EP3937860A1 - Endoprothèse pour ostium coronaire - Google Patents

Endoprothèse pour ostium coronaire

Info

Publication number
EP3937860A1
EP3937860A1 EP20717267.7A EP20717267A EP3937860A1 EP 3937860 A1 EP3937860 A1 EP 3937860A1 EP 20717267 A EP20717267 A EP 20717267A EP 3937860 A1 EP3937860 A1 EP 3937860A1
Authority
EP
European Patent Office
Prior art keywords
stent
tubular body
coronary
coronary ostium
intermediate region
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20717267.7A
Other languages
German (de)
English (en)
Inventor
Antonio Colombo
Franco Vallana
Paolo Gaschino
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alvimedica Tibbi UEruenler Sanayi Ve Dis Ticaret AS
Original Assignee
Alvimedica Tibbi UEruenler Sanayi Ve Dis Ticaret AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alvimedica Tibbi UEruenler Sanayi Ve Dis Ticaret AS filed Critical Alvimedica Tibbi UEruenler Sanayi Ve Dis Ticaret AS
Publication of EP3937860A1 publication Critical patent/EP3937860A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—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
    • A61F2/91—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—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
    • A61F2/91—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
    • 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0048—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present disclosure relates to stents.
  • One or more embodiments may relate to stents that can be inserted into coronary ostia.
  • stent is commonly used to refer to devices useful for endoluminal insertion (for example, in a blood vessel) with subsequent expansion in situ so as to obtain a local support of the lumen.
  • EP 1 561 436 Al EP 1 834 606 Al, EP 1 994 950 A2 , or EP 2 253 339 Al .
  • the object of one or more embodiments is to provide a solution that will be able to contribute to the further development and further diffusion of techniques based upon the use of stents.
  • the above object may be achieved thanks to a stent having the characteristics recalled in the ensuing claims.
  • FIG. 4 is a more detailed view of a stent according to embodiments, represented in an ideal plane development .
  • Figures 1 and 2 are a schematic representation of the proximal portion of the ascending tract of the aortic artery A. This is the portion of the aortic artery A closest to the cardiac muscle, which is able to receive the blood pumped by the left ventricle LV of the cardiac muscle through the aortic valve AV.
  • the coronary ostia i.e., the openings present in the wall of the aorta at the Valsalva sinuses VS through which the blood pumped by the cardiac muscle can spread towards the coronary arteries CA (only partially represented in the figures), which have the function of facilitating blood irrigation of the cardiac muscle.
  • a by now widespread intervention procedure envisages replacement of an aortic valve that is suffering (for example, as a result of calcification of the valve leaflets), with a prosthetic aortic valve PAV that can be located at the aortic-valve annulus so as to substitute for the natural cardiac valve in its operation .
  • percutaneous valves which can be implanted via a surgical operation with minimal invasiveness, for example by resorting to a positioning system (the so-called delivery system) introduced through a passage of reduced section open towards the aortic annulus, or else (in the case of percutaneous valves in the strict sense) by positioning the prosthetic valve via catheterization performed through the vascular system.
  • delivery system the so-called delivery system
  • Implantation of a prosthetic aortic valve PAV of the above sort can be obtained without removing the valve leaflets of the natural valve, with the latter valve leaflets (designated by LF in the schematic representation of Figure 1) that are divaricated by the prosthetic valve PAV positioned (for example, expanded) at the implantation site and pushed towards the aortic wall, in particular at the Valsalva sinuses VS.
  • the leaflets LF may end up extending into the coronary ostia CO (to a greater or lesser extent according to the anatomical characteristics of the patient in whom the prosthetic aortic valve is implanted) , thus possibly interfering in an undesirable way with the flow of the blood within the coronary arteries CA.
  • One or more embodiments may regard stents (designated as a whole by the reference 10), which can be implanted in at least one of the coronary ostia CO in such a way as to maintain the leaflets LF at a distance from the coronary ostia CO themselves, so as to facilitate (also thanks to the as a whole apertured structure of the stent 10) flow of the blood in the coronary arteries CA.
  • stent is currently meant an implantation device that comprises a tubular body provided with an apertured or openwork wall, such as a structure of a meshed type.
  • a stent is designed for being inserted into a lumen, such as a blood vessel (by positioning it in situ, for example, by means of catheterization through the vascular system) , and then expanded radially from a diameter of introduction to a diameter of expansion, where, in the expanded condition, the stent exerts an action of support and anchorage on the lumen.
  • a stent as exemplified herein comprises a tubular body having an inner surface 101 and an outer surface
  • this wall thickness is represented schematically and designated by d in Figure 3.
  • the tubular body of the stent 10 extends in a longitudinal direction (represented in the figures by a longitudinal axis X10) between mutually opposite ends
  • first portion 10a which is to be implanted in an intra-ostial position (i.e., within the coronary artery CA) and extends from the first end 103 to an intermediate region 105 here exemplified by an (ideal) plane transverse to the longitudinal direction X10 in an intermediate position between the ends 103 and 104; and
  • a second portion 10b which is to be located in an extra-ostial position (i.e., on the outside of the coronary ostium, projecting in the Valsalva sinus VS) and extends between the intermediate region 105 and the second end 104 of the tubular body of the stent 10.
  • a stent 10 as exemplified herein can be implanted (according to implantation procedures in themselves known) in such a way as to have the intra-ostial portion 10a that extends within the initial stretch of the coronary artery CA, facilitating anchorage in situ of the stent, and the extra-ostial portion 10b that projects on the outside of the ostium CO in the Valsalva sinus, hence within the aortic artery, with the capacity (also following upon a possible shaping as discussed in what follows) to keep the valve leaflets LF at a distance and facilitate perviousness of the ostium and hence proper irrigation of the cardiac muscle through the coronary arteries CA.
  • the first portion 10a of the tubular body 10 of the stent can be expanded from a radially contracted condition of insertion into the coronary ostium with a first diameter (represented dashed and designated by D1 in Figure 3) to a radially expanded condition in which the stent 10 performs an action of stenting (and hence support) of the coronary wall as a result of its expansion to a second diameter (designated by D2 in Figure 3) .
  • a coronary ostium CO normally presents in an adult subject a diameter comprised between 4 and 5 mm, with values of 3 mm and 6 mm that may be encountered in certain subjects.
  • a stent 10 as exemplified herein may consequently present (at least as regards the intra- ostial portion 10a) :
  • a first diameter Dl of less than 4 mm (3 mm), such as to enable insertion into the ostium
  • a stent as exemplified herein is hence suited to being produced in an assortment of stents with maximum values of the diameter D2 equal, for example, to 4.5 mm, 5 mm, 5.5 mm, and 6 mm.
  • a stent as exemplified herein has a wall thickness d (which can be assumed as being substantially constant throughout the length of the stent, considering the technologies of manufacture thereof) having a value such that the ratio between the wall thickness (d in Figure 2) and the diameter D2 (i.e., the diameter of the first portion 10a in the radially expanded condition) is greater than 0.03 and optionally comprised between 0.03 and 0.055: it is, hence, a stent having a wall that is, so to speak, rather "thick" - as compared to the value of the diameter in the expanded condition .
  • peripheral stents iliac-artery stents, femoral-artery stents, etc.
  • iliac-artery stents iliac-artery stents, femoral-artery stents, etc.
  • wall thickness in the region of, for example, 170 pm.
  • peripheral stents of this sort such a value of wall thickness is accompanied by a diameter of expansion greater than the diameter of expansion of a coronary-ostium stent. Consequently, in these stents the ratio d/D2 is (amply) lower than the values referred to herein.
  • a value of wall thickness d of 160-170 pm is accompanied by a value of diameter D2 correlated to the dimensions of a coronary ostium, thus giving rise to a stent with a thick wall that is as a whole somewhat rigid and resistant to bending.
  • a stent according to one or more embodiments hence moves in a direction opposite to what is normally envisaged for a conventional stent, which, given that it is designed to be brought into the implantation site via catheterization through the vascular system, presents a high degree of flexibility so that it can be flexed, bent, and folded as it follows the path, which may even be rather tortuous, towards the implantation site .
  • the ratio between the length of the first portion 10a and the length of the second portion 10b of the tubular body of the stent 10 may be comprised between 1:1 (hence with the intermediate region 105 located approximately half way between the end 103 and the end 104 of the stent 10) and 2:1 (i.e., with the portion 10a approximately twice as long as the portion 10b) .
  • One or more embodiments may envisage facilitating the person who performs the operation of implantation in obtaining a proper positioning of the stent 10 with the portion 10a implanted in intra-ostial position, the portion 10b implanted in extra-ostial position, and the intermediate region 105 substantially aligned with the ostium itself.
  • the choice may fall on materials commonly used in the production of stents via techniques that envisage cutting (for example, via laser beam) starting from a micro-tube made of metal material, such as steel or L 605 or MP35 alloys.
  • a stent as exemplified herein may on the other hand be compatible with production using super-elastic materials, such as the alloy commonly referred to as nitinol .
  • nitinol can also present shape-memory and/or self-expandability characteristics .
  • a stent 10 may be suitable for being manufactured (also here according to criteria in themselves known to persons skilled in the sector) either as balloon-expandable stent or as self-expandable stent.
  • the stent 10 can be fitted on a balloon located at one end of an implantation catheter and then be made to advance towards the implantation site in a radially contracted condition (diameter D1 of the portion 10a) and then be expanded (radially expanded condition, with diameter D2) by inflating the balloon.
  • the latter can then be deflated and withdrawn axially from the expanded stent with the possibility, exemplified schematically in Figure 3, of using the balloon B for shaping the portion 10b that projects on the outside of the ostium, for example for bestowing thereon an at least slightly widened and diverging (funnel-shaped) conformation, or else deflected sideways according to a periscope shape, on the basis of the implantation requirements.
  • the stent 10 can be brought into the implantation site, keeping it in a radially contracted condition via a sheath that can then be withdrawn, enabling ( self-) expansion of the stent.
  • One or more embodiments may, however, envisage the presence of marking characteristics such as to enable identification of the position of the intermediate region 105.
  • Figure 4 exemplifies the possible application on the tubular body of the stent 10 (optionally in the intermediate region 105) of one or more markers 106 made of radio-opaque material: markers of this kind are used in stents of a conventional type (on the other hand, more often than not located in an end position of the stent itself, as the ones designated by 103a and 104a in Figure 4) .
  • the effect of marking may result from the fact that the meshed structure (openwork structure) of the tubular body of the stent can present a variation in the intermediate region 105.
  • Figure 4 is a representation of the stent 10 in an ideal plane development.
  • the wall of the stent 10, having a tubular shape is presented developed in the plane .
  • Figure 4 shows by way of example a stent 10 comprising a plurality of radially expandable annular segments 2, which have, for example, a sinusoidal-wave serpentine shape and are connected together by bridge elements 8, 8', which separate adjacent segments 2 and maintain the distance between these segments both in the radially contracted condition and in the radially expanded condition.
  • each annular segment 2 may be obtained as a specular image of the adjacent annular segment or segments about a plane perpendicular to the longitudinal axis X10 of the stent. Hence, the peaks of one segment are longitudinally aligned with the troughs of an adjacent segment.
  • the bridge elements 8 may comprise a concave portion, or else a U- or V-shaped portion having an apex 12.
  • the U or V shape is joined to two connection arms that extend from the U or V shape (according to a general lambda configuration) and join up to adjacent sinusoidal segments 2 in a "zero point" of the sinusoidal waveform of each segment.
  • the connection point is between a peak and a trough of each of the segments. In this way, radial expansion of the stent 10 can be rendered independent of any possible bending thereof in the longitudinal direction X10.
  • connection elements (or links) 8' albeit continuing to extend between zero points of the sinusoidal waveform of adjacent segments 2, do not present the lambda shape described previously, presenting, instead, a simple linear profile .
  • the corresponding variation of the meshed structure of the wall of the stent 10 constitutes a marking characteristic that can be observed in radioscopy thanks to the radio opacity of the material of the stent 10 and is hence able to guide the person performing the implantation operation, without necessarily having to envisage the presence of markers, such as the marker designated by 106 in Figure 4. It will on the other hand be appreciated that, in one or more embodiments, this variation of the meshed structure of the wall of the stent 10 may even be a local variation, limited to the intermediate region 105,
  • Another possible difference between the portions 10a and 10b, that can be used as marking characteristic for identifying the position of the intermediate region 105, may result from the fact that the meshed structure of the tubular body of the stent 10 is more "dense" in the portion 10a as compared to the portion 10b.
  • the above different geometry may on the other hand be linked to purposes other than the need to perform a marking function.
  • the fact that the meshed structure of the portion 10a is denser than that of the portion 10b may be dictated by the fact that the portion 10a, which is to extend within the coronary artery CA, is not in itself to be traversed by the blood flow: flow of the blood within the coronary artery occurs, in fact, through the axial lumen of the portion 10a, which pushes against the walls of the coronary artery so that the wall of the stent 10a is not in itself traversed by the blood flow (i.e., in the radial direction with respect to the axis X10) .
  • a less dense meshed structure of the portion 10b projecting within the aorta A facilitates the flow of blood, which, in this region, will flow both through the axial orifice of the stent 10 and in the radial direction through its wall, which is possibly shaped as exemplified on the right in Figure 3.
  • the meshed structure of the wall of the tubular body of the stent 10 results from the fact that the aforesaid wall of the tubular body comprises solid elements (the segments 2 and the connection elements 8, 8', commonly known as “struts") separated by apertures.
  • a surface void ratio namely, a ratio between
  • the aforesaid ratio can range between 5.5 and 7 for the intra-ostial portion 10a and between 6.3 and 8.1 for the extra-ostial portion 10b.
  • the meshed structure of the stent 10 may be denser (i.e., less apertured) in the portion 10a and less dense (i.e., more apertured) in the portion 10b.
  • This fact can be expressed in a way substantially independent of the diameter of expansion of the stent 10 by saying that the solid fraction of the portion 10a (i.e., the fraction of the unit surface of the stent 10 occupied by the struts 2, 8) has a value greater than the solid fraction of the portion 10a (i.e., the fraction of the unit surface of the stent 10 occupied by the struts 2, 8' ) ⁇
  • the value of the solid fraction in the portion 10a i.e., the fraction of the unit surface of the stent 10 occupied by the struts 2, 8 in the portion 10a and
  • the value of the solid fraction in the portion 10b i.e., the fraction of unit surface of the stent lb occupied by the struts 2, 8' in the portion 10b
  • the stent 10 presents characteristics of medicated stent (also commonly referred to as Drug Eluting Stent - DES) .
  • the above term identifies stents provided on which is an active agent that is to be transferred to the wall of the vessel in which the stent is implanted.
  • agents that are to perform an antagonistic function of restenosis of the wall of the vessel.
  • the mechanism of restenosis is put down to a mechanism of mechanical injury to the wall of the vessel such as to trigger a mechanism of growth of tissue that is liable to lead to gradual re-occlusion of the treated vessel.
  • the corresponding literature (both the scientific literature and the patent literature) is extremely extensive .
  • rapamycin a monopeptide that has the most widely used properties as rapamycin, FK506, or paclitaxel.
  • FK506, or paclitaxel the agents known as rapamycin, FK506, or paclitaxel.
  • the first portion 10a of the stent is the carrier of an effective amount of active agent (for example, rapamycin) which is to be released towards the wall of the coronary vessel CA, whereas the portion 10b is substantially without the aforesaid active agent, which, with the portion 10b projecting into the aorta, would be subject to a rapid flushing-off by the blood flow, thus dispersing in the circulatory system.
  • active agent for example, rapamycin
  • a carrier for example, a polymeric carrier
  • One or more embodiments may, for this purpose, resort to the solution (which is also documented in some of the documents cited in the introductory part of the present description) that envisages formation, at least on the outer wall 102 of the stent 10 and in the intra-ostial portion 10a, of a surface patterning of the struts (2 and 8, for example) comprising furrows 14 that can function as reservoirs for loading an active agent that can be gradually released towards the wall of the vessel, against which the outer surface 102 of the stent is brought into contact as a result of expansion of the stent itself.
  • One or more embodiments may resort to the above solution in the portion 10a, which is to be implanted in the coronary vessel.
  • the presence of the aforesaid surface patterning may present the further advantage of promoting a firm anchorage of the portion 10a, hence of the stent 10 as a whole, in the implantation site.
  • a coronary-ostium stent (for example, the stent 10) as exemplified herein, may comprise a tubular body with an inner surface (for example, 101) and an outer surface (for example, 102) having a wall thickness (for example d in Figure 3) between them, wherein:
  • the tubular body extends in a longitudinal direction (for example, X10) between a first end (for example, 103) and a second end (for example, 104) opposite to one another and comprises a first, intra- ostial, portion (for example, 10a), from said first end (103) to an intermediate region (for example, 105) of the tubular body between said first and second ends, and a second, extra-ostial, portion (for example, 10b), from said intermediate region to said second end; and
  • the first portion of the tubular body can be expanded from a radially contracted condition of insertion with a first diameter (for example, D1 in Figure 3) to a radially expanded condition of stenting of the ostium with a second diameter (for example, D2 in Figure 3) .
  • the ratio between said wall thickness and said second diameter may be greater than 0.03 and, optionally, between 0.03 and 0.055.
  • the ratio between the length of the first portion of the tubular body and the length of the second portion of the tubular body may be between 1 : 1 and 2:1.
  • a coronary-ostium stent as exemplified herein may comprise at least one marking characteristic (for example, a marker 106 and/or a variation of geometry 8, 8') in said intermediate region.
  • marking characteristic for example, a marker 106 and/or a variation of geometry 8, 8'
  • the tubular body may comprise a meshed structure
  • the at least one marking characteristic in said intermediate region may comprise a variation (for example, 8, 8') of said meshed structure in said intermediate region
  • said first portion and said second portion may be provided and not provided, respectively, with an effective amount of releasable active agent.
  • said first portion and said second portion may provided and not provided, respectively, with a surface patterning (for example, 14) .
  • said surface patterning may comprise recesses provided at least on the outer surface of the tubular body, said recesses being filled with a releasable active agent.
  • the tubular body may comprise a meshed structure formed by struts (for example, 2, 8 in the portion 10a and or 2, 8' in the portion 10b) having apertures between them, wherein:
  • said first value is higher than said second value, optionally with a ratio between said first value and said second value of approximately 1.19.
  • the tubular body may comprise metal material.
  • the tubular body may be of the balloon-expandable type (see, for example, B in Figure 3) .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Ceramic Products (AREA)

Abstract

La présente invention concerne une endoprothèse pour ostium coronaire (10) comprenant un corps tubulaire ayant une surface interne (101) et une surface externe (102) ayant une épaisseur de paroi (d) entre elles. Le corps tubulaire de l'endoprothèse (10) s'étend dans une direction longitudinale (X10) entre une première extrémité (103) et une seconde extrémité (104), qui sont opposées l'une à l'autre, et comprend une première partie intra-ostiale (10a), de la première extrémité (103) à une région intermédiaire (105) du corps tubulaire entre la première extrémité (103) et la seconde extrémité (104), et une seconde partie extra-ostiale (10b), de la région intermédiaire susmentionnée (105) à la seconde extrémité (104). La première partie (10a) du corps tubulaire peut être déployée à partir d'un état radialement contracté d'insertion avec un premier diamètre (D1) jusqu'à un état radialement déployé de pose d'endoprothèse de l'ostium avec un second diamètre (D2). Le rapport entre l'épaisseur de paroi (d) susmentionnée et le second diamètre (D2) susmentionné est supérieur à 0,03, de préférence entre 0,03 et 0,055.
EP20717267.7A 2019-03-12 2020-03-11 Endoprothèse pour ostium coronaire Pending EP3937860A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000003579A IT201900003579A1 (it) 2019-03-12 2019-03-12 Stent per ostio coronarico
PCT/IB2020/052144 WO2020183385A1 (fr) 2019-03-12 2020-03-11 Endoprothèse pour ostium coronaire

Publications (1)

Publication Number Publication Date
EP3937860A1 true EP3937860A1 (fr) 2022-01-19

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Country Link
EP (1) EP3937860A1 (fr)
IT (1) IT201900003579A1 (fr)
WO (1) WO2020183385A1 (fr)

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* Cited by examiner, † Cited by third party
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EP0806190B1 (fr) 1996-05-08 2004-01-02 SORIN BIOMEDICA CARDIO S.p.A. Un stent pour angioplastie
IT1289728B1 (it) 1996-12-10 1998-10-16 Sorin Biomedica Cardio Spa Dispositivo di impianto e corredo che lo comprende
IT1289815B1 (it) 1996-12-30 1998-10-16 Sorin Biomedica Cardio Spa Stent per angioplastica e relativo procedimento di produzione
US6451049B2 (en) 1998-04-29 2002-09-17 Sorin Biomedica Cardio, S.P.A. Stents for angioplasty
IT1292295B1 (it) 1997-04-29 1999-01-29 Sorin Biomedica Cardio Spa Stent per angioplastica
IT1293691B1 (it) 1997-08-08 1999-03-08 Sorin Biomedica Cardio Spa Stent per angioplastica, particolarmente per il trattamento di vasi presentanti biforcazioni.
IT1293690B1 (it) 1997-08-08 1999-03-08 Sorin Biomedica Cardio Spa Stent per angioplastica, particolarmente per il trattamento di lesioni aorto-ostiali ed ostiali.
IT1307263B1 (it) 1999-08-05 2001-10-30 Sorin Biomedica Cardio Spa Stent per angioplastica con azione antagonista della restenosi,relativo corredo e componenti.
ATE352268T1 (de) 1999-11-23 2007-02-15 Sorin Biomedica Cardio Srl Verfahren zur übertragung radioaktiver stoffe auf stents in der angioplastie und bausatz
EP1212986A1 (fr) 2000-12-08 2002-06-12 SORIN BIOMEDICA CARDIO S.p.A. Stent pour angioplastie et son méthode de manufacture
DE60120955T3 (de) * 2001-07-20 2015-06-25 Cid S.P.A. Stent
EP1310242A1 (fr) 2001-11-13 2003-05-14 SORIN BIOMEDICA CARDIO S.p.A. Support et kit pour l'administration endoluminale des agents actifs
ATE538820T1 (de) 2003-02-21 2012-01-15 Sorin Biomedica Cardio Srl Verfahren zur herstellung eines stents und entsprechender stent
ITTO20040056A1 (it) 2004-02-05 2004-05-05 Sorin Biomedica Cardio Spa Stent per l'erogazione endoliminale di principi o agenti attivi
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ITTO20070356A1 (it) 2007-05-21 2008-11-22 Sorin Biomedica Cardio Srl "composizione per il rilascio di principi attivi da dispositivi di impianto"
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Also Published As

Publication number Publication date
WO2020183385A1 (fr) 2020-09-17
IT201900003579A1 (it) 2020-09-12

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