EP2142140A1 - Implant, procédé et dispositif pour produire un implant de ce type - Google Patents

Implant, procédé et dispositif pour produire un implant de ce type

Info

Publication number
EP2142140A1
EP2142140A1 EP08734876A EP08734876A EP2142140A1 EP 2142140 A1 EP2142140 A1 EP 2142140A1 EP 08734876 A EP08734876 A EP 08734876A EP 08734876 A EP08734876 A EP 08734876A EP 2142140 A1 EP2142140 A1 EP 2142140A1
Authority
EP
European Patent Office
Prior art keywords
wall element
implant
elements
flow
profiled
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08734876A
Other languages
German (de)
English (en)
Inventor
Kirsi SCHÜSSLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Acandis GmbH and Co KG
Original Assignee
Acandis GmbH and Co KG
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 Acandis GmbH and Co KG filed Critical Acandis GmbH and Co KG
Publication of EP2142140A1 publication Critical patent/EP2142140A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/068Modifying the blood flow model, e.g. by diffuser or deflector
    • 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
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Definitions

  • the invention relates to an implant and to a method and a device for producing such an implant.
  • An implant with the features of the preamble of claim 1 is known, for example, from EP 1 153 581 A1.
  • vascular sections after stent implantation continues to be a major clinical problem despite numerous advancements in the field. It is generally recognized that neointimal hyperplasia is the main cause of restenosis following stent placement. Although the mechanisms responsible for the occurrence of restenosis have not yet been fully elucidated, damage to the endothelium and smooth muscle cells of the vessel wall due to stent implantation, reduced compliance through rigid stent structures, and shear stress change at the vascular wall (wall shear stress) of the stented vessel sections as a trigger for the neointimal hyperplasia and thus for restenosis.
  • the stented vessel sections not only lead to a change in the shear stress on the vessel wall, but also can promote the undesired formation of thrombi by changes in the hemodynamics of the natural blood flow. Furthermore, it is known that the formation of restenosis may be dependent on the stent geometry. In general, it is believed that low shear stress on the vessel wall promotes neointimal hyperplasia.
  • a stent is proposed in this connection, in the interior of which a flow cylinder arranged centrally in the longitudinal direction of the stent is fastened. Due to the reduced flow diameter between the flow cylinder and the surrounding wall of the stent, the flow velocity in the stent is increased, so that adjusts a steeper flow profile near the wall.
  • the attachment of the flow cylinder in the stent is problematic in terms of manufacturing technology.
  • the flow cylinder affects the flexibility of the stent.
  • WO 03/1057328 discloses a braided multilayer stent having a core for influencing hemodynamics inside. Also with this stent it comes manufacturing problems.
  • the invention has for its object to provide an implant with a wall element that is relatively easy to manufacture and improved in terms of reducing restenosis after implantation.
  • the invention further has the task of specifying a method and a device for producing such an implant.
  • this object is achieved with respect to the implant by the subject-matter of claim 1, with regard to the method by the subject-matter of claim 9 and with respect to the device by the subject-matter of claim 11.
  • the invention is therefore based on the idea of specifying an implant with a wall element, which comes into contact with a fluid in the implanted state, wherein the wall element is adapted to influence a flow behavior of the fluid.
  • the wall element is profiled discontinuously.
  • the invention uses a different approach than the stents, which cause a reduction in the effective flow diameter through a cylinder arranged in the flow channel.
  • the wall or a wall element is modified by a discontinuous profiling which influences the flow behavior. This has the advantage that no additional flow body, such as the flow cylinder, consuming connected to the wall Need to become. Rather, a cross-sectional constriction is achieved by the wall element itself by its discontinuous profiling.
  • the invention has the particular advantage that the shear stress on the vessel wall is increased by influencing the hemodynamics in the bloodstream, in particular by increasing the flow velocity, and thus inhibiting neointimal hyperplasia and restenosis. Furthermore, early endothelialization of the implant is promoted, which also has a positive effect, since it counteracts the occurrence of neointimal hyperplasia. Influencing the flow dynamics, in particular increasing the flow velocity, also inhibits the formation of thrombi.
  • the implant is particularly well suited for the treatment of aneurysms.
  • the narrow mesh size of aneurysm stents required to cover the aneurysm leads to negative side effects, such as restenosis and formation of thrombi. These undesirable side effects are avoided or at least less pronounced by the discontinuous profiling of the wall element.
  • the invention is not limited to stents, in particular intraluminal stents, but generally includes implants, in particular medical or endovascular implants, which are impinged by a fluid, or generally have a flow control function, such as stent grafts, protection filter etc.
  • the wall element on profile elements with discontinuously arranged inflow surfaces are not connected to each other continuously, but generally have abrupt transitions, so that the overall result is a discontinuous profile or a discontinuous contouring of the inside of the wall element.
  • Such a wall element or an implant with such a wall element can be produced easily and with comparatively low costs.
  • a particularly effective influencing of the flow behavior is achieved when the inflow surfaces have a main orientation which extends substantially in the flow direction.
  • the inflow surfaces can, with respect to the wall element, in each case be inclined and / or convexly curved and / or concavely curved. Due to the different design of the inflow, a different influence on the flow behavior can be adjusted.
  • the discontinuous profiling of the wall element is achieved in that the inflow surfaces each have an end remote from the wall element, in particular a free end, which protrudes in the implanted state in the fluid flow.
  • the profile elements can form a profile of the wall element that is serrated in cross-section. Such a cross-sectional profile can be produced in a simple manner.
  • the profile elements may form a pattern, in particular a helical pattern.
  • the pattern formation ensures that a desired flow behavior is impressed on the fluid over a longer flow path.
  • the wall element may comprise a grid structure with grid elements, such as webs, end bends, connectors and the like, wherein at least some of the grid elements for forming the leading surfaces are each arranged in a different plane than an inner surface of the wall element.
  • This design is particularly suitable for stents and is characterized by a production-friendly construction. There are no additional separate elements required to be connected to the stent to form a wall profile. Rather, the discontinuous profile is formed by the already existing grid elements, which are modified such that they are each arranged in a different plane than the inner surface of the wall element.
  • the inner surface of the wall element is therefore not continuous, but generally has a discontinuous profiled contour.
  • the method according to the invention for producing such an implant is based on the fact that the wall element is profiled intermittently to influence the flow behavior of a fluid which comes into contact with the wall element in the implanted state.
  • the wall element can be locally deformed such that discontinuously arranged inflow surfaces of the profile elements are formed.
  • FIG. 1 shows a cross section through a conventional implant without profiling, which is arranged on a forming tool.
  • FIG. 2 shows a cross section through an implant according to an inventive
  • FIG. 3 shows a schematic cross section through an implant according to an embodiment of the invention in the implanted state.
  • Fig. 4 is a plan view of the implant according to FIG. 3 (detail).
  • a conventional tubular stent is shown, which is arranged on a cylindrical mandrel as a shaping tool.
  • the design elements for example, the webs lie on a cylindrical surface and form a wall element 10 with an inner surface 10a and an outer surface 10b.
  • the inner surface 10a forms or delimits a flow channel through which blood flows in the implanted state.
  • the outer surface 10b abuts against the vessel wall in the implanted state and supports it.
  • the inner surface 10a forms a flat, non-profiled lateral surface. This means that all design elements (lands, connectors, end curves) in the same plane, i. are arranged in the lateral surface formed by the inner surface 10a.
  • the design elements or grid elements 14a of the implant according to FIG. 2 are arranged in a different plane than the inner surface 10a of non-profiled wall sections in such a way that the wall element 10 is profiled discontinuously.
  • the grid elements 14a form profile elements 11 with inflow surfaces 12 b ⁇ > ⁇ >. Deflection surfaces for deflecting the fluid flow in the implanted state. While the inner surface 10a of the stent according to FIG. 1 extends parallel to the longitudinal axis of the stent, the inner surface 10a of the implant according to FIGS. 2 to 4 is not arranged in sections parallel to the longitudinal axis. In particular, inner surface 10a is partially inclined or employed.
  • the respective inner surface 10 a of the protruding grid elements 14 a acts as inflow or deflection surface 12 for the fluid flow.
  • the inflow surfaces 12 of the various grid elements 14a and the profile elements 11 are arranged discontinuously and at least in the profile space, i. interrupted outside the unprofiled original lateral surface. This generally results in an abrupt or discontinuous transition between the profile elements 11.
  • Fig. 3 the discontinuous shape of the wall profile is clearly visible, wherein the profile elements 11 have peaks or ends 13 which protrude into the flow channel.
  • the ends 13 correspond to the end curves 16, which respectively connect adjacent webs 15.
  • the ends 13, and the end bends 16 are in the implanted state of the sections not profiled wall sections or of the wall sections, which mainly fulfill a support function in the implanted state, arranged radially inwardly spaced.
  • the inflow surfaces 12 have a main or preferential orientation, which extends substantially in the flow direction, as shown by the arrow S in Fig. 3. This means that the inflow surfaces 12 are set in the same direction and thus all have a substantially identical angle of inclination.
  • the inflow surfaces 12, or the associated grating elements 14a may be inclined, the inflow surfaces 12 themselves being straight or flat, as shown in FIG. Age- natively or additionally, the inflow surfaces 12, or the associated grating elements 14a may be concavely or convexly curved.
  • different angles of inclination for individual inflow surfaces 12 or different radii of curvature can be set.
  • the grid elements 14a are unidirectionally inclined or curved in the flow direction. Different geometry properties can be combined with each other, in particular combined in a pattern.
  • the lattice structure 14 of the stent according to the embodiment of the invention is particularly well recognizable.
  • the lattice structure 14 comprises webs 15, wherein at least some of the webs 15 or, in general, some of the web elements 14a for forming the inflow surfaces 12 are each arranged in a different plane than an inner surface 10a of the wall element 10 in a non-profiled region.
  • at least two webs 12 arranged downstream in the direction of flow S are bent radially inward with their end bends 16 or ends 13 or generally grid elements 14 a or protrude radially inwards.
  • the non-profiled regions are determined by the grating elements 14a arranged in the original lateral surface, in particular the end curves 16a, 16b.
  • the discontinuously profiled regions are formed by the bent or projecting grid elements 14a, in particular the webs 12 and end bends 16.
  • the inner surfaces 10a of the profiled and non-profiled regions of the wall element 10 form intersecting planes.
  • the profile elements 11 are part of the wall element 10 in the present example and differ from the wall element 10 by the inwardly projecting or exposed position or arrangement.
  • the deformation, ie the bending of the grid elements 14 a can take place in the region between two webs 15 bounding end curves 16, 16 a, wherein the web 15 in the Near one of the two end curves or, for example, in the middle of the web is bent, depending on how large the inflow area 12 thereby achieved should be.
  • This principle is applicable to the entire stent, with various patterns, for example a helical or spiral pattern, by appropriate placement of the profiling, i. the bent elements can be achieved.
  • the profiling extends over a certain length or partial length of the stent.
  • the hollow cylindrical overall shape of the stent is retained.
  • the profile elements 11 form local and discontinuously arranged constrictions of the flow diameter of the implant in the implanted state.
  • the wall element 10 is at least partially moved out of the surface originally formed by the wall element 10. This can be, for example. be done by., That s_die webs 15 are bent radially inwardly and / or radially outward. This ensures that the individual webs 15 are made relative to the original cylindrical lateral surface of the stent.
  • a shaping tool 18 according to FIG. 2 which has a correspondingly profiled mandrel.
  • the forming tool 18 according to FIG. 2 is at least two-parted and has an inner part 18b and an outer part 18a.
  • the outer profile of the inner part 18b and the réelleprof ⁇ l the outer part 18a are complementary, so that the shaping tool in the assembled state has a profile corresponding to the employee of the implant.
  • the wall element 10 or the implant can preferably be produced from a shape memory material, such as Nitinol.
  • a shape memory material such as Nitinol.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Optics & Photonics (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (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)

Abstract

L'invention concerne un implant comportant un élément de paroi (10) qui, à l'état implanté, vient en contact avec un fluide. Ledit élément de paroi (10) est adapté pour influer sur le comportement en écoulement dudit fluide. L'invention se caractérise en ce que l'élément de paroi (10) est profilé de manière discontinue.
EP08734876A 2007-03-30 2008-03-28 Implant, procédé et dispositif pour produire un implant de ce type Withdrawn EP2142140A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007015462A DE102007015462A1 (de) 2007-03-30 2007-03-30 Implantat sowie Verfahren und Vorrichtung zum Herstellen eines derartigen Implantats
PCT/EP2008/002509 WO2008119520A1 (fr) 2007-03-30 2008-03-28 Implant, procédé et dispositif pour produire un implant de ce type

Publications (1)

Publication Number Publication Date
EP2142140A1 true EP2142140A1 (fr) 2010-01-13

Family

ID=39587862

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08734876A Withdrawn EP2142140A1 (fr) 2007-03-30 2008-03-28 Implant, procédé et dispositif pour produire un implant de ce type

Country Status (4)

Country Link
US (1) US20100256733A1 (fr)
EP (1) EP2142140A1 (fr)
DE (1) DE102007015462A1 (fr)
WO (1) WO2008119520A1 (fr)

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KR101300437B1 (ko) 2004-05-25 2013-08-26 코비디엔 엘피 동맥류용 혈관 스텐트
US8623067B2 (en) 2004-05-25 2014-01-07 Covidien Lp Methods and apparatus for luminal stenting
AU2005247490B2 (en) 2004-05-25 2011-05-19 Covidien Lp Flexible vascular occluding device
US20060206200A1 (en) 2004-05-25 2006-09-14 Chestnut Medical Technologies, Inc. Flexible vascular occluding device
US8152833B2 (en) 2006-02-22 2012-04-10 Tyco Healthcare Group Lp Embolic protection systems having radiopaque filter mesh
US9301831B2 (en) 2012-10-30 2016-04-05 Covidien Lp Methods for attaining a predetermined porosity of a vascular device
US9452070B2 (en) 2012-10-31 2016-09-27 Covidien Lp Methods and systems for increasing a density of a region of a vascular device
US9943427B2 (en) 2012-11-06 2018-04-17 Covidien Lp Shaped occluding devices and methods of using the same
US9157174B2 (en) 2013-02-05 2015-10-13 Covidien Lp Vascular device for aneurysm treatment and providing blood flow into a perforator vessel
US10022252B2 (en) 2015-06-10 2018-07-17 Cook Medical Technologies Llc Spiral blood flow device with diameter independent helix angle
CN113317879B (zh) * 2021-05-28 2022-06-07 郑州大学第一附属医院 一种预测肝硬化患者tips术后支架再狭窄的试剂盒

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US5108417A (en) * 1990-09-14 1992-04-28 Interface Biomedical Laboratories Corp. Anti-turbulent, anti-thrombogenic intravascular stent
US5782905A (en) * 1996-05-03 1998-07-21 Zuli Holdings Ltd. Endovascular device for protection of aneurysm
GB9828696D0 (en) * 1998-12-29 1999-02-17 Houston J G Blood-flow tubing
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DE60012146D1 (de) 2000-05-09 2004-08-19 Endoart Sa Mit einem zentralen Deflektor versehenes vaskuläres Implantat
US6635083B1 (en) * 2001-06-25 2003-10-21 Advanced Cardiovascular Systems, Inc. Stent with non-linear links and method of use
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WO2008061185A1 (fr) * 2006-11-15 2008-05-22 Georgia Tech Research Corporation Manipulation d'écoulement dans des écoulements biologiques utilisant des générateurs de tourbillons

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Also Published As

Publication number Publication date
US20100256733A1 (en) 2010-10-07
DE102007015462A1 (de) 2008-10-02
WO2008119520A1 (fr) 2008-10-09

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