EP1549360A2 - Implant dans la vessie - Google Patents

Implant dans la vessie

Info

Publication number
EP1549360A2
EP1549360A2 EP03773514A EP03773514A EP1549360A2 EP 1549360 A2 EP1549360 A2 EP 1549360A2 EP 03773514 A EP03773514 A EP 03773514A EP 03773514 A EP03773514 A EP 03773514A EP 1549360 A2 EP1549360 A2 EP 1549360A2
Authority
EP
European Patent Office
Prior art keywords
implant
bladder
implant according
active substance
active ingredient
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.)
Withdrawn
Application number
EP03773514A
Other languages
German (de)
English (en)
Inventor
Martin Rahe
Rudi Maier
Michael Wagener
Raymond Glocker
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.)
Templatech Igr GmbH
Original Assignee
TEMPLATECH GmbH
Uroplant GmbH
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 TEMPLATECH GmbH, Uroplant GmbH filed Critical TEMPLATECH GmbH
Publication of EP1549360A2 publication Critical patent/EP1549360A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/042—Urinary bladders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
    • 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
    • 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

Definitions

  • Bladder infections are a recurring problem for many patient groups.
  • the object of the invention aims to limit the risk of infection in advance by using the urethra - sh.
  • Drawing Pos. (4) - immigrant germs can be switched off directly in the entrance area of the bladder (3).
  • the decisive advantage of the solution according to the invention is the fact that antibiotics no longer have to be used, that is to say that no resistant bacterial strains can arise.
  • the patient is kept free from urinary tract infections and the treatment costs are reduced considerably. By reducing the risk of breeding resistance, an increased therapeutic reserve is maintained.
  • the basic idea of the invention is therefore to interrupt the transport of the germs to the ureters (2) directly in the bladder.
  • an ascending urinary tract infection can be prevented in advance, without first treating it with a medication via the normal bloodstream channels or secondly by removing the germs by flushing the bladder with the help of a catheter.
  • Another aspect that must be seen in traditional methods of treating urinary tract infections is the fact that treatment can only take place after the germs have been diagnosed. In most cases there is no prophylactic early detection at this point.
  • a graft that is deposited in the bladder and kills germs can not only prevent infection over a long period of time, but is also suitable for treating an existing infection.
  • the invention is based on the object of bringing together an active substance carrier with special properties with a suitable active substance which, as a graft, necessarily in a thread-like geometry (12), can be introduced into the bladder space with sufficient depot capacity via the urethra.
  • the graft In order to prevent mechanical irritation of the bladder roof and front wall due to contractions of the bladder, the graft must be extremely flexible and soft. With spastic urinary blisters it may be necessary to prevent the contractions of the specific muscles by injecting botulinum toxin. Other conditions that have to be placed on the graft are absolute urinary permeability, as well as the need for no chemical or other impairments of the bladder periphery. It is also important that the effectiveness lasts for a long time - e.g. 6 to 12 months - and if possible the end of which is shown to the patient (e.g. dye).
  • graft can be removed at any time and in a simple manner.
  • the object of the invention is achieved by using a corresponding plastic polymer with the said memory properties, which fulfills the conditions mentioned above, and as a matrix with a suitable germicidal biocide such as e.g. Nanosilver or magnesium oxide nanoparticles is equipped.
  • a suitable germicidal biocide such as e.g. Nanosilver or magnesium oxide nanoparticles is equipped.
  • shape memory plastics are planned, which among other things developed by mnemoscience GmbH in Aachen.
  • these materials When deformed, these materials are able to save a pre-programmed shape and later to restore them independently and accurately using a stimulus such as temperature.
  • the speed of the process is adjustable.
  • the exemplary embodiment of the catheter shape (12) of the graft, FIG. 5, should make it possible for the plastic polymer, when elongated, to be introduced directly into the bladder space with the aid of a lubricant.
  • the memory properties of the polymer thread (12) mean that the temperature change causes the thread to wind up like a ball (not shown graphically) or to break up into many extremely thin threads like a cotton ball (6) so that it no longer can be rinsed out through the bladder outlet (4) and remains in the bladder for a long time.
  • a compressed state (10) - temperature state 1 - the graft can be inserted minimally invasively into the urinary bladder via a catheter.
  • the plastic By heating to body temperature, the plastic remembers its original shape and takes up its programmed volume or shape (9) and thus its large surface area.
  • the shown forms of the grafts which are only examples of many possibilities, ensure sufficient flexibility to adapt to the frequent changes in volume of the bladder and the required permeability to the urine. Furthermore, it must always be ensured that an intermittent catheterization remains possible despite the implant.
  • Another feature that distinguishes the polymer for the intended purpose is the possibility that a special programming technology can be used to determine whether the implant should be biodegradable or bio-stable.
  • the plastic can also be adjusted in such a way that it dissolves in the pH-acid range or also decomposes enzymatically.
  • the active substance is a substance that has the active substance:
  • nanoparticulate silver Fig. 4 (5) has an antimicrobial and fungicidal effect even in very low concentrations (50 to 1000 ppm) in certain polymers, without showing any harmful effects.
  • the silver ions released from the finely divided silver act on microbes in three different ways:
  • the silver ions metabolized by the microorganisms block the
  • silver ions are channeled through the same channels as the essential calcium ions in the
  • the third effect that results from compounding carrier materials with nanoparticulate silver is the fact that the bacterial adhesion to hydrophilic surfaces is significantly reduced. The germs no longer colonize the object, which initially avoids the potential incrustation of the graft. From a chemical point of view, the optimal suitability of the nano-Ag technology for the purpose according to the invention is based on the provision of a very large reservoir of effective silver ions without excess and in a safe concentration. In fact, silver ions only develop when bacterial metabolites come into contact with the metallic silver.
  • the regulation of the ion release takes place via a complex control loop, in which the primary parameters, the solubility of the silver salts formed on the surface, the wetting of the matrix polymer, which has to be of sufficient size, and the corrosion of the metallic silver are decisive.
  • This control circuit ensures that with sufficient contact area metallic silver only releases as much silver ions as is required for the new formation of the pending silver compounds. These in turn depend on the chemical environment. Specifically: if there are many germs, a relatively large amount of silver is metabolized. If there are no germs, no silver is used.
  • This strictly controlled system avoids high concentrations of silver ions, thereby realizing the long-term germicidal effect.
  • the active substance carrier e.g. by taking a medication or by bladder irrigation with a suitable active ingredient
  • pH change, enzyme etc. can be dissolved and thus removed in order to avoid instrumental removal.
  • the implant is inserted
  • Implant fiber (greatly enlarged)
  • Catheter or thread shape e.g. 30 cm long and 4mm 0

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Certaines infections, notamment des infections des voies urinaires, constituent un problème de santé important qui engendre des coûts énormes, en raison des résistances aux antibiotiques qui augmentent de façon alarmante. Des recherches indiquent, selon une estimation prudente, que 5-6 millions de patients en Europe présentent un risque élevé d'augmentation d'infection des voies urinaires. Ces infections, notamment chroniques, impliquent des frais de traitement énormes, avec l'inconvénient d'une médication par voie orale qui constitue un poids pour tout l'organisme. L'objectif de la présente invention est d'empêcher l'apparition d'infections, à l'aide d'un implant de vessie dopé en argent, en éliminant déjà à l'entrée de la vessie les germes qui arrivent à 95 % par l'urètre dans la vessie. Ce procédé permet non seulement d'empêcher l'apparition d'une infection sur une période de plusieurs mois, mais également de traiter une infection existante. La solution proposée par cette invention est avantageuse en ce qu'elle évite l'utilisation d'antibiotiques et empêche l'apparition de souches de bactéries résistantes.
EP03773514A 2002-10-12 2003-10-13 Implant dans la vessie Withdrawn EP1549360A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10247689 2002-10-12
DE10247689A DE10247689A1 (de) 2002-10-12 2002-10-12 Implantat in der Harnblase
PCT/DE2003/003395 WO2004034930A2 (fr) 2002-10-12 2003-10-13 Implant dans la vessie

Publications (1)

Publication Number Publication Date
EP1549360A2 true EP1549360A2 (fr) 2005-07-06

Family

ID=32038588

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03773514A Withdrawn EP1549360A2 (fr) 2002-10-12 2003-10-13 Implant dans la vessie

Country Status (5)

Country Link
US (1) US20060105010A1 (fr)
EP (1) EP1549360A2 (fr)
JP (1) JP2006502769A (fr)
DE (1) DE10247689A1 (fr)
WO (1) WO2004034930A2 (fr)

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US9586035B2 (en) * 2007-12-11 2017-03-07 Massachusetts Institute Of Technology Implantable drug delivery device and methods for treatment of the bladder and other body vesicles or lumens
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RU2598057C2 (ru) 2011-02-04 2016-09-20 ТАРИС Биомедикал ЛЛК Имплантируемое устройство для контролируемого высвобождения лекарственного средства с низкой растворимостью
HUE072250T2 (hu) 2013-03-15 2025-11-28 Taris Biomedical Llc Gyógyszeradagoló eszközök gyógyszeráteresztõ résszel
CN105705173A (zh) * 2013-05-24 2016-06-22 东北大学 用于将软组织整合入硬组织的纳米材料
ES2956840T3 (es) 2013-08-19 2023-12-29 Taris Biomedical Llc Dispositivos de administración de fármacos de múltiples unidades
US10737078B2 (en) 2014-06-26 2020-08-11 Taris Biomedical Llc Intravesical drug delivery devices and methods including elastic polymer-drug matrix systems
KR102658706B1 (ko) 2015-04-23 2024-04-17 타리스 바이오메디컬 엘엘씨 약물-투과성 성분을 구비한 약물 전달 장치 및 방법
KR102271744B1 (ko) * 2018-07-25 2021-07-01 가톨릭대학교 산학협력단 생체 모사형 인공방광 및 이의 제어방법
WO2022072930A1 (fr) * 2020-10-02 2022-04-07 Petrychenko Dmitri Dispositifs à libération prolongée et agents thérapeutiques pour le traitement à long terme d'une infection des voies urinaires in vivo
EP4533083A4 (fr) * 2022-06-29 2026-07-08 Indian Inst Scient Dispositif de piégeage et mises en oeuvre correspondantes

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Also Published As

Publication number Publication date
DE10247689A1 (de) 2004-04-22
US20060105010A1 (en) 2006-05-18
WO2004034930A2 (fr) 2004-04-29
WO2004034930A3 (fr) 2004-08-05
JP2006502769A (ja) 2006-01-26

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