WO2005042058A2 - Catheter a port presentant des caracteristiques d'utilisation ameliorees et une matiere antimicrobienne - Google Patents

Catheter a port presentant des caracteristiques d'utilisation ameliorees et une matiere antimicrobienne 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
Authority
WO
WIPO (PCT)
Prior art keywords
port
port catheter
catheter
catheter according
antimicrobial material
Prior art date
Application number
PCT/EP2004/012229
Other languages
German (de)
English (en)
Other versions
WO2005042058A3 (fr
Original Assignee
Guggenbichler, Meinrad
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 Guggenbichler, Meinrad filed Critical Guggenbichler, Meinrad
Publication of WO2005042058A2 publication Critical patent/WO2005042058A2/fr
Publication of WO2005042058A3 publication Critical patent/WO2005042058A3/fr

Links

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

La présente invention concerne un cathéter à port présentant des caractéristiques d'utilisation améliorées et permettant un accès sous-cutané permanent par voie veineuse centrale ou par voie intra-artérielle, afin d'administrer sur un long terme des substances thérapeutiques. Ce cathéter à port présente une chambre à port, une membrane à port, un fond dur et un raccord permettant la connexion à un système de tuyau. Cette invention est caractérisée en ce que toutes les parties du cathéter à port et du système de tuyau sont chargées de manière superficielle et intérieure avec de l'argent élémentaire nanométrique et en ce que la chambre à port présente une forme lisse et arrondie de tous les côtés permettant d'exclure des niches d'écoulement mort et/ou qui entravent l'écoulement. Le cathéter à port selon cette invention est à paroi mince, indéformable, plat et discoïde et présente de préférence un revêtement anti-percement en céramique, polyuréthanne dur ou métal.
PCT/EP2004/012229 2003-10-28 2004-10-28 Catheter a port presentant des caracteristiques d'utilisation ameliorees et une matiere antimicrobienne WO2005042058A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE10350130.4 2003-10-28
DE10350130 2003-10-28
DE102004026661 2004-01-21
DE102004026661.1 2004-01-21
DE102004048732.4 2004-10-05
DE102004048732 2004-10-05

Publications (2)

Publication Number Publication Date
WO2005042058A2 true WO2005042058A2 (fr) 2005-05-12
WO2005042058A3 WO2005042058A3 (fr) 2005-09-22

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PCT/EP2004/012229 WO2005042058A2 (fr) 2003-10-28 2004-10-28 Catheter a port presentant des caracteristiques d'utilisation ameliorees et une matiere antimicrobienne

Country Status (1)

Country Link
WO (1) WO2005042058A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007035063A1 (de) * 2007-07-26 2009-01-29 Spiegelberg (Gmbh & Co.) Kg Verfahren zur Herstellung eines antimikrobiellen Kunststoffproduktes

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4054139A (en) * 1975-11-20 1977-10-18 Crossley Kent B Oligodynamic catheter
US5041098A (en) * 1989-05-19 1991-08-20 Strato Medical Corporation Vascular access system for extracorporeal treatment of blood
US6451003B1 (en) * 2000-08-16 2002-09-17 Biolink Corporation Method and apparatus for overcoming infection in a tissue pocket surrounding an implanted device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4054139A (en) * 1975-11-20 1977-10-18 Crossley Kent B Oligodynamic catheter
US5041098A (en) * 1989-05-19 1991-08-20 Strato Medical Corporation Vascular access system for extracorporeal treatment of blood
US6451003B1 (en) * 2000-08-16 2002-09-17 Biolink Corporation Method and apparatus for overcoming infection in a tissue pocket surrounding an implanted device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007035063A1 (de) * 2007-07-26 2009-01-29 Spiegelberg (Gmbh & Co.) Kg Verfahren zur Herstellung eines antimikrobiellen Kunststoffproduktes
US8673441B2 (en) 2007-07-26 2014-03-18 Spiegelberg (Gmbh & Co.) Kg Antimicrobial plastics product and process for production thereof

Also Published As

Publication number Publication date
WO2005042058A3 (fr) 2005-09-22

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