EP1478308A1 - Prothese veineuse - Google Patents

Prothese veineuse

Info

Publication number
EP1478308A1
EP1478308A1 EP03704679A EP03704679A EP1478308A1 EP 1478308 A1 EP1478308 A1 EP 1478308A1 EP 03704679 A EP03704679 A EP 03704679A EP 03704679 A EP03704679 A EP 03704679A EP 1478308 A1 EP1478308 A1 EP 1478308A1
Authority
EP
European Patent Office
Prior art keywords
fluid valve
stent framework
vein
blood vessel
prosthesis according
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Withdrawn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
EP03704679A
Other languages
German (de)
English (en)
Inventor
Harald Fischer
Bernd Vogel
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.)
Karlsruher Institut fuer Technologie KIT
Original Assignee
Forschungszentrum Karlsruhe 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 Forschungszentrum Karlsruhe GmbH filed Critical Forschungszentrum Karlsruhe GmbH
Publication of EP1478308A1 publication Critical patent/EP1478308A1/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Withdrawn legal-status Critical Current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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2475—Venous valves
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded

Definitions

  • the invention relates to a vein prosthesis according to the preamble of claim 1.
  • a possible treatment of these symptoms is carried out with the help of support stockings, which enclose the leg as a whole, build up a counter pressure to the blood pressure and thus relieve the tissue in the leg.
  • the functionality of the body's own venous valves is not restored.
  • venous valves maintaining or restoring the functionality of the venous valves is of particular importance for the sustainable or preventive treatment of varicose veins. Because of a relevant finding of it it can be assumed that the tissue around the body's own venous valves has already been damaged, ie dilated, it is advisable to either replace the body's own venous valve by inserting a vein prosthesis, ie an artificial venous valve, or to relieve it by switching the hammers together.
  • a vein prosthesis ie an artificial venous valve
  • a biological valve prosthesis consisting of a fluid valve and a support sleeve.
  • the fluid valve which consists of a chemically fixed biological material, is inserted into a blood vessel at the desired location and is fixed there in this position by the support cuff surrounding the blood vessel.
  • the support cuff is shown as a tubular component, so that an application is only possible for a major surgical intervention, the blood vessel having to be separated and threaded into the support cuff.
  • the object of the invention is to propose a vein prosthesis which can be used intravenously with the aid of a catheter and does not require an additional protective cuff which is arranged around the blood vessel.
  • the invention proposes the features set out in claim 1. Further advantageous features that further develop the invention can be seen in the characterizing parts of the subclaims.
  • the central feature of the invention is the integration of a stent framework made of a biocompatible material as a component of the venous prosthesis, which has the ability to grow together with the tissue of the blood vessel at the point of contact with the blood vessel.
  • the inner lumen of the stent framework remains free of adhesions and blood can therefore flow through it.
  • the venous prosthesis is particularly advantageously permanently fixed in the blood vessel without separate parts.
  • the tissue due to the applied stent scaffold, the tissue provides additional stability against unwanted dilation.
  • a unidirectional fluid valve is inserted or incorporated into the stent framework.
  • the fluid valve In order to prevent the fluid valve from growing together with the tissue of the blood vessel or another body's own tissue, it must be made of a cell-repellent material or coated with it.
  • Plasma polymerized polyethylene glycols (hydrogels), for example, are proposed as such materials.
  • the venous prosthesis is first inserted radially elastically compressed (crimped) into a catheter.
  • the actual intervention takes place in a particularly patient-friendly, advantageously minimally invasive (endoluminal) manner, with the catheter being inserted into the blood vessel near the selected position for the application of the venous prosthesis in a first step. If the position is reached with the distal end of the catheter, the venous prosthesis is pushed out of the catheter.
  • the radial elastic compression of the vein prosthesis is eliminated by the hyperelastic (superelastic) property of the material, causing the stent structure to expand radially and to contact the wall of the blood vessel.
  • a required slight oversize of the diameter of the relieved vein prosthesis compared to that of the blood vessel causes a slight radial pressure to the outside and thus fixation of the vein prosthesis in the blood vessel at the desired position.
  • shape memory materials or hyperelastic materials which must also be biocompatible.
  • a particularly suitable group of materials for this are metallic shape memory alloys, in particular NiTi alloys, which have pronounced superelastic properties and can also be processed well in the submillimeter range using laser or eroding processes. sen.
  • Other suitable shape memory materials with the required properties are shape memory polymers or superelastic copper alloys, which also have good biocompatible properties on the one hand and sufficient elastic properties on the other.
  • Typical representatives of the group of hyperelastic biocompatible materials (eg Elasteon) suitable for the purpose described are hyperelastic polymers or single-crystalline copper alloys.
  • the geometric design of the stent framework with the fluid valve must also be designed such that it can be radially elastically compressed. It is proposed to design the stent framework as a sieve-shaped tube piece, with all openings in the tube wall being as uniform as possible, for example diamond-shaped, the larger diagonals of each of these diamond-shaped openings being aligned axially to the tube.
  • the fluid valve on the other hand, must have a surface that is cell-repellent and therefore cannot grow together with the tissue of the blood vessel or with other tissue components in the body. It is proposed to either manufacture the fluid valve itself as a separate component from a cell-repellent material or, if the fluid valve is worked out together with the stent framework from one and the same pipe section, for example with an eroding or laser processing method, to coat with such a material.
  • the fluid valve is to be designed as a unidirectional fluid valve, whereby an absolute seal in one direction and an absolute frictionless flow in the other direction are not absolutely necessary. Rather, a bidirectional flow is completely sufficient for use as a vein prosthesis if the flow resistance in the direction is significant. edge over the flow resistance in the other direction. It is therefore completely sufficient for the purpose of a vein prosthesis if, depending on the position, the fluid channel is only largely opened or closed by the fluid valve.
  • vein prosthesis or parts thereof In order to avoid rejection reactions with medication, it is also advisable to coat or manufacture the vein prosthesis or parts thereof with a polymer containing or permeating medication.
  • Fig. 1 a to c examples of vein prostheses with stent structure and separately used, open fluid valves, and
  • fluid valves 2 inserted separately into the stent framework 1. It makes sense to produce these fluid valves 2 from a cell-repellent material, preferably a corresponding plastic, and to cast, fuse, glue or connect them in another way with the stent framework 1.
  • a cell-repellent material preferably a corresponding plastic
  • An injection molding, immersion or micro casting process is suitable for the production of the fluid valve as a plastic part.
  • the fluid valve can also be made of a metallic material, preferably a nickel-titanium alloy, and can be made using a welding process or in another form, e.g. B. solder or adhesive process, fixed in the stent framework.
  • FIGS. 1 a to c the direction of flow of the respective unidirectional fluid valve 2 is shown by an arrow 4.
  • Fig. 1 a shows a fluid valve 2 with two flaps 3, which are designed to be relatively flexible and open or close radially depending on the flow direction and thus significantly increase or reduce the flow resistance depending on the flow direction.
  • the flaps above all have to be flexible and not necessarily elastic.
  • the effect of the unidirectional fluid valve is improved in that the bending resistance of the rolling curvature areas 5 decreases as the rolling progresses in the direction of the arrow (arrow 4).
  • a thin wire made of a shape memory alloy is also conceivable as a support structure for a flap 3 made of a polymer.
  • FIG. 1 b and c each show a fluid valve with one (FIG. 1 b) or a plurality of flaps 3 (FIG. 1 c), which are connected to the valve seat 6 via flexible joints or jointless connections made of a shape memory alloy.
  • both the flaps 3 and the valve seats 6 must have sufficient flexibility.
  • the flap 3 of the exemplary embodiment according to FIG. 1 b is to be provided with sufficient elastic bending capacity for this.
  • FIGS. 2 a to c show exemplary embodiments in which the stent framework 1 and the fluid valves 2 are worked out from a blank.
  • the fluid valves 2 have one (FIGS. 2 a and c) or two flaps 3 (FIG. 2 b), which are each connected to the stent framework via an elastic bending element 7 (bending structure as part of the blank).
  • 2 a and b also show cutouts 8 in the stent framework 1, which cover the areas from which the flaps 3 are worked out.
  • the vein prosthesis is preferably produced from a biocompatible material, the fluid valves 2 being to be coated with a cell-repellent material.
  • wire material shape memory material or hyperelastic material
  • shape memory material shape memory material or hyperelastic material

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une prothèse veineuse destinée à être implantée dans un vaisseau sanguin. L'objectif de cette invention est de proposer une prothèse veineuse, pouvant être implantée par voie intraveineuse à l'aide d'un cathéter et sans manchon de soutien supplémentaire, agencé autour du vaisseau sanguin. A cet effet, ladite prothèse veineuse est constituée d'une structure à stent en matériau biocompatible, implantée dans le vaisseau sanguin et croissant avec ce dernier, et d'une valve unidirectionnelle à fluide, solidement implantée dans la structure à stent et constituée d'un matériau repoussant les cellules ou recouverte d'un matériau repoussant les cellules.
EP03704679A 2002-02-26 2003-02-22 Prothese veineuse Withdrawn EP1478308A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10208202A DE10208202A1 (de) 2002-02-26 2002-02-26 Venenprothese
DE10208202 2002-02-26
PCT/EP2003/001813 WO2003071990A1 (fr) 2002-02-26 2003-02-22 Prothese veineuse

Publications (1)

Publication Number Publication Date
EP1478308A1 true EP1478308A1 (fr) 2004-11-24

Family

ID=27740423

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03704679A Withdrawn EP1478308A1 (fr) 2002-02-26 2003-02-22 Prothese veineuse

Country Status (6)

Country Link
US (1) US20040243219A1 (fr)
EP (1) EP1478308A1 (fr)
JP (1) JP4262604B2 (fr)
AU (1) AU2003206949A1 (fr)
DE (1) DE10208202A1 (fr)
WO (1) WO2003071990A1 (fr)

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US7670368B2 (en) 2005-02-07 2010-03-02 Boston Scientific Scimed, Inc. Venous valve apparatus, system, and method
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Also Published As

Publication number Publication date
JP2005518249A (ja) 2005-06-23
DE10208202A1 (de) 2003-09-11
AU2003206949A1 (en) 2003-09-09
WO2003071990A1 (fr) 2003-09-04
JP4262604B2 (ja) 2009-05-13
US20040243219A1 (en) 2004-12-02

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