WO2011069525A1 - Système de marquage à base de nanoparticules pour visualiser des dispositifs médicaux dans différentes modalités d'imagerie médicale - Google Patents

Système de marquage à base de nanoparticules pour visualiser des dispositifs médicaux dans différentes modalités d'imagerie médicale Download PDF

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Publication number
WO2011069525A1
WO2011069525A1 PCT/EP2009/008791 EP2009008791W WO2011069525A1 WO 2011069525 A1 WO2011069525 A1 WO 2011069525A1 EP 2009008791 W EP2009008791 W EP 2009008791W WO 2011069525 A1 WO2011069525 A1 WO 2011069525A1
Authority
WO
WIPO (PCT)
Prior art keywords
marking system
marking
nanoparticles
mri
medical device
Prior art date
Application number
PCT/EP2009/008791
Other languages
English (en)
Inventor
Paul J. A. Borm
Viorel Rusu
Original Assignee
Magnamedics 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 Magnamedics Gmbh filed Critical Magnamedics Gmbh
Priority to PCT/EP2009/008791 priority Critical patent/WO2011069525A1/fr
Publication of WO2011069525A1 publication Critical patent/WO2011069525A1/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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0127—Magnetic means; Magnetic markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3995—Multi-modality markers

Definitions

  • Nanoparticle-based Marking System for Visualizing Medical Devices in different Medical Imaging Modalities
  • the present invention relates to magnetic resonance imaging and X-ray fluoroscopic imaging of medical devices.
  • the present invention concerns a marking system for medical devices; more particularly a marking system that visualizes medical devices which are provided with said marking system in different medical imaging modalities, especially in X-ray fluoroscopic imaging and in magnetic resonance imaging (MRI).
  • MRI magnetic resonance imaging
  • Medical imaging techniques such as X-ray fluoroscopic imaging, computer tomography (CT), magnetic resonance imaging and positron emission tomography (PET) are among the most important and versatile methods which are used by physicians today for diagnostic purposes. Beyond that, physicians also use medical imaging techniques in visualizing the guidance and placement of medical devices such as guidewires, catheters, stents, biopsy needles or the like within a patient's body.
  • CT computer tomography
  • PET positron emission tomography
  • X-ray fluoroscopy is the preferred imaging modality for cardiovascular interventional procedures because of its temporal and spatial resolution.
  • X-ray fluoroscopy has some drawbacks such as the patient's exposure to ionizing radiation.
  • MRI is a medical imaging modality which does not use ionizing radiation and has the potential to supplant X-ray fluoroscopy. Moreover, MRI has greater soft tissue contrast than X-ray based imaging techniques. Beyond mere diagnostic purposes, interventional magnetic resonance (iMR) angiography as well as stent placements under MRI have been performed to demonstrate feasibility of MRI.
  • iMR interventional magnetic resonance
  • X-ray fluoroscopy is an imaging modality which utilizes ionizing X-ray radiation. Visualization and tracking of medical devices under X-ray fluoroscopy is accomplished either by the devices inherent absorption of X-rays or by securing radiopaque markers to the medical device. Radiopaque material absorbes X- rays and thereby creates contrast within the image, and thus is visible.
  • MRI Magnetic resonance Imaging
  • T1 longitudinal relaxation time
  • T2 transverse relaxation time
  • proton density and flow proton density and flow.
  • MRIs provide a distribution map of protons and their properties in organs and tissues.
  • MRI contrast agents usually shorten either the T1 relaxation time or the T2 relaxation time.
  • Suitable ions for MRI contrast agents are for example chromium(lll), manganese(ll), iron(ll), iron(lll), cobalt(ll), nickel(ll), copper(ll), praseodymium(lll), neodymium(lll), samarium(lll), ytterbium(lll), gadolinium(lll), terbium(lll), dysprosium(lll), holmium(lll) and erbium(lll).
  • Devices to be used in MRI shall not comprise an electrically conductive element, because if the conductive element has the right shape and/or size, it may serve as an antenna for the radio frequency signal used in MRI.
  • plastic devices are used in MRI.
  • plastic devices poorly show-up in MRI, because the signals from the protons in polymers are broad and chemically shifted from protons in water from which the majority of MRI signal is derived.
  • the present invention concerns a marking system for medical devices such that the medical devices become visible in X-ray fluoroscopy and MRI, wherein the marking system comprises radiopaque nanoparticles and paramagnetic particles, and consists of one or more marking elements.
  • the present invention concerns methods for manufacturing a marking system for medical devices, wherein the marking system comprises radiopaque nanoparticles and paramagnetic particles, and consists of one or more marking elements, such that the medical devices become visible in X-ray fluoroscopy and MRI.
  • the present invention concerns the use of a marking system comprising radiopaque nanoparticles and paramagnetic particles, and consisting of one or more marking elements for visualizing and tracking a medical device which is provided with the marking system in X-ray fluoroscopy and MRI.
  • the present invention concerns medical devices which are provided with a marking system comprising a combination of radiopaque nanoparticles and paramagnetic particles to render said medical device visible in X-ray fluoroscopic imaging as well as in MRI.
  • the present invention concerns methods of manufacturing medical devices which are visible in X-ray fluorography and MRI, wherein said medical devices are provided with a marking system consisting of at least one marking element and comprising radiopaque nanoparticles and paramagnetic particles.
  • the present invention concerns the use of medical devices provided with the marking system consisting of at least one marking element and comprising radiopaque nanoparticles and paramagnetic particles for visualizing and tracking the medical device in a patient's body by X-ray fluoroscopy and/or MRI.
  • the marking system of the present invention comprises a combination of radiopaque nanoparticles and paramagnetic particles.
  • Radiopaqe nanoparticles are nanoparticles which absorb X-rays and thereby cause a contrast in X-ray fluoroscopic images.
  • Suitable materials for radiopaque nanoparticles include for example gold, platinum, tungsten, tantalum, rhenium, bismuth, silver, iridium and nitrinol.
  • radiopaque nanoparticles for the marking system of the present invention may consist of any one of the materials or mixtures thereof.
  • Paramagnetic particles comprise a paramagnetic material.
  • Paramagnetic material possesses magnetism only in the presence of an externally applied magnetic field and do not retain any magnetization in the absence of an externally applied magnetic field.
  • paramagnetic materials are attracted to magnetic fields and hence have a relative magnetic permeability of greater than one, i. e. a positive magnetic susceptibility.
  • Paramagnetic particles of the marking system of the present invention may consist of a paramagnetic material that is selected from the group comprising gadolinium, dysprosium, terbium, and alloys and oxides thereof.
  • the term "paramagnetic particles” also included paramagnetic nanoparticles.
  • Paramagnetic nanoparticles may consist of a paramagnetic material selected from the group comprising nickel, iron, magnesium, cobalt, and alloys and oxides thereof.
  • Preferred paramagnetic material of paramagnetic nanoparticles are selected from the group of iron oxides. Suitable paramagnetic iron oxides include FeO, Fe 2 0 3 , Fe30 4 .
  • the paramagnetic particles may also consist of mixed iron oxides or mixtures of different iron oxides.
  • the marking system of the present invention consists of one or more marking elements, wherein the marking elements comprise the radiopaque nanoparticles and/or paramagnetic nanoparticles.
  • the marking system consists of one or more marking elements, wherein the marking element, at least one of the marking elements or all the marking elements of the marking system contain radiopaque nanoparticles and paramagnetic particles.
  • marking elements are designated multi-functional marking elements, because they provide visualization in both X-ray fluoroscopy and MRI.
  • the amount of paramagnetic particles is equal to or greater than the amount of radiopaque nanoparticles within the same marking element.
  • the radiopaque nanoparticles and the paramagnetic particles are present in separate marking elements.
  • the marking system comprises two types of marking elements. The first type of marking elements contains radiopaque nanoparticles but no paramagnetic particles whereas the second type of marking elements contains the paramagnetic particles.
  • the marking system consists of a combination of at least one multi-functional marking element with at least one marking element containing the radiopaque nanoparticles and at least one marking element containing the paramagnetic nanoparticles.
  • the marking elements may comprise a polymeric matrix wherein the radiopaque nanoparticles and/or paramagnetic particles are embedded.
  • the polymer of the polymer matrix may be an elastomer and/or an organogel.
  • the polymer of the polymer matrix be selected from the group of polymers comprising polyethylene, polyesters, polyamides, polyurethanes, Pebax, Arnitel, Hytrel, polypropylene, polyolefines and polyimides.
  • the marking elements may be present in form of solid bars, rods or disks.
  • the marking elements may be present in form of bands or rings or in form of deposits on a medical device or within pockets which are present in the medical device.
  • the marking elements may have a generally annular shape or a generally linear shape.
  • the marking system of the present invention may be manufactured in that the marking elements are formed by adding a suitable amount of radiopaque nanoparticles and/or a suitable amount of paramagnetic particles to a solution, dispersion or melt of a polymer, casting into a mould or extruding the resultant mixture, and letting the solidify in that it may cool down or in that the solvent is removed by drying.
  • the prefabricated marking elements may then be secured to the medical device or secured to components of the medical device during the devices manufacturing such that the marking elements become incorporated into the medical device.
  • the present invention comprises the use of the marking system for visualizing and tracking medical devices, in particular of medical devices otherwise not visible in X-ray fluoroscopy and MRI, in these medical imaging modalities.
  • the marking system of the present invention is incorporated into or secured to a medical device, preferably a medical device formed of a polymer body. Therefore, the present invention also comprises medical devices which are provided with the marking system of the present invention.
  • Preferred medical device to be provided with the marking system of the present invention are catheters, in particular balloon catheters, guidewires, stents, biopsy needles or coils.
  • the medical devices may be provided with the marking system of the present invention in that prefabricated marking elements are secured to the medical device. It is also possible to secure the marking element(s) or a portion of the marking element to components of the medicinal device during the devices manufacturing such that these marking elements may become incorporated into the medical device.
  • the medical device or a component of the medical device is coated, at least in a portion of said device or component, with a polymer solution or polymer dispersion which further contain radiopaque nanoparticles and/or paramagnetic particles.
  • the medical devices which are provided with the marking system of the present invention can be used in X-ray fluoroscopy and/or MRI. These medical devices are visualised in X-ray fluoroscopy and MRI due to their labelling with the marking system, and can easily be tracked when introduced into a patient's body.
  • Fig. 1A is a side view of the tip of a guide wire comprising different marking elements located at the core of the guide wire.
  • Fig. 1 B is a side view of the tip of a guide wire comprising different marking elements, wherein a first marking element is located at the core of the guide wire and a second marking element is encapsulated in the sheath of the guide wire.
  • Fig. 1C s a side view of the tip of a guide wire comprising different marking elements, wherein a first marking element is located at the core of the guide wire and a second marking element is secured to the sheath of the guide wire.
  • Fig. 2A is a side view of the tip of a guide wire comprising a multi-functional marking element that is secured to the core of the guide wire.
  • Fig. 2B is a side view of the tip of a guide wire comprising a multi-functional marking element that is encapsulated in the sheath of the guide wire.
  • Fig. 2C is a side view of the tip of a guide wire comprising a multi-functional marking element that is secured to the sheath of the guide wire.
  • the guidewire 1 comprises a core 2 and a sheath 3.
  • the guidewire further comprises a hydrophilic coating 4.
  • the guidewire further includes two types of marking elements, a first marking element 5 and a second marking element 6, wherein the first marking element 5 contains radiopaque nanoparticles.
  • the second marking element 6 contains paramagnetic particles. It is to be understood that in a different embodiment, the marking element 5 may contain the paramagnetic particles whereas the marking element 6 contains the radiopaque nanoparticles.
  • the marking elements are positioned along the longitudinal axis of the guide wire.
  • the marking elements of the two types may be secured to the core 2 of the guidewire 1 (Fig. 1A).
  • the marking element 6 may also be encapsulated within the sheath 3 of the guidewire 1 (Fig. 1 B) or secured to the sheath 3 of the guidewire 1 (Fig. 1C).
  • the other type of marking element 5 may also be encapsulated within the sheath 3 or secured to the sheath 3 instead of being secured to the core 2 of the guidewire 1.
  • the guidewire 1 comprises a core 2 and a sheath 3.
  • the guidewire further comprises a hydrophilic coating 4.
  • the guidewires further comprise a multi- functional marking element 7 which comprises radiopaque nanoparticles as well as paramagnetic particles.
  • the multi-functional marking element 7 that may either be secured to the core 2 of the guidewire 1 (Fig. 2A), encapsulated into the sheath 3 of the guidewire 1 (Fig. 2B), or secured to the sheath 3 of the guidewire 1.

Abstract

La présente invention concerne un système de marquage pour des dispositifs médicaux et des dispositifs médicaux qui deviennent visibles dans différentes modalités d'imagerie médicale, où le système de marquage est constitué d'au moins un élément de marquage (5, 6) et comprend des nanoparticules radio-opaques et des particules paramagnétiques.
PCT/EP2009/008791 2009-12-09 2009-12-09 Système de marquage à base de nanoparticules pour visualiser des dispositifs médicaux dans différentes modalités d'imagerie médicale WO2011069525A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2009/008791 WO2011069525A1 (fr) 2009-12-09 2009-12-09 Système de marquage à base de nanoparticules pour visualiser des dispositifs médicaux dans différentes modalités d'imagerie médicale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2009/008791 WO2011069525A1 (fr) 2009-12-09 2009-12-09 Système de marquage à base de nanoparticules pour visualiser des dispositifs médicaux dans différentes modalités d'imagerie médicale

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WO2011069525A1 true WO2011069525A1 (fr) 2011-06-16

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013003988A1 (fr) * 2011-07-05 2013-01-10 Shao Weixing Procède de fabrication d'un dispositif de localisation pour une opération de colonne vertébrale
WO2017210020A1 (fr) * 2016-06-01 2017-12-07 Becton, Dickinson And Company Cathéters magnétisés, dispositifs, utilisations et procédés d'utilisation de cathéters magnétisés
EP2629813B1 (fr) 2010-10-18 2019-07-24 MaRVis Interventional GmbH Corps en forme de tige, et dispositif médical
US11062833B2 (en) 2016-08-30 2021-07-13 Becton, Dickinson And Company Cover for tissue penetrating device with integrated magnets and magnetic shielding
US11382529B2 (en) 2016-05-13 2022-07-12 Becton, Dickinson And Company Electro-magnetic needle catheter insertion system
US11413429B2 (en) 2016-06-01 2022-08-16 Becton, Dickinson And Company Medical devices, systems and methods utilizing permanent magnet and magnetizable feature
US11826522B2 (en) 2016-06-01 2023-11-28 Becton, Dickinson And Company Medical devices, systems and methods utilizing permanent magnet and magnetizable feature
US11877839B2 (en) 2016-06-01 2024-01-23 Becton, Dickinson And Company Invasive medical devices including magnetic region and systems and methods

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US5817017A (en) * 1994-04-12 1998-10-06 Pharmacyclics, Inc. Medical devices and materials having enhanced magnetic images visibility
US20050175702A1 (en) * 2002-06-01 2005-08-11 Muller-Schulte Detlef P. Thermosensitive polymer carriers having a modifiable physical structure for biochemical analysis, diagnosis and therapy
WO2005089664A1 (fr) 2004-03-12 2005-09-29 Boston Scientific Limited Marqueurs pour visualisation par irm et par rayons x
WO2008087213A1 (fr) * 2007-01-19 2008-07-24 Cinvention Ag Implant poreux dégradable réalisé à l'aide d'un moulage de poudre

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5817017A (en) * 1994-04-12 1998-10-06 Pharmacyclics, Inc. Medical devices and materials having enhanced magnetic images visibility
US20050175702A1 (en) * 2002-06-01 2005-08-11 Muller-Schulte Detlef P. Thermosensitive polymer carriers having a modifiable physical structure for biochemical analysis, diagnosis and therapy
WO2005089664A1 (fr) 2004-03-12 2005-09-29 Boston Scientific Limited Marqueurs pour visualisation par irm et par rayons x
WO2008087213A1 (fr) * 2007-01-19 2008-07-24 Cinvention Ag Implant poreux dégradable réalisé à l'aide d'un moulage de poudre

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2629813B1 (fr) 2010-10-18 2019-07-24 MaRVis Interventional GmbH Corps en forme de tige, et dispositif médical
WO2013003988A1 (fr) * 2011-07-05 2013-01-10 Shao Weixing Procède de fabrication d'un dispositif de localisation pour une opération de colonne vertébrale
US11382529B2 (en) 2016-05-13 2022-07-12 Becton, Dickinson And Company Electro-magnetic needle catheter insertion system
WO2017210020A1 (fr) * 2016-06-01 2017-12-07 Becton, Dickinson And Company Cathéters magnétisés, dispositifs, utilisations et procédés d'utilisation de cathéters magnétisés
CN109414569A (zh) * 2016-06-01 2019-03-01 贝克顿·迪金森公司 磁化导管、装置、用途和使用磁化导管的方法
US10583269B2 (en) 2016-06-01 2020-03-10 Becton, Dickinson And Company Magnetized catheters, devices, uses and methods of using magnetized catheters
CN109414569B (zh) * 2016-06-01 2021-09-28 贝克顿·迪金森公司 磁化导管、装置、用途和使用磁化导管的方法
US11413429B2 (en) 2016-06-01 2022-08-16 Becton, Dickinson And Company Medical devices, systems and methods utilizing permanent magnet and magnetizable feature
US11826522B2 (en) 2016-06-01 2023-11-28 Becton, Dickinson And Company Medical devices, systems and methods utilizing permanent magnet and magnetizable feature
US11877839B2 (en) 2016-06-01 2024-01-23 Becton, Dickinson And Company Invasive medical devices including magnetic region and systems and methods
US11062833B2 (en) 2016-08-30 2021-07-13 Becton, Dickinson And Company Cover for tissue penetrating device with integrated magnets and magnetic shielding
US11742125B2 (en) 2016-08-30 2023-08-29 Becton, Dickinson And Company Cover for tissue penetrating device with integrated magnets and magnetic shielding

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