DE10247397B3 - Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat - Google Patents

Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat Download PDF

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Publication number
DE10247397B3
DE10247397B3 DE10247397A DE10247397A DE10247397B3 DE 10247397 B3 DE10247397 B3 DE 10247397B3 DE 10247397 A DE10247397 A DE 10247397A DE 10247397 A DE10247397 A DE 10247397A DE 10247397 B3 DE10247397 B3 DE 10247397B3
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DE
Germany
Prior art keywords
intermediate piece
bushing
rigid
socket
subcutaneous
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
DE10247397A
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English (en)
Inventor
Hans Dr. Grundei
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ORTHODYNAMICS GMBH, DE
Original Assignee
Eska Implants GmbH and Co KG
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 Eska Implants GmbH and Co KG filed Critical Eska Implants GmbH and Co KG
Priority to DE10247397A priority Critical patent/DE10247397B3/de
Priority to DE10311990A priority patent/DE10311990B4/de
Priority to AT03017531T priority patent/ATE300924T1/de
Priority to EP03017531A priority patent/EP1407727B1/de
Priority to ES03017531T priority patent/ES2246448T3/es
Priority to DE50300899T priority patent/DE50300899D1/de
Priority to JP2003343060A priority patent/JP2004130130A/ja
Priority to US10/678,707 priority patent/US6869450B2/en
Application granted granted Critical
Publication of DE10247397B3 publication Critical patent/DE10247397B3/de
Priority to HK04107914A priority patent/HK1067292A1/xx
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/50Prostheses not implantable in the body
    • A61F2/78Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
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    • A61FFILTERS 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
    • A61F2/00Filters 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
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Abstract

Es wird ein subkutanes, intramuskuläres Lager (1) für ein starres transkutanes Implantat (2) beschrieben, welches intrakorporal in einem Knochenstumpf verankerbar ist und welches ein Zwischenstück (3) zwischen dem intrakorporal zu verankernden Teil (2) und einer daran ankoppelbaren extrakorporalen Kopplungseinrichtung (4) aufweist.
Vorgeschlagen wird eine mit dem Zwischenstück (3) fest verbundene starre Buchse (5), derart, dass zwischen der Wandung der Buchse (5) und dem Zwischenstück (3) ein in Richtung intrakorporal geschlossener Ringraum (6) ausgebildet ist, in den die extrakorporale Kopplungseinrichtung (4) setzbar ist.
Auf die Außenwandung der Buchse (5) ist ein Schlauch (7) aus flexiblem Material und auf den flexiblen Schlauch (7) metallische Wolle (8) aufgebracht.

Description

  • Die Erfindung betrifft ein subkutanes, intramuskuläres Lager für ein . starres transkutanes Implantat, welches intrakorporal in einem Knochenstumpf verankerbar ist und welches ein Zwischenstück zwischen dem intrakorporalen zu verankernden Teil und einer daran ankoppelbaren extrakorporalen Kopplungseinrichtung aufweist.
  • Ein derartiges Lager ist bekannt aus der DE-100 40 590 A1 Das darin beschriebene Lager besteht aus einem flexiblen Material und es weist eine Tülle auf, die das Implantat distal fest umschließt, sowie eine intrakorporal anzuordnende Überwurfhülse in Form eines flexiblen Faltenbalges, der proximal mit einem angeformten Bund in abdichtender Weise mit der Tülle verbunden ist, derart, dass zwischen der Innenwandung des Faltenbalges und Außenwandung der Tülle ein Hohlraum einer Mindestbreite frei bleibt. Dabei ist distal am Faltenbalg ein flexibles Gitternetzwerk angeordnet, dem sich distalseitig ein weiteres Gitternetzwerk mit einem höheren E-Modul anschließt.
  • Mit diesem Lager wird das Ziel verfolgt, dass sich Weichteile gegenüber dem starren Implantat bewegen können, ohne dass die Durchbruchstelle im Körperstumpfteil einem erhöhten Risiko einer Entzündung ausgesetzt wird.
  • Wenn dieses bekannte Lager auch bereits in der Praxis erfolgreich eingesetzt worden ist, birgt es das Risiko, dass im Falle beispielsweise einer Reinigung der Durchtrittstelle des Implantates durch den Oberschenkelstumpf mit einer Kanüle durch das flexible Material, in den meisten Fällen Silikon, hindurch gestochen wird und eine Verkeimung stattfindet. Darüber hinaus besteht das Risiko, dass bei Reinigung des Beinstumpfes die Tülle vom Implantat abgezogen wird.
  • Vor diesem Hintergrund ist es nun die Aufgabe der vorliegenden Erfindung, ein gattungsgemäßes, subkutanes intramuskuläres Lager der eingangs genannten Art so weiterzubilden, dass die Sicherheit gegen eine Verkeimung der Durchtrittstelle des Implantates und der angrenzenden Bereiche des Oberschenkelstumpfes deutlich erhöht wird und dass ein versehentliches Entfernen der Keimschranke verhindert wird.
  • Gelöst wird diese Aufgabe durch das Lager mit den Merkmalen des Anspruches 1. Vorteilhafte Weiterbildungen ergeben sich aus den Unteransprüchen.
  • Dem gemäß wird vorgeschlagen, dass das Lager eine mit dem Zwischenstück fest verbundene starre Buchse derart aufweist, dass zwischen der Wandung der Buchse und dem Zwischenstück ein in Richtung intrakorporal geschlossener Ringraum ausgebildet ist, in den die extrakorporale Koppelungseinrichtung setzbar ist, und darüber hinaus einen auf die Außenwandung der Buchse aufgebrachten Schlauch aus flexiblem Material und auf den flexiblen Schlauch aufgebrachte metallische Wolle aufweist.
  • Gegenüber dem bekannten Lager ist die Buchse vorliegend ein starres Element, das nicht etwa durch Injektionskanülen durchdrungen werden kann. Die feste Verbindung zwischen dem Zwischenstück und der starren Buchse verhindert ein versehentliches Abziehen der Buchse vom Zwischenstück. Der auf der Außenwandung der Buchse aufgebrachte Schlauch aus flexiblem Material, vorzugsweise aus Silikon, bewirkt einen Ausgleich zwischen dem Gewebe und den Muskeln auf der einen Seite und der starren Verbindung mit dem Knochenstumpf. Die auf den flexiblen Schlauch aufgebrachte metallische Wolle dient zum Eingranulieren von umgebenden Gewebe, welches so die Keimschranke noch deutlich erhöht.
  • Die Buchse kann durch Aufschrumpfen auf das Zwischenstück fest mit diesem verbunden sein. Alternativ kann sie mit diesem verschweißt sein. Es ist auch möglich, die Buchse und das Zwischenstück einstöckig auszubilden.
  • Die metallische Wolle besteht vorzugsweise aus Titanfasern, einem körperverträglichen Metall. Das Zwischenstück ist vorzugsweise als Doppelkonus mit einem zylindrischen Mittelabschnitt ausgebildet, mit dem die Buchse verbunden ist.
  • Keime oder Schmutzpartikel können beim Einsatz des erfindungsgemäßen Lagers nicht zum Knochenstumpf vordringen, sondern werden wirksam abgeblockt. Ein versehentliches Eindringen von beispielsweise Keimen durch Anwendung einer Injektionsnadel ist nicht möglich, da die Buchse aus einem starren, vorzugsweise metallischen Material besteht. Besonders bevorzugt wird Titan als Werkstoff.
  • Im folgenden wird ein Ausführungsbeispiel der Erfindung anhand der einzigen Zeichnungsfigur näher erläutert. Diese zeigt schematisch einen Schnitt durch einen Oberschenkelstumpf und durch das implantierte subkutane Lager.
  • Der Oberschenkelstumpf ist allgemein mit dem Bezugszeichen 10 versehen. Bei dem Knochenstumpf 11 handelt es sich vorliegend um einen Femursfumpf. In den Femurstumpf 11 ist eine starres transkutanes Implantat 2 gesetzt. Es ist distalseitig abgeschlossen durch eine Metallhülse 12, die proximal einen umlaufenden Flansch 13 aufweist, der den Femurstumpf 11 einfasst.
  • Im Inneren der Metallhülse 12 ist eine konische Klemmhülse 14 ausgebildet. Diese ist vorgesehen zur Herstellung einer konischen Klemmverbindung mit dem vorliegend als Doppelkonus ausgebildeten Zwischenstück 3. Das Zwischenstück 3 weist einen zylindrischen Mittelabschnitt 9 auf, auf dem die Buchse 5 vorliegend aufgeschrumpft ist. Dem Mittelabschnitt 9 schließt sich distalseitig ein weiterer Konus 15 zur Herstellung einer konischen Verklemmung mit einer konischen Klemmhülse 17 in einem Adapter der extrakorporalen Kopplungseinrichtung 4 an.
  • Die Buchse 5 ist so ausgebildet, dass zwischen ihrer Wandung und dem Zwischenstück ein in Richtung intrakorporal oder proximal geschlossener Ringraum 6 ausgebildet ist. In diesen Ringraum 6 ist die extrakorporale Kopplungseinrichtung 4 gesetzt. Mit einem Sicherungsmittel 18 wird die Verbindung zwischen dem subkutanen Lager und der Koppelungseinrichtung 4 arretiert.
  • Auf die Außenwandung der Buchse 5 ist ein Schlauch 7 aus Silikon aufgebracht. Der Schlauch 7 kann auf die Buchse 5 aufgeschrumpft und/oder dort verklebt sein. Der Schlauch 7 gestattet Ausgleichsbewegungen des starren Implantates gegenüber dem es umgebenden Gewebe. Mit dem flexiblen Schlauch 7 ist eine Schicht von metallischer Wolle 8 verklebt. Die metallische Wolle dient als Keimschranke nach Eingranulieren von umgebendem Gewebe.
  • Distalseitig geht der flexible Schlauch 7 einstückig über in ein flexibles Gitternetzwerk 19 mit einer großen Anzahl von Durchbrechungen 20, welche nach der Operation im Laufe der Zeit durchsetzt werden von muskulärem Gewebe.
  • Noch weiter distalseitig ist mit dem Gitternetzwerk 19 metallische Wolle 21 verklebt, welche nach Eingranulieren von Gewebematerial als weitere Keimschranke dient.

Claims (7)

  1. Subkutanes, intramuskuläres Lager (1) für ein starres transkutanes Implantat (2), welches intrakorporal in einem Knochenstumpf verankerbar ist und welches ein Zwischenstück (3) zwischen dem intrakorporal zu verankernden Teil (2) und einer daran ankoppelbaren extrakorporalen Kopplungseinrichtung (4) aufweist, gekennzeichnet durch, – eine mit dem Zwischenstück (3) fest verbundene starre Buchse (5) derart, dass zwischen der Wandung der Buchse (5) und dem Zwischenstück (3) ein in Richtung intrakorporal geschlossener Ringraum (6) ausgebildet ist, in den die extrakorporale Kopplungseinrichtung (4) setzbar ist, – einen auf die Außenwandung der Buchse (5) aufgebrachten Schlauch (7) aus flexiblem Material, und – auf den flexiblen Schlauch (7) aufgebrachte metallische Wolle (8).
  2. Lager nach Anspruch 1, dadurch gekennzeichnet, dass die Buchse (5) durch Aufschrumpfen auf das Zwischenstück (3) fest mit diesem verbunden ist.
  3. Lager nach Anspruch 1, dadurch gekennzeichnet, dass die Buchse (5) mit dem Zwischenstück (3) verschweißt ist.
  4. Lager nach Anspruch 1, dadurch gekennzeichnet, dass die Buchse (5) mit dem Zwischenstück (3) einstückig ausgebildet ist.
  5. Lager nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass der flexible Schlauch (7) aus Silikon besteht.
  6. Lager nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die metallische Wolle (8) aus Titanfasern gebildet ist.
  7. Lager nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass das Zwischenstück (3) ein Doppelkonus mit einem zylindrischen Mittelabschnitt (9) ist, mit welchem die Buchse (5) verbunden ist.
DE10247397A 2002-10-08 2002-10-08 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat Expired - Fee Related DE10247397B3 (de)

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DE10247397A DE10247397B3 (de) 2002-10-08 2002-10-08 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
DE10311990A DE10311990B4 (de) 2002-10-08 2003-03-12 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
EP03017531A EP1407727B1 (de) 2002-10-08 2003-08-06 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
ES03017531T ES2246448T3 (es) 2002-10-08 2003-08-06 Soporte intramuscular subcutaneo para un implante transcutaneo rigido.
AT03017531T ATE300924T1 (de) 2002-10-08 2003-08-06 Subkutanes, intramuskuläres lager für ein starres transkutanes implantat
DE50300899T DE50300899D1 (de) 2002-10-08 2003-08-06 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
JP2003343060A JP2004130130A (ja) 2002-10-08 2003-10-01 剛性の経皮的なインプラントのための皮下の筋内の支持構造体
US10/678,707 US6869450B2 (en) 2002-10-08 2003-10-02 Subcutaneous, intramuscular support for a rigid transcutaneous implant
HK04107914A HK1067292A1 (en) 2002-10-08 2004-10-14 Subcutaneous, intra-muscular coupling for a rigid transcutaneous implant.

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DE10247397A DE10247397B3 (de) 2002-10-08 2002-10-08 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
DE10311990A DE10311990B4 (de) 2002-10-08 2003-03-12 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat

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DE10311990A Expired - Fee Related DE10311990B4 (de) 2002-10-08 2003-03-12 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
DE50300899T Expired - Lifetime DE50300899D1 (de) 2002-10-08 2003-08-06 Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat

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EP (1) EP1407727B1 (de)
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EP1649834A1 (de) * 2004-10-25 2006-04-26 ESKA Implants GmbH & Co. Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
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DE10311990B4 (de) * 2002-10-08 2006-04-27 Eska Implants Gmbh & Co. Subkutanes, intramuskuläres Lager für ein starres transkutanes Implantat
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US20040068324A1 (en) 2004-04-08
ES2246448T3 (es) 2006-02-16
DE10311990B4 (de) 2006-04-27
EP1407727B1 (de) 2005-08-03
ATE300924T1 (de) 2005-08-15
HK1067292A1 (en) 2005-04-08
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