WO2001021101A1 - Extenseur souple expansible et procede de fabrication correspondant - Google Patents

Extenseur souple expansible et procede de fabrication correspondant Download PDF

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Publication number
WO2001021101A1
WO2001021101A1 PCT/RU2000/000374 RU0000374W WO0121101A1 WO 2001021101 A1 WO2001021101 A1 WO 2001021101A1 RU 0000374 W RU0000374 W RU 0000374W WO 0121101 A1 WO0121101 A1 WO 0121101A1
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WO
WIPO (PCT)
Prior art keywords
stent
circular members
unitary circular
connecting component
unitary
Prior art date
Application number
PCT/RU2000/000374
Other languages
English (en)
Inventor
Andrei Vladimirovich Karev
Sergei Appolonovich Pulnev
Vladimir Konstantinovich Ryzhkov
Original Assignee
Andrei Vladimirovich Karev
Sergei Appolonovich Pulnev
Ryzhkov Vladimir Konstantinovi
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
Priority claimed from RU99121158/14A external-priority patent/RU99121158A/ru
Application filed by Andrei Vladimirovich Karev, Sergei Appolonovich Pulnev, Ryzhkov Vladimir Konstantinovi filed Critical Andrei Vladimirovich Karev
Priority to AU75641/00A priority Critical patent/AU7564100A/en
Publication of WO2001021101A1 publication Critical patent/WO2001021101A1/fr

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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
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • 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

Definitions

  • the present invention relates to pressure expandable endoprostheses, or stent devices for implanting in a body cavity or duct, primarily of the type of tortuous blood vessels and vessel bifurcations, to maintain a patency of the duct and so to allow the flow of fluid therethrough.
  • the present invention relates to manufacture of such stent devices.
  • the stent devices or stents capable upon application of an appropriate external force to expand from a contracted state (characterized by a reduced diameter of the stent) to an expanded state characterized by a diameter greater than or equal to that of the duct wall, are widely used, particularly in treatment of stenosed vessels, arterial aneurysms, biliary tract diseases, etc.
  • stents employing various principles of expanding the stent after it is delivered to an appropriate position inside a vessel or another duct have been proposed and employed.
  • One proposed stent type (disclosed, for example, in U.S. Patents Nos. 4,580,568, 4,665,771 , 4,733,665) is designed to be disposed, while in compressed or contracted state, about an expandable member such as a balloon on the distal end of a balloon catheter, for subsequent positioning in the desired location within a blood vessel by advancing the catheter through the patient's vascular system.
  • the expandable member is then used to bring the stent into its expanded state by means of inflating the balloon or by applying to the stent an external force of some other kind directed radially outwards, so that a periphery of the stent comes into a contact with walls of the vessel or of another corporal duct being treated and keeps them apart, ensuring patency of the treated vessel.
  • the application of the external force to the stent is stopped (i.e. by deflating the balloon) and the delivery device is withdrawn from the blood system of the patient, leaving the expanded stent within the blood vessel holding open the lumen of the vessel.
  • the described method of implanting the stents inside a human body and the manner of performing their function of holding open the lumen through the treated vessel defines a rather high and, to a certain degree, contradictory requirements to their mechanical properties.
  • the stent while in the contracted state, the stent must have a minimal diameter and be flexible, to a rather high degree, so it can be delivered to a required location even through small, bent and tortuous vessels. Further, to minimize a risk of thrombosis and/or other adverse effects for the stented vessel after the implantation (such as intimal hyperplasia), the area of contact between the vessel's walls and metal components of the stent must be minimized.
  • the stent when expanded, the stent must display a considerable radial, or "hoop" strength to maintain its expanded shape in the conditions of the complex interaction with a fluid flowing therethrough and especially to withstand substantial radial pressure exerted by walls of the stented duct, which pressure, in addition, can be variable along the length of the stent.
  • Various prior art stents satisfy all these requirements only to a limited degree.
  • stents composed of metal wire mesh as described in U.S. Patents Nos. 4,665,771 and 5,575,818 or in Russian patent No.
  • 2,089,131 usually do not possess high radial strength, especially at stent's edges, while stents made as a metal cylinder tube with a plurality of slits in its circumference (as described in U.S. Patents Nos. 4,733,665 and 5,916,264 or EP applications Nos. EP 0,878,174 and EP 0,884,028), or combined from both wire and tube members (as in U.S. Patent No. 5,383,892) are not flexible enough to be inserted into small or tortuous blood vessels.
  • the stent With object to achieve higher flexibility, it was proposed to make the stent from a plurality of a short closed circular structures (or rings) interconnected by metal (i.e. wire) cross-ties extending generally longitudinally.
  • the cross-ties can be made flexible to change their length in response to a bending force applied to said circular structure (see, for example International Application WO 97/14375 and U.S. Patent No. 5,879,370).
  • presence of the cross-ties results in increase of the area of undesirable contact between metal components of the stent and the vessel walls without any desirable increase of the radial strength of the stent.
  • the first object of the present invention to provide a stent applicable for implantation inside various body cavities and ducts, including vessels of small diameter, bent or tortuous vessels, bifurcations and vessel ostiums.
  • a stent and a method for manufacturing this stent are provided.
  • the stent of the present invention comprises a plurality (at least two) of unitary circular members preferably made from an appropriate metal alloy, such as stainless steel or nitinol, and capable, upon application of a radial force, to expand inside of a body cavity or duct from a contracted to an expanded state and to maintain, while in this expanded state, an open lumen through said cavity or duct. All or at least a part of the unitary circular members are connected to each other by connecting components or by a single connecting component, as is common the with prior art stents. However, contrary to the prior art stents of this type, the connecting component or components are made not of the same or similar materials as unitary circular members themselves, but of a thin, flexible, non-rigid biocompatible material other than metal.
  • an appropriate metal alloy such as stainless steel or nitinol
  • such flexible, non-rigid biocompatible material is selected from the group of biocompatible polymers including polytetrafluoroethylene, polyurethane, polycarbonate urethane, silicone rubber, polyester, polyamide and their combinations.
  • Some of the preferred embodiments of the invention contemplate the use of connecting components in the shape of one or a plurality of threads, preferably made of polytetrafluoroethylene or other materials, widely used in threads employed in surgical practice. Threads of this type can be obtained, for example, from Gore (Germany) or Ethicon (Johnson and Johnson company, USA). In one of the preferred embodiments a plurality of such threads braided into a mesh in the shape of a cylinder is used.
  • Other embodiments of the present invention employ connecting components in the shape of one or several thin bands.
  • the method for manufacturing the stent of the present invention comprises a step of producing at least one string of unitary circular members interconnected by at least one flexible non-rigid connecting component.
  • Alternative modifications of this critical step are developed, all of them providing economically viable procedures for connecting unitary circular members into the string. Some of these modifications are simple and flexible enough to be implemented directly in a clinic for the purpose of producing a stent optimized for a particular case of implantation.
  • the strings of circular members provided by the present invention may include all unitary circular members constituting the stent or, alternatively, the stent may comprise two or more strings non-connected between themselves.
  • the stent of the invention may include one or several separate unitary circular members non-connected to any string. Easiness and flexibility of connecting unitary circular members by means of flexible non-rigid connecting components provided by the present invention make it possible to include into the stent circular members of practically any shapes and of various dimensions and materials. Owing to this it becomes possible to attain with the stent of the invention a wide range of characteristics desired in different applications, including stenting tortuous and/or small vessels and bifurcations, treating vascular aneurysms, etc.
  • ring-form circular members provides the stent with a desired high radial strength, which is necessary to conserve its expanded shape for prolonged periods.
  • minimization of the area of contact between the vessel's walls and metal members of the stent due to absence of any metal links between these members ensures a very high flexibility of the stent, with no adverse effects, for example, such as thrombosis or intimal hyperplasia.
  • such effects constitute one of the main disadvantages of the prior art stents which include such metal links or are made entirely from a metal cylinder.
  • the non-rigid biocompatible material is selected from a group of biodegradable polymers, including polyvalerate, polylactic acid, polyglycolic acid and their combinations.
  • biodegradable polymers including polyvalerate, polylactic acid, polyglycolic acid and their combinations.
  • Use of the biodegradable connecting components additionally minimizes potential adverse influence on the vessel inside which the stent is implanted.
  • Figure 1 is a simplified perspective view of a plurality of unitary circular members of a stent assembled in a contracted state on the balloon of a delivery system with the aid of a single connecting component;
  • Figure 2 is a simplified perspective view of the same circular members in an expanded state
  • Figure 3 is perspective view, on a larger scale, of the one of the circular members shown in Figs. 1 and 2;
  • Figure 4 is a simplified perspective view of the same circular members in an expanded state assembled on the balloon of a delivery system with the aid of several connecting components;
  • Figure 5 is a very schematic presentation of the circular members similar to those shown in Figs. 1 and 2, but positioned at acute angles to the longitudinal axis of the stent;
  • Figure 6 shows circular members of the stent positioned in a zone of a location of an ostium of a lateral branch;
  • Figure 7 is a side view of an embodiment of the stent with the connecting component in the form of a mesh;
  • Figure 8 is a simplified perspective representation of the circular members, shown in the expanded state, of the stent designed for stenting a bifurcation;
  • Figure 9 is a simplified perspective view, on a larger scale, of some tools used for manufacturing one of the preferred embodiments of the stent according to the present invention.
  • Fig. 1 illustrates one of the preferred embodiments of the stent 1 according to the present invention.
  • the stent 1 comprises a plurality of unitary circular members 2 (for clarity, only 6 of them are represented).
  • Unitary members of any appropriate configurations employed in the prior art stents or of any other configurations which may be proposed in future may be employed to form the stent 1.
  • the choice of particular configuration(s) evidently is determined by characteristics of a vessel or other body cavity to be stented and by a character of lesion to be treated.
  • An embodiment shown in Fig. 1 uses metal members 2, all of which have the same shape and dimensions.
  • Unitary circular members 2 are shown in Fig. 1 in their contracted state (corresponding to their minimal diameter). They are placed on a delivery device represented in Fig. 1 by a balloon catheter 3 comprising an angioplastic balloon 4 mounted onto a guide wire 5. Members 2 have no direct contact with each other, that is they are separately arranged along a longitudinal axis O Oi of the stent 1 (which axis coincides with an axis of the delivery device 3). A distance (or distances) p between adjoining circular members 2 mounted on the delivery device shall be selected with a view to obtain a desired distance (or distances) p' between these members after they will acquire an expanded configuration (shown in Fig. 2) inside a cavity to be treated.
  • each member 2 has a generally cylindrical shape.
  • a generally cylindrical shape means any hollow figure which, when in expanded state, can be mounted, substantially without any clearance, onto a periphery of a circular cylinder.
  • the optimal shape of the members 2 corresponds to a ring 6, that is to a closed three-dimensional unit of a cylindrical shape with an internal diameter at least twice as large as its length.
  • each of the rings 6 is made from a single piece of an appropriate metal material (such as a stainless steel or nitinol) and, as shown in Fig. 3, includes several straight portions 8 which are oriented generally parallel to the axis of the stent 1 and connected by curved portions 10.
  • a sinusoidal or any other appropriate shape may be employed, provided it permits to expand the unitary members 2 symmetrically by applying to them a radially, outwardly extending force.
  • the expanded members 2 will have somewhat shorter lengths than when they are in the contracted state, which means that values p' will be somewhat larger than corresponding p values. Because particular configurations of the unitary members used in the present invention do not constitute a part of the present invention and various appropriate configurations of such members are well known to those skilled in the art, a detailed description of these members is not included into the specification. Instead, reference is made to the above-mention patent documents which are included herein by reference.
  • a distinctive feature of the stent 1 of the present invention is that it comprises one or more connecting components made of a thin, flexible biocompatible material, other than metal. Examples of appropriate materials for use in the connecting components will be given below.
  • the embodiment shown in Figs. 1 , 2 comprises only one connecting component 7 shaped as a thread or a very narrow band connecting all unitary circular members 2 into a single string of circular members.
  • the embodiment of the stent 1 shown in Fig. 4 illustrates flexibility of the present invention in selecting appropriate shape and/or structure of connecting components.
  • the stent is formed by the unitary circular members 2 of the same type as the above-described embodiment, but, instead of a single connecting component, a plurality of connecting components are used, four of which are shown in Fig. 4. Two of them, namely components 71 and 72 connecting respectively the first (counting from the left) circular member 2 to the second one and the fifth circular member 2 to the last (the sixth) one, are formed as thin bands of an appropriate non-rigid biocompatible material.
  • end zones of the components 71 and 72 have different shapes, characterized by different areas of contact between these components and corresponding circular members 2. This is done with the purpose to illustrate additional capabilities of the stent according to the present invention for optimization its mechanical characteristics in accordance with various specific tasks.
  • Each of two other connecting components 73 and 74 is made of the single thread similar to the one shown in Figs. 1 and 2. Again, to illustrate design flexibility of the stent, the component 73 is shown displaced around the axis of the stent relative to other connecting components, while the connecting component 74 connects three adjacent circular members 2.
  • One more configuration of the stent 1 comprising at least some of the circular members 20 positioned on the delivery device 3 at an angles different from normal (i.e. selected in the range of 10° to 50°), in relation to the longitudinal axis O ⁇ - O ⁇ is very schematically shown in Fig. 5.
  • an axis O 2 - O 2 of each of such unitary members forms an acute angle ⁇ with the axis O-i - 0- .
  • different circular members composing the stent 1 may have inclination angles ⁇ different not only in value, but also in direction.
  • two inclined circular members, 20a and 20b, located in the left part of the stent 1 are connected by the connecting component 71 in the form of a narrow band, similar to that shown in Fig. 4.
  • Connecting component 75 which connects two other inclined circular members, 20c and 20d, is made of two thin threads similar to that designated as 73 in Fig. 4. Thin threads constituting the connecting component 75 are displaced around the axis O - Oi of the stent relative to each other.
  • a distinctive feature of this embodiment consists in that two middle circular members, 20b and 20c, are not connected between themselves by any connecting component.
  • the stent 1 shown in Fig. 5 consists not of a single string (as do stents shown in Figs. 1 , 2, 4), but of two separate, non-connected strings 31 and 32.
  • the described inclined orientation of at least some of the circular members 26 may be of a specific interest for stenting ostium of a vessel, because the use of such members makes it possible to strengthen a wall W of the affected zone of a vessel V without closing an ostium U of lateral branch B. It can be seen from Fig. 5 and especially from Fig. 6 that in the circular member intended to be mounted at a substantial inclination to the axis of the stent, its straight portions 28 preferably make an acute angle with the axis O 2 -O 2 of such member, the value of this angle being approximately equal to the angle ⁇ .
  • the straight segments 28 will be oriented substantially parallel to the axis of the stent, that is at an angle to the axis O 2 -O 2 of the member 20.
  • the connected members illustrated in Figs. 1 , 2 and 4 to 6 can be made of any appropriate non-rigid biocompatible material (other than metal), for example of any of materials developed for stent-grafts (described in particular in EP 0,747,069, EP 0,797,963, EP 0,841 ,040). These materials include, for example, various polymers, such as polyamide, polycarbonate urethane, polyester, polyolefin, polytetrafluoroethylene, polyurethane, silicone rubber and their co-polymers and combinations.
  • One of the preferable polymer materials for production of connecting components in accordance with the present invention is polytetrafluoroethylene.
  • Another group of preferred materials is constituted by biodegradable polymers such as polyisobuterate, polyvalerate, polylactic acid, polyglycolic acid and their combinations.
  • the main function of the connecting component(s) according to the present invention is distinctly different from those performed by polymer components in stent-grafts or in stents with unitary circular members made of an appropriate polymer.
  • the connecting component or components 7 serve mainly a purely technological purpose of simplifying the procedure of mounting the plurality of circular members 2 which have no rigid connections between themselves, onto the delivery device 3.
  • connecting components to a certain degree, prevent displacements of the unitary members relative to each other during the delivery of the stent to the affected body cavity.
  • the connecting component(s) is (are) no more needed. For that reason, there is no necessity to form the connecting component as a sheath typical for the stent-grafts. Moreover, it becomes possible to limit the connecting component(s) to one or several thin threads of the type shown in Fig. 1 , 4 and 5, or to one or several narrow bands (of the type shown in Figs. 4 and 5).
  • the connecting component(s) is (are) made from one of the appropriate biodegradable materials mentioned above.
  • the connecting component 7 consists of several bands or threads
  • these parts of the connecting component preferably are mutually displaced around the longitudinal axis 0- ⁇ - Oi of the stent by an appropriate angle.
  • the connecting component consists of two bands
  • their relative displacement preferably equals 180°.
  • Fig. 7 illustrates a further embodiment of the stent 1 using circular members made as simple metal rings 18.
  • the main novel feature of this embodiment consists in that the connecting component used therein is formed as a net, or a mesh 76 of a generally cylindrical shape.
  • the mesh 76 is made of a plurality of threads 77 similar to the one shown in Fig. 5, with each thread 77 extending along a helical configuration around the longitudinal axis of the stent.
  • the number of individual threads used for weaving, or braiding the mesh 76 preferably is selected in the range of 5 to 50 threads, depending mainly on the diameter and configuration of the employed unitary circular members.
  • the connecting component of this type ensures the most reliable and convenient connection between circular members 18 forming a single string 34, while exerting no or minimal pressure on the walls of the stented duct, or cavity.
  • stents of many different configurations and sizes can be successfully employed in the stent of the present invention.
  • These configurations include simple rings, hollow cylinders of extended lengths, for example formed by a plurality of mutually interconnected rings (similar to those described with reference to Fig. 1-3) separated form each other in the direction of the axis of the stent.
  • the stent formed by circular members of different diameters is particularly suitable for implantation into a vessel or other duct having a diameter varying along its length.
  • the annular members 2, 18, 20 it is possible to use practically any unitary circular members employed in any of prior art stents, including stents of matrix type (known as Palmaz stents).
  • the whole stents may be included, as unitary circular members, into the stent of the present invention.
  • the range of characteristics attainable with the stent of the present invention may be additionally broadened by combining unitary circular members connected by the flexible connecting component into a string of circular members, with other members or strings not connected with any other member (as shown in Fig. 5).
  • stent's parameters along its length can be also achieved by using circular members of the same type, but made from different materials or from the same material but subjected to different type of mechanical and/or thermal treatment.
  • the middle member(s) and the end members of the stent for dealing with residual stenosis can be made of nitinol and of stainless steel, correspondingly.
  • the stent of the present invention can be optimized also by varying distances between different pairs of unitary circular components or a pitch of threads forming the connecting component in the form of the mesh. In some special cases at least one of these distances may be increased up to 20 mm or even to 30 mm.
  • All described options for optimizing the stent of the present invention can be readily achieved due to a great flexibility of the stent's design combined with a relative easiness of mounting unitary circular members, at least part of which are interconnected by at least one connecting component, onto the delivering device.
  • Fig. 8 Flexibility of the stent design provided by the present invention and its other advantages are illustrated by Fig. 8 which give a perspective view of a next embodiment of the stent designed specially for stenting bifurcations.
  • the stent is shown mounted, in the expanded state, on the delivery device, of which, for purposes of clarity, only guide- wire structure 51 is presented.
  • the embodiment of the stent of Fig. 8 consists of three separate parts, or branches 21 , 22, 23 which are not connected between themselves.
  • Each branch 21 , 22, 23 is composed by circular members 6 1 , 6 2 , 6 3 similar in design to circular members 6 of the stent shown in Figs. 1 to 3.
  • circular members in each branch have their particular diameters, matched to a diameter of the vessel into which this branch is to be implanted, with the largest circular members being members 6 1 used in the part 21 corresponding to the zone immediately preceding the bifurcation.
  • the distances between adjoining circular members are made equal along each of the branches 21-23, but they are not equal for all these parts, the largest again being the distances between circular members 6-, in the part 21.
  • All circular members 6 1 , 6 2 or 6 3 of each branch 21 , 22, 23 are interconnected into a single string with the aid of a single connecting component 78 (in the branch 22) or (in the branches 21 and 23) with two connecting components 79 mutually displaced around the periphery of the branch.
  • the connecting component 78 connects the branches 22 and 23.
  • All connecting components 78, 79 employed in this embodiment of the stent of the present invention are formed as the thin bands similar to those employed in the embodiments of Figs. 4 to 6.
  • a method for manufacturing the stent according to the present invention will be described, starting with the stent embodiments illustrated by Figs. 1 to 6.
  • a set of unitary circular members, such as 2, 18 or 20 or their combination required to make a particular stent 1 is produced by any of suitable production method well known to those skilled in the art (and disclosed in a number of patents cited above) or by an appropriate combinations of these methods (especially in the case when the stent includes circular members of different configurations and/or of different materials).
  • all those members which must be connected into a string are mounted, in the expanded state, one by one, in the proper order onto a mandrel 40 of a substantially cylindrical shape shown in Fig. 9.
  • FIG. 9 For clarity, only two circular members 18 made as a simple metal rings are shown in Fig. 9. The distances between adjoining members are selected to be the same as the required distances between the same members in the implanted stent.
  • a shallow groove 42 is formed in a side surface 44 of the mandrel (for clarity, the depth of the groove in Fig. 9 is strongly exaggerated).
  • a shape and dimensions of the groove 42 in the transverse direction substantially coincide with corresponding parameters of the connecting component to be produced using this particular mandrel.
  • the mandrel 40 shown in the Fig. 9 is intended for manufacturing the string of the circular members in form of rings 18, which rings are connected by a thin band generally of the type indicated as 71 or 72 in Figs. 4 and 5. After all rings 18 are mounted to their intended locations, the mandrel 40 is fixed by any suitable means (not shown) in a horizontal position, with the groove 42 open upwards, with its bottom 46 oriented horizontally.
  • a special cover 60 is placed over the mandrel 40.
  • an inner surface of the cover is cylindrical and has a generally complimentary shape to the side surface of the mandrel 60.
  • a number of recesses or cuts 64 are made in the inner surface 62 (only two of them are shown in Fig. 9). These recesses are complimentary in shape to circular members 18 mounted onto the mandrel 40 and their dimensions are made approximately equal to (but slightly larger) than corresponding dimensions of the circular members.
  • a cut 66 or cuts is (are) made through a side surface 62 of the cover 60.
  • a shape and dimensions of this cut approximately correspond to those of at least one of the connecting components to be formed. It means that a cross-section of the cut in a transverse plane passing through upper edges of the groove 42 (when the cover 60 is placed over the mandrel 40) is similar in shape and has slightly smaller dimensions than those of the groove 42.
  • Either the mandrel 40 or the cover 60 or both are preferably supplied with guiding and latching means (not shown) to place and lock the cover in relation to the mandrel in a position, in which the cut 66 is located in close proximity and directly opposite in radial direction to the groove 42 (that is directly above the groove).
  • the cover 60 Owing to selection of the described shape and dimensions of the cover 60, it can fit very tightly over the mandrel, with no gaps remaining between the inner surface 62 of the cover and the side surface 44 of the mandrel 40. Evidently, with the cover 60 lowered onto the mandrel 40 as described, small upper segments 19 of rings 18 located above the groove 42 will extend through cuts 64. After the cover 60 is locked in the proper position, the step of connecting circular members 18 mounted onto the mandrel is performed. This step starts with applying a thin layer of an appropriate liquid material through the cut 66 on segments 19 of the rings 18 and on the bottom 46 of the groove 42. By making the width of the cut 66 less than the width of the groove 42 it becomes possible to make a thickness of an applied layer of the liquid material higher than the depth of the groove 42 and in this way to ensure that segments 19 are being covered by the liquid material from all sides.
  • the preferred process of solidification according to the present invention is polymerization.
  • a suitable heat treatment such as curing of the applied liquid material should be conducted, whenever appropriate. Curing or other suitable heat treatments employed for increasing the rate of polymerization process are well known to persons skilled in the art and amply disclosed in a number of publications. For that reason there is no need to describe them here. Also, standard and well-known equipment for implementing such heat treatment can be employed.
  • polymerization can be replaced by using a solution of appropriated polymer with subsequent vaporization of a solvent.
  • solutions of polyolefins in toluene or of silicone rubbers in heptane can be used for this purpose.
  • 50% polybuterate and 50% polyvalerate dissolved in chloroform may be recommended.
  • the process of manufacturing the string of interconnected circular members according to the present invention is complete.
  • the cover 60 is unlocked and taken away from the mandrel 40, so that the string of rings 18 connected by the formed thin band of flexible, non-rigid material can be removed from the mandrel 40.
  • materials for making the circular members, the connecting component, the mandrel and the cover must be selected in such a way that the material of the connecting component has a high adhesion to the material of the circular members (or materials, if they are produced from different materials) and a low adhesion to the materials of the mandrel and the cover.
  • appropriate additional measures can be employed, such as covering with appropriate coating(s) any or some of the mentioned parts in zones open to contact with the material of the connecting component.
  • this cover can be supplied with any number of cuts needed to produce a single string of the circular members comprising any suitable connecting component or several components or even two or more separate strings.
  • a cover with a single narrow slit is needed; while to make the stent of Fig. 4, the cover must have four cuts, two of them being slit-wide, while two other, located at both ends, being similar to the cut 66 shown in Fig. 9.
  • the grove or groves formed in the mandrel must match, both in shape and dimensions, all cuts made in the cover.
  • the means fixing the mandrel 40 in a position shall be unlocked and the mandrel shall be turned around its axis by an angle equal to an angle spacing of parts forming the connected component. In this way the next groove 42 will be placed in the upper position suitable for filling. After that the same cover or another cover having a cut of a required shape and dimensions is locked on the mandrel, so that the above-described step of applying a layer of a liquid material can be performed.
  • matched pairs of the mandrel and the cover having a large length, suitable for mounting a large number of circular members can be employed.
  • all circular members in this case should have the same shape and dimensions.
  • a string having a required number n (n > 2) of the circular members can be obtained by cutting or otherwise severing a connecting component connecting unitary circular members numbered n and n + 1 counting from any end of said mandrel.
  • the additional advantage of this approach is that it makes it possible to obtain, using absolutely the same equipment, strings containing any required number of circular members.
  • the same approach can be employed in production of strings containing a predetermined number of circular members. In this case corresponding sections of the cut or cuts formed in the cover may be closed prior to performing the step of connecting circular members.
  • the mesh 76 is attached to two circular members, such as rings 18, for example, by winding opposite ends of each thread 77 around corresponding ring 18. If the string 34 must include more than two circular members, then another length of the mesh 76 is provided and attached at one end to one of the connected members 18 and at the other end to the next circular member.
  • any number of circular members can be connected into a string, without any limitation to configurations and dimensions of employed circular members.
  • segments of the mesh 76 connecting different circular members can be made different in length, number of threads, an angle between crossed threads, etc.
  • productivity of this method may be limited by the necessity to attach a large number of threads to each of the employed circular members.
  • Both movable holders are made capable to rotate around this longitudinal axis and to move forward and away from said axis.
  • the movable holders are placed at different distances from said axis, so one of these holders may be considered as an external holder and the other one as an internal holder.
  • the external holder performs a stepwise turn around the common axis of the holders.
  • the holders change their positions relative to their common axis, with the external holder making a step inwards, and the internal holder making a step outwards. That is, the former internal holder becomes the external holder, and vice versa.
  • the described sequence of rotational and rectilinear motions of the holders is then repeated, starting with the step-wise turn of the holder which at the moment is the internal one.
  • the movable holders are stopped, and appropriate circular member, such as the ring 18, is inserted between two groups of threads 77 connected to the external and the internal holders correspondingly, until it butts against joints of the already formed mesh 76.
  • appropriate circular member such as the ring 18
  • the step-wise rotation is resumed, so that the mesh starts to form around the inserted ring 18 firmly holding it in the required position.
  • the next ring 18 is inserted, and so on.
  • a very long string 34 can be produced which then can be cut to a number of short strings containing a required number n of circular members.
  • one or several circular members can be installed in an inclined position relative to the axis of the stent. Employment of one or several strings, instead of separated circular members, substantially facilitates assembling all members on the balloon (especially if the connecting component in form of the mesh is used) in any required location and/or position, and at the same time ensures maximal flexibility of the stent.
  • the delivery of the stent of the present invention to the affected duct is performed by transporting the balloon 4 bearing the stent along the guide-wire 5, exactly in the same way as with standard prior art stents, so there is no need in detailed description of this step.
  • the high flexibility of the proposed stent and its lower rigidity in the axial direction due to the absence of any rigid links between the circular members, make it possible to navigate the stent easily through small, bend and/or tortuous pathways to the desired location.
  • the danger of dislocation of any circular member forming a part of the string is substantially less than in the case of employing completely separate, non-connected circular members.
  • Implantation of the stent 1 at a desired location consists in a radial expansion of the circular members by inflating the balloon 4 till circular members will come into contact with inner walls of the affected duct. This step is also performed exactly as with the prior art pressure expandable stents. In the initial period after the stent is implanted but before endothelial growth will reliably anchors the circular members to the walls of the vessel or other duct, the connecting component(s) help(s) to prevent (in the same way as metal links between members do in prior art stents) any undesired dislocations of the circular members relative to the vessel.
  • connecting components of the proposed stent being flexible, non-rigid and highly compatible with tissues of the stented duct, do not exert any adverse influence on the walls of the duct. This effect is especially pronounced in case the connecting component is made of a biodegradable material.
  • the connecting component or components in the form of band can be employed for a task of prolonged supply of an affected vessel by appropriate substances, such as drugs etc.
  • Substantially increased flexibility in selecting circular members composing the stent ensures the optimal radial strength of the stent along its entire length, and, what is also important, by combining in one stent circular members of various configurations, materials and/or dimensions, it becomes possible to meet this condition of optimal strength for a very wide range of types, forms and dimensions of affected ducts, including bifurcations, aneurysms, vessel ostiums, biliary ducts, etc., etc.
  • the final stages of manufacturing the stent of the present invention are so easy and flexible that, especially in unique or urgent cases, the stent can be produced from the available circular members directly in the clinic, according to the specification of a surgeon conducting the stenting operation and employing a procedure described above with reference to Fig. 9.
  • a surgeon conducting the stenting operation and employing a procedure described above with reference to Fig. 9.

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

Abstract

L'invention concerne un extenseur expansible sous pression, utilisé dans un vaisseau sanguin ou un autre canal du corps humain, qui possède une résistance circulaire élevée et une plus grande souplesse et qui réduit au minimum les effets indésirables. L'extenseur comprend plusieurs éléments circulaires unitaires (2, 18, 20, 26) de forme généralement cylindrique, faits à partir d'un alliage métallique approprié et disposés l'un après l'autre le long d'un axe longitudinal de l'extenseur. La totalité ou au moins une partie des éléments circulaires unitaires sont reliés les uns aux autres par un élément de liaison unique (7, 76) ou par plusieurs éléments de liaison (71, 72, 73, 74) faits d'un matériau biocompatible non métallique, non rigide, fin et souple. Dans un exemple favori, le matériau biocompatible non rigide se présente comme du polytétrafluoroèthylene. Un autre groupe de matériaux favoris est constitué de polymères biodégradables. Certains modes de réalisation préférés utilisent les éléments de liaison en forme d'un ou de plusieurs fils (7, 73, 75) ou de bandes minces (71, 72, 73). Dans un autre mode de réalisation préféré, on utilise en tant qu'élément de liaison une grille (76) constituée de plusieurs fils (77) d'un matériau biocompatible non rigide dans lequel chaque fil suit un tracé hélicoïdal. Dans l'un des modes de réalisation préférés du procédé de fabrication de l'extenseur, la fabrication d'une chaîne d'éléments circulaires interconnectés consiste en ce qui suit: (a) assembler entre eux les éléments circulaires (18) à raccorder, de manière à former une chaîne sur la périphérie d'un mandrin (40) de forme sensiblement cylindrique; (b) recouvrir de façon étanche ces membres circulaires unitaires (18) sur le mandrin au moyen d'un couvercle amovible (60) fait d'un matériau imperméable, ledit couvercle (60) comportant une ou plusieurs fentes traversantes (66) dont la forme et les dimensions correspondent à celles du ou des éléments de liaison à former; (c) et appliquer aux éléments circulaires unitaires (18) une couche de matière liquide en passant par la ou les fentes traversantes (66) faite(s) dans le mandrin (40); après solidification, cette couche forme le ou les éléments de liaison.
PCT/RU2000/000374 1999-09-22 2000-09-20 Extenseur souple expansible et procede de fabrication correspondant WO2001021101A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU75641/00A AU7564100A (en) 1999-09-22 2000-09-20 Flexible expandable stent and method for manufacturing the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU99121158/14A RU99121158A (ru) 1999-09-22 Способ протезирования сосуда или сосудистой бифуркации, стент для осуществления этого способа (варианты) и способ его изготовления
RU99121158 1999-09-22

Publications (1)

Publication Number Publication Date
WO2001021101A1 true WO2001021101A1 (fr) 2001-03-29

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WO (1) WO2001021101A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
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WO2003049641A1 (fr) * 2001-12-10 2003-06-19 Advanced Cardiovascular Systems, Inc. Endoprothese polymerique dotee d'anneaux metalliques
WO2003057075A2 (fr) * 2001-12-27 2003-07-17 Advanced Cardiovascular Systems, Inc. Stent intravasculaire hybride
WO2006029617A1 (fr) * 2004-09-17 2006-03-23 Optiray Medizintechnik Gmbh Prothese de renfort
EP2196175A1 (fr) * 2008-12-12 2010-06-16 Abbott Laboratories Vascular Enterprises Limited Endoprothèse toroïde couverte et procédés de fabrication
US8672995B2 (en) 2005-08-19 2014-03-18 C. R. Bard, Inc. Polymer prosthesis
US8926688B2 (en) 2008-01-11 2015-01-06 W. L. Gore & Assoc. Inc. Stent having adjacent elements connected by flexible webs
US9622888B2 (en) 2006-11-16 2017-04-18 W. L. Gore & Associates, Inc. Stent having flexibly connected adjacent stent elements
US10299948B2 (en) 2014-11-26 2019-05-28 W. L. Gore & Associates, Inc. Balloon expandable endoprosthesis
US10548749B2 (en) 2013-06-20 2020-02-04 Biiosensors International Group, Ltd. Vascular stent with a mixed configuration of connectors
US10568752B2 (en) 2016-05-25 2020-02-25 W. L. Gore & Associates, Inc. Controlled endoprosthesis balloon expansion
US11931484B2 (en) 2008-06-20 2024-03-19 Razmodics Llc Composite stent having multi-axial flexibility and method of manufacture thereof

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EP0634152A1 (fr) * 1993-06-15 1995-01-18 Esa Viherkoski Stent urétral biodégradable
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WO1998020810A1 (fr) * 1996-11-12 1998-05-22 Medtronic, Inc. Protheses intracavitaires souples radialement expansibles
EP0878174A2 (fr) 1997-05-15 1998-11-18 Jomed Implantate GmbH Extenseur coronaire
EP0884028A1 (fr) 1997-05-17 1998-12-16 Jomed Implantate GmbH Stent radialement dilatable pour le placement dans la zone bifurquée d'un vaisseau corporel
US5851228A (en) * 1995-06-01 1998-12-22 Meadox Medicals, Inc. Implantable intraluminal prosthesis
US5916264A (en) 1997-05-14 1999-06-29 Jomed Implantate Gmbh Stent graft

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US4580568A (en) 1984-10-01 1986-04-08 Cook, Incorporated Percutaneous endovascular stent and method for insertion thereof
US4665771A (en) 1984-10-15 1987-05-19 Mitchell Frank R Hypocyclic drive
US4733665C2 (en) 1985-11-07 2002-01-29 Expandable Grafts Partnership Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft
US4733665A (en) 1985-11-07 1988-03-29 Expandable Grafts Partnership Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4733665B1 (en) 1985-11-07 1994-01-11 Expandable Grafts Partnership Expandable intraluminal graft,and method and apparatus for implanting an expandable intraluminal graft
EP0634152A1 (fr) * 1993-06-15 1995-01-18 Esa Viherkoski Stent urétral biodégradable
WO1995017859A1 (fr) 1993-12-28 1995-07-06 Sergei Appolonovich Pulnev Extenseur
US5575818A (en) 1995-02-14 1996-11-19 Corvita Corporation Endovascular stent with locking ring
US5851228A (en) * 1995-06-01 1998-12-22 Meadox Medicals, Inc. Implantable intraluminal prosthesis
WO1997037617A1 (fr) * 1996-04-08 1997-10-16 Swaminathan Jayaraman Extenseurs interconnectes multiples et leur procede de revetement
WO1998020810A1 (fr) * 1996-11-12 1998-05-22 Medtronic, Inc. Protheses intracavitaires souples radialement expansibles
US5916264A (en) 1997-05-14 1999-06-29 Jomed Implantate Gmbh Stent graft
EP0878174A2 (fr) 1997-05-15 1998-11-18 Jomed Implantate GmbH Extenseur coronaire
EP0884028A1 (fr) 1997-05-17 1998-12-16 Jomed Implantate GmbH Stent radialement dilatable pour le placement dans la zone bifurquée d'un vaisseau corporel

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003049641A1 (fr) * 2001-12-10 2003-06-19 Advanced Cardiovascular Systems, Inc. Endoprothese polymerique dotee d'anneaux metalliques
US7674416B2 (en) 2001-12-27 2010-03-09 Advanced Cardiovascular Systems, Inc. Hybrid intravascular stent
WO2003057075A2 (fr) * 2001-12-27 2003-07-17 Advanced Cardiovascular Systems, Inc. Stent intravasculaire hybride
WO2003057075A3 (fr) * 2001-12-27 2004-01-15 Advanced Cardiovascular System Stent intravasculaire hybride
US6866805B2 (en) 2001-12-27 2005-03-15 Advanced Cardiovascular Systems, Inc. Hybrid intravascular stent
WO2006029617A1 (fr) * 2004-09-17 2006-03-23 Optiray Medizintechnik Gmbh Prothese de renfort
DE102004045224B4 (de) * 2004-09-17 2010-12-30 Thilo Dr. Fliedner Stützprothese
US8672995B2 (en) 2005-08-19 2014-03-18 C. R. Bard, Inc. Polymer prosthesis
US9622888B2 (en) 2006-11-16 2017-04-18 W. L. Gore & Associates, Inc. Stent having flexibly connected adjacent stent elements
US10456281B2 (en) 2006-11-16 2019-10-29 W.L. Gore & Associates, Inc. Stent having flexibly connected adjacent stent elements
US8926688B2 (en) 2008-01-11 2015-01-06 W. L. Gore & Assoc. Inc. Stent having adjacent elements connected by flexible webs
US9943428B2 (en) 2008-01-11 2018-04-17 W. L. Gore & Associates, Inc. Stent having adjacent elements connected by flexible webs
US11865020B2 (en) 2008-01-11 2024-01-09 W. L. Gore & Associates, Inc. Stent having adjacent elements connected by flexible webs
US11103372B2 (en) 2008-01-11 2021-08-31 W. L. Gore & Associates, Inc. Stent having adjacent elements connected by flexible webs
US11931484B2 (en) 2008-06-20 2024-03-19 Razmodics Llc Composite stent having multi-axial flexibility and method of manufacture thereof
EP2196175A1 (fr) * 2008-12-12 2010-06-16 Abbott Laboratories Vascular Enterprises Limited Endoprothèse toroïde couverte et procédés de fabrication
US11648136B2 (en) 2013-06-20 2023-05-16 Biosensors International Group, Ltd. Vascular stent with a mixed configuration of connectors
US10548749B2 (en) 2013-06-20 2020-02-04 Biiosensors International Group, Ltd. Vascular stent with a mixed configuration of connectors
US10299948B2 (en) 2014-11-26 2019-05-28 W. L. Gore & Associates, Inc. Balloon expandable endoprosthesis
US11285029B2 (en) 2014-11-26 2022-03-29 W. L. Gore & Associates, Inc. Balloon expandable endoprosthesis
US11857444B2 (en) 2014-11-26 2024-01-02 W. L. Gore & Associates, Inc. Balloon expandable endoprosthesis
US10543116B2 (en) 2014-11-26 2020-01-28 W. L. Gore & Associates, Inc. Balloon expandable endoprosthesis
US11779481B2 (en) 2016-05-25 2023-10-10 W. L. Gore & Associates, Inc. Controlled endoprosthesis balloon expansion
US10568752B2 (en) 2016-05-25 2020-02-25 W. L. Gore & Associates, Inc. Controlled endoprosthesis balloon expansion

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