WO2005042058A2 - Port catheter having improved performance characteristics, and antimicrobial material - Google Patents

Port catheter having improved performance characteristics, and antimicrobial material Download PDF

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Publication number
WO2005042058A2
WO2005042058A2 PCT/EP2004/012229 EP2004012229W WO2005042058A2 WO 2005042058 A2 WO2005042058 A2 WO 2005042058A2 EP 2004012229 W EP2004012229 W EP 2004012229W WO 2005042058 A2 WO2005042058 A2 WO 2005042058A2
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WO
WIPO (PCT)
Prior art keywords
port
port catheter
catheter
catheter according
antimicrobial material
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PCT/EP2004/012229
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German (de)
French (fr)
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WO2005042058A3 (en
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Guggenbichler, Meinrad
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Publication of WO2005042058A2 publication Critical patent/WO2005042058A2/en
Publication of WO2005042058A3 publication Critical patent/WO2005042058A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/62—Encapsulated active agents, e.g. emulsified droplets
    • A61L2300/624—Nanocapsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0226—Subcutaneous access sites for injecting or removing fluids having means for protecting the interior of the access site from damage due to the insertion of a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0273—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing catheters into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0285—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port

Definitions

  • the invention relates to a port catheter with improved performance properties for a permanent central venous or intra-arterial subcutaneous access for the long-term administration of therapeutic agents.
  • cytostatics with subsequent large amounts of irrigation fluid in patients with malignancies
  • the administration of antibiotics in chronically ill patients cystic fibrosis, chronic osteomelitis
  • the emergency supply of medication and blood products in chronically ill patients hemophilia, sickle cell anemia, uncontrollable epileptic Seizures, AIDS
  • the administration of pain medication Cancer patients require safe, permanent and permanent central venous access.
  • Subcutaneously implanted intra-arterial tubing which is fed either directly via a motor syringe or via an injection chamber, is increasingly used.
  • cytostatics for example in breast cancer
  • intra-arterial access for infusions into the hepatic artery in liver metastases
  • vasoactive substances and antibiotics for poor blood flow to extremities with trophic ulcers.
  • Other use cases are also becoming increasingly topical.
  • Two systems can be used for these central venous or intra-arterial leads.
  • the port catheter is generally implanted completely subcutaneously and, thanks to the percutaneous puncture of the port membrane, a puncture-capable membrane, preferably made of silicone, integrated into the port chamber and easily palpable with a diameter of 12 to 15 mm under the skin, allows repeated, direct access to the central venous system.
  • the port chamber consists of a housing made of a solid material (mainly metal) and a cover. In the port systems used up to now, the port chamber is made of titanium.
  • Titan itself owns negligible toxicity, which is due to a thin oxide layer that forms, with which the metal spontaneously coats and thus passivates against chemical influences.
  • this oxide layer is relatively easily colonized by bacterial germs, which means that a biofilm can form on the surface of such port implants in a short time.
  • the hollow port chamber is connected to a catheter tube.
  • the catheter tube is made of silicone or soft polyurethane and is inserted into the central bloodstream after appropriate length adjustment by surgical section venae or by the Seidinger method.
  • the port membrane consists of a high-purity silicone that is suitable for medical purposes and that seals completely again after frequent punctures with specially ground injection needles.
  • the entire port component is a class III medical device, and its costs and expectations of its integrity are correspondingly high.
  • the known port catheters have significant shortcomings and disadvantages. Problems also arise with the implantation of these long-term-oriented catheter systems. The problems with cuffed, tunneled Hickman-type catheters are primarily of an infectious nature. Although these catheters have a protected connection to the outside, there is an inevitable risk of contamination of the entry point, Luer locks and the subcutaneous tunnel, which creates a risk of infection, particularly for the central vascular system is given.
  • the component size of conventional port catheters is a negative factor with regard to the improvement in quality of life expected with the placement of the port implant.
  • the height and shape of the currently available port systems can be used, particularly in this patient group, for ischemia and nectrosis of the skin and subcutaneous adipose tissue located above the port system to lead.
  • a not inconsiderable risk is thrombosis of the port catheter, which can occur both as an early and as a late complication.
  • a procrastination of thrombi or coagulum the formation of which in a currently common port chamber cannot be ruled out due to the unfavorable flow conditions, can lead to obstruction of the outlet and thus to failure of the port system.
  • the object of the invention is to provide a port catheter with improved usage properties to the effect that a material is developed which presents a risk of infection and the septic associated therewith Complications in long-term care practically preclude and that a component shape is developed that avoids both thrombosis of the port catheter and unnecessary stress on the tissue areas in the immediate area of the implant.
  • the invention is based on the idea of using a port catheter which, according to the invention, consists of a catheter which can be completely or partially subcutaneously laid, with a port chamber serving to hold an injection liquid, with a port membrane, a puncture-resistant hard floor and a connecting piece for coupling to a hose system to load its parts and / or parts of the associated hose system superficially and / or internally with nanoscale elemental silver particles, and to give the port chamber an antithrombic design by having an internal bulge that has a flat and smooth shape that is rounded on all sides, so that Dead niches and / or niches obstructing the flow of the injection liquid are excluded.
  • Nanoscale elemental silver particles are understood to mean, in particular, those described for the production of the antimicrobial plastic body in WO 01/09229 A1.
  • the port catheter can have a thin-walled, dimensionally stable sheathing which preferably consists of a hard polyurethane or also a ceramic and which is loaded on the surface and / or internally with nanoscale elemental silver.
  • the bulge of the port catheter has a lining which consists of a puncture-proof material, particularly preferably of a ceramic or a hard polyurethane or of a physiologically harmless metal, which is also superficially and / or internally loaded with nanoscale elemental silver.
  • the connecting piece of the port catheter is preferably connected to the associated hose system by easily detachable but fixed coupling elements.
  • the port catheter according to the invention can have an extremely flat construction, in particular in such a way that the port chamber is designed to be discus-shaped flat and / or elliptical or rotationally symmetrical egg-shaped with regard to shape and / or bulge.
  • the port membrane preferably consists of a silicone that is loaded with nanoscale elemental silver.
  • the antimicrobial effect of the surface and / or internally loaded parts of the port catheter can be enhanced by activating the nanoscale silver, in particular by adding preferably silver phosphate (Ag PO).
  • Ag PO silver phosphate
  • For the possibility of activating nanoscale, elemental silver reference is made to the compositions of nanoscale, elemental silver described in WO 2004/024205 A1 and their production processes. The relevant disclosure points of WO 2004/024205 A1 are expressly regarded as part of the present description of the invention and are referred to.
  • an antimicrobial material which consists of an oxidic and / or carbide-seeing and / or nitridic ceramic base material, in which chem finely dispersed antimicrobial metal particles that have a large effective surface are introduced.
  • the antimicrobial metal particles are preferably those as described for the production of the antimicrobial plastic body in WO 01/09229 A1.
  • express reference is therefore made to the relevant disclosure points of WO 01/09229 A1 as part of the present description and reference is made to this.
  • the base material is particularly preferably aluminum oxide and / or titanium oxide, silicon oxide, zirconium oxide, magnesium oxide, aluminum titanate, barium titanate, silicon carbide, boron carbide, silicon nitrite, aluminum nitrite.
  • the metal particles consist of nanoscale silver and / or copper. In a further preferred embodiment, the content of metal particles is 0.2 to 5.0% by mass.
  • the content of metal particles is particularly preferably determined after the processing of the material by a concentration gradient from outside to inside.
  • a product made from the antimicrobial material is preferably brought into a predetermined physical habit by the known working steps, such as molding, casting, pressing or sintering.
  • the antimicrobial material in its physical form is particularly preferably used in human medicine and comparatively in veterinary medicine, in particular for long-term implants, such as, for example, for port catheters, artificial femoral heads and acetabular cups, artificial knee joints, as implants for bone defects, such as skull cap defects, vertebral defects, in dentistry as dentures, denture implants, or outside of medicine for clinical components with oligody- Namely effect, especially in the food industry or in drinking water treatment, for example as ceramic sealing washers for fittings, sinks and others.
  • implants such as, for example, for port catheters, artificial femoral heads and acetabular cups, artificial knee joints, as implants for bone defects, such as skull cap defects, vertebral defects, in dentistry as dentures, denture implants, or outside of medicine for clinical components with oligody- Namely effect, especially in the food industry or in drinking water treatment, for example as ceramic sealing washers for fittings, sinks and others.
  • the port catheter according to the invention is to be explained using an exemplary embodiment.
  • the figure shows a port catheter to be laid subcutaneously in a sectional side view.
  • the port catheter has a port chamber 1 in the form of a flat, disc-shaped bulge, which is formed by a dimensionally stable jacket 2, which advantageously has an essentially flat bottom side facing the body, which is made of hard polyurethane.
  • the casing 2 has a liner 3 made of ceramic on the chamber side, which was applied, for example, by spraying technology.
  • the lining 3 is thus highly puncture-proof when an injection needle is inserted through the port membrane 5 into the port chamber 1 during percutaneous injection of the liquids or therapeutic agents provided in each case.
  • the port membrane 5 consists, as is common practice, of silicone as the base material.
  • the port chamber 1 opens into a connecting piece 4, to which the draining hose system (not shown) is attached when the port catheter is laid subcutaneously.
  • all components of the port catheter - sheathing 2, lining 3, connecting piece 4 and port membrane 5 - are superficially and internally loaded with nanoscale elemental silver, which was already applied and introduced in the process of manufacturing the components.
  • the silver content in the components is 0.1 to 5 mass%.
  • the mechanical strength of the components of the port catheter is in no way impaired by the proportion of nanosilver.
  • the port catheter according to the invention demonstrated its excellent usage properties in long-term use over several months. There were none infections and septic complications.
  • the catheter has a high level of shape stability and can be safely placed. The danger of its thrombosis can practically be excluded.
  • the tissue load in the port area can be assessed as negligible.

Abstract

Disclosed is a port catheter having improved performance characteristics for providing permanent central venous or intraarterial subcutaneous access to administer therapeutic agents over an extended period of time. Said port catheter comprises a port chamber (1), a port membrane (5), a hard bottom, and a connecting nozzle that is to be coupled to a tube system. The invention is characterized in that the surface and interior of all parts of the port catheter and tube system are loaded with nanoscale elementary silver while the port chamber has a smooth and rounded shape on all sides such that recesses that stop or obstruct the flow are eliminated. The inventive port catheter has thin walls, is dimensionally stable, flat and discus-shaped and is preferably provided with a perforation-proof ceramic, hard polyurethane, or metal lining.

Description

"Portkatheter mit verbesserten Gebrauchseigenschaften und antimikrobieller Werkstoff''Port catheter with improved usage properties and antimicrobial material'
Die Erfindung betrifft einen Portkatheter mit verbesserten Gebrauchseigenschaften für einen dauerhaften zentralvenösen oder intraarteriellen subkutanen Zugang zur längerfristigen Verabreichung von Therapeutika.The invention relates to a port catheter with improved performance properties for a permanent central venous or intra-arterial subcutaneous access for the long-term administration of therapeutic agents.
Die Applikation von Therapeutika in Verbindung mit dauerhaft gelegten zentralvenösen oder intraarteriellen Zugängen stützt sich auf vielfältige Indikationen, hat aber auch umfangreiche Komplikationen zur Folge.The application of therapeutic agents in connection with permanently placed central venous or intra-arterial approaches is based on a variety of indications, but also results in extensive complications.
Die Verabreichung von Cytostatika mit nachfolgenden großen Mengen an Spülflüssigkeit bei Patienten mit Malignomen, die Gabe von Antibiotika bei chronisch kranken Patienten (Mucoviscidose, chron. Osteomelitis), die notfallmäßige Versorgung mit Medikamenten und Blutprodukten bei chronisch Erkrankten (Hämophile, Sichelzell-Anämie, unbeherrschbare epileptische Anfälle, AIDS) sowie die Verabreichung von Schmerzmedikamenten bei Krebspatienten erfordern einen sicheren, jederzeit verfügbaren und dauerhaften zentralvenösen Zugang. Auch subkutan implantierte intraarterielle Schlauchleitungen, die entweder direkt über eine Motorspritze oder über eine Injektionskammer gespeist werden, finden zunehmend Anwendung. Sie dienen zur lokalen Applikation von Cytostatika, zum Beispiel bei Brustkrebs, und als intraarterieller Zugang für Infusionen in die Leberarterie bei Lebermetastasen sowie zur lokalen Verabreichung vasoaktiver Substanzen und Antibiotika bei Minderdurchblutung von Extremitäten mit trophischen Ulzera. Auch weitere Anwendungsfälle gewinnen zunehmend an Aktualität.The administration of cytostatics with subsequent large amounts of irrigation fluid in patients with malignancies, the administration of antibiotics in chronically ill patients (cystic fibrosis, chronic osteomelitis), the emergency supply of medication and blood products in chronically ill patients (hemophilia, sickle cell anemia, uncontrollable epileptic Seizures, AIDS) and the administration of pain medication Cancer patients require safe, permanent and permanent central venous access. Subcutaneously implanted intra-arterial tubing, which is fed either directly via a motor syringe or via an injection chamber, is increasingly used. They are used for the local application of cytostatics, for example in breast cancer, and as an intra-arterial access for infusions into the hepatic artery in liver metastases, as well as for the local administration of vasoactive substances and antibiotics for poor blood flow to extremities with trophic ulcers. Other use cases are also becoming increasingly topical.
Für Erwachsene, insbesondere aber für Kinder, bedeutet die Implantation eines dauerhaften und jederzeit zugänglichen zentralvenösen oder intraarteriellen Zugangs eine wesentliche Erleichterung der Behandlung und eine Verbesserung der Lebensqualität. Allein in Deutschland werden bei diesen Patientengruppen jährlich ca. 80.000 derartige zentrale Zugänge gelegt.For adults, but especially for children, the implantation of a permanent central venous or intra-arterial access that is accessible at all times significantly facilitates treatment and improves the quality of life. In Germany alone, approximately 80,000 such central accesses are made to these patient groups every year.
Für diese zentralvenösen oder intraarteriellen Zuleitungen kommen zwei Systeme in Frage.Two systems can be used for these central venous or intra-arterial leads.
Es sind einerseits subkutan gelegte, mit einem Cuff versehene Langzeitkatheter vom Typ Hickman/Broviac/Groshong (ca. 25 %) und andererseits subkutan implantierte Portkatheter (ca. 75 %). Der Portkatheter wird im allgemeinen vollständig subkutan implantiert und erlaubt durch die perkutane Punktion der Portmembran, einer in die Portkammer integrierten punktions- fähigen, vorzugsweise aus Silikon bestehenden Membran, die mit einem Durchmesser von 12 bis 15mm unter der Haut gut tastbar ist, den wiederholten, direkten Zugang zum zentralvenösen System. Die Portkammer besteht aus einem Gehäuse aus einem festen Material (überwiegend aus Metall) und aus einem Deckel. Bei den bisher in Verwendung befindlichen Portsystemen besteht die Portkammer aus Titan. Titan selbst besitzt zwar eine vernachlässigbar geringe Toxizität, was auf einer sich bildenden dünnen Oxidschicht beruht, mit der sich das Metall spontan überzieht und damit gegen chemische Einflüsse passiviert. Untersuchungen haben jedoch ergeben, dass diese Oxidschicht relativ leicht durch bakterielle Keime besiedel- bar ist, wodurch sich in kurzer Zeit ein Biofilm auf der Oberfläche derartiger Port-Implantate bilden kann.On the one hand, there are subcutaneously inserted, cuffed long-term catheters of the type Hickman / Broviac / Groshong (approx. 25%) and on the other hand subcutaneously implanted port catheters (approx. 75%). The port catheter is generally implanted completely subcutaneously and, thanks to the percutaneous puncture of the port membrane, a puncture-capable membrane, preferably made of silicone, integrated into the port chamber and easily palpable with a diameter of 12 to 15 mm under the skin, allows repeated, direct access to the central venous system. The port chamber consists of a housing made of a solid material (mainly metal) and a cover. In the port systems used up to now, the port chamber is made of titanium. Titan itself owns negligible toxicity, which is due to a thin oxide layer that forms, with which the metal spontaneously coats and thus passivates against chemical influences. However, studies have shown that this oxide layer is relatively easily colonized by bacterial germs, which means that a biofilm can form on the surface of such port implants in a short time.
Die hohle Portkammer ist mit einem Katheterschlauch konnektiert. Der Katheterschlauch besteht aus Silikon oder Weich-Polyurethan und wird nach entsprechender Längenanpassung durch operative Sectio venae oder nach Methode Seidinger in den zentralen Blutkreislauf eingeführt. Die Portmembran besteht aus einem für medizinische Zwecke geeigneten hochreinen Silikon, das auch nach häufigen Punktionen mit speziell geschliffenen Injektionsnadeln wieder vollkommen abdichtet. Beim gesamten Port-Bauteil han- delt es sich um ein Medizinprodukt der Klasse III, entsprechend hoch sind seine Kosten und die Erwartungen an seine tadellose Funktionalität.The hollow port chamber is connected to a catheter tube. The catheter tube is made of silicone or soft polyurethane and is inserted into the central bloodstream after appropriate length adjustment by surgical section venae or by the Seidinger method. The port membrane consists of a high-purity silicone that is suitable for medical purposes and that seals completely again after frequent punctures with specially ground injection needles. The entire port component is a class III medical device, and its costs and expectations of its impeccable functionality are correspondingly high.
Die bekannten Portkatheter weisen nicht unerhebliche Mängel und Nachteile auf. Auch mit der Implantation dieser langzeitorientierten Katheter- Systeme treten Probleme auf. Bei den gecufften, tunnelierten Kathetern vom Hickman-Typ sind die Probleme in erster Linie infektiöser Art. Obwohl diese Katheter eine geschützte Verbindung nach außen besitzen, besteht eine nicht auszuschließende Gefahr der Kontamination von Eintrittsstelle, Luerlocks sowie des subkutanen Tunnels, wodurch eine Infektionsgefahr insbesondere für das zentrale Gefäßsystem gegeben ist.The known port catheters have significant shortcomings and disadvantages. Problems also arise with the implantation of these long-term-oriented catheter systems. The problems with cuffed, tunneled Hickman-type catheters are primarily of an infectious nature. Although these catheters have a protected connection to the outside, there is an inevitable risk of contamination of the entry point, Luer locks and the subcutaneous tunnel, which creates a risk of infection, particularly for the central vascular system is given.
Bei der Versorgung mit subkutan langzeitimplantierten Kathetersystemen, wie dem Portkatheter, können aktuell bei schwerkranken Patienten, die ohnehin einen abwehrgeschwächten Gesamtzustand besitzen, schwerwiegen- de Komplikationen auftreten, wie bakterielle Infektionen, Narbenschämien u.a.. Die Rate der Infektionen bei derartigen langzeitimplantierten Kathetern liegt trotz aller medizinischen Sorgfalt leider noch bei 0,2 bis 7,1 pro 1000 Kathetertage. Da Portkatheter aber im Durchschnitt für mehr als 250 Tage gelegt sind, ist jeder zehnte bis jeder zweite Patient von einer mehr oder weniger schweren septischen Komplikation betroffen. Implantierte Portsysteme bringen zwar erhebliche Vorteile bei der Pflege der Patienten, aber Patientenfälle, bei denen auftretende Probleme eine vorzeitige Explantation des Portsystems erforderlich machen, betragen immerhin 10 bis 27 % und liegen im Mittel bei 12 %. Dabei ist die Komplikationsrate bei zentralvenösen Ports im allgemeinen niedriger als bei arteriellen Portsystemen.Serious complications such as bacterial infections and scarring can currently occur in critically ill patients who already have an overall weakened immune system when using subcutaneously long-term implanted catheter systems, such as the port catheter among others. Despite all medical care, the rate of infections with such long-term implanted catheters is unfortunately still 0.2 to 7.1 per 1000 catheter days. However, since port catheters are placed on average for more than 250 days, every tenth to every second patient is affected by a more or less severe septic complication. Implanted port systems offer considerable advantages in patient care, but patient cases in which problems arise that require early explantation of the port system amount to 10 to 27% and are on average 12%. The complication rate for central venous ports is generally lower than for arterial port systems.
Außerdem ist besonders für junge Patienten die Bauteilgröße üblicher Portkatheter ein Negativfaktor im Hinblick auf die mit dem Setzen des Port- Implantates erwartete Verbesserung der Lebensqualität. Da in zunehmen- dem Maße Portkatheter auch bei Früh- und Neugeborenen sowie bei jungen Säuglingen implantiert werden, können Bauhöhe und Formgebung der gegenwärtig zur Verfügung stehenden Port-Systeme insbesondere bei dieser Patientengruppe zur Ischämie und Nektrose der über dem Portsystem liegenden Haut und des subkutanen Fettgewebes führen.In addition, especially for young patients, the component size of conventional port catheters is a negative factor with regard to the improvement in quality of life expected with the placement of the port implant. As port catheters are increasingly being implanted in premature and newborn babies as well as in young infants, the height and shape of the currently available port systems can be used, particularly in this patient group, for ischemia and nectrosis of the skin and subcutaneous adipose tissue located above the port system to lead.
Ein nicht unerhebliches Risiko besteht auch in einer Thrombosierung des Portkatheters, die sowohl als Früh- als auch als Spätkomplikation auftreten kann. Eine Verschleppung von Thromben bzw. Koageln, deren Entstehung in einer derzeit üblichen Portkammer aufgrund der ungünstigen Strömungs- Verhältnisse aber nicht auszuschließen ist, kann dabei bis zur Obstruktion des Auslasses und damit zum Versagen des Portsystems führen.A not inconsiderable risk is thrombosis of the port catheter, which can occur both as an early and as a late complication. A procrastination of thrombi or coagulum, the formation of which in a currently common port chamber cannot be ruled out due to the unfavorable flow conditions, can lead to obstruction of the outlet and thus to failure of the port system.
Die Aufgabe der Erfindung besteht in der Bereitstellung eines Portkatheters mit verbesserten Gebrauchseigenschaften dahingehend, dass ein Werkstoff entwickelt wird, der eine Infektionsgefahr und damit verbundene septische Komplikationen in einer langzeitorientierten Versorgung praktisch ausschließt, und dass eine Bauteilform entwickelt wird, die sowohl eine Throm- bosierung des Portkatheters als auch unnötige Belastungen der Gewebebereiche im unmittelbaren Bereich des Implantates vermeidet.The object of the invention is to provide a port catheter with improved usage properties to the effect that a material is developed which presents a risk of infection and the septic associated therewith Complications in long-term care practically preclude and that a component shape is developed that avoids both thrombosis of the port catheter and unnecessary stress on the tissue areas in the immediate area of the implant.
Diese Aufgabe wird durch den Gegenstand der Hauptansprüche gelöst. Vorteilhafte Ausgestaltungen sind in den Unteransprüchen angegeben.This object is achieved by the subject matter of the main claims. Advantageous refinements are specified in the subclaims.
Der Erfindung liegt der Gedanke zugrunde, einen Portkatheter zu verwen- den, der aus einem vollständig oder teilweise subkutan verlegbaren Katheter mit einer zur Aufnahme einer Injektionsflüssigkeit dienenden Portkammer, mit einer Portmembran, einem durchstichfesten Hartboden sowie einem Anschlussstutzen zur Koppelung mit einem Schlauchsystem besteht, erfindungsgemäß seine Teile und/oder Teile des zugehörigen Schlauchsystems oberflächlich und/oder innerstofflich mit nanoskaligen elementaren Silberpartikeln zu beladen, und der Portkammer eine antithrombische Gestaltung zu geben, indem sie eine innere Ausbauchung aufweist, die eine flache und glatte und allseitig gerundete Form aufweist, so dass strömungstote und/oder die Strömung der Injektionsflüssigkeit behindernde Nischen aus- geschlossen sind.The invention is based on the idea of using a port catheter which, according to the invention, consists of a catheter which can be completely or partially subcutaneously laid, with a port chamber serving to hold an injection liquid, with a port membrane, a puncture-resistant hard floor and a connecting piece for coupling to a hose system to load its parts and / or parts of the associated hose system superficially and / or internally with nanoscale elemental silver particles, and to give the port chamber an antithrombic design by having an internal bulge that has a flat and smooth shape that is rounded on all sides, so that Dead niches and / or niches obstructing the flow of the injection liquid are excluded.
Unter nanoskaligen elementaren Silberpartikeln werden dabei insbesondere solche verstanden, wie sie für die Herstellung des antimikrobiellen Kunststoffkörpers in WO 01/09229 A1 beschrieben werden. Für die Herstellung und die Zusammensetzung nanoskaliger elementarer Silberpartikel wird deshalb ausdrücklich die diesbezüglichen Offenbarungsstellen der WO 01/09229 A1 als Teil der vorliegenden Erfindungsbeschreibung angesehen und darauf verwiesen. Der Portkatheter kann eine dünnwandige, formstabile Ummantelung besitzen, die vorzugsweise aus einem Hartpolyurethan oder auch einer Keramik besteht und die oberflächlich und/oder innerstofflich mit nanoskaligem elementarem Silber beladen ist. Die Ausbauchung des Portkatheters besitzt eine Auskleidung, die aus einem durchstichsicheren Material besteht, insbesondere bevorzugt aus einer Keramik oder aus einem Hartpolyurethan oder aus einem physiologisch unbedenklichen Metall, welche oberflächlich und/oder innerstofflich ebenfalls mit nanoskaligem elementarem Silber beladen sind. Der Anschlussstutzen des Portkatheters ist vorzugsweise durch einfach lösbare, aber feste Koppelelemente mit dem zugehörigen Schlauchsystem verbunden. Der erfindungsgemäße Portkatheter kann eine extrem flache Bauweise aufweisen und zwar insbesondere derart, dass die Portkammer hinsichtlich Form und/oder Ausbauchung diskusförmig flach und/oder elliptisch oder rotationssymmetrisch eiförmig gestaltet ist. Die Portmembran besteht vorzugsweise aus einem Silikon, das mit nanoskaligem elementarem Silber beladen ist.Nanoscale elemental silver particles are understood to mean, in particular, those described for the production of the antimicrobial plastic body in WO 01/09229 A1. For the production and the composition of nanoscale elemental silver particles, the relevant disclosure points of WO 01/09229 A1 are therefore expressly considered and referred to as part of the present description of the invention. The port catheter can have a thin-walled, dimensionally stable sheathing which preferably consists of a hard polyurethane or also a ceramic and which is loaded on the surface and / or internally with nanoscale elemental silver. The bulge of the port catheter has a lining which consists of a puncture-proof material, particularly preferably of a ceramic or a hard polyurethane or of a physiologically harmless metal, which is also superficially and / or internally loaded with nanoscale elemental silver. The connecting piece of the port catheter is preferably connected to the associated hose system by easily detachable but fixed coupling elements. The port catheter according to the invention can have an extremely flat construction, in particular in such a way that the port chamber is designed to be discus-shaped flat and / or elliptical or rotationally symmetrical egg-shaped with regard to shape and / or bulge. The port membrane preferably consists of a silicone that is loaded with nanoscale elemental silver.
Die antimikrobielle Wirkung der oberflächlich und/oder innerstofflich belade- nen Teile des Portkatheters kann durch Aktivierung des nanoskaligen Sil- bers verstärkt werden, insbesondere durch einen Zusatz von vorzugsweise Silberphosphat (Ag PO). Für die Möglichkeit zur Aktivierung von nanoskaligem, elementaren Silber wird auf die in WO 2004/024205 A1 beschriebenen Zusammensetzungen nanoskaligen, elementaren Silbers und deren Herstellungsverfahren verwiesen. Die diesbezüglichen Offenbarungsstellen der WO 2004/024205 A1 werden ausdrücklich als Teil der vorliegenden Erfindungsbeschreibung angesehen und darauf verwiesen.The antimicrobial effect of the surface and / or internally loaded parts of the port catheter can be enhanced by activating the nanoscale silver, in particular by adding preferably silver phosphate (Ag PO). For the possibility of activating nanoscale, elemental silver, reference is made to the compositions of nanoscale, elemental silver described in WO 2004/024205 A1 and their production processes. The relevant disclosure points of WO 2004/024205 A1 are expressly regarded as part of the present description of the invention and are referred to.
Das der Erfindung zugrundeliegende Problem wird ferner durch einen anti- mikrobiellen Werkstoff gelöst, der aus einem oxidischen und/oder carbidi- sehen und/oder nitridischen keramischen Grundmaterial besteht, in wel- chem feinstdispers antimikrobiell wirksame Metallpartikel, die eine große effektive Oberfläche aufweisen, eingebracht sind. Die antimikrobiell wirksamen Metallpartikel sind vorzugsweise solche, wie sie für die Herstellung des antimikrobiellen Kunststoffkörpers in WO 01/09229 A1 beschrieben werden. Für die Herstellung und Zusammensetzung dieser Metallpartikel wird deshalb ausdrücklich auf die diesbezüglichen Offenbarungsstellen der WO 01/09229 A1 als Teil der vorliegenden Beschreibung angesehen und darauf verwiesen.The problem on which the invention is based is also solved by an antimicrobial material which consists of an oxidic and / or carbide-seeing and / or nitridic ceramic base material, in which chem finely dispersed antimicrobial metal particles that have a large effective surface are introduced. The antimicrobial metal particles are preferably those as described for the production of the antimicrobial plastic body in WO 01/09229 A1. For the production and composition of these metal particles, express reference is therefore made to the relevant disclosure points of WO 01/09229 A1 as part of the present description and reference is made to this.
Insbesondere bevorzugt ist das Grundmaterial Aluminiumoxid und/oder Titanoxid, Siliciumoxid, Cirkoniumoxid, Magnesiumoxid, Aluminiumtitanat, Ba- riumtitanat, Siliciumcarbid, Borcarbid, Siliciumnitrit, Aluminiumnitrit. In einer bevorzugten Ausführungsform bestehen die Metallpartikel aus nanoskaligem Silber und/oder Kupfer. In einer weiter bevorzugten Ausführungsform beträgt der Gehalt an Metallpartikeln 0,2 bis 5,0 Masse-%.The base material is particularly preferably aluminum oxide and / or titanium oxide, silicon oxide, zirconium oxide, magnesium oxide, aluminum titanate, barium titanate, silicon carbide, boron carbide, silicon nitrite, aluminum nitrite. In a preferred embodiment, the metal particles consist of nanoscale silver and / or copper. In a further preferred embodiment, the content of metal particles is 0.2 to 5.0% by mass.
Insbesondere bevorzugt ist der Gehalt an Metallpartikeln nach der Verarbeitung des Werkstoffs durch ein Konzentrationsgefälle von außen nach innen bestimmt. Ein aus dem antimikrobiellen Werkstoff hergestelltes Pro- dukt wird vorzugsweise durch die bekannten Arbeitsschritte, wie Formen, Gießen, Pressen oder Sintern in einen vorgegebenen gegenstandlichen Habitus gebracht.The content of metal particles is particularly preferably determined after the processing of the material by a concentration gradient from outside to inside. A product made from the antimicrobial material is preferably brought into a predetermined physical habit by the known working steps, such as molding, casting, pressing or sintering.
Insbesondere bevorzugt wird der antimikrobielle Werkstoff in seinem gegen- ständlichen Habitus in der Humanmedizin und vergleichsweise in der Veterinärmedizin angewendet, insbesondere für Langzeitimplantate, wie beispielsweise für Portkatheter, künstliche Hüftköpfe und -pfannen, künstliche Kniegelenke, als Implantate bei Knochendefekten, wie Schädelkalottendefekten, Wirbeldefekten, in der Zahnmedizin als Zahnersatz, Zahnersatzim- plantat, oder auch außerhalb der Medizin für klinische Bauteile mit oligody- namischer Wirkung, insbesondere in der Lebensmittelindustrie oder in der Trinkwasseraufbereitung, beispielsweise als keramische Dichtscheiben für Armaturen, Waschbecken und anderem.The antimicrobial material in its physical form is particularly preferably used in human medicine and comparatively in veterinary medicine, in particular for long-term implants, such as, for example, for port catheters, artificial femoral heads and acetabular cups, artificial knee joints, as implants for bone defects, such as skull cap defects, vertebral defects, in dentistry as dentures, denture implants, or outside of medicine for clinical components with oligody- Namely effect, especially in the food industry or in drinking water treatment, for example as ceramic sealing washers for fittings, sinks and others.
Der erfindungsgemäße Portkatheter soll an einem Ausführungsbeispiel erläutert werden. Die Figur zeigt einen subkutan zu verlegenden Portkatheter im Schnitt einer Seitenansicht.The port catheter according to the invention is to be explained using an exemplary embodiment. The figure shows a port catheter to be laid subcutaneously in a sectional side view.
Der Portkatheter besitzt eine Portkammer 1 in Form einer flachen, diskus- förmigen Ausbauchung, die durch eine formstabile Ummantelung 2 gebildet ist, die vorteilhafterweise eine dem Körper zugewandte im wesentlichen ebene Bodenseite aufweist, welche aus Hartpolyurethan besteht. Die Ummantelung 2 besitzt kammerseitig eine Auskleidung 3 aus einer Keramik, die beispielsweise durch Spritztechnik aufgetragen wurde. Die Auskleidung 3 ist damit in hohem Grade durchstichsicher beim Einstich einer Injektionsnadel durch die Portmembran 5 in die Portkammer 1 bei der perkutanen Injektion der jeweils vorgesehenen Flüssigkeiten bzw. Therapeutika. Die Portmembran 5 besteht, wie allgemein üblich, aus Silikon als Grundmaterial. Die Portkammer 1 mündet in einen Anschlussstutzen 4, dem bei der subkutanen Verlegung des Portkatheters das ableitende Schlauchsystem (nicht gezeigt) aufgesteckt ist. Alle Bauteile des Portkatheters - Ummantelung 2, Auskleidung 3, Anschlussstutzen 4 und Portmembran 5 - sind erfindungsgemäß oberflächlich und innerstofflich mit nanoskaligem elementarem Silber beladen, das bereits im Prozess der Fertigung der Bauteile auf- und eingebracht wurde. Der Silbergehalt in den Bauteilen liegt bei 0,1 bis 5 Masse-%. Die mechanische Festigkeit der Bauteile des Portkatheters wird durch den Anteil an Nanosilber in keiner Weise beeinträchtigt.The port catheter has a port chamber 1 in the form of a flat, disc-shaped bulge, which is formed by a dimensionally stable jacket 2, which advantageously has an essentially flat bottom side facing the body, which is made of hard polyurethane. The casing 2 has a liner 3 made of ceramic on the chamber side, which was applied, for example, by spraying technology. The lining 3 is thus highly puncture-proof when an injection needle is inserted through the port membrane 5 into the port chamber 1 during percutaneous injection of the liquids or therapeutic agents provided in each case. The port membrane 5 consists, as is common practice, of silicone as the base material. The port chamber 1 opens into a connecting piece 4, to which the draining hose system (not shown) is attached when the port catheter is laid subcutaneously. According to the invention, all components of the port catheter - sheathing 2, lining 3, connecting piece 4 and port membrane 5 - are superficially and internally loaded with nanoscale elemental silver, which was already applied and introduced in the process of manufacturing the components. The silver content in the components is 0.1 to 5 mass%. The mechanical strength of the components of the port catheter is in no way impaired by the proportion of nanosilver.
Der erfindungsgemäße Portkatheter bewies im Langzeiteinsatz über mehre- re Monate seine hervorragenden Gebrauchseigenschaften. Es traten keine katheterbedingten Infektionen und septischen Komplikationen auf. Der Katheter besitzt eine hohe Formstabilität und lässt sich sicher plaziert implantieren. Die Gefahr seiner Thrombosierung kann praktisch ausgeschlossen werden. Die Gewebebelastung im Portbereich ist als unerheblich zu bewer- ten. The port catheter according to the invention demonstrated its excellent usage properties in long-term use over several months. There were none infections and septic complications. The catheter has a high level of shape stability and can be safely placed. The danger of its thrombosis can practically be excluded. The tissue load in the port area can be assessed as negligible.

Claims

Patentansprüche: claims:
1. Portkatheter mit verbesserten Gebrauchseigenschaften, bestehend aus einem vollständig oder teilweise subkutan verlegbaren Katheter, der eine die Injektionsflüssigkeit aufnehmende Portkammer, eine zur Injektion dienende Portmembran, einen Hartboden sowie einen Anschlussstutzen zur Koppelung mit einem Schlauchsystem aufweist, dadurch gekennzeichnet, dass Teile des Portkatheters und/oder des Schlauchsystems oberflächlich und/oder innerstofflich mit nanoskaligen Silberpartikeln beladen sind und dass die Portkammer (1 ) eine an- tithrombische Gestaltung besitzt, indem sie eine innere Ausbauchung aufweist, die eine glatte und allseitig gerundete Form aufweist, so dass strömungstote und/oder die Strömung behindernde Nischen ausge- schlössen sind.1. Port catheter with improved performance properties, consisting of a completely or partially subcutaneously routable catheter, which has a port chamber that receives the injection liquid, a port membrane for injection, a hard floor and a connecting piece for coupling to a hose system, characterized in that parts of the port catheter and / or the hose system is superficially and / or internally loaded with nanoscale silver particles and that the port chamber (1) has an anti-thrombic design in that it has an internal bulge which has a smooth and rounded shape on all sides, so that flow-dead and / or niches that obstruct the flow are excluded.
2. Portkatheter nach Anspruch 1 , dadurch gekennzeichnet, dass sämtliche Teile des Portkatheters und/oder des Schlauchsystems oberflächlich und/oder innerstofflich mit nanoskaligen Silberpartikeln bela- den sind.2. Port catheter according to claim 1, characterized in that all parts of the port catheter and / or the tube system are superficially and / or internally loaded with nanoscale silver particles.
3. Portkatheter nach Anspruch 1 oder 2, gekennzeichnet durch eine dünnwandige, formstabile Ummantelung (2) und eine die Ausbauchung durchstichsicher auskleidende Auskleidung (3).3. Port catheter according to claim 1 or 2, characterized by a thin-walled, dimensionally stable sheathing (2) and a bulge-resistant lining lining (3).
Portkatheter nach Anspruch 3, dadurch gekennzeichnet, dass die Ummantelung (2) aus einem Hartpolyurethan oder aus einer Keramik besteht, die oberflächlich und/oder innerstofflich mit nanoskaligem Silber beladen sind. Port catheter according to claim 3, characterized in that the sheathing (2) consists of a hard polyurethane or a ceramic which is loaded on the surface and / or internally with nanoscale silver.
5. Portkatheter nach Anspruch 3 oder 4, dadurch gekennzeichnet, dass die Auskleidung (3) aus einer Keramik oder aus einem Hartpolyurethan oder aus einem physiologisch unbedenklichen Metall besteht, die oberflächlich und/oder innerstofflich mit nanoskaligem Silber beladen sind.5. Port catheter according to claim 3 or 4, characterized in that the lining (3) consists of a ceramic or a hard polyurethane or of a physiologically harmless metal, which are superficially and / or internally loaded with nanoscale silver.
6. Portkatheter nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass der Anschlussstutzen (4) durch eine feste, aber lösbare Koppelung mit dem Schlauchsystem verbunden ist.6. Port catheter according to one of claims 1 to 5, characterized in that the connecting piece (4) is connected to the hose system by a fixed but detachable coupling.
7. Portkatheter nach einem der Ansprüche 1 bis 6, gekennzeichnet durch eine flache Gestaltung.7. Port catheter according to one of claims 1 to 6, characterized by a flat design.
8. Portkatheter nach Anspruch 1 , dadurch gekennzeichnet, dass die Portkammer (1 ) in ihrer Form und/oder hinsichtlich der inneren Ausbauchung flach und diskusförmig und/oder elliptisch oder rotationssymmetrisch eiförmig gestaltet ist.8. Port catheter according to claim 1, characterized in that the port chamber (1) is designed in its shape and / or with respect to the inner bulge flat and disc-shaped and / or elliptical or rotationally symmetrical egg-shaped.
9. Portkatheter nach einem der Ansprüche 1 bis 8, dadurch gekenn- zeichnet, dass die Portmembran (5) aus einem mit nanoskaligem Silber beladenen Silikon besteht.9. Port catheter according to one of claims 1 to 8, characterized in that the port membrane (5) consists of a silicone loaded with nanoscale silver.
10. Portkatheter nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass die antimikrobiell wirksame Beladung der Teile des Portkatheters aus aktiviertem nanoskaligem Silber besteht.10. Port catheter according to one of claims 1 to 9, characterized in that the antimicrobial loading of the parts of the port catheter consists of activated nanoscale silver.
11. Portkatheter nach Anspruch 9, dadurch gekennzeichnet, dass die Aktivierung des nanoskaligen Silbers durch Silberphosphat erfolgt ist. 11. Port catheter according to claim 9, characterized in that the activation of the nanoscale silver has been effected by silver phosphate.
12. Antimikrobieller Werkstoff aus einem oxidischen und/oder carbidischen und/oder nitridischen keramischen Grundmaterial, in welchem feinstdispers antimikrobiell wirksame Metallpartikel, die eine große effektive Oberfläche aufweisen, eingebracht sind.12. Antimicrobial material made of an oxidic and / or carbidic and / or nitridic ceramic base material, in which finely dispersed antimicrobial metal particles with a large effective surface are introduced.
13. Antimikrobieller Werkstoff nach Anspruch 12, dadurch gekennzeichnet, dass das Grundmaterial aus Aluminiumoxid und/oder Titanoxid, Siliciumoxid, Zirkoniumoxid, Magnesiumoxid, Aluminiumtitanat, Bari- umtitanat, Siliciumcarbid, Borcarbid, Siliciumnitrid, Aluminiumnitrit be- steht.13. Antimicrobial material according to claim 12, characterized in that the base material consists of aluminum oxide and / or titanium oxide, silicon oxide, zirconium oxide, magnesium oxide, aluminum titanate, barium titanate, silicon carbide, boron carbide, silicon nitride, aluminum nitrite.
14. Antimikrobieller Werkstoff nach einem der Ansprüche 12 oder 13, dadurch gekennzeichnet, dass die Metallpartikel aus nanoskaligem Silber und/oder Kupfer bestehen.14. Antimicrobial material according to one of claims 12 or 13, characterized in that the metal particles consist of nanoscale silver and / or copper.
15. Antimikrobieller Werkstoff nach einem der Ansprüche 12 bis 14, dadurch gekennzeichnet, dass der Gehalt an Metallpartikeln 0,2 bis 5,0 Masse-% beträgt.15. Antimicrobial material according to one of claims 12 to 14, characterized in that the content of metal particles is 0.2 to 5.0% by mass.
16. Antimikrobieller Werkstoff nach einem der Ansprüche 12 bis 15, dadurch gekennzeichnet, dass der Gehalt an Metallpartikeln nach der gegenständlichen Verarbeitung des Werkstoffes durch ein Konzentrationsgefälle von außen nach innen bestimmt ist.16. Antimicrobial material according to one of claims 12 to 15, characterized in that the content of metal particles is determined after the objective processing of the material by a concentration gradient from outside to inside.
17. Antimikrobieller Werkstoff nach einem der Ansprüche 12 bis 16, dadurch gekennzeichnet, dass er durch im wesentlichen bekannte Arbeitsschritte, wie Formen, Gießen, Pressen, Sintern, in einen vorgegebenen gegenständlichen Habitus gebracht ist. 17. Antimicrobial material according to one of claims 12 to 16, characterized in that it is brought into a predetermined objective habit by essentially known working steps, such as molding, casting, pressing, sintering.
8. Antimikrobieller Werkstoff nach einem der Ansprüche 12 bis 17, dadurch gekennzeichnet, dass er im gegenständlichen Habitus in der Humanmedizin und vergleichsweise in der Veterinärmedizin Anwendung findet, insbesondere für Langzeitimplantate, wie beispielsweise für Portkatheter, künstliche Hüftköpfe und -pfannen, künstliche Kniegelenke, als Implantate bei Knochendefekten, wie Schädelkalottendefekten, Wirbeldefekten, in der Zahnmedizin als Zahnersatz, Zahnersatzimplantat, oder auch außerhalb der Medizin nfür technische Bauteile mit oligodynamischer Wirkung, insbesondere in der Lebensmitte- lindustrie oder in der Trinkwasseraufbereitung, beispielsweise als keramische Dichtscheiben in Armaturen, Waschbecken und anderem. 8. Antimicrobial material according to one of claims 12 to 17, characterized in that it is used in the present habit in human medicine and comparatively in veterinary medicine, in particular for long-term implants, such as for port catheters, artificial femoral heads and acetabular cups, artificial knee joints, as Implants for bone defects, such as cranial defects, vertebral defects, in dentistry as dentures, denture implants, or also outside of medicine for technical components with an oligodynamic effect, especially in the food industry or in drinking water treatment, for example as ceramic sealing washers in fittings, sinks and others ,
PCT/EP2004/012229 2003-10-28 2004-10-28 Port catheter having improved performance characteristics, and antimicrobial material WO2005042058A2 (en)

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DE102007035063A1 (en) * 2007-07-26 2009-01-29 Spiegelberg (Gmbh & Co.) Kg Process for the preparation of an antimicrobial plastic product

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