EP1670392A2 - Stent with improved durability - Google Patents
Stent with improved durabilityInfo
- 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- Withdrawn
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
The invention relates to a stent with improved durability. Said stent comprises a tubular grid wall extending around a longitudinal axis and consisting of elastic wall segments that are successively arranged circumferentially along the axis and are interconnected by means of connection segments. Said wall segments comprise spring elements that are interconnected by means of connection elements, forming a connection angle, and the spring elements have an undulating structure with respectively at least one crest and one trough.
Description
"Stent mit verbesserter Haltbarkeit" "Stent with improved durability"
Die Erfindung betrifft einen Stent zur Implantation in o- der um ein Hohlorgan, mit mehreren achsial hintereinander angeordneten ringförmigen Wandsegmenten, die eine elastische Struktur aufweisen und die mittels Verbindungsele- menten miteinander verbunden sind.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.
Gattungsgemäße Stents und ihre Verwendung sind an sich bekannt und werden zur Erweiterung und Offenhaltung röhrenförmiger Hohlorgane in diese eingesetzt. Derartige Stents weisen eine gitter- oder spiralförmige Struktur auf, die aus hintereinander achsial aufgereihten Wandsegmenten aufgebaut ist . Die Wandsegmente selbst werden aus miteinander in vielfältiger Weise verbundenen kurzen elastischen Ste- . gen gebildet. Zwischen und innerhalb der Wandsegmente wer- den durch die Stege begrenzte Gitteröffnungen gebildet, die es ermöglichen, dass diese Struktur an ihrem Implantationsort in das Gewebe einwachsen kann. Solche Stents sind an sich bekannt und beispielsweise in der DE-A 197 46 88 oder auch der WO 03/063 733 beschrieben.Generic 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 werden in ein Hohlorgan, wie z. B. Blutgefäße, Harnleiter, Speiseröhren oder Gallenwege eingesetzt, um zu gewährleisten, dass diese eine lichte Weite beibehalten und der Durchfluss von Körperflüssigkeiten nicht behindert wird. Insbesonders in Blutgefäßen kommt es häufig zu Ablagerungen, die zum vollständigen Verschließen des Blutgefäßes führen können, was schwerwiegende gesundheitliche Folgen hat . In ein solches erkranktes Hohlorgan wird dann zur
Stützung der Organwand ein solcher Stent mittels eines Katheters eingesetzt. Häufig werden beispielsweise auch selbstexpandierende oder expandierbare Stents verwendet, die in einem ersten Zustand mit geringem Durchmesser in das Hohlorgan eingeführt und in dieser Position dann in einen zweiten Zustand mit größerem Durchmesser durch eine innere intrinsische Federkraft von selbst expandieren oder aktiv expandiert werden. Stents kommen aber auch dann zum Einsatz, wenn ein Hohlorgan, wie beispielsweise ein Blut- gefäß, nicht mehr genügend Festigkeit aufweist, um in seiner ursprünglichen Form zu verbleiben. Dies führt zu sogenannten Aneurismen. In diesem Fall besteht das Risiko, dass sich das Hohlorgan, insbesonders ein Blutgefäß, an einer derartig erkrankten Stelle aufweitet und dabei rei- ßen kann. Dies führt zu einer unerwünschten inneren Blutung. Um eine solche innere Verletzung zu vermeiden, wird ein Stent, insbesondere ein beschichteter Stent, derart in das erkrankte Gefäß eingesetzt, dass das erweiterte aneu- , rysmatisch veränderte Segment vom Stent überbrückt wird. Die beiden Enden des Stents dichten dann jeweils das davor und dahinter liegende gesunde Segment ab.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. However, 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. In order to avoid such an internal injury, 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.
Neben einer ausreichenden Stützfähigkeit muss ein solcher Stent aber auch genügend Flexibilität aufweisen, um Bewe- gungen seines Trägers oder der Blutgefäße bzw. Hohlorgane folgen zu können. Gerade bei selbstexpandierenden Stents ist es auch erforderlich, dass der Stent auf den geringen Durchmesser in dem ersten Zustand komprimiert wird und dass er dann auf den großen Durchmesser bei dem zweiten Zustand expandieren kann. Diese Flexibilität wird dadurch gewährleistet, dass mehrere elastische, ringförmige Wandsegmente mittels einzelner Verbindungselemente miteinander verbunden sind.
Es hat sich jedoch gezeigt, dass bei starker Beanspruchung wie sie beispielsweise beim Einsetzen solcher gattungsgemäßer Stents mittels eines Katheters, der bei der Einfüh- rung dem jeweiligen Hohlorgan bzw. Blutgefäß folgend starke Windungen und Krümmungen durchlaufen muss, die Integrität und Stabilität solcher Stents nicht immer gewährleistet ist. So kann es vorkommen, dass in manchen Fällen einzelne Wandelemente insbesonders an ihren Verbindungsstellen also an verbindenden Segmenten, Elementen und Punkten brechen, wodurch die Funktion und/oder der Halt des Stents im Körper stark beeinträchtigt werden kann. Die Erfindung hat daher zum Ziel, einen Stent der zuvor beschriebenen gattungsgemäßen Art bereitzustellen, der auch bei starker Beanspruchung bei der Expansion und/oder Einführung des Stents in das entsprechende Hohlorgan eine verbesserte Haltbarkeit insbesonders Bruchsicherheit zeigt. Darüber hinaus soll dieser Stent eine verbesserte Flexibilität aufweisen. Dieses Ziel wird durch die in den Ansprüchen definierten Merkmale erreicht.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. It has been shown, however, that in the case of heavy loads such as, for example, when such generic stents are inserted by means of a catheter which, during insertion, has to undergo large turns and curvatures following the respective hollow organ or blood vessel, the integrity and stability of such stents is not always is guaranteed. It may happen that in some cases individual wall elements break, particularly at their connection points, ie at connecting segments, elements and points, which can severely impair the function and / or retention of the stent in the body. The aim of the invention is therefore to provide a stent of the generic type described above which, even under heavy stress during expansion and / or insertion of the stent into the corresponding hollow organ, shows improved durability, in particular resistance to breakage. In addition, this stent is said to have improved flexibility. This goal is achieved by the features defined in the claims.
Die erfindungsgemäße Lösung zeichnet sich dadurch aus, dass bei einem Stent der gattungsgemäßen Art mit ringförmigen elastischen Wandsegmenten die Federelemente enthal- ten, diese einzelnen Federelemente wellenförmig ausgebildet sind.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.
Der erfindungsgemäße Stent ist in seiner Grundstruktur ein gitterförmiger Schlauch bzw. Hohlzylinder, der um bzw. entlang einer zentralen Achse verläuft. Der Stent selbst ist entlang dieser Achse flexibel und biegbar, damit er beim Einschieben in ein Körperorgan Windungen, Biegungen bzw. Abzweigungen überwinden kann. Die schlauchförmige
Gitterstruktur wird durch eine mit Öffnungen versehene Wand gebildet, wobei die Wand elastische ringförmige um die Achse verlaufende Wandsegmente enthält, die über Verbindungssegmente miteinander verbunden sind. Die ringför- migen Wandsegmente selbst sind aus Wandelementen aufgebaut, die zu einem die Achse umgebenden Ring zusammenge- fasst sind. Die ringförmigen Wandsegmente sind entlang der zentralen Achse aufgereiht, wobei die einzelnen Segmente durch Verbindungssegmente miteinander verbunden werden. Einzelne ringförmige Wandsegmente enthalten Federelemente, welche dem Wandsegment die gewünschte Elastizität verleihen, um eine Expansion des Stents radial zur zentralen, biegbaren Achse zu ermöglichen, wobei der Durchmesser des durch die Wand gebildeten, inneren Schlauchlumens bzw. des Hohlzylinders, vergrößert wird. Auf diese Weise entfalten die Wandsegmente die gewünschte elastische Stützwirkung auf das Hohlorgan. Die Wandsegmente werden dabei vorzugsweise vollständig aus in der Wandebene liegenden benach- . harten Federelementen bzw. Stegen gebildet, die V-förmig bzw. zickzackförmig einen Ring um die Stentachse bilden.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.
Vorzugsweise sind die Wandsegmente aus dem Federelement aufgebaut .The wall segments are preferably constructed from the spring element.
Die Federelemente sind üblicherweise biegsame Stege, die an ihren Enden V-förmig über Verbindungspunkte oder Verbindungselemente miteinander verbunden sind. Die Erfindung zeichnet sich nun durch eine besondere Ausgestaltung dieser biegsamen Stege bzw. Federelemente aus.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.
Erfindungsgemäß sind diese Federstege nämlich nicht gerade bzw. linear sondern wellenförmig, wodurch die auf die Verbindungspunkte wirkenden Kräfte bei der Expansion und bei einer Biegung entlang der Schlauch- oder Stentachse stark
verringert werden. Dabei verläuft die wellenförmige Struktur zweckmäßigerweise in der Wandfläche. In seiner einfachsten Form wird diese Struktur aus einer einfachen Welle gebildet, d. h. aus einem Wellental und einem Wellen- berg. Dabei weist der kurvenförmige Wellenverlauf mindestens einen Wendepunkt auf. Selbstverständlich ist es erfindungsgemäß möglich, die Federelemente aus mehreren hintereinander verlaufenden, wellenförmigen Kurven zu bilden. Erfindungsgemäß ist es auch möglich, die wellenförmige Struktur anstatt sinusförmig rund auch in einer Zickzackstruktur verlaufen zu lassen.According to the invention, 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. Of course, according to the invention it is possible to form the spring elements from a plurality of wavy curves running one behind the other. According to the invention, it is also possible to have the wave-shaped structure run in a zigzag structure instead of being sinusoidal.
In einer weiteren erfindungsgemäßen Ausführungsform sind die Federelemente derart ausgestaltet, dass der zwischen ihnen an den V-förmigen VerbindungsSegmenten gebildeteIn a further embodiment according to the invention, the spring elements are designed in such a way that the one formed between them on the V-shaped connecting segments
Winkel bezogen auf das Winkelinnere konkav verläuft, d. h. dass der von zwei benachbarten Federelementen tangential gebildete Winkel zum Federstegende bzw. zum Federverbindungselement hin abnimmt und kleiner wird. Das heißt, dass bezogen auf den Verbindungspunkt der Federn eine symmetrische Struktur gebildet wird, die derjenigen des griechischen Buchstabens v in symmetrischer Schreibweise entspricht .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.
In einer Weiterbildung der Erfindung sind die einzelnen Wandsegmente mittels eines durchgehenden Längsstegs miteinander verbunden. In einer besonderen Ausführungsform ist der Längssteg linear durchgehend ausgebildet und kann so Druckspannungen oder Zugspannungen in Längsrichtung aufnehmen, ohne dass dadurch eine Längenänderung desIn a development of the invention, the individual wall segments are connected to one another by means of a continuous longitudinal web. In a special embodiment, 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 bewirkt wird. Gleichermaßen bewirkt ein Kontrahieren, also ein Zusammendrücken der einzelnen Wandsegmente ebenfalls keine Längenänderung des Stents, da die dabei
eventuell auftretenden Zugspannungen oder Druckspannungen auf den durchgehenden Längssteg übertragen und von diesem aufgenommen werden.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.
Eine Weiterbildung der Erfindung zeichnet sich dadurch aus, dass die ringförmigen Wandsegmente Wandelemente umfassen bzw. aus einer Mehrzahl solcher Elemente gebildet sind. Diese Wandelemente sind vorzugsweise Federelemente die wechselweise unter einem aus ersten Federelementen und zweiten Federelementen gebildeten Winkel zueinander angeordnet sind. Hierdurch ergibt sich für die Wandsegmente eine zickzackartige elastische Struktur, wodurch eine gute, elastische Federwirkung erreicht wird, die auch eine zur Stentachse radiale Expansion ermöglicht und die Stütz- Wirkung auf das Hohlorgan bewirkt.A further development of the invention is characterized in that the 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.
Die Verbindungssegmente verbinden zweckmäßigerweise entweder nur erste oder zweite Federelemente miteinander. Die . VerbindungsSegmente selbst sind gegenüber entlang der Stentlangsachse einwirkende Schub- und Zugkräften nicht elastisch und im wesentlichen starr, d. h. dass diese zusammen mit den durch sie verbundenen Federelementen diese Zug- und Schubkräfte aufnehmen und eine Längenänderung des Stents verhindern. Dadurch bilden die jeweils verbundenen ersten bzw. die zweiten Federelemente gemeinsam mit den Verbindungssegmenten den durchgehenden Längssteg. Zu diesem Zweck sollten die VerbindungsSegmente und die damit verbundenen Federelemente jeweils parallel zu einander angeordnet sein. Dies gilt wieder im Bezug auf die Projek- tion auf eine Umfangsflache des Stents. Auf diese Weise wird gewährleistet, dass die Krafteinleitung nur entlang des Längsstegs wirkt und keine Querkomponente hat, die zu einer unerwünschten Verkürzung oder Verlängerung des
Stents führen könnte. Dies schließt eine longitudinale Expansion oder Kontraktion ermöglichende nicht linearen Verlauf aus, wie er z. B. durch einen zickzackförmigen oder wellenförmigen Verlauf des Längssteges entsteht.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. As a result, the respectively connected first and second spring elements together with the connecting segments form the continuous longitudinal web. For this purpose, 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. In this way it is ensured that the force is only applied along the longitudinal web and has no transverse component that leads to an undesirable shortening or lengthening of the Could lead to stents. This precludes a longitudinal expansion or contraction enabling a non-linear course, as it is e.g. B. arises from a zigzag or wavy course of the longitudinal web.
Eine Ausführungsform der Erfindung zeichnet sich durch mehrere in einer Projektion auf eine Außenumfangsflache zueinander parallele Längsstege aus, die in Umfangsrich- tung voneinander beabstandet angeordnet sind. Dies können beispielsweise drei oder vier Längsstege sein. Auf diese Weise werden die Wandsegmente besonders wirkungsvoll zueinander positioniert, wobei gleichzeitig eine Längenänderung des Stents zuverlässig vermieden wird.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. In this way, 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.
Es ist auch möglich, dass der Längssteg eine schraubenlinienartige Gestalt hat. Dies kann beispielsweise dann der Fall sein, wenn der Längssteg aus den Verbindungssegmenten und den ersten bzw. zweiten Federelementen besteht. Dies . führt zu einem besonders einfachen Aufbau. Längenän- derungen aufgrund von Druckspannungen oder Zugspannungen oder durch ein Zusammendrücken des Stents werden trotzdem zuverlässig vermieden.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.
Die Verbindungssegmente sowie die Verbindungselemente kön- nen auch eine größere Materialdicke bzw. Breite aufweisen als die Federelemente. Insbesondere dann, wenn ein selbstexpandierender Stent mittels Laser aus einem röhrenförmigen Körper mit geringem Durchmesser geschnitten wird, ergibt sich ein geringer Aufwand. In dem ersten Zustand mit geringem Durchmesser sind die Verbindungssegmente dann beispielsweise in etwa S-förmig ausgebildet. In dem zweiten Zustand mit größerem Durchmesser weisen die Verbindungssegmente dann zumindest eine Komponente parallel zu
dem Längssteg auf. Die VerbindungsSegmente können beispielsweise die doppelte Breite der Federelemente haben. Dadurch ergibt sich ein besonders einfaches SchnittmusterThe connecting segments and the connecting elements can also have a greater material thickness or width than the spring elements. In particular, if a self-expanding stent is cut from a tubular body with a small diameter by means of a laser, there is little effort. In the first state with a small diameter, the connecting segments are then, for example, approximately S-shaped. In the second state with a larger diameter, the connecting segments then 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
Vorzugsweise ist der Stent einstückig ausgeführt. Auf diese Weise ergibt sich eine stabile Konstruktion ohne unnötige Kanten oder Sollbruchstellen.The stent is preferably made in one piece. In this way, a stable construction results without unnecessary edges or predetermined breaking points.
Als Material für den Stent kann ein Formgedächtnis-Mate- rial, wie beispielsweise ein sogenanntes Memory-Metall, nämlich eine Nickel-Titan-Legierung, wie sie auch unter dem Namen Nitinol vertrieben wird, verwendet werden. Auch Polymere, wie sie in anderen Bereichen der Medizin zur Implantation im Körper verwendet werden, sind zur Herstel- lung des erfindungsgemäßen Stents geeignet. Aus einem röhrenförmigen Körper mit geringem Durchmesser kann dann beispielsweise mittels Laserstrahlung ein geeignetes Schnittmuster zum Bereitstellen der Federelemente und der Verbindungssegmente herausgeschnitten werden. Auf bekannte Weise kann diesem röhrenförmigen Körper dann die expandierte Form aufgeprägt werden. Wird der so erzeugte Stent anschließend in den Zustand mit kleinem Durchmesser komprimiert und beispielsweise mittels eines Katheters in ein erkranktes Blutgefäß eingeführt, so kann der Stent an sei- ner Position durch Erwärmen über die sog. Konversionstemperatur wieder automatisch in die eingeprägte Form gebracht werden.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. If 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.
Als weitere Materialien für den Stent bieten sich außerdem Edelstahl, Kunststoff oder sog. selbstauflösende Materialien an. Insbesondere diese selbstauflösenden Materialien sind dann von Vorteil, wenn ein Stent nicht dauerhaft gelegt werden soll. Wenn keine selbstexpandierenden Stents
verwendet werden, können diese an der gewünschten Position beispielsweise mittels eines Ballonkatheters expandiert werden.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.
Vorzugsweise sollte die Oberfläche des Stents bearbeitet, insbesondere veredelt, geglättet und/oder poliert sein. Auf diese Weise ergibt sich eine glatte und körperverträgliche Oberfläche.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.
Diese erfindungsgemäße wellenförmige Ausbildung der Federstege ist vorzugsweise derart, dass sie zu keinem wesentlichen Betrag zur longitudinalen Elastizität führt, d. h. dass durch die Stege ihre Länge bei Zug und Druckbeanspruchung entlang der Stentlangsachse ändern.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.
Die Erfindung soll anhand der folgenden Figuren näher erläutert werden. Es zeigenThe invention will be explained in more detail with reference to the following figures. Show it
Fig. 1 einen nicht expandierten geschnittenen Stent wie er in der nicht vorveröffentlichten DE-A 102 43 136 bzw. der darauf beruhenden PCT/DE03/...... beschrieben ist.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 zeigt den Ausschnitt eines Stents von Fig. 1 in expandierter Form.FIG. 2 shows the detail of a stent from FIG. 1 in expanded form.
Fig. 3 zeigt einen erfindungsgemäßen Stent in nicht expandierter Form.3 shows a stent according to the invention in an unexpanded form.
Fig. 4 zeigt einen vergrößerten Ausschnitt des erfindungs- gemäßen Stents von Fig. 3 in expandierter Form.FIG. 4 shows an enlarged section of the stent according to the invention from FIG. 3 in expanded form.
Fig. 5 zeigt eine alternative Ausführungsform eines expandierten erfindungsgemäßen Stents in vergrößerter Form.
In Fig. 1 ist eine allgemeine schematische Darstellung eines Schnittmusters zum Herstellen eines nicht expandierte] Stents dargestellt. Dabei wird der Stent 10 wird mittels Laserstrahlung aus einem Röhrchen aus einem geeigneten Material, beispielsweise aus einem Formgedächtnis-Material, nämlich eines Memory-Metalls, wie z.B. Nitinol, ausgeschnitten. Dabei zeigt Fig. 1 eine vergrößerte Teildarstellung eines auf die Umfangsflache des Stents projizier- ten Schnittmusters in abgewickelter Darstellung. Der leichteren Übersicht halber sind in der Fig. 1 nur zwei erste Federelemente 14 und zwei zweite Federelemente 15 mit Bezugszeichen versehen. Wie sich der Figur entnehmen läßt, sind in einem ersten Zustand nach dem Einschneiden des Schnittmusters in das Röhrchen aus Memory-Metall die ersten Federelemente 14 und die zweiten Federelemente 15 einander benachbart angeordnet und über Verbindungspunkte bzw. Verbindungselemente 17 miteinander verbunden. Die ersten Federelemente 14 und die diesen benachbarten zwei- ten Federelemente 15 sind dabei parallel aneinander liegend angeordnet. Gut in der Figur zu sehen ist die in etwa S-förmige Gestalt der Verbindungssegmente 12. Außerdem wird in der Fig. 1 deutlich, dass einander benachbart angeordnete Wandsegmente 11 jeweils um einen Versatz gegen- einander versetzt angeordnet sind, der der Dicke des ersten Federelementes 14 und des zweiten Federelementes 15 entspricht. Auf diese Weise ist in dem ersten Zustand ein erstes Federelement 14 eines Wandsegmentes 11 an seinen Enden jeweils mittels Verbindungssegmenten 12 mit einem um den Versatz versetzten ersten Federelements 14 der benachbarten Wandsegmente 11 verbunden. Nach dem Einschneiden des in Fig. 1 dargestellten Schnittmusters in einen röhrenförmigen Rohling aus z. B. Memory-Metall wird der so
hergestellte Stent in einen zweiten Zustand expandiert, der einen größeren Durchmesser hat als der erste Zustand. Dieser zweite Zustand wird dem Stent 10 dann auf bekannte Weise aufgeprägt. Zur Implantation mittels eines Katheters wird der so vorbereitetet Stent 10 dann in einen Zustand mit geringem Durchmesser zusammengedrückt. Nach der gewünschten Positionierung kann der Stent 10 dann durch Erwärmen über die sogenannten Konversionstemperatur wieder in die eingeprägte Form des zweiten Zustands expandiert werden. Es ist aber auch möglich, den Stent 10 mittels eines Ballonkatheters zu expandieren.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. In this case, 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. For the sake of clarity, only two first spring elements 14 and two second spring elements 15 are provided with reference numerals in FIG. 1. As can be seen in the figure, in a first state after the cutting pattern has been cut into the tube made of memory metal, 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. In addition, it is clear in FIG. 1 that 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. In this way, in the first state, 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. After cutting the pattern shown in Fig. 1 in a tubular blank made of z. B. 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. For implantation by means of a catheter, the stent 10 thus prepared is then compressed into a state with a small diameter. After the desired positioning, the stent 10 can then be expanded again into the impressed shape of the second state by heating above the so-called conversion temperature. However, it is also possible to expand the stent 10 by means of a balloon catheter.
Fig. 2 zeigt eine vergrößerte Teildarstellung des Stents 10 von Fig. 1 in expandierter Form. Wie der Figur zu ent- nehmen ist, weisen die Wandsegmente 11 jeweils erste Federelemente 14 und zweite Federelemente 15 auf. Die ersten Federelemente 14 und die zweiten Federelemente 15 sind zueinander jeweils unter einem Winkel angeordnet. Auf diese . Weise bilden die ersten Federelemente 14 und die zweiten Federelemente 15 eine zickzackartige Struktur. Dadurch sind die Wandsegmente 11 jeweils in Radialrichtung federnd nachgiebig ausgebildet.FIG. 2 shows an enlarged partial illustration of the stent 10 from FIG. 1 in an expanded form. As can be seen from the figure, 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. As a result, the wall segments 11 are each designed to be resilient in the radial direction.
Wie der Fig. 2 außerdem zu entnehmen ist, verbinden die Verbindungssegmente 12 jeweils einander benachbarte erste Federelemente 14 der einzelnen Wandsegmente 11 miteinander. Auf diese Weise bilden die Verbindungssegmente 12 gemeinsam mit den durch diese verbundenen ersten Federelementen 14 die Längsstege 13. Die einzelnen Wandsegmente 11 sind in der Figur gegen benachbarte Wandsegmente 11 jeweils um einen Versatz versetzt angeordnet, der in etwa der gemeinsamen Dicke des ersten Federelementes 14 und des zweiten Federelementes 15 entspricht. Die Verbindungsseg-
mente 12 haben eine in etwa S-förmige Struktur. Auf diese Weise ergibt sich eine in etwa zu den ersten Federelementen 14 parallele Krafteinleitrichtung 16 von einem ersten Federelement 14 zu einem an dieses angrenzende ersten Fe- derelement 14. Die Verbindungssegmente 12 weisen außerdem in etwa die doppelte Dicke der ersten Federelemente 14 auf. Wenn in diesem Fall die Krafteinleitung von einem ersten Federelement 14 zum dazu benachbarten ersten Federelement 14 nicht perfekt parallel zu deren Erstreckungs- richtungen erfolgt, lassen sich trotzdem auftretende Querkräfte bis zu einem gewissen Maß durch diese verdickte Ausführung der Verbindungselemente 12 aufnehmen, ohne dass es zu einer Längenänderung des Stents 10 kommt.As can also be seen in FIG. 2, the connecting segments 12 each connect adjacent first spring elements 14 of the individual wall segments 11 to one another. In this way, 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. If in this case the introduction of force from a first spring element 14 to the adjacent first spring element 14 does not take place perfectly parallel to their directions of extension, transverse forces which occur can still be absorbed to a certain extent by this thickened design of the connecting elements 12 without it increasing a change in length of the stent 10 comes.
Fig. 3 zeigt einen geschnittenen erfindungsgemäßen Stent in nicht expandierter Form. Dabei sind die Federelemente 14, 15 der ringförmigen Wandsegmente 11 wellenförmig ausgestaltet. Im Beispiel der Figur besteht die wellenförmige Ausgestaltung aus drei Wellenbergen bzw. -tälern oder auch drei hintereinander geschalteten Wellen. Prinzipiell ist es möglich die Federelemente mit mehr oder weniger Wellen zu versehen. In seiner einfachsten Form besteht das erfindungsgemäße Federelement 14, 15 aus einem Wellenberg und einem Wellental wie dies beispielsweise in Fig. 4 darge- stellt ist. Dabei weist der zwischen den Verbindungspunkten 17 der Federelemente 14, 15. Dabei weist der kurvenwellenförmige Verlauf der Federelemente 14, 15 zwischen den Verbindungspunkten 17 mindestens einen Wendepunkt, vorzugsweise mindestens drei Wendepunkte auf. Die Segmente 14, 15 bilden an ihrem Verbindungspunkt 17 zueinander einen Verbindungswinkel 24 aus. In der erfindungsgemäßen bevorzugten Ausführungsform sind die Federelemente derart wellenförmig ausgestaltet, dass ihre Welllenkurve bezüg-
lieh des Verbindungswinkels 24 konkav verläuft. Dabei nimmt die Größe des Verbindungswinkels zum Verbindungs- punkt 17 laufend ab. Es hat sich gezeigt, dass durch mit einer solchen erfindungsgemäßen Ausgestaltung auf die Ver- bindungspunkte 17 und die Verbindungssegmente 12 wirkende Kräfte stark verringert werden, wodurch die Haltbarkeit des Stents zunimmt.3 shows a cut stent according to the invention in an unexpanded form. The spring elements 14, 15 of the annular wall segments 11 are designed in a wave shape. In the example of the figure, the wave-shaped configuration consists of three wave peaks or valleys or three waves connected in series. In principle, it is possible to provide the spring elements with more or fewer shafts. In its simplest form, 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 has between the connection points 17 of the spring elements 14, 15. 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. In the preferred embodiment according to the invention, 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.
Fig. 5 zeigt eine alternative erfindungsgemäße Ausfüh- rungsform, bei der die Wellenstruktur der Federelemente 14, 15 durch eine Zickzacklinie ausgestaltet ist. Dabei entsprechen die Spitzen 20 bzw. 22 den Wellenbergen 20, 22 von Fig. 4. Auch bei dieser Ausführungsform ist der von den Federelementen 14, 15 am Verbindungselement 17 gebil- dete Winkel 24 zum Verbindungspunkt 17 kleiner als in der Mitte zwischen den Verbindungspunkten. In einer bevorzugten Ausführungsform enthalten die Verbindungssegmente 12 eine' röntgenopaque Markierung (nicht dargestellt) . Beson- . ders bevorzugt ist es, dass die Verbindungssegmente 12 mit den Federelementen 14, 15 einen longitudinalen Längssteg 13 ausbilden, der longitudinal auf den Stent einwirkende Zug- und Scherkräfte aufnimmt . Dabei werden in einem Längssteg jeweils nur Verbindungselemente oder Federelemente 14, 15 verbunden, so dass mehrerer Längsstege paral- lel zueinander verlaufen und sich nicht kreuzen. In einer zweckmäßigen Weiterbildung umläuft die Markierung die Gitterwand des Stents spiralförmig in achsialer Richtung z . B. entlang oder parallel des Längssteges 13.
"Stent mit verbesserter Haltbarkeit"5 shows an alternative embodiment according to the invention, in which 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. Also in this embodiment, 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. In a preferred embodiment, 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. In this case, only connecting elements or spring elements 14, 15 are connected in each case in a longitudinal web, so that a plurality of longitudinal webs run parallel to one another and do not cross. In an expedient development, the marking revolves around the grid wall of the stent in a spiral in the axial direction z. B. along or parallel to the longitudinal web 13. "Stent with improved durability"
BezugszeichenlisteLIST OF REFERENCE NUMBERS
10 Stent 11 Wandsegment10 stent 11 wall segment
12 Verbindungssegment12 connecting segment
13 LängsSteg13 longitudinal bridge
14 erstes Federelement14 first spring element
15 zweites Federelement 16 Krafteinleitrichtung15 second spring element 16 force introduction direction
17 Verbindungspunkt17 connection point
20 Wellenberg20 Wellenberg
22 Wellental22 trough
24 ' Verbindungswinkel
24 ' connection angle
Claims
1. Stent (10) mit einer um eine longitudinale Achse verlaufenden röhrenförmigen Gitterwand aus elastischen Wand- Segmenten (11) , die circumferential entlang der Achse hintereinander angeordnet sind und die über Verbindungssegmente (12) miteinander verbunden sind, wobei die Wandsegmente (11) Federelemente (14, 15) umfassen, die über Verbindungselemente (17) unter Bildung eines Verbindungswin- kels (24) miteinander verbunden sind, dadurch gekennzeichnet, dass die Federelemente (14, 15) eine wellenförmige Struktur mit mindestens je einem Wellenberg (20) und einem Wellental (22) aufweisen.1. stent (10) with a tubular axis running around a longitudinal axis made of elastic wall segments (11), which are arranged circumferentially along the axis one behind the other and which are connected to each other via connecting segments (12), the wall segments (11) spring elements (14, 15), which are connected to one another via connecting elements (17) to form a connecting angle (24), characterized in that the spring elements (14, 15) have a wave-shaped structure with at least one wave crest (20) and one Have trough (22).
2. Stent nach Anspruch 1, dadurch gekennzeichnet, dass die wellenförmige Struktur zum Verbindungselement (17) bezüglich des Winkels (24) konkav ausgebildet ist.2. Stent according to claim 1, characterized in that the wavy structure to the connecting element (17) is concave with respect to the angle (24).
3. Stent nach einem der vorhergehenden Ansprüche, da- durch gekennzeichnet, dass die Federelemente (14, 15) mit den VerbidungsSegmenten (12) unter Ausbildung eines Längsstegs (13) miteinander verbunden sind, der in der Gitterwand in axialer Richtung verläuft.3. Stent according to one of the preceding claims, characterized in that the spring elements (14, 15) are connected to one another with the connecting segments (12) to form a longitudinal web (13) which runs in the lattice wall in the axial direction.
4. Stent nach einem der vorgehenden Ansprüche, dadurch gekennzeichnet, dass der Längssteg (13) die Wand spiralförmig umläuft . 4. Stent according to one of the preceding claims, characterized in that the longitudinal web (13) revolves around the wall in a spiral.
5. Stent nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass er mehrere parallel zueinander verlaufende Längsstege (13) enthält.5. Stent according to one of the preceding claims, characterized in that it contains a plurality of parallel longitudinal webs (13).
6. Stent nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Stent röntgenopaque Markierungen aufweist.6. Stent according to one of the preceding claims, characterized in that the stent has radiopaque markings.
7. Stent nach einem der vorhergehenden Ansprüche, da- durch gekennzeichnet, dass die Markierungen auf einer die7. Stent according to one of the preceding claims, characterized in that the markings on one of the
Gitterwand spiralförmig umlaufenden Linie angeordnet sind.Grid wall are arranged spirally circumferential line.
8. Stent nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Verbindungssegmente (12) und/oder die Verbindungselemente (17) eine größere Materialbreite aufweisen als die Federelemente (14, 15).8. Stent according to one of the preceding claims, characterized in that the connecting segments (12) and / or the connecting elements (17) have a greater material width than the spring elements (14, 15).
9. Stent nach Anspruch 8, dadurch gekennzeichnet, dass die Verbindungen (12, 17) mindestens doppelt so breit sind wie Federelemente (14, 15).9. Stent according to claim 8, characterized in that the connections (12, 17) are at least twice as wide as spring elements (14, 15).
10. Stent nach einem der vorhergehenden Ansprüche, erhältlich durch Schneiden eines Hohlzylinders zu einem einstückigen Gebilde. 10. Stent according to one of the preceding claims, obtainable by cutting a hollow cylinder into a one-piece structure.
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DE10342759A DE10342759A1 (en) | 2003-09-16 | 2003-09-16 | Stent with improved durability |
PCT/DE2004/002070 WO2005027788A2 (en) | 2003-09-16 | 2004-09-16 | Stent with improved durability |
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EP (1) | EP1670392A2 (en) |
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US20070067017A1 (en) | 2007-03-22 |
DE10342759A1 (en) | 2005-04-14 |
BRPI0414132A (en) | 2007-12-11 |
WO2005027788A3 (en) | 2005-10-27 |
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