WO2000027307A1 - Stent extensible a fourche et son dispositif de mise en place - Google Patents

Stent extensible a fourche et son dispositif de mise en place Download PDF

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Publication number
WO2000027307A1
WO2000027307A1 PCT/IL1998/000541 IL9800541W WO0027307A1 WO 2000027307 A1 WO2000027307 A1 WO 2000027307A1 IL 9800541 W IL9800541 W IL 9800541W WO 0027307 A1 WO0027307 A1 WO 0027307A1
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WO
WIPO (PCT)
Prior art keywords
stent
legs
trousers
bifurcation
pockets
Prior art date
Application number
PCT/IL1998/000541
Other languages
English (en)
Inventor
Valerian Voinov
Original Assignee
Brainwave Cardio-Vascular Technologies Ltd.
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 Brainwave Cardio-Vascular Technologies Ltd. filed Critical Brainwave Cardio-Vascular Technologies Ltd.
Priority to AU10508/99A priority Critical patent/AU1050899A/en
Priority to PCT/IL1998/000541 priority patent/WO2000027307A1/fr
Publication of WO2000027307A1 publication Critical patent/WO2000027307A1/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
    • A61F2/90Stents 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
    • AHUMAN NECESSITIES
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    • 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
    • AHUMAN NECESSITIES
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    • 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
    • A61F2/856Single tubular stent with a side portal passage
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    • 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
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    • 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
    • A61F2/885Stents 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 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
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    • 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
    • A61F2002/91525Stents 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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
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    • 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
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    • 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
    • A61F2002/91533Stents 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 characterised by the phase between adjacent bands
    • AHUMAN NECESSITIES
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    • 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
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    • 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
    • A61F2002/9155Adjacent bands being connected to each other
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Definitions

  • the invention discussed herein relates generally to medical technology, specifically to expandable cardiovascular stents, which are used for the radical recovery of arterial lumina with subsequent restoration of normal blood flow.
  • the term "stent” refers to a device employed to expand a blood vessel and to maintain the achieved size of the lumen.
  • stents are delivered to the target area in the cardiovascular system on an inflatable balloon, located on the tip of a transluminal catheter. Upon reaching the target site, the balloon is inflated leading to the expansion of the stent thereby widening the lumen of the vessel.
  • Other, less common stent delivery systems also exist.
  • the most widely used method is "T" stenting, when two mesh stents are used to cover the bifurcation area (Fig. 1, pos 1, 2, 3, 4) of the treated coronary vessel.
  • two guide wires (5, 6) are introduced into one of the major coronary arteries, for example, proximal LAD (2) and into a smaller vessel, for example diagonal D (3).
  • two kissing balloons are placed across the bifurcation area and predilation of the bifurcation is performed.
  • a stent (7) is delivered to the target area and deployed in the LAD.
  • the second stent (9) is advanced to the side branch and deployed.
  • the balloon previously used for predilation of the branch is advanced and inflated through the stent (7) into the branch to widen the stent cell diameter through which a second stent (9) will be introduced.
  • Another important flaw of the technique is the complicated positioning of the second stent, which in many cases leads to either gaps at the carina (4) or protrusion of the side branch stent into the main vessel.
  • T stenting is successful in many cases and remains the primary method of stenting coronary artery bifurcations, especially of the large vessels (>3.0 mm).
  • it continues to be a cumbersome procedure with hampered long-term clinical results.
  • Coiled stents such as Gianturco-Roubin II and Crossflex II seem to provide an easier approach to bifurcations, and are also widely used in clinical practice.
  • the guidewires (5, 6) are placed in both vessels and both vessels (2, 3) are predilated with the help of the balloons. Then, the wire is either removed from the straightest vessel or left alone, and the stent (10) is deployed into the most angulated artery (3). Then, if it had been removed, the wire is repositioned in the straight vessel (2) and the second stent (11) is deployed there with proximal overlap of the first one (10).
  • coiled stent technique is technically less complicated, it also has crucial flaws, such as possible plaque prolapse through stent struts. Also, coiled stents without axial support may be damaged during recrossing and balloon dilation, which may lead to higher complication rates.
  • Yet another "Y” technique or “three-stent” includes subsequent placement and deployment of two stents (12, 13) in the two arteries (2, 3) immediately after the bifurcation, and then, using two kissing balloons with their distal parts protruding into both arteries, deployment of the third stent (14) in the segment (1) just proximal to the bifurcation.
  • This technique provides more complete lesion coverage, while maintaining access to both vessels.
  • the guide wire is repassed to the branch, and the second stent (21) is delivered and deployed in the side branch.
  • the second stent design There are two variations of the second stent design: 1) conventional design, when the stent is deployed just distally of the bifurcation; 2) "JoStent" design, when the proximal part of the second stent is placed in the proximal vessel, overlapping the proximal part of the first stent (Fig. 6). Though this method seems to be more advanced than the previously described techniques, it either does not provide optimal coverage of the diseased vessel (variation 1), or doubles the proximal vessel wall area covered by the stent (variation 2).
  • the Optimal Expandable Bifurcated Stent should posess the following characteristics: 1. Stent geometry closely corresponding to the Y-shaped anatomy of bifurcation vessels.
  • FIG. 7 There is a known "Y" Stent design presented in PCT/TL 98/00275 of June 14, '98.
  • the constructive elements which are preliminarily formed on a thin metallic sheet surface (22) as a single Y-shaped structure, in their established form are stents (23, 24, 25) connected one to another.
  • Each of these common stent legs includes two relatively rigid bands (26, 27), (28, 29), (30, 31) executed as a chain of consecutively attached pockets, formed by the bending of the saw-shaped profile protrusions.
  • the closed loops, elements (34 and 35), forming the strutted rings along the longitudinal axis of the stent upon its expansion, are fastened to the saw-shaped profile bases, for example (32, 33).
  • two kissing balloons (36, 37) can be used, which are advanced in the vessel with the help of two guide wires (38, 39) as is shown in Figs. 8, 9a, 9b and 10.
  • One of the main obstacles in the designing of such devices is providing a minimal outward diameter of the unexpanded stent located on uninflated kissing balloons, that allows free realization of the interventional procedure. Notwithstanding the fact that in the "Y" prototype stent a single design construction is achieved, however the stent's assembled form as seen from the situation shown in Fig. 9a, is impossible, since the presented cross section (Fig. 9a) is determined by Fig. 8.
  • Fig 8 shows uninflated kissing balloons (36, 37) at which the outward diameter is determined in general by the sizes of sufficiently rigid polymer tubes (on Fig. 8 the polymer tubes are not shown). Being pressed to each other, the said tubes cannot form an oval in accordance with Fig 9a. As a result, the sum total of the diametrical sizes including the four thicknesses of the said polymer tubes' walls, four thicknesses of the unexpanded stent lateral legs' walls, already deformed to some degree, and another four thicknesses of the oppositely located pockets formed from the rigid band's walls form a sufficiently large outward diameter, which is unacceptable for the normal device implantation into a bifurcation vessel.
  • the diagonal D does not directly correspond to the " Y" stent common form, rather for example, is situated at an negative angle.
  • the diagonal D is directed to the opposite side in relation to the blood flow from the main vessel. Performing such a bend of the "Y" prototype stent lateral leg is impossible.
  • one more drawback of the "Y" prototype stent is its incomplete use of the stent's surface (Fig. 10, pos. 40, 41, 42) at the location of the joint between the three component devices connection (43) that does not allow for efficient covering of the bifurcation carina area with metal.
  • the prototype "Y" stent cannot cover all the necessary area of the restored vascular channel to the full degree, and so does not fulfill the objectives of intravasculasr intervention.
  • the purpose of this invention is to create a "Y" stent design with heightened flexibility in all spatial directions, with a technological possibility for the decrease of the unexpanded device's outward diameter, and a simultaneous securing of longitudinal rigidity that guarantees the preservation of the linear axial sizes upon manipulations during the whole period of intravascular intervention.
  • the said purpose is achieved by the fact that in the Sheet Expandable Trousers Stent, the constructive elments, preliminarily formed on a thin metallic sheet surface as a single Y-shaped structure. All the three legs of which in an established form are stents, connected one to another. Each stent includes oppositely located relatively rigid bands, with a possibility of forming chains of consecutively attached pockets, and closed loops, fastened to the said bands, forming strutted rings upons the stent's expansion. The longitudinal flexibility of the said stent legs is determined in advance according to an algorithm of breaks of the said relatively rigid bands in accordance with the bifurcation segment's anatomy.
  • the proposed algorithm of the sequence of breaks of oppositely located relatively rigid bands to which the closed loops are fastened comprise unions of two, four, six and other even number of said closed loops in each said rigid band.
  • the pattern of discontinuity of the relatively rigid band parts can be performed either in accordance with the proposed algorithm or in other different combinations determined by the required stent longitudinal rigidity.
  • the lateral legs can contain repeated rigid bands parts, executed only as the bases of the said pockets and the closed loops fastened to them.
  • the proposed Sheet Expandable Trousers Stent can contain lateral legs only, thus forming a single V-shaped structure, in the said legs of which the end strutted rings are connected by plates.
  • the said lateral legs can be provided with pockets for the deployment in them of a polymer thread, loaded with therapeutic agents for local drug delivery.
  • the proposed Device for the implantation of the Trousers Stent contains two guide wires, two polymer tubes and two kissing balloons of a guiding catheter.
  • the lateral sides of the said polymer tube, in place of the longitudinal deployment of the said balloons, are executed by a flat thinning of their cylindrical sizes in such a way that the minimal wall thickness of the said tubes in place of their thinning comprises not less than the said balloon's double walls thickness.
  • the said tubes' kissing thinned surfaces grant the unexpanded stent single Y-shaped structure oval cross section of minimal size. Where pockets are maintained on the stent legs, another side of each of the polymer tubes, parallel to the previously executed surface, is flattly thinned.
  • the proposed "Y" stent design is devoid of the prototype stent's drawbacks. Thanks to heightened longitudinal flexibility, more successful performance of intravascular intervention is achieved into all bifurcation segments simultaneously, regardless of anatomical peculiarities of their location on the cardiac muscle.
  • the proposed " Y" stent design is superior to the prototype stent due to its fundamentally smaller diametrical size in unexpanded form.
  • Fig. 1 shows the stages of "T" stenting technique execution in an example of a schematic depiction of heavy damage covering the front proximal diagonal bifurcation.
  • Fig. 2 shows schematically the stages of Coil Stent technique execution.
  • Fig. 3 shows schematically the stages of " Y" stent technique execution.
  • Fig. 4 shows schematically the stages of "V stent technique execution.
  • Fig. 5 shows the scheme of "JoStent" Side Branch.
  • Fig. 6 shows schematically damage covering the bifurcation in an example of applying two " JoStents" Side Branch.
  • Fig. 7. shows a stencil of the strutted and outline constructive elements, which according to the prototype " Y" stent, is executed on a thin metallic sheet surface.
  • Fig. 8 shows the prototype " Y" stent before expansion located on uninflated kissing balloons of a guiding catheter.
  • Fig. 9 shows the prototype "Y" stent cross-section in accordance with Fig. 8.
  • Fig. 10 shows the prototype "Y" stent's initial orientation in the bifurcation.
  • Fig. 11 a, b, c, d, e show schematically in a graphic form the algorithm of creating sections of oppositely located rigid bands, consisting of an alternating chain of consecutively attached pockets or of the rigid bands replacing them.
  • Fig.1 If shows schematically how, in case of need, it is possible to violate the periodicity of relatively rigid bands placement in accordance with the anatomical condition of the bifurcation segments.
  • Fig. 12 shows a stencil of strutted and outline constructive elements of "Y" stent according to the invention, with a maximal longitudinal flexibility of all three stent legs, according to the algorithm in Fig. l ie.
  • Fig. 13 shows a stencil of strutted and outline constructive elements of "Y" stent according to the invention, with an evenly decreased longitudinal flexibility of all three stent legs according to the algorithm in Fig. l id.
  • Fig. 14 shows a stencil of strutted and outline constructive elements of "Y" stent according to the invention, where the longitudinal flexibility of all three stent legs are implemented not evenly but selectively for the bifurcation carina area according to the algorithm in Fig. 1 If
  • Fig. 15 shows a " Y" stent, according to the invention, prior to expansion located on uninflated kissing balloons of the guiding catheter.
  • Fig. 16 a, b show "Y" stent cross-sections in accordance with Fig. 15.
  • Fig. 17 shows the " Y" stent's initial orientation in the bifurcation segments, according to the invention.
  • Fig. 18 shows schematically the stages of "Y" stent technique execution, according to the invention.
  • Fig. 11a and Fig. 1 lb show that under the single formation of closed loops, the formation of the device is either impossible (Fig. 11a) or irrational (Fig. 1 lb), since, in the latter case a breaking of one of the loops takes place that leads to the instability of the stent sizes in the axial direction. Further, in Fig 11 the stages of algorithm development from a maximal longitudinal flexibility variant (Fig. 1 lc) to the variants of increasing relatively longitudinal rigidity (Fig. 1 Id, e) are schematically illustrated.
  • Fig. l ie shows a constructive variant of uniting already two closed loops (47 and 48), i.e. of four closed loops by one protrusion (44).
  • Fig. 1 le shows a constructive variant of uniting three closed loops (49 and 50) i.e., of six closed loops by one protrusion (44).
  • Fig. 1 If presents an example of a non-periodical quantity of united closed loops.
  • three closed loops (51 and 52) united by one protrusion element (44) of the relatively rigid bands, located along the edges of the stent legs, are combined with the neighboring section of loop (53) and section of loop (54), in the middle of the stent leg, i.e. in a place for example of the desired maximal longitudinal flexibility.
  • This example shows the possibility of increasing the longitudinal flexibility on any "Y" stent section where the vessel curvature is, as a rule, heightened, and can naturally facilitate conducting procedural manipulations and the correct placement of the stent functional legs in bifurcation segments.
  • Fig. 12 shows a flat stencil of the future "Y" stent strutted outline constructive elements according to the invention, with a greater longitudinal flexibility according to the proposed algorithm.
  • the closed loops (56 and 57) are periodically united by a protrusion (58) of the relatively rigid band. Therefore, the opposite breaks of the relatively rigid band are creating a structure corresponding to the algorithm in Fig. 1 lc, on each of the stent legs (59, main vessel, 60, proximal LAD and 61, diagonal D).
  • each saw-shaped profile protrusion (62) has a closed slot, the bases of which form sections of one rigid band. This avoids the stretching of the saw-shaped protrusions (62) in the axial direction upon the stent's expansion. It is supposed that the local therapeutic action of the polymer thread loaded with medical agents is able to serve all three vessel segments along the blood flow and therefore, there is no need to make pockets along the stent side legs for proximal LAD and diagonal D, replacing them by rigid band (63) sections.
  • Fig. 13 shows the same as Fig. 12 with relatively even longitudinal flexibility of the legs of the future "Y" stent (64), according to the invention, realized according to the algorithm in Fig. l id.
  • Fig. 14 shows the same as Fig. 12, where the longitudinal flexibility of the legs of the stent (65), according to the invention, is uneven but increased only on those stent segments that are located in the bifurcation carina area due to the execution of breaks (66 and 67) of the relatively rigid bands in the leg for the main vessel and breaks (68, 69), (70, 71) in the side legs for proximal LAD and diagonal D, accordingly.
  • Fig. 15 shows the location of the legs of the "Y" stent (72), according to the invention, on uninflated kissing balloons (73 and 74) in a three dimensional image. Position (75) marks one of the closed loops (main vessel), while positions (76 and 77) mark the closed loops of the legs of the stent (proximal LAD and diagonal D).
  • Fig. 16 a, b show two cross-sections in accordance with Fig. 15, on which two guide wires (78), two polymer tubes (79), two balloons (80, 81), side legs (82, 83) and pockets (84) of the stent main leg (85) are marked.
  • Position (86) shows polymer tubes (79) kissing surfaces on both cross-sections (Fig. 16) executed by the thinning of the cylindrical sizes for the creation of the minimal size oval cross-section of the unexpanded stent single Y-shaped structure.
  • Fig. 17 shows a general scheme of the three "Y" stent legs' simultaneous introduction into bifurcation segments.
  • Position (87) marks guide wires, position (88), a balloon and position (89), a stent side leg, for the implantation into proximal LAD, position (90), a balloon and position (91), a stent side leg for the implantation into diagonal D, as well as stent design element (92) intended for the introduction into the main vessel.
  • the technique "Y" stent implantation for covering the bifurcation lesion includes the following steps. Before implantation, the "Y" stent is located on two kissing balloons (80, 81), and has a cross section of minimal oval form (Figs. 15, 16). First, according to the known technique (Fig. 18a) two guide wires (78) are introduced into proximal LAD and diagonal D. Then, the kissing balloons are placed across the bifurcation area and predilation is performed. The stent is delivered to the target area and deployed into the main vessel.
  • the stent is placed in the bifurcation area in such a way that the pockets of the main leg of the stent should turn out to be in the geometrical axes of the intersectional plane of proximal LAD and diagonal D.
  • This allows the legs of the stent for proximal LAD and diagonal D to open freely and form an angle between themselves and easily move in the bifurcation vessel.
  • the free angle variation insures the necessary spatial orientation of the device in the vessel and optimal anatomic position before expansion (18b).
  • the legs of the stent are expanded in proximal LAD and diagonal D, and then, by the simultaneous inflation of the same balloons in the main vessel (Fig. 18c).
  • the implanted stent covers the bifurcation lesion as a whole, and does not violate the vessel's natural dynamics upon contraction of the cardiac muscle. This creates the most favorable conditions for the optimal reconstruction of the traumatized vascular tissue.
  • the linear axial size of the stent legs could be disparate depending on the sizes and location of the lesion in the bifurcation vessel.
  • the length of the stent leg for the main vessel can be minimized to be comprised of a single pair of closed loops, or be absent completely, while the left stent side legs remain connected to each other and become a N-shaped structure.
  • the pockets for the deployment of a polymer thread carrying therapeutic agents can be located on the stent's side legs.
  • the achieved single Y-shaped stent design structure contributes to the simplification of the technique and decreases trauma in the stenting procedure due to the single mechanical action on the vessels.
  • An additional merit of the stent design consists in the possibility of the metal coating of the bifurcation carina area that should contribute to the more effective treatment of the lesion in that vessel segment and to the generally more favorable outcome of intravascular intervention.

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Abstract

La présente invention concerne un stent en forme de fourche dont les éléments constitutifs sont préalablement réalisés sous forme de patron sur la surface d'une mince feuille métallique. Le stent (55), qui est positionné sur deux ballonnets accolés et non gonflés d'un cathéter de guidage, présente un diamètre extérieur minimum et, comte tenu du raccordement algorithmique proposé des boucles fermées (56, 57) par les saillies (58) de cordons relativement rigides, offre une certaine souplesse longitudinale en des points déterminés par les particularités anatomiques des segments de fourche. Avec ce stent, il est possible de placer en une zone de bifurcation de carène un élément métallique qui devrait contribuer à rendre plus efficace le traitement de la lésion dans la partie de vaisseau considéré et, de façon générale, à augmenter les chances de réussite d'une intervention intravasculaire.
PCT/IL1998/000541 1998-11-08 1998-11-08 Stent extensible a fourche et son dispositif de mise en place WO2000027307A1 (fr)

Priority Applications (2)

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AU10508/99A AU1050899A (en) 1998-11-08 1998-11-08 The sheet expandable trousers stent and device for its implantation
PCT/IL1998/000541 WO2000027307A1 (fr) 1998-11-08 1998-11-08 Stent extensible a fourche et son dispositif de mise en place

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003053507A1 (fr) * 2001-12-21 2003-07-03 Imad Sheiban Ensemble catheter a ballonnet raccorde
EP1369097A1 (fr) 2002-06-07 2003-12-10 CathNet-Science Holding A/S Assemblage de cathéter avec ballonnets
EP1472991A2 (fr) * 2003-04-25 2004-11-03 Medtronic Vascular, Inc. Stent avec bifurcation avec des corps principaux concentriques
US6964681B2 (en) 2002-01-29 2005-11-15 Medtronic Vascular, Inc. Flared stent and method of use
WO2006083809A1 (fr) 2005-02-01 2006-08-10 Stent Tech, Inc. Appareil d’endoprothese bifurquee et son procede
US7641684B2 (en) 2003-10-16 2010-01-05 Minvasys, Sa Catheter system for stenting bifurcated vessels
DE102009033757A1 (de) * 2009-07-17 2011-01-27 Golestani, Reza, Dr. med. Bifurkationsstent
EP1469778B1 (fr) * 2001-11-21 2011-02-09 Koninklijke Philips Electronics N.V. Procede et appareil de mesure semi-automatique d'anevrysme et centrage de stent a l'aide de donnees image volumetriques
WO2011089619A2 (fr) * 2010-01-22 2011-07-28 Concept Medical Research Private Limited Méthode et ensemble cathéter à ballonnet pour traiter des lésions de bifurcation
US8128685B2 (en) 2005-02-01 2012-03-06 Stent Tech, Inc Bifurcated stenting appratus and method
US8932340B2 (en) 2008-05-29 2015-01-13 Boston Scientific Scimed, Inc. Bifurcated stent and delivery system
US9278015B2 (en) 2003-10-16 2016-03-08 Minvasys Catheter system for stenting and drug treatment of bifurcated vessels
US9427340B2 (en) 2004-12-14 2016-08-30 Boston Scientific Scimed, Inc. Stent with protruding branch portion for bifurcated vessels
US9492297B2 (en) 2006-09-12 2016-11-15 Boston Scientific Scimed, Inc. Multilayer balloon for bifurcated stent delivery and methods of making and using the same
WO2022060994A1 (fr) * 2020-09-16 2022-03-24 Restore Endosystems, Llc Dispositifs et procédés de traitement de vaisseaux sanguins bifurqués
EP3870105A4 (fr) * 2018-10-25 2022-08-03 Endologix LLC Greffes d'endoprothèse à bifurcation, endoprothèses, et procédés

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5649977A (en) * 1994-09-22 1997-07-22 Advanced Cardiovascular Systems, Inc. Metal reinforced polymer stent
US5800526A (en) * 1995-03-17 1998-09-01 Endotex Interventional Systems, Inc. Multi-anchor stent
US5810872A (en) * 1997-03-14 1998-09-22 Kanesaka; Nozomu Flexible stent
US5836964A (en) * 1996-10-30 1998-11-17 Medinol Ltd. Stent fabrication method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5649977A (en) * 1994-09-22 1997-07-22 Advanced Cardiovascular Systems, Inc. Metal reinforced polymer stent
US5800526A (en) * 1995-03-17 1998-09-01 Endotex Interventional Systems, Inc. Multi-anchor stent
US5836964A (en) * 1996-10-30 1998-11-17 Medinol Ltd. Stent fabrication method
US5810872A (en) * 1997-03-14 1998-09-22 Kanesaka; Nozomu Flexible stent

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1469778B1 (fr) * 2001-11-21 2011-02-09 Koninklijke Philips Electronics N.V. Procede et appareil de mesure semi-automatique d'anevrysme et centrage de stent a l'aide de donnees image volumetriques
WO2003053507A1 (fr) * 2001-12-21 2003-07-03 Imad Sheiban Ensemble catheter a ballonnet raccorde
GB2385530A (en) * 2001-12-21 2003-08-27 Imad Sheiban Branched balloon catheter assembly and stent
US6964681B2 (en) 2002-01-29 2005-11-15 Medtronic Vascular, Inc. Flared stent and method of use
US7867269B2 (en) 2002-01-29 2011-01-11 Medtronic Vascular, Inc. Flared stent and method for use
EP1369097A1 (fr) 2002-06-07 2003-12-10 CathNet-Science Holding A/S Assemblage de cathéter avec ballonnets
EP1472991A2 (fr) * 2003-04-25 2004-11-03 Medtronic Vascular, Inc. Stent avec bifurcation avec des corps principaux concentriques
EP1472991A3 (fr) * 2003-04-25 2004-11-10 Medtronic Vascular, Inc. Stent avec bifurcation avec des corps principaux concentriques
US9278015B2 (en) 2003-10-16 2016-03-08 Minvasys Catheter system for stenting and drug treatment of bifurcated vessels
US7641684B2 (en) 2003-10-16 2010-01-05 Minvasys, Sa Catheter system for stenting bifurcated vessels
US9427340B2 (en) 2004-12-14 2016-08-30 Boston Scientific Scimed, Inc. Stent with protruding branch portion for bifurcated vessels
WO2006083809A1 (fr) 2005-02-01 2006-08-10 Stent Tech, Inc. Appareil d’endoprothese bifurquee et son procede
US8128685B2 (en) 2005-02-01 2012-03-06 Stent Tech, Inc Bifurcated stenting appratus and method
US9492297B2 (en) 2006-09-12 2016-11-15 Boston Scientific Scimed, Inc. Multilayer balloon for bifurcated stent delivery and methods of making and using the same
US8932340B2 (en) 2008-05-29 2015-01-13 Boston Scientific Scimed, Inc. Bifurcated stent and delivery system
DE102009033757A1 (de) * 2009-07-17 2011-01-27 Golestani, Reza, Dr. med. Bifurkationsstent
DE102009033757B4 (de) * 2009-07-17 2017-04-13 Reza Golestani Bifurkationsstentsystem
US8585642B2 (en) 2010-01-22 2013-11-19 Concept Medical Research Private Limited Method and a balloon catheter assembly for treating bifurcation lesions
WO2011089619A3 (fr) * 2010-01-22 2011-10-06 Concept Medical Research Private Limited Méthode et ensemble cathéter à ballonnet pour traiter des lésions de bifurcation
WO2011089619A2 (fr) * 2010-01-22 2011-07-28 Concept Medical Research Private Limited Méthode et ensemble cathéter à ballonnet pour traiter des lésions de bifurcation
EP3870105A4 (fr) * 2018-10-25 2022-08-03 Endologix LLC Greffes d'endoprothèse à bifurcation, endoprothèses, et procédés
WO2022060994A1 (fr) * 2020-09-16 2022-03-24 Restore Endosystems, Llc Dispositifs et procédés de traitement de vaisseaux sanguins bifurqués

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