EP0944367A1 - Flexible expandable vascular support - Google Patents
Flexible expandable vascular supportInfo
- Publication number
- EP0944367A1 EP0944367A1 EP98930744A EP98930744A EP0944367A1 EP 0944367 A1 EP0944367 A1 EP 0944367A1 EP 98930744 A EP98930744 A EP 98930744A EP 98930744 A EP98930744 A EP 98930744A EP 0944367 A1 EP0944367 A1 EP 0944367A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- group
- insert
- strand
- rings
- strands
- 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- Withdrawn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
- 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
-
- 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
- A61F2002/91525—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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
-
- 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
-
- 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
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
Definitions
- the invention relates to an expandable insert with the features of the preamble of claim 1.
- the known inserts have three tubular sections or segments that are made of a material that is compatible with an implant.
- the three tubular segments are each connected to one another via bridge webs which are intended to allow the segments to be tilted or interleaved.
- the individual segments are formed by cutting out rectangular sections from the jacket of the tubular segments.
- adjacent cutouts are offset from one another in the circumferential direction.
- the rectangular cutouts have long sides parallel to the axis and narrow sides running in the circumferential direction.
- the front narrow sides are not connected to each other, so that the front side of the tubular segment looks crenellated.
- the interconnected segments are aligned coaxially to one another in the unused state of the insert and are connected by bridges between the narrow faces at the front.
- straight, parallel bridge webs run obliquely from one end face of a segment in the direction of the narrow side adjacent to the opposite narrow side in the circumferential direction.
- Each narrow side of a segment is connected to a narrow side of the adjacent section, so that the inclined bridge webs give the insert a twisted appearance.
- the rings with a shorter strand length can absorb compression forces well, while the rings with a longer strand length cover the spaces that arise between the rings of the first group relatively evenly.
- the rings of the second group also allow flexibility in use for bending loads to the extent required.
- the strand length of the second group is 1.2 to 2.0 times as long as the strand length of the first group, in particular 1.3 to 1.5 times as large, because there is a good relationship between these conditions Expandability and length reduction when expanding results.
- An increased flexibility with respect to bending stresses results if the strand length of the second group is 1.7 to 1.9 times as long as the strand length of the first group.
- the meandering strands of the second group have longitudinal sections which, in the unexpanded state, run parallel to the central axis of the base body.
- the meander-shaped strands of the first group have peripheral portions which extend in the unexpanded state in the circumferential direction of the body '.
- FIG. 1 shows the developed lateral surface of a cylindrical, tubular stent in the unexpanded state.
- the jacket section 1 is shown in a plan view, the view showing the cylindrical, tubular base body being cut open along an axially parallel cutting line 2 and shown flatly spread out.
- the outer surface is formed by a number of meandering strands 3a, b and 4a, b.
- the material strands 3a and 3b are curved in a meandering or undulating manner in the circumferential direction of the insert, with almost semicircular arc sections 5 and straight longitudinal sections 6 running parallel to the axis alternating.
- the strand length of the encircling material strand 3a or 3b is approximately 14.5 mm, which in the embodiment shown results in a diameter of 1.8 mm in the unexpanded state.
- the meandering strand 3a or 3b can be periodic recurring shape are considered, each period comprising two longitudinal sections 6 and two arc sections 5. In this exemplary embodiment, three periodic regions are thus arranged in the circumferential direction.
- the material strands 4a and 4b are also arranged circumferentially in a meandering fashion.
- arc sections 7 and longitudinal sections 8 alternate, the longitudinal sections 8 running approximately parallel to the longitudinal sections 6 of the material strands 3a and 3b in the unexpanded state of the insert.
- the material strands 4a, 4b also have a periodicity, the number of periods in this exemplary embodiment being twice as large as the number of periods of the material strands 3a, 3b. In the figure 1, the embodiment has six periodic sections.
- the length of the material strands 4a, 4b is approximately 11 mm in the present exemplary embodiment, which also leads to a diameter of 1.8 mm in the present design.
- the material strands 3a and 3b prevail approximately centrally in the respective longitudinal section 6 of the material strand 3a, 3b.
- the material strands 4a, 4b penetrate the material strands 3a, 3b approximately at right angles.
- the expandable insert according to the invention is cut as a one-piece element on a tube with an outside diameter of 1.8 mm.
- implantable stainless steel is used as the material, but also other implantable materials.
- the material thickness in the radial direction is essentially constant over the entire range of use.
- FIG. 2 shows an insert according to FIG. 1 in the second, expanded state.
- the diameter of the Use in the expanded state is 3.5 mm in this embodiment.
- the resulting deformation by the application of a force acting radially from the inside leads to the material strands 4a and 4b being fully stretched, that is to say in practice forming a circular ring of 11 mm in circumference.
- the longer material strands 3a and 3b are deformed into wavy, almost sinusoidal material strands.
- the material strands 4a and 4b which are annular in the expanded state, oppose a uniform radial force exerting a great structural resistance, which reliably prevents the insert from collapsing in the treating blood vessel.
- a lower material thickness can be used with the same resistance (recoil) compared to the known inserts. In both cases, the risk of a renewed narrowing of the cross-section of the treating blood vessel, also called re-stenosis, is lower than in the known applications.
- the inserts according to the invention are inserted into the blood vessels to be treated with a balloon catheter.
- the balloon catheter is expanded by injecting a fluid, whereupon the inserts expand permanently in the radial direction due to plastic deformation.
- the insert After removing the balloon catheter, the insert remains in the blood vessel and we are surrounded by the intima within a short time.
Abstract
The invention relates to an expandable insert which can be used as a vascular support in blood vessels, wherein said insert can be plastically deformed from a non-expanded into an expanded state by applying a radial force which is directed from the inside outwards. The inventive insert comprises at least one tubular substantially cylindrical base body section, whose outer surface consists of a plurality of meander-shaped peripheral rings forming a single-piece material strand of a specific length. The insert is particularly rigid in relation to the externally operating radial forces since it is provided with a first group of rings whose length substantially corresponds to the perimeter of the insert when expanded and with a second group of rings which are longer than the perimeter of the insert when expanded.
Description
Flexible expandierbare GefäßstützeFlexible expandable stent
Die Erfindung betrifft einen expandierbaren Einsatz mit den Merkmalen des Oberbegriffs des Anspruchs 1.The invention relates to an expandable insert with the features of the preamble of claim 1.
Derartige Einsätze, auch „Stents" genannt, sind bekannt aus der US-PS 5102417 sowie aus der US-PS 5195984.Such inserts, also called "stents", are known from US Pat. No. 5,102,417 and from US Pat. No. 5,195,984.
Die bekannten Einsätze weisen drei rohrförmige Abschnitte oder Segmente auf, die aus einem als Implantat verträglichen Material hergestellt sind. Die drei rohrförmigen Segmente sind jeweils über Brückenstege miteinander verbunden, die ein Kippen oder ein Verschränken der Segmente gegeneinander erlauben sollen.The known inserts have three tubular sections or segments that are made of a material that is compatible with an implant. The three tubular segments are each connected to one another via bridge webs which are intended to allow the segments to be tilted or interleaved.
Die einzelnen Segmente sind geformt durch Ausschneiden von rechteckigen Ausschnitten aus dem Mantel der rohrförmigen Segmente. Dabei sind jeweils in Umfangsrichtung benachbarte Ausschnitte gegeneinander versetzt. Die rechteckigen Ausschnitte weisen achsparallele Langseiten und in Umfangsrichtung verlaufende Schmalseiten auf. Die stirnseitigen Schmalseiten sind untereinander nicht verbunden, so daß durch die Freiräume die Stirnseite des
rohrförmigen Segments zinnenartig aussieht. Bei den bekannten Einsätzen sind die miteinander verbundenen Segmente im unbenutzten Zustand des Einsatzes koaxial zueinander ausgerichtet und durch Brücken zwischen den stirnseitigen Schmalseiten verbunden. In der US-PS 5102417 verlaufen gerade, parallele Brückenstege von einer Stirnseite eines Segments schräg in Richtung auf die der gegenüberliegenden Schmalseite in Umfangsrichtung benachbarten Schmalseite. Jede Schmalseite eines Segments ist mit einer Schmalseite des benachbarten Abschnitts verbunden, so daß die schräg verlaufenden Brückenstege dem Einsatz ein verdrilltes Aussehen verleihen.The individual segments are formed by cutting out rectangular sections from the jacket of the tubular segments. In this case, adjacent cutouts are offset from one another in the circumferential direction. The rectangular cutouts have long sides parallel to the axis and narrow sides running in the circumferential direction. The front narrow sides are not connected to each other, so that the front side of the tubular segment looks crenellated. In the known inserts, the interconnected segments are aligned coaxially to one another in the unused state of the insert and are connected by bridges between the narrow faces at the front. In US Pat. No. 5,102,417, straight, parallel bridge webs run obliquely from one end face of a segment in the direction of the narrow side adjacent to the opposite narrow side in the circumferential direction. Each narrow side of a segment is connected to a narrow side of the adjacent section, so that the inclined bridge webs give the insert a twisted appearance.
Aus der US-PS 5195984 ist ein Einsatz bekannt, bei dem benachbarte Segmente jeweils zwischen zwei sich genau gegenüberliegenden Schmalseiten durch eine gerade, achsparallele Brücke verbunden sind. Zwischen jedem Segment gibt es lediglich einen Brückensteg, so daß der Zwischenraum zwischen den Segmenten im wesentlichen frei bleibt.An application is known from US Pat. No. 5,195,984 in which adjacent segments are each connected between two exactly opposite narrow sides by a straight, axially parallel bridge. There is only one bridge between each segment, so that the space between the segments remains essentially free.
Diese Einsätze erweisen sich in der Praxis bei geringen Materialstärken als nicht ausreichend steif gegenüber einer Kompression in radialer Richtung.In practice, these inserts prove to be insufficiently stiff with respect to compression in the radial direction with small material thicknesses.
Es ist daher Aufgabe der Erfindung, einen expandierbaren Einsatz zur Verwendung als Gefäßstütze in Blutgefäßen zu schaffen, bei dem bei ausreichender Flexibilität für die Anpassung an Gefäßkrümmungen eine besonders große Widerstandsfähigkeit (Recoil) gegenüber radial von außen einwirkenden Kräften besteht.It is therefore an object of the invention to provide an expandable insert for use as a vascular support in blood vessels, in which, with sufficient flexibility for adapting to vessel curvatures, there is a particularly great resistance (recoil) to forces acting radially from the outside.
Diese Aufgabe wird von einem expandierbaren Einsatz mit den Merkmalen des Anspruchs 1 gelöst.This object is achieved by an expandable insert with the features of claim 1.
Weil eine erste Gruppe von Ringen vorgesehen ist, deren Stranglänge im wesentlichen dem Umfang des Einsatzes im expandierten Zustand entspricht und eine zweite Gruppe von
Ringen vorgesehen ist, deren Stranglänge größer ist als der Umfang des Einsatzes im expandierten Zustand, können die Ringe mit kürzerer Stranglänge Kompressionskräfte gut aufnehmen, während die Ringe mit größerer Stranglänge die Zwischenräume, die sich zwischen den Ringen der ersten Gruppe ergeben, relativ gleichmäßig abdecken. Die Ringe der zweiten Gruppe ermöglichen darüber hinaus eine Flexibilität des Einsatzes bei Biegebeanspruchungen im erforderlichen Umfang.Because a first group of rings is provided, the strand length of which essentially corresponds to the scope of use in the expanded state, and a second group of Rings are provided, the strand length of which is greater than the scope of use in the expanded state, the rings with a shorter strand length can absorb compression forces well, while the rings with a longer strand length cover the spaces that arise between the rings of the first group relatively evenly. The rings of the second group also allow flexibility in use for bending loads to the extent required.
Es ist vorteilhaft, wenn die Stranglänge der zweiten Gruppe 1,2 bis 2,0 mal so groß ist wie die Stranglänge der ersten Gruppe, insbesondere 1,3 bis 1,5 mal so groß ist, weil sich bei diesen Verhältnissen eine gute Relation zwischen Expandierbarkeit und Längenverkürzung beim Expandieren ergibt. Eine gesteigerte Flexibilität gegenüber Biegebeanspruchungen ergibt sich, wenn die Stranglänge der zweiten Gruppe 1,7 bis 1,9 mal so groß ist wie die Stranglänge der ersten Gruppe.It is advantageous if the strand length of the second group is 1.2 to 2.0 times as long as the strand length of the first group, in particular 1.3 to 1.5 times as large, because there is a good relationship between these conditions Expandability and length reduction when expanding results. An increased flexibility with respect to bending stresses results if the strand length of the second group is 1.7 to 1.9 times as long as the strand length of the first group.
Eine Anordnung mit guter Abdeckung der entstehenden Zwischenräume wird erreicht, wenn die mäanderförmigen Stränge der zweiten Gruppe Längsabschnitte aufweisen, die im nicht expandierten Zustand parallel zu der Mittenachse des Grundkörpers verlaufen. Außerdem ist für die Stabilität von Vorteil, wenn die mäanderförmigen Stränge der ersten Gruppe Umfangsabschnitte aufweisen, die im nicht expandierten Zustand in Umfangsrichtung des Grundkörpers' verlaufen.An arrangement with good coverage of the resulting gaps is achieved if the meandering strands of the second group have longitudinal sections which, in the unexpanded state, run parallel to the central axis of the base body. In addition, for the stability of advantageous if the meander-shaped strands of the first group have peripheral portions which extend in the unexpanded state in the circumferential direction of the body '.
Hierbei ergibt sich eine besonders vorteilhafte Konstruktion, wenn sich die Stränge der ersten Gruppe und die Stränge der zweiten Gruppe jeweils im Bereich der Längsabschnitte kreuzen, insbesondere dann, wenn die Umfangsabschnitte der ersten Gruppe mittig mit den Längsabschnitten der zweiten Gruppe verbunden sind.
Ein sehr gleichmäßiges Öffnungsbild des Einsatzes im expandierten Zustand wird erreicht, wenn die Anzahl der sich periodisch wiederholenden Mäander eines Strangs der ersten Gruppe doppelt so groß ist wie die Anzahl der Mäander eines Strangs der zweiten Gruppe, wenn beispielsweise die Mäander der ersten Gruppe drei oder vier und die Mäander der zweiten Gruppe entsprechend sechs oder acht periodische Segmente aufweisen.This results in a particularly advantageous construction if the strands of the first group and the strands of the second group each intersect in the area of the longitudinal sections, in particular if the peripheral sections of the first group are connected centrally to the longitudinal sections of the second group. A very uniform opening pattern of the insert in the expanded state is achieved if the number of periodically repeating meanders of a strand of the first group is twice as large as the number of meanders of a strand of the second group, for example if the meanders of the first group are three or four and the meanders of the second group correspondingly have six or eight periodic segments.
Im folgenden ist anhand der Zeichnung ein Ausführungsbeispiel der Erfindung dargestellt. Es zeigen:An exemplary embodiment of the invention is shown below with reference to the drawing. Show it:
Fig. 1: die abgewickelte Mantelfläche einer expandierbaren Gefäßstütze im nicht expandierten Zustand; sowie1: the developed lateral surface of an expandable stent in the unexpanded state; such as
Fig. 2: die Mantelfläche einer expandierbaren Gefäßstütze nach Fig. 1 im expandierten Zustand.2: the outer surface of an expandable stent graft according to FIG. 1 in the expanded state.
Die Figur 1 zeigt die abgewickelte Mantelfläche einer zylindrischen, rohrförmigen Gefäßstütze im nicht expandierten Zustand.FIG. 1 shows the developed lateral surface of a cylindrical, tubular stent in the unexpanded state.
Der Mantelabschnitt 1 ist in einer Draufsicht dargestellt, wobei der Ansicht zylindrische, rohrförmige Grundkörper entlang einer achsparallelen Schnittlinie 2 aufgeschnitten und eben ausgebreitet dargestellt ist. Die Mantelfläche ist gebildet von einer Anzahl von mäanderförmigen Materialsträngen 3a, b sowie 4a, b. Die Matrerialstränge 3a und 3b sind mäander- oder wellenförmig in Umfangrichtung des Einsatzes geschwungen, wobei sich nahezu halbkreisförmige Bogenabschnitte 5 und gerade, achsparallel verlaufende Längsabschnitte 6 abwechseln. Bei dem Ausführungsbeispiel gemäß Figur 1 ist die Stranglänge des umlaufenden Materialstrangs 3a bzw. 3b etwa 14,5 mm, was bei der dargestellten Gestaltung einen Durchmesser im nicht expandierten Zustand von 1,8 mm ergibt. Der mäanderförmig umlaufende Strang 3a bzw. 3b kann als periodisch
wiederkehrende Form betrachtet werden, wobei jede Periode zwei Längsabschnitte 6 und zwei Bogenabschnitte 5 umfaßt. Bei diesem Ausführungsbeispiel sind also drei periodische Bereiche in Umfangsrichtung angeordnet.The jacket section 1 is shown in a plan view, the view showing the cylindrical, tubular base body being cut open along an axially parallel cutting line 2 and shown flatly spread out. The outer surface is formed by a number of meandering strands 3a, b and 4a, b. The material strands 3a and 3b are curved in a meandering or undulating manner in the circumferential direction of the insert, with almost semicircular arc sections 5 and straight longitudinal sections 6 running parallel to the axis alternating. In the exemplary embodiment according to FIG. 1, the strand length of the encircling material strand 3a or 3b is approximately 14.5 mm, which in the embodiment shown results in a diameter of 1.8 mm in the unexpanded state. The meandering strand 3a or 3b can be periodic recurring shape are considered, each period comprising two longitudinal sections 6 and two arc sections 5. In this exemplary embodiment, three periodic regions are thus arranged in the circumferential direction.
Die Materialstränge 4a und 4b sind ebenfalls mäanderförmig in Umfangsrichtung umlaufend angeordnet. Auch hier wechseln sich Bogenabschnitte 7 und Längsabschnitte 8 ab, wobei die Längsabschnitte 8 im nicht expandierten Zustand des Einsatzes etwa parallel zu den Längsabschnitten 6 der Materialstränge 3a und 3b verlaufen. Auch die Materialstränge 4a, 4b weisen eine Periodizität auf, wobei die Anzahl der Perioden bei diesem Ausführungsbeispiel doppelt so groß ist wie die Anzahl der Perioden der Materialstränge 3a, 3b. In der Figur 1 weist das Ausführungsbeispiel sechs periodische Abschnitte auf. Die Länge der Materialstränge 4a, 4b beträgt im vorliegenden Ausführungsbeispiel etwa 11 mm, was ebenfalls bei der vorliegenden Gestaltung zu einem Durchmesser von 1,8 mm führt.The material strands 4a and 4b are also arranged circumferentially in a meandering fashion. Here, too, arc sections 7 and longitudinal sections 8 alternate, the longitudinal sections 8 running approximately parallel to the longitudinal sections 6 of the material strands 3a and 3b in the unexpanded state of the insert. The material strands 4a, 4b also have a periodicity, the number of periods in this exemplary embodiment being twice as large as the number of periods of the material strands 3a, 3b. In the figure 1, the embodiment has six periodic sections. The length of the material strands 4a, 4b is approximately 11 mm in the present exemplary embodiment, which also leads to a diameter of 1.8 mm in the present design.
Die Materialstränge 3a und 3b durchsetzen sich bei dem vorliegenden Ausführungsbeispiel etwa mittig im jeweiligen Längsabschnitt 6 des Materialstrangs 3a, 3b. Die Materialstränge 4a, 4b durchsetzen dabei die Materialstränge 3a, 3b etwa rechtwinklig.In the present exemplary embodiment, the material strands 3a and 3b prevail approximately centrally in the respective longitudinal section 6 of the material strand 3a, 3b. The material strands 4a, 4b penetrate the material strands 3a, 3b approximately at right angles.
In der Praxis wird der erfindungsgemäße exp.andierbare Einsatz als einstückiges Element auf einem Rohr mit dem Außendurchmesser 1,8 mm geschnitten. Als Material kommt hier insbesondere implantatfähiger Edelstahl zum Einsatz, aber auch andere implantatfähige Materialien. Die Materialstärke in Radialrichtung ist über den gesamten Bereich des Einsatzes im wesentlichen konstant.In practice, the expandable insert according to the invention is cut as a one-piece element on a tube with an outside diameter of 1.8 mm. In particular, implantable stainless steel is used as the material, but also other implantable materials. The material thickness in the radial direction is essentially constant over the entire range of use.
In der Figur 2 ist ein Einsatz gemäß Figur 1 in dem zweiten, expandierten Zustand dargestellt. Der Durchmesser des
Einsatzes im expandierten Zustand beträgt bei diesem Ausführungsbeispiel 3,5 mm. Die sich ergebende Verformung durch Anwendung einer von innen her radial wirkenden Kraft führt dazu, daß die Materialstränge 4a und 4b voll gestreckt sind, also in der Praxis einen Kreisring von 11 mm Umfang bilden. Die längeren Materialstränge 3a und 3b werden bei der vorliegenden Konfiguration zu wellenförmigen, nahezu sinusförmigen Materialsträngen verformt.FIG. 2 shows an insert according to FIG. 1 in the second, expanded state. The diameter of the Use in the expanded state is 3.5 mm in this embodiment. The resulting deformation by the application of a force acting radially from the inside leads to the material strands 4a and 4b being fully stretched, that is to say in practice forming a circular ring of 11 mm in circumference. In the present configuration, the longer material strands 3a and 3b are deformed into wavy, almost sinusoidal material strands.
Die Am expandierten Zustand kreisringförmigen Materialstränge 4a und 4b setzen einer gleichförmig von außen einwirkenden Radialkraft einen großen strukturellen Widerstand entgegen, der ein Kollabieren des Einsatzes im behandelnden Blutgefäß zuverlässig verhindert. Alternativ kann bei gleicher Widerstandskraft (Recoil) gegenüber den bekannten Einsätzen eine geringere Materialstärke verwendet werden. In beiden Fällen ist die Gefahr einer erneuten Querschnittsverengung des behandelnden Blutgefäßes, auch Re-Stenose genannt, geringer als bei den bekannten Einsätzen.The material strands 4a and 4b, which are annular in the expanded state, oppose a uniform radial force exerting a great structural resistance, which reliably prevents the insert from collapsing in the treating blood vessel. Alternatively, a lower material thickness can be used with the same resistance (recoil) compared to the known inserts. In both cases, the risk of a renewed narrowing of the cross-section of the treating blood vessel, also called re-stenosis, is lower than in the known applications.
Die Anwendung des Einsatzes in der Praxis ist im Prinzip bekannt.The application of the application in practice is known in principle.
Bei ihrer Verwendung werden die erfindungsgemäßen Einsätze mit einem Ballonkatheter in die zu behandelnden Blutgefäße eingeführt. Der Ballonkatheter wird durch Einpressen eines Fluids erweitert, woraufhin sich die Einsätze in radialer Richtung durch plastische Verformung dauerhaft ausdehnen.When used, the inserts according to the invention are inserted into the blood vessels to be treated with a balloon catheter. The balloon catheter is expanded by injecting a fluid, whereupon the inserts expand permanently in the radial direction due to plastic deformation.
Nach dem Entfernen des Ballonkatheters verbleibt der Einsatz im Blutgefäß und wir innerhalb kurzer Zeit von der Intima umschlossen.After removing the balloon catheter, the insert remains in the blood vessel and we are surrounded by the intima within a short time.
Es ist offensichtlich, daß auch andere Gestaltungen der die erfindungsgemäßen Vorteile bieten, so sind beispielsweise Ω- förmige Gestaltungen denkbar.
It is obvious that other designs which offer the advantages according to the invention are also conceivable, for example Ω-shaped designs.
Claims
1. Expandierbarer Einsatz zur Verwendung als Gefäßstütze in 'Blutgefäßen, wobei der Einsatz durch Anwendung einer von innen nach außen gerichteten Radialkraft von einem nicht expandierten Zustand in einen expandierten Zustand plastisch verformbar ist, mit wenigstens einem im wesentlichen zylindrischen Grundkörperabschnitt, dessen Mantelfläche von einer Anzahl umlaufender mäanderförmiger Ringe gebildet ist, wobei die Ringe jeweils einen einstückigen Materialstrang mit einer bestimmten Stranglänge bilden, d a d u r c h g e k e n n z e i c h n e t , daß eine erste Gruppe von Ringen vorgesehen ist, deren Stranglänge im wesentlichen dem Umfang des Einsatzes im expandierten Zustand entspricht, und eine zweite Gruppe von Ringen vorgesehen ist, deren Stranglänge größer ist als der Umfang des Einsatzes im expandierten Zustand.1.Expandable insert for use as a vascular support in 'blood vessels, the insert being plastically deformable from an unexpanded state into an expanded state by using a radial force directed from the inside out, with at least one essentially cylindrical base body section, the lateral surface of which is of a number circumferential meandering rings is formed, the rings each forming an integral strand of material with a certain strand length, characterized in that a first group of rings is provided, the strand length of which essentially corresponds to the scope of use in the expanded state, and a second group of rings is provided is, the strand length is greater than the scope of use in the expanded state.
2. Einsatz nach Anspruch 1, dadurch gekennzeichnet, daß die Stranglänge der zweiten Gruppe 1,2 bis 2,0 mal so groß ist wie die Stranglänge der ersten Gruppe.2. Use according to claim 1, characterized in that the strand length of the second group is 1.2 to 2.0 times as large as the strand length of the first group.
3. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die Stranglänge der zweiten Gruppe 1,3 bis 1,5 mal so groß ist wie die Stranglänge der ersten Gruppe.3. Use according to one of the preceding claims, characterized in that the strand length of the second group is 1.3 to 1.5 times as long as the strand length of the first group.
4. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die Stranglänge der zweiten Gruppe
1,7 bis 1,9 mal so groß ist wie die Stranglänge der ersten Gruppe.4. Use according to one of the preceding claims, characterized in that the strand length of the second group Is 1.7 to 1.9 times the length of the first group.
5. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die mäanderförmigen Stränge der zweiten Gruppe Längsabschnitte aufweisen, die im nicht expandierten Zustand parallel zu der Mittenachse des Grundkörpers verlaufen.5. Use according to one of the preceding claims, characterized in that the meandering strands of the second group have longitudinal sections which, in the non-expanded state, run parallel to the central axis of the base body.
6. .Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die mäanderförmigen Stränge der ersten Gruppe Umfangsabschnitte aufweisen, die im nicht expandierten Zustand in Umfangsrichtung des Grundkörpers verlaufen.6. .Use according to one of the preceding claims, characterized in that the meandering strands of the first group have circumferential sections which run in the non-expanded state in the circumferential direction of the base body.
7. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß sich die Stränge der ersten Gruppe und die Stränge der zweiten Gruppe jeweils im Bereich der Längsabschnitte kreuzen.7. Use according to one of the preceding claims, characterized in that the strands of the first group and the strands of the second group each intersect in the region of the longitudinal sections.
8. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die Anzahl der Mäander je eines Strangs der ersten Gruppe doppelt so groß ist wie die Anzahl der Mäander des entsprechenden Strangs der zweiten Gruppe .8. Use according to one of the preceding claims, characterized in that the number of meanders each of a strand of the first group is twice as large as the number of meanders of the corresponding strand of the second group.
9. Einsatz nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß die Stränge der ersten Gruppe im expandierten Zustand des Einsatzes im wesentlichen zu einem Kreisring gestreckt sind.
9. Insert according to one of the preceding claims, characterized in that the strands of the first group are substantially stretched into a circular ring in the expanded state of the insert.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19722384A DE19722384A1 (en) | 1997-05-28 | 1997-05-28 | Flexible expandable stent |
DE19722384 | 1997-05-28 | ||
PCT/EP1998/003148 WO1998053763A1 (en) | 1997-05-28 | 1998-05-28 | Flexible expandable vascular support |
Publications (1)
Publication Number | Publication Date |
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EP0944367A1 true EP0944367A1 (en) | 1999-09-29 |
Family
ID=7830777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP98930744A Withdrawn EP0944367A1 (en) | 1997-05-28 | 1998-05-28 | Flexible expandable vascular support |
Country Status (5)
Country | Link |
---|---|
US (1) | US6190405B1 (en) |
EP (1) | EP0944367A1 (en) |
AU (1) | AU8107298A (en) |
DE (2) | DE19722384A1 (en) |
WO (1) | WO1998053763A1 (en) |
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-
1998
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- 1998-05-28 AU AU81072/98A patent/AU8107298A/en not_active Abandoned
- 1998-05-28 EP EP98930744A patent/EP0944367A1/en not_active Withdrawn
- 1998-05-28 WO PCT/EP1998/003148 patent/WO1998053763A1/en not_active Application Discontinuation
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Also Published As
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US6190405B1 (en) | 2001-02-20 |
DE19880674D2 (en) | 1999-11-25 |
AU8107298A (en) | 1998-12-30 |
DE19722384A1 (en) | 1998-12-03 |
WO1998053763A1 (en) | 1998-12-03 |
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