WO2010097235A1 - Implant médical possédant une structure de grille, dispositif médical, procédé pour leur fabrication, et procédé pour l'introduction de l'implant médical dans un système d'alimentation - Google Patents

Implant médical possédant une structure de grille, dispositif médical, procédé pour leur fabrication, et procédé pour l'introduction de l'implant médical dans un système d'alimentation Download PDF

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Publication number
WO2010097235A1
WO2010097235A1 PCT/EP2010/001213 EP2010001213W WO2010097235A1 WO 2010097235 A1 WO2010097235 A1 WO 2010097235A1 EP 2010001213 W EP2010001213 W EP 2010001213W WO 2010097235 A1 WO2010097235 A1 WO 2010097235A1
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WO
WIPO (PCT)
Prior art keywords
grid
webs
folding
lattice
expanded state
Prior art date
Application number
PCT/EP2010/001213
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German (de)
English (en)
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WO2010097235A9 (fr
Inventor
Giorgio Cattaneo
Original Assignee
Acandis Gmbh & Co.Kg
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Publication date
Application filed by Acandis Gmbh & Co.Kg filed Critical Acandis Gmbh & Co.Kg
Publication of WO2010097235A1 publication Critical patent/WO2010097235A1/fr
Publication of WO2010097235A9 publication Critical patent/WO2010097235A9/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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • 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
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs

Definitions

  • the invention relates to a medical implant with a lattice structure, a medical device and a method for the production thereof as well as a method for introducing a medical implant into a delivery system.
  • a generic implant having the features of the preamble of claim 1 is known for example from US 6,843,802 Bl.
  • the implant according to US Pat. No. 6,843,802 B1 is a self-expanding stent whose wall is formed from a lattice structure.
  • the grid structure comprises closed grid cells whose geometry determines the flexibility of the stent. Good flexibility is important to be able to implant the stent in tortuous vessels with small radii of curvature.
  • the geometry responsible for the flexibility in the implanted state is achieved by the elongated shape of the grid cells, which lead to an extension of the stent when deformed.
  • the geometry of the grid cells of the stent according to US Pat. No. 6,843,802 B1 has the disadvantage that compressing during crimping and introduction into a delivery system, for example a catheter, can distort the lattice structure. This makes it difficult to accommodate the stent in the delivery system.
  • the distortion of the lattice structure is particularly noticeable in the region of the connection between two lattice webs, ie in the region of a tip of a lattice cell (Tip) noticeable.
  • the outer area of the grid web expands particularly strongly.
  • the stretching of the grid web at its outer edge is greater, the wider the grid web is.
  • the overstretching is particularly pronounced when the angle of the grating is large.
  • a great angle is for flexibility decisive. This increases the force required for the deformation of the lattice structure while reducing the opening angle of the individual lattice cells, and the crimping process is made more difficult. This applies not only in the connection region of two grid bars, but everywhere where the grid web undergoes a deformation.
  • grating structure for crimping can be achieved by reducing the width of the grating webs.
  • thin grid webs have the disadvantage that they are difficult to produce with conventional processes, for example by laser cutting.
  • the radial force of such lattice structures which acts in the implanted state on the vessel wall, so that it may lead to insufficient expansion of the vessel, e.g. comes in a stenosis or in the expansion of a thrombus.
  • Thin grid bars also lead to a low coverage of the vessel wall. The narrower the grid bars are, the larger the unprotected, uncovered area of the vessel wall.
  • Particles may detach from the stenosis or thrombus and coils may migrate into the vessel.
  • Very thin grid bars can cut into the vessel wall.
  • the forces acting on the vessel wall are concentrated on a small bridge surface, which promotes inflammatory reactions.
  • the invention is based on the object to improve a medical implant of the type mentioned so that the implant is easy to insert into a delivery system and has good mechanical properties in the implanted state.
  • the invention is further based on the object to provide a method for producing such an implant and a method for introducing a medical implant into a delivery system.
  • this object with regard to the medical implant by the subject-matter of claim 1, with regard to the medical device by the subject-matter of claim 22, with regard to the method for producing such an implant by the subject-matter of claim 18 and with respect to the Method for introducing an implant into a delivery system by the subject-matter of claim 21.
  • the invention is based on the idea to provide a medical implant with a lattice structure comprising lattice webs and for insertion into a delivery system in a compressed state and implanted in a expanded state is convertible.
  • the lattice webs each have a longitudinal extent and a transverse extent and are foldable along their longitudinal extent such that the lattice webs are folded in the compressed state and unfolded in the expanded state.
  • the transverse extent of the unfolded grid bars in the expanded state is greater than the transverse extent of the folded grid bars in the compressed state.
  • the unfolded grid bars in the expanded state form a covering surface.
  • the foldable grid bars are thus adapted such that they assume a folded or folded configuration in the feed system.
  • the foldable lattice webs assume an expanded, wide configuration that results in good coverage of the vessel wall.
  • the foldable grid bars thus fold in the implanted state, i. in the at least partially expanded state in the vessel other than in the compressed state or during crimping for insertion into a delivery system such as a microcatheter.
  • the invention combines both the advantage of good crimpability and the small crimp dimensions with the advantage of the large coverage area in the implanted state by wide grid webs. This is made possible by the longitudinal foldability of the grid webs according to the invention.
  • the improved crimpability of the implant according to the invention is also favored by the nature of the expansion of the implant from the crimped to the expanded state, which occurs in other ways than in conventional stents.
  • the transition between the crimped and expanded state not only leads to a deformation of the web in the longitudinal direction, but also to a change or deformation of the grid web in cross section. This is an overstretching of the grid bars in the outer area during crimping and the associated Longitudinal deformation avoided or at least reduces the risk of such overstretching.
  • the invention allows a greater deformation of the grid structure or the grid webs, which is facilitated by a simultaneous deformation, or tapering of the cross-sectional profile of the webs.
  • the web thus fulfills the requirements of a broad bridge in terms of coverage, force distribution and vessel protection.
  • the invention makes use of the advantages of a thin structure.
  • a further advantage of the invention is that the longitudinally foldable grid webs in the deployed state of the expanded implant have a flat or at least approximately flat cross-sectional profile and do not or only slightly protrude into the lumen or into the flow cross-section. This has a positive effect on the flow conditions. Thick webs, on the other hand, disturb the blood flow and swirls or dust areas can form behind the web. With conventional webs, the web thickness can only be reduced to a limited extent, otherwise the stability required for crimping will not be achieved and the webs distorted or twisted.
  • the folding webs can be formed with a small thickness or wall thickness, ie with a low radial extension, which improves the flow properties, without the crimping stability is impaired.
  • the folding web can increase the radial force acting on the vessel wall in the implanted state by virtue of the fact that the folding mechanism generates an additional restoring force in the cross-sectional plane.
  • the grid webs at least in sections each have at least two folding sections, which are at least partially connected in the longitudinal direction of the respective grid web and movable relative to each other for folding the grid web.
  • the formation of the lattice webs with two folding sections offers a possibility of changing the width of the lattice webs by a relative movement of the folding sections relative to one another such that the lattice webs have a reduced transverse extent in the folded state and an increased transverse extent in the expanded state.
  • the grid bars can be profiled at least in sections.
  • the grid webs may at least partially have a V-shaped cross-sectional profile.
  • the profiling of the grid webs acts as a folding means, which initiates the folding process of the grid bars in a deformation of the grid structures, so that the transverse extent of the grid bars during crimping or during expansion is variable.
  • the at least partially provided V-profile is particularly easy to manufacture and allows a simple and reliable functioning folding movement through the folding sections.
  • the grid webs have a folded edge arranged in the longitudinal direction of the respective grid web.
  • the folding edge represents a possibility to set a predetermined folding structure of the grid bars.
  • the fold edge may connect the fold sections, the fold edge forming the bridge base about which the fold sections are pivotable.
  • the folding edge and the folding sections have different opening angles at least in the expanded state. This ensures that the folding sections are movable in a large area relative to each other, so that in the implanted state, a large coverage area and in the compressed state, a small crimp dimension is achieved.
  • the distance of the folding sections of a grid web can be smaller in the compressed state than in the expanded state, wherein the folding sections are close to each other, so that a compact shape in the compressed state of the implant is achieved.
  • the folding sections of a GitL bar can abut each other in the compressed state, whereby particularly small crimp dimensions are achieved.
  • the folding sections can be arranged at least in sections in the circumferential direction of the grid structure and the Cover form. This ensures that the folding sections create a flat surface against the vessel wall and fulfill the support function in the implanted state.
  • the folding sections in the expanded state of rest have the shape of the vessel.
  • the lattice structure is oversized relative to the vessel diameter. Due to the residual radial force, the folding sections can bear against the vessel wall under deformation. It is advantageous in that the folding sections, or at least one outer region of the folding sections is flexible and can adapt to the profile of the vessel.
  • the folding sections can be connected in the implanted state by the folding edge, which interrupts the covering surface formed by the folding sections.
  • the folding edge is thus formed so that it is present in the partially expanded state and forms a cavity to the vessel wall out, which can be used for example for the storage of drugs.
  • the folding sections can be stretched in the implanted state such that the folding sections form a continuous covering surface.
  • a particularly large coverage of the vessel wall, a broad application of force and a small extension of the web is achieved in the vessel lumen.
  • the grid webs may be formed in their longitudinal extent at least partially rectilinear and / or curved, in particular multiple curved with the same and / or different radii. This makes it clear that the foldability of the grid bars is applicable to different configurations of the grid structure, so that the underlying principle of the foldability of the invention is flexible in different implant types or grid structures used.
  • the grid bars may include tips and / or connectors connecting two or more adjacent longitudinal bars.
  • the foldability of the grid webs is not limited to the longitudinal webs, but also in the region of the connections between the Lekssst ⁇ gcn, ie in the range of tips and / or connectors applicable, whereby the flexibility of the grid structure during crimping is further improved.
  • the grid bars are partially interrupted and form Faltaus Sammlungsstellen.
  • the Faltaus Sammlungsstellen allow a relative movement of the folded portions of the grid bars, in particular in Longitudinal direction of the grid webs, so that the folding sections can dodge in the region of Faltaus Sammlungsstellen. As a result, the longitudinal foldability of the grid webs is further improved.
  • the Querersteckung the grid bars may be different sizes in the expanded state sections. This also further improves the foldability of the grid bars, since the folding function can be limited, for example, to the areas of the grid bars or the grid structure in which a large covering area is particularly effective. Other areas of the lattice structure that are more difficult to fold on the other hand can be left out.
  • the transverse hemming of the grid bars in the area of the tips and / or the connectors can be smaller than in the area of the longitudinal bars.
  • the foldability is improved, since due to the geometry of the tips and / connectors in these areas, the folding is more difficult than in the region of the longitudinal webs and due to the relatively smaller coverage area, the effect of covering the vessel wall is less than in the region of the longitudinal webs.
  • the grid webs can be reinforced in the middle region between two adjacent covering surfaces, in particular in the region of the folded edges.
  • the material safety is improved during the folding process, since the deformation caused by the folding of the grid bars occurs particularly strong in the central region between two adjacent covering surfaces, in particular in the region of the fold edges.
  • the area at the lateral edge of the web, which serves as a folding section and cover (outside), may be thin-walled in such a way that an adaptation to the vessel wall is achieved.
  • the lattice webs may have a surface structuring, in particular in the region of the covering surface.
  • the invention is further based on the idea of specifying a method for producing an implant, in which a grid structure is produced with grid bars, which have a longitudinal extent and a transverse extent.
  • the lattice structure is adapted in such a way that it can be converted into a compressed state for insertion into a delivery system and into an expanded state for implantation.
  • the grid webs are adapted such that they are foldable along their longitudinal extent such that the grid webs in the compressed state folded and unfolded in the expanded state.
  • the transverse extent of the unfolded grid bars in the expanded state is greater than the transverse extent of the folded grid bars in the compressed state and the folded grid bars in the expanded state a covering surface.
  • the grid bars are deposited on a profiled substrate by a PVD method, in particular by sputtering.
  • PVD methods in connection with profiled substrates makes it possible in a simple manner to realize the foldability of the grid webs, since the profiled cross section of the substrate is imaged during the deposition of the material for the grid webs in the geometry of the grid webs and forms the folding profile.
  • PVD processes make it possible to produce very thin webs, which is particularly advantageous in the area of folding sections.
  • a continuous layer is deposited on the profiled substrate, etched into the formation of the grid bars, or the grid structure, in particular lithographically etched.
  • the manufacturing process is further simplified because the PVD process is decoupled from the actual structuring of the layer.
  • the invention is further based on the idea of specifying a method for introducing an implant into a delivery system, wherein the implant has a lattice structure comprising lattice webs with a longitudinal extent and a transverse extent.
  • the grid structure is converted from an expanded state into a compressed state and introduced into the feed system.
  • the invention relates to a medical device, in particular for removing concretions from hollow organs of the body or for recanalizing hollow organs of the body, with a lattice structure comprising lattice webs.
  • the medical device is for introduction into a delivery system in a compressed state I and for treatment in a hollow body organ in an expanded state II convertible.
  • the lattice webs each have a longitudinal extent and a transverse extent, wherein the lattice webs are foldable along their longitudinal extent such that the lattice webs are folded in the compressed state I and unfolded in the expanded state II.
  • the transverse extent the unfolded grid bars in the expanded state II is greater than the transverse extent of the folded grid bars in the compressed state I.
  • the unfolded grid bars form a covering area in the expanded state II.
  • devices for removing concrements for example thrombus removal systems or thrombectomy devices, baskets, in particular suction baskets, for catching or catching thrombi or, in general, concrements, are disclosed as medical devices.
  • the medical device may include systems for recanalizing hollow organs of the body, such as recanalization systems, filters, for example for the treatment of carotid stenosis, and / or occlusion systems.
  • Fig. Ia a cross section through a foldable grid web in the expanded
  • Fig. Ib is a cross section through the web of FIG. I a in the compressed
  • Fig. 2a shows a cross section through three foldable grid bars in the implanted
  • Fig. 2b shows a cross section through the grid bars according to Fig. 2a in the compressed
  • FIG. 3a shows a cross section through a substrate with a layer deposited thereon for producing the grid webs
  • FIG. 3b shows the substrate according to FIG. 3a with a structured layer from which the
  • Grid bars are etched out
  • 3c, 3d further process examples for the production of the grid webs
  • FIG. 4a shows a cross section through a deposited layer substrate for the alternative production of the lattice webs
  • FIG. 4b shows a cross-section through a substrate with a layer deposited thereon, which is reinforced in the region of the fold edge;
  • 5a shows a cross section through a foldable grid web after another
  • FIG. 5b shows a cross section through the grid web according to FIG. 5a in a vessel with a large diameter
  • FIG. 5c shows a cross section through the grid web according to FIG. 5a in a vessel with a relatively smaller diameter
  • Fig. 6 is a perspective view of a section of a foldable
  • Fig. 7 is a perspective view of a section of a foldable
  • Fig. 8a, 8b a comparison of the grid web of Figure 6 in the unfolded and in the folded state.
  • Fig. 9a, 9b a comparison of the grid web of Figure 7 in the unfolded and in the folded state.
  • FIG. 10 is a perspective view of a section of a grid web with a curved geometry.
  • FIG. 11 shows a perspective view of a detail of a grid web with folding sections arranged in sections
  • FIG. 12 is a perspective view of a section of a grid web with surface-structured folding sections
  • FIG. 13 shows a cross section through a foldable grid web after another
  • Fig. 14a, 14b a comparison of two grid structures with wide and narrow grid bars
  • 15 is a schematic representation of a stent according to an embodiment of the invention in the implanted state.
  • 16a, 16b show an arrangement of four diamond-shaped grid cells for explaining the flexibility that can be generated by the grid structure
  • 17a, 17b show two different states of deformation of the arrangement according to FIGS. 12a, 12b and
  • 18a, 18b an arrangement of four diamond-shaped grid cells with different diamond angles.
  • the implant may be a stent used to treat stenosis, thrombosis, or aneurysms.
  • the invention is preferably suitable for use in stents, without being limited thereto.
  • the invention is also applicable to other medical implants having a grid structure comprising grid bars suitable, for example thrombosis scavengers, filters and the like. Implants are therefore also devices and instruments that are used temporarily within the body, such as thrombus.
  • the grid structure may include open or closed grid cells that allow flexibility of the grid structure to conform to the vessel shape.
  • the lattice structure may include, for example, diamond-shaped cells, without being limited thereto. An example of such closed cells is given in FIGS. 16a, 16b.
  • the invention is applicable to all grid structures in which the flexibility is based on a deformation mechanism of the grid cells.
  • the deformation mechanism can be, for example, that the grid cells are elongated during deformation.
  • FIGS. 16a, 16b An example of this is shown in FIGS. 16a, 16b. It can be seen that the individual grid cells of the grid structure deform, i. during the transition from the configuration according to FIG. 16 a into the configuration according to FIG. 16 b in the longitudinal direction of the implant, in particular of the stent.
  • the flexibility that can be achieved in this way is used, as shown in FIG. 15, to insert the stent or, in general, the implant into vessels which have a high curvature, for example in the region of a bifurcation.
  • the deformation mechanism as shown in Figs. 16a, 16b.
  • the deformation also serves to adapt the grid structure to the vessel wall / or to the wall of the cavity. Beyond lengthening / shortening, the grid cell undergoes a reduction / increase in circumferential extent so that the entire perimeter of the grid can change and adapt to the wall.
  • the largest possible opening angle ⁇ is advantageous, since a comparatively large elongation is then achieved with a relatively small change in the angle of the opening angle of the grid cell.
  • FIGS. 17a, 17b show that the elongation of the grid cell is achieved by 40% at a large opening angle ⁇ in the undeformed state by a smaller angle change (FIG. 17b) than in a grid structure with one smaller opening angle ⁇ in the undeformed state (Fig. 18b). In the latter case, a larger angle change is required to achieve the desired elongation of 40%.
  • the possibility of Extension limited, because small deformations already lead to the maximum extension of the grid cell, in which the opening angle approaches a value of 0 °.
  • a large opening angle ⁇ in the undeformed state is advantageous for the flexibility in the vessel. This applies if, as shown in FIGS. 17 a, 17 b, a limited angle change for the vessel flexibility is realized and the opening angle ⁇ in the implanted state is relatively large.
  • a very small opening angle ⁇ is set in the deformed state, which is required to bring the stent or generally the implant into a compressed state, wherein the crimp diameter is sufficiently small to be in the feeding system to be introduced.
  • the grid cell undergoes a relatively large change in angle when the opening angle ⁇ in the undeformed state is large. This can lead to a strong distortion of the lattice structure during crimping. To avoid this distortion, the material of the webs can be reduced, so that the web width is lowered. However, this leads to the problems mentioned in the introduction of thin webs.
  • the invention therefore takes a different approach and suggests, as exemplified by the embodiment of FIG. Ia, Ib, 2a, 2b, to design the grid bars 11 foldable.
  • the strong deformation of the grid cells during crimping is compensated by the folding movement of the grid bars 11, whereby a distortion of the grid structure 10 during crimping is reduced.
  • the foldability of the lattice webs 11 ensures that they form a broad covering surface 12 for the vessel wall G in the implanted state.
  • the lattice webs 11 illustrated in FIGS. 1, 2 are elements of the lattice structure of a medical implant, which have a transverse extent Hb and a longitudinal extent I Ia.
  • the transverse extent Ib is designated in the cross-sectional view according to FIG. 1 and the longitudinal extent Ha in FIG. 6 in each case with the double arrow.
  • the longitudinal extent Ha describes the extent of the web in the longitudinal direction, ie the web length, which may be straight or curved.
  • the transverse extension Hb describes the extension of the web in the transverse direction, so the web width.
  • In the grid bars 11 are generally elongated elements which are distributed over the circumference of the implant and in places to form the Grid structure 10 are interconnected.
  • An example of grid webs 11 in the region of a connection point is shown in FIG. 6. It can be seen that a tip 15 (tip) connects two longitudinal webs 16.
  • the tip 15 is curved and the longitudinal webs 16 are formed in a straight line.
  • the invention is not restricted to curved or straight lattice webs 11, that is to say encompasses all possible geometries of the webs, that is to say multi-lattice webs, as shown in FIG.
  • the individual lattice webs 11 have an outer side 20 and an inner side 21.
  • the outer side 20 is in the implanted state in direct contact with the vessel wall G and supports it.
  • the inside 21 of the lattice web 11 is oriented radially inwards and limits the lumen of the implant or the stent.
  • the transverse Hb corresponds to the width of the grid webs on the one hand in the expanded state (Fig. Ia) and on the other hand in the compressed state (Fig. Ib) and is variable between the two states.
  • the grid webs 11 as shown in FIG. 1, 2 along its longitudinal extent I Ia foldable.
  • the grid webs 11 each have at least two folding sections 12a, 12b which extend in the longitudinal direction L of the respective grid web 11 (FIG. 6).
  • the two folding portions 12a, 12b are formed so that they are movable relative to each other for folding.
  • the folding sections 12a, 12b are connected to one another in the longitudinal direction L of the respective grid web 11, in particular in sections, the connection point between the folding sections 12a, 12b acting as a type of joint about which the folding sections 12a, 12b are pivotable.
  • the connection between the two folding sections 12a, 12b can be effected, for example, by a folding edge 14, which is arranged substantially centrally between the two folding sections 12a, 12b.
  • the folding edge 14 extends in the longitudinal direction L of the respective grid web 11.
  • the folding edge 14 acts as a folding means and is in the expanded state II before such that the folding edge 14 during compression of the stent triggers the folding process of the individual grid bars.
  • the folding edge 14 and the folding portions 12a, 12b have different opening angles ⁇ l, ⁇ 2, wherein the opening angle ⁇ 2 between the folding portions 12a, 12b is greater than the opening angle ⁇ l of the folding edge 14.
  • the angle of the folding sections and the folding edge can be the same size.
  • the folding sections and the legs of the folding edge are then each arranged in a plane. Also in this case, an additional radial force, caused by the elastic deformation of the folding sections is exerted on the vessel wall in the implanted state.
  • the folding sections can be connected, the folding edge forming a contact point, for example, in the form of a rounded profile between the two folding sections.
  • the folding sections 12a, 12b are arranged in the circumferential direction U of the lattice structure 10 and form the covering surface 12.
  • the folding edge 14 connecting the folding sections 12a, 12b interrupts the covering surface 12 formed by the folding sections 12a, 12b , This results in cavities 22 between the unfolded grid bars 11 and the vessel wall G, which can be used for example for the storage of drugs.
  • the grid bars 11 are folded such that the transverse extent Hb of the folded grid bars 11 is smaller than the transverse extent Hb of the unfolded grid bars 11 in the expanded state II.
  • the space requirement of Grid webs 11 reduced during crimping, so that, as shown in Fig. 2b, the system can be brought to a relatively small crimp diameter.
  • the grid webs 11 are at least partially profiled such that they are foldable.
  • this profiling is achieved by a V-shaped cross-sectional profile, wherein the two outwardly directed legs of the V-shaped profile form the folding portions 12a, 12b.
  • the base or bottom of the V-shaped profile between the two folding sections 12a, 12b forms the folding edge 14, about the longitudinal axis of which the folding sections 12a, 12b are pivotable.
  • the exemplary embodiments shown are lattice webs formed in one piece or in one piece, in which the cover, that is to say the folding sections 12a, 12b, merges continuously into the base of the lattice web 11 or into the folded edge 14. It is also possible to replace the Ia, the Prof ⁇ ltechnik form with a single opening angle such that a simple V-shape of the lattice web 11 is formed in contrast to the double-V shape of FIG. Ia. Angles between the embodiment of FIG.
  • FIG. 5a represents a lattice tegprofil with flatter outer areas or flatter folding sections 12a , 12b as the folding sections 12a, 12b shown in Fig. Ia.
  • the angle between the folding means 12 and one of the folding sections 12a, 12b and / or along the folding section 12a, 12b can change from the inside to the outside. Viewed in the direction of the transverse extent, different areas with different angles can be provided.
  • a continuous change of the angle in the region of the folding means 12 and / or the folding portion 12a, 12b may be formed.
  • the continuous change in angle can lead to a rounded shape of the web profile, in particular in the region of the folding means 12.
  • the shape of the grid webs automatically adapts to the vessel diameter.
  • the shape of the ridge in a large diameter vessel resulting in a relatively small radial force is shown in Fig. 5b.
  • the folding sections 12a, 12b are stretched and the folding edge 14 is flatter than for large diameter vessels, so that a greater radial force acts on the vessel wall ( Figure 5c).
  • Figure 5c the V-shaped profiling of the lattice webs 11 in their longitudinal direction L, not only is the foldability of the lattice webs achieved, but also their adaptation to different vessel diameters or vessel wall shapes.
  • the dimensions of the grid bars are in principle freely selectable. Thicknesses have proved particularly favorable . 25, ⁇ . 20, ⁇ . 15, ⁇ . 12, ⁇ . 10, ⁇ . 7, ⁇ 5 ⁇ m proved.
  • the values mentioned above can be found over the entire web, in particular the mentioned Transverse cover I Ib present or at least in the region of the folding sections 12a, 12b.
  • the web thickness can alternatively ⁇ . 100, ⁇ . 80, ⁇ 70, ⁇ 60, ⁇ 50, ⁇ . 40, ⁇ 30 microns.
  • the web thickness can be variable over the transverse extent Hb and / or over the longitudinal extent I Ia.
  • the wall thickness in the region of the folding edge is greater than in the region of the folding sections, (FIG. 4 b), which is advantageous for the stability of the structure.
  • the wall thickness can also be greater in the area of the folding sections than in the area of the folding edge. This leads to an improved foldability of the fold edge with smaller forces.
  • the length of the folding sections 12a, 12b is designated A in FIG. 13 and may be ⁇ 20, ⁇ 30, ⁇ 40, ⁇ 50, ⁇ 60, ⁇ 70 ⁇ m, in particular for grid diameters of less than or equal to 5 mm. In particular for grating diameters less than or equal to 12 mm, A> _ 50 ⁇ m> . 100 ⁇ m:> 150 ⁇ m ⁇ 200 ⁇ m ⁇ 250 ⁇ m ⁇ 300 ⁇ m. In the case of symmetrically foldable grid bars, the lengths A apply to both folding sections 12a, 12b.
  • the folding edge 14 forms, as shown in Fig. 13, a base of the web with two legs V-shaped arranged. This applies to all of the embodiments disclosed in the context of this application, that is also independent of the dimensions given below. It has proven to be expedient if the length S of a leg of the web base or of the folded edge is 14> 5,> 10,> 20,> 30 ⁇ m.
  • the ratio of the transverse extent Ha or the web width B according to FIG. 13 in the crimped state, ie in the compressed state I and in the expanded state II, ie at rest, can be ⁇ 50%, ⁇ 40%, ⁇ 30%, ⁇ 20%, ⁇ 10 %.
  • FIGS. 6 and 10 to 12 Further exemplary embodiments, which differ in the geometry of the grid webs, are shown in FIGS. 6 and 10 to 12.
  • FIG. 6 is the basic shape of the grid webs 11, in which two rectilinear longitudinal webs 16 with a tip 15th are connected.
  • the tip or tip 15 is curved and has two folding sections 12a, 12b, which are likewise curved.
  • the folding sections 12a, 12b of the individual web sections 15, 16 are connected to one another and form a continuous folding section, which is arranged laterally on both sides of the grid web 11 and forms its outer regions. Between the folding sections 12a, 12b of the section of the grid web 11 shown in FIG. 6 in the expanded state of rest, the folding edge is shown
  • the folding edge 14 arranged in the form of a web base.
  • the folding edge 14 is continuous in the interconnected web portions, i. the longitudinal webs 16 and the connection point 15 is formed.
  • the folding edge 14 is likewise rectilinear, as are the folding sections 12a, 12b, which extend in the longitudinal direction of the longitudinal webs 16.
  • the folded edge 14 follows the curvature of the connection tip
  • the tip 15 may also represent the connection to the longitudinally arranged cell.
  • the folding sections 12a, 12b, or the outer folding section of the respective cell on the tip 15 represent a continuous folding section with the outer folding section of the longitudinally adjacent cell.
  • FIG. 7 has all the features of the embodiment of FIG. 6 and additionally includes Faltausretes make 17 in the region of the connection tip 15.
  • the Faltausretes make 17 interrupt the folding sections 12a, 12b in the region of the junction 15 and each form a wedge-shaped recess the inner radius and / or outer radius of the connection tip 15th
  • the longitudinal webs 16 are repeatedly curved, in particular S-shaped curved. It is clear that the invention is not only applicable to straight grid bars, but the shape of the grid bars or their longitudinal extent is arbitrary selectable.
  • the transverse extent Hb of the lattice webs 11 in the expanded state II is in sections of different sizes. Specifically, the transverse extent Hb of the grid webs 11 in the region of the tips 15 is smaller than in the region of the longitudinal webs 16.
  • the cover formed by the unfolded folding sections 12a, 12b is limited to the straight web areas, in particular on the longitudinal webs 16.
  • the curved web areas for example in the region of the connection point or connecting tip 15 no folding sections 12a, 12b are provided.
  • the covering surface 12 formed in the unfolded or expanded state II is wider at the points where the deformation of the web during crimping is small, in particular in straight web sections.
  • the covering surface 12 is narrower or completely omitted in the expanded state II. As a result, the mechanical stress on the cover surface or the web cover is reduced.
  • the width or transverse extent Hb of the lattice webs which determines the size of the covering surface 12, can be designed so variable along the longitudinal direction of the lattice web that optimum interaction between high radial force (broad web portions) and great flexibility and crimpability (thin web portions) is achieved.
  • the covering surface 12 may be selectively provided with complex profiles in some places.
  • the tip represents a connection between cells arranged in the longitudinal direction of the implant and in this region the width of the continuous folding section is reduced or the folding section is omitted in this area.
  • the covering surface 12 has a surface structuring, for example in the form of openings or perforations.
  • Other surface structures including closed structures, suitable for improved endothelialization may be provided.
  • the geometry of the surface structures, in particular the openings is arbitrary. For example, structures or openings with dimensions between 5 and 100 ⁇ m, in particular between 10 and 60 ⁇ m, in particular between 20 and 30 ⁇ m, are suitable for good cell growth.
  • In the region of the longitudinal webs 16 slots 19 may be provided.
  • circular openings 19 may be provided.
  • the perforations also ensure better circulation of lateral vessels.
  • the profiled grid bars 11 behave differently in the vessel as well as during crimping than conventional stents.
  • the entire web folds along its longitudinal extension Ha as shown in Figs. 8a, 8b and Fig. 9a, 9b. It happens to a relative movement between the folding portions 12a, 12b, which are moved towards each other during crimping.
  • the width of the grid webs or their transverse extent Hb is reduced, as shown clearly in FIGS. 8b, 9b. In this way, the crimp diameter is reduced despite a high number of webs with wide covering surface 12.
  • the expansion of the stent from the crimped to the expanded state I, II is carried out in a different manner than in conventional stents.
  • the deformation that occurs at the transition between the crimped and expanded configuration not only by the deformation of the grid web in the longitudinal direction, but also by an effect on the transverse extent deformation of the grid web in Cross-section.
  • the V-shaped profiling of the lattice webs associated with the deformation elongation of the lattice webs 11 is transferred in a different manner than before to the cross section. Due to the shape of the V-profile, a high force can be generated despite low deformation.
  • the deformation of the V-profile can also be done with a large diamond deformation or deformation of the grid cell without overstretching.
  • the deformation of the V-profile takes place along the entire length of the web and is not concentrated on specific areas, as in a conventional design at the junction between two webs (connecting tip). As a result, webs of smaller wall thickness can be made without overstretching the deformation of the V-profile.
  • FIGS. 3a, 3b, 3c, 3d With regard to the method for producing the foldable grid webs, reference is made to FIGS. 3a, 3b, 3c, 3d and FIGS. 4a, 4b.
  • the profiled grid webs in particular the V-shaped profiled grid webs are produced by a PVD method, in particular by sputtering.
  • a substrate S for example made of a sacrificial material, is provided, which images the negative profile of the implant to be produced, in particular of the stent.
  • the production of the profile of the sacrificial material can be done for example by a galvanic, a lithographic, impression or LIGA method.
  • a layer is deposited on the substrate S to form a thin-walled, V-shaped grid web. The layer thickness can be set as thin as desired, in particular by sputtering.
  • the individual grid bars are separated.
  • a suitable method for structuring the grid bars is lithographic etching.
  • FIGGS. 3c, 3d after sputtering, the coated surface of the substrate S is mechanically polished. The areas that connect the bars are thereby removed on one level.
  • the negative profile is formed in the form of substrate recesses.
  • the negative profile of the substrate can also be formed by elevations.
  • a web profile can thereby be produced in which the base has a thicker wall thickness in the region of the folding edge 14 than the covering surface 12 or the folding sections 12a, 12b. This design of the grid bars leads to an increased radial force and stabilization of the web.
  • the web can be made in a diameter and subsequently brought by deformation and possibly heat treatment to the target diameter.
  • the stent may be made of nitinol, a chromium-cobalt alloy, a bioabsorbable material, e.g. Be magnesium.
  • the grid structure can be produced in a preferred variant as a flat structure.
  • a subsequent winding follows, in which the structure assumes a cylindrical or round profile. This is suitable e.g. especially for the manufacturing method according to FIGS. 4a, 4b, in which the cover, which later faces the vessel wall, is oriented inwards.
  • the connection to a round profile after winding can be done by melting techniques, by laser, soldering, mechanical connection (crimping) also by additional elements, or gluing.
  • the material or the film may remain open. So it is possible to form by heat treatment, the film without connecting them.
  • the final shape is not a completely closed cylinder, but has a laterally open structure. It could, for example, be advantageous if the system covers, for example, an aneurysm on one side and leaves a vessel open on the other side.
  • the film could be planar during manufacture and crimping in the delivery system and only conform to the shape of the vessel or lumen after implantation in the vessel.
  • the invention and the embodiments embodying the invention have the advantage that the grid bars are variable in their width, without the need for additional elements are required.
  • the change in the web width is achieved by the foldability of the grid webs in the longitudinal direction. This allows the Grid webs in the deployed or expanded state of the implant form a relatively large coverage area, which supports the expansion of the vessel and allows better coverage and a finer force distribution. In the compressed state or in the crimped state, the grid webs are folded together, so that the web width is reduced and the grid webs require comparatively little space. In this way, very small crimp diameters are possible.
  • the invention thus combines the good mechanical properties of the implant with the good crimpability in small delivery systems.
  • All features of mentioned embodiments are also in connection with the medical device, in particular in connection with temporarily insertable into the body devices, such as devices for removing concrements, especially thrombus removal systems or thrombectomy devices, baskets, especially suction baskets, for gripping or catching thrombi or generally concretions, as well as systems and devices for recanalizing hollow organs of the body, in particular recanalization systems, filters, for example for the treatment of carotid stenosis, and / or occlusion systems disclosed and claimed.
  • temporarily insertable into the body devices such as devices for removing concrements, especially thrombus removal systems or thrombectomy devices, baskets, especially suction baskets, for gripping or catching thrombi or generally concretions, as well as systems and devices for recanalizing hollow organs of the body, in particular recanalization systems, filters, for example for the treatment of carotid stenosis, and / or occlusion systems disclosed and claimed.

Abstract

La présente invention a pour objet un implant médical possédant une structure de grille (10), qui comprend des barreaux de grille (11) et qui est convertible pour l'introduction dans un système d'alimentation dans un état comprimé I et pour l'implantation dans un état expansé II, les barreaux de grille (11) présentant chacun une extension longitudinale (11a) et une extension transversale (11b). La présente invention est caractérisée en ce que les barreaux de grille (11) sont pliables le long de leur extension longitudinale (11a), de telle sorte que les barreaux de grille (11) soient pliés dans l'état comprimé I et dépliés dans l'état expansé II, l'extension transversale (11b) des barreaux de grille dépliés (11) dans l'état expansé II étant plus grande que l'extension transversale (11b) des barreaux de grille pliés (11) dans l'état comprimé I et les barreaux de grille dépliés (11) formant dans l'état expansé II une surface de couverture (12).
PCT/EP2010/001213 2009-02-26 2010-02-26 Implant médical possédant une structure de grille, dispositif médical, procédé pour leur fabrication, et procédé pour l'introduction de l'implant médical dans un système d'alimentation WO2010097235A1 (fr)

Applications Claiming Priority (2)

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DE102009010825.4 2009-02-26
DE200910010825 DE102009010825B4 (de) 2009-02-26 2009-02-26 Medizinisches Implantat mit einer Gitterstruktur, Verfahren zu dessen Herstellung sowie Verfahren zum Einbringen des medizinischen Implantats in ein Zufuhrsystem

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WO2010097235A9 WO2010097235A9 (fr) 2011-10-20

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Citations (6)

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US5282823A (en) * 1992-03-19 1994-02-01 Medtronic, Inc. Intravascular radially expandable stent
WO2003009779A2 (fr) * 2001-07-26 2003-02-06 Avantec Vascular Corporation Administration d'agents potentiellement therapeutiques
WO2003075799A1 (fr) * 2002-03-04 2003-09-18 Endovascular Technologies, Inc. Dispositif de greffe endovasculaire et procedes permettant de fixer des constituants de celui-ci
WO2003099165A1 (fr) * 2002-05-23 2003-12-04 Allium Inc. Dispositif medical a partie tubulaire
WO2003105695A2 (fr) * 2002-06-13 2003-12-24 Existent, Inc. Structures mecaniques et implants comprenant lesdites structures
US6843802B1 (en) 2000-11-16 2005-01-18 Cordis Corporation Delivery apparatus for a self expanding retractable stent

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Publication number Priority date Publication date Assignee Title
WO2001026584A1 (fr) * 1999-10-14 2001-04-19 United Stenting, Inc. Extenseurs dotes d'elements de renfort multicouches
US20080065196A1 (en) * 2006-09-12 2008-03-13 Michael Wayne Davis Intra-Columnar Cell Features to Improve Drug Distribution and Scaffolding of a Stent
DE102007032340A1 (de) * 2007-07-11 2009-01-15 Acandis Gmbh & Co. Kg Stent mit einer rohrförmigen Gitterstruktur und Verfahren zum Herstellen eines derartigen Stents
DE102008010507B3 (de) * 2008-02-22 2009-08-20 Acandis Gmbh & Co. Kg Stent und Verfahren zum Herstellen eines derartigen Stents

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5282823A (en) * 1992-03-19 1994-02-01 Medtronic, Inc. Intravascular radially expandable stent
US6843802B1 (en) 2000-11-16 2005-01-18 Cordis Corporation Delivery apparatus for a self expanding retractable stent
WO2003009779A2 (fr) * 2001-07-26 2003-02-06 Avantec Vascular Corporation Administration d'agents potentiellement therapeutiques
WO2003075799A1 (fr) * 2002-03-04 2003-09-18 Endovascular Technologies, Inc. Dispositif de greffe endovasculaire et procedes permettant de fixer des constituants de celui-ci
WO2003099165A1 (fr) * 2002-05-23 2003-12-04 Allium Inc. Dispositif medical a partie tubulaire
WO2003105695A2 (fr) * 2002-06-13 2003-12-24 Existent, Inc. Structures mecaniques et implants comprenant lesdites structures

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WO2010097235A9 (fr) 2011-10-20
DE102009010825A1 (de) 2010-09-23

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