EP1670392A2 - Stent presentant une plus grande durabilite - Google Patents

Stent presentant une plus grande durabilite

Info

Publication number
EP1670392A2
EP1670392A2 EP04786789A EP04786789A EP1670392A2 EP 1670392 A2 EP1670392 A2 EP 1670392A2 EP 04786789 A EP04786789 A EP 04786789A EP 04786789 A EP04786789 A EP 04786789A EP 1670392 A2 EP1670392 A2 EP 1670392A2
Authority
EP
European Patent Office
Prior art keywords
stent
spring elements
segments
stent according
wall
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Withdrawn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
EP04786789A
Other languages
German (de)
English (en)
Inventor
Rainer Trapp
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.)
Light-Cut & Co KG GmbH
Original Assignee
Campus & Cokg GmbH
Campus & Co KG GmbH
Campus & Cokg GmbH
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 Campus & Cokg GmbH, Campus & Co KG GmbH, Campus & Cokg GmbH filed Critical Campus & Cokg GmbH
Publication of EP1670392A2 publication Critical patent/EP1670392A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention relates to a stent for implantation in or around a hollow organ, with a plurality of annular wall segments arranged axially one behind the other, which have an elastic structure and which are connected to one another by means of connecting elements.
  • stents and their use are known per se and are used to expand and keep open tubular hollow organs therein.
  • Such stents have a lattice or spiral structure which is constructed from wall segments which are lined up axially one behind the other.
  • the wall segments themselves are made up of short elastic webs connected to one another in a variety of ways. gene formed. Between and within the wall segments, lattice openings are defined by the webs, which enable this structure to grow into the tissue at its implantation location.
  • Such stents are known per se and are described, for example, in DE-A 197 46 88 or also WO 03/063 733.
  • Stents are placed in a hollow organ, such as. B. blood vessels, ureters, esophagus or bile ducts are used to ensure that they maintain a clear width and the flow of body fluids is not obstructed. In particular in blood vessels, there are often deposits that can lead to the complete closure of the blood vessel, which has serious health consequences. In such a diseased hollow organ is then Such a stent is used to support the organ wall by means of a catheter. Self-expanding or expandable stents are also frequently used, for example, which are introduced into the hollow organ in a first state with a small diameter and then expand or actively expand in this position into a second state with a larger diameter by means of an internal intrinsic spring force.
  • stents are also used when a hollow organ, such as a blood vessel, is no longer strong enough to remain in its original shape. This leads to so-called aneurisms. In this case, there is a risk that the hollow organ, in particular a blood vessel, may expand and tear in such a diseased area. This leads to an undesirable internal bleeding.
  • a stent in particular a coated stent, is inserted into the diseased vessel in such a way that the enlarged aneurally, rysmatically modified segment is bridged by the stent. The two ends of the stent then seal the healthy segment in front and behind.
  • such a stent In addition to sufficient support, such a stent must also have sufficient flexibility to be able to follow movements of its wearer or of the blood vessels or hollow organs. In the case of self-expanding stents in particular, it is also necessary that the stent is compressed to the small diameter in the first state and that it can then expand to the large diameter in the second state. This flexibility is ensured by the fact that several elastic, ring-shaped wall segments are connected to one another by means of individual connecting elements.
  • the solution according to the invention is characterized in that, in the case of a stent of the generic type with annular elastic wall segments, the spring elements contain, these individual spring elements are wave-shaped.
  • the basic structure of the stent according to the invention is a grid-shaped tube or hollow cylinder which runs around or along a central axis.
  • the stent itself is flexible and bendable along this axis so that it can overcome turns, bends or branches when inserted into a body organ.
  • the tubular one Lattice structure is formed by a wall provided with openings, the wall containing elastic ring-shaped wall segments running around the axis, which are connected to one another via connecting segments.
  • the ring-shaped wall segments themselves are made up of wall elements which are combined to form a ring surrounding the axis.
  • the ring-shaped wall segments are lined up along the central axis, the individual segments being connected to one another by connecting segments.
  • Individual ring-shaped wall segments contain spring elements which give the wall segment the desired elasticity in order to allow the stent to expand radially to the central, bendable axis, the diameter of the inner tube lumen or the hollow cylinder formed by the wall being increased. In this way, the wall segments develop the desired elastic support effect on the hollow organ.
  • the wall segments are preferably made entirely of adjacent ones lying in the wall plane. hard spring elements or webs formed, which form a V-shaped or zigzag ring around the stent axis.
  • the wall segments are preferably constructed from the spring element.
  • the spring elements are usually flexible webs which are connected to one another at their ends in a V-shape via connecting points or connecting elements.
  • the invention is now characterized by a special configuration of these flexible webs or spring elements.
  • these spring bars are not straight or linear but rather wave-shaped, as a result of which the forces acting on the connection points are strong during expansion and during a bend along the tube or stent axis be reduced.
  • the wavy structure expediently runs in the wall surface. In its simplest form, this structure is formed from a simple wave, ie from a wave trough and a wave crest.
  • the curved wave shape has at least one turning point.
  • the wave-shaped structure run in a zigzag structure instead of being sinusoidal.
  • the spring elements are designed in such a way that the one formed between them on the V-shaped connecting segments
  • Angle is concave with respect to the inside of the angle, d. H. that the angle formed tangentially by two adjacent spring elements to the spring web end or to the spring connecting element decreases and becomes smaller. This means that a symmetrical structure is formed in relation to the connection point of the springs, which corresponds to that of the Greek letter v in symmetrical notation.
  • the individual wall segments are connected to one another by means of a continuous longitudinal web.
  • the longitudinal web is linearly continuous and can thus absorb compressive stresses or tensile stresses in the longitudinal direction without thereby causing a change in the length of the
  • Stents is effected. Similarly, contracting, i.e. compressing the individual wall segments, likewise does not result in a change in the length of the stent, since it does so any tensile or compressive stresses that may occur are transferred to the continuous longitudinal web and are absorbed by it.
  • annular wall segments comprise wall elements or are formed from a plurality of such elements.
  • These wall elements are preferably spring elements which are arranged alternately to one another at an angle formed by first spring elements and second spring elements. This results in a zigzag-like elastic structure for the wall segments, as a result of which a good, elastic spring action is achieved, which also enables radial expansion relative to the stent axis and brings about the supporting action on the hollow organ.
  • the connecting segments expediently connect either only first or second spring elements to one another.
  • the connecting segments themselves are not elastic and essentially rigid with respect to shear and tensile forces acting along the longitudinal axis of the stent, ie they, together with the spring elements connected by them, absorb these tensile and shear forces and prevent a change in length of the stent.
  • the respectively connected first and second spring elements together with the connecting segments form the continuous longitudinal web.
  • the connecting segments and the spring elements connected to them should each be arranged parallel to one another. This again applies to the projection onto a circumferential surface of the stent.
  • One embodiment of the invention is characterized by a plurality of longitudinal webs which are parallel to one another in a projection onto an outer circumferential surface and are spaced apart from one another in the circumferential direction.
  • This can be, for example, three or four longitudinal webs.
  • the wall segments are positioned particularly effectively with respect to one another, while at the same time reliably preventing a change in the length of the stent.
  • the longitudinal web it is also possible for the longitudinal web to have a helical shape. This can be the case, for example, if the longitudinal web consists of the connecting segments and the first or second spring elements. This. leads to a particularly simple structure. Length changes due to compressive or tensile stress or by compressing the stent are nevertheless reliably avoided.
  • the connecting segments and the connecting elements can also have a greater material thickness or width than the spring elements.
  • the connecting segments are then, for example, approximately S-shaped.
  • the connecting segments assign at least one component in parallel the longitudinal web.
  • the connecting segments can, for example, have twice the width of the spring elements. This results in a particularly simple sewing pattern
  • the stent is preferably made in one piece. In this way, a stable construction results without unnecessary edges or predetermined breaking points.
  • a shape memory material such as a so-called memory metal, namely a nickel-titanium alloy, as is also sold under the name Nitinol, can be used as the material for the stent.
  • Polymers such as those used in other areas of medicine for implantation in the body, are also suitable for producing the stent according to the invention.
  • a suitable cutting pattern for providing the spring elements and the connecting segments can then be cut out of a tubular body with a small diameter, for example by means of laser radiation. The expanded shape can then be impressed on this tubular body in a known manner.
  • the stent produced in this way is then compressed into the state with a small diameter and, for example, inserted into a diseased blood vessel by means of a catheter, the stent in its position can be automatically brought back into the embossed shape by heating above the so-called conversion temperature.
  • Stainless steel, plastic or so-called self-dissolving materials are also suitable as further materials for the stent. These self-dissolving materials are particularly advantageous if a stent should not be permanently inserted. If there are no self-expanding stents are used, they can be expanded at the desired position, for example by means of a balloon catheter.
  • the surface of the stent should preferably be processed, in particular refined, smoothed and / or polished. This results in a smooth and body-friendly surface.
  • This wave-shaped design of the spring bars according to the invention is preferably such that it does not lead to any significant amount of longitudinal elasticity, i. H. that the webs change their length along the longitudinal axis of the stent under tension and compression.
  • Fig. 1 shows an unexpanded cut stent as described in the unpublished DE-A 102 43 136 or the PCT / DE03 / ...... based thereon.
  • FIG. 2 shows the detail of a stent from FIG. 1 in expanded form.
  • FIG 3 shows a stent according to the invention in an unexpanded form.
  • FIG. 4 shows an enlarged section of the stent according to the invention from FIG. 3 in expanded form.
  • FIG. 5 shows an alternative embodiment of an expanded stent according to the invention in enlarged form.
  • 1 shows a general schematic representation of a cutting pattern for producing an unexpanded stent.
  • the stent 10 is cut out from a tube made of a suitable material, for example from a shape memory material, namely a memory metal, such as, for example, nitinol, by means of laser radiation.
  • 1 shows an enlarged partial representation of a sectional pattern projected onto the circumferential surface of the stent in a developed representation.
  • first spring elements 14 and two second spring elements 15 are provided with reference numerals in FIG. 1.
  • the first spring elements 14 and the second spring elements 15 are arranged adjacent to one another and connected to one another via connecting points or connecting elements 17.
  • the first spring elements 14 and the second spring elements 15 adjacent to them are arranged lying parallel to one another.
  • the roughly S-shaped shape of the connecting segments 12 can be clearly seen in the figure.
  • wall segments 11 arranged adjacent to one another are each offset from one another by an offset which corresponds to the thickness of the first spring element 14 and the second spring element 15 corresponds.
  • a first spring element 14 of a wall segment 11 is connected at its ends by means of connecting segments 12 to a first spring element 14 of the adjacent wall segments 11 which is offset by the offset.
  • Memory metal is so manufactured stent expanded into a second state, which has a larger diameter than the first state.
  • This second state is then impressed on the stent 10 in a known manner.
  • the stent 10 thus prepared is then compressed into a state with a small diameter.
  • the stent 10 can then be expanded again into the impressed shape of the second state by heating above the so-called conversion temperature.
  • FIG. 2 shows an enlarged partial illustration of the stent 10 from FIG. 1 in an expanded form.
  • the wall segments 11 each have first spring elements 14 and second spring elements 15.
  • the first spring elements 14 and the second spring elements 15 are each arranged at an angle to one another. To this .
  • the first spring elements 14 and the second spring elements 15 thus form a zigzag-like structure.
  • the wall segments 11 are each designed to be resilient in the radial direction.
  • the connecting segments 12 each connect adjacent first spring elements 14 of the individual wall segments 11 to one another.
  • the connecting segments 12 together with the first spring elements 14 connected by them form the longitudinal webs 13.
  • the individual wall segments 11 are each offset in the figure from adjacent wall segments 11 by an offset which is approximately equal to the common thickness of the first spring element 14 and of the second spring element 15 corresponds.
  • the connecting segment elements 12 have an approximately S-shaped structure. This results in a force introduction direction 16 approximately parallel to the first spring elements 14 from a first spring element 14 to a first spring element 14 adjoining the latter.
  • the connecting segments 12 also have approximately twice the thickness of the first spring elements 14.
  • the spring elements 14, 15 of the annular wall segments 11 are designed in a wave shape.
  • the wave-shaped configuration consists of three wave peaks or valleys or three waves connected in series.
  • the spring element 14, 15 according to the invention consists of a wave crest and a wave trough, as shown for example in FIG. 4.
  • the curve-shaped course of the spring elements 14, 15 between the connection points 17 has at least one turning point, preferably at least three turning points.
  • the segments 14, 15 form a connection angle 24 at their connection point 17 to one another.
  • the spring elements are designed in a wave-like manner in such a way that their wave curve lent the connection angle 24 is concave.
  • the size of the connection angle to the connection point 17 decreases continuously. It has been shown that the forces acting on the connection points 17 and the connection segments 12 with such an embodiment according to the invention greatly reduce the strength of the stent.
  • the wave structure of the spring elements 14, 15 is configured by a zigzag line.
  • the tips 20 and 22 correspond to the wave crests 20, 22 of FIG. 4.
  • the angle 24 formed by the spring elements 14, 15 on the connecting element 17 to the connecting point 17 is smaller than in the middle between the connecting points.
  • the connecting segments 12 contain a ' radiopaque marking (not shown). Special. it is preferred that the connecting segments 12 with the spring elements 14, 15 form a longitudinal longitudinal web 13 which absorbs tensile and shear forces acting longitudinally on the stent.

Abstract

L'invention concerne un stent présentant une plus grande durabilité. Ledit stent comporte une paroi en treillis tubulaire s'étendant autour d'un axe longitudinal, composée de segments de paroi élastiques disposés de façon périphérique les uns derrière les autres le long de l'axe, et reliés les uns aux autres par l'intermédiaire de segments de liaison. Lesdits segments de paroi comportent également des éléments ressorts reliés les uns aux autres par l'intermédiaire d'éléments de liaison à un certain angle de liaison, les éléments élastiques présentant une structure sinusoïdale respectivement composée d'une crête et d'un creux.
EP04786789A 2003-09-16 2004-09-16 Stent presentant une plus grande durabilite Withdrawn EP1670392A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10342759A DE10342759A1 (de) 2003-09-16 2003-09-16 Stent mit verbesserter Haltbarkeit
PCT/DE2004/002070 WO2005027788A2 (fr) 2003-09-16 2004-09-16 Stent presentant une plus grande durabilite

Publications (1)

Publication Number Publication Date
EP1670392A2 true EP1670392A2 (fr) 2006-06-21

Family

ID=34305810

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04786789A Withdrawn EP1670392A2 (fr) 2003-09-16 2004-09-16 Stent presentant une plus grande durabilite

Country Status (5)

Country Link
US (1) US20070067017A1 (fr)
EP (1) EP1670392A2 (fr)
BR (1) BRPI0414132A (fr)
DE (1) DE10342759A1 (fr)
WO (1) WO2005027788A2 (fr)

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WO2005027788A2 (fr) 2005-03-31
US20070067017A1 (en) 2007-03-22
BRPI0414132A (pt) 2007-12-11
DE10342759A1 (de) 2005-04-14
WO2005027788A3 (fr) 2005-10-27

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