WO2009007331A2 - Bioresorbable implant - Google Patents

Bioresorbable implant Download PDF

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Publication number
WO2009007331A2
WO2009007331A2 PCT/EP2008/058726 EP2008058726W WO2009007331A2 WO 2009007331 A2 WO2009007331 A2 WO 2009007331A2 EP 2008058726 W EP2008058726 W EP 2008058726W WO 2009007331 A2 WO2009007331 A2 WO 2009007331A2
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WO
WIPO (PCT)
Prior art keywords
bioresorbable
primary structure
secondary structure
implant according
implant
Prior art date
Application number
PCT/EP2008/058726
Other languages
German (de)
French (fr)
Other versions
WO2009007331A9 (en
Inventor
Günter Lob
Original Assignee
Resoimplant Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Resoimplant Gmbh filed Critical Resoimplant Gmbh
Publication of WO2009007331A2 publication Critical patent/WO2009007331A2/en
Publication of WO2009007331A9 publication Critical patent/WO2009007331A9/en

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Classifications

    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the invention relates to a bioresorbable implant which, at least partially, is formed by a bioresorbable polymer, ie a polymer which is degraded in the body of a patient after implantation of the implant.
  • Bioresorbable implants thus represent, for some applications, an alternative to implants, for example made of stainless steel, which either remain permanently in the body or have to be removed again (eg after the healing of bone fractures) in a second operation.
  • the degradation time on the one hand can not be accurately predicted and, on the other hand, ideally should depend on the also not exactly predictable, individual healing process.
  • the present invention aims to provide a solution to this problem.
  • the solution consists in that the bioresorbable implant has a hybrid structure, namely, on the one hand, a supporting primary structure of a bioresorbable polymer and, on the other hand, a secondary structure embedded in the supporting primary structure, which can be influenced from outside the body of a patient when the implant is implanted.
  • the secondary structure can be designed so that it is to be changed by external influence so that it has a higher degradation rate after the change than before the change.
  • the secondary structure can also be chosen so that it can be influenced from the outside in such a way that it releases a substance after the external action at an increased rate, which causes an accelerated degradation (bioresorption) of the primary structure and possibly also of the secondary structure itself.
  • the secondary structure is designed such that, after being changed, it releases water as the substance which causes an accelerated degradation of the primary structure. Since the secondary structure is embedded in the primary structure, water is released in the interior of the primary structure, which degrades the primary structure. This amounts to the fact that the surface of the primary structure, to which their decomposition begins, is significantly increased after external influence, so that the degradation is accelerated.
  • the secondary structure can contain, for example, water-filled microspheres (also called microspheres) which are designed to absorb radiation coming from the outside and consequently to open it, so that the Water can escape from the microspheres and cause hydrolysis of the primary structure from the inside.
  • microspheres also called microspheres
  • the secondary structure may be formed by a bioresorbable polymer that changes its structure under exposure to radiation such that the time constant for bioresorption is shortened.
  • the primary structure or the secondary structure comprises constituents which heat up under the influence of external radiation (for example by absorption of the radiation) and thereby cause a release of a substance which decomposes the primary structure or the secondary structure.
  • the bioresorbable polymer forming the primary structure is a polylactide.
  • FIG. 1 shows, by way of example, a detail of an implant according to the invention with a contiguous primary structure and a secondary structure.
  • the implant 10 has an outer surface 12 and is formed by a cohesive primary structure 14 which is embedded in a secondary structure 16.
  • the primary structure 14 forms a framework which includes interconnected spaces which form the secondary structure.
  • the spaces forming the secondary structure are preferably filled with a material which is different from a material forming the primary structure 14.
  • the material forming the primary structure 14 is preferably polylactide.
  • the material forming the secondary structure 16 contains microparticles 20 which are excitable by external radiation and consequently give off a substance which decomposes the secondary structure and / or the primary structure in an accelerated manner, for example water.
  • the particles may in particular be water-containing microspheres. - A -
  • the surface 12 may be formed by a third material, which thus virtually forms a coating of the implant 10.

Abstract

The invention relates to a bioresorbable implant with a supporting primary structure of a bioresorbable polymer and a secondary structure which is embedded into the supporting primary structure and which, in the implanted state of the implant, can be influenced from outside a body of a patient in such a way that the secondary structure can be modified so that, after the modification, it can either be degraded itself with a higher rate of body-intrinsic substances than before the modification, or which, after the modification, releases, at an increased rate, a substance which brings about an accelerated bioresorption of the primary structure.

Description

Bioresorbierbares Implantat Bioresorbable implant
Die Erfindung betrifft ein bioresorbierbares Implantat, welches, zumindest teilweise, von einem bioresorbierbaren Polymer gebildet ist, also einem Polymer, welches nach Implantation des Implantats im Körper eines Patienten abgebaut wird.The invention relates to a bioresorbable implant which, at least partially, is formed by a bioresorbable polymer, ie a polymer which is degraded in the body of a patient after implantation of the implant.
Aus dem Stand der Technik sind eine Reihe solcher Implantate bekannt, die je nach Form und verwendetem Material sowie nach Implantationsort eine unterschiedliche Degradationsrate aufweisen, also eine unterschiedliche Geschwindigkeit, mit der das Implantat im Körper abgebaut wird. Die Degradationsrate wird üblicherweise so eingestellt, dass das Implantat ausreichend lange eine Festigkeit behält, wie sie für einen Heilungsprozess erforderlich ist, ohne dass das Implantat dauerhaft im Körper verbleibt. Bioresorbierbare Implantate stellen somit für einige Anwendungsfälle eine Alternative zu Implantaten, beispielsweise aus rostfreiem Stahl dar, die entweder dauerhaft im Körper verbleiben oder (z. B. nach der Verheilung von Knochenbrüchen) in einer zweiten Operation wieder entfernt werden müssen. Bei bioresorbierbaren Implantaten besteht regelmäßig das Problem, dass die Degradationszeit zum Einen nicht genau vorhergesagt werden kann und zum Anderen idealerweise vom ebenfalls nicht genau vorhersagbaren, individuellen Heilungsverlauf abhängen sollte.A number of such implants are known from the prior art which, depending on the shape and the material used and on the place of implantation, have a different rate of degradation, ie a different speed with which the implant is broken down in the body. The rate of degradation is usually adjusted so that the implant retains sufficient strength for a sufficient period of time required for a healing process without the implant remaining permanently in the body. Bioresorbable implants thus represent, for some applications, an alternative to implants, for example made of stainless steel, which either remain permanently in the body or have to be removed again (eg after the healing of bone fractures) in a second operation. In the case of bioresorbable implants, there is the regular problem that the degradation time on the one hand can not be accurately predicted and, on the other hand, ideally should depend on the also not exactly predictable, individual healing process.
Die vorliegende Erfindung hat das Ziel, für dieses Problem eine Lösung zu bieten.The present invention aims to provide a solution to this problem.
Erfindungsgemäß besteht die Lösung darin, dass das bioresorbierbare Implantat eine hybride Struktur aufweist, nämlich zum Einen eine tragende Primärstruktur aus einem bioresorbierbaren Polymer und zum Anderen eine in die tragende Primärstruktur eingebettete Sekundärstruktur, die bei implantiertem Implantat von außerhalb des Körpers eines Patienten beeinflussbar ist. Dabei kann die Sekundärstruktur so gestaltet sein, dass sie durch äußeren Einfluss so zu verändern ist, dass sie nach der Veränderung eine höhere Degradationsrate besitzt, als vor der Veränderung. Alternativ kann die Sekundärstruktur auch so gewählt sein, dass sie von außen derart zu beeinflussen ist, dass sie nach der äußeren Einwirkung mit einer erhöhten Rate einen Stoff abgibt, der eine beschleunigte Degradation (Bioresorption) der Primärstruktur und gegebenenfalls auch der Sekundärstruktur selbst bewirkt.According to the invention, the solution consists in that the bioresorbable implant has a hybrid structure, namely, on the one hand, a supporting primary structure of a bioresorbable polymer and, on the other hand, a secondary structure embedded in the supporting primary structure, which can be influenced from outside the body of a patient when the implant is implanted. In this case, the secondary structure can be designed so that it is to be changed by external influence so that it has a higher degradation rate after the change than before the change. Alternatively, the secondary structure can also be chosen so that it can be influenced from the outside in such a way that it releases a substance after the external action at an increased rate, which causes an accelerated degradation (bioresorption) of the primary structure and possibly also of the secondary structure itself.
Gemäß einer bevorzugten Ausführungsvariante ist die Sekundärstruktur so aus- gebildet, dass sie nach ihrer Veränderung Wasser als jenen Stoff abgibt, der eine beschleunigte Degradation der Primärstruktur bewirkt. Da die Sekundärstruktur in die Primärstruktur eingebettet ist, wird quasi im Inneren der Primärstruktur Wasser frei, welches die Primärstruktur degradiert. Dies läuft darauf hinaus, dass die Oberfläche der Primärstruktur, an der deren Zersetzung ansetzt, nach äußerer Beeinflussung deutlich vergrößert ist, so dass die Degradation beschleunigt ist.According to a preferred embodiment variant, the secondary structure is designed such that, after being changed, it releases water as the substance which causes an accelerated degradation of the primary structure. Since the secondary structure is embedded in the primary structure, water is released in the interior of the primary structure, which degrades the primary structure. This amounts to the fact that the surface of the primary structure, to which their decomposition begins, is significantly increased after external influence, so that the degradation is accelerated.
Die Sekundärstruktur kann beispielsweise mit Wasser gefüllte Mikrokugeln (auch Microspheres genannt) enthalten, die ausgebildet sind, eine von außen kommende Strahlung zu absorbieren und sie infolgedessen zu öffnen, so dass das Wasser aus den Mikrokugeln austreten und eine Hydrolyse der Primärstruktur von innen bewirken kann.The secondary structure can contain, for example, water-filled microspheres (also called microspheres) which are designed to absorb radiation coming from the outside and consequently to open it, so that the Water can escape from the microspheres and cause hydrolysis of the primary structure from the inside.
Alternativ dazu kann die Sekundärstruktur von einem bioresorbierbaren Polymer gebildet sein, das seine Struktur unter Strahlungseinwirkung derart verändert, dass sich die Zeitkonstante für die Bioresorption verkürzt.Alternatively, the secondary structure may be formed by a bioresorbable polymer that changes its structure under exposure to radiation such that the time constant for bioresorption is shortened.
Eine weitere Alternative besteht darin, dass die Primärstruktur oder die Sekundärstruktur Bestandteile aufweist, die sich unter Einfluss äußerer Strahlung erwärmen (beispielsweise durch Resorption der Strahlung) und dadurch eine Freisetzung eines die Primärstruktur oder die Sekundärstruktur zersetzenden Stoffes bewirken.A further alternative is that the primary structure or the secondary structure comprises constituents which heat up under the influence of external radiation (for example by absorption of the radiation) and thereby cause a release of a substance which decomposes the primary structure or the secondary structure.
Vorzugsweise ist das bioresorbierbare Polymer, welches die Primärstruktur bildet, ein Polylactid.Preferably, the bioresorbable polymer forming the primary structure is a polylactide.
Figur 1 zeigt beispielhaft einen Ausschnitt aus einem erfindungsgemäßen Implantat mit einer zusammenhängenden Primärstruktur und einer Sekundärstruktur.FIG. 1 shows, by way of example, a detail of an implant according to the invention with a contiguous primary structure and a secondary structure.
Das Implantat 10 besitzt eine äußere Oberfläche 12 und ist von einer in sich zusammenhängenden Primärstruktur 14 gebildet, die in eine Sekundärstruktur 16 eingebettet ist. Die Primärstruktur 14 bildet dabei ein Gerüst, welches miteinander verbundene Räume einschließt, welche die Sekundärstruktur bilden. Die die Sekundärstruktur bildenden Räume sind vorzugsweise mit einem Material aufge- füllt, welches von einem die Primärstruktur 14 bildenden Material verschieden ist. Das die Primärstruktur 14 bildende Material ist vorzugsweise Polylactid. Das die Sekundärstruktur 16 bildende Material enthält Mikropartikel 20, die durch äußere Strahlung anregbar sind und infolgedessen einen die Sekundärstruktur und/oder die Primärstruktur beschleunigt zersetzenden Stoff, beispielsweise Wasser, abgeben. Die Partikel können insbesondere Wasser enthaltende Mikrokugeln sein. - A -The implant 10 has an outer surface 12 and is formed by a cohesive primary structure 14 which is embedded in a secondary structure 16. The primary structure 14 forms a framework which includes interconnected spaces which form the secondary structure. The spaces forming the secondary structure are preferably filled with a material which is different from a material forming the primary structure 14. The material forming the primary structure 14 is preferably polylactide. The material forming the secondary structure 16 contains microparticles 20 which are excitable by external radiation and consequently give off a substance which decomposes the secondary structure and / or the primary structure in an accelerated manner, for example water. The particles may in particular be water-containing microspheres. - A -
Die Oberfläche 12 kann von einem dritten Material gebildet sein, welches somit quasi eine Beschichtung des Implantats 10 bildet. The surface 12 may be formed by a third material, which thus virtually forms a coating of the implant 10.

Claims

Patentansprüche claims
1. Bioresorbierbares Implantat mit einer tragenden Primärstruktur aus einem bioresorbierbaren Polymer und einer in die tragende Primär- struktur eingebetteten Sekundärstruktur, die bei implantiertem Implantat von außerhalb eines Körpers eines Patienten derart beeinflussbar ist, dass die Sekundärstruktur dahingehend zu verändern ist, dass sie nach der Veränderung entweder selbst mit einer größeren Rate von körpereigenen Stoffen abbaubar ist, als vor der Verände- rung oder die nach der Veränderung mit erhöhter Rate einen Stoff abgibt, mit der eine beschleunigte Bioresorption der Primärstruktur bewirkt.A bioresorbable implant having a supporting primary structure of a bioresorbable polymer and a secondary structure embedded in the supporting primary structure, which in the case of an implanted implant can be influenced from outside a body of a patient in such a way that the secondary structure is modified in such a way that it changes after the change is degradable even with a greater rate of endogenous substances than before the change or, after the change, at an increased rate, gives off a substance that causes an accelerated bioresorption of the primary structure.
2. Bioresorbierbares Implantat nach Anspruch 1 , dadurch gekennzeich- net, dass die Sekundärstruktur nach ihrer Veränderung Wasser als jenen Stoff abgibt, der eine beschleunigte Bioresorption der Primärstruktur bewirkt.2. Bioresorbable implant according to claim 1, characterized marked, that the secondary structure after its change gives off water as that substance, which causes an accelerated bioresorption of the primary structure.
3. Bioresorbierbares Implantat nach Anspruch 2, dadurch gekennzeich- net, dass die Sekundärstruktur mit Wasser gefüllte Mikrokugeln enthält, die ausgebildet sind, eine von außen kommende Strahlung zu absorbieren und sich infolgedessen zu öffnen, so dass das Wasser aus den Mikrokugeln austreten und eine Hydrolyse der Primärstruktur von innen bewirken kann.3. bioresorbable implant according to claim 2, marked thereby, that the secondary structure contains water-filled microspheres, which are adapted to absorb an incoming radiation from outside and consequently open, so that the water escape from the microspheres and a hydrolysis can effect the primary structure from within.
4. Bioresorbierbares Implantat nach Anspruch 1 , dadurch gekennzeichnet, dass die Sekundärstruktur von einem bioresorbierbaren Polymer gebildet ist, dass seine Struktur unter Strahlungseinwirkung derart verändert, dass sich die Zeitkonstante für die Bioresorption verkürzt.4. bioresorbable implant according to claim 1, characterized in that the secondary structure is formed by a bioresorbable polymer that changes its structure under the action of radiation in such a way that shortens the time constant for bioresorption.
5. Bioresorbierbares Implantat nach Anspruch 1 , dadurch gekennzeichnet, dass de Primärstruktur oder die Sekundärstruktur Bestandteile aufweist, die sich unter Einfluss äußerer Strahlung erwärmen und da- durch eine Freisetzung eines die Primärstruktur oder die Sekundärstruktur zersetzenden Stoffes bewirken.5. Bioresorbable implant according to claim 1, characterized in that the primary structure or the secondary structure has components which heat up under the influence of external radiation and thereby by a release of the primary structure or the secondary structure decomposing substance.
6. Bioresorbierbares Implantat nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass das bioresorbierbare Polymer ein PoIy- lactid ist. 6. Bioresorbable implant according to one of claims 1 to 5, characterized in that the bioresorbable polymer is a polylactide.
PCT/EP2008/058726 2007-07-06 2008-07-04 Bioresorbable implant WO2009007331A2 (en)

Applications Claiming Priority (2)

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DE200710031945 DE102007031945A1 (en) 2007-07-06 2007-07-06 Bioresorbable implant
DE102007031945.4 2007-07-06

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US8287538B2 (en) 2008-01-14 2012-10-16 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US8906022B2 (en) 2010-03-08 2014-12-09 Conventus Orthopaedics, Inc. Apparatus and methods for securing a bone implant
US8961518B2 (en) 2010-01-20 2015-02-24 Conventus Orthopaedics, Inc. Apparatus and methods for bone access and cavity preparation
US9730739B2 (en) 2010-01-15 2017-08-15 Conventus Orthopaedics, Inc. Rotary-rigid orthopaedic rod
US10022132B2 (en) 2013-12-12 2018-07-17 Conventus Orthopaedics, Inc. Tissue displacement tools and methods
US10918426B2 (en) 2017-07-04 2021-02-16 Conventus Orthopaedics, Inc. Apparatus and methods for treatment of a bone

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Cited By (13)

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Publication number Priority date Publication date Assignee Title
US8287538B2 (en) 2008-01-14 2012-10-16 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US11399878B2 (en) 2008-01-14 2022-08-02 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US10603087B2 (en) 2008-01-14 2020-03-31 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US9517093B2 (en) 2008-01-14 2016-12-13 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US9788870B2 (en) 2008-01-14 2017-10-17 Conventus Orthopaedics, Inc. Apparatus and methods for fracture repair
US9730739B2 (en) 2010-01-15 2017-08-15 Conventus Orthopaedics, Inc. Rotary-rigid orthopaedic rod
US9848889B2 (en) 2010-01-20 2017-12-26 Conventus Orthopaedics, Inc. Apparatus and methods for bone access and cavity preparation
US8961518B2 (en) 2010-01-20 2015-02-24 Conventus Orthopaedics, Inc. Apparatus and methods for bone access and cavity preparation
US9993277B2 (en) 2010-03-08 2018-06-12 Conventus Orthopaedics, Inc. Apparatus and methods for securing a bone implant
US8906022B2 (en) 2010-03-08 2014-12-09 Conventus Orthopaedics, Inc. Apparatus and methods for securing a bone implant
US10022132B2 (en) 2013-12-12 2018-07-17 Conventus Orthopaedics, Inc. Tissue displacement tools and methods
US10076342B2 (en) 2013-12-12 2018-09-18 Conventus Orthopaedics, Inc. Tissue displacement tools and methods
US10918426B2 (en) 2017-07-04 2021-02-16 Conventus Orthopaedics, Inc. Apparatus and methods for treatment of a bone

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WO2009007331A9 (en) 2009-04-09
DE102007031945A1 (en) 2009-01-08

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