WO2022085313A1 - ステント - Google Patents
ステント Download PDFInfo
- Publication number
- WO2022085313A1 WO2022085313A1 PCT/JP2021/032691 JP2021032691W WO2022085313A1 WO 2022085313 A1 WO2022085313 A1 WO 2022085313A1 JP 2021032691 W JP2021032691 W JP 2021032691W WO 2022085313 A1 WO2022085313 A1 WO 2022085313A1
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- WO
- WIPO (PCT)
- Prior art keywords
- stent
- main body
- struts
- cell
- cells
- Prior art date
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Images
Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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Definitions
- the present invention relates to a stent used to dilate the lumen of a living body.
- an indwelling stent When an indwelling stent is used to dilate the lumen of a blood vessel, restenosis or reocclusion may occur in the blood vessel after the stent is placed, or complications such as thrombosis may occur.
- a balloon when used to dilate the lumen of a blood vessel, the blood vessel is temporarily closed, so that a vascular infarction may occur especially in a blood vessel on the distal side.
- the linearization of the blood vessels dilated by the balloon may cause bleeding complications due to rupture or infarction, such as damage to the blood vessels and perforating branches of surrounding blood vessels.
- An object of the present invention is to provide a stent having a large surface area and excellent shape followability and diameter reduction property to a vascular structure.
- the present invention is a stent that is inserted into a catheter and extruded from the catheter into the blood vessel to be used to dilate the blood vessel, in which a plurality of first cells composed of struts arranged in a frame shape are arranged in the circumferential direction.
- a plurality of second cells consisting of a first stent body that is spread and continuous in the central axis direction and a plurality of second cells consisting of struts arranged in a frame shape are spread in the circumferential direction and are continuous in the central axis direction, and the first stent body is said.
- the second stent body is provided with a second stent body to be inserted into the first stent body, and in a state where the second stent body is inserted into the first stent body, an intersecting portion of the second cell is formed in a hole portion of the first cell. It relates to a stent that is arranged and the first stent body and the second stent body are not radially connected to each other.
- the second stent body may be configured to press the first stent body outward in the radial direction.
- intersection portion of the second cell is arranged in the pore portion of the first cell
- one intersection portion of the second cell is arranged in the pore portion of the first cell. May be good.
- the ratio of the non-pore portion to the unit area of the surface of the portion where the first stent body and the second stent body overlap is It may be 5 to 50%.
- the plurality of first cells include a set of first struts and one set of first struts spaced apart from the set of first struts in a ring direction inclined with respect to the circumferential direction.
- the plurality of second cells have a set of second struts and one set of second struts spaced apart from the set of second struts in a ring direction inclined with respect to the circumferential direction. It may be configured to be provided.
- the plurality of the first cells are connected at a substantially S-shaped first intersection in the annular direction inclined with respect to the circumferential direction, and the plurality of the second cells are connected in the annular direction inclined with respect to the circumferential direction. It may be configured to be connected at the second intersection portion of a substantially S shape.
- the ring direction in which the plurality of first cells are connected at the first crossing portion and the ring direction in which the plurality of second cells are connected at the second crossing portion are line-symmetrical in the radial direction. It may be configured.
- the proximal end of the first stent body and the proximal end of the second stent body may be connected at different positions in the axial direction of the pusher wire.
- a coating film may be provided between the first stent main body and the second stent main body.
- a wire having high contrast may be spirally wound around at least one of the first stent main body and the second stent main body.
- a stent having a large surface area and excellent shape followability and diameter reduction property to a vascular structure.
- FIG. 17A is a cross-sectional view taken along the line s4-s4 of FIG. 17A.
- FIG. 18A is a cross-sectional view taken along the line s5-s5.
- FIG. 18A is a cross-sectional view taken along the line s6-s6.
- FIG. 19A is a cross-sectional view taken along the line s7-s7.
- 19A is a cross-sectional view taken along the line s8-s8.
- FIG. 5 is a side view schematically showing another configuration in which the distal end portion of the stent 1 and the distal end shaft 3 are connected in the first connection form. It is a side view schematically showing the structure which connected the distal end portion of the stent 1 and the distal end shaft 3 by the 4th connection form.
- FIG. 5 is a side view schematically showing another configuration on the distal side of the stent 1. It is a schematic side view of the stent 1F of the eleventh embodiment.
- FIG. 2 is a cross-sectional view taken along the line s9-s9 of FIG. 24.
- the proximal side close to the practitioner is the LD1 side
- the distal side away from the practitioner is the LD2 side
- the direction orthogonal to the axial direction LD is the diameter. It will be described as a direction RD.
- the direction in which the cells are spread is described as the circumferential direction (circumferential direction OD).
- the circumferential direction includes, in addition to the radial RD, a direction inclined with respect to the radial RD.
- FIG. 1 is a schematic side view of the stent 1 of the first embodiment.
- FIG. 2 is a schematic perspective view of the stent 1 shown in FIG.
- FIG. 3A is a development view in which a part of the first stent main body 10 of the first embodiment is virtually spread out in a plane.
- FIG. 3B is a development view in which a part of the second stent main body 20 of the first embodiment is virtually spread out in a plane.
- FIG. 3C is a development view in which a part of the stent 1 of the first embodiment is virtually spread out in a plane.
- FIG. 4A is a diagram illustrating an outer diameter D1 of a single first stent main body 10.
- FIG. 4B is a diagram illustrating an outer diameter D2 of a single second stent main body 20.
- FIG. 5 is a diagram illustrating a procedure for interpolating the second stent main body 20 into the first stent main body 10.
- FIG. 6 is a cross-sectional view taken along the line s1-s1 of FIG.
- the struts of the first stent main body 10 are shown in black in order to easily distinguish the first stent main body 10 from the second stent main body 20, and the second stent main body is shown. Twenty struts are shown on a white background.
- the “cell” means a portion surrounded by a wire-shaped material forming a mesh pattern.
- the "cell” includes not only a form in which the shape and size of the stent body are the same, but also a form in which the shape and size are different.
- the "strut” refers to an elongated strip-shaped portion made of the wire-shaped material.
- the opening of a cell is also referred to as a “vacancy portion”, and the portion where struts of adjacent cells are connected or overlapped with each other is also referred to as an “intersection portion”.
- the points where the struts intersect are also called "intersections”.
- the intersecting portion may have a certain range (area).
- the intersection may include a plurality of intersections.
- the stent 1 of the first embodiment is used, for example, to expand a narrowed or occluded blood vessel by being housed (inserted) in a catheter (not shown) and extruded outward from the catheter in a blood vessel lumen to expand. Used in. As shown in FIGS. 1 and 2, the stent 1 is configured to have a substantially cylindrical shape in a expanded state. Although not shown, the stent 1 has an elongated cylindrical shape in a reduced diameter state. Further, in the stent 1, the pusher wire 2 is connected to the end of the proximal LD1 and the distal end shaft 3 is connected to the end of the distal LD2.
- connection method between the proximal end of the stent 1 and the pusher wire 2 examples include welding, UV adhesion, infiltration of silver wax, etc., but the connection method used in general medical equipment is used. If there is, there is no particular limitation.
- the connection form between the proximal end of the stent 1 and the pusher wire 2 will be described later.
- the pusher wire 2 is a member operated by the practitioner when moving the stent 1.
- the practitioner advances the stent 1 in the catheter or blood vessel by pushing or pulling the pusher wire 2 through an operation unit (not shown) connected to the proximal side LD1 of the pusher wire 2. It can be retracted or retracted.
- the practitioner can temporarily place or recover the stent 1 at the lesion site by advancing or rearwarding the pusher wire 2.
- the distal end shaft 3 is a member that serves as a marker for confirming the position of the distal side X2 of the stent 1 in an X-ray transmission image. It is formed.
- the material having high contrast medium means a material in which radiation such as X-rays is opaque or has a low radiation transmittance.
- the distal end shaft 3 may be made of the same material as the pusher wire 2, for example.
- the stent 1 includes a first stent main body 10 and a second stent main body 20.
- the first stent body 10 is a substantially cylindrical structure arranged outside the stent 1.
- the second stent body 20 is a substantially cylindrical structure arranged inside the first stent body 10.
- the stent 1 is configured as a two-layered stent in which the second stent body 20 is interpolated into the first stent body 10. In a state where the second stent body 20 is inserted into the first stent body 10, the first stent body 10 and the second stent body 20 are not connected to each other in the radial direction.
- first stent body 10 and the second stent body 20 are connected via the pusher wire 2 or via the distal end shaft 3, but with the pusher wire 2 and the distal end shaft 3. There is no connection between them. Therefore, the stent 1 can independently deform the first stent body 10 and the second stent body 20 on the same layer.
- a second stent body 20 having a larger outer diameter than the first stent body 10 is inserted into the first stent body 10 in a reduced diameter state. It is made.
- the inserted second stent main body 20 is in a state of constantly pressing the first stent main body 10 to the outside of the radial RD. Therefore, the stent 1 strengthens the first stent body 10 and the second stent body 20 while maintaining a state in which the first stent body 10 and the second stent body 20 can be independently deformed on the same layer. Can be brought into close contact with.
- the ends of the first stent body 10 and the second stent body 20 are gradually reduced in diameter toward the pusher wire 2 side, and the diameter of the first stent body 10 and the second stent body 20 is gradually reduced toward the pusher wire 2. It is connected.
- the ends of the first stent body 10 and the second stent body 20 are gradually reduced in diameter toward the distal end shaft 3 and with the distal end shaft 3. It is connected.
- the first stent main body 10 has a plurality of outer cells (first cells) 12 composed of struts 11 arranged in a frame shape, which are spread in the radial direction (circumferential direction) RD. Further, in the first stent main body 10, a plurality of outer cells 12 spread in the radial direction RD are continuously arranged in the axial direction LD. That is, the first stent main body 10 has a mesh pattern in which a plurality of outer cells 12 composed of struts 11 arranged in a frame shape are spread in the radial direction RD and continuous in the axial direction LD. A hole portion 13 is formed in the outer cell 12. Further, the adjacent outer cells 12 are connected to each other at the intersection portion 14.
- a plurality of inner cells (second cells) 22 composed of struts 21 arranged in a frame shape are spread in the radial direction (circumferential direction) RD. Further, in the second stent main body 20, the plurality of inner cells 22 spread in the radial direction RD are continuously arranged in the axial direction LD. That is, the second stent main body 20 has a mesh pattern in which a plurality of inner cells 22 made of struts 21 arranged in a frame shape are spread in the radial direction RD and continuous in the axial direction LD. A hole portion 23 is formed in the inner cell 22. Further, the adjacent inner cells 22 are connected to each other at the intersection portion 24.
- the outer cell 12 constituting the first stent main body 10 and the inner cell 22 constituting the second stent main body 20 have the same size as an example. It is configured to have a shape and an arrangement. That is, in the first embodiment, the mesh pattern of the first stent main body 10 shown in FIG. 3A and the mesh pattern of the second stent main body 20 shown in FIG. 3B are substantially the same pattern. The mesh pattern of the first stent main body 10 and the mesh pattern of the second stent main body 20 may be different.
- the first stent body 10 and the second stent body 20 have the inner cell 22 (second stent body 20) in the hole portion 13 of the outer cell 12 (first stent body 10).
- the intersection portion 24 of the inner cell 22 is arranged in the hole portion 13 of the outer cell 12
- the intersection portion 24 of one inner cell 22 is provided in the hole portion 13 of one outer cell 12. They are stacked so that they are arranged.
- the density of the mesh pattern becomes high in the entire stent, so that the surface area of the stent 1 can be further increased.
- the ratio of the non-pore portion to the unit area of the surface of the portion where the first stent main body 10 and the second stent main body 20 overlap is 5 to 50%.
- the relationship between the outer diameter D1 of the single first stent main body 10 and the outer diameter D2 of the single second stent main body 20 is D1 ⁇ D2. Is set to be. Therefore, according to the procedure indicated by the arrow in FIG. 5, the diameter of the second stent body 20 having a larger outer diameter than that of the first stent body 10 is reduced to the second stent body 20A, and this is inserted into the first stent body 10.
- the self-expanding force of the second stent body 20 makes it possible to fabricate a stent 1 having a two-layer structure in which the second stent body 20 is in close contact with the inside of the first stent body 10.
- FIG. 5 shows only an annular cell row spread in the circumferential direction in each stent body for easy understanding.
- the first stent body 10 and the second stent body 20 are in the radial RD due to the self-expanding force of the second stent body 20 described above, as shown in FIG. It will be in close contact with each other without any gaps. Therefore, in the axial LD of the stent 1 (see FIG. 1), the problem that the positions of the first stent main body 10 and the second stent main body 20 are relatively displaced is unlikely to occur.
- the second stent body 20 inserted into the first stent body 10 in a reduced diameter state itself becomes a self-expanding body (elastic body). Therefore, the second stent main body 20 is always in a state of pressing the first stent main body 10 toward the outside of the radial RD. Therefore, even if the first stent main body 10 and the second stent main body 20 are not connected to each other in the radial direction, the first stent main body 10 and the second stent main body 20 can be brought into close contact with each other more firmly.
- the first stent main body 10 and the second stent main body 20 are not connected to each other in the radial direction, the first stent main body 10 and the second stent main body 20 are independently connected to each other on the same layer. It is possible to maintain a state in which it can be deformed. Further, the stent 1 having a two-layer structure has an expansion force obtained by adding the expansion force of the outer first stent body 10 and the expansion force of the inner second stent body 20. Therefore, even if the surface area is the same, the expansion force can be increased as compared with the one-layer structure stent.
- the material constituting the stent 1 (first stent main body 10, second stent main body 20), a material having high rigidity of the material itself and high biocompatibility is preferable.
- Such materials include, for example, titanium, nickel, stainless steel, platinum, gold, silver, copper, iron, chromium, cobalt, aluminum, molybdenum, manganese, tantalum, tungsten, niobium, magnesium, calcium or alloys containing these.
- the stent 1 is particularly preferably made of a material having superelastic properties, such as a nickel titanium (Ni—Ti) alloy.
- the mesh pattern of the first stent main body 10 and the second stent main body 20 can be produced, for example, by laser processing a substantially cylindrical tube made of the above material.
- polyolefins such as PE and PP
- synthetic resin materials such as polyamide, polyvinyl chloride, polyphenylene sulfide, polycarbonate, polyether, and polymethylmethacrylate
- biodegradable resins biodegradable polymers
- PLA polylactic acid
- PHB polyhydroxybutyrate
- PGA polyglycolic acid
- poly ⁇ caprolactone poly ⁇ caprolactone
- the alloys include Ni—Ti alloy, Cu—Mn alloy, Cu—Cd alloy, Co—Cr alloy, Cu—Al—Mn alloy, Au—Cd—Ag alloy, Ti—Al—V alloy, magnesium and Zr, Y. , Ti, Ta, Nd, Nb, Zn, Ca, Al, Li, Mn and the like.
- a non-biodegradable resin can be used as the material of the stent 1.
- the stent 1 may be formed of any material as long as it has biocompatibility.
- the stent 1 may contain a drug.
- the term "stent 1 containing a drug” means that the stent 1 carries the drug so that the drug can be eluted.
- the drug is not limited, but for example, a physiologically active substance can be used.
- Physiologically active substances include agents that suppress intimal thickening, anticancer agents, immunosuppressants, antibiotics, antirheumatic agents, antithrombotic agents, HMG-CoA reductase inhibitors, ACE inhibitors, calcium antagonists, anti-high fats.
- Hemologic agents include muscle growth inhibitor, anti-inflammatory drug, interferon and the like, and a plurality of these drugs can also be used.
- the stent 1 having a two-layer structure can be produced by interpolating the second stent body 20 into the first stent body 10.
- the two-layer structure stent 1 is radially reduced in diameter from the state shown in FIG. 1 and is housed in the lumen of a catheter (not shown). When the stent 1 housed in the catheter is pushed out, the shape as shown in FIG. 1 is restored.
- the stent 1 By forming the stent 1 with an elastic material such as a superelastic alloy or a shape memory alloy, the above-mentioned shape recovery function can be obtained.
- the production of the stent 1 is not limited to laser processing, and can be produced by, for example, another method such as cutting processing.
- the stent 1 of the first embodiment has a two-layer structure including a first stent main body 10 and a second stent main body 20, and a second stent main body is formed in a hole portion 13 of an outer cell 12 of the first stent main body 10.
- the intersections 24 of the cells 22 of the 20 are overlapped so as to be arranged (see FIG. 3C).
- the first stent body 10 and the second stent body 20 are not connected to each other in the radial direction in a state where the second stent body 20 is inserted into the first stent body 10. ..
- the first stent main body 10 and the second stent main body 20 can be deformed independently on the same layer, and an interference state that hinders mutual deformation is unlikely to occur. Therefore, the stent as a whole You can increase the flexibility.
- the stent 1 of the first embodiment is excellent in shape followability to the vascular structure because the bending rigidity does not become too high even if the surface area is increased.
- the stent 1 of the first embodiment since the first stent main body 10 and the second stent main body 20 can be independently deformed on the same layer, the diameter of the stent 1 is reduced. If so, the diameters of the stents in each layer can be reduced without interfering with each other. As described above, since the stent 1 of the first embodiment has excellent diameter reduction property, it can be easily stored in a catheter having a smaller diameter than a stent having a large surface area with a mesh pattern having a single layer structure. can.
- the stent 1 of the first embodiment has a large surface area and is excellent in shape followability to the vascular structure and diameter reduction property.
- the wire-shaped material is woven into the stent to have a two-layer structure, the wire-shaped material is stretched between the layers, so that each braided layer cannot be independently deformed on the same layer. Therefore, even if the surface area is increased by the stent having a two-layer structure by crocheting, it is difficult to obtain the shape followability and the diameter reduction property as in the stent 1 of the first embodiment.
- FIG. 7 is a diagram illustrating an internal state when the stent 1 is bent.
- FIG. 7 schematically shows the internal state when the stent 1 is temporarily placed in a bent blood vessel.
- the arrow A1 drawn inside the stent 1 indicates the direction in which the self-expanding force (pressure) of the second stent body 20 acts.
- the second stent main body 20 is in a state of constantly pressing the first stent main body 10 outward by a self-expanding force.
- kink means that the cross section of the stent is crushed into a substantially elliptical shape.
- a force for buckling the stent 1 is applied as shown by an arrow A2 in FIG. 7. This force is particularly large inside the flexion, but acts so that the self-expanding force of the second stent body 20 indicated by the arrow A1 opposes the force of the arrow A2. Therefore, even if the bending radius of the stent 1 becomes small in the bent blood vessel, the stent 1 can be made difficult to break.
- the vascular lumen is expanded, so that the patency of the lesion site can be ensured. Then, by collecting the stent 1 after a predetermined period of time without indwelling it for a long period of time, restenosis or reocclusion may occur in the blood vessel after the stent is indwelled, or complications such as thrombosis may occur. Can be suppressed. Further, since the stent 1 of the first embodiment has excellent shape followability, it is difficult for the blood vessel to become linear as in the case of expanding the blood vessel lumen with a balloon.
- the stent 1 of the first embodiment is less likely to cause hemorrhagic complications due to rupture or infarction, such as damage to blood vessels and perforating branches of surrounding blood vessels.
- the stent 1 of the first embodiment can be used not only for stenosis caused in the lumen of blood vessels but also for stenosis caused in organs of the digestive system such as the esophagus and the large intestine. That is, the stent 1 of the first embodiment can be used for all living tissues having a luminal structure in the body.
- the stent 1 of the first embodiment can also be used for the treatment of cerebral vasospasm in which the cerebral blood vessels are narrowed due to the spasm.
- a balloon is used to dilate a blood vessel.
- treatment with a balloon may cause vascular occlusion or damage to blood vessels.
- the stent 1 of the first embodiment is excellent in shape followability as described above, it is difficult for the blood vessel to become linear as in the case of expanding the blood vessel lumen with a balloon.
- the stent 1 of the first embodiment is unlikely to cause hemorrhagic complications due to rupture or infarction such as damage to blood vessels and perforating branches of surrounding blood vessels even when used for the treatment of cerebral vasospasm. It should be noted that the stent of another embodiment described later also has the same effect as the stent 1 of the first embodiment.
- the stent 1A of the second embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the first embodiment.
- other configurations are the same as those of the first embodiment. Therefore, in the second embodiment, the entire illustration of the stent 1A is omitted.
- the same reference numerals are appropriately added to the ends (last two digits) of the parts that perform the same functions as those of the first embodiment, and duplicate explanations are appropriately omitted.
- FIG. 8A is a developed view of the first stent main body 110 of the second embodiment virtually expanded in a plane.
- FIG. 3B is a developed view of the second stent main body 120 of the second embodiment virtually spread out in a plane.
- FIG. 8C is a development view in which the stent 1A of the second embodiment is virtually spread out in a plane.
- the circumferential OD is inclined with respect to the radial RD.
- a plurality of outer cells (first cells) 112 are spread in the circumferential direction OD.
- a plurality of outer cells 112 spread in the circumferential direction OD are continuously arranged in the axial direction LD. That is, the first stent main body 110 has a mesh pattern in which a plurality of outer cells 112 are spread in the circumferential direction OD and are continuous in the axial direction LD.
- the outer cell 112 includes two struts 111 arranged on the long side and two struts 111 arranged on the short side.
- the struts 111 on the long side and the struts 111 on the short side are diagonally connected to each other so as to form a substantially parallelogram when spread out in a plane.
- a hole portion 113 is formed in the outer cell 112. Further, the adjacent outer cells 112 are connected to each other at the intersection portion 114.
- a plurality of inner cells (second cells) 122 are spread in the circumferential direction OD.
- the plurality of inner cells 122 spread in the circumferential direction OD are continuously arranged in the axial direction LD. That is, the second stent main body 120 has a mesh pattern in which a plurality of inner cells 122 are spread in the circumferential direction OD and are continuous in the axial direction LD.
- the inner cell 122 includes two struts 121 arranged on the long side and two struts 121 arranged on the short side.
- the strut 121 on the long side and the strut 121 on the short side are diagonally connected to each other so as to form a substantially parallelogram when expanded in a plane.
- a hole portion 123 is formed in each inner cell 122. Further, the adjacent inner cells 122 are connected to each other at the intersection portion 124.
- the plurality of outer cells 112 constituting the first stent main body 110 and the plurality of inner cells 122 constituting the second stent main body 120 have the same size, shape, and arrangement as an example. It is configured to be. That is, in the second embodiment, the mesh pattern of the first stent main body 110 shown in FIG. 8A and the mesh pattern of the second stent main body 120 shown in FIG. 8B are substantially the same pattern. The mesh pattern of the first stent main body 110 and the mesh pattern of the second stent main body 120 may be different.
- the first stent main body 110 and the second stent main body 120 are formed in the hole portion 113 of the outer cell 112 (first stent main body 110) and the inner cell 122.
- the intersection portions 124 of (second stent body 120) are overlapped so as to be arranged.
- the intersection portion 124 of the inner cell 122 is arranged in the hole portion 113 of the outer cell 112
- the intersection portion 124 of one inner cell 122 is arranged in the hole portion 113 of one outer cell 112. They are stacked so that they are arranged.
- the stent 1B of the third embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the first embodiment.
- other configurations are the same as those of the first embodiment. Therefore, in the third embodiment, the entire illustration of the stent 1B is omitted.
- the same reference numerals are appropriately added to the ends (last two digits) of the parts that perform the same functions as those of the first embodiment, and duplicate explanations are appropriately omitted.
- FIG. 9A is a developed view of the first stent main body 210 of the third embodiment virtually spread out in a plane.
- FIG. 9B is a developed view of the second stent main body 220 of the third embodiment virtually spread out in a plane.
- FIG. 9C is a development view in which the stent 1B of the third embodiment is virtually spread out in a plane.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- a plurality of outer cells (first cells) 212 are spread in the radial (circumferential) RD.
- the plurality of outer cells 212 spread in the radial RD are continuously arranged in the axial LD. That is, the first stent main body 210 has a mesh pattern in which a plurality of outer cells 212 are spread in the radial direction RD and are continuous in the axial direction LD.
- the outer cell 212 has a set of struts (first struts) 211 (hereinafter, also referred to as “211a-211b”) in the ring direction CD1 and a space (vacancy portion 213) between the struts 211 and the struts 211.
- the strut (first strut) 211 to be arranged is provided.
- the outer cell 212 includes two struts 211 which are arranged at intervals (pore portions 213) so as to face each other in the ring direction CD2.
- the ratio of the interval L1 of the struts 211a-221b of one set and the interval L2 of the vacancy portion 213 is, for example, about 1: 3 to 1:10.
- the struts 211 disposed away from the ring direction CD1 with respect to the set of struts 211 are with one of the struts 211a of the set of struts 211 in the other outer cell 212 adjacent to the ring direction CD1.
- a hole portion 213 is formed in the outer cell 212. Further, in each outer cell 212 arranged along the ring direction CD1, a set of struts 211a-211b and a strut 211 extending along the ring direction CD1 are connected at the intersecting portion 214.
- a plurality of inner cells (second cells) 222 are spread in the radial direction (circumferential direction) RD.
- the plurality of inner cells 222 spread in the radial direction RD are continuously arranged in the axial direction LD. That is, the second stent main body 220 has a mesh pattern in which a plurality of inner cells 222 are spread in the radial direction RD and are continuous in the axial direction LD.
- the inner cell 222 is spaced from a set of struts (second struts) 221 (hereinafter, also referred to as “221a-221b”) and the set of struts 221 (vacant portion 223) in the ring direction CD1. It comprises one strut (second strut) 221 to be arranged. Further, the inner cell 222 includes two struts 221 arranged at intervals (vacancy portions 213) so as to face each other in the ring direction CD2. The ratio of the interval L3 of the set of struts 221a-221b to the interval L4 of the vacant portion 223a is, for example, about 1: 3 to 1:10.
- the struts 221 disposed away from the ring direction CD1 with respect to one set of struts 221 are with one of the struts 221a of the set of struts 221 in the other inner cell 222 adjacent to the ring direction CD1.
- a hole portion 223 is formed in the inner cell 222. Further, in each inner cell 222 arranged along the ring direction CD1, a set of struts 221a-221b and a strut 221 extending along the ring direction CD1 are connected at an intersecting portion 224.
- the plurality of outer cells 212 constituting the first stent main body 210 and the plurality of inner cells 222 constituting the second stent main body 220 have the same size, shape, and arrangement as an example. It is configured to be. That is, in the third embodiment, the mesh pattern of the first stent main body 210 shown in FIG. 9A and the mesh pattern of the second stent main body 220 shown in FIG. 9B are substantially the same pattern. The mesh pattern of the first stent main body 210 and the mesh pattern of the second stent main body 220 may be different.
- the first stent main body 210 and the second stent main body 220 are formed in the hole portion 213 of the outer cell 212 (first stent main body 210) and the inner cell 222 (second stent main body).
- the intersecting portions 224 of 220) are overlapped so as to be arranged.
- the crossing portion 224 of the inner cell 222 is arranged in the hole portion 213 of the outer cell 212
- the crossing portion 224 of one inner cell 222 is arranged in the hole portion 213 of one outer cell 212. They are stacked so that they are arranged.
- FIG. 10A is a cross-sectional view of the stent 1A of the second embodiment described above when it is expanded in a blood vessel.
- FIG. 10A shows a hypothetical cross section of a stent 1A dilated in a blood vessel, for example, diagonally cut along the s2-s2 line of FIG. 8C.
- FIG. 10B is a cross-sectional view of the stent 1B of the third embodiment when it is expanded in a blood vessel.
- FIG. 10B shows a hypothetical cross section of a stent 1B dilated in a blood vessel, for example, diagonally cut along the s3-s3 line of FIG. 9C.
- the strut 111 constituting the outer cell 112 of the first stent body 110 and the inner cell 122 of the second stent body 120 are obtained.
- the constituent struts 121 are alternately arranged in the circumferential direction. Therefore, the open cross section of the stent 1A has many irregularities along the circumferential direction and a large step.
- the "circumferential direction” means the circumferential direction when the stent is viewed from the axial direction (central axial direction).
- FIG. 10B when the stent 1B of the third embodiment is expanded inside the blood vessel BV, a set of struts 211 (211a-211b: FIG. 9A) constituting the outer cell 212 of the first stent main body 210 is formed. (See) and a set of struts 221 (221a-221b: see FIG. 9B) constituting the inner cell 222 of the second stent main body 220 are alternately arranged along the circumferential direction. Therefore, the open cross section of the stent 1B has a shape with few irregularities and gentle steps along the circumferential direction.
- the stent 1B of the third embodiment since the stent 1B of the third embodiment has less unevenness in the opening cross section, it can be expanded in a shape closer to a circle. Therefore, according to the stent 1B of the third embodiment, the inner wall of the narrowed blood vessel BV can be expanded more uniformly.
- the stent 1C of the fourth embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the third embodiment. Therefore, in the description and drawings of the fourth embodiment, the same reference numerals are given to the portions having the same functions as those of the third embodiment (last two digits), and duplicate explanations are appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- FIG. 11 is a schematic perspective view of the stent 1C of the fourth embodiment.
- FIG. 12A is a developed view of the first stent main body 310 of the fourth embodiment virtually spread out in a plane.
- FIG. 12B is a development view of the second stent main body 320 of the fourth embodiment virtually spread out in a plane.
- FIG. 12C is a developed view of the stent 1C of the fourth embodiment virtually spread out in a plane.
- the stent 1C of the fourth embodiment includes a first stent main body 310 and a second stent main body 320.
- the first stent body 310 is a substantially cylindrical structure arranged outside the stent 1C.
- the second stent body 320 is a substantially cylindrical structure arranged inside the first stent body 310.
- the stent 1C has a double structure in which the second stent body 320 is interpolated into the first stent body 310.
- the pusher wire 2 and the distal end shaft 3 shown in FIG. 1 are not shown.
- the first stent main body 310 has a plurality of outer cells (first cells) 312 spread in the radial (circumferential) RD.
- first cells outer cells
- a plurality of outer cells 312 spread in the radial direction RD are continuously arranged in the axial direction LD. That is, the first stent main body 310 has a mesh pattern in which a plurality of outer cells 312 are spread in the radial direction RD and continuous in the axial direction LD.
- the outer cell 312 is spaced from a set of struts (first struts) 311 (hereinafter, also referred to as “311a-311b”) and the set of struts 311 (vacant portion 313) in the ring direction CD1. It comprises one strut (first strut) 311 to be arranged. Further, the outer cell 312 includes two struts 311 arranged at intervals (pore portions 313) so as to face each other in the ring direction CD2.
- the struts 311 disposed away from the ring direction CD1 with respect to one set of struts 311 are with one strut 311a of the set of struts 311 in the other outer cell 312 adjacent to the ring direction CD1.
- a hole portion 313 is formed in the outer cell 312. Further, in each outer cell 312 arranged along the ring direction CD1, a set of struts 311a-311b and a strut 311 extending along the ring direction CD1 are connected at a substantially S-shaped first crossing portion 314. ing.
- the first crossing portion 314 is deformed so as to be stretched in the radial RD when the expanded stent 1C is bent into a substantially U shape (see FIG. 7). Therefore, the outer cell 312 spread in the radial direction RD can be bent more flexibly. As shown in FIG. 12A, in the first stent body 310, each first crossing portion 314 is arranged parallel to the radial RD.
- the second stent main body 320 has a plurality of inner cells (second cells) 322 spread in the radial direction (circumferential direction) RD.
- the plurality of inner cells 322 spread in the radial direction RD are continuously arranged in the axial direction LD. That is, the second stent main body 320 has a mesh pattern in which a plurality of inner cells 322 are spread in the radial direction RD and are continuous in the axial direction LD.
- the inner cell 322 has a set of struts (second struts) 321 (hereinafter, also referred to as “321a-321b”) in the ring direction CD1 and a space (vacancy portion 323) between the set of struts 321 and the struts 321. It comprises one strut (second strut) 321 to be arranged. Further, the inner cell 322 includes two struts 321 arranged at intervals (pore portions 323) so as to face each other in the ring direction CD2.
- the struts 321 arranged apart from the ring direction CD1 with respect to one set of struts 321 are with one of the struts 321a of the set of struts 321 in the other inner cell 322 adjacent to the ring direction CD1.
- a hole portion 323 is formed in the inner cell 322. Further, in each inner cell 322 arranged along the ring direction CD1, one set of struts 321a-321b and the struts 321 extending along the ring direction CD1 are connected at a substantially S-shaped second crossing portion 324. ing.
- the second crossing portion 324 is an inner cell spread in the radial RD because it is deformed so as to be stretched in the radial RD when the expanded stent 1C is bent into a substantially U shape (see FIG. 7).
- the 322 can be bent more flexibly.
- each second crossing portion 324 is arranged parallel to the radial RD.
- the plurality of outer cells 312 constituting the first stent main body 310 and the plurality of inner cells 322 constituting the second stent main body 320 have the same size, shape, and arrangement as an example. It is configured to be. That is, in the fourth embodiment, the mesh pattern of the first stent main body 310 shown in FIG. 12A and the mesh pattern of the second stent main body 320 shown in FIG. 12B are substantially the same pattern. The mesh pattern of the first stent main body 310 and the mesh pattern of the second stent main body 320 may be different.
- the first stent main body 310 and the second stent main body 320 have the inner cell 322 (second stent main body 320) in the hole portion 313 of the outer cell 312 (first stent main body 310).
- Second intersection 324 are overlapped so as to be arranged.
- the second intersecting portion 324 of the inner cell 322 is arranged in the hole portion 313 of the outer cell 312
- the second of the inner cell 322 is located in the hole portion 313 of one outer cell 312.
- the intersecting portions 324 are overlapped so as to be arranged.
- each outer cell 312 of the first stent main body 310 is connected at the first crossing portion 314 having a substantially S shape in the ring direction CD1.
- each inner cell 322 of the second stent body 320 is connected at a substantially S-shaped second crossing portion 324 in the annular direction CD2.
- the first intersecting portion 314 of the first stent main body 310 and the second intersecting portion 324 of the second stent main body 320 are arranged in parallel with the radial RD as shown in FIG. 12C. According to this configuration, when the expanded stent 1C is bent into a substantially U shape (see FIG. 7), the outer cell 312 and the inner cell 322 spread in the radial RD can be bent more flexibly. Therefore, the shape followability of the stent 1C can be further improved.
- the stent 1D of the fifth embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the third embodiment. Therefore, in the description and drawings of the fifth embodiment, the same reference numerals are given to the portions having the same functions as those of the third embodiment (last two digits), and duplicate explanations are appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- FIG. 13 is a schematic perspective view of the stent 1D of the fifth embodiment.
- FIG. 14A is a developed view of the first stent main body 410 of the fifth embodiment virtually spread out in a plane.
- FIG. 14B is a development view of the second stent main body 420 of the fifth embodiment virtually spread out in a plane.
- FIG. 14C is a developed view of the stent 1D of the fifth embodiment virtually spread out in a plane.
- the stent 1D of the fifth embodiment includes a first stent main body 410 and a second stent main body 420.
- the first stent body 410 is a substantially cylindrical structure arranged outside the stent 1D.
- the second stent body 420 is a substantially cylindrical structure arranged inside the first stent body 410.
- the stent 1D has a double structure in which the second stent body 420 is interpolated into the first stent body 410.
- the pusher wire 2 and the distal end shaft 3 shown in FIG. 1 are not shown.
- a plurality of outer cells (first cells) 412 are spread in the radial direction (circumferential direction) RD.
- the plurality of outer cells 412 spread in the radial RD are continuously arranged in the axial LD. That is, the first stent main body 410 has a mesh pattern in which a plurality of outer cells 412 are spread in the radial direction RD and continuous in the axial direction LD.
- the configuration of the first stent main body 410 is substantially the same as that of the first stent main body 310 of the fourth embodiment, and therefore detailed description thereof will be omitted.
- the struts 411, 411a, 411b, the outer cell 412, the hole portion 413, and the first crossing portion 414 are the struts 311 and 311a of the first stent body 310 of the fourth embodiment. , 311b, the outer cell 312, the hole portion 313, and the first intersection portion 314.
- each outer cell 312 of the first stent body 410 is connected at the first crossing portion 414 in the annular direction CD1.
- a plurality of inner cells (second cells) 422 are spread in the radial (circumferential) RD.
- the plurality of inner cells 422 spread in the radial RD are continuously arranged in the axial LD. That is, the second stent main body 420 has a mesh pattern in which a plurality of inner cells 422 are spread in the radial direction RD and are continuous in the axial direction LD.
- the inner cell 422 has a set of struts (second struts) 421 (hereinafter, also referred to as “421a-421b”) in the ring direction CD2 and a space (vacancy portion 423) from the set of struts 421. It comprises one strut (second strut) 421 to be arranged. Further, the inner cell 422 includes two struts 421 arranged at intervals (pore portions 423) so as to face each other in the ring direction CD2.
- the struts 421 disposed distantly from the ring direction CD2 with respect to the set of struts 421 are with one of the struts 421a of the set of struts 421 in the other inner cells 422 adjacent to the ring direction CD2.
- a hole portion 423 is formed in the inner cell 422. Further, in each inner cell 422 arranged along the ring direction CD2, a set of struts 421a-421b and a strut 421 extending along the ring direction CD1 are connected at a substantially S-shaped second crossing portion 424. ing. The second crossing portion 424 deforms so as to be stretched in the radial RD when the expanded stent 1D is bent into a substantially U shape (see FIG. 7), so that the inner cell spread in the radial RD is spread. The 422 can be bent more flexibly.
- each inner cell 422 of the second stent body 420 is connected at the second crossing portion 424 in the annular direction CD2. Therefore, in the stent 1D of the fifth embodiment, the annular direction CD1 to which each outer cell 412 of the first stent body 410 is connected at the first crossing portion 414 (see FIG. 14A) and each inner cell of the second stent body 420.
- the annular direction CD2 to which the 422 is connected at the second crossing portion 424 is axisymmetric in the radial RD.
- Second intersection 424 is overlapped so as to be arranged. Specifically, in a configuration in which the second intersecting portion 424 of the inner cell 422 is arranged in the hole portion 413 of the outer cell 412, the second of the inner cell 422 is arranged in the hole portion 413 of one outer cell 412. The intersecting portions 424 are stacked so as to be arranged.
- the first intersecting portion 414 of the outer cell 412 and the second intersecting portion 424 of the inner cell 422 are arranged in parallel with the radial RD and are arranged alternately. Even when the cell shape of each stent body is configured as shown in FIGS. 14A and 14B, by overlapping the mesh patterns of each stent body as described above, the density of the mesh pattern becomes high in the entire stent, so that the stent 1D The surface area of the stent can be increased.
- each outer cell 412 of the first stent main body 410 is connected at the first crossing portion 414 having a substantially S shape in the ring direction CD1.
- each inner cell 422 of the second stent body 420 is connected at the second crossing portion 424 having a substantially S-shape in the ring direction CD2.
- the first intersecting portion 414 of the first stent main body 410 and the second intersecting portion 424 of the second stent main body 420 are arranged in parallel to the radial RD as shown in FIG. 14C. According to this configuration, when the expanded stent 1D is bent into a substantially U shape (see FIG. 7), the outer cell 412 and the inner cell 422 spread in the radial RD can be bent more flexibly. Therefore, the shape followability of the stent 1D can be further improved.
- the stent 1E of the sixth embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the third embodiment. Therefore, in the description and drawings of the sixth embodiment, the same reference numerals are given to the portions having the same functions as those of the third embodiment (last two digits), and duplicate explanations are appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- FIG. 15 is a schematic perspective view of the stent 1E of the sixth embodiment.
- FIG. 16A is a development view of the first stent main body 510 of the sixth embodiment virtually spread out in a plane.
- FIG. 16B is a developed view of the second stent main body 520 of the sixth embodiment virtually spread out in a plane.
- FIG. 16C is a developed view of the stent 1E of the sixth embodiment virtually spread out in a plane.
- the circumferential OD is inclined with respect to the radial RD.
- the stent 1E of the sixth embodiment includes a first stent main body 510 and a second stent main body 520.
- the first stent body 510 is a substantially cylindrical structure arranged outside the stent 1E.
- the second stent body 520 is a substantially cylindrical structure arranged inside the first stent body 510.
- the stent 1E of the sixth embodiment has a double structure in which the second stent body 520 is interpolated into the first stent body 510.
- the pusher wire 2 and the distal end shaft 3 shown in FIG. 1 are not shown.
- the first stent main body 510 has a plurality of outer cells (first cells) 512 spread in the circumferential direction OD.
- first cells outer cells
- a plurality of outer cells 512 spread in the circumferential direction OD are continuously arranged in the axial direction LD. That is, the first stent main body 510 has a mesh pattern in which a plurality of outer cells 512 are spread in the circumferential direction OD and are continuous in the axial direction LD.
- the outer cell 512 is spaced from a set of struts (first struts) 511 (hereinafter, also referred to as “511a-511b”) and the set of struts 511 (vacant portion 513) in the ring direction CD1. It comprises one strut (first strut) 511 to be arranged. Further, the outer cell 512 includes two struts 511 which are arranged at intervals (pore portions 513) so as to face each other in the ring direction CD2.
- the struts 511 located apart from the ring-direction CD1 with respect to the set of struts 511 are with one strut 511a of the set of struts 511 in the other outer cell 512 adjacent to the ring-direction CD1.
- a set of struts 511a-511b arranged in the ring direction CD1 and one strut 511 constitute the long side of the outer cell 512. Further, the two struts 511 arranged in the ring direction CD2 constitute the short side of the outer cell 512.
- the struts 511a-511b and 511 on the long side and the struts 511 on the short side are diagonally connected to each other so as to form a substantially parallelogram when spread out in a plane.
- a hole portion 513 is formed in the outer cell 512. Further, in each outer cell 512 arranged along the ring direction CD1, a set of struts 511a-511b and a strut 511 extending along the ring direction CD1 are connected at a substantially S-shaped first crossing portion 514. ing. The first crossing portion 514 deforms so as to be stretched in the radial RD when the expanded stent 1E is bent into a substantially U shape (see FIG. 7). Therefore, the outer cell 512 spread in the radial direction RD can be bent more flexibly. As shown in FIG. 16A, in the first stent body 510, each first crossing portion 514 is arranged parallel to the circumferential OD.
- the second stent main body 520 has a plurality of inner cells (second cells) 522 spread in the circumferential OD.
- the plurality of inner cells 522 spread in the circumferential direction OD are continuously arranged in the axial direction LD. That is, the second stent main body 520 has a mesh pattern in which a plurality of inner cells 522 are spread in the circumferential direction OD and continuous in the axial direction LD.
- the inner cell 522 is spaced from a set of struts (second struts) 521 (hereinafter, also referred to as “521a-521b”) and the set of struts 521 (vacant portion 523) in the ring direction CD1. It comprises one strut (second strut) 521 to be arranged. Further, the inner cell 522 includes two struts 521 arranged at intervals (vacancy portions 523) so as to face each other in the ring direction CD2.
- the struts 521 dislocated away from the ring direction CD1 with respect to one set of struts 521 are with one of the struts 521a of the set of struts 521 in the other inner cell 522 adjacent to the ring direction CD1. Become.
- a set of struts 521a-521b arranged in the ring direction CD1 and one strut 521 constitute the long side of the inner cell 522. Further, the two struts 521 arranged in the ring direction CD2 constitute the short side of the inner cell 522.
- the struts 521a-521b and 521 on the long side and the struts 521 on the short side are diagonally connected to each other so as to form a substantially parallelogram when spread out in a plane.
- a hole portion 523 is formed in the inner cell 522. Further, in each inner cell 522 arranged along the ring direction CD1, a set of struts 521a-521b and a strut 521 extending along the ring direction CD1 are connected at a substantially S-shaped second crossing portion 524. ing. The second crossing portion 524 is deformed so as to be stretched in the radial RD when the expanded stent 1E is bent into a substantially U shape (see FIG. 7). Therefore, the inner cell 522 spread in the radial direction RD can be bent more flexibly. As shown in FIG. 16B, in the second stent body 520, each second crossing portion 524 is arranged parallel to the circumferential OD.
- Second intersection 524 is overlapped so as to be arranged. Specifically, in a configuration in which the second intersecting portion 524 of the inner cell 522 is arranged in the hole portion 513 of the outer cell 512, the second of the inner cell 522 is arranged in the hole portion 513 of one outer cell 512.
- the intersecting portions 524 are stacked so as to be arranged.
- the first crossing portion 514 of the outer cell 512 and the second crossing portion 524 of the inner cell 522 are arranged in parallel with the circumferential OD and are arranged alternately. Even when the cell shape of each stent body is configured as shown in FIGS. 16A and 16B, by overlapping the mesh patterns of each stent body as described above, the density of the mesh pattern becomes high in the entire stent, so that the stent 1E The surface area of the stent can be increased.
- each outer cell 512 of the first stent main body 510 is connected at the first crossing portion 514 having a substantially S shape in the ring direction CD1.
- each inner cell 522 of the second stent body 520 is connected at a substantially S-shaped second crossing portion 524 in the annular direction CD1.
- the first crossing portion 514 of the first stent main body 510 and the second crossing portion 524 of the second stent main body 520 are arranged parallel to the circumferential OD as shown in FIG. 16C. According to this configuration, when the expanded stent 1E is bent into a substantially U shape (see FIG. 7), the outer cell 512 and the inner cell 522 spread in the circumferential OD can be bent more flexibly. Therefore, the shape followability of the stent 1E can be further improved.
- FIG. 17A is a side view schematically showing a configuration in which the proximal end of the stent 1 and the pusher wire 2 are connected in the first connection form.
- FIG. 17B is a cross-sectional view taken along the line s4-s4 of FIG. 17A.
- the stent 1 of the first embodiment (see FIG. 1) is given as an example of the stent for explaining the connection mode, but other stents are used. It may be applied to the stent of the embodiment. Further, in each figure described below, the configuration of the stent 1 is simplified.
- the end 101 of the proximal LD1 of the first stent body 10 is connected to the pusher wire 2 at the connecting portion 102.
- the end 201 of the proximal LD1 of the second stent body 20 is connected to the pusher wire 2 at the connection 202.
- the connection portion 102 of the first stent main body 10 and the connection portion 202 of the second stent main body 20 are formed at the same position in the axial LD of the pusher wire 2.
- the connection portion 102 of the first stent main body 10 and the connection portion 202 of the second stent main body 20 schematically show a position and a range thereof connected by welding or the like.
- the connecting portion 102 of the first stent main body 10 and the connecting portion 202 of the second stent main body 20 are formed at equal intervals in the radial direction of the pusher wire 2 (the direction orthogonal to the axial LD).
- FIG. 17B shows an example in which the connection portion 102 of the first stent main body 10 and the connection portion 202 of the second stent main body 20 are provided at intervals of 90 degrees in the circumferential direction, but the present invention is not limited to this.
- FIG. 18A is a side view schematically showing a configuration in which the proximal end of the stent 1 and the pusher wire 2 are connected in the second connection form.
- FIG. 18B is a sectional view taken along line s5-s5 of FIG. 18A.
- FIG. 18C is a cross-sectional view taken along the line s6-s6 of FIG. 18A.
- the vertical direction in the figure is the first radial direction RD1
- the left-right direction in the figure orthogonal to the first radial direction RD1 is the second radial direction RD2.
- the directions of the first radial direction RD1 and the second radial direction RD2 are not limited to the vertical direction and the horizontal direction of the drawing.
- the end 101 of the proximal LD1 of the first stent body 10 and the end 201 of the proximal LD1 of the second stent body 20 are located at different positions in the axial LD of the pusher wire 2. It is connected to the. Specifically, the end 101 of the first stent body 10 extends from the distal LD2 to the proximal LD1 along the side surface of the pusher wire 2. Then, the end portion 101 of the first stent main body 10 is connected at the connection portion 102 at the LD1 proximal to the connection portion 202 of the second stent main body 20.
- the end 201 of the second stent body 20 is located on the distal LD2 of the pusher wire 2. Then, the end portion 201 of the second stent main body 20 is connected at the connection portion 202 at the LD2 distal to the end portion 101 of the first stent main body 10.
- the connecting portion 102 of the first stent main body 10 and the connecting portion 202 of the second stent main body 20 are formed at equal intervals when viewed from the axial LD of the pusher wire 2.
- the connecting portions 202 of the second stent body 20 are formed at intervals of 180 degrees in the first radial direction RD1.
- the end portion 101 of the first stent body 10 is in contact with the side surface of the pusher wire 2, but is not connected at the connection portion 102.
- the connecting portions 102 of the first stent main body 10 are formed at intervals of 180 degrees in the second radial direction RD2.
- the end 101 of the first stent body 10 and the end 201 of the second stent body 20 are not connected at the same position, so that heat during welding is generated. As a result, it is possible to suppress a problem that the pusher wire 2 is distorted or the like.
- the positions of the connection portion 102 of the first stent main body 10 and the connection portion 202 of the second stent main body 20 are exchanged, and the connection portion 102 of the first stent main body 10 is replaced with the second stent. It may be provided on the LD2 distal to the connection portion 202 of the main body 20.
- FIG. 19A is a side view schematically showing a configuration in which the proximal end of the stent 1 and the pusher wire 2 are connected in a third connection form.
- FIG. 19B is a cross-sectional view taken along the line s7-s7 of FIG. 19A.
- FIG. 19C is a cross-sectional view taken along the line s8-s8 of FIG. 19A.
- the vertical direction in the figure is orthogonal to the first radial direction RD1 and the first radial direction RD1 as in the eighth embodiment.
- the direction is the second radial direction RD2.
- the end 101 of the first stent body 10 and the end 201 of the second stent body 20 are connected to different positions in the axial LD of the pusher wire 2.
- the end 101 of the first stent body 10 is extended from the distal LD2 to the proximal LD1 so as to straddle the end 201 of the second stent body 20.
- the end 101 of the first stent body 10 is connected at the connection portion 102 at the LD1 proximal to the end 201 of the second stent body 20.
- the end 201 of the second stent body 20 is located on the distal LD2 of the pusher wire 2.
- the end portion 201 of the second stent main body 20 is connected at the connection portion 202 at the LD2 distal to the end portion 101 of the first stent main body 10.
- the connecting portion 102 of the first stent main body 10 and the connecting portion 202 of the second stent main body 20 are formed at equal intervals when viewed from the axial LD of the pusher wire 2.
- the connecting portion 202 of the second stent body 20 is formed at an interval of 180 degrees in the first radial direction RD1.
- the connecting portion 102 of the first stent main body 10 is formed in the first radial direction RD1 at an interval of 180 degrees, similarly to the connecting portion 202 of the second stent main body 20.
- connection portion 102 of the first stent main body 10 and the connection portion 202 of the second stent main body 20 are exchanged, and the connection portion 102 of the first stent main body 10 is replaced with the second stent main body 10. It may be provided on the LD2 distal to the connection portion 202 of the stent body 20.
- the connecting portion 202 of the second stent main body 20 is formed at an interval of 180 degrees in the second radial direction RD2, and the connecting portion 102 of the first stent main body 10 is formed 180 degrees in the second radial direction RD2. It may be formed at intervals of.
- FIG. 20 is a side view schematically showing a configuration in which the distal end portion of the stent 1 and the distal end shaft 3 are connected in the first connection form (seventh embodiment).
- the end 103 of the distal LD2 of the first stent body 10 is connected to the distal end shaft 3 at the connection 104.
- the end 203 of the distal LD2 of the second stent body 20 is connected to the distal shaft 3 at the connection 204.
- the connecting portion 104 of the first stent main body 10 and the connecting portion 204 of the second stent main body 20 are formed at the same position in the axial LD of the distal end shaft 3.
- the connecting portion 104 of the first stent main body 10 and the connecting portion 204 of the second stent main body 20 are formed at equal intervals when viewed from the axial LD of the distal end shaft 3 (for example,). , See FIG. 17B).
- FIG. 21 is a side view schematically showing another configuration in which the distal end portion of the stent 1 and the distal end shaft 3 are connected in the first connection form (see FIG. 20).
- a metal wire 30 having a high contrast medium may be inserted inside the stent 1.
- the end of the distal LD2 of the metal wire 30 is connected to the distal end shaft 3.
- the end portion of the LD1 on the proximal side of the metal wire 30 is connected to the pusher wire 2 (see FIG. 1).
- FIG. 22 is a side view schematically showing a configuration in which the distal end portion of the stent 1 and the distal end shaft 3 are connected in the fourth connection form.
- the end 203 of the distal LD2 of the second stent body 20 is connected to the distal shaft 3 by a connection 204.
- the end of the distal LD2 of the first stent body 10 is not connected to the distal end shaft 3. That is, in the fourth connection mode, on the distal side of the stent 1, only the end portion 203 of the distal side LD2 of the second stent body 20 is connected to the distal end shaft 3.
- the distal side of the stent 1 may be connected to the distal end shaft 3 only by the end portion 103 of the distal side LD2 of the first stent main body 10.
- FIG. 23 is a side view schematically showing another configuration on the distal side of the stent 1.
- the distal LD2 of the first stent body 10 and the distal LD2 of the second stent body 20 may be opened.
- the end of the proximal LD1 of the first stent body 10 and the end of the proximal LD1 of the second stent body 20 are pusher wires 2, respectively. It is connected to (see FIG. 1).
- FIG. 24 is a schematic side view of the stent 1F of the eleventh embodiment.
- FIG. 25 is a cross-sectional view taken along the line s9-s9 of FIG. 24.
- the same members as those of the first embodiment are designated by the same reference numerals as those of the first embodiment, and duplicate description will be omitted.
- the stent 1F of the eleventh embodiment includes a coating film 40 between the first stent main body 10 and the second stent main body 20.
- the coating film 40 is formed in a substantially cylindrical shape and extends along the axial LD of the stent 1F.
- a material such as PTFE or ePTFE can be used.
- the film thickness of the coating film 40 is, for example, about 0.05 to 0.2 mm.
- the coating film 40 is not limited to between the first stent main body 10 and the second stent main body 20, and may be provided outside the first stent main body 10.
- the coating film 40 may contain a drug.
- the coating film 40 contains a drug, it means that the coating film 40 carries the drug so that the drug can be eluted.
- the agent is not limited, but for example, the agent exemplified in the configuration in which the agent is contained in the stent 1 of the first embodiment can be used. Further, the coating film 40 may be made of an antithrombotic material having an antithrombotic effect on blood.
- FIG. 26 is a schematic diagram showing an example in which a wire 31 having high contrast medium (hereinafter, also referred to as “wire 31”) is loosely wound around a strut 11 of the first stent main body 10.
- the wire 31 may be wound around all the struts 11 of the first stent body 10 or only a part of the struts 11.
- FIG. 27 is a schematic diagram showing an example in which a wire 31 having high contrast medium is tightly wound (in a coil shape) around a strut 11 of a first stent main body 10.
- the wire 31 may be wound around all the struts 11 of the first stent body 10 or only a part of the struts 11.
- the wire 31 may be wound around the strut 21 of the second stent body 20 in the same manner. Further, the strand 31 may be wound around both the first stent main body 10 and the second stent main body 20, or may be wound only around either one.
- FIG. 28 is a schematic diagram showing an example in which a wire 31 having high contrast medium is wound around a stent 1 in the first form.
- the strand 31 is spirally wound around the second stent body 20 located inside the stent 1.
- One end 31a of the strand 31 is connected to the proximal LD1 of the second stent body 20.
- the other end 31b of the wire 31 is connected to the distal LD2 of the second stent body 20.
- a plurality of strands 31 may be wound around the strands 31. When a plurality of strands 31 are wound, it can be confirmed that the expanded stent 1 is not partially opened in the blood vessel.
- the wire 31 may be connected to the strut 21 (see FIG. 3B) of the second stent main body 20 by welding or the like. Further, the strand 31 is not limited to the second stent main body 20, and may be connected to the first stent main body 10 located outside the stent 1, or may be connected to different stent main bodies. For example, one end of the wire 31 may be connected to the proximal LD1 of the second stent body 20, and the other end may be connected to the distal LD2 of the first stent body 10. ..
- FIG. 29 is a schematic diagram showing an example in which a wire 31 having a high contrast medium is wound around the stent 1 in the second form.
- the strand 31 is spirally wound around both ends of the second stent body 20 so as to reciprocate.
- One end of the wire 31 is connected to the proximal LD1 of the second stent body 20.
- the strand 31 is spirally wound around the second stent body 20 from the proximal LD1 to the distal LD2 of the stent 1.
- the strand 31 is folded back at the end of the distal LD2 of the second stent body 20 and is spirally wound around the second stent body 20 from the distal LD2 of the stent 1 toward the proximal LD1. ..
- the other end of the wire 31 is connected to the proximal LD1 of the second stent body 20. Also in the second form shown in FIG. 29, the same effect as the above-mentioned first form can be obtained.
- the strand 31 may be connected to the strut 21 of the second stent main body 20 by welding or the like. Further, the strand 31 is not limited to the second stent main body 20, and may be connected to the first stent main body 10 located outside the stent 1, or may be connected to different stent main bodies. For example, one end of the wire 31 may be connected to the proximal LD1 of the second stent body 20, and the other end may be connected to the distal LD2 of the first stent body 10. ..
- the stent 1G of the thirteenth embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the first embodiment.
- other configurations are the same as those of the first embodiment.
- the same reference numerals are appropriately added to the endings (last two digits) of the parts that perform the same functions as those of the first embodiment, and duplicate explanations are appropriately omitted.
- FIG. 30 is a schematic perspective view of the stent 1G of the thirteenth embodiment.
- FIG. 31A is a development view in which a part of the first stent main body 610 of the thirteenth embodiment is virtually spread out in a plane.
- FIG. 31B is a developed view of a part of the second stent main body 620 of the thirteenth embodiment virtually expanded in a plane.
- FIG. 31C is a development view in which a part of the stent 1G of the thirteenth embodiment is virtually spread out in a plane.
- the stent 1G of the thirteenth embodiment includes a first stent main body 610 and a second stent main body 620.
- the first stent body 610 is a substantially cylindrical structure arranged outside the stent 1G.
- the second stent body 620 is a substantially cylindrical structure arranged inside the first stent body 610.
- the stent 1G has a double structure in which the second stent body 620 is interpolated into the first stent body 610.
- the pusher wire 2 and the distal end shaft 3 shown in FIG. 1 are not shown.
- the first stent main body 610 has a plurality of outer cells (first cells) 612 composed of struts 611 arranged in a frame shape spread in the radial (circumferential) RD.
- first cells outer cells
- a plurality of outer cells 612 spread in the radial RD are continuously arranged in the axial LD. That is, the first stent body 610 has a mesh pattern in which a plurality of outer cells 612 are spread in the radial direction RD and continuous in the axial direction LD.
- a hole portion 613 is formed in the outer cell 612. Further, the outer cells 612 adjacent to each other in the radial direction RD are connected to each other at the intersecting portion 614.
- the intersecting portion 614 is a portion to which each strut 611 of the four adjacent outer cells 612 is connected.
- the intersecting portion 614 has an elongated substantially rectangular shape in the axial direction LD.
- Each strut 611 is connected to each of the four corners of the intersection 614.
- Each strut 611 has a curved portion 615 formed at a portion connected to the intersecting portion 614. Therefore, as compared with the intersection portion 14 (outer cell 12) of the first embodiment, the strut 611 has a shape extending in the axial direction LD at the intersection portion 614 (outer cell 612) of the present embodiment. Therefore, when the expanded stent 1G is bent into a substantially U shape (see FIG.
- each strut 611 connected to the intersecting portion 614 can be independently deformed. Therefore, the outer cell 612 spread in the radial RD can be bent more flexibly.
- the first stent main body 610 is excellent in shape followability and diameter reduction property because the outer cell 612 spread in the radial direction can be flexed more flexibly.
- the second stent main body 620 has a plurality of inner cells (second cells) 622 made of struts 621 arranged in a frame shape and spread in the radial direction (circumferential direction) RD.
- the plurality of inner cells 622 spread in the radial RD are continuously arranged in the axial LD. That is, the second stent body 620 has a mesh pattern in which a plurality of inner cells 622 are spread in the radial direction RD and continuous in the axial direction LD.
- a hole portion 623 is formed in the inner cell 622.
- the inner cells 622 adjacent to each other in the radial direction RD are connected to each other at the intersecting portion 624.
- the intersecting portion 624 is a portion to which each strut 621 of the four adjacent inner cells 622 is connected.
- the intersecting portion 624 has an elongated substantially rectangular shape in the axial direction LD.
- Each strut 621 is connected to each of the four corners of the intersection 624.
- Each strut 621 has a curved portion 625 formed at a portion connected to the intersecting portion 624. Therefore, as compared with the intersection portion 24 (inner cell 22) of the first embodiment, in the intersection portion 624 (inner cell 622) of the present embodiment, the strut 621 has a shape extending in the axial direction LD.
- each strut 621 connected to the intersecting portion 624 can be independently deformed in the radial RD. Therefore, the inner cell 622 spread in the radial direction RD can be bent more flexibly.
- the second stent main body 620 is excellent in shape followability and diameter reduction property because the inner cell 622 spread in the radial direction can be flexed more flexibly.
- the outer cell 612 constituting the first stent main body 610 and the inner cell 622 constituting the second stent main body 620 have the same size as an example. It is configured to have a shape and an arrangement. That is, in the thirteenth embodiment, the mesh pattern of the first stent main body 610 shown in FIG. 13A and the mesh pattern of the second stent main body 620 shown in FIG. 31B are substantially the same pattern. The mesh pattern of the first stent main body 610 and the mesh pattern of the second stent main body 620 may be different.
- the first stent body 610 and the second stent body 620 are arranged in the pore portion 613 of the outer cell 612 (first stent body 610) and the inner cell 622 (second stent body 620).
- the intersecting portion 624 is arranged.
- the intersection portion 624 of the inner cell 622 is arranged in the hole portion 613 of the outer cell 612
- the intersection portion 624 of one inner cell 622 is provided in the hole portion 613 of one outer cell 612. They are stacked so that they are arranged.
- the density of the mesh pattern becomes high in the entire stent, so that the surface area of the stent 1G can be further increased.
- the intersecting portion 614 of the outer cell 612 has a configuration as shown in FIG. 31A
- the intersecting portion 624 of the inner cell 622 has a configuration as shown in FIG. 31B. It has excellent followability and diameter reduction.
- the outer cell 612 and the inner cell 622 have the above-mentioned configuration, not only is it easy to store the reduced diameter stent 1G in the catheter, but also the stent 1G whose diameter is expanded in the blood vessel is catheterized. It has the effect of being easy to re-store inside.
- the stent 1H of the 14th embodiment will be described.
- the cell shapes of the 1st stent main body and the 2nd stent main body are different from those of the 4th embodiment (see FIGS. 12A and 12B).
- the stent 1H of the 14th embodiment other configurations are the same as those of the 4th embodiment. Therefore, in the 14th embodiment, the entire illustration of the stent 1H is omitted.
- the same reference numerals are given to the parts that perform the same functions as those of the 4th embodiment, and duplicate description will be appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- FIG. 32A is a developed view of the first stent main body 310 of the 14th embodiment virtually expanded in a plane.
- FIG. 32B is a developed view of the second stent main body 320 of the 14th embodiment virtually spread out in a plane.
- FIG. 32C is a developed view of the stent 1H of the 14th embodiment virtually spread out in a plane.
- the arrangement of the first crossing portion 314 of the first stent main body 310 of the 14th embodiment is different from that of the 4th embodiment.
- the row C1 in which the first crossing portions 314 are arranged every other and the first crossing portion 314 are each cell. It has a row C2 arranged between them.
- the columns C1 and C2 are alternately arranged in the ring direction CD2.
- other configurations are the same as those of the 4th embodiment.
- the arrangement of the second crossing portion 324 is different from that of the 4th embodiment.
- the row C3 in which the second crossing portion 324 is arranged every other row and the second crossing portion 324 are each cell. It has a row C4 arranged in between.
- the columns C3 and C4 are alternately arranged in the ring direction CD2.
- other configurations are the same as those of the 4th embodiment.
- the plurality of outer cells 312 constituting the first stent main body 310 and the plurality of inner cells 322 constituting the second stent main body 320 have the same size, shape, and arrangement as an example. It is configured to be. That is, in the 14th embodiment, the mesh pattern of the first stent main body 310 shown in FIG. 32A and the mesh pattern of the second stent main body 320 shown in FIG. 32B are substantially the same pattern. The mesh pattern of the first stent main body 310 and the mesh pattern of the second stent main body 320 may be different.
- the hole portion 313 of the first stent main body 310 and the second crossing portion 324 of the second stent main body 320 are provided in the row C5, in the annular direction CD1, the hole portion 313 of the first stent main body 310 and the second crossing portion 324 of the second stent main body 320 are provided.
- the arranged cells and the cells in which the portion where the second intersecting portion 324 does not exist are arranged are alternately arranged.
- the second crossing portion 324 of the second stent main body 320 is arranged in the hole portion 313 of the first stent main body 310.
- the first stent main body 310 and the second stent main body 320 are overlapped so that the rows C5 and C6 are alternately arranged in the ring direction CD2.
- each stent body is configured as shown in FIGS. 32A and 32B as in the 14th embodiment, by superimposing the mesh patterns of each stent body as described above, the mesh pattern of the entire stent can be changed. Due to the higher density, the surface area of the stent 1H can be increased. Further, also in the stent 1H of the 14th embodiment, similarly to the stent 1C of the 4th embodiment, when the expanded stent 1H is bent into a substantially U shape (see FIG. 7), it is spread in the radial RD. Since the outer cell 312 and the inner cell 322 can be flexed more flexibly, the shape followability of the stent 1H can be further enhanced.
- the stent 1J of the fifteenth embodiment will be described.
- the cell shapes of the first stent main body and the second stent main body are different from those of the fourth embodiment (see FIGS. 12A and 12B).
- other configurations are the same as those of the fourth embodiment. Therefore, in the fifteenth embodiment, the entire illustration of the stent 1J is omitted.
- the parts having the same functions as those of the fourth embodiment are designated by the same reference numerals, and duplicate description will be appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- FIG. 33A is a developed view of the first stent main body 310 of the fifteenth embodiment virtually expanded in a plane.
- FIG. 33B is a development view of the second stent main body 320 of the fifteenth embodiment virtually spread out in a plane.
- FIG. 33C is a developed view of the stent 1J of the fifteenth embodiment virtually spread out in a plane.
- the first stent main body 310 of the fifteenth embodiment includes an outer cell 312J (described later) having a different strut 311 configuration in a plurality of outer cells 312. As shown in FIG. 33A, the first stent body 310 of the fifteenth embodiment is an outer cell 312 in which the struts 311b are omitted from a set of struts 311a-311b arranged in the annular direction CD1 (hereinafter, “outer”). It also has a cell 312J).
- a convex portion 314p is formed at a portion where the crossing portion 314 to which one of the struts 311b is not connected and the strut 311 extending in the ring direction CD1 are connected. Since the convex portion 314p protrudes to the distal LD2, it is possible to suppress the interference between the convex portion 314p and the end portion of the catheter when the stent 1H having an enlarged diameter in the blood vessel is re-stored in the catheter. ..
- the outer cell 312J may be regularly arranged on the first stent main body 310, or may be irregularly arranged. In the first stent main body 310 of the fifteenth embodiment, other configurations are the same as those of the fourth embodiment.
- the second stent main body 320 of the fifteenth embodiment includes an inner cell 322J (described later) having a different strut 321 configuration in a plurality of inner cells 322. As shown in FIG. 33B, the second stent main body 320 of the fifteenth embodiment has an inner cell 322 in which the struts 321b are omitted from a set of struts 321a-321b arranged in the ring direction CD1 (hereinafter, “inside”. It also has a cell 322J).
- a convex portion 324p is formed at a portion where one of the struts 321b is not connected to the intersecting portion 324 and the strut 321 extending in the ring direction CD1 is connected. Since the convex portion 324p protrudes to the distal LD2, it is possible to suppress the interference between the convex portion 324p and the end portion of the catheter when the stent 1H having an enlarged diameter in the blood vessel is re-stored in the catheter. ..
- the inner cells 322J may be arranged regularly or irregularly.
- other configurations are the same as those of the fourth embodiment.
- the plurality of outer cells 312 (including 312J) constituting the first stent main body 310 and the plurality of inner cells 322 (including 322J) constituting the second stent main body 320 are As an example, they are configured to have the same size, shape, and arrangement. That is, in the fifteenth embodiment, the mesh pattern of the first stent main body 310 shown in FIG. 33A and the mesh pattern of the second stent main body 320 shown in FIG. 33B are substantially the same pattern. The mesh pattern of the first stent main body 310 and the mesh pattern of the second stent main body 320 may be different.
- the first stent main body 310 and the second stent main body 320 are arranged in the pore portion 313 of the outer cell 312 (first stent main body 310) with the inner cell 322 ( The second crossing portion 324 of the second stent body 320) is overlapped so as to be arranged.
- the second crossing portion 324 of the inner cell 322 is arranged in the hole portion 313 of the outer cell 312 (312J)
- the second intersecting portion 324 of the inner cell 322 is overlapped so as to be arranged.
- each stent body is configured as shown in FIGS. 33A and 33B as in the fifteenth embodiment, by superimposing the mesh patterns of each stent body as described above, the mesh pattern of the entire stent can be changed. Since the density is high, the surface area of the stent 1J can be increased. Further, also in the stent 1J of the fifteenth embodiment, similarly to the stent 1C of the fourth embodiment, when the expanded stent 1J is bent into a substantially U shape (see FIG. 7), it is spread in the radial RD. Since the outer cell 312 (312J) and the inner cell 322 (322J) can be flexed more flexibly, the shape followability of the stent 1J can be further improved.
- the convex portion 314p of the first stent main body 310 and the convex portion 324p of the second stent main body 320 both project to the distal LD2. Therefore, when the stent 1J whose diameter has been expanded in the blood vessel is re-stored in the catheter, the interference between the convex portions 314P and 324p and the end portion of the catheter can be suppressed. Therefore, according to the stent 1J of the fifteenth embodiment, the stent 1J whose diameter has been expanded in the blood vessel can be smoothly re-stored in the catheter.
- the stent 1K of the 16th embodiment will be described.
- the cell shapes of the 1st stent main body and the 2nd stent main body are different from those of the 4th embodiment (see FIGS. 12A and 12B).
- the stent 1K of the 16th embodiment other configurations are the same as those of the 4th embodiment. Therefore, in the 16th embodiment, the entire illustration of the stent 1K is omitted.
- the same reference numerals are given to the parts that perform the same functions as those of the 4th embodiment, and duplicate description will be appropriately omitted.
- the ring directions in which the cells are diagonally connected to each other in the radial direction (circumferential direction) RD will be described as the ring directions CD1 and CD2.
- the "cell” is not limited to the form in which the struts 311 are arranged in the frame shape, and the form in which the struts 311 are not arranged in the frame shape (for example, the outer cell 312K and the inner cell 322K described later). ) Shall be included.
- FIG. 34A is a developed view of the first stent main body 310 of the 16th embodiment virtually expanded in a plane.
- FIG. 34B is a developed view of the second stent main body 320 of the 16th embodiment virtually spread out in a plane.
- FIG. 34C is a developed view of the stent 1K of the 16th embodiment virtually spread out in a plane.
- the first stent main body 310 of the 16th embodiment includes outer cells 312K (described later) having different sizes in a plurality of outer cells 312. As shown in FIG. 34A, the first stent body 310 of the 16th embodiment is the outer cell 312 in which the common strut 311 is omitted in the two outer cells 312 adjacent to the annular direction CD2 (hereinafter, “outer cell 312K”. Also known as).
- the hole portion 313K of the outer cell 312K has twice the size of the hole portion 313 of the other outer cell 312.
- the outer cell 312K may be regularly arranged on the first stent main body 310, or may be irregularly arranged. In the first stent main body 310 of the 16th embodiment, other configurations are the same as those of the 4th embodiment.
- the second stent main body 320 of the 16th embodiment includes inner cells 322K (described later) having different sizes in a plurality of inner cells 322. As shown in FIG. 34B, the second stent body 320 of the 16th embodiment has an inner cell 322 in which the common strut 321 is omitted in the two inner cells 322 adjacent to the annular direction CD2 (hereinafter, “inner cell 322K”). Also known as).
- the hole portion 323K of the inner cell 322K has twice the size of the hole portion 323 of the other inner cell 322.
- the inner cell 322K may be regularly arranged on the second stent main body 320, or may be irregularly arranged. In the second stent main body 320 of the 16th embodiment, other configurations are the same as those of the 4th embodiment.
- the first stent main body 310 and the second stent main body 320 are placed in the hole portion 313 of the outer cell 312 (first stent main body 310) in the inner cell 322 ( The second crossing portion 324 of the second stent body 320) is overlapped so as to be arranged.
- the second intersecting portion 324 of the inner cell 322 is arranged in the hole portion 313 of the outer cell 312
- the second of the inner cell 322 is located in the hole portion 313 of one outer cell 312.
- the intersecting portions 324 are overlapped so as to be arranged.
- the stent 1K has two second intersecting portions 324 of the inner cell 322 arranged in the pore portion 313K of the outer cell 312K. It will be in the form of a stent.
- each stent body is configured as shown in FIGS. 34A and 34B as in the 16th embodiment, by superimposing the mesh patterns of each stent body as described above, the mesh pattern of the entire stent can be changed. Due to the higher density, the surface area of the stent 1K can be increased. Further, also in the stent 1K of the 16th embodiment, similarly to the stent 1C of the 4th embodiment, when the expanded stent 1K is bent into a substantially U shape (see FIG. 7), it is spread in the radial RD. Since the outer cell 312 (312K) and the inner cell 322 (322K) can be flexed more flexibly, the shape followability of the stent 1K can be further improved.
- the stent 1 of the first embodiment has a two-layer structure including a first stent main body 10 and a second stent main body 20, but is not limited thereto. Yet another stent body may be provided outside the first stent body 10 and / or inside the second stent body 20. The same applies to the stents of other embodiments.
- the surface of the first stent body 10 and / or the second stent body 20 may be coated with a drug, a carbon-based material coating, or a metal or polymer having high contrast medium.
- Drugs include, for example, drugs used for the same purposes as drug-eluting stents (DES).
- Examples of the carbon-based material coating include an antithrombotic inactivating coating such as diamond-like carbon (DLC). The same applies to the stents of other embodiments.
- connection portion of the first stent main body and the connection portion of the second stent main body may be formed at one place each with respect to the pusher wire 2, or may be formed at three or more places. good.
- the positions of the intersections and struts omitted from the stent body are not limited to the illustrated examples. If the stent whose diameter has been expanded in the blood vessel can be re-stored in the catheter, the position of the crossing portion and the strut omitted from the stent body can be appropriately selected.
- Pusher wire 3 Distal end shaft 10 110, 210, 310, 410, 510, 610 First stent body 20, 120 , 220, 320, 420, 520, 620 Second stent body 12, 112, 212, 312 (312J, 312K), 412, 512, 612 External cells 22, 122, 222, 222 (322J, 322K), 422, 522 , 622 Inner cells 11, 111, 211 (211a, 211b), 311 (311a, 311b), 411 (411a, 411b), 511 (511a, 511b), 611 struts (outer cells) 21, 121, 221 (221a, 221b), 321 (321a, 321b), 421 (421a, 421b), 521 (521a, 521b), 621 struts (inner cell) 13, 113, 213,
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Abstract
Description
本明細書等において、形状、幾何学的条件、これらの程度を特定する用語、例えば、「直交」、「方向」等の用語については、その用語の厳密な意味に加えて、ほぼ直交しているとみなせる程度の範囲、概ねその方向とみなせる範囲を含む。本明細書等においては、軸線方向(中心軸方向)LDにおいて、施術者に近い近位側をLD1側、施術者から離れた遠位側をLD2側とし、軸線方向LDと直交する方向を径方向RDとして説明する。また、本明細書等においては、セルが敷き詰められる方向を周方向(周方向OD)として説明する。周方向には、径方向RDのほか、径方向RDに対して傾斜する方向が含まれる。
図1は、第1実施形態のステント1の模式的な側面図である。図2は、図1に示すステント1の模式的な斜視図である。図3Aは、第1実施形態の第1ステント本体10の一部を仮想的に平面状に広げた展開図である。図3Bは、第1実施形態の第2ステント本体20の一部を仮想的に平面状に広げた展開図である。図3Cは、第1実施形態のステント1の一部を仮想的に平面状に広げた展開図である。図4Aは、単体の第1ステント本体10の外径D1を説明する図である。図4Bは、単体の第2ステント本体20の外径D2を説明する図である。図5は、第1ステント本体10に第2ステント本体20を内挿する手順を説明する図である。図6は、図1のs1-s1線断面図である。
図1及び図2に示すように、ステント1は、拡径した状態において、略円筒形状となるように構成されている。図示していないが、ステント1は、縮径した状態において、細長い円筒形状となる。また、ステント1は、近位側LD1の端部にプッシャワイヤ2が接続され、遠位側LD2の端部に遠位端シャフト3が接続されている。ステント1の近位側の端部とプッシャワイヤ2との接続方法としては、例えば、溶接、UV接着、銀ロウの浸潤等が挙げられるが、一般的な医療機器に使用されている接続方法であれば、特に制限されない。なお、ステント1の近位側の端部とプッシャワイヤ2との接続形態については、後述する。
第1実施形態のステント1は、第1ステント本体10と第2ステント本体20とからなる二層構造であって、第1ステント本体10の外セル12の空孔部分13に、第2ステント本体20の内セル22の交点部分24が配置されるように重ねられている(図3C参照)。各ステント本体のメッシュパターンを上記のように重ねることにより、ステント全体でメッシュパターンの密度が高くなるため、ステント1の表面積をより大きくすることができる。したがって、第1実施形態のステント1によれば、狭窄した血管をより均一に拡張することができる。
なお、ワイヤ状の材料を編み込んでステントを二層構造とした場合、ワイヤ状の材料が層間にも張り巡らされるため、それぞれの編み込み層を同一層上で独立して変形させることができなくなる。そのため、編み込みにより二層構造としたステントで表面積を大きくしたとしても、第1実施形態のステント1のような形状追従性及び縮径性を得ることは困難となる。
図7は、ステント1を屈曲させた場合の内部の状態を説明する図である。図7では、ステント1を、屈曲した血管内で一時的に留置した場合の内部の状態を模式的に示している。図7において、ステント1の内側に描いた矢印A1は、第2ステント本体20の自己拡張力(圧力)の作用する方向を示している。図7に示すように、ステント1において、第2ステント本体20は、自己拡張力により、第1ステント本体10を外側に向けて常に押圧した状態となる。そのため、屈曲の半径が小さな血管内において、ステント1に、いわゆる「キンク」と呼ばれる現象が生じにくくなる。キンクとは、ステントの断面が潰れて略楕円形になることをいう。また、屈曲した血管内では、図7に矢印A2で示すように、ステント1を座屈させようとする力が加わる。この力は、特に、屈曲の内側で大きくなるが、この矢印A2の力に対して、矢印A1に示す第2ステント本体20の自己拡張力が対向するように作用する。そのため、屈曲した血管内において、ステント1の屈曲の半径が小さくなっても、ステント1を折れにくくすることができる。
次に、第2実施形態のステント1Aについて説明する。第2実施形態のステント1Aは、第1ステント本体及び第2ステント本体のセル形状が第1実施形態と相違する。第2実施形態のステント1Aにおいて、その他の構成は、第1実施形態と同じである。そのため、第2実施形態では、ステント1Aの全体の図示を省略する。また、以下の説明及び図面において、第1実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を適宜に付して、重複する説明を適宜に省略する。
次に、第3実施形態のステント1Bについて説明する。第3実施形態のステント1Bは、第1ステント本体及び第2ステント本体のセル形状が第1実施形態と相違する。第3実施形態のステント1Bにおいて、その他の構成は、第1実施形態と同じである。そのため、第3実施形態では、ステント1Bの全体の図示を省略する。また、以下の説明及び図面において、第1実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を適宜に付して、重複する説明を適宜に省略する。
次に、第4実施形態のステント1Cについて説明する。第4実施形態のステント1Cは、第1ステント本体及び第2ステント本体のセル形状が第3実施形態と相違する。そのため、第4実施形態の説明及び図面において、第3実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を付して、重複する説明を適宜に省略する。第4実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。
次に、第5実施形態のステント1Dについて説明する。第5実施形態のステント1Dは、第1ステント本体及び第2ステント本体のセル形状が第3実施形態と相違する。そのため、第5実施形態の説明及び図面において、第3実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を付して、重複する説明を適宜に省略する。第5実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。
次に、第6実施形態のステント1Eについて説明する。第6実施形態のステント1Eは、第1ステント本体及び第2ステント本体のセル形状が第3実施形態と相違する。そのため、第6実施形態の説明及び図面において、第3実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を付して、重複する説明を適宜に省略する。第6実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。
図17Aは、ステント1の近位側の端部とプッシャワイヤ2とを第1の接続形態で接続した構成を模式的に示す側面図である。図17Bは、図17Aのs4-s4線断面図である。なお、第7実施形態及び後述する第8、第9実施形態の説明では、接続形態を説明するためのステントとして、第1実施形態のステント1(図1参照)を例として挙げるが、他の実施形態のステントに適用してもよい。また、以下に説明する各図では、ステント1の構成を簡略化している。
図18Aは、ステント1の近位側の端部とプッシャワイヤ2とを第2の接続形態で接続した構成を模式的に示す側面図である。図18Bは、図18Aのs5-s5線断面図である。図18Cは、図18Aのs6-s6線断面図である。図18B及び図18Cにおいては、各接続部の位置を分かり易くするため、図中の上下方向を第1径方向RD1、第1径方向RD1と直交する図中の左右方向を第2径方向RD2とする。なお、第1径方向RD1及び第2径方向RD2の向きは、図面の上下方向及び左右方向に限定されない。
図19Aは、ステント1の近位側の端部とプッシャワイヤ2とを第3の接続形態で接続した構成を模式的に示す側面図である。図19Bは、図19Aのs7-s7線断面図である。図19Cは、図19Aのs8-s8線断面図である。図19B及び図19Cにおいては、各接続部の位置を分かり易くするため、第8実施形態と同じく、図中の上下方向を第1径方向RD1、第1径方向RD1と直交する図中の左右方向を第2径方向RD2とする。
上述した第7~第10実施形態に示すステント1の近位側の端部とプッシャワイヤ2との接続形態は、ステント1の遠位側LD2と遠位端シャフト3との接続形態にも適用することができる。図20は、ステント1の遠位側の端部と遠位端シャフト3とを第1の接続形態(第7実施形態)で接続した構成を模式的に示す側面図である。
図24は、第11実施形態のステント1Fの模式的な側面図である。図25は、図24のs9-s9線断面図である。第11実施形態の説明及び図面において、第1実施形態と同等の部材等には、第1実施形態と同一の符号を付し、重複する説明を省略する。
図24及び図25に示すように、第11実施形態のステント1Fは、第1ステント本体10と第2ステント本体20との間に被覆膜40を備えている。被覆膜40は、略筒状に形成され、ステント1Fの軸線方向LDに沿って延在している。被覆膜40としては、例えば、PTFE、ePTFE等の材料を用いることができる。被覆膜40の膜厚は、例えば、0.05~0.2mm程度である。
次に、ステントに造影性の高い素線を巻き付ける実施形態について説明する。本実施形態では、造影性の高い素線を巻き付けるステントとして、第1実施形態のステント1(図1参照)を例として説明するが、他の実施形態のステントに適用してもよい。
図26は、第1ステント本体10のストラット11に造影性の高い素線31(以下、「素線31」ともいう)を疎に巻き付けた例を示す模式図である。図26に示す例において、素線31は、第1ステント本体10のすべてのストラット11に巻き付けてもよいし、一部のストラット11にのみ巻き付けてもよい。
次に、第13実施形態のステント1Gについて説明する。第13実施形態のステント1Gは、第1ステント本体及び第2ステント本体のセル形状が第1実施形態と相違する。第13実施形態のステント1Gにおいて、その他の構成は、第1実施形態と同じである。以下の説明及び図面において、第1実施形態と同様の機能を果たす部分には、末尾(下2桁)に同一の符号を適宜に付して、重複する説明を適宜に省略する。
次に、第14実施形態のステント1Hについて説明する。第14実施形態のステント1Hは、第1ステント本体及び第2ステント本体のセル形状が第4実施形態(図12A、図12B参照)と相違する。第14実施形態のステント1Hにおいて、その他の構成は、第4実施形態と同じである。そのため、第14実施形態では、ステント1Hの全体の図示を省略する。第14実施形態の説明及び図面において、第4実施形態と同様の機能を果たす部分には、同一の符号を付して、重複する説明を適宜に省略する。第14実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。
次に、第15実施形態のステント1Jについて説明する。第15実施形態のステント1Jは、第1ステント本体及び第2ステント本体のセル形状が第4実施形態(図12A、図12B参照)と相違する。第15実施形態のステント1Jにおいて、その他の構成は、第4実施形態と同じである。そのため、第15実施形態では、ステント1Jの全体の図示を省略する。第15実施形態の説明及び図面において、第4実施形態と同様の機能を果たす部分には、同一の符号を付して、重複する説明を適宜に省略する。第15実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。
次に、第16実施形態のステント1Kについて説明する。第16実施形態のステント1Kは、第1ステント本体及び第2ステント本体のセル形状が第4実施形態(図12A、図12B参照)と相違する。第16実施形態のステント1Kにおいて、その他の構成は、第4実施形態と同じである。そのため、第16実施形態では、ステント1Kの全体の図示を省略する。第16実施形態の説明及び図面において、第4実施形態と同様の機能を果たす部分には、同一の符号を付して、重複する説明を適宜に省略する。第16実施形態においては、セル同士が径方向(周方向)RDに対して斜めに接続される環方向を、環方向CD1、CD2として説明する。また、第16実施形態において「セル」とは、ストラット311が枠形に配置された形態に限らず、ストラット311が枠形に配置されていない形態(例えば、後述の外セル312K、内セル322K)を含むものとする。
第14~第16実施形態において、ステント本体から省略する交差部分やストラットの位置は、図示の例に限定されない。血管内で拡径したステントをカテーテル内へ再収納することができれば、ステント本体から省略する交差部分やストラットの位置は、適宜に選択することができる。
2 プッシャワイヤ
3 遠位端シャフト
10、110、210、310、410、510、610 第1ステント本体
20、120、220、320、420、520、620 第2ステント本体
12、112、212、312(312J、312K)、412、512、612 外セル
22、122、222、322(322J、322K)、422、522、622 内セル
11、111、211(211a、211b)、311(311a、311b)、411(411a、411b)、511(511a、511b)、611 ストラット(外セル)
21、121、221(221a、221b)、321(321a、321b)、421(421a、421b)、521(521a、521b)、621 ストラット(内セル)
13、113、213、313(313K)、413、513、613 空孔部分(外セル)
23、123、223、323(323K)、423、523、623 空孔部分(内セル)
14、114 交点部分(外セル)
24、124 交点部分(内セル)
214、314、614 交差部分(外セル)
224、324、624 交差部分(内セル)
314、414、514 第1交差部分(外セル)
324、424、524 第2交差部分(内セル)
314p、324p 凸部
30 金属線
31 造影性の高い素線
40 被覆膜
Claims (10)
- カテーテル内に挿入され、血管内において前記カテーテルから押し出されて血管を拡張するために用いられるステントであって、
枠形に配置されたストラットからなる複数の第1セルが周方向に敷き詰められ且つ中心軸方向に連続する第1ステント本体と、
枠形に配置されたストラットからなる複数の第2セルが周方向に敷き詰められ且つ中心軸方向に連続しており、前記第1ステント本体に内挿される第2ステント本体と、
を備え、
前記第1ステント本体に前記第2ステント本体が内挿された状態において、前記第1セルの空孔部分に、前記第2セルの交差部分が配置されており、
前記第1ステント本体と前記第2ステント本体は、径方向において互いに連結されていないステント。 - 前記第1ステント本体に前記第2ステント本体が内挿された状態において、前記第2ステント本体は、前記第1ステント本体を径方向の外側に向けて押圧している、
請求項1に記載のステント。 - 前記第1セルの空孔部分に前記第2セルの交差部分が配置されている構成において、1つの前記第1セルの空孔部分に1つの前記第2セルの交差部分が配置される、
請求項1又は2に記載のステント。 - 前記第1ステント本体に前記第2ステント本体が内挿された状態において、前記第1ステント本体と前記第2ステント本体とが重なり合った部分の表面の単位面積当たりにおいて非空孔部分の占める割合は、5~50%である、
請求項1~3のいずれかに記載のステント。 - 複数の前記第1セルは、周方向に対して傾斜する環方向において、1組の第1ストラットと、前記1組の第1ストラットと間隔を空けて配置される1つの第1ストラットとを備え、
複数の前記第2セルは、周方向に対して傾斜する環方向において、1組の第2ストラットと、前記1組の第2ストラットと間隔を空けて配置される1つの第2ストラットとを備える、
請求項1~4のいずれかに記載のステント。 - 複数の前記第1セルは、周方向に対して傾斜する環方向において、略S字形の第1交差部分において接続され、
複数の前記第2セルは、周方向に対して傾斜する環方向において、略S字形の第2交差部分において接続される、
請求項5に記載のステント。 - 複数の前記第1セルが前記第1交差部分において接続される環方向と、複数の前記第2セルが前記第2交差部分において接続される環方向とは、径方向において線対称となる、
請求項6に記載のステント。 - 前記第1ステント本体の近位側の端部と前記第2ステント本体の近位側の端部は、プッシャワイヤの軸線方向において異なる位置に接続されている、
請求項1~7のいずれかに記載のステント。 - 前記第1ステント本体と前記第2ステント本体との間に被覆膜を備える、
請求項1~8のいずれかに記載のステント。 - 前記第1ステント本体と前記第2ステント本体との少なくとも一方には、造影性の高い素線が螺旋状に巻き付けられている、
請求項1~9のいずれかに記載のステント。
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