WO2005048848A2 - Surgical implant made of resorbable material - Google Patents

Surgical implant made of resorbable material Download PDF

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Publication number
WO2005048848A2
WO2005048848A2 PCT/DE2004/002568 DE2004002568W WO2005048848A2 WO 2005048848 A2 WO2005048848 A2 WO 2005048848A2 DE 2004002568 W DE2004002568 W DE 2004002568W WO 2005048848 A2 WO2005048848 A2 WO 2005048848A2
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WO
WIPO (PCT)
Prior art keywords
surgical implant
implant according
fractures
substances
surgical
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PCT/DE2004/002568
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German (de)
French (fr)
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WO2005048848A3 (en
Inventor
Frank Schure
Original Assignee
Frank Schure
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Publication of WO2005048848A2 publication Critical patent/WO2005048848A2/en
Publication of WO2005048848A3 publication Critical patent/WO2005048848A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8665—Nuts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Definitions

  • the invention relates to a surgical implant for insertion into or on the bone, comprising fixing means for restoring the continuity of bones of the human or animal body after fractures and in osteotomies.
  • fractures are treated by conservative or surgical treatment measures. With these treatments, the retention of the repositioned bones can be achieved by permanent extension, a plaster or plastic bond or by splinting. If these conservative measures do not heal fractures, there is an indication of surgical fracture treatment, such as non-repositionable joint fractures on stressed joints, shaft fractures, chain or serial fractures, open fractures, closed fractures, fractures close to the trunk in the event of multiple injuries, fractures of the geriatric patient, pathological fractures and irreversible epiphyseal injuries.
  • surgical fracture treatment such as non-repositionable joint fractures on stressed joints, shaft fractures, chain or serial fractures, open fractures, closed fractures, fractures close to the trunk in the event of multiple injuries, fractures of the geriatric patient, pathological fractures and irreversible epiphyseal injuries.
  • the osteosynthesis methods used in these cases are based on two principles, interfragmentary compression and splinting, or the combination of both methods, the compression being able to be achieved statically by interfragmentary lag screws. Depending on the type of bone, specific screws are used for this.
  • the applied compression force can be up to 2.00.0 to 3000 Newton.
  • Intramullary or extramedullary implants are used for splinting.
  • the task of the splint is to shift the reduction in the physiological load by transferring the force from the central main fragment to the peripheral fragment across the fracture gap.
  • plates are available that allow compression on the fracture and at the same time allow the insertion of lag screws.
  • the implants used in these osteosynthesis processes have the disadvantage that they are made of materials such as stainless steel or chromium-nickel alloys and have to be surgically removed after the continuity of the bone has been restored. This can make it next to the anesthetic load of the patient leads to infections in the area of the surgical wound. Furthermore, the wounds caused by the procedure must be healed, which leads to increased healing costs and a reduction in the quality of life of the patient. Furthermore, allergic reactions often occur to the materials used for the fixative agents for fracture treatment.
  • Another disadvantage of osteosynthesis with commercially available implants made of stainless steel or chromium-nickel alloys is that the degree of stiffness of the materials used goes beyond that of the bone to be treated and can therefore lead to osteoporosia of the bone, which can lead to a renewed fracture increased after removal of the implants.
  • the invention is therefore based on the object of designing and developing a surgical implant of the type mentioned in such a way that it does not have to be removed from the body by postoperative measures after the continuity of the bone has been restored, does not cause any allergies in the patient and the degree of stiffness of which corresponds to the bone to be treated.
  • a surgical implant comprising fixing means for restoring the continuity of bones, characterized in that the fixing means consists of a human or animal body absorbable Material are made.
  • implants in osteosynthesis processes which are made of resorbable materials, eliminates the postoperative treatment for removing the implants after the continuity of the bone has been restored.
  • the patient's recovery after the surgical fracture treatment can be shortened overall by the wound healing process after the postoperative treatment. This significantly improves a patient's quality of life after fracture treatment.
  • no allergies are triggered by the materials used for the implants, since the substances contained therein are not foreign to the body.
  • the fact that the materials used their degree of stiffness through absorption of Modifying material during the treatment period of the fracture can effectively prevent the bone loss that occurs when using commercially available surgical implants, thereby reducing the risk of a new fracture.
  • the surgical implant from a material that is composed of naturally occurring substances and / or of synthetically producible substances.
  • a combination of the substances or the materials would offer the possibility of producing implants with a large variability in terms of their properties, such as, for example, the tensile strength, the bendability, the absorption time and the degree of rigidity.
  • a material for the implant could be used which has a low degree of stiffness and is absorbed by the body after a short time, since on the one hand it is known that the bones in small children are softer than those of adults, and secondly, a fracture heals faster at this age than in adults.
  • targeted selection of a suitable material for the implant could also prevent the additional age-related degradation of the bone tissue during surgical fracture treatment during the retention of the bone.
  • the substances mentioned above should be able to be produced biotechnologically.
  • the production could take place in fermentation cultures of bacteria, cells or fungi.
  • optimized culture conditions such as nutrient content, fumigation, temperature and an optimal milieu (pH condition)
  • the above-mentioned substances could be produced effectively and controllably.
  • the substances produced in this way could, for example, be specifically released into the culture medium by the organisms as exo-polymers or exo-copolymers.
  • the material properties can be calculated so that the resorption time of an implant can be controlled.
  • data from the patient to be treated or empirically determined data could also be used to calculate the resorption time, so that the processing of these data can be used to calculate the suitable material for a patient-specific and fracture-specific application.
  • the implant can be X-ray diagnosed. This could be done by coating or introducing a material that can be represented by an X-ray contrast, for which purpose calcium phosphate would be an option.
  • the fixing means for osteosynthesis could be designed as screws, nails, nuts, plates, claws, clips or the like.
  • a combination of the fixing means listed above is also conceivable.
  • resorbable plates in connection with resorbable nails and / or screws and nuts could be used.
  • claws could also be used for the surgical treatment of a fracture, which claws can be placed around the bone in the area of the fracture.
  • clips could be used for the fixing.
  • the screws, nails, nuts, plates, claws, clips or the like could advantageously be stiffened by special formations. It could be are ribs or indentations in the material, which make it possible to stiffen even soft materials so that they can be used for osteosynthesis. Particularly in the case of the flat design of the implant, such as, for example, in the case of the osteosynthesis plates or the claws, a fabric texture made of elongated polymer or copolymer threads in conjunction with a stiffening by means of ribs could serve to provide a bending and tear-resistant implant.
  • the material used for the fixing means is designed similar to a carbon fiber structure. It is known that the use of carbon fibers can achieve maximum strength with an extremely low weight. Thus, through the formation of the material similar to a carbon fiber structure, a maximum strength - corresponding to the commercially available implants - could be achieved with an extremely low weight of the implant.
  • the underside of the means could be provided with knobs, teeth or the like.
  • the knobs, teeth or the like serve for improved contact of the implant with the periosteum.
  • the material itself or in combination with suitable substances accelerates and intensifies the immigration of granulocytes into the area of tissue damage.
  • This reaction triggered by a stimulus is also referred to as leukotaxis.
  • substances introduced into the operating area such as leukotaxins, such as leukotrienes or substances similar to leukotriene, and / or stimuli physically triggered by the implant, could lead to accelerated and increased immigration of granulocytes. In addition to the fracture, this could also heal the tissue damage caused by the fracture or the surgical procedure more quickly.
  • the surgical implant could be used in the osteosynthesis of displaced and conservatively irreparable fractures of the bones.
  • Fractures are treated that do not heal with conservative measures.
  • Repositionable joint fractures on stressed joints, shaft fractures, chain or serial fractures, open fractures, closed fractures, standard fractures in the case of multiple injuries, fractures in geriatric patients, pathological fractures and irreversible epiphyseal injuries could also be treated.
  • the surgical implant could also be used for fractures of the scaphoid.
  • This special application of the surgical implant could prevent the typical complications of the scaphoid fracture, such as the formation of a pseudarthrosis, a wrist arthrosis in the radial area and fragment necrosis.

Abstract

Disclosed is a surgical implant that is to be implanted into or onto a bone. Said surgical implant comprises fixing means for restoring continuity of bones in a human or animal body following fractures or in case of osteotomies. The inventive surgical implant is characterized in that the means are made of a material that can be resorbed by the human or animal body.

Description

CHIRURGISCHES IMPLANTAT SURGICAL IMPLANT
Die Erfindung betrifft ein chirurgisches Implantat zum Einbringen in oder an den Knochen, umfassend fixierende Mittel zur Wiederherstellung der Kontinuität von Knochen des menschlichen oder tierischen Körpers nach Frakturen und bei Osteotomien.The invention relates to a surgical implant for insertion into or on the bone, comprising fixing means for restoring the continuity of bones of the human or animal body after fractures and in osteotomies.
Die Behandlung von Frakturen erfolgt je nach Ausbildung der Fraktur durch konservative oder operative Behandlungsmaßnahmen. Bei diesen Behandlungen kann die Retention der reponierten Knochen durch eine Dauerextension, einen Gips- oder Kunststoff verband oder durch eine Schienung erreicht werden. Wenn Frakturen durch diese konservative Maßnahmen nicht verheilen, besteht die Indikation einer operativen Frakturbehandlung, wie zum Beispiel bei nicht reponierbaren Gelenkfrakturen an belasteten Gelenken, Schaftfrakturen, Ketten- oder Serienfrakturen, offenen Frakturen, geschlossenen Frakturen, stammnahen Frakturen bei Mehrfachverletzungen, Frakturen des geriatrischen Patienten, pathologischen Frakturen und irreponiblen Epiphysenverletzungen. Die in diesen Fällen verwendeten Osteosynthese-Verfahren beruhen auf zwei Prinzipien, der interfragmentären Kompression und der Schienung, oder der Kombination beider Verfahren, wobei die Kompression statisch durch interfragmentäre Zugschrauben erreicht werden kann. Dafür werden je nach Knochenart spezifische Schrauben verwendet. Dabei kann die anliegende Kompressionskraft bis zu 2.00,0 bis 3.000 Newton betragen. Bei der Schienung werden intra- oder extramedulläre Implantate verwendet. Die Aufgabe der Schiene besteht darin, die Reduktion der physiologischen Last durch Übertragung der Kraft vom zentralen Hauptfragment auf as periphere Fragment über den Frakturspalt hinweg zu verlagern. Hierfür stehen für die extramedulläre Schienung Platten zur Verfügung, die eine Kompression auf die Fraktur gestatten und gleichzeitig das Einbringen von Zugschrauben erlauben.Depending on the formation of the fracture, fractures are treated by conservative or surgical treatment measures. With these treatments, the retention of the repositioned bones can be achieved by permanent extension, a plaster or plastic bond or by splinting. If these conservative measures do not heal fractures, there is an indication of surgical fracture treatment, such as non-repositionable joint fractures on stressed joints, shaft fractures, chain or serial fractures, open fractures, closed fractures, fractures close to the trunk in the event of multiple injuries, fractures of the geriatric patient, pathological fractures and irreversible epiphyseal injuries. The osteosynthesis methods used in these cases are based on two principles, interfragmentary compression and splinting, or the combination of both methods, the compression being able to be achieved statically by interfragmentary lag screws. Depending on the type of bone, specific screws are used for this. The applied compression force can be up to 2.00.0 to 3000 Newton. Intramullary or extramedullary implants are used for splinting. The task of the splint is to shift the reduction in the physiological load by transferring the force from the central main fragment to the peripheral fragment across the fracture gap. For the extramedullary splinting, plates are available that allow compression on the fracture and at the same time allow the insertion of lag screws.
Ganz allgemein haben die bei diesen Osteosynthese-Verfahren verwendeten Implantate den Nachteil, dass sie aus Materialien, wie zum Beispiel Edelstahlen oder Chrom-Nickel-Legierungen, hergestellt sind und nach der Wiederherstellung der Kontinuität des Knochens operativ entfernt werden müssen. Dadurch kann es neben der Narkosebelastung des Patienten zu Infektionen im Bereich der Operationswunde kommen. Des Weiteren müssen die durch den Eingriff verursachten Wunden ausgeheilt werden, was zu erhöhten Heilungskosten und einer Herabsetzung der Lebensqualität des Patienten führt. Des Weiteren treten oftmals allergische Reaktionen auf die für die fixierenden Mittel zur Frakturbehandlung verwendeten Materialien auf. Ein weiterer Nachteil bei der Osteosynthese mit handelsüblichen Implantaten aus Edelstahlen oder Chrom-Nickel-Legierungen besteht auch darin, dass der Steifheitsgrad der verwendeten Materialien über den der zu behandelnden Knochen hinaus geht und somit zur Osteoporosie des Knochens führen kann, welche das Risiko einer erneuten Fraktur nach Entfernung der Implantate erhöht.In general, the implants used in these osteosynthesis processes have the disadvantage that they are made of materials such as stainless steel or chromium-nickel alloys and have to be surgically removed after the continuity of the bone has been restored. This can make it next to the anesthetic load of the patient leads to infections in the area of the surgical wound. Furthermore, the wounds caused by the procedure must be healed, which leads to increased healing costs and a reduction in the quality of life of the patient. Furthermore, allergic reactions often occur to the materials used for the fixative agents for fracture treatment. Another disadvantage of osteosynthesis with commercially available implants made of stainless steel or chromium-nickel alloys is that the degree of stiffness of the materials used goes beyond that of the bone to be treated and can therefore lead to osteoporosia of the bone, which can lead to a renewed fracture increased after removal of the implants.
Der Erfindung liegt daher die Aufgabe zugrunde, ein chirurgisches Implantat der eingangs genannten Art derart auszugestalten und weiterzubilden, dass es nach der Wiederherstellung der Kontinuität des Knochens nicht durch postoperative Maßnahmen aus dem Körper entfernt werden muss, keine Allergien beim Patienten hervorruft und dessen Steifheitsgrad dem der zu behandelnden Knochen entspricht.The invention is therefore based on the object of designing and developing a surgical implant of the type mentioned in such a way that it does not have to be removed from the body by postoperative measures after the continuity of the bone has been restored, does not cause any allergies in the patient and the degree of stiffness of which corresponds to the bone to be treated.
Das chirurgische Implantat löst die voranstehende Aufgabe - in materiell ausgestalteter Hinsicht - durch die Merkmale des Patentanspruchs 1. Danach ist ein chirurgisches Implantat umfassend fixierende Mittel zur Wiederherstellung der Kontinuität von Knochen, dadurch gekennzeichnet, dass die fixierenden Mittel aus einem vom menschlichen oder tierischen Körper resorbierbaren Material hergestellt sind.The surgical implant achieves the above object - in material terms - through the features of patent claim 1. According to this, a surgical implant comprising fixing means for restoring the continuity of bones, characterized in that the fixing means consists of a human or animal body absorbable Material are made.
Erfindungsgemäß ist erkannt worden, dass durch den Einsatz von Implantaten in Osteosynthese-Verfahren, welche aus resorbierbaren Materialien hergestellt sind, die postoperative Behandlung zur Entfernung der Implantate nach der Wiederherstellung der Kontinuität des Knochens entfällt. Dadurch kann die Genesung des Patienten nach der operativen Frakturbehandlung insgesamt um den Wundheilungs- prozess nach der postoperativen Behandlung verkürzt werden. Dadurch wird die Lebensqualität eines Patienten nach einer Frakturbehandlung erheblich verbessert. Zudem werden durch die für die Implantate verwendeten Materialien keine Allergien ausgelöst, da die darin enthaltenden Substanzen nicht körperfremd sind. Dadurch, dass die verwendeten Materialien ihren Steifheitsgrad durch Resorption des Materials während der Behandlungsdauer der Fraktur verändern, kann effektiv der bei der Verwendung von handelsüblichen chirurgischen Implantaten auftretende Knochenabbau verhindert werden, wodurch das Risiko einer erneuten Fraktur vermindert wird.According to the invention, it has been recognized that the use of implants in osteosynthesis processes, which are made of resorbable materials, eliminates the postoperative treatment for removing the implants after the continuity of the bone has been restored. As a result, the patient's recovery after the surgical fracture treatment can be shortened overall by the wound healing process after the postoperative treatment. This significantly improves a patient's quality of life after fracture treatment. In addition, no allergies are triggered by the materials used for the implants, since the substances contained therein are not foreign to the body. The fact that the materials used their degree of stiffness through absorption of Modifying material during the treatment period of the fracture can effectively prevent the bone loss that occurs when using commercially available surgical implants, thereby reducing the risk of a new fracture.
Im Konkreten ist es vorgesehen das chirurgische Implantat aus einem Material herzustellen, das sich aus natürlich vorkommenden Substanzen und/oder aus synthetisch herstellbaren Substanzen zusammensetzt. Durch eine Kombination der Substanzen oder der Materialien würde sich die Möglichkeit bieten, Implantate mit einer großen Variabilität bezüglich ihrer Eigenschaften herzustellen, wie zum Beispiel der Zugfestigkeit, der Biegefähigkeit, der Resorptionszeit und dem Steifheitsgrad. So könnte zum Beispiel bei der Behandlung von operativ zu behandelnden Frakturen am Knochen eines Kleinkindes, ein Material für das Implantat verwendet werden, welches einen geringen Steifheitsgrad aufweist und vom Körper nach kurzer Zeit resorbiert wird, da zum einen bekannt ist, dass die Knochen im Kleinkindalter weicher sind als die von Erwachsenen, und zum anderen eine Ausheilung einer Fraktur in diesem Alter schneller als bei Erwachsenen erfolgt. So könnte auch bei geriatrischen Patienten durch gezielte Auswahl eines geeigneten Materials für das Implantat ein zu dem durch das Alter bedingter zusätzlicher Abbau des Knochengewebes bei einer operativen Frakturbehandlung während der Retention des Knochens verhindert werden.In concrete terms, it is provided to manufacture the surgical implant from a material that is composed of naturally occurring substances and / or of synthetically producible substances. A combination of the substances or the materials would offer the possibility of producing implants with a large variability in terms of their properties, such as, for example, the tensile strength, the bendability, the absorption time and the degree of rigidity. For example, in the treatment of fractures to be treated on the bones of a small child, a material for the implant could be used which has a low degree of stiffness and is absorbed by the body after a short time, since on the one hand it is known that the bones in small children are softer than those of adults, and secondly, a fracture heals faster at this age than in adults. In geriatric patients, for example, targeted selection of a suitable material for the implant could also prevent the additional age-related degradation of the bone tissue during surgical fracture treatment during the retention of the bone.
Es würde sich bei der Auswahl der für das Material verwendeten Substanzen anbieten, synthetische und/oder natürlich vorkommende Substanzen oder Substanzgemische zu verwenden, welche schon in anderen medizinischen Bereichen wie bei der Versorgung von Wunden ihre Anwendung finden. Dazu zählen unter anderem Polydioxanon (PDS), Vicryl und Monocryl, welche als Substanzen in chirurgischen Nahtmaterialien ihre Verwendung haben. Es könnten aber auch Poly-L-Lactid (PLA) oder Polyglycolid (PGA) als Ausgangsstoffe für ein chirurgisches Implantat verwendet werden. Grundsätzlich sollten nur solche Substanzen oder Mischungen aus diesen Substanzen verwendet werden, die in einer bestimmten Resorptionszeit durch Hydrolyse vom Körper abgebaut werden können. Bei einem solchen Prozess könnte das Material in Milchsäure, Wasser, Glykose und Kohlendioxid gespalten und vom Körper abgebaut werden. Bezüglich einer einfachen und kostengünstigen Herstellung der oben genannten Substanzen, sollten diese biotechnologisch herstellbar sein. Die Herstellung könnte in Fermentationskulturen von Bakterien, Zellen oder Pilzen stattfinden. Durch optimierte Kulturbedingungen wie den Nährstoffgehalt, die Begasung, die Temperatur und einem optimalen Milieu (pH-Bedingung) könnten die oben genannten Substanzen effektiv und regulierbar hergestellt werden. Im Speziellen könnten die so hergestellten Substanzen zum Beispiel als Exo-Polymere oder Exo- Copolymere gezielt von den Organismen in das Kulturmedium abgegeben werden.When selecting the substances used for the material, it would make sense to use synthetic and / or naturally occurring substances or substance mixtures which are already used in other medical fields, such as in the care of wounds. These include polydioxanone (PDS), vicryl and monocryl, which are used as substances in surgical sutures. However, poly-L-lactide (PLA) or polyglycolide (PGA) could also be used as starting materials for a surgical implant. In principle, only those substances or mixtures of these substances should be used that can be broken down by hydrolysis in a certain absorption time. With such a process, the material could be broken down into lactic acid, water, glycose and carbon dioxide and broken down by the body. With regard to simple and inexpensive production of the substances mentioned above, they should be able to be produced biotechnologically. The production could take place in fermentation cultures of bacteria, cells or fungi. Through optimized culture conditions such as nutrient content, fumigation, temperature and an optimal milieu (pH condition), the above-mentioned substances could be produced effectively and controllably. In particular, the substances produced in this way could, for example, be specifically released into the culture medium by the organisms as exo-polymers or exo-copolymers.
Besonders vorteilhaft wäre, wenn die Materialeigenschaften so berechenbar sind, dass die Resorptionszeit eines Implantats steuerbar ist. Zur Berechnung der Resorptionszeit könnten neben den Daten über die Materialeigenschaft auch Daten von dem zu behandelnden Patienten oder empirisch ermittelte Daten dienen, so dass sich aus der Verarbeitung dieser Daten das geeignete Material für eine patientenspezifische und frakturspezifische Anwendung berechnen lässt.It would be particularly advantageous if the material properties can be calculated so that the resorption time of an implant can be controlled. In addition to the data on the material properties, data from the patient to be treated or empirically determined data could also be used to calculate the resorption time, so that the processing of these data can be used to calculate the suitable material for a patient-specific and fracture-specific application.
Es würde sich als vorteilhaft erweisen, wenn das Implantat röntgendiagnostisch darstellbar ist. Dieses könnte durch Beschichtung oder Einbringung eines einen Röntgenkontrast darstellbaren Werkstoffes erfolgen, wozu sich zum Beispiel Calciumphosphat anbieten würde.It would prove to be advantageous if the implant can be X-ray diagnosed. This could be done by coating or introducing a material that can be represented by an X-ray contrast, for which purpose calcium phosphate would be an option.
Die fixierenden Mittel für die Osteosynthese könnten als Schrauben, Nägel, Muttern, Platten, Krallen, Clips oder dergleichen ausgebildet sein. Auch eine Kombination der oben aufgeführten fixierenden Mittel ist denkbar. So könnten zum Beispiel bei der Indikation einer operativen Behandlung einer Fraktur resorbierbare Platten in Verbindung mit resorbierbaren Nägeln und/oder Schrauben und Muttern zum Einsatz kommen. In besonders vorteilhafter Weise könnten zur operativen Behandlung einer Fraktur aber auch Krallen verwendet werden, die sich im Bereich der Fraktur um den Knochen legen lassen. Damit sich die Anzahl der in den Knochen einzubringenden Schrauben oder Nägel zum Fixieren der Krallen und der Platten am Knochen verringert, könnten für die Fixierung Clips verwendet werden.The fixing means for osteosynthesis could be designed as screws, nails, nuts, plates, claws, clips or the like. A combination of the fixing means listed above is also conceivable. For example, in the indication of a surgical treatment of a fracture, resorbable plates in connection with resorbable nails and / or screws and nuts could be used. In a particularly advantageous manner, claws could also be used for the surgical treatment of a fracture, which claws can be placed around the bone in the area of the fracture. In order to reduce the number of screws or nails to be inserted into the bone for fixing the claws and the plates to the bone, clips could be used for the fixing.
In vorteilhafter Weise könnten die Schrauben, Nägel, Muttern Platten, Krallen, Clips oder dergleichen durch spezielle Ausformungen versteift sein. Dabei könnte es sich um Rippen oder Vertiefungen im Material handeln, welche es ermöglichen, auch weiche Materialien so zu versteifen, dass diese für den Einsatz bei der Osteosynthese verwendbar sind. Besonders bei der flächigen Ausgestaltung des Implantats, wie zum Beispiel bei den Osteosynthesplatten oder den Krallen, könnte eine Gewebetextur aus längsgestreckten Polymer- oder Copolymerfäden in Verbindung mit einer Versteifung durch Ausbildung von Rippen zur Bereitstellung eines biege- und reißfesten Implantats dienen.The screws, nails, nuts, plates, claws, clips or the like could advantageously be stiffened by special formations. It could be are ribs or indentations in the material, which make it possible to stiffen even soft materials so that they can be used for osteosynthesis. Particularly in the case of the flat design of the implant, such as, for example, in the case of the osteosynthesis plates or the claws, a fabric texture made of elongated polymer or copolymer threads in conjunction with a stiffening by means of ribs could serve to provide a bending and tear-resistant implant.
Des Weiteren ist denkbar, dass das für die fixierenden Mittel verwendete Material ähnlich einer Carbonfaserstruktur ausgebildet ist. Es ist bekannt, dass durch den Einsatz von Carbonfasern eine maximale Festigkeit bei einem extrem niedrigen Gewicht erreicht werden kann. Somit könnte durch die Ausbildung des Materials ähnlich einer Carbonfaserstruktur eine maximale - den handelsüblichen Implantaten entsprechende - Festigkeit bei einem extrem niedrigen Gewicht des Implantats erreicht werden.Furthermore, it is conceivable that the material used for the fixing means is designed similar to a carbon fiber structure. It is known that the use of carbon fibers can achieve maximum strength with an extremely low weight. Thus, through the formation of the material similar to a carbon fiber structure, a maximum strength - corresponding to the commercially available implants - could be achieved with an extremely low weight of the implant.
Zur besseren Haftung am Knochen könnte die Unterseite der Mittel mit Noppen, Zähnen oder dergleichen versehen sein. Durch Vergrößerung der Oberfläche der Mittel, dienen die Noppen, Zähne oder dergleichen für einen verbesserten Kontakt des Implantats mit der Knochenhaut.For better adhesion to the bone, the underside of the means could be provided with knobs, teeth or the like. By increasing the surface area of the means, the knobs, teeth or the like serve for improved contact of the implant with the periosteum.
Es ist auch denkbar, dass das Material an sich oder in Verbindung mit geeigneten Stoffen die Einwanderung von Granulozyten in den Bereich der Gewebsschädigung beschleunigt und verstärkt. Diese durch einen Reiz ausgelöste Reaktion wird auch als Leukotaxis bezeichnet. Dementsprechend könnten in den Operationsbereich eingebrachte Stoffe wie Leukotaxine, wie zum Beispiel Leukotriene oder leukotrienähnliche Stoffe, und/oder durch das Implantat physikalisch ausgelöste Reize zu der beschleunigten und vermehrten Einwanderung von Granulozyten führen. Dadurch könnten neben der Fraktur auch die durch die Fraktur oder den operativen Eingriff bedingte Gewebsschädigung schneller ausheilen.It is also conceivable that the material itself or in combination with suitable substances accelerates and intensifies the immigration of granulocytes into the area of tissue damage. This reaction triggered by a stimulus is also referred to as leukotaxis. Accordingly, substances introduced into the operating area, such as leukotaxins, such as leukotrienes or substances similar to leukotriene, and / or stimuli physically triggered by the implant, could lead to accelerated and increased immigration of granulocytes. In addition to the fracture, this could also heal the tissue damage caused by the fracture or the surgical procedure more quickly.
Im Speziellen könnte das chirurgische Implantat bei der Osteosynthese von dislozierten und konservativ nicht reponierbaren Frakturen der Knochen seine Verwendung finden. So könnten zum Beispiel durch einen einmaligen operativen Eingriff Frakturen behandelt werden, die mit konservativen Maßnahmen nicht verheilen. Des Weiteren könnten reponierbare Gelenkfrakturen an belasteten Gelenken, Schaftfrakturen, Ketten- oder Serienfrakturen, offene Frakturen, geschlossene Frakturen, Standardfrakturen bei Mehrfachverletzungen, Frakturen bei geriatrischen Patienten, pathologische Frakturen und irreponible Epiphysen-Verletzungen behandelt werden.In particular, the surgical implant could be used in the osteosynthesis of displaced and conservatively irreparable fractures of the bones. For example, through a single surgical procedure Fractures are treated that do not heal with conservative measures. Repositionable joint fractures on stressed joints, shaft fractures, chain or serial fractures, open fractures, closed fractures, standard fractures in the case of multiple injuries, fractures in geriatric patients, pathological fractures and irreversible epiphyseal injuries could also be treated.
In besonders vorteilhafter Weise könnte das chirurgische Implantat auch bei Frakturen des Kahnbeins verwendet werden. Durch diese spezielle Anwendung des chirurgischen Implantats könnte den typischen Komplikationen bei der Kahnbeinfraktur wie der Ausbildung einer Pseudarthrose, einer Handgelenksarthrose im radialen Bereich und einer Fragment-Nekrose vorgebeugt werden.In a particularly advantageous manner, the surgical implant could also be used for fractures of the scaphoid. This special application of the surgical implant could prevent the typical complications of the scaphoid fracture, such as the formation of a pseudarthrosis, a wrist arthrosis in the radial area and fragment necrosis.
Abschließend sei angemerkt, dass es zahlreiche Möglichkeiten gibt, die Lehre der vorliegenden Erfindung in vorteilhafter Weise auszugestalten und weiterzubilden. Die voranstehend erörternden Ausführungsbeispiele dienen lediglich der Erläuterung der beanspruchten Lehre, schränken diese jedoch nicht auf die Ausführungsbeispiele ein. In conclusion, it should be noted that there are numerous possibilities for advantageously designing and developing the teaching of the present invention. The exemplary embodiments discussed above serve only to explain the claimed teaching, but do not restrict it to the exemplary embodiments.

Claims

Patentansprüche claims
1. Chirurgisches Implantat zum Einbringen in oder an den Knochen, umfassend fixierende Mittel zur Wiederherstellung der Kontinuität von Knochen des menschlichen oder tierischen Körpers nach Frakturen und bei Osteotomien, dadurch gekennzeichnet, dass die Mittel aus einem vom menschlichen oder tierischen Körper resorbierbaren Material hergestellt sind.1. Surgical implant for insertion into or on the bones, comprising fixing means for restoring the continuity of bones of the human or animal body after fractures and in osteotomies, characterized in that the means are made of a material that is resorbable by the human or animal body.
2. Chirurgisches Implantat nach Anspruch 1 , dadurch gekennzeichnet, dass das Material synthetische und/oder natürlich vorkommende Substanzen umfasst.2. Surgical implant according to claim 1, characterized in that the material comprises synthetic and / or naturally occurring substances.
3. Chirurgisches Implantat nach Anspruch 2, dadurch gekennzeichnet, dass die Substanzen insbesondere Poly-L-Lactid (PLA), Poly-D,L-Lactid (PDLA), Polyglycolid (PGA), Polydioxanon (PDS), Vicryl oder Monocryl oder eine Mischung davon umfassen.3. Surgical implant according to claim 2, characterized in that the substances in particular poly-L-lactide (PLA), poly-D, L-lactide (PDLA), polyglycolide (PGA), polydioxanone (PDS), Vicryl or Monocryl or one Include mixture of these.
4. Chirurgisches Implantat nach Anspruch 2 oder 3, dadurch gekennzeichnet, dass die Substanzen biotechnologisch herstellbar sind.4. Surgical implant according to claim 2 or 3, characterized in that the substances can be produced biotechnologically.
5. Chirurgisches Implantat nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass durch die Auswahl des Materials die Verweildauer des Implantats im Knochen steuerbar ist.5. Surgical implant according to one of claims 1 to 4, characterized in that the residence time of the implant in the bone can be controlled by the selection of the material.
6. Chirurgisches Implantat nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass durch Beschichtung und/oder Einbringung eines Werktoffes die Mittel röntgendiagnostisch darstellbar sind.6. Surgical implant according to one of claims 1 to 5, characterized in that the agents can be displayed by X-ray diagnosis by coating and / or introducing a working material.
7. Chirurgisches Implantat nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Mittel Schrauben, Nägel, Muttern, Platten, Krallen, Clips oder dergleichen umfassen. 7. Surgical implant according to one of claims 1 to 6, characterized in that the means comprise screws, nails, nuts, plates, claws, clips or the like.
8. Chirurgisches Implantat nach Anspruch 7, dadurch gekennzeichnet, dass die Schrauben, Nägel, Muttern, Platten Krallen, Clips oder dergleichen durch spezielle Ausformung aussteifbar sind.8. Surgical implant according to claim 7, characterized in that the screws, nails, nuts, plates, claws, clips or the like can be stiffened by special shaping.
9. Chirurgisches Implantat nach Anspruch 8, dadurch gekennzeichnet, dass die Ausformung insbesondere Rippen und/oder Vertiefungen umfasst.9. Surgical implant according to claim 8, characterized in that the shape comprises in particular ribs and / or depressions.
10. Chirurgisches Implantat nach einem der Ansprüche 7 bis 9, dadurch gekennzeichnet, dass die Schrauben, Nägel, Muttern, Platten, Krallen, Clips oder dergleichen mittels einer Carbonfaser ähnlichen Struktur verstärkt sind.10. Surgical implant according to one of claims 7 to 9, characterized in that the screws, nails, nuts, plates, claws, clips or the like are reinforced by means of a structure similar to carbon fiber.
11. Chirurgisches Implantat nach einem der Ansprüche 7 bis 9, dadurch gekennzeichnet, dass die Unterseite der am Knochen anliegenden Mittel mit Noppen, Zähnen oder dergleichen versehen ist.11. Surgical implant according to one of claims 7 to 9, characterized in that the underside of the means lying against the bone is provided with knobs, teeth or the like.
12. Chirurgisches Implantat nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass das Material und/oder zusätzliche Stoffe in oder auf dem Material einen Granulozytenreiz im Bereich der Fraktur stimulieren und angiogenetisch wirken.12. Surgical implant according to one of claims 1 to 10, characterized in that the material and / or additional substances in or on the material stimulate a granulocyte stimulus in the region of the fracture and have an angiogenic effect.
13. Chirurgisches Implantat nach einem der Ansprüche 1 bis 11 zur Verwendung bei der Osteosynthese von dislozierten und konservativ nicht reponierbaren Frakturen der Knochen.13. Surgical implant according to one of claims 1 to 11 for use in the osteosynthesis of displaced and conservatively irreparable fractures of the bones.
14. Chirurgisches Implantat nach einem der Ansprüche 1 bis 12 zur Verwendung bei der Schraubenosteosynthese insbesondere bei Frakturen des Kahnbeins zur Vorbeugung von Pseudarthrosen, Handgelenksarthrosen und Fragmentnekrosen. 14. Surgical implant according to one of claims 1 to 12 for use in screw osteosynthesis, in particular in fractures of the scaphoid for the prevention of non-union arthrosis, wrist arthrosis and fragment necrosis.
PCT/DE2004/002568 2003-11-21 2004-11-22 Surgical implant made of resorbable material WO2005048848A2 (en)

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