WO2020043818A1 - Dispositif de cathéter et son procédé de fabrication - Google Patents

Dispositif de cathéter et son procédé de fabrication Download PDF

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Publication number
WO2020043818A1
WO2020043818A1 PCT/EP2019/073077 EP2019073077W WO2020043818A1 WO 2020043818 A1 WO2020043818 A1 WO 2020043818A1 EP 2019073077 W EP2019073077 W EP 2019073077W WO 2020043818 A1 WO2020043818 A1 WO 2020043818A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
catheter device
antimicrobial agent
matrix material
area
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2019/073077
Other languages
German (de)
English (en)
Inventor
Egon Wiest
Albertus Scheule
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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
Priority claimed from DE202018104963.1U external-priority patent/DE202018104963U1/de
Priority claimed from DE102018121189.9A external-priority patent/DE102018121189A1/de
Application filed by Individual filed Critical Individual
Publication of WO2020043818A1 publication Critical patent/WO2020043818A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • 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

Definitions

  • the present invention relates to a catheter device for the
  • a permanent catheter is implanted, the distal end of which lies in the area of the effusion, for example in the chest area, in particular the pleura, or in the abdominal area.
  • the patient can connect the proximal end of the catheter to a collection vessel, which can also be referred to as a collection reservoir, if required or at regular intervals.
  • Implant permanent catheter The catheter is tunneled subcutaneously and inserted into the body cavity.
  • the present invention is therefore based on the object
  • the object is achieved by a catheter device for deriving effusions from a body cavity, which comprises a catheter.
  • the catheter device is characterized in that the catheter consists of a matrix material with a homogeneously incorporated antimicrobial agent and the catheter device has at least one ingrowth area which covers part of the length of the catheter and which is free of antimicrobial agent at least on the outside of the catheter device.
  • the catheter device which can also be referred to as a catheter system, represents a device for deriving effusions from a body cavity, which device comprises a catheter.
  • the catheter device is a device in which the catheter can be permanently implanted and the effusions can be derived by the patient himself in home use.
  • the catheter consists of a matrix material with a homogeneously incorporated antimicrobial agent.
  • the antimicrobial agent is also referred to below as an antimicrobial agent or only as an agent.
  • the Agent is preferably in particle form in the matrix material.
  • the agent is stored in the matrix material. The storage is homogeneous. This homogeneous incorporation can be achieved, for example, by adding the antimicrobial agent to the matrix material while the matrix material is still in a powder or liquid state.
  • the antimicrobial agent can be mixed with the matrix material.
  • Body fluids e.g. blood, serum, effusion liquid
  • Body fluids consistently release small amounts of ions of the antimicrobial agent from the matrix material. This will reduce the risk of infection. Because the antimicrobial agent is not only provided in the surface of the catheter, but is embedded homogeneously in the matrix material, long-term release of the agent or of ions from the agent can be ensured.
  • the antimicrobial coating is not distributed homogeneously in the catheter material, but rather the catheter material is coated on the outer skin, there are some fundamental disadvantages.
  • An outer coating relies on diffusion of the silver ions into and out of the catheter material. A high diffusion rate is desirable for a good distribution in the material, but leads to a disproportionately fast release of the antimicrobial material to the environment, so that a systemic effect cannot be excluded. To avoid this, the doping in such external coatings is very low. However, in the case of continuous use of the catheter, this leads to a
  • the delivery rate is essentially constant and the homogeneous mixing creates a reservoir of antimicrobial agent, which ensures the antimicrobial effectiveness of the catheter over its lifetime and, at the same time, systemic effects can be excluded.
  • the homogeneous distribution is essential for an infection-inhibiting property in a catheter that remains implanted over a longer period of time, typically longer than 30 days maintain antimicrobial activity during this time.
  • superficially coated catheters are therefore not suitable for use as permanent catheters or, in this application, are penalized
  • homogeneous embedding can also ensure that the formation of a biofilm also prevents or in the lumen of the catheter
  • the catheter device has at least one ingrowth area which covers part of the length of the catheter and which is free of antimicrobial agents at least on the outside of the catheter device.
  • Waxing area is a part of the length of the catheter device that is suitable because of the material and / or the geometry in this part for growing into surrounding body tissue. According to the invention
  • Wax area at least the outside of the catheter device free of antimicrobial agents. Due to the antimicrobial agent, the Formation of a biofilm on the catheter device is prevented or at least slowed down. In the ingrowth area, on the other hand, the necessary formation of a biofilm and thus the ingrowth into the tissue are made possible due to the absence of antimicrobial agents on the outside of the catheter device. Providing a wax-in area allows the catheter to grow into the surrounding body tissue and thus prevent the catheter from being pulled out of the body unintentionally. This pulling out poses a great danger, particularly in home use, since the patient himself exchanges the collecting vessel and this is not necessarily medically trained.
  • the matrix material comprises silicone.
  • the matrix material particularly preferably consists of silicone.
  • the antimicrobial agent is preferably metal particles.
  • Silver particles are particularly preferably used.
  • the amount of silver particles is preferably 0.5% to 1.5%, preferably 1% based on the matrix material.
  • body fluids e.g. blood, serum,
  • effusion liquid constantly removes small amounts of Ag + ions from the catheter material.
  • Ag + ions are known for their antimicrobial activity, which is based, among other things, on the weakening of bacterial cell membranes.
  • the silver ions can penetrate the cell and bind there, in particular, to thio- or amino-functionalized proteins and enzymes, thereby depriving these substances of their molecular biological function or preventing cell division and thus bacterial growth by binding directly to the cellular DNA.
  • the antimicrobial agent is in particle form, it can easily be embedded in the matrix material.
  • the particle shape can release the agent, for example in the form of ions, for a long time
  • the metal particles in particular silver particles, can have a size in
  • the silver particles preferably have a size in the range from 3.5 pm to 10 pm. Silver particles of a small size, in particular less than 100 nm, are preferably not used. Due to the small size, the metal particles do not influence the properties of the matrix material, in particular the silicone. In addition, the metal particles can be distributed homogeneously even with a thin wall of the catheter.
  • the incorporated antimicrobial agent is present in the matrix material over the entire wall thickness of the catheter. This allows the amount of antimicrobial agent to be maximized. In contrast to surface-treated catheters, delivery of the agent over a long period of time can therefore be guaranteed. In addition, the agent can also be dispensed into the lumen. The above-mentioned advantages can thus be achieved.
  • the waxing area can be marked by a
  • Treatment of the surface of the catheter are generated in this area, by which the antimicrobial agent is removed from the matrix material.
  • a sheath around the catheter is provided in the ingrowth area, which is free of antimicrobial agents.
  • a sheath which can also be referred to as a cuff or cuff, a surface treatment of the catheter to remove the
  • a mechanical infection barrier can be created by a sheathing.
  • the casing is made of a material that is non-antimicrobial.
  • the sheathing consists of a polymer, in particular polyester.
  • the casing preferably has a rough surface. This can further increase the ingrowth.
  • the casing can have a length that can range from a few millimeters to a few centimeters.
  • the casing has two functions. On the one hand, it enables the catheter to grow into the body tissue and, on the other hand, it serves as an additional infection barrier.
  • the sheath can have a width, that is to say an extension in the longitudinal direction of the catheter, which is in the range from a few millimeters to a few centimeters.
  • the width of the cuff is preferably 9 to 11 mm, preferably 10 mm.
  • the catheter preferably has a safety valve.
  • the safety valve is located at the proximal end of the catheter.
  • the safety valve can be a self-closing valve. The safety valve ensures that an open connection to the body cavity is only established if a collecting reservoir that is compatible with the safety valve
  • Connection option has to be connected to the catheter. In this way, on the one hand, the inadvertent discharge of effusion is avoided, on the other hand, no foreign bodies can penetrate into the body cavity via the catheter and thus, for example, cause infections. If the catheter is used to drain effusions in the pleural area, this prevents this
  • Safety valve also prevents air from flowing into the pleural space and thus counteracts a pleumothorax.
  • the catheter has at least one of them
  • the catheter lumen has an inclined drainage opening in the catheter wall.
  • the drainage openings are preferably orthogonal to the lumen.
  • the at least one drainage opening is preferably provided in a part of the length of the catheter that lies between the ingrowth area and the distal end of the catheter. In the implanted state, this part of the catheter lies in the body cavity in which the effusion is located.
  • the catheter has a strip
  • the X-ray contrast substance which is preferably introduced into the outside of the catheter. This can simplify the placement of the catheter during the implantation and the correct position of the catheter can also be checked via X-ray images after the implantation.
  • the X-ray contrast substance can be barium sulfate, for example.
  • the invention relates to a method for producing a catheter device according to the invention. The procedure is thereby
  • the matrix material is mixed with the antimicrobial agent, then the catheter is molded and the ingrowth area is formed on the molded catheter.
  • the antimicrobial agent can be added to the matrix material
  • the catheter material can therefore, for example, be silicone with suspended microsilver.
  • the ingrowth area is produced by applying a sheath to the outside of the catheter.
  • the material of the sheath can be in the part of the length of the catheter in which the Wax area should be formed around the catheter.
  • the sheath can be glued to the catheter material, for example. A silicone adhesive can be used for this.
  • Figure 1 is a schematic longitudinal sectional view of an embodiment of the catheter device according to the invention.
  • Figure 2 is a schematic cross-sectional view of the embodiment of the invention.
  • the catheter device 1 shows an embodiment of a catheter device 1 according to the invention in longitudinal section.
  • the catheter device 1 consists of a catheter 10, a sheath 2 and a connector 3.
  • the catheter 10 has a lumen 100, which can also be referred to as an inner lumen.
  • the lumen 100 extends from the distal end 101 to the proximal end 102 of the catheter 10.
  • the end 101 of the catheter 10 is referred to here as the distal end 101, which lies in the implanted state in the body cavity in which the effusion exists.
  • the proximal end 102 denotes the end of the catheter 10 which, in the implanted state of the catheter 10, outside the
  • a connector 3 is introduced into the catheter 10 at the proximal end 102.
  • a valve 4 is located in the connection 3.
  • the connection 3 serves to connect the catheter device 1 to a connecting tube (not shown), via which the catheter device can be connected to a collecting reservoir (not shown).
  • a connecting tube not shown
  • a collecting reservoir not shown.
  • Drainage openings 105 are provided.
  • the area in which the drainage openings 105 are provided is also referred to as the drainage path 103.
  • a sheath 2 is applied to the outside of the catheter 10.
  • the sheath 2 is connected to the catheter 10 via fastening areas 20, for example glued.
  • the middle region of the length of the catheter 10 lies in the implanted state of the catheter 10
  • Tunnel area that is in the area in which the catheter 10 is guided subcutaneously. This central region of the catheter is therefore also referred to as tunnel section 104.
  • the casing 2 is located in the tunnel section 104
  • Sheath 2 forms the ingrowth area 109, in which the outside of the catheter device 1 is free of antimicrobial agent.
  • FIG. 2 shows a cross-sectional view of the catheter 10 along the section line A-A in FIG. 1. In this view, the structure of the catheter 10
  • the catheter material consists of a matrix material 106, which is preferably silicone.
  • Antimicrobial agent 107 is embedded in the matrix material 106.
  • the antimicrobial agent 107 preferably represents silver particles.
  • the antimicrobial agent 107 is homogeneously distributed in the matrix material 106 and is therefore also present on the outer circumference of the catheter 10 and on the inner circumference of the catheter facing the lumen 100.
  • a strip of X-ray contrast substance 108 is also shown in FIG.
  • the x-ray contrast substance 108 is introduced into a groove which is provided in the outer surface of the catheter 10.
  • the strip of the x-ray contrast substance 108 can extend over the entire length of the catheter 10.
  • the present invention provides a catheter device for home care, which preferably comprises silver-containing agent with an antimicrobial effect to prevent infections. Avoiding catheter-induced infections is of particular importance in home care. In order to significantly reduce the risk of infection from permanent catheters, the following requirements are met by the catheter according to the invention. Antimicrobial effectiveness is achieved. The spectrum of activity is available in broadband in particular when silver is used as an antimicrobial agent and shows activity against fungi and gram-positive and gram-negative bacteria. Furthermore, the catheter device according to the invention ensures that the effectiveness of the antimicrobial agent lasts for a long time, for example over months, since the catheter is designed as a growing permanent catheter, the explantation of which is only possible in
  • the antimicrobial effectiveness must not have a toxic effect on the patient's organism. Furthermore, bacterial resistance should not be triggered by the use of the catheter. This
  • Catheter material into which finely divided silver particles with a size distribution in the micrometer range are homogeneously incorporated.
  • the catheter device according to the invention is designed for permanent use.
  • it can be implanted subcutaneously in a tunnel and a firm ingrowth of the catheter into the surrounding tissue can be ensured.
  • This ingrowth is a fundamental requirement for home use, since it effectively prevents accidental delocalization of the catheter in the patient's unmonitored home environment.
  • An antimicrobial effect such as is achieved, for example, by the silicone-microsilver composite material that is preferably used, counteracts the ingrowth since, if it does not prevent the necessary formation of a biofilm, it clearly slows it down.
  • the catheter device Ingrowth area is provided, which is formed, for example, by a non-sterile, non-antimicrobial cuff, in particular polymer cuff (polyester cuff) from a few millimeters to a few centimeters in width, on the one hand allows the catheter to grow into the body tissue and on the other hand one can additional infection barrier is created.
  • a non-sterile, non-antimicrobial cuff in particular polymer cuff (polyester cuff) from a few millimeters to a few centimeters in width

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un dispositif de cathéter destiné à l'évacuation d'épanchements hors d'une cavité corporelle, qui comprend un cathéter (10). Le dispositif de cathéter est caractérisé en ce que le cathéter (10) est constitué d'un matériau de matrice (106) doté d'un agent antimicrobien incorporé de manière homogène, et le dispositif de cathéter (1) présentant au moins une zone de croissance (109) qui recouvre une partie de la longueur du cathéter (10) et qui est exempte d'agent antimicrobien au moins sur la face externe du dispositif de cathéter (1). L'invention concerne en outre un procédé destiné à la fabrication d'un tel dispositif de cathéter (1).
PCT/EP2019/073077 2018-08-30 2019-08-29 Dispositif de cathéter et son procédé de fabrication Ceased WO2020043818A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE202018104963.1U DE202018104963U1 (de) 2018-08-30 2018-08-30 Kathetervorrichtung
DE102018121189.9A DE102018121189A1 (de) 2018-08-30 2018-08-30 Kathetervorrichtung und Verfahren zur Herstellung
DE202018104963.1 2018-08-30
DE102018121189.9 2018-08-30

Publications (1)

Publication Number Publication Date
WO2020043818A1 true WO2020043818A1 (fr) 2020-03-05

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ID=67809496

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2019/073077 Ceased WO2020043818A1 (fr) 2018-08-30 2019-08-29 Dispositif de cathéter et son procédé de fabrication

Country Status (1)

Country Link
WO (1) WO2020043818A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3830359A1 (de) * 1988-06-07 1989-12-14 Weikl Andreas Dr In den koerper, in koerperteile oder in koerperhoehlen einfuehrbares und/oder implantierbares teil
WO1993011821A1 (fr) * 1991-12-13 1993-06-24 Rochester Medical Corporation Canule bactericide a liberation prolongee
WO1995018637A1 (fr) * 1994-01-11 1995-07-13 Spire Corporation Catheter presentant un traitement de surface antimicrobien de longue duree
EP1917985A1 (fr) * 2006-09-29 2008-05-07 Tyco Healthcare Group LP Cathéters incluant un manchon antimicrobien et procédés pour la fabrication de cathéters
US20170281824A1 (en) * 2016-03-29 2017-10-05 Rymed Technologies, Llc Anti-Microbial Medical Materials and Devices

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3830359A1 (de) * 1988-06-07 1989-12-14 Weikl Andreas Dr In den koerper, in koerperteile oder in koerperhoehlen einfuehrbares und/oder implantierbares teil
WO1993011821A1 (fr) * 1991-12-13 1993-06-24 Rochester Medical Corporation Canule bactericide a liberation prolongee
WO1995018637A1 (fr) * 1994-01-11 1995-07-13 Spire Corporation Catheter presentant un traitement de surface antimicrobien de longue duree
EP1917985A1 (fr) * 2006-09-29 2008-05-07 Tyco Healthcare Group LP Cathéters incluant un manchon antimicrobien et procédés pour la fabrication de cathéters
US20170281824A1 (en) * 2016-03-29 2017-10-05 Rymed Technologies, Llc Anti-Microbial Medical Materials and Devices

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