG. 25, and can be folded to the outer periphery of the inner tube 112 when not expanded. As shown in FIG. 26, the balloon 103 has an expandable portion that is a cylindrical portion (preferably, a cylindrical portion) having substantially the same diameter so that the attached stent 101 can be expanded. The substantially cylindrical portion may not be a perfect cylinder, but may be a polygonal column. As described above, the balloon 103 is liquid-tightly fixed to the inner tube 112 with the front end side joint portion 103a and the rear end side joint portion 103b to the front end of the outer tube 113 with an adhesive or heat fusion. . Further, in this balloon 103, the space between the expandable portion and the joint portion is formed in a tapered shape.
The balloon 103 forms an expansion space 103 c between the inner surface of the balloon 103 and the outer surface of the inner tube 112. The expansion space 103c communicates with the expansion lumen 116 on the entire periphery at the rear end. In this way, the rear end of the balloon 103 communicates with the expansion lumen having a relatively large volume, so that the expansion fluid can be reliably injected into the balloon from the expansion lumen 116.

As a material for forming the balloon 103, a material having a certain degree of flexibility is preferable. For example, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate). Copolymer), polyvinyl chloride, polyamide elastomer, polyurethane, polyester (for example, polyethylene terephthalate), thermoplastic resin such as polyarylene sulfide (for example, polyphenylene sulfide), silicone rubber, latex rubber, and the like. In particular, a stretchable material is preferable, and the balloon 103 is preferably biaxially stretched having high strength and expansion force.
As the size of the balloon 103, the outer diameter of the cylindrical portion (expandable portion) when expanded is 2 to 4 mm, preferably 2.5 to 3.5 mm, and the length is 10 to 50 mm, preferably 20-40 mm. Moreover, the outer diameter of the front end side joint portion 103a is 0.9 to 1.5 mm, preferably 1 to 1.3 mm, and the length is 1 to 5 mm, preferably 1 to 1.3 mm. Moreover, the outer diameter of the rear end side joint portion 103b is 1 to 1.6 mm, preferably 1.1 to 1.5 mm, and the length is 1 to 5 mm, preferably 2 to 4 mm.

As shown in FIGS. 25 and 26, the vasodilator 100 has two X-rays fixed to the outer surface of the shaft main body at the positions corresponding to both ends of the cylindrical portion (expandable portion) when expanded. Contrast members 117 and 118 are provided. It should be noted that two X-ray contrast members fixed to the outer surface of the shaft main body 102 (in this embodiment, the inner tube 112) at the positions corresponding to both ends of the predetermined length of the central portion of the stent 101 may be provided. Furthermore, it is good also as what provides the single X-ray contrast property member fixed to the outer surface of the shaft main-body part of the position used as the center part of a stent.
The X-ray contrast members 117 and 118 are preferably ring-shaped members having a predetermined length, or those obtained by winding linear components in a coil shape, and the forming material is, for example, gold, platinum, tungsten, or the like. Alternatively, an alloy thereof, a silver-palladium alloy, or the like is preferable.

A stent 101 is attached so as to enclose the balloon 103. The stent is manufactured by processing a metal pipe having a smaller diameter than that at the time of stent expansion and an inner diameter larger than the outer diameter of the folded balloon. Then, a balloon is inserted into the manufactured stent, and a uniform force is applied to the outer surface of the stent inward to reduce the diameter, thereby forming a product-state stent. That is, the stent 101 is completed when the balloon is compressed and attached.
A linear rigidity imparting body (not shown) may be inserted between the inner tube 112 and the outer tube 113 (within the balloon expansion lumen 116). The rigidity imparting body prevents extreme bending of the main body 102 of the living organ expanding device 100 at the bent portion without significantly reducing the flexibility of the living organ expanding device 100, and the distal end of the living organ expanding device 100. Easy to push the part. It is preferable that the tip of the rigidity imparting body has a smaller diameter than other parts by a method such as polishing. In addition, it is preferable that the distal end of the small diameter portion of the rigidity imparting body extends to the vicinity of the distal end portion of the main body outer tube 113. The rigidity imparting body is preferably a metal wire, and is preferably an elastic metal such as stainless steel having a wire diameter of 0.05 to 1.50 mm, preferably 0.10 to 1.00 mm, a superelastic alloy, etc. Is a high-strength stainless steel for springs and a superelastic alloy wire.

In the living organ dilator 100 of this embodiment, as shown in FIG. 24, a branch hub 110 is fixed to the proximal end. The branch hub 110 has a guide wire inlet 109 that communicates with the guide wire lumen 115 to form a guide wire port, and communicates with the inner tube hub fixed to the inner tube 112 and the balloon expansion lumen 116, and the injection port 111. And an outer tube hub fixed to the outer tube 113. The outer tube hub and the inner tube hub are fixed to each other. As a material for forming the branch hub 110, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used.
Note that the structure of the living organ dilator is not limited to the above, and may have a guide wire insertion port communicating with the guide wire lumen at an intermediate portion of the living organ dilator.

Next, a vasodilator according to another embodiment of the present invention will be described with reference to an embodiment shown in the drawings.
FIG. 27 is a partially omitted front view of a living organ dilator according to another embodiment of the present invention. FIG. 28 is an enlarged longitudinal sectional view of the vicinity of the distal end portion of the living organ dilator shown in FIG.
The living organ dilator 200 of this embodiment is used to push out the stent 203 from the distal end of the sheath 202 by inserting the sheath 202, the stent 203 accommodated in the distal end portion of the sheath 202, and slidably inserted in the sheath 202. An inner tube 204.
As the stent 203, the above-described self-expanding stent is used which is formed in a cylindrical shape, is compressed in the direction of the central axis when inserted into the living body, and is expanded outwardly when being placed in the living body and can be restored to the shape before compression. The

As shown in FIG. 27, the living organ dilator 200 of this embodiment includes a sheath 202, a self-expanding stent 203, and an inner tube 204.
As shown in FIGS. 27 and 28, the sheath 202 is a tubular body, and the front end and the rear end are open. The distal end opening functions as a discharge port of the stent 203 when the stent 203 is placed in a stenosis in the body cavity. When the stent 203 is pushed out from the distal end opening, the stress load is released and the stent 203 expands and restores the shape before compression. The distal end portion of the sheath 202 is a stent housing part 222 that houses the stent 203 therein. The sheath 202 includes a side hole 221 provided on the proximal end side with respect to the storage part 222. The side hole 221 is for leading the guide wire to the outside.
The outer diameter of the sheath 202 is preferably about 1.0 to 4.0 mm, and particularly preferably 1.5 to 3.0 mm. Further, the inner diameter of the sheath 202 is preferably about 1.0 to 2.5 mm. The length of the sheath 202 is preferably 300 to 2500 mm, particularly about 300 to 2000 mm.

A sheath hub 206 is fixed to the proximal end portion of the sheath 202 as shown in FIG. The sheath hub 206 includes a sheath hub main body and a valve body (not shown) that is housed in the sheath hub main body and that holds the inner tube 204 in a slidable and liquid-tight manner. The sheath hub 206 includes a side port 261 that branches obliquely rearward from the vicinity of the center of the sheath hub body. The sheath hub 206 is preferably provided with an inner tube locking mechanism that restricts the movement of the inner tube 204.
As shown in FIGS. 27 and 28, the inner tube 204 includes a shaft-shaped inner tube main body 240, a tip 247 provided at the tip of the inner tube main body 240 and protruding from the tip of the sheath 202, and an inner tube. And an inner tube hub 207 fixed to the base end portion of the main body 240.

  The distal end portion 247 preferably protrudes from the distal end of the sheath 202 and is formed in a tapered shape that gradually decreases in diameter toward the distal end as shown in FIG. By forming in this way, the insertion into the constricted portion is facilitated. In addition, the inner tube 204 is preferably provided with a stopper that is provided on the distal end side of the stent 203 and prevents movement of the sheath in the distal direction. The proximal end of the distal end portion 247 of the inner tube 204 can be brought into contact with the distal end of the sheath 202, and functions as the stopper.

  Further, as shown in FIG. 28, the inner tube 204 includes two projecting portions 243 and 245 for holding the self-expanding stent 203. The protrusions 243 and 245 are preferably annular protrusions. On the proximal end side of the distal end portion 247 of the inner tube 204, a stent holding projection 243 is provided. A stent push-out protrusion 245 is provided on the proximal side of the stent holding protrusion 243 by a predetermined distance. A stent 203 is disposed between the two protrusions 243 and 245. The outer diameters of these protrusions 243 and 245 are large enough to abut on a compressed stent 203 described later. For this reason, the movement of the stent 203 to the distal end side is restricted by the protruding portion 243, and the movement to the proximal end side is restricted by the protruding portion 245. Further, when the inner tube 204 moves to the distal end side, the stent 203 is pushed to the distal end side by the protruding portion 245 and is discharged from the sheath 202. Furthermore, as shown in FIG. 28, the proximal end side of the stent extruding protrusion 245 is preferably a tapered portion 246 that gradually decreases in diameter toward the proximal end side. Similarly, the proximal end side of the stent holding projection 243 is preferably a tapered portion 244 that gradually decreases in diameter toward the proximal end side, as shown in FIG. In this way, when the inner tube 204 protrudes from the distal end of the sheath 202 and the stent 203 is released from the sheath, and the inner tube 204 is re-stored in the sheath 202, the protruding portion is caught by the distal end of the sheath. To prevent that. Moreover, the protrusions 243 and 245 may be formed of different members from an X-ray contrast material. Thereby, the position of the stent can be accurately grasped under X-ray imaging, and the procedure becomes easier.

As shown in FIG. 28, the inner tube 204 has a lumen 241 extending from the distal end to at least the proximal end side of the stent accommodating portion 222 of the sheath 202, and an inner tube side hole 242 communicating with the lumen 241 on the proximal end side from the stent accommodating portion. And. In the living organ dilator 200 of this embodiment, the lumen 241 terminates at the side hole 242 formation site. The lumen 241 is for inserting one end of a guide wire from the distal end of the living organ dilator 200, partially passing through the inner tube, and then leading out from the side surface of the inner tube. The inner tube side hole 242 is located slightly on the distal end side of the living organ dilator 200 from the sheath side hole 221. The center of the inner tube side hole 242 is preferably 0.5 to 10 mm from the center of the sheath side hole 221.
Note that the living organ dilator is not limited to the above-described type, and the lumen 241 may extend to the proximal end of the inner tube. In this case, the side hole 221 of the sheath becomes unnecessary.
The inner tube 204 penetrates through the sheath 202 and protrudes from the rear end opening of the sheath 202. As shown in FIG. 27, an inner tube hub 207 is fixed to the proximal end portion of the inner tube 204.

FIG. 1 is a front view of an in-vivo stent according to an embodiment of the present invention. FIG. 2 is a development view of the in-vivo stent of FIG. FIG. 3 is an explanatory diagram for explaining the operation of the in-dwelling stent of FIG. FIG. 4 is a partially enlarged view of FIG. FIG. 5 is an enlarged sectional view taken along line AA in FIG. FIG. 6 is a partially enlarged view of an in-vivo stent according to another embodiment of the present invention. FIG. 7 is an enlarged sectional view taken along line BB in FIG. FIG. 8 is a partially enlarged view of an in-vivo stent according to another embodiment of the present invention. FIG. 9 is an enlarged sectional view taken along the line CC of FIG. FIG. 10 is a front view of an in-vivo stent according to another embodiment of the present invention. FIG. 11 is a developed view of the in-vivo stent of FIG. FIG. 12 is an explanatory diagram for explaining the operation of the in-dwelling stent of FIG. 13 is a partially enlarged view of the in-vivo stent of FIG. FIG. 14 is an enlarged sectional view taken along the line DD of FIG. FIG. 15 is a front view of an in-vivo stent according to another embodiment of the present invention. 16 is a development view of the in-vivo indwelling stent of FIG. 15 at the time of expansion. FIG. 17 is an explanatory diagram for explaining the operation of the in-vivo stent in FIG. 15. FIG. 18 is a partially enlarged view of FIG. FIG. 19 is a front view of an in-vivo stent according to another embodiment of the present invention. 20 is a development view of the in-vivo indwelling stent of FIG. FIG. 21 is an explanatory diagram for explaining the action of the in-vivo stent in FIG. FIG. 22 is a partially enlarged view of FIG. 23 is an enlarged cross-sectional view taken along line EE in FIG. FIG. 24 is a partially omitted front view of the living organ dilator according to the embodiment of the present invention. FIG. 25 is an enlarged partial cross-sectional view of the distal end portion of the biological organ dilator shown in FIG. FIG. 26 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 27 is a partially omitted front view of a living organ dilator according to another embodiment of the present invention. FIG. 28 is an enlarged longitudinal sectional view of the vicinity of the distal end portion of the living organ dilator shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Stent for in-vivo indwelling 3 Biodegradable material linear component 21, 22, 23, 24 Metal linear component

Claims (12)

A stent for in-vivo indwelling, which is composed of linear components and is in close contact with the in-vivo tissue by being deformed during the in-vivo indwelling operation,
The stent includes a metal stent base formed in a substantially cylindrical shape by a non-biodegradable metal linear component, and a plurality of biodegradable materials having one end and the other end joined to the metal linear component. Formed by wire-forming components, and
The metal stent substrate, a plurality of metallic linear spiral body formed into a spiral shape and substantially parallel to the axial direction of the stent by non-biodegradable metallic linear components of zigzag, each Formed by one end side metal wavy annular portion connected to one end of a metal linear spiral body and the other end side metal wavy annular portion connected to the other end of each metal linear spiral body Has been
The biodegradable material-made linear components are connected to the plurality of metal linear spiral bodies and have a zigzag shape, and the plurality of biodegradable material-made linear components are all It extends in a direction different from the spiral direction of the metal linear spiral body ,
After the disappearance of the biodegradable material-made linear component, the stent has the one end side metal wavy annular portion, the other end side metal wavy annular portion, and the one end side metal wavy annular portion. And the plurality of metal wire spirals connected to the other end side metal wavy annular portion, the gap between the side surfaces of the stent is increased, and the flexibility is improved. In vivo indwelling stent. The metal linear spiral body includes a joint with the biodegradable material-made linear component, and the joint is the metal stent base of the biodegradable material-made linear component. The in-vivo indwelling stent according to claim 1, further comprising a disengagement suppressing unit that suppresses disengagement from the body. A cutout portion is formed in a side portion of the free end portion of the joint portion of the metal linear spiral body, and a part of the linear component made of the biodegradable material is free of the joint portion. The in-vivo indwelling stent according to claim 2 which has penetrated into a cutout part of an end portion. The stent includes a joint between the metal linear spiral body and the biodegradable material-made linear component, and the biodegradable material-made linear component is the metal at the joint. The stent for in-vivo indwelling of Claim 1 which coat | covers the outer surface and inner surface of a wire-made component. The in-vivo stent according to any one of claims 1 to 4, wherein the biodegradable material is a biodegradable metal or a biodegradable polymer. The in-vivo stent according to claim 5, wherein the biodegradable metal is pure magnesium or a magnesium alloy. The magnesium alloy contains at least one element selected from a biocompatible element group consisting of Zr, Y, Ti, Ta, Nd, Nb, Zn, Ca, Al, Li, and Mn. 6. A stent for in-vivo placement according to 6. The biodegradable polymer is at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, polyhydroxybutyric acid, cellulose, polyhydroxybutyrate valeric acid, and polyorthoester, or a combination thereof. The in-vivo stent according to claim 5, which is a polymer, a mixture, or a composite. The non-biodegradable metal linear component is an easily plastic deformable metal linear component, and the stent is formed in a substantially tubular body and has a diameter for insertion into a living body lumen. The stent for in-vivo placement according to any one of claims 1 to 8, which expands when a force spreading in the radial direction from the inside of the stent is applied. The non-biodegradable metal linear component is a superelastic metal linear component, and the stent is formed in a substantially cylindrical shape, is compressed in the central axis direction when inserted into the living body, and is placed when placed in the living body The in-vivo stent according to any one of claims 1 to 9, wherein the stent is expanded outward and restored to a shape before compression. A tubular shaft main body, a foldable and expandable balloon provided at the distal end of the shaft main body, and a balloon mounted so as to enclose the balloon in a folded state and expanded by expansion of the balloon A biological organ dilating device comprising the stent according to claim 9. A sheath, a stent according to claim 10 housed in a distal end portion of the sheath, and an inner tube through which the stent is slidably inserted and pushed out from the distal end of the sheath. Living organ expansion device.

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