DE10125999A1 - Implantable bio-resorbable vessel-wall-support consists of a framework of interconnected arms with different cross-sections, thicknesses and widths - Google Patents
Implantable bio-resorbable vessel-wall-support consists of a framework of interconnected arms with different cross-sections, thicknesses and widthsInfo
- Publication number
- DE10125999A1 DE10125999A1 DE2001125999 DE10125999A DE10125999A1 DE 10125999 A1 DE10125999 A1 DE 10125999A1 DE 2001125999 DE2001125999 DE 2001125999 DE 10125999 A DE10125999 A DE 10125999A DE 10125999 A1 DE10125999 A1 DE 10125999A1
- Authority
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- Germany
- Prior art keywords
- webs
- wall support
- different
- designed
- vessel
- 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.)
- Ceased
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Classifications
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- 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
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- 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
- A61F2002/91508—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 the meander having a difference in amplitude along the band
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- 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
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
Abstract
Description
Die Erfindung betrifft eine implantierbare, bioresorbierbare Gefäßwand stütze und insbesondere ein Koronarstent, die aus einem bioresorbierbaren Polymer- oder Metallmaterial besteht. Die Gefäßwandstütze ist dabei aus einem Tragwerk von miteinander verbundenen Stegen gebildet, das durch Aufweiten (Dilatation) mit Hilfe eines Ballonkatheters nach dem Verbrin gen an den Implantationsort verankerbar ist.The invention relates to an implantable, bioresorbable vessel wall support and in particular a coronary stent that consists of a bioresorbable Polymer or metal material is made. The vessel wall support is off a structure of interconnected webs formed by Widening (dilation) with the help of a balloon catheter after the consumption is anchored to the implantation site.
Zum Hintergrund der Erfindung ist festzuhalten, daß die Bioresorbierbar keit von Gefäßwandstützen die Nachteile von dauerhaft implantierten Stüt zen beheben soll. Es sind dies beispielsweise eine mögliche permanente Reizung des Gewebes, das einen Koronarstent umgibt, da letzterer die durch den Herzschlag verursachten Biegebewegungen des gestützten Koro nargefäßes aufgrund seiner Steifigkeit nicht nachvollzieht. Ferner ist zur Aufweitung eines Körpergefäßes die Unterstützung durch die Gefäßwand stütze in der Regel - je nach Anwendungsfall - nur über einen Zeitraum von einigen Monaten erforderlich. Danach bliebe die von der Verengung betrof fene Gefäßpartie auch ohne Unterstützung offen.In the background of the invention it should be noted that the bioresorbable vascular wall supports the disadvantages of permanently implanted supports zen should fix. For example, this is a possible permanent one Irritation of the tissue surrounding a coronary stent, since the latter bending movements of the supported coro caused by the heartbeat not understand due to its stiffness. Furthermore, the Widening of a body vessel's support through the vessel wall support - depending on the application - only over a period of required a few months. After that, it would remain affected by the narrowing Open vascular part open without support.
Aus dem Stand der Technik sind nun Gefäßwandstützen oder Stents aus unterschiedlichen bioresorbierbaren Materialien bekannt. So offenbart die DE 195 39 449 A1 einen bioresorbierbaren Koronarstent, der aus einer vis kosen Lösung von Poly-Beta-Hydroxy-Buttersäure als bioresorbierbarem Polymer-Material aufgebaut wird. Allerdings ist dieser Stent hülsenförmig und weist kein Tragwerk von miteinander verbundenen Stegen auf. Vascular wall supports or stents are now made from the prior art different bioabsorbable materials known. So the reveals DE 195 39 449 A1 discloses a bioresorbable coronary stent, which consists of a vis kosen solution of poly-beta-hydroxy-butyric acid as a bioabsorbable Polymer material is built up. However, this stent is sleeve-shaped and has no structure of interconnected webs.
Ein Koronarstent aus dem vorstehend angegebenen Polymermaterial mit einem solchen Tragwerk von miteinander verbundenen Stegen ist allerdings aus der DE 197 45 294 A1 bekannt, die sich mit der Strukturierung dieses Materials mit Hilfe ultrakurzer Laserpulse beschäftigt.A coronary stent made from the above polymer material Such a structure of interconnected webs is, however known from DE 197 45 294 A1, which deals with the structuring of this Materials used with the help of ultra-short laser pulses.
Die DE 198 56 983 A1 schließlich offenbart implantierbare, bioresorbier bare Gefäßwandstützen aus einem Tragwerk von miteinander verbundenen Stegen, die aus einem bioresorbierbaren Metallmaterial gebildet sind. Von einer Bioresorbierbarkeit des Materials kann dann die Rede sein, wenn sich eine entsprechende Metall-Materialkombination - eine Metall-Legierung oder ein sogenanntes elektrochemisches Lokalelement - sich im Körper ohne schädliche Auswirkungen auf den Implantatträger zersetzt.Finally, DE 198 56 983 A1 discloses implantable, bioresorbents Bare vessel wall supports from a structure of interconnected Bridges that are formed from a bioabsorbable metal material. Of Bioresorbability of the material can be considered if a corresponding metal-material combination - a metal alloy or a so-called electrochemical local element - in the body decomposes without harmful effects on the implant carrier.
Ein aus dem Stand der Technik grundsätzlich bekanntes, bereits angespro chenes Problem liegt nun darin, daß Gefäßwandstützen und insbesondere Koronarstents möglichst geringe Irritationen der von ihnen beaufschlagten und gestützten Gefäßbereiche hervorrufen sollen. Dazu ist es aus dem Stand der Technik bereits bekannt, den Stent in bestimmten Bereichen be züglich seiner Festigkeit zu modifizieren, was beispielsweise über unter schiedliche Auslegung der Resorptionsrate des Stentmaterials erfolgen kann. So ist aus der WO 00 50103 A1 ein resorbierbarer Polymer-Stent überwiegend für urologische Anwendungen bekannt, der Abschnitte unter schiedlicher Resorptionszeit aufweist. Dazu werden in diesen unterschied lichen Abschnitten unterschiedliche Polymer-Materialien verwendet. Alter nativ dazu kann ein einheitliches Polymer-Material eingesetzt werden, das hinsichtlich des ionischen oder kovalenten Charakters seiner Bindungen so modifiziert ist, daß sich Bereiche unterschiedlicher mechanischer Eigen schaften des Stents ergeben. Diese Druckschrift zeigt im übrigen keine Ge fäßwandstützen mit einem röhrenförmigen Tragwerk von miteinander ver bundenen Stegen, sondern mit stäbchenartigen, an den Enden mit so be zeichneten "ringelschwanzförmigen" Verankerungselementen versehene Urinaltrakt-Stents.One already known from the prior art, already addressed Chenes problem is that vascular wall supports and in particular Coronary stents as little as possible irritation of the ones they apply and to cause supported vascular areas. It is from the Prior art already known to be the stent in certain areas to modify in terms of its strength, for example, what is below different interpretation of the resorption rate of the stent material can. WO 00 50103 A1 is a resorbable polymer stent Known primarily for urological applications, the sections below has different absorption times. A distinction is made in these sections used different polymer materials. age natively, a uniform polymer material can be used that regarding the ionic or covalent nature of its bonds modified is that areas of different mechanical properties properties of the stent. Otherwise, this document shows no Ge vessel wall supports with a tubular structure from each other ver tied webs, but with rod-like, at the ends with so be drew "ring-tailed" anchoring elements provided Urinary tract stents.
Aus der WO 99 33410 A1 ist ein bioresorbierbarer Polymer-Stent bekannt, bei dem an einem bandförmigen Trägerteil seitlich Laschen abstehen, die zu einem röhrenförmigen Tragwerk zusammengesteckt und nach dem Ein führen in den Körper radial aufgedehnt werden können. Im Trägerband und den seitlichen Laschen sind jeweils streifenförmige Zonen vorgesehen, die aufgrund einer lokalen Modifikation des Polymer-Materials oder der Ver wendung eines von den umgebenden Bereichen unterschiedlichen Polymers eine kürzere Resorptionszeit aufweisen. Dies ermöglicht das Auftrennen des Stents in Umfangsrichtung, um damit eine Aufhebung der radialen Fe stigkeit der Stütze einige Zeit nach der Implantation zu bewirken. Dadurch soll das sogenannte "arterielle Remodelling" ermöglicht werden, bei der sich der freie Durchmesser der vom Stent gestützten Arterie von selbst ver größert, was durch einen radial festen Stent verhindert werden würde.A bioresorbable polymer stent is known from WO 99 33410 A1, in which tabs protrude laterally on a band-shaped support part put together to a tubular structure and after the on lead into the body can be expanded radially. In the carrier tape and the side tabs are each strip-shaped zones provided due to a local modification of the polymer material or the Ver use of a different polymer from the surrounding areas have a shorter absorption time. This enables the separation of the stent in the circumferential direction in order to thereby cancel the radial Fe stability of the support some time after the implantation. Thereby the so-called "arterial remodeling" should be made possible in the the free diameter of the artery supported by the stent ver increases what would be prevented by a radially fixed stent.
Schließlich zeigt die WO 00 62708 A1 einen hülsenförmigen, mit einer nicht unterbrochenen Wandung versehenen Stent, der an verschiedenen axialen Positionen in seiner Hülsenwand mit Einschnürungen versehen ist. Diese dienen einerseits einer Erhöhung der Flexibilität des Stents quer zu seiner Längsachse. Andererseits kann im Bereich der Einschnürung der Stent degradieren und damit die einzelnen ringförmigen Bereiche zwischen den Einschnürungen voneinander separieren. Finally, WO 00 62708 A1 shows a sleeve-shaped one uninterrupted wall stent attached to different axial positions in its sleeve wall is provided with constrictions. On the one hand, these serve to increase the flexibility of the stent across its longitudinal axis. On the other hand, in the area of constriction Degrade stent and thus the individual annular areas between separate the constrictions from each other.
Die vorstehend erörterten Gefäßwandstützen auf Polymerbasis zeigen das Problem, das die unterschiedliche Einstellung von mechanischen Eigen schaften und die Auftrennbarkeit der Stents in einzelne Teile durch eine chemische Modifikation des Polymer-Materials in bestimmten Zonen oder durch die Verwendung von grundsätzlich unterschiedlichen Polymer- Materialien erzeugt wird. Dies ist herstellungstechnisch äußert aufwendig. Dies gilt um so mehr für die Gefäßwandstützen aus Metallmaterial, da hier geeignete Modifikationen in selektierten Zonen, wie Härteänderungen oder die Verwendung von Mischmaterialien in Form etwa unterschiedlicher Le gierungsbestandteile mit vernünftigem Herstellungsaufwand überhaupt nicht realisierbar sind.The polymer-based vessel wall supports discussed above show this Problem that the different setting of mechanical eigen and the separability of the stents into individual parts by a chemical modification of the polymer material in certain zones or through the use of fundamentally different polymer Materials is generated. This is extremely complex in terms of production technology. This applies all the more to the vessel wall supports made of metal material, since here suitable modifications in selected zones, such as changes in hardness or the use of mixed materials in the form of approximately different Le Ging components with reasonable manufacturing costs at all are not feasible.
Insofern liegt der Erfindung die Aufgabe zugrunde, gattungsgemäße Ge fäßwandstützen so weiterzubilden, daß sie sich auf einfache Weise entspre chend den Anforderungen an das Resorptionsverhalten und ihre mechani schen Eigenschaften anpassen können.In this respect, the invention is based on the object, generic Ge to further develop barrel wall supports in such a way that they correspond in a simple manner according to the requirements of the absorption behavior and their mechani properties.
Diese Aufgabe wird durch die im Kennzeichnungsteil des Anspruches 1 angegebenen Merkmale gelöst. Demnach können die Resorptionszeiten des Stegmaterials in unterschiedlichen Stützenbereichen durch gezielte unter schiedliche Querschnitte der Stege variabel ausgelegt werden. Im Gegen satz zum Stand der Technik wird also die Modifikation ausgesuchter Stent zonen nicht auf chemischem, sondern auf rein mechanischem Weg erzielt, was insbesondere im Zusammenhang mit den aus einem Tragwerk von mit einander verbundenen Stegen bestehenden Stents von besonderer Bedeu tung ist. Diese sind nämlich sehr filigran aufgebaut, so daß eine chemische Modifikation entsprechend sehr kleiner Bereiche zu einem unvertretbar hohen Herstellungsaufwand führen würde. This object is achieved by the in the characterizing part of claim 1 specified features solved. Accordingly, the absorption times of the Bridge material in different column areas through targeted under different cross-sections of the webs can be designed variably. In the opposite The modification of selected stent becomes the state of the art zones not achieved chemically, but purely mechanically, which in particular in connection with having a structure of interconnected webs of existing stents of particular importance tung is. This is because they are very filigree, so that a chemical Modification according to very small areas to an unacceptable would lead to high manufacturing costs.
Wenngleich nun die Resorptionszeiten durch unterschiedliche Dicken der Stege variabel ausgelegt werden kann, ist die Variierung der Resorptionsra te bevorzugtermaßen durch unterschiedliche Stegbreiten hervorzurufen. Da die Stents aus einem Bandmaterial ausgestanzt und zu einem röhrenförmi gen Tragwerk zusammengerollt oder aus einem rohrförmigen Material durch Laserschneiden hergestellt werden, ist das Erzeugen unterschiedli cher Stegbreiten durch eine einfache Anpassung der Schnittkontur sehr viel einfacher möglich als eine Variierung der Materialstärke des Steges in be stimmten Zonen. Auch eine Querschnittsvariierung durch z. B. beim Stan zen mit eingearbeitete Perforationen ist herstellungstechnisch einfach zu realisieren.Although now the absorption times due to different thicknesses of the Can be designed variably, is the variation of the resorption te preferably caused by different web widths. There the stents are punched out of a band material and formed into a tubular The structure is rolled up or made of a tubular material are produced by laser cutting, the production is different bridge widths by simply adjusting the cutting contour very much easier possible than a variation of the material thickness of the web in be agreed zones. A cross-sectional variation by z. B. Stan zen with integrated perforations is easy to manufacture realize.
Gemäß einer weiteren bevorzugten Ausführungsform ist es vorgesehen, daß die Querschnittsflächen und insbesondere die Breiten der Stege derart aus gelegt sind, daß Tragwerkelemente, die die radiale Festigkeit der Gefäß wandstütze gewährleisten, langsamer resorbierbar sind als Tragwerk elemente, die die axiale Festigkeit gewährleisten. Eine solche Auslegung wird dem Einsatzzweck eines Stents besonders gerecht, da die radiale Festigkeit gerade das Offenhalten eines verengten Gefäßes gewährleistet. Dahingegen ist eine axiale Festigkeit unter Umständen sogar nachteilig, da sie den Biegewiderstand des Stents gegen die ständigen Bewegungen des von ihm gestützten Gefäßes sogar erhöhen, was zu Gefäßwand-Irritationen führen kann.According to a further preferred embodiment, it is provided that the cross-sectional areas and in particular the widths of the webs are placed that structural elements, which the radial strength of the vessel ensure wall support, are more slowly resorbable than supporting structure elements that ensure axial strength. Such an interpretation is particularly suitable for the purpose of a stent, since the radial Strength ensures that a narrowed vessel is kept open. In contrast, axial strength may even be disadvantageous because the bending resistance of the stent against the constant movements of the the vessel supported by him may even increase, causing irritation to the wall of the vessel can lead.
Gemäß einer besonders bevorzugten Ausführungsform ist es in diesem Zu sammenhang vorgesehen, die Gefäßwandstütze in radial umlaufenden, mit Abstand zueinander angeordneten Zonen mit geringeren Querschnitten zu versehen, so daß ein Auftrennen der Gefäßwandstütze in einzelne Ringab schnitte begünstigt wird.According to a particularly preferred embodiment, it is in this case provided, the vessel wall support in radially circumferential, with Zones with smaller cross sections arranged at a distance from one another provided so that a separation of the vessel wall support into individual rings cuts is favored.
Ein weiterer Aspekt der Erfindung im Zusammenhang mit einer mecha nisch bedingten Auslegung der Resorptionszeiten unterschiedlicher Stegbe reiche liegt in der Variierung durch unterschiedliche Oberflächenbeschaf fenheiten der Stege. So wird eine glatte Oberfläche aufgrund der geringeren wirksamen Fläche zu einer gegenüber Bereichen mit rauher Oberfläche langsameren Resorption führen. Weitere Alternativen zur unterschiedlichen Auslegung von Stegbereichen in ihrer Oberflächenbeschaffenheit können in dem Aufbringen von Beschichtungen oder einer Hydrophobierung be stimmter Oberflächenbereiche liegen.Another aspect of the invention in connection with a mecha nically conditioned interpretation of the resorption times of different webs rich lies in the variation due to different surface finishes the bridges. So a smooth surface due to the smaller effective area to an area with a rough surface result in slower absorption. Other alternatives to the different Design of web areas in their surface condition can in the application of coatings or hydrophobization coherent surface areas.
Weitere Merkmale, Einzelheiten und Vorteile der Erfindung sind der nach folgenden Beschreibung entnehmbar, in der ein Ausführungsbeispiel an hand der beigefügten Zeichnungen näher erläutert wird. Es zeigen:Further features, details and advantages of the invention are according to following description can be seen in the an embodiment hand is explained in more detail by the accompanying drawings. Show it:
Fig. 1 eine Abwicklung eines Tragwerks eines röhrenförmigen Stents und Fig. 1 is a development of a structure of a tubular stent and
Fig. 2 eine vergrößerte, ausschnittsweise Draufsicht auf die Stegstruktur des Tragwerkes gemäß Fig. 1. FIG. 2 is an enlarged, partial top view of the web structure of the supporting structure according to FIG. 1.
Wie aus Fig. 1 deutlich wird, besteht ein in seiner Grundstruktur an sich bekannter Stent 1 aus einem feinstrukturierten Tragwerk von Längsstegen 2 und diese verbindenden Querstegen 3. Die Längsstege 2 verzweigen sich dabei in einander parallele Stränge 4, die jeweils am Ende über einen aus gebauchten Bogen 5 paarweise miteinander verbunden sind. Links und rechts bezogen auf Fig. 1 setzen sich die Längsstege 2 mit ihren Verzwei gungssträngen 4 bis zum Ende des rohrförmigen Stents 1 fort. In Richtung der Querstege 3 ist die Struktur zylindrisch geformt, so daß die oben bezüg lich Fig. 1 auslaufenden Querstege 3 in die unten auslaufenden Querstege 3 übergehen. Die Einhüllende des Tragwerkes ist also eine Zylinderform, wobei die abgekröpften Querstege 3 bei der übliche Dilatation des Stents 1 und die damit verbundene Durchmessererweiterung gereckt werden.As is clear from FIG. 1, a stent 1 known per se in its basic structure consists of a finely structured supporting structure of longitudinal webs 2 and transverse webs 3 connecting them . The longitudinal webs 2 branch into parallel strands 4 , each of which is connected in pairs at the end via a bulged arch 5 . Left and right based on Fig. 1, the longitudinal webs 2 continue with their branching strands 4 to the end of the tubular stent 1 . In the direction of the crosspieces 3, the structure is cylindrically shaped, so that the above bezüg Lich Fig. 1 expiring transverse bars 3 pass into the expiring bottom transverse webs 3. The envelope of the supporting structure is therefore a cylindrical shape, the bent cross webs 3 being stretched during the usual dilation of the stent 1 and the associated widening of the diameter.
Die gezeigte Tragwerkstruktur aus Längsstegen 2 und Querstegen 3 ist durch ein geeignetes Stanzwerkzeug oder - bevorzugtermaßen - durch eine Laserschneidapparatur aus einem entsprechenden Blechmaterial, wie z. B. einer Zink-Kalzium-Legierung oder Zink-Titan-Legierung, hergestellt. Weitere geeignete Materialien sind der eingangs erwähnten DE 198 56 983 A1 entnehmbar.The structural structure shown, consisting of longitudinal webs 2 and transverse webs 3, can be made by a suitable punching tool or - preferably - by a laser cutting apparatus made of a corresponding sheet metal material, such as, for. B. a zinc-calcium alloy or zinc-titanium alloy. Further suitable materials can be found in the aforementioned DE 198 56 983 A1.
Wie nun aus Fig. 2 hervorgeht, weist das Tragwerk in unterschiedlichen Zonen unterschiedliche Stegbreiten auf. So sind die Querstege 3 von einer mittleren Breite b0 von z. B. 84 µm sowie die Längsstränge 4 und die diese verbindenden Bögen 5 von einer mittleren Breite b1 von z. B. 74 µm. Fer ner sind zwei quer zur Axialrichtung A des Stents 1 verlaufende Reihen der aus den Strängen 4 und den Bögen 5 gebildeten, schlüssellochförmigen Tragwerkelemente durch Längsstege 2 mit einer größeren Breite b2 von z. B. 120 µm verbunden.As can now be seen from FIG. 2, the structure has different web widths in different zones. So the crossbars 3 are of an average width b0 of z. B. 84 microns and the longitudinal strands 4 and the connecting arches 5 of an average width b1 of z. B. 74 microns. Fer ner are two transverse to the axial direction A of the stent 1 extending rows of the keyhole-shaped supporting elements formed from the strands 4 and the arches 5 by longitudinal webs 2 with a larger width b2 of z. B. 120 microns connected.
Zwischen diesen zwei Reihen ist jeweils eine quer zur Axialrichtung A ra dial um den Stent 1 laufende Zone Z der Gefäßwandstütze vorgesehen, in der die in Axialrichtung A verlaufenden Stege 2' eine gegenüber den Brei ten b0, b1 und b2 wesentlich geringere Breite b3 aufweisen. Da die Dicke der Stege 2, 2', 3, 4, 5 konstant ist, ist die Querschnittsfläche im Bereich der Stege 2' wesentlich geringer als im Bereich der anderen Tragwerksele mente 2, 3, 4, 5. Dadurch ist die Resorptionszeit - also die Zerfallszeit des bioresorbierbaren Metallmaterials - im Bereich der schmalen Stege 2' we sentlich niedriger als im Bereich der anderen Stege 2, 3, 4, 5. Damit ist die Resorptionszeit der die axiale Festigkeit gewährleistenden Stege 2 höher mit der Folge, daß die die radiale Festigkeit des Stents 1 gewährleistenden Stege 3, 4, 5 in einem größeren Zeitraum resorbiert werden als die Stege 2'. Dies bedeutet, daß sich die Stentstruktur mit der Zeit in Axialrichtung A auftrennt und nur die zwischen den Zonen Z gebildeten Bereiche in einem Zwischenstadium körperlich vorhanden bleiben. Dann kann der Stent 1 mit seinen einzelnen ringartigen Bereichen B das Gefäß nach wie vor in radia ler Richtung abstützen. Andererseits kann sich das Gefäß an verschiedenen Axialpositionen des Stents 1 ohne weiteres deformieren und auslenken, da die einzelnen ringartigen Bereiche durch die resorbierten Zonen Z mecha nisch voneinander getrennt sind.Between these two rows, a zone Z of the vessel wall support running transversely to the axial direction A ra dial around the stent 1 is provided, in which the webs 2 'running in the axial direction A have a width b3 which is substantially smaller than the widths b0, b1 and b2. Since the thickness of the webs 2 , 2 ', 3 , 4 , 5 is constant, the cross-sectional area in the area of the webs 2 ' is substantially smaller than in the area of the other supporting elements 2 , 3 , 4 , 5 . As a result, the resorption time - that is to say the disintegration time of the bioresorbable metal material - in the region of the narrow webs 2 'is considerably shorter than in the region of the other webs 2 , 3 , 4 , 5 . The resorption time of the webs 2 that ensure the axial strength is thus higher, with the result that the webs 3 , 4 , 5 that ensure the radial strength of the stent 1 are absorbed in a larger period of time than the webs 2 '. This means that the stent structure separates over time in the axial direction A and only the areas formed between the zones Z remain physically present in an intermediate stage. Then the stent 1 with its individual ring-like regions B can still support the vessel in the radial direction. On the other hand, the vessel can easily deform and deflect at different axial positions of the stent 1 , since the individual ring-like regions are mechanically separated from one another by the resorbed zones Z.
Claims (7)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE2001125999 DE10125999A1 (en) | 2001-05-18 | 2001-05-18 | Implantable bio-resorbable vessel-wall-support consists of a framework of interconnected arms with different cross-sections, thicknesses and widths |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE2001125999 DE10125999A1 (en) | 2001-05-18 | 2001-05-18 | Implantable bio-resorbable vessel-wall-support consists of a framework of interconnected arms with different cross-sections, thicknesses and widths |
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| DE10125999A1 true DE10125999A1 (en) | 2002-11-21 |
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| Application Number | Title | Priority Date | Filing Date |
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| DE2001125999 Ceased DE10125999A1 (en) | 2001-05-18 | 2001-05-18 | Implantable bio-resorbable vessel-wall-support consists of a framework of interconnected arms with different cross-sections, thicknesses and widths |
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| DE (1) | DE10125999A1 (en) |
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| CN102599997A (en) * | 2012-04-22 | 2012-07-25 | 张发明 | Fragmented-falling nonvascular orifice bracket |
| US8298466B1 (en) | 2008-06-27 | 2012-10-30 | Abbott Cardiovascular Systems Inc. | Method for fabricating medical devices with porous polymeric structures |
| DE102012000466B3 (en) * | 2012-01-13 | 2013-04-18 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Producing components, which are formed in portion of series of fine structures and spaces, comprises e.g. establishing component on substrate layerwise by selective laser melting, and connecting fine structures in selective laser melting |
| US8834553B2 (en) | 2009-09-11 | 2014-09-16 | Gi Dynamics, Inc. | Anchors with biodegradable constraints |
| US9265596B2 (en) | 2009-09-11 | 2016-02-23 | Gi Dynamics, Inc. | Anchors with open heads |
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| CN102599997B (en) * | 2012-04-22 | 2015-09-09 | 张发明 | A kind of can the non-vascular orifice bracket that comes off of burst |
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