WO2014119987A1 - Cathéter intraveineux en matériau composite polymère avec des nanoparticules orientées, à faible coefficient de frottement et à faible adhérence microbienne - Google Patents

Cathéter intraveineux en matériau composite polymère avec des nanoparticules orientées, à faible coefficient de frottement et à faible adhérence microbienne Download PDF

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Publication number
WO2014119987A1
WO2014119987A1 PCT/MX2014/000032 MX2014000032W WO2014119987A1 WO 2014119987 A1 WO2014119987 A1 WO 2014119987A1 MX 2014000032 W MX2014000032 W MX 2014000032W WO 2014119987 A1 WO2014119987 A1 WO 2014119987A1
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WO
WIPO (PCT)
Prior art keywords
catheter
patient
nanoparticles
oriented
intravenous
Prior art date
Application number
PCT/MX2014/000032
Other languages
English (en)
Spanish (es)
Inventor
José Antonio Arellano Cabrera
José María Rodriguez Lelis
María Teresa Lucas Jimenez
Alfredo Chalita Vizcarra
Original Assignee
Equipos Médicos Vizcarra, S.A.
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 Equipos Médicos Vizcarra, S.A. filed Critical Equipos Médicos Vizcarra, S.A.
Publication of WO2014119987A1 publication Critical patent/WO2014119987A1/fr

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Classifications

    • 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
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • 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
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • 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
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/10—Materials for lubricating medical devices
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • 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
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046—Coatings for improving slidability
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Definitions

  • the present invention is related to the hospital instrument manufacturing industry. More specifically it relates to the instrument manufacturing industry for venous canalization and the administration of medications directly into the vascular system. Even more specifically it relates to the manufacturing industry of peripheral, central and other intravenous catheters, which are made of biocompatible composite materials reinforced with nano particles. BACKGROUND OF THE INVENTION
  • IV intravenous therapy starts from the need to transfer blood from one human being to another, and dates from approximately 1492.
  • the administration of medications to the vascular system of patients by specific treatments and when the medication It will be supplied with long periods of time, it represents a challenge in the design of medication delivery systems.
  • the device most commonly used to achieve this are intravenous catheters, which are formed from a pipe with a diameter smaller than the vein where it will be inserted and are made of soft, flexible, waterproof and non-reactive materials to the medications of the selected therapy , in addition to being made of a biocompatible material with living tissues.
  • intravenous catheters are plastic materials such as silicones, polyurethanes, PVC, polytetrafluoroethylene and others; These materials are injected or extruded through a die so that pipes of different diameters are formed according to the required lumen size.
  • intravenous catheters are typically made with a radiopaque compound used to visualize the catheter during medical procedures such as a PTCA. diagnostic imaging or as security to visualize in specific cases the location of the catheter in the patient's vascular system by means of x-rays and avoid tissue damage.
  • intravenous catheters are used for intravenous administration of a fluid
  • a disposable needle that passes through the catheter is used;
  • the needle makes a cut in the patient's skin and vein and allows the catheter to enter.
  • the needle is removed leaving the intravenous catheter in place for connection to an intravenous bag or a bottle, or a cap for later use .
  • a lubricant coating is applied to the catheters on its external surface with the aim of making the puncture and placement of this device as painless as possible to the patient.
  • This lubricant coating is often a type of silicone or hydrophilic gel which becomes lubricant after absorbing water.
  • a biocompatible material to provide a low coefficient of friction is polytetrafluoroethylene, however it is a material that due to its low adhesion energies is difficult to adhere to another material and the processing and manufacturing of intravenous catheters results in a very complicated process.
  • catheters should cover are phlebitis complications [2] which may occur in percentages above 75% of hospitalized patients [3], which means a problem in clinical treatment, patient dissatisfaction, continuous catheter replacement and prolonged hospitalization stays that increase the costs of hospitalization services. Health.
  • One of the factors that causes phlebitis is related to the type of medication administered that can irritate the tissues in the catheterization zone.
  • the other factors are related to infectious agents due to the growth of microorganisms between the catheter and the puncture site.
  • mechanical factors such as the type of catheter material, site size and duration of catheterization.
  • Oligodynamic metals such as silver in the form of ions and small amounts are very effective as bactericides.
  • a collagen-shaped silver polymeric coating is used which dissolves once the catheter is in the patient's vascular system thus preventing the growth of microorganisms in the puncture site.
  • Other similar solutions can be found in patents US 005759564A, US 006060000A and others.
  • oligodynamic metals in the form of a fluid coating presents the problem that the coating dissolves very quickly and then there is no longer antibacterial protection and in most intravenous catheters their stay in the patient's vascular system is prolonged, In addition to the fact that infections can enter the patient's body through the inside or outside of the catheter and not all catheters are coated in both areas.
  • the main objective of the invention is to achieve an intravenous catheter that has a low coefficient of friction with the patient's skin and vein so as to minimize tissue damage caused by puncture and placement of the catheter.
  • Another objective is to achieve an intravenous catheter made of polymer composite material reinforced with nanoparticles oriented in specific directions, which also prevents the growth of bacterial agents causing infections or phlebitis.
  • Still another objective is an intravenous catheter that presents the mechanical properties necessary to avoid the phenomena of roll up and flourish of the catheter when the puncture is performed and its placement in the vascular system of the patient and has sufficient flexibility to adapt to the shape and movements of the vein during its time of use.
  • This invention relates to an intravenous catheter for the administration of medications or fluids to a patient's vascular system, particularly it relates to peripheral, central intravenous catheters and other types of catheters that are placed in a patient's vascular system for administration or fluid removal
  • the catheter manufacturing material is composed of a material composed of a polymeric matrix which is reinforced with nanoparticles oriented in specific directions and which is produced by means of the injection and / or extrusion of said material for the formation of a pipe that serves as a base component for catheter fabrication.
  • This invention relates to a medical device that meets the characteristics of be a catheter for their mechanical and according c to the type of orientation properties of nanoparticles, avoids phenomena arremangado and flourish of the catheter tip that is inserted into the vein of the patient through the skin by cutting a introducer needle, in addition to being a catheter that due to the composition of the material that forms it has low coefficients of friction between its exterior and the punctured skin when the patient's vascular system is placed.
  • the material from which the catheter is formed has the characteristic of being a material that prevents the growth of infectious agents in the area of catheterization of the patient avoiding the generation of phlebitis and the problems related to this condition.
  • the polymer composite composite catheter with oriented nanoparticles, low coefficient of friction and low microbial adhesion of this invention is composed of a pipe made of biocompatible polymeric material to which a percentage of biocompatible nano particles that range in ranges are added during processing 10 to 50 percent of the total material processed.
  • the nanoparticles are in ranges of sizes greater than 1 nm and oriented in specific directions, within the polymeric material by physical means, so that the resulting pipe is of a polymeric composite material with nano particles oriented in specific directions.
  • the pipe that forms the catheter is cut into sections that range in lengths greater than 1 cm, where the distal part of the catheter pipe is formed by physical means in determined geometries according to the type of medical procedure to which it will be applied; while in the anterior part of the catheter a component is attached that allows the coupling with the serum tubes for the administration of medication, with devices for the extraction of fluids and others related to catheterization procedures.
  • the base pipe for catheter fabrication can be formed in ranges of outside diameter greater than 0.1 mm and can be formed in ranges of internal diameter greater than 0.1 mm.
  • the orientation of the nanoparticles in the polymer composite material meet with two main functions; The first is to provide the catheter with mechanical resistance to flourish and roll up during the puncture and canalization process, in addition to providing the catheter with flexibility to deform depending on the movement of the patient's vein when it has already been placed.
  • the second main function is that according to the type of nanoparticles selected and the type of orientation they provide the catheter with low coefficients of friction with the patient's skin and vein, in addition to being nanoparticles with bactericidal properties, thus preventing the formation of infectious agents. in the catheterization zone. Even more nanoparticles have radiopacity properties.
  • Fig. 1 illustrates an isometric view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.
  • Fig. 2 shows a side sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.
  • Fig. 3 illustrates a cross-sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.
  • Fig. 4 shows a side sectional view of one of the possible configurations of the distal tip of the intravenous catheter made of polymeric composite material reinforced with nanoparticles oriented in specific directions.
  • FIG. 1 An isometric view of the intravenous catheter made of polymeric composite material reinforced with nanoparticles oriented in specific directions is shown in Figure 1.
  • the pipe (1) made of polymeric composite material reinforced with nanoparticles is attached to a hub or canopy (2 ) which serves as a coupling to intravenous infusion systems or other devices depending on the particular application of the catheter, in addition the anterior part of the pipe (1) is formed by physical means in specific geometries (1 1) depending on the particular application of the catheter
  • the pipe (1) is placed inside the patient's body in the treatment areas while the pavilion (2) is outside to be coupled to the infusion systems or other medical devices necessary for the specific treatment
  • the layers that form the intravenous catheter pipe (1) made of polymer composite material reinforced with nanoparticles oriented in specific directions are shown in the side sectional view of Figure 2. Inside the pipe there is a gap or lumen (14 ) where the fluids circulate through the catheter, this lumen (14) can be formed in diameters of ranges greater than 0.1 mm.
  • the lumen wall (13) is formed of the composite polymeric material reinforced with nanoparticles, which are oriented in directions with orientation angles between 0 and 360 degrees and with a concentration in the polymer matrix with ranges between 10 and 50% of reinforcing particles.
  • a coating (12) made of particles with bactericidal properties and friction coefficients of less than 0.9.
  • the coating (12) is diffused with the surface of the lumen wall (13) formed a second compound representing the surface of the catheter pipe (1).
  • FIG. 3 A cross-sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions is shown in Figure 3.
  • the layers forming the catheter tubing (1) having internal diameters or lumen (14) are indicated. in ranges greater than 0.1 mm and external diameters with ranges greater than 0.1 mm with lumen wall thicknesses (13) greater than 0.01 mm.
  • a coating (12) of a compound made of bactericidal materials with low coefficient of friction is applied in order to reduce the resistance to displacement of the catheter through the patient's tissues and besides avoiding the adhesion and microbial growth that can generate infections.
  • the lumen wall (13) is reinforced with nano particles which, through its orientation, increase the resistance of the catheter pipe (1) in the axial direction of the pipe and increase the flexibility in the transverse direction of the catheter pipe ( one).
  • a sectional view of the tip formed of the catheter pipe (1) is shown in Figure 4.
  • the pipe formed by a lumen (14) with a lumen wall (13) coated on its outside by a coating (12) in The anterior part is formed by mechanical or thermal physical means in specific geometries (11) depending on the type of treatment and application of the catheter.
  • a possible specific geometry (1 1) is that shown in Figure 4 which corresponds to a specific geometry (11) characteristic of a peripheral intravenous catheter, in which the different layers that form the catheter tubing can be observed ( 1) made of polymer composite material reinforced with nano particles oriented in specific directions.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un cathéter intraveineux pour l'administration de médicaments ou de liquides au système vasculaire d'un patient, notamment, des cathéters intraveineux périphériques, centraux et autres types de cathéter qui sont posés dans le système vasculaire d'un patient pour l'administration ou le prélèvement de liquides. Le cathéter comprend un conduit (1) possédant une lumière (14) avec une paroi de lumière (13) conçue avec une matrice polymère renforcée par des nanoparticules orientées dans des directions spécifiques et à bas coefficient de frottement, la paroi de la lumière (13) est enduite d'un revêtement (12) élaboré avec un composé de matériau à faible coefficient de frottement et bactéricide. Le cathéter en matériau composite polymère avec des nanoparticules orientées, à faible coefficient de frottement et à faible adhérence microbienne de cette invention présente les avantages a) de diminuer les forces de résistance ou le frottement du cathéter avec les tissus du patient lors de la pose, b) de posséder des composés de matériau bactéricide qui réduisent la fixation de micro-organismes sur la surface du cathéter et leur croissance, ce qui évite ainsi la formation d'infections dans les zones de cathétérisme. En outre, c) l'orientation des éléments de renforcement spécifiques dote le cathéter de propriétés mécaniques qui offrent un confort au patient pendant la procédure de cathétérisme et tout le traitement associé.
PCT/MX2014/000032 2013-01-30 2014-01-29 Cathéter intraveineux en matériau composite polymère avec des nanoparticules orientées, à faible coefficient de frottement et à faible adhérence microbienne WO2014119987A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MX2013001220A MX2013001220A (es) 2013-01-30 2013-01-30 Cateter intravenoso de material compuesto polimerico con nanoparticulas orientadas, de bajo coeficiente de friccion y baja adherencia microbiana.
MXMX/A/2013/001220 2013-01-30

Publications (1)

Publication Number Publication Date
WO2014119987A1 true WO2014119987A1 (fr) 2014-08-07

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003026532A2 (fr) * 2001-09-28 2003-04-03 Boston Scientific Limited Dispositifs medicaux contenant des nanomateriaux, et methodes therapeutiques faisant appel auxdits dispositifs
WO2005115496A1 (fr) * 2004-05-20 2005-12-08 Boston Scientific Scimed, Inc. Dispositifs médicaux ayant plusieurs couches
WO2006100156A2 (fr) * 2005-03-24 2006-09-28 Nolabs Ab Dispositif d'acces medical intravasculaire, interstitiel ou intra-organes et procede de fabrication faisant appel a du monoxyde d'azote
WO2007056058A2 (fr) * 2005-11-03 2007-05-18 Paragon Intellectual Properties, Llc Microcatheter a ballon radio-opaque et procedes de fabrication
US20110264080A1 (en) * 2010-04-23 2011-10-27 Sukgyung AT Co., Ltd. Medical Devices Having Extremely High Radiopacity Containing Ytterbium Compound

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003026532A2 (fr) * 2001-09-28 2003-04-03 Boston Scientific Limited Dispositifs medicaux contenant des nanomateriaux, et methodes therapeutiques faisant appel auxdits dispositifs
WO2005115496A1 (fr) * 2004-05-20 2005-12-08 Boston Scientific Scimed, Inc. Dispositifs médicaux ayant plusieurs couches
WO2006100156A2 (fr) * 2005-03-24 2006-09-28 Nolabs Ab Dispositif d'acces medical intravasculaire, interstitiel ou intra-organes et procede de fabrication faisant appel a du monoxyde d'azote
WO2007056058A2 (fr) * 2005-11-03 2007-05-18 Paragon Intellectual Properties, Llc Microcatheter a ballon radio-opaque et procedes de fabrication
US20110264080A1 (en) * 2010-04-23 2011-10-27 Sukgyung AT Co., Ltd. Medical Devices Having Extremely High Radiopacity Containing Ytterbium Compound

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