DE19856983A1 - Implantable, bioresorbable vascular wall support, in particular coronary stent - Google Patents
Implantable, bioresorbable vascular wall support, in particular coronary stentInfo
- Publication number
- DE19856983A1 DE19856983A1 DE19856983A DE19856983A DE19856983A1 DE 19856983 A1 DE19856983 A1 DE 19856983A1 DE 19856983 A DE19856983 A DE 19856983A DE 19856983 A DE19856983 A DE 19856983A DE 19856983 A1 DE19856983 A1 DE 19856983A1
- Authority
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- Germany
- Prior art keywords
- wall support
- vessel wall
- support according
- metal
- alloy
- 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.)
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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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
- 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
Eine implantierte bioresorbierbare Gefäßwandstütze, insbesondere Koronarstent, bestehend aus einer sich im Körper ohne schädliche Auswirkungen auf den Implantat-Träger zersetzenden Metall-Materialkombination. Letztere kann als Legierung oder galvanisches Lokalelement ausgebildet sein.An implanted bioresorbable vascular wall support, in particular a coronary stent, consisting of a metal-material combination that decomposes in the body without harmful effects on the implant carrier. The latter can be designed as an alloy or a galvanic local element.
Description
Die Erfindung betrifft eine implantierbare, bioresorbierbare Gefäßwand stütze, insbesondere einen Koronarstent.The invention relates to an implantable, bioresorbable vessel wall support, especially a coronary stent.
Zum Hintergrund der Erfindung ist festzuhalten, daß sogenannte "Gefäß wandstützen" oder - wie sie im Fachjargon genannt werden - "Stents" zur Therapie von Stenosen, also krankhaft verengten Passagen eines Koronar gefäßes eingesetzt werden. Dazu wird ein solcher Koronarstent mittels ei nes Katheters transvenös in den Körper eingeführt und durch das Gefäßsy stem an die Problemstelle im Herzen vorgeschoben. In diesem Zustand des Einführens und Vorschiebens darf der Stent für eine ausreichende Beweg lichkeit einen Außendurchmesser von lediglich etwa 1 mm aufweisen. Ist die stenotische Koronargefäß-Passage erreicht, wird der Stent dauerhaft aufgeweitet, um die Stenose zu beheben. Dazu wird der Stent mittels des Katheters, auf dem er eingeführt wurde, unter plastischer Verformung bis auf einen Durchmesser von etwa 4 mm radial aufgeweitet. Zu diesem Zweck ist der Katheter als Ballonkatheter ausgeführt, bei dem der den Stent tragende Längsabschnitt durch Anlegen eines Überdrucks mittels Koch salzlösung ähnlich einem Luftballon dilatiert wird.In the background of the invention it should be noted that so-called "vessel wall supports "or - as they are called in technical jargon -" stents " Therapy of stenoses, i.e. pathologically narrow passages of a coronary vessel are used. For this purpose, such a coronary stent is created using an egg A catheter is inserted transvenously into the body and through the vascular system stem advanced to the problem area in the heart. In this state of The stent may be inserted and advanced for sufficient movement have an outer diameter of only about 1 mm. Is When the stenotic passage through the coronary artery is reached, the stent becomes permanent expanded to correct the stenosis. To do this, the stent is removed using the Catheter on which it was inserted, with plastic deformation until expanded radially to a diameter of about 4 mm. To this The purpose of the catheter is a balloon catheter in which the stent load-bearing longitudinal section by applying an overpressure by means of a cook salt solution is dilated like a balloon.
Herkömmliche implantierte Stents bestehen aus einem für den medizini schen Einsatz geeigneten Metallmaterial, das gegebenenfalls zur Vermei dung thrombotischer Probleme mit einer antikoagulative wirkenden Be schichtung versehen sein kann. Nachteil bei solchen dauerhaft implantier ten Stents ist die nachweislich auftretende permanente Reizung des den Stent umgebenden Gewebes, da er die durch den Herzschlag verursachten Biegebewegungen des von ihm gestützten Koronargefäßes aufgrund seiner Steifigkeit nicht nachvollzieht.Conventional implanted stents consist of one for medical use use suitable metal material, which may be used to avoid of thrombotic problems with an anticoagulant effect Layering can be provided. Disadvantage with such a permanent implant ten stents is the demonstrable permanent irritation of the Stent surrounding tissue as it is caused by the heartbeat Bending movements of the coronary vessel supported by him due to his Not understand rigidity.
Ferner ist darauf hinzuweisen, daß zur Aufweitung einer Stenose die Unter stützung durch den Stent in der Regel nur über einen Zeitraum von einigen Monaten erforderlich ist. Danach bliebe die von der Stenose betreffende Gefäßpartie auch ohne Unterstützung offen.It should also be noted that the sub support from the stent is usually only available over a period of a few Months is required. After that, the one affected by the stenosis would remain Vascular section open without support.
Zur Behebung der vorgenannten Probleme wurde bereits vorgeschlagen, Stents aus bioresorbierbaren Materialien herzustellen, die im Körper im Verlauf weniger Monate zersetzt werden. Ein Herstellungsverfahren für solche bioresorbierbaren Koronarstents ist z. B. aus der DE 195 39 449 A1 bekannt. Dort wird aus einer viskosen Lösung von Poly-Beta-Hydroxy- Buttersäure als bioresorbierbaren Polymermaterial in einem Lösungsmittel durch sukzessives, schichtweises Aufbringen der Polymerlösung auf einen Positiv-Formkern in mehreren Schritten durch Abscheiden des Polymer materials unter Abdampfen des Lösungsmittels und unter zumindest teil weiser Anlösung der vorher abgeschiedenen Schicht ein in seiner Polymer struktur homogener Stenterrohling aufgebaut. Dieser wird vom Positiv- Formkern abgezogen und zur Endformgebung des Stents nachbearbeitet.To solve the above problems, it has already been suggested Manufacture stents from bioabsorbable materials that are in the body in the Decompose over the course of a few months. A manufacturing process for such bioresorbable coronary stents is e.g. B. from DE 195 39 449 A1 known. There a viscous solution of poly-beta-hydroxy Butyric acid as a bioabsorbable polymer material in a solvent by successively applying the polymer solution in layers to one Positive mold core in several steps by separating the polymer materials with evaporation of the solvent and at least partially wise dissolution of the previously deposited layer in its polymer structurally homogeneous stenter blank constructed. This is from the positive Mold core removed and reworked to final shape of the stent.
Bioresorbierbare Koronarstents aus Polymermaterialien weisen zwar die gewünschte biologische Resorbierbarkeit und Körperverträglichkeit auf. Bioresorbable coronary stents made of polymer materials have the desired biological absorption and body tolerance.
Probleme bereiten jedoch die oft unzureichenden mechanischen Eigen schaften, wie beispielsweise eine mangelnde plastische Verformbarkeit dieses Stents. Dies führt bei der Dilatation auf immerhin den 4fachen Durchmesser zu einer Rißbildung mit der Folge einer herab gesetzten me chanischen Stabilität und zu einer hohen Rückverformung. Letzteres be deutet, daß für einen Enddurchmesser von 4 mm die maximale Aufweitung deutlich darüber liegen muß. Dies wiederum führt zu einer weiter erhöhten Rißbildung mit entsprechender Destabilisierung des Stents.Problems, however, are caused by the often inadequate mechanical properties properties, such as a lack of plastic deformability of this stent. This leads to four times the dilation Diameter to form a crack, resulting in a reduced me mechanical stability and high recovery. The latter be indicates that for a final diameter of 4 mm the maximum expansion must be significantly higher. This in turn leads to a further increase Crack formation with corresponding destabilization of the stent.
Zur Lösung der vorstehenden Problematik sieht die Erfindung laut Patent anspruch 1 vor, die Gefäßwandstütze aus einer sich im Körper ohne schäd liche Auswirkungen auf den Implantat-Träger zersetzenden Metall- Materialkombination herzustellen. Die Metall-Materialkombination ist da bei so auszulegen, daß sich das Material der Gefäßwandstütze mit einer bestimmten Zersetzungsrate und ohne die Produktion von körperschädli chen Zersetzungsprodukten auflöst. Eine derartige Gefäßwandstütze vereint also die vorteilhaften mechanischen Eigenschaften von Metall-Stents mit der Bioresorbierbarkeit von Stents auf Polymer-Basis.According to the patent, the invention provides a solution to the above problems Claim 1 before, the vascular wall support from one in the body without damage effects on the metal Manufacture material combination. The metal-material combination is there when interpreted so that the material of the vessel wall support with a certain decomposition rate and without the production of bodily harm dissolves Chen decomposition products. Such a vessel wall support united thus the beneficial mechanical properties of metal stents the bioresorbability of polymer-based stents.
In einer ersten grundsätzlichen Ausführungsform der Erfindung ist die Metall-Materialkombination als Metall-Legierung ausgelegt, wobei durch die Auswahl der Legierungspartner - wie im folgenden noch näher erläutert wird - die Voraussetzung der körperverträglichen Zersetzung erreicht wird. Die Metall-Legierung hat also mithin aus einer Materialkombination zu bestehen, die sich im Körper verhältnismäßig schnell - also in einer Zeit spanne von einigen Monaten - in unschädliche Bestandteile zersetzt, was mit dem anschaulichen Begriff der "körperverträglichen Korrosion" zu um schreiben ist.In a first basic embodiment of the invention Metal-material combination designed as a metal alloy, whereby by the selection of the alloy partners - as explained in more detail below will - the condition of body-compatible decomposition is reached. The metal alloy therefore has a combination of materials exist in the body relatively quickly - i.e. at a time span of a few months - decomposed into harmless components what to deal with the descriptive concept of "body-compatible corrosion" is to write.
Um eine entsprechend gleichmäßige Korrosion zu erreichen, besteht eine solche Legierung aus einer Komponente A, die sich mit einer schützenden Oxidschicht überzieht. Diese Komponente A ist aus einem oder mehreren Metallen der Gruppe Magnesium, Titan, Zirkon, Niob, Tantal, Zink oder Silizium ausgewählt. Um eine gleichmäßige Auflösung der genannten Oxidschicht zu erreichen, wird der Legierung ferner eine Komponente B zugesetzt, die eine ausreichende Löslichkeit in Blut oder interstitieller Flüs sigkeit besitzt, wie Lithium, Natrium, Kalium, Calcium, Eisen oder Man gan.In order to achieve a correspondingly uniform corrosion, there is a such an alloy from a component A, which deals with a protective Oxide layer. This component A is one or more Metals from the group magnesium, titanium, zircon, niobium, tantalum, zinc or Silicon selected. To achieve a uniform resolution of the above To reach oxide layer, the alloy is also a component B added that have sufficient solubility in blood or interstitial rivers has liquid, such as lithium, sodium, potassium, calcium, iron or man gan.
Die vorstehenden Elemente eigenen sich deswegen, weil sie entweder oh nehin im menschlichen Körper vertreten sind - wie Magnesium, Zink, Na trium, Kalium, Calcium, Eisen und Mangan - oder als nichttoxisch bekannt sind - wie Titan, Zirkon, Niob, Tantal, Silizium und Lithium. Die Kombi nation einer passivierenden und einer löslichen Komponente ermöglicht dabei eine zeitgerechte, gleichmäßige Zersetzung in körperverträgliche Ab bauprodukte. Die Korrosionsgeschwindigkeit kann über das Verhältnis der beiden Komponenten eingestellt werden.The above elements are suitable because they are either oh are no longer represented in the human body - such as magnesium, zinc, Na trium, potassium, calcium, iron and manganese - or known as non-toxic are - like titanium, zircon, niobium, tantalum, silicon and lithium. The station wagon nation of a passivating and a soluble component thereby a timely, even decomposition into body-compatible ab construction products. The rate of corrosion can depend on the ratio of both components can be set.
Die Legierung ist in besonders bevorzugter Weise so zusammenzusetzen, daß die Korrosionsprodukte lösliche Salze, wie Natrium-, Kalium-, Calci um-, Eisen- oder Zinksalze sind oder nichtlösliche Korrosionsprodukte, wie Titan-, Tantal- oder Nioboxid als kolloide Partikel entstehen. Die Korrosi onsgeschwindigkeit wird dabei über die Zusammensetzung so eingestellt, daß Gase, wie Wasserstoff, der bei der Korrosion von Lithium, Natrium, Kalium, Magnesium, Calcium oder Zink entsteht, sich physikalisch lösen und keine makroskopischen Gasblasen bilden.The alloy is particularly preferably composed in such a way that that the corrosion products soluble salts, such as sodium, potassium, calci um, iron or zinc salts are or insoluble corrosion products, such as Titanium, tantalum or niobium oxide are formed as colloidal particles. The corrosi speed is adjusted via the composition so that gases, such as hydrogen, which are associated with the corrosion of lithium, sodium, Potassium, magnesium, calcium or zinc are formed, physically dissolve and do not form macroscopic gas bubbles.
Als mögliche Legierung kann ferner beispielsweise eine aus der Luftfahrt bekannte, sogenannte Superleicht-Legierung aus Lithium und Magnesium eingesetzt werden, die bei dem vorstehend genannten Einsatzgebiet aller dings hinsichtlich großer Dauerhaltbarkeit und geringer Reaktionsfreudig keit optimiert ist. Das Magnesium-Lithium-Verhältnis liegt in der Größen ordnung von 60 : 40, wobei die Dauerhaltbarkeit über die Zugabe weiterer Komponenten, wie Zink, oder die Begasung durch Wasserstoff erhöht wird. Auch werden spezielle Schmelz- und Schmiedeverfahren zur Erhöhung der Dauerhaltbarkeit angewendet.A possible alloy can also be, for example, one from aviation known, so-called super light alloy of lithium and magnesium are used in the aforementioned field of application of all dings in terms of great durability and low reactivity is optimized. The magnesium-lithium ratio is in the sizes order of 60: 40, the durability over the addition of further Components, such as zinc, or fumigation by hydrogen is increased. Special melting and forging processes are also used to increase the Durability applied.
Für die Umsetzung der vorliegenden Erfindung können Lithium. Magnesium-Legierungen eingesetzt werden, die bei herkömmlicher Be handlung und in der Körpersphäre eine geringere Dauerhaltbarkeit besit zen. Als Zersetzungsprodukte sind Lithium- und Magnesium-Hydroxid zu erwarten, die beide als nicht-toxisch und körperverträglich zu betrachten sind.Lithium can be used to implement the present invention. Magnesium alloys are used, which in conventional Be action and less durability in the body sphere Zen. Lithium and magnesium hydroxide are added as decomposition products expect to consider both of them non-toxic and tolerable to the body are.
Eine Problematik bei der geschilderten Lithium-Magnesium-Legierung liegt darin, daß die Zersetzungsprodukte Lithium-Hydroxid und Magnesi um-Hydroxid schwer löslich sind und sich unter Kohlendioxidaufnahme zu den ebenfalls schwer löslichen Karbonaten umsetzen. Insbesondere Lithi um-Hydroxid ist dabei sehr voluminös. Die Korrosionsprodukte schlagen sich folglich als Krusten auf dem Stent nieder, die ein vielfaches des Stent volumens einnehmen können.A problem with the described lithium-magnesium alloy is that the decomposition products lithium hydroxide and magnesi um hydroxide are sparingly soluble and increase with absorption of carbon dioxide implement the also difficultly soluble carbonates. Especially Lithi um hydroxide is very voluminous. The corrosion products hit consequently settled as crusts on the stent, which are a multiple of the stent volume can take.
Insoweit sind andere Legierungskombinationen besser geeignet, beispiels weise ein Natrium-Magnesium-Legierung. Da Natrium-Hydroxid als Kor rosionsprodukt eine hohe Löslichkeit besitzt, zersetzt sich diese Legierung ohne voluminöse Krusten. Natrium geht in Lösung und Magnesium- Hydroxid bildet einen feinen Niederschlag, der gefahrlos in die sich bil dende Gefäßhaut, die sogenannte Intima, eingelagert werden kann.In this respect, other alloy combinations are more suitable, for example wise a sodium-magnesium alloy. Since sodium hydroxide as a cor corrosion product has a high solubility, this alloy decomposes without voluminous crusts. Sodium goes into solution and magnesium Hydroxide forms a fine precipitate that can be safely stored in the bil vascular skin, the so-called intima, can be stored.
Neben der Realisierung der Metall-Materialkombination in Form einer Metallegierung kann in einer weiteren grundsätzlichen Ausführungsform die Metall-Materialkombination als elektrochemisches Lokal-Element aus gelegt sein. Dieses besteht einerseits aus einem den Körper der Ge fäßwandstütze bildenden, im wesentlichen reinen ersten Metall und ande rerseits aus einer damit in Kontakt stehenden Lokalelektrode aus einem zweiten Metall. Letztere bildet mit dem Stützenkörper ein Lokal-Element, bei dem das Potential des Stützenkörpers entsprechend der elektrochemi schen Spannungsreihe verschoben ist. Die entstehende Kontaktspannung verursacht den Korrosionsprozeß des Stentkörpers. Die Korrosionsrate und damit die Zersetzungszeit des Stents kann über die Größe der Kontaktflä che zwischen dem korrodierbaren Stentkörper und der damit verbundenen Lokalelektrode bzw. über die Auswahl des Partnerelementes selbst gesteu ert werden.In addition to the realization of the metal-material combination in the form of a Metal alloy can be in a further basic embodiment the metal-material combination as an electrochemical local element be laid. On the one hand, this consists of a body of Ge essentially pure first metal and others on the other hand from a local electrode in contact with it from a second metal. The latter forms a local element with the column body, in which the potential of the support body according to the electrochemical voltage series is shifted. The resulting contact voltage causes the corrosion process of the stent body. The corrosion rate and so that the decomposition time of the stent can exceed the size of the contact surface che between the corrodible stent body and the associated Local electrode or controlled by the selection of the partner element itself be recognized.
Gemäß zweier alternativer Ausführungsformen kann das Partnerelement als Beschichtung auf dem Stützenkörper oder als eigenständiges, an dem Stüt zenkörper angebrachtes, beispielsweise daran angeschweißtes Metallteil ausgebildet sein. Im letzteren Fall können die Lokalelektroden in einer ty pischen Doppelfunktion auch als Röntgenmarker dienen.According to two alternative embodiments, the partner element can be as Coating on the support body or as an independent, on the support metal body attached, for example welded to it be trained. In the latter case, the local electrodes can be in a ty double function also serve as an X-ray marker.
Im folgenden wird die Erfindung in zwei bevorzugten Ausführungsbei spielen näher erläutert:The invention will now be described in two preferred embodiments play explained in more detail:
Es wird ein bioresorbierbarer Metallstent aus einer Legierung hergestellt, bei der die Komponente A aus Zink und die Komponente B aus Calcium besteht. Das Gewichtsverhältnis von Zink zu Calcium beträgt dabei minde stens 21 : 1. Bei dieser Zn-Ca-Legierung handelt es sich um eine Legierung, bei der die Korrosionsprodukte beider Komponenten als lösliche Salze an fallen, was besonders vorteilhaft für die vorliegende Anwendung ist. Calci um-Hydroxid besitzt dabei eine so hohe Löslichkeit, daß bei langsamer Korrosion über mehrere Wochen oder Monate das Löslichkeitsprodukt nicht überschritten wird. Das Calcium-Hydroxid wird also in gelöster Form vom Blut abtransportiert und verstoffwechselt. Die Korrosionsgeschwin digkeit wird im übrigen über das Verhältnis der beiden Komponenten ein gestellt, was über einfache Versuche ermittelbar ist.A bioresorbable metal stent is made from an alloy, in which component A is made of zinc and component B is made of calcium consists. The weight ratio of zinc to calcium is at least at least 21: 1. This Zn-Ca alloy is an alloy in which the corrosion products of both components appear as soluble salts fall, which is particularly advantageous for the present application. Calci um hydroxide has such a high solubility that slower Corrosion over several weeks or months is the solubility product is not exceeded. The calcium hydroxide is therefore in dissolved form transported away from the blood and metabolized. The corrosion rate Incidentally, the ratio of the two components determines the asked what can be determined by simple experiments.
Um die mechanischen Eigenschaften, wie Duktilität, Härte und Zugfestig keit, des Metallstents zu verbessern, können entsprechende Legierungsbe standteile in geringer Konzentration zugesetzt werden. Beispielsweise könnte ist der Legierung das Nichtmetall Phosphor im Prozentbereich zu gegeben werden. The mechanical properties such as ductility, hardness and tensile strength Ability to improve the metal stent, appropriate alloying ingredients are added in low concentration. For example Percentage of non-metal phosphorus could be added to the alloy are given.
Bei einem bioresorbierbaren Metallstent besteht der Stützenkörper aus rei nem Zink, das sich - wie galvanische Versuche zeigen - bei externen Strö men von einigen mA ohne Gasentwicklung und ohne Oxidbildung auflöst, wie dies für korrodierbare Metallstents anzustreben ist.In the case of a bioresorbable metal stent, the support body consists of rei zinc, which - as galvanic tests show - with external currents of a few mA without gas evolution and without oxide formation, how to strive for corrodible metal stents.
Zur Erzeugung eines solchen "externen" Stromes ist nun ein Lokal- Element z. B. in Form einer Goldelektrode galvanisch oder durch Laser schweißen auf dem Stent angebracht und führt als Lokalelektrode zusam men mit dem Stützenkörper zu einer Kontaktspannung, da die Goldelektro de näherungsweise das Potential der Zinkelektrode annimmt und das Po tential der Zinkelektrode geringfügig positiver wird. Es folgt ein entspre chender Strom, der zur aktiven Zinkauflösung führt. An der Goldelektrode fließen entsprechende kathodische Ströme. Der Austauschstrom insgesamt wird wegen der geringen kathodischen Ströme der Goldelektrode von der Fläche der Goldelektrode bestimmt. Über diesen Mechanismus kann die Korrosionsrate also über die Fläche des Lokal-Elementes eingestellt wer den.To generate such an "external" current, a local Element z. B. in the form of a gold electrode galvanically or by laser welding attached to the stent and brings together as a local electrode men with the support body to a contact voltage, since the gold electro de approximates the potential of the zinc electrode and the Po potential of the zinc electrode becomes slightly more positive. A corresponding follows current that leads to active zinc dissolution. On the gold electrode corresponding cathodic currents flow. The total exchange current is due to the low cathodic currents of the gold electrode Surface of the gold electrode determined. With this mechanism the Corrosion rate over the area of the local element the.
Wie Versuche gezeigt haben, stellt sich bei einem Gold-Lokal-Element auf Zink ein Austauschstrom nach wenigen Minuten ein, der über mehrere Ta ge konstant bleibt. Insoweit ist eine konstante Korrosionsrate erzielbar, wobei beispielsweise ein 10 mg schwerer Stent bei 10 µA Korrosionsstrom sich in zirka 30 bis 40 Tagen auflösen wird.As experiments have shown, a gold local element arises Zinc an exchange current after a few minutes, which over several Ta ge remains constant. In this respect, a constant corrosion rate can be achieved for example a 10 mg stent at 10 µA corrosion current will dissolve in about 30 to 40 days.
Claims (16)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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DE19856983A DE19856983A1 (en) | 1998-06-25 | 1998-12-10 | Implantable, bioresorbable vascular wall support, in particular coronary stent |
EP99111383A EP0966979B1 (en) | 1998-06-25 | 1999-06-11 | Implantable bioresorbable support for the vascular walls, in particular coronary stent |
DE59913189T DE59913189D1 (en) | 1998-06-25 | 1999-06-11 | Implantable, bioabsorbable vessel wall support, in particular coronary stent |
US09/339,927 US6287332B1 (en) | 1998-06-25 | 1999-06-25 | Implantable, bioresorbable vessel wall support, in particular coronary stent |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE19828245 | 1998-06-25 | ||
DE19856983A DE19856983A1 (en) | 1998-06-25 | 1998-12-10 | Implantable, bioresorbable vascular wall support, in particular coronary stent |
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Publication Number | Publication Date |
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DE19856983A1 true DE19856983A1 (en) | 1999-12-30 |
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Application Number | Title | Priority Date | Filing Date |
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DE19856983A Withdrawn DE19856983A1 (en) | 1998-06-25 | 1998-12-10 | Implantable, bioresorbable vascular wall support, in particular coronary stent |
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DE (1) | DE19856983A1 (en) |
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