DE29608321U1 - Marker element - Google Patents

Marker element

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Publication number
DE29608321U1
DE29608321U1 DE29608321U DE29608321U DE29608321U1 DE 29608321 U1 DE29608321 U1 DE 29608321U1 DE 29608321 U DE29608321 U DE 29608321U DE 29608321 U DE29608321 U DE 29608321U DE 29608321 U1 DE29608321 U1 DE 29608321U1
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DE
Germany
Prior art keywords
marking element
ray
bone
marking
diameter
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Expired - Lifetime
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DE29608321U
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German (de)
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Aesculap AG
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Aesculap AG
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Priority to DE29608321U priority Critical patent/DE29608321U1/en
Publication of DE29608321U1 publication Critical patent/DE29608321U1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/04—X-ray contrast preparations
    • A61K49/0409—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • 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
    • A61L31/026—Ceramic or ceramic-like structures, e.g. glasses
    • 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
    • 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
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30032—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in absorbability or resorbability, i.e. in absorption or resorption time
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/3008—Properties of materials and coating materials radio-opaque, e.g. radio-opaque markers
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30968—Sintering
    • 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
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Ceramic Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Gyroscopes (AREA)
  • Surgical Instruments (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Description

MarkierungselementMarking element

Die Erfindung betrifft ein Markierungselement zur Erzeugung eines Röntgenkontrastes insbesondere bei einem resorbierbaren Implantat, hergestellt unter Verwendung von Calzium, Phosphor, Sauerstoff und Wasserstoff.The invention relates to a marking element for generating an X-ray contrast, in particular in a resorbable implant, produced using calcium, phosphorus, oxygen and hydrogen.

Einen Röntgenkontrast erzeugende Markierungselemente sind beispielsweise aus der EP 0 146 699 Al bekannt. In dieser europäischen Offenlegungsschrift wird vorgeschlagen, zur Festlegung eines Bezugspunktes im menschlichen Knochengerüst mehrere Implantate in den Knochen einzusetzen, wobei die Implantate jeweils ein Verankerungsteil aus Kunststoff sowie ein daran angeordnetes Markierungselement in Form einer Metallkugel umfassen. Die Metallkugel wird durch das Verankerungsteil ortsfest im Knochen gehalten und weist einen Durchmesser von mindestens 0,2 mm auf. Das derart ausgebildete Markierungselement erzeugt in einem Röntgenbild einen starken Kontrast und ist dadurch auf einfache Weise identifizierbar.Marking elements that produce an X-ray contrast are known, for example, from EP 0 146 699 A1. In this European patent application, it is proposed to insert several implants into the bone in order to establish a reference point in the human bone structure, whereby the implants each comprise an anchoring part made of plastic and a marking element in the form of a metal ball arranged thereon. The metal ball is held in place in the bone by the anchoring part and has a diameter of at least 0.2 mm. The marking element designed in this way produces a strong contrast in an X-ray image and is therefore easy to identify.

Werden mehrere dieser Markierungselemente beispielsweise in zwei benachbarte Knochen des Skeletts eingebracht, so bilden diese in den Röntgenaufnahmen Bezugspunkte, mit deren Hilfe Veränderungen der relativen Orientierung der Knochen festgestellt und quantitativ erfaßt werden können. Die metallischen Markierungselemente verbleiben allerdings dauerhaft im jeweiligen Knochen. Da es sich dabei um körperfremdes Material handelt, kann dies zu einer Schädigung des Knochengewebes führen. Sollen die Markierungselemente entfernt werden, so ist dazu eine weitere Operation erforderlich.If several of these marking elements are inserted into two adjacent bones of the skeleton, for example, they form reference points in the X-ray images that can be used to determine and quantify changes in the relative orientation of the bones. However, the metal marking elements remain permanently in the respective bone. Since this is foreign material, this can lead to damage to the bone tissue. If the marking elements are to be removed, another operation is required.

A 53 290 uA 53 290 u

7. Mai 19967 May 1996

In der EP 0 412 280 Bl wird ein Markierungselement vorgeschlagen in Form eines röntgenologisch darstellbaren Kontrastmittels, das in einen Aufnahmeraum eines resorbierbaren Befestigungsmittels zur Fixierung von Knochenfragmenten einfüllbar ist. Das Kontrastmittel diffundiert allmählich durch die Wände des Aufnahmeraumes hindurch in das benachbarte Körpergewebe. Da das Material nicht resorbierbar ist, verbleibt es ebenfalls als körperfremdes Material im Gewebe. Bei dieser Ausgestaltung des Markierungselements ist zu dessen Entfernung keine weitere Operation erforderlich. Statt dessen findet ein andauernder Diffusionsprozeß statt. Dies hat zur Folge, daß sich das Kontrastmittel zunehmend verteilt und verdünnt. Eine röntgenologische Bestimmung des ursprünglichen Ortes des Kontrastmittels und damit des Aufnahmeraums des Befestigungsmittels wird dadurch im Laufe der Zeit immer schwieriger und ungenauer.EP 0 412 280 Bl proposes a marking element in the form of an X-ray-visible contrast agent that can be filled into a receiving space of a resorbable fastening agent for fixing bone fragments. The contrast agent gradually diffuses through the walls of the receiving space into the adjacent body tissue. Since the material is not resorbable, it also remains in the tissue as a foreign material. With this design of the marking element, no further operation is required to remove it. Instead, a continuous diffusion process takes place. This means that the contrast agent is increasingly distributed and diluted. An X-ray determination of the original location of the contrast agent and thus of the receiving space of the fastening agent therefore becomes increasingly difficult and less precise over time.

Ein in seiner ursprünglichen Position verbleibendes Markierungselement wird in der EP 0 360 139 A2 vorgeschlagen. Diese Offenlegungsschrift beschreibt ein Befestigungsmittel aus resorbierbarem Werkstoff, beispielsweise eine Gewindestange oder eine Schraube, wobei in deren Spitze ein Calziumphosphatgranulatteilchen eingepreßt ist. Dieses bildet ein Markierungselement, das einen Röntgenkontrast erzeugt und dadurch die Spitze des ansonsten auf einer Röntgenaufnahme nicht erkennbaren resorbierbaren Befestigungselements röntgenologisch sichtbar macht. Dies gibt beispielsweise dem Operateur eine Kontrollmöglichkeit an die Hand, um mit Hilfe eines intraoperativ eingesetzten Bildwandlers zu beurteilen, ob das Befestigungsmittel einwandfrei am Knochenfragment positioniert ist. Typischerweise sind die beschriebenen Granulatteilchen porös, da sie dadurch als Knochenersatzstoff im Hartgewebe besser integriert werden.A marking element that remains in its original position is proposed in EP 0 360 139 A2. This publication describes a fastening device made of resorbable material, for example a threaded rod or a screw, with a calcium phosphate granulate particle pressed into the tip. This forms a marking element that creates an X-ray contrast and thus makes the tip of the resorbable fastening element, which would otherwise not be visible on an X-ray, visible on an X-ray. This gives the surgeon, for example, a control option to assess whether the fastening device is correctly positioned on the bone fragment using an intraoperative image converter. The granulate particles described are typically porous, as this allows them to be better integrated into the hard tissue as a bone substitute.

A 53 290 uA 53 290 u

7. Mai 19967 May 1996

— 3 ——3—

Auch bei einer derartigen Ausgestaltung des Markierungselements entfällt eine nachträgliche Operation zu seiner Entfernung, denn das aus Calziumphosphat bestehende Markierungselement wird im Hartgewebe integriert und entweder resorbiert oder über den Metabolismus abgebaut. Es hat sich allerdings gezeigt, daß die bekannten Markierungselemente insbesondere bei intraoperativ eingesetzten Bildwandlern nicht in allen Fällen zweifelsfrei erkannt werden können. Die Bestimmung der bekannten Markierungselemente gestaltet sich zum Teil schwierig und zeitaufwendig, und deren Positionsbestimmung ist oft mit einer gewissen Ungenauigkeit verbunden.Even with such a design of the marking element, a subsequent operation to remove it is not necessary, because the marking element consisting of calcium phosphate is integrated into the hard tissue and is either reabsorbed or broken down via metabolism. However, it has been shown that the known marking elements cannot be identified with certainty in all cases, especially with image converters used intraoperatively. Determining the known marking elements is sometimes difficult and time-consuming, and determining their position is often associated with a certain inaccuracy.

Aufgabe der vorliegenden Erfindung ist es, ein gattungsgemäßes Markierungselement derart auszugestalten, daß es bei Verwendung von intraoperativ eingesetzten Bildwandlern eindeutiger und schneller erkannt werden kann und eine genauere Positionsbestimmung ermöglicht.The object of the present invention is to design a generic marking element in such a way that it can be recognized more clearly and quickly when using intraoperatively used image converters and enables a more precise position determination.

Diese Aufgabe wird bei einem Markierungselement der eingangs genannten Art erfindungsgemäß dadurch gelöst, daß das Markierungselement eine kompakte Struktur aufweist mit einer die Röntgendichte des bei der Applikation des Markierungselements diesem benachbarten Knochens übersteigenden Röntgendichte und daß der Durchmesser des Markierungselements in allen Dimensionen mindestens 0,5 mm beträgt.This object is achieved according to the invention in a marking element of the type mentioned at the outset in that the marking element has a compact structure with an X-ray density that exceeds the X-ray density of the bone adjacent to the marking element when it is applied and that the diameter of the marking element is at least 0.5 mm in all dimensions.

Erfindungsgemäß ist das Markierungselement so kompakt ausgebildet, so daß seine Röntgendichte größer ist als diejenige des Knochens, der dem Markierungselement bei dessen Applikation benachbart ist. Durch die höhere Röntgendichte wird ein ausreichender Kontrast bei einem röntgenbildgebenden Verfahren erzielt. In Verbindung mit einem Mindestdurchmesser vonAccording to the invention, the marking element is designed to be so compact that its X-ray density is greater than that of the bone adjacent to the marking element when it is applied. The higher X-ray density achieves sufficient contrast in an X-ray imaging procedure. In conjunction with a minimum diameter of

A 53 290 uA 53 290 u

7. Mai 19967 May 1996

0,5 mm hat eine derart kompakte Struktur eine besonders gute röntgenologische Erkennbarkeit des Markierungselements auch in einem intraoperativ zum Einsatz kommenden Bildwandler zur Folge. Unsicherheiten in der Positionsbestimmung werden dadurch reduziert. Die kompakte Struktur hat außerdem den Vorteil, daß das Markierungselement während der Abbauzeit des resorbierbaren Implantats praktisch nicht zerfällt. Dadurch wird sichergestellt, daß das Markierungselement während des gesamten Heilungsprozesses eindeutig erkennbar ist und seine exakte Position festgestellt werden kann.0.5 mm, such a compact structure results in particularly good radiological recognizability of the marking element, even in an image converter used intraoperatively. This reduces uncertainties in determining the position. The compact structure also has the advantage that the marking element practically does not disintegrate during the degradation time of the resorbable implant. This ensures that the marking element is clearly recognizable throughout the entire healing process and its exact position can be determined.

Bei einer vorteilhaften Ausführungsform der Erfindung ist vorgesehen, daß der Durchmesser des Markierungselements in allen Dimensionen mindestens 0,7 mm beträgt. Eine derartige Gestalt ermöglicht selbst unter schwierigen Bedingungen eine besonders einfache und sichere Identifizierung und Lokalisierung des Markierungselements.In an advantageous embodiment of the invention, the diameter of the marking element is at least 0.7 mm in all dimensions. Such a design enables particularly simple and reliable identification and localization of the marking element, even under difficult conditions.

Das Markierungselement kann aus Hydroxylapatit bestehen. Dieser Werkstoff hat eine geringe Resorptionsgeschwindigkeit, er wird aber aufgrund der hervorragenden Bioaktivität im Knochen integriert.The marking element can be made of hydroxyapatite. This material has a low resorption rate, but it is integrated into the bone due to its excellent bioactivity.

Bei einer besonders bevorzugten Ausführungsform ist vorgesehen, daß das Markierungselement aus einem dichtgesinterten Formkörper besteht. So kann beispielsweise ein gesinterter Hydroxylapatitformkörper zum Einsatz kommen, der so verdichtet ist, daß er eine höhere Röntgendichte aufweist als diejenige des bei der Applikation des Markierungselements diesem benachbarten Knochens.In a particularly preferred embodiment, the marking element consists of a densely sintered molded body. For example, a sintered hydroxyapatite molded body can be used which is compacted in such a way that it has a higher X-ray density than that of the bone adjacent to the marking element when it is applied.

Für eine sichere Erkennbarkeit weist das Markierungselement erfindungsgemäß neben einer kompakten Struktur eine derartigeFor reliable recognition, the marking element according to the invention has, in addition to a compact structure, such a

A 53 290 uA 53 290 u

7. Mai 19967 May 1996

Gestalt auf, daß der Durchmesser in jeder Dimension zumindest 0,5 mm beträgt. Dies hat zur Folge, daß bei jeder möglichen Strahlrichtung der während einer Untersuchung zum Einsatz kommenden Röntgenstrahlung eine Projektion des Markierungselements erzeugt wird, die eine sichere Identifizierung und Lokalisierung ermöglicht.shape so that the diameter is at least 0.5 mm in every dimension. This means that a projection of the marking element is generated in every possible beam direction of the X-rays used during an examination, which enables reliable identification and localization.

Das erfindungsgemäße Markierungselement kann, wie eingangs erwähnt, beispielsweise zur Festlegung eines röntgenologisch erkennbaren Bezugspunktes im Knochengewebe verwendet werden. Es kann auch in bekannter Weise zusammen mit einem resorbierbaren Implantat, beispielsweise einem Befestigungsmittel zur Fixierung von Knochenfragmenten, zum Einsatz kommen. Hierzu wird das zum Beispiel kugelförmig mit einem Durchmesser von 0,7 mm ausgestaltete Markierungselement aus dichtgesintertem Hydroxylapatitgranulat am distalen oder proximalen Ende des resorbierbaren Implantats angeordnet und mit diesem in den Knochen eingesetzt, so daß es sich nach der Applikation entweder am Knochenrand oder im Weichgewebe befindet. Dadux-ch ermöglicht das erfindungsgemäße Markierungselement bei intraoperativer Verwendung eines Bildwandlers eine schnelle und eine eindeutige Beurteilung der Lage des Implantats.The marking element according to the invention can, as mentioned at the beginning, be used, for example, to establish an X-ray-recognizable reference point in the bone tissue. It can also be used in a known manner together with a resorbable implant, for example a fastening means for fixing bone fragments. For this purpose, the marking element made of densely sintered hydroxyapatite granules, which is designed, for example, spherical with a diameter of 0.7 mm, is arranged at the distal or proximal end of the resorbable implant and inserted into the bone with it, so that after application it is either at the edge of the bone or in the soft tissue. Dadux-ch the marking element according to the invention enables a quick and clear assessment of the position of the implant when an image converter is used intraoperatively.

Claims (4)

A 53 290 u 7. Mai 1996 SCHUTZANSPRÜCHEA 53 290 u 7 May 1996 PROTECTION CLAIMS 1. Markierungselement zur Erzeugung eines Röntgenkontrasts insbesondere bei einem resorbierbaren Implantat, hergestellt unter Verwendung von Calzium, Phosphor, Sauerstoff und Wasserstoff, dadurch gekennzeichnet, daß das Markierungselement eine kompakte Struktur aufweist mit einer die Röntgendichte des bei der Applikation des Markierungselements diesem benachbarten Knochens übersteigenden Röntgendichte und daß der Durchmesser des Markierungselements in allen Dimensionen mindestens 0,5 mm beträgt.1. Marking element for generating an X-ray contrast, in particular in a resorbable implant, manufactured using calcium, phosphorus, oxygen and hydrogen, characterized in that the marking element has a compact structure with an X-ray density that exceeds the X-ray density of the bone adjacent to the marking element when it is applied, and that the diameter of the marking element is at least 0.5 mm in all dimensions. 2. Markierungselement nach Anspruch 1, dadurch gekennzeichnet, daß es in allen Dimensionen einen Durchmesser von mindestens 0,7 mm aufweist.2. Marking element according to claim 1, characterized in that it has a diameter of at least 0.7 mm in all dimensions. 3. Markierungselement nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß es aus einem dichtgesinterten Formkörper besteht.3. Marking element according to claim 1 or 2, characterized in that it consists of a densely sintered molded body. 4. Markierungselement nach Anspruch 1, 2 oder 3, dadurch gekennzeichnet, daß es aus dichtgesintertem Hydroxylapatit besteht.4. Marking element according to claim 1, 2 or 3, characterized in that it consists of densely sintered hydroxyapatite.
DE29608321U 1996-05-08 1996-05-08 Marker element Expired - Lifetime DE29608321U1 (en)

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Cited By (9)

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WO1998010712A1 (en) * 1996-09-13 1998-03-19 Osteotech, Inc. Surgical implant containing a resorbable radiopaque marker
DE29717890U1 (en) * 1997-10-08 1999-02-04 Dr. H.C. Robert Mathys Stiftung, Bettlach Device for implanting marking bodies in a bone
US7939108B2 (en) 2000-12-14 2011-05-10 Osteotech, Inc. Method of making demineralized bone particles
US7959941B2 (en) 2001-10-12 2011-06-14 Warsaw Orthopedic, Inc. Bone graft comprising a demineralized bone matrix and a stabilizing agent
US8002813B2 (en) 1999-10-15 2011-08-23 Warsaw Orthopedic, Inc. Volume maintaining osteoinductive/osteoconductive compositions
US8268008B2 (en) 2003-06-11 2012-09-18 Warsaw Orthopedic, Inc. Osteoimplants and methods for their manufacture
US8545864B2 (en) 2005-11-02 2013-10-01 Warsaw Orthopedic, Inc. Hemostatic bone graft
US8663672B2 (en) 2000-07-19 2014-03-04 Warsaw Orthopedic, Inc. Osteoimplant and method of making same
US8722075B2 (en) 2008-10-24 2014-05-13 Warsaw Orthopedic, Inc. Compositions and methods for promoting bone formation

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2260790A3 (en) * 1996-09-13 2011-04-06 Osteotech, Inc. Surgical implant containing a resorbable radiopaque marker
WO1998010712A1 (en) * 1996-09-13 1998-03-19 Osteotech, Inc. Surgical implant containing a resorbable radiopaque marker
DE29717890U1 (en) * 1997-10-08 1999-02-04 Dr. H.C. Robert Mathys Stiftung, Bettlach Device for implanting marking bodies in a bone
US8002813B2 (en) 1999-10-15 2011-08-23 Warsaw Orthopedic, Inc. Volume maintaining osteoinductive/osteoconductive compositions
US8197474B2 (en) 1999-10-15 2012-06-12 Warsaw Orthopedic, Inc. Volume maintaining osteoinductive/osteoconductive compositions
US8663672B2 (en) 2000-07-19 2014-03-04 Warsaw Orthopedic, Inc. Osteoimplant and method of making same
US9999520B2 (en) 2000-07-19 2018-06-19 Warsaw Orthopedic, Inc. Osteoimplant and method of making same
US9387094B2 (en) 2000-07-19 2016-07-12 Warsaw Orthopedic, Inc. Osteoimplant and method of making same
US7939108B2 (en) 2000-12-14 2011-05-10 Osteotech, Inc. Method of making demineralized bone particles
US8529962B2 (en) 2000-12-14 2013-09-10 Warsaw Orthopedic, Inc. Method of making demineralized bone particles
US7959941B2 (en) 2001-10-12 2011-06-14 Warsaw Orthopedic, Inc. Bone graft comprising a demineralized bone matrix and a stabilizing agent
US8753689B2 (en) 2001-12-14 2014-06-17 Warsaw Orthopedic, Inc. Method of making demineralized bone particles
US9393116B2 (en) 2003-06-11 2016-07-19 Warsaw Orthopedic, Inc. Osteoimplants and methods for their manufacture
US8268008B2 (en) 2003-06-11 2012-09-18 Warsaw Orthopedic, Inc. Osteoimplants and methods for their manufacture
US8545864B2 (en) 2005-11-02 2013-10-01 Warsaw Orthopedic, Inc. Hemostatic bone graft
US8722075B2 (en) 2008-10-24 2014-05-13 Warsaw Orthopedic, Inc. Compositions and methods for promoting bone formation

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