WO2016159161A1 - Stent à flexibilité élevée - Google Patents

Stent à flexibilité élevée Download PDF

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Publication number
WO2016159161A1
WO2016159161A1 PCT/JP2016/060528 JP2016060528W WO2016159161A1 WO 2016159161 A1 WO2016159161 A1 WO 2016159161A1 JP 2016060528 W JP2016060528 W JP 2016060528W WO 2016159161 A1 WO2016159161 A1 WO 2016159161A1
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WIPO (PCT)
Prior art keywords
stent
axial direction
straight line
virtual
coil
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PCT/JP2016/060528
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English (en)
Japanese (ja)
Inventor
康宏 正林
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康宏 正林
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Publication of WO2016159161A1 publication Critical patent/WO2016159161A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents 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

Definitions

  • the present invention relates to a highly flexible stent that is placed in the lumen structure of a living body in order to expand the lumen.
  • the reticular cylindrical stent In a living organ having a luminal structure such as a blood vessel, trachea, intestine, etc., when stenosis occurs, the reticular cylindrical stent is used to ensure the patency of the lesion site by expanding the stenotic lumen. used.
  • These living organs often have a locally bent or tapered structure (that is, a tubular structure in which the lumen cross-sectional diameter is locally different in the axial direction).
  • Highly conformable stents that can flexibly adapt to such complex vascular structures are desired.
  • stents have also been applied to cerebrovascular treatment.
  • the cerebrovascular system has a complex structure among the tubular organs of a living body. In the cerebrovascular system, there are a large number of bent portions and portions having a tapered structure. Therefore, the stent requires a particularly high shape followability.
  • the flexibility in the axial direction means rigidity with respect to bending along the longitudinal axis or ease of bending.
  • the flexibility in the radial direction means rigidity with respect to expansion / contraction in a direction perpendicular to the longitudinal axis or ease of expansion / contraction.
  • Axial mechanical flexibility is a characteristic necessary to flexibly bend along the longitudinal axis and adapt to the bending site of a living tubular organ.
  • Radial flexibility is a property required to flexibly change the radius of the stent along the shape of the outer wall of the luminal structure of the tubular organ of a living body so that the stent adheres to the outer wall of the luminal structure.
  • radial flexibility not only the rigidity of the stent is lowered, but also in consideration of the fact that the stent is placed in a living organ having a tapered structure. Therefore, it is necessary to have such a characteristic that the expansion force of the stent does not change greatly with respect to the change in the lumen cross-sectional diameter.
  • the structure of the stent is generally roughly divided into two types, an open cell type and a closed cell type.
  • An open-cell stent exhibits a very flexible mechanical characteristic in the axial direction thereof, and thus has a high shape following ability and has been effective as a stent structure that is placed in a bent tubular organ.
  • a part of the stent struts may flared out in the radial direction of the stent when bent. Risk of tissue damage.
  • Such a closed cell structure stent does not have the risk of the stent struts popping out radially outside the stent unlike the open cell structure stent, but tends to lack flexibility in structure. Therefore, when a stent having a closed cell structure is applied to a bent tubular organ, there is a risk that the stent will buckle and obstruct the flow of liquid such as blood in the tubular organ. Furthermore, the closed-cell stent is structurally inferior to the open-cell stent in terms of diameter reduction. Therefore, the stent cannot be placed in a small-diameter tubular organ having a diameter of about 2 mm, and the living tissue is damaged. There was a risk of letting.
  • a spiral stent has been devised as a technique that exhibits high flexibility while being a stent of a closed cell structure (see, for example, Patent Document 1).
  • the stent of patent document 1 is provided with the helical annular body which has a wavy pattern, and the coil-shaped element which connects an adjacent annular body in the expansion
  • the ratio of internal and external rotations on the left and right legs varies from person to person, for example, for patients with high frequency of internal rotation of both legs, if the stent is a stent that follows the internal rotation of the right leg The stent cannot follow the internal rotation of the left leg. As a result, the load on the blood vessel wall due to the stent differs between the left and right legs, so that the ratio of causing complications after placement of the stent differs between the left and right legs despite treatment with the same stent.
  • one leg for example, the right foot, has an internal rotation and an external rotation, so that a stent that follows the internal rotation cannot follow the external rotation well.
  • the above-mentioned problems cause the following clinical problems. (1) The risk that the stent will break under repeated torsional loads increases. (2) The risk of the blood vessel wall being damaged due to repeated stress concentration locally from the stent increases.
  • the coil-like element can be approximately considered as a part of the structure of the winding spring. Moreover, when this stent receives a torsional load, deformation concentrates on the coiled element. For this reason, the response of the torsional deformation of the stent can be predicted by considering the torsional deformation of the spring structure of the coiled element.
  • the stent of Patent Document 1 is composed of a spring body, when subjected to left and right torsion, the stent behaves similar to the torsional deformation of the winding spring described above. This deformation behavior changes the load on the blood vessel wall due to a large difference in the amount of deformation in the radial direction of the stent with respect to left and right twist deformation. Therefore, even if treatment is performed with the same stent as described above, there is a possibility that the treatment results may differ depending on the treatment target site and individual differences.
  • stents have a problem of suppressing shortening.
  • a stent mounted in a reduced diameter state on a catheter is expanded (expanded) in a blood vessel during the operation, the entire length of the stent is shortened in the axial direction as compared with the time of contraction (crimping).
  • the shortening of the stent in the axial direction when the diameter-reduced stent is expanded is called “shortening”.
  • the ratio of the length of the stent at the time of deployment to the length of the stent at the time of diameter reduction is referred to as a “shortening rate”.
  • the shortening rate at the time of deployment is large, it becomes difficult to place the stent in an accurate position. Therefore, it is desired to reduce the shortening rate as much as possible.
  • an object of the present invention is to provide a highly flexible stent capable of suppressing the amount of deformation in the radial direction of the stent with respect to a torsional load and suppressing shortening during deployment of the stent.
  • the present invention provides a plurality of wavy pattern bodies having a wavy pattern and arranged side by side in the axial direction, and a plurality of coil shapes that are arranged between adjacent wavy pattern bodies and extend spirally around the axis.
  • a high-flexibility stent in which all of the crests on the opposite sides of the wavy pattern of adjacent wavy pattern bodies are connected to each other by the coil-shaped element, with respect to the axial direction
  • the ring direction of the wavy pattern body is inclined with respect to the radial direction, and is connected by the coil-shaped element when viewed in the radial direction.
  • An angle ⁇ 1 at which a part or all of the first virtual lines that virtually connect the tops with respect to the radial direction is a first inclination angle of 30 degrees or less, and the wavy line shape Axis against pattern body
  • the amount of deformation in the stent radial direction with respect to the torsional load is reversed because the winding direction of one of the coiled elements located on one side of the direction is opposite to the winding direction of the other coiled element located on the other side in the axial direction Suppressed It relates to a highly flexible stent.
  • One of the first imaginary lines located on one side in the axial direction with respect to the wavy line pattern body is a small inclined first imaginary line inclined at the first inclination angle, and is located on the other side in the axial direction.
  • the other first virtual straight line may be a large inclined first virtual straight line other than the small inclined first virtual straight line in the first virtual straight line.
  • the small inclined first virtual line and the large inclined first virtual line may be alternately arranged in the axial direction.
  • the one imaginary straight line located on one side in the axial direction with respect to the wavy line pattern body and the first imaginary straight line located on the other side in the axial direction are inclined slightly at the first inclination angle.
  • the first virtual straight line may be used.
  • the wavy pattern body is formed by connecting a plurality of substantially V-shaped corrugated elements, each having two legs connected at the top, in the circumferential direction.
  • the angle ⁇ 2 at which a part or all of the second imaginary lines of the second imaginary lines that virtually connect the both ends of the part incline with respect to the axial direction may be a second inclination angle of 30 degrees or less. .
  • the top connecting the two legs connects the two legs in the two legs in the circumferential direction. It does not need to be located between the ends opposite to the top.
  • the small inclined second imaginary straight line that is inclined at the second inclination angle is connected by the coiled element and is adjacent in the axial direction, and is one of the adjacent small inclined second imaginary straight lines.
  • the angle ⁇ 21 at which the small inclined second virtual line is inclined with respect to the axial direction is less than 10 degrees
  • the angle ⁇ 22 at which the other small inclined second virtual line is inclined with respect to the axial direction is 10 degrees or more and 30 Or less.
  • the one small inclined second virtual line and the other small inclined second virtual line may be alternately arranged in the axial direction.
  • a highly flexible stent that can suppress the amount of deformation in the radial direction of the stent with respect to a torsional load and that can suppress shortening during deployment of the stent.
  • FIG. 3 is a partially enlarged view of the stent shown in FIG. 2. It is the elements on larger scale of the stent shown in FIG. It is a figure shown about the various angles in the stent shown in FIG. It is a figure which shows a state when the diameter shown in FIG. 5 is reduced. It is explanatory drawing which shows the change of the length of a stent.
  • FIG. 6 is a development view (corresponding to FIG.
  • FIG. 5 shows a highly flexible stent according to a second embodiment of the present invention virtually developed on a plane.
  • FIG. 6 is a development view (corresponding to FIG. 5) showing a highly flexible stent according to a third embodiment of the present invention virtually developed on a plane.
  • FIG. 10 is a development view (corresponding to FIG. 5) showing a highly flexible stent according to a fourth embodiment of the present invention virtually developed on a plane.
  • FIG. 10 is a development view (corresponding to FIG. 5) showing a highly flexible stent according to a fifth embodiment of the present invention virtually developed on a plane. It is an expanded view (corresponding to FIG. 5) showing the highly flexible stent of the sixth embodiment of the present invention virtually expanded on a plane. It is an expanded view (corresponding to FIG.
  • FIG. 1 is a perspective view of a highly flexible stent according to the first embodiment of the present invention in an unloaded state.
  • FIG. 2 is a development view in which the highly flexible stent according to the first embodiment of the present invention in an unloaded state is virtually developed on a plane.
  • FIG. 3 is a partially enlarged view of the stent shown in FIG.
  • the stent 11 has a substantially cylindrical shape.
  • the peripheral wall of the stent 11 has a mesh pattern structure in which a plurality of closed cells having congruent shapes surrounded by a wire-like material are spread in the circumferential direction.
  • the stent 11 is shown in a state of being deployed in a plane. Further, in FIG. 2, in order to show the periodicity of the mesh pattern, the mesh pattern is virtually repeated in a form that is more repeated than the actual developed state.
  • the peripheral wall of the stent 11 means a portion that separates the inside and the outside of the substantially cylindrical cylinder of the stent 11.
  • the cell is also referred to as an opening or a compartment, and refers to a portion surrounded by a wire-like material that forms the mesh pattern of the stent 11.
  • the stent 11 is made of stainless steel or a biocompatible material such as tantalum, platinum, gold, cobalt, titanium, or an alloy thereof.
  • the stent 11 has a plurality of annular bodies 13 as a plurality of wavy pattern bodies arranged side by side in the axial direction (that is, the central axial direction) LD, and a plurality of annular bodies 13 arranged in the axial direction LD.
  • the annular body 13 has a wavy line pattern formed by connecting a plurality of substantially V-shaped wave elements 17 in which two leg portions 17 a are connected by a top portion 17 b in the circumferential direction.
  • the substantially V-shaped waveform element 17 is connected in a state where the top portions 17b are alternately arranged on the opposite side.
  • the end portions 17c on the opposite side to the top portion 17b are connected and integrated.
  • the ring direction CD of the annular body 13 When viewed in the radial direction RD perpendicular to the axial direction LD, the ring direction CD of the annular body 13 is inclined with respect to the radial direction RD.
  • An angle ⁇ 3 at which the ring direction CD of the annular body 13 is inclined with respect to the radial direction RD is, for example, 30 degrees to 60 degrees.
  • the radial direction RD is a direction perpendicular to the axial direction LD, and therefore there are innumerable numbers.
  • the radial direction RD in “when viewed in the radial direction RD” in FIGS. 3 and 4 is a direction penetrating the paper surface of FIGS. 3 and 4.
  • the radial direction RD in “inclination” is a direction along the paper surface of FIGS.
  • Japanese Patent Application No. 2014-165104 regarding the basic contents of the present invention.
  • the contents described in Japanese Patent Application No. 2014-165104 can be appropriately applied to or incorporated in the present invention.
  • each coil-like element 15 Both end portions of each coil-like element 15 are connected to the opposite top portions 17b of the two adjacent annular bodies 13, respectively. Note that all of the opposing top portions 17b of the adjacent annular bodies 13 are connected to each other by the coil-like elements 15.
  • the stent 11 has a so-called closed cell structure. That is, two apexes 17b located adjacent to each other along the wavy line pattern among the three apexes 17b connected to each other by the legs 17a along the wavy pattern on one of the adjacent annular bodies 13 are respectively coiled.
  • the element 15 is connected to two apexes located next to each other along the wavy line pattern among the three apexes connected to each other by the legs 17a along the wavy pattern on the other of the adjacent annular bodies 13, A cell is formed. And all the top parts 17b of the wavy pattern of each annular body 13 are shared by three cells.
  • the plurality of coil-like elements 15 are arranged at equal intervals along the ring direction CD of the annular body 13. Each coil-like element 15 extends spirally around the central axis. As shown in FIG. 3, the winding direction (right winding) of one coil-like element 15 (15R) located on one side in the axial direction LD with respect to the annular body 13 and the other located on the other side of the axial direction LD. The coiling element 15 (15L) is wound in the opposite direction (left-handed). The length of one coil-shaped element 15R is longer than the length of the leg portion 17a. The length of the other coil-like element 15L is shorter than the length of the leg portion 17a.
  • a corrugated portion 19 is formed on the top portion 17 b of the waveform element 17.
  • the knob portion 19 includes an extension portion 19a that extends linearly in the axial direction LD, and a substantially semicircular portion (tip portion) 19b formed at the tip thereof.
  • the extension portion 19 a has a width that is greater than the width of the coiled element 15.
  • a slit 21 extending in the axial direction LD from the inner peripheral edge is formed in the top 17b of the wave element 17.
  • the two leg portions 17a are connected to a region where the slit 21 is not provided in the extended portion 19a and a substantially semicircular portion 19b of the knob-like portion 19 through a linear portion extending substantially parallel to the axial direction LD. Is done.
  • tip part 19b is a substantially semicircle substantially semicircle part, it does not need to be a substantially semicircle (not shown).
  • a curved portion 15 a is formed at both ends of each coil-like element 15. Both end portions of each coil-shaped element 15 are connected to the top portions 17b (specifically, the knob-shaped portions 19) of the two adjacent annular bodies 13 on the opposite sides via the curved portions 15a. As shown in FIG. 4, the curved portions 15 a at both ends of the coiled element 15 have an arc shape. The tangential direction of the coiled element 15 at the connection end between the coiled element 15 and the top 17b of the wavy pattern of the annular body 13 coincides with the axial direction LD.
  • the center in the width direction of the end of the coil-shaped element 15 and the apex (the center in the width direction) of the top portion 17b of the annular body 13 are shifted (not coincident).
  • One end edge in the width direction of the end portion of the coil-shaped element 15 and the end edge in the width direction of the top portion 17 b of the annular body 13 coincide with each other.
  • the stent 11 is provided with the structure as described above, thereby realizing excellent shape followability and diameter reduction and making the stent less susceptible to metal fatigue.
  • the ridge 19 provided on the top 17b of the corrugated element 17 of the annular body 13 of the stent 11 has an effect of reducing metal fatigue.
  • the slit 21 extending from the inner peripheral edge of the top portion 17 b of the corrugated element 17 of the annular body 13 of the stent 11 has an effect of improving the diameter reduction property of the stent 11.
  • Conventional stents having a closed cell structure are structurally lacking in flexibility, and thus there is a risk of causing buckling in bent blood vessels and inhibiting blood flow.
  • the influence of the deformation is propagated not only in the radial direction RD of the stent but also in the axial direction LD, and the stent cannot be locally deformed independently.
  • the stent cannot be adapted to a complicated vascular structure such as an aneurysm, and a gap is formed between the peripheral wall of the stent and the vascular wall.
  • the stent may become slippery in the lumen and may cause migration (migration) of the stent after placement.
  • the stent 11 of the present embodiment when the stent 11 of the present embodiment is deformed from the expanded (expanded) state to the reduced diameter (crimped) state, the stent 11 is compressed so that the wavy pattern of the annular body 13 is folded, and the coil 11
  • the state-like element 15 is in a state of being pulled in the axial direction LD while lying in the axial direction LD like a coil spring.
  • the corrugated element 17 is deformed like opening and closing of tweezers when the diameter of the stent 11 is reduced and expanded.
  • the leg portion 17a The central part bulges outward in a barrel shape and easily deforms.
  • the portions of the annular body 13 that are swollen in the barrel shape of the leg portions 17a of the corrugated elements 17 adjacent in the circumferential direction are Contact.
  • a slit 21 is provided at the root portion of the corrugated element 17 of the annular body 13. Therefore, when the diameter of the stent 11 is reduced, the stent 11 is deformed, and the leg portions 17a of the wave elements 17 adjacent to each other in the circumferential direction in the annular body 13 are difficult to contact with each other, and the diameter reduction rate can be increased. .
  • the slit 21 is provided in the top portion 17 b of the corrugated element 17 of the annular body 13 of the stent 11, the length of the extended portion 19 a of the knob-like portion 19 provided in the top portion 17 b has a length exceeding the slit 21.
  • the volume ratio which transforms into a martensite phase in the peripheral part of slit 21 at the time of load increases. Therefore, by configuring the stent 11 to include the corrugated element 17 having the apex portion 17b, the stent 11 is provided with a change in expansion force with respect to a change in the diameter of the stent 11 and a small change in expansion force even with different blood vessel diameters. Can be realized.
  • the curved portions 15a provided at both ends of the coiled element 15 of the stent 11 have the effect of further smoothing the deformation of the coiled element 15 at the connecting portion with the annular body 13 and increasing the diameter reduction property of the stent 11. .
  • the coiled element 15 When the diameter of the stent 11 is reduced, the coiled element 15 is deformed so as to be stretched in the axial direction LD. Therefore, in order to increase the flexibility of the stent 11, it is necessary to design the connection portion between the top portion 17 b of the annular body 13 and the coiled element 15 to be flexible.
  • a curved portion 15 a having an arc shape is provided at both ends of the coiled element 15, and the top portion 17 b of the annular body 13 and the coiled element 15 are connected via the curved portion 15 a.
  • the configuration in which the tangential direction of the curved portion 15a at the connection end where the coiled element 15 and the top portion 17b of the annular body 13 are connected coincides with the axial direction LD facilitates deformation due to the diameter reduction and expansion of the stent 11. At the same time, the effect of moderating the change in the expansion force with respect to the change in the diameter of the stent 11 is achieved.
  • the coil-like element 15 is deformed like a coil spring and extends in the axial direction LD, thereby enabling deformation in the radial direction RD accompanying the diameter reduction of the stent 11. Therefore, by making the tangential direction of the curved portion 15a at the connection end where the annular body 13 and the coil-shaped element 15 connect coincide with the axial direction LD, the deformation characteristics of the coil-shaped element 15 in the axial direction LD are effectively exhibited. become able to. As a result of the coil-shaped element 15 being able to be smoothly deformed in the axial direction LD, the diameter reduction and expansion of the stent 11 are facilitated. In addition, the natural deformation of the coiled element 15 in the axial direction LD can be promoted, so that an unexpected deformation resistance can be prevented, and the response of the expansion force to the change in the diameter of the stent 11 becomes gentle. Play.
  • the stent 11 is inserted into the catheter in a state of being reduced in diameter, is pushed by an pusher such as a pusher, moves through the catheter, and is deployed at a lesion site. At this time, the force in the axial direction LD applied by the extruder is transmitted to the entire stent 11 while interacting between the annular body 13 and the coiled element 15 of the stent 11.
  • the stent 11 having the above-described structure is manufactured by laser processing, for example, a biocompatible material, particularly preferably a tube formed of a superelastic alloy.
  • a biocompatible material particularly preferably a tube formed of a superelastic alloy.
  • the stent 11 is manufactured by expanding a tube of about 2 to 3 mm to a desired diameter after laser processing and applying shape memory processing to the tube in order to reduce costs. It is preferable.
  • the production of the stent 11 is not limited to laser machining, and can be produced by other methods such as cutting.
  • FIG. 5 is a diagram showing various angles in the stent shown in FIG.
  • FIG. 6 is a diagram illustrating a state when the diameter of the stained illustrated in FIG. 5 is reduced.
  • FIG. 7 is an explanatory diagram showing changes in the length of the stent.
  • the first virtual straight line L1 that virtually connects the top portions 17b connected by the coil-like element 15 (15R) (the top portion 17b is indicated by ⁇ ).
  • An angle ⁇ 1 at which some or all of the first virtual lines L1 are inclined with respect to the radial direction RD is a first inclination angle of 30 degrees or less.
  • the coiled element 15 is indicated by a broken line.
  • the first virtual straight line L1 does not coincide with the direction in which the coiled element 15 (15R) extends.
  • One first imaginary straight line L1 located on one side in the axial direction LD with respect to the annular body 13 is a small inclined first imaginary straight line L11 inclined at the first inclination angle ⁇ 1, and is located on the other side in the axial direction LD.
  • the other first virtual straight line L1 to be performed is the large inclined first virtual straight line L12.
  • the large inclined first virtual straight line L12 is a straight line other than the small inclined first virtual straight line L11 in the first virtual straight line L1.
  • the small inclined first imaginary straight line L11 and the large inclined first imaginary straight line 12 are alternately arranged in the axial direction LD.
  • a part or all of the second virtual straight line L2 of the second virtual straight line L2 that virtually connects both ends of the leg portion 17a is the axial direction LD.
  • the angle ⁇ 2 that is inclined with respect to is a second inclination angle of 30 degrees or less.
  • the end portion of the leg portion 17a is the top portion 17b or the end portion 17c opposite to the top portion 17b.
  • the top portion 17 b connecting the two leg portions 17 a and 17 a has two leg portions 17 a and 17 a in the two leg portions 17 a and 17 a in the circumferential direction. Are not located between the ends opposite to the top 17b.
  • one of the opposite end portions is another apex portion 17b, and the other is the opposite end portion 17c.
  • the top 17b connecting the two legs 17a, 17a, another top 17b, and the opposite end 17c are arranged in this order. is doing.
  • the small inclined second imaginary straight line L2 inclined at the second inclination angle ⁇ 2 is connected by the coiled element 15 and is adjacent to the axial direction LD.
  • the angle ⁇ 22 that is inclined with respect to the angle is different.
  • the angle ⁇ 21 at which one small inclined second virtual straight line L21 is inclined with respect to the axial direction LD is less than 10 degrees
  • the angle ⁇ 22 at which the other small inclined second virtual straight line L22 is inclined with respect to the axial direction LD is It is 10 degrees or more and 30 degrees or less.
  • One small inclined second virtual straight line L21 and the other small inclined second virtual straight line L22 are alternately arranged in the axial direction LD.
  • the central axis of the cross section of the stent is likely to be shifted in a strong blood vessel in the skull.
  • the annular body 13 having a wavy pattern can be easily deformed in the circumferential direction, so that the stent 11 can flexibly cope with contraction and expansion in the radial direction RD.
  • the coil-shaped element 15 which connects the adjacent annular bodies 13 and 13 extends spirally around the central axis, and is deformed like a coil spring. Therefore, when the stent 11 is bent, the coiled element 15 extends outside the bent part, and the coiled element 15 contracts inside the bent part. Accordingly, the entire stent 11 can be flexibly deformed in the axial direction LD.
  • the external force or deformation locally applied to the stent 11 is transmitted in the radial direction RD by the wavy line-shaped annular body 13 and also transmitted in the circumferential direction by the coiled element 15. Therefore, the annular body 13 and the coiled element 15 can be deformed almost independently at each portion. Thereby, even when the stent 11 is applied to a lesion site of a special blood vessel such as a cerebral aneurysm, the stent 11 can be placed in conformity with the blood vessel structure of the lesion site. For example, when the stent 11 is placed at the site of a cerebral aneurysm, the annular body 13 having a wavy pattern is disposed at the neck portion of the aneurysm. Thereby, the annular body 13 expands in the radial direction RD and protrudes into the space of the aneurysm, and the stent 11 can be stably fixed to this portion.
  • the coil-shaped element 15 contacts the blood vessel wall around the neck portion of the aneurysm along the shape of the blood vessel wall and functions as an anchor. Therefore, the risk that the stent 11 moves is also reduced. Furthermore, since the stent 11 has a closed cell structure, even when applied to a bending site, the strut of the stent 11 protrudes outward in a flared shape to damage the blood vessel wall, or the strut of the stent 11 is blood. The risk of causing alienation can be reduced.
  • the deformation of one coiled element 15 and the deformation of the other coiled element 15 cancel each other, so that the deformation amount in the radial direction RD of the coiled element 15 in the entire stent 11 is suppressed.
  • the difference in deformation amount in the radial direction RD can be reduced with respect to the left and right twist deformation.
  • the material of the stent is preferably a material having high rigidity and high biocompatibility.
  • a material include titanium, nickel, stainless steel, platinum, gold, silver, copper, iron, chromium, cobalt, aluminum, molybdenum, manganese, tantalum, tungsten, niobium, magnesium, calcium, and alloys containing these. It is done.
  • synthetic resin materials such as polyolefin such as PE and PP, polyamide, polyvinyl chloride, polyphenylene sulfide, polycarbonate, polyether, and polymethyl methacrylate can be used.
  • biodegradable resins such as polylactic acid (PLA), polyhydroxybutyrate (PHB), polyglycolic acid (PGA), and poly- ⁇ -caprolactone can also be used.
  • PLA polylactic acid
  • PHB polyhydroxybutyrate
  • PGA polyglycolic acid
  • poly- ⁇ -caprolactone poly- ⁇ -caprolactone
  • the stent may contain a drug.
  • that the stent contains the drug means that the stent releasably carries the drug so that the drug can be eluted.
  • the drug is not limited, and for example, a physiologically active substance can be used.
  • the surface of the stent may be covered with the drug.
  • the surface of the stent may be directly coated with the drug, or the drug may be included in a polymer, and the stent may be coated with the polymer.
  • a groove or a hole for storing the drug in the stent may be provided as a reservoir, and the drug or a mixture of the drug and the polymer may be stored therein.
  • the reservoir for storing is described in, for example, JP-T-2009-524501.
  • a diamond-like carbon (DLC layer) layer can be coated on the surface of the stent.
  • the DLC layer may be a DLC layer containing fluorine (F-DLC layer).
  • F-DLC layer fluorine
  • the stent is excellent in antithrombogenicity and biocompatibility.
  • a catheter is inserted into the patient's blood vessel and allowed to reach the lesion site.
  • the stent 11 is reduced in diameter (crimped) and placed in the catheter.
  • the wavy pattern of the annular body 13, the slit 21 formed in the top portion 17 b of the annular body 13, the curved portion 15 a of the coiled element 15, and the tangential direction of the curved portion 15 a at the connection end coincide with the axial direction LD. Due to the combined and synergistic effects of the configuration, the diameter reduction is enhanced. Therefore, it becomes easy to insert the stent 11 into a thinner catheter as compared with the conventional stent, and the stent 11 can be applied to a thinner blood vessel.
  • the stent 11 is a composite and synergistic structure in which a plurality of annular bodies 13 are connected by a coil-shaped element 15, a curved portion 15a of the coil-shaped element 15, and a tangential direction of the curved portion 15a at the connection end coincides with the axial direction LD.
  • the stent 11 can be flexibly deformed along the catheter even when the catheter is inserted into a meandering blood vessel, and the stent 11 can be moved to the lesion site. Easy to transport.
  • the following effects are show
  • An angle ⁇ 1 at which L1 is inclined with respect to the radial direction RD is a first inclination angle of 30 degrees or less. That is, the first virtual straight line L1 is greatly inclined with respect to the axial direction LD and is in a state along the radial direction RD.
  • the coiled element 15 is disposed so as to extend along the axial direction LD when the diameter of the stent is reduced. In that case, the stent deforms and extends so as to extend along the axial direction LD while maintaining the geometrical relationship between the coiled element 15 and the corrugated element 17. Thereafter, when the stent is pushed out of the catheter and deployed, the stent is shortened and large shortening is likely to occur.
  • the stent 11 of the first embodiment As shown in FIGS. 6 and 7, even when the diameter of the stent 11 is reduced, the coiled element 15 is more along the radial direction RD than the axial direction LD. Try to extend. Therefore, the stent 11 is difficult to extend along the axial direction LD.
  • ⁇ L in FIG. 7 indicates the difference in the length of the stent 11 between the expanded state and the reduced diameter, that is, the extended length (shortened length) of the stent 11. Therefore, even if the stent 11 is pushed out of the catheter and deployed, the stent 11 is not easily shortened and large shortening is unlikely to occur. Further, since the coil-shaped element 15 extends along the radial direction RD, the stent 11 is easily bent and deformed, and the flexibility is improved.
  • the stent 11 of the first embodiment when viewed in the radial direction RD, part or all of the second virtual straight line L2 of the second virtual straight line L2 that virtually connects the both ends of the leg portion 17a. Is inclined with respect to the axial direction LD is a second inclination angle of 30 degrees or less.
  • the waveform element 17 tends to be in a state along the radial direction RD, and hardly extends along the axial direction LD. Therefore, the stent is difficult to extend along the axial direction LD. Therefore, the stent is not easily shortened and large shortening is unlikely to occur.
  • the stent of this embodiment can be used as both an indwelling type and a collection type stent, it is preferable to use the stent as an indwelling type.
  • the stent 11 can suppress the occurrence of metal fatigue due to the configuration in which the ridge portion 19 is provided on the top portion 17b of the annular body 13, and the stent 11 is repeatedly reduced in diameter and expanded due to an indwelling error. Breakage of the stent 11 due to repeated deformation of the stent 11 due to pulsation can be suppressed.
  • the stent 11 has a structure in which a slit 21 is provided in the top portion 17b of the annular body 13 to increase a region that transforms into a martensite phase in the deformed portion at the time of crimping, a curved portion 15a of the coiled element 15, and a connection end.
  • a slit 21 is provided in the top portion 17b of the annular body 13 to increase a region that transforms into a martensite phase in the deformed portion at the time of crimping, a curved portion 15a of the coiled element 15, and a connection end.
  • FIG. 8 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the second embodiment of the present invention virtually developed on a plane.
  • FIG. 9 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the third embodiment of the present invention virtually developed on a plane.
  • FIG. 10 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the fourth embodiment of the present invention virtually developed on a plane.
  • FIG. 11 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the fifth embodiment of the present invention virtually developed on a plane.
  • FIG. 12 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the sixth embodiment of the present invention virtually developed on a plane.
  • FIG. 13 is a developed view (corresponding to FIG. 5) showing the highly flexible stent of the seventh embodiment of the present invention virtually developed on a plane.
  • one first virtual straight line L1 is a small inclined first virtual straight line L11
  • the other first virtual straight line L1 is a large inclined first virtual straight line L1. It is a straight line L12.
  • the small inclined first virtual straight line L11 and the large inclined first virtual straight line L12 are alternately arranged in the axial direction LD.
  • the angle ⁇ 2 at which all the second virtual straight lines L2 of the second virtual straight lines L2 that virtually connect the both ends of the legs 17a are inclined with respect to the axial direction LD is 30 degrees. It is super.
  • both of the first and second first virtual straight lines L1 are small inclined first virtual straight lines L11.
  • Other configurations are the same as those of the second embodiment.
  • more coil-like elements 15 extend along the radial direction RD than in the second embodiment, so that the flexibility is further improved.
  • the small inclined first imaginary line L11 that is one of the first imaginary lines L1 is inclined so as to intersect the radial direction RD.
  • the waveform elements 17 connected to both ends of the coil-shaped element 15 corresponding to the small inclined first imaginary straight line L11 are overlapped (entered).
  • the waveform elements 17 connected to both ends of the coiled element 15 corresponding to the small inclined first virtual straight line L11 do not overlap ( It does not enter) and is disposed outside the axial direction LD.
  • the stent 11C of the fourth embodiment has the above-described configuration, it is possible to realize a stent that flexibly bends and responds flexibly to left and right twists while ensuring a large surface area of the stent. .
  • the stent 11D of the fifth embodiment not only the small inclined first virtual straight line L11 that is one first virtual straight line L1, but also the first small inclined first that is the other first virtual straight line L1.
  • the virtual straight line L11 is also inclined so as to intersect the radial direction RD.
  • the waveform elements 17 connected to both ends of the coil-shaped element 15 corresponding to the small inclined first virtual line L11 which is the other first virtual line L1 are also overlapped (entered).
  • Other configurations are the same as those of the fourth embodiment.
  • the stent 11D of the fifth embodiment also has an effect equal to or greater than that of the fourth embodiment.
  • the stent 11E of the sixth embodiment is an embodiment in which the coiled element 15 in the stent 11C of the fourth embodiment and the corrugated element 17 in the stent 11 of the first embodiment are combined. That is, in the stent 11E of the sixth embodiment, as in the fourth embodiment, the small inclined first imaginary line L11 that is one of the first imaginary lines L1 is inclined so as to intersect the radial direction RD. . In the axial direction LD, the waveform elements 17 connected to both end portions of the coil-shaped element 15 corresponding to the small inclined first virtual straight line L11 are overlapped (entered).
  • a part or all of the second virtual straight lines L2 of the second virtual straight lines L2 that virtually connect the both ends of the legs 17a are axes.
  • the angle ⁇ 2 inclined with respect to the direction LD is a second inclination angle of 30 degrees or less.
  • the stent 11F of the seventh embodiment is an embodiment in which the coiled element 15 in the stent 11D of the fifth embodiment and the corrugated element 17 in the stent 11 of the first embodiment are combined. That is, in the stent 11F of the seventh embodiment, as in the fifth embodiment, not only the small inclined first virtual straight line L11 that is one first virtual straight line L1, but also the small one that is the other first virtual straight line L1.
  • the inclined first virtual straight line L11 is also inclined so as to intersect the radial direction RD.
  • the waveform elements 17 connected to both ends of the coil-shaped element 15 corresponding to the small inclined first virtual line L11 which is the other first virtual line L1 are also overlapped (entered).
  • a part or all of the second virtual straight lines L2 of the second virtual straight lines L2 that virtually connect the both ends of the legs 17a are axes.
  • the angle ⁇ 2 inclined with respect to the direction LD is a second inclination angle of 30 degrees or less.
  • the wavy pattern body 13 forms an annular body.
  • a wavy pattern body 13 that is discontinuous in the circumferential direction and does not form an annular body can be employed.
  • the wavy line pattern body 13 that does not form an annular body has a shape in which one or more struts (leg portions 17a) that constitute the wavy line pattern body are removed, compared to the wavy line pattern body that forms an annular body.
  • the number of struts to be pulled out can be appropriately set to one or more within the range in which the shape of the stent 11 can be realized.
  • an additional strut extending in the ring direction CD can be provided so as to connect the coiled elements 15 adjacent in the ring direction CD.
  • the shape of the additional strut, the position where it is provided, the number, etc. are not particularly limited.
  • one adjacent coiled element 15R can be deformed, and the other adjacent coiled element 15L can be deformed.
  • FIG. 14 is a development view showing various modified examples of the coil-like element 15.
  • the coiled element 15-1 has a greater degree of bending (curvature) than the coiled element 15 shown in FIG.
  • the coiled element 15-2 has a greater degree of bending (curvature) than the coiled element 15-1.
  • the coiled element 15-3 has a curved shape that protrudes in a direction orthogonal to the ring direction CD.
  • the coil-shaped element 15-4 has a curved shape having four inflection points.
  • the angle ⁇ 1 at which the first virtual straight line L1 is inclined with respect to the radial direction RD is not the first inclination angle of 30 degrees or less.
  • FIG. 15 is a diagram (corresponding to FIG. 4) showing a modification of the shape of the connecting portion between the coiled element 15 and the top portion 17b of the annular body 13.
  • the center in the width direction of the end portion of the coil-shaped element 15 coincides with the vertex (the center in the width direction) of the top portion 17 b of the annular body 13.
  • One edge in the width direction of the end portion of the coil-shaped element 15 and the edge in the width direction of the top portion 17b of the annular body 13 are shifted (not coincident).
  • FIG. 16 is a development view (corresponding to FIG. 2) showing a first modification in which the thickness of some coil-like elements is reduced.
  • FIG. 17 is a development view (corresponding to FIG. 2) showing a second modified example in which the thickness of a part of the coil-like elements is reduced.
  • FIG. 18 is a development view (corresponding to FIG. 2) showing a third modification in which the thickness of some coil-like elements is reduced.
  • FIG. 19 is a development view (corresponding to FIG. 2) showing a fourth modification in which the thickness of some coil-like elements is reduced.
  • the third modification is configured such that the position of the thin coil-shaped element 15 ⁇ / b> R is shifted in the axial direction LD as compared with the second modification shown in FIG. 17.
  • the fourth modification one (right-handed) coiled element 15R located at both ends in the axial direction LD is not thinner than the first modification shown in FIG.
  • the other one (right-handed) coiled element 15R is thin and configured.
  • a part of the coil-shaped element 15 is configured to be thin, so that the stent 11 can be flexibly rigid while maintaining the rigidity in the radial direction RD. Can be increased (flexibility can be increased).
  • the example in which one (right-handed) coiled element 15 (15R) is thinned has been described, but the present invention is not limited to this.
  • the other (left-handed) coiled element 15 (15L) can also be made thinner. Even in this case, the same effect as that obtained when one (right-handed) coiled element 15 (15R) is thinned can be obtained.
  • FIG. 20 is a diagram showing a relationship in length in the axial direction between legs that are adjacent to each other in the axial direction across the coiled element, where (A) shows the case where the lengths are equal, and (B) shows the length. Shows different cases.
  • the lengths of the leg portions 17a adjacent to each other in the axial direction LD with the coiled element 15 interposed therebetween are different from each other. Specifically, the relationship is (a)> (b).
  • FIG. 21A and 21B are views showing a state in which the stent is bent along the axial direction, in which FIG. 21A is a view as viewed from the pulled side, FIG. 21B is a view as viewed from an unloaded side, and FIG. These are the figures seen from the side compressed.
  • FIG. 21 when the stent 11 is greatly bent along the axial direction LD, the annular body 13 and the coiled element 15 facing the annular body 13 on the compressed side shown in FIG. Easy to touch. If both come into contact, buckling is likely to occur.
  • the length of the leg portion 17a is short (b), as shown in FIG. 21C, the distance (c) until the annular body 13 and the coiled element 15 come into contact with each other can be increased. Therefore, buckling can be suppressed when the stent 11 is greatly bent along the axial direction LD.
  • FIG. 22 is a development view showing a modified example in which the structure of the end portion in the axial direction is different.
  • the end portions of the struts may be substantially aligned at the end portion of the stent 11 in the axial direction LD (the end portion located on the lower side of FIG. 22). In this case, it is easy to push the stent 11 when the diameter of the stent 11 is reduced (crimped). Moreover, since the position of the edge part of a strut is substantially equal when the stent 11 is detained, safety is high.
  • FIG. 23 is a diagram illustrating a first modification example related to visibility improvement.
  • FIG. 24 is a diagram illustrating a second modification example related to improvement in visibility.
  • various struts (coiled element 15, annular body 13) are provided with holes 25, and members 23 a with high visibility are embedded in the holes 25.
  • various struts (coiled element 15, annular body 13) are provided with holes 25, and wire-like members 23b having high visibility are passed through the holes 25. Yes.
  • the wire-like member 23b is further wound around various struts (the coil-like element 15 and the annular body 13).
  • the material of the members 23a and 23b having high visibility may be metal or synthetic resin.
  • struts that are not substantially bent or struts that are not substantially deformed are preferable.
  • the strut that does not substantially bend and the strut that does not substantially deform includes the other coil-shaped element 15L having a short length.
  • the part in which the hole 25 for the members 23a and 23b with high visibility is provided is preferably a part of the strut that is not substantially deformed. The reason is as follows. Stress is not easily applied to the strut portions around the hole 25, and the strut portions around the hole 25 are not easily damaged. In addition, the highly visible members 23a / 23b fitted / passed through the holes 25 are not easily damaged or fall off from the holes 25.
  • the spiral direction of the coiled element 15 may be left-handed or right-handed.
  • the first imaginary straight line L1 that defines the angle ⁇ 1 may be inclined in the pushing direction of the stent with respect to the radial direction RD, or may be inclined in the pulling-back direction of the stent opposite to the pushing direction.
  • the second imaginary straight line that defines the angle ⁇ 2 may be inclined in either the left or right direction with respect to the axial direction LD.
  • the second inclination angle ⁇ 2 at which the second virtual straight line L2 is inclined with respect to the axial direction LD and the angle ⁇ 22 at which the other small inclination second virtual straight line L22 is inclined with respect to the axial direction LD are 30 degrees.
  • the leg portion 17a corresponding to the second virtual straight line L2 having the second inclination angle ⁇ 2 and the leg portion 17a corresponding to the other small inclined second virtual straight line L22 having the inclination angle ⁇ 22 are excessive to the leg portion 17a adjacent thereto.
  • the second inclination angle ⁇ 2 and the angle ⁇ 22 may exceed 30 degrees if they do not come into strong contact with each other.
  • the stent of the present invention can be applied to cerebral blood vessels, lower limb blood vessels, and other blood vessels.
  • Ring body (wavy line pattern body) 15 coil-like element 15L other coil-like element 15R one coil-like element 17 corrugated element 17a leg 17b top 17c opposite end CD ring direction LD axial direction L1 first virtual straight line L11 small inclined first virtual straight line L12 large Inclined first virtual straight line L2 Second virtual straight line L21 One small inclined second virtual straight line L22 The other small inclined second virtual straight line RD Radial direction ⁇ 1 First inclined angle ⁇ 2 Second inclined angle

Abstract

La présente invention concerne un stent qui est doté de corps à motif ondulé (13) qui ont un motif ondulé et sont disposés côte à côte dans une direction axiale LD, et de multiples éléments en forme de bobine (15) qui sont disposés entre des corps à motif ondulé (13) et s'étendent en spirale autour de la ligne d'axe. Lorsque l'on observe dans la direction radiale RD, qui est perpendiculaire à la direction axiale LD, la direction circulaire CD des corps à motif ondulé (13) est inclinée par rapport à la direction radiale RD. Lorsque l'on observe dans la direction radiale RD, une partie ou la totalité de premières lignes imaginaires L1, qui sont entre les sommets 17b raccordés par un élément de type bobine (15), sont inclinées par rapport à la direction radiale RD d'un angle θ1, qui est un premier angle d'inclinaison inférieur ou égal à 30 ° La direction d'enroulement d'un élément semblable à une bobine (15, 15R) positionné d'un côté du corps à motif ondulé (13) dans la direction axiale LD est à l'opposé de la direction d'enroulement de l'autre élément de type bobine (15, 15L) positionné de l'autre côté dans la direction axiale LD.
PCT/JP2016/060528 2015-03-31 2016-03-30 Stent à flexibilité élevée WO2016159161A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060247759A1 (en) * 2005-04-04 2006-11-02 Janet Burpee Flexible stent
JP2009513300A (ja) * 2005-10-31 2009-04-02 ボストン サイエンティフィック リミテッド ステント構成
JP2015008931A (ja) * 2013-06-28 2015-01-19 株式会社World Medish 高柔軟性ステント

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060247759A1 (en) * 2005-04-04 2006-11-02 Janet Burpee Flexible stent
JP2009513300A (ja) * 2005-10-31 2009-04-02 ボストン サイエンティフィック リミテッド ステント構成
JP2015008931A (ja) * 2013-06-28 2015-01-19 株式会社World Medish 高柔軟性ステント

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