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WO2008129249A2 - Marqueur de position - Google Patents

Marqueur de position Download PDF

Info

Publication number
WO2008129249A2
WO2008129249A2 PCT/GB2008/001347 GB2008001347W WO2008129249A2 WO 2008129249 A2 WO2008129249 A2 WO 2008129249A2 GB 2008001347 W GB2008001347 W GB 2008001347W WO 2008129249 A2 WO2008129249 A2 WO 2008129249A2
Authority
WO
WIPO (PCT)
Prior art keywords
marker
bio
marker according
polymeric material
radiopaque material
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/GB2008/001347
Other languages
English (en)
Other versions
WO2008129249A3 (fr
Inventor
Mark De Langen
Stuart Green
Jorge Schlegel
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.)
Invibio Ltd
Original Assignee
Invibio Ltd
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 Invibio Ltd filed Critical Invibio Ltd
Priority to CA002684564A priority Critical patent/CA2684564A1/fr
Priority to EP08737008A priority patent/EP2139420A2/fr
Publication of WO2008129249A2 publication Critical patent/WO2008129249A2/fr
Publication of WO2008129249A3 publication Critical patent/WO2008129249A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • 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
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • images of the abnormality are used by a radiologist to adjust the irradiating device and to direct radiation solely at the abnormality while minimizing or eliminating adverse effects to surrounding healthy tissue.
  • visualization techniques are used to follow the progress of the treatment.
  • markers in the form of wire or beads made of highly radiopaque materials such as gold or tantalum.
  • the gold or tantalum marker may lead to production of artefacts in the image produced, for example information may be missing and/or "starbursts" may be present, leading to difficulties in accurately interpreting the images.
  • MRI techniques eddy currents may be produced in the gold or tantalum which again may result in the production of artefacts which render image interpretation more difficult. It is desirable that any fiducial marker is visible under MRI, CT and X-ray imaging so that, in any situation, one or more of the techniques may be used to visualize any marker .
  • Said marker preferably has a dimension in a second direction perpendicular to the first direction which is less than said maximum dimension in said first direction.
  • the ratio of the maximum dimension in said first direction to said dimension in said second direction may be greater than 1, preferably greater than 1.1, more preferably greater than 1.3, especially greater than 1.5.
  • the ratio may be less than 5, preferably less than 4, more preferably less than 3, especially less than 2.
  • the volume of the marker may be less than 20mm 3 , suitably less than 15mm 3 , preferably less than 10mm 3 , more preferably less than 8mm 3 , especially less than 6mm 3 .
  • the volume may be at least 0.75mm 3 , preferably at least lmm 3 .
  • Said marker preferably has a substantially constant cross- section along at least 50%, suitably at least 70%, preferably at least 90%, more preferably at least 95%, especially about 100%, of its extent in one direction, for example said first direction referred to.
  • Said cross- section is preferably substantially symmetrical about a first plane which bisects the cross-section in one direction; preferably also it is symmetrical about two mutually orthogonal planes which bisect the cross-section.
  • Said cross-section preferably includes a substantially circular outer wall.
  • Said cross-section described may be substantially annular or circular. It preferably includes substantially no void areas.
  • Said cross-section is preferably of substantially constant shape on moving from one side of the marker to an opposite side thereof.
  • Said fiducial marker may be in the form of an extruded tube, coil or solid member.
  • Said marker preferably includes substantially no void areas; it is preferably substantially solid throughout.
  • Said radiopaque material is preferably an integral part of said marker.
  • Said radiopaque material is preferably not fiowable within the marker.
  • Said radiopaque material is preferably substantially immovably fixed in position in said marker so that its position relative to that of the polymeric material is substantially immovably fixed.
  • Said radiopaque material is preferably covered, at least in part, by said bio-compatible polymeric material.
  • Said radiopaque material is preferably substantially fully enclosed by said bio-compatible polymeric material.
  • Said bio-compatible polymeric material may have a Notched Izod Impact Strength (specimen 80mm x 10mm x 4mm with a cut 0.25mm notch (Type A), tested at 23°C, in accordance with ISO180) of at least 4KJm “2 , preferably at least 5KJm "2 , more preferably at least 6KJm “2 .
  • Said Notched Izod Impact Strength measured as aforesaid, may be less than 10KJm "2 , suitably less than 8KJm "2 .
  • Said bio-compatible polymeric material may have a flexural modulus, measured in accordance with ISO178 (80mm x 10mm x
  • Said bio-compatible polymeric material may be amorphous or semi-crystalline. It is preferably semi-crystalline .
  • the level and extent of crystallinity in a polymer is preferably measured by wide angle X-ray diffraction (also referred to as Wide Angle X-ray Scattering or WAXS), for example as described by Blundell and Osborn (Polymer 24 , 953, 1983).
  • WAXS Wide Angle X-ray Scattering
  • crystallinity may be assessed by Differential Scanning Calerimetry (DSC).
  • Ar is selected from the following moieties (vi) to (x)
  • Suitable moieties Ar are moieties (ii) , (in), (iv) and (v) and, of these, moieties, (ii), (in) and (v) are preferred.
  • Other preferred moieties Ar are moieties (vii) , (viii) , (ix) and (x) and, of these, moieties (vii), (viii) and (x) are especially preferred.
  • An especially preferred class of bio-compatible polymeric materials are polymers (or copolymers) which consist essentially of phenyl moieties in conjunction with ketone and/or ether moieties. That is, in the preferred class, the first polymer material does not include repeat units which include -S-, -SO 2 - or aromatic groups other than phenyl.
  • Preferred bio-compatible polymeric materials of the type described include:
  • said bio-compatible polymeric material is selected from polyetheretherketone, polyetherketone, polyetherketoneetherketoneketone and polyetherketoneketone .
  • said polymeric material is selected from polyetherketone and polyetheretherketone.
  • said polymeric material is polyetheretherketone.
  • Said radiopaque material may comprise a compound, for example a salt incorporating zirconium moieties.
  • Said radiopaque material preferably includes oxygen moieties .
  • Said radiopaque material may be a ceramic. It may be a zirconium ceramic salt. Said radiopaque material preferably includes zirconium moieties and oxygen moieties. Said material is preferably an oxide which comprises zirconium moieties. Said material is preferably zirconium dioxide.
  • Said radiopaque material preferably has a decomposition temperature which is greater than 300 0 C, suitably greater than 325°C, preferably greater than 350 0 C, more preferably greater than 500 0 C, especially greater than 700 0 C, suitably so it can be melt-processed with the preferred bio-compatible polymeric materials.
  • the total wt% of all bio-compatible polymeric materials in said marker may be at least 40wt%, preferably at least 50wt% .
  • the total may be less than 85wt%, preferably less than 70wt%, more preferably less than 65wt%.
  • the sum of the wt% of all particulate radiopaque materials and all bio-compatible polymeric materials in said marker may be at least 80wt%, preferably at least 90wt%, more preferably at least 95wt%, especially at least 99wt%.
  • said fiducial marker includes 60 to 85wt% of biocompatible polymeric material (preferably of formula [xx] above, especially polyetheretherketone) and 15 to 40wt% of a radiopaque material (especially particulate material, for example a zirconium oxide) .
  • said fiducial marker includes 15-30wt% of a zirconium compound as aforesaid and 70-85wt% of a polyaryletherketone, especially polyetheretherketone.
  • a fiducial marker may comprise first and second fillers encapsulated in said biocompatible polymeric material, which may be of formula [xx] and is preferably polyetheretherketone .
  • a first filler may be a metal, suitably in powderous form, which may be selected from stainless steel, tantalum and titanium.
  • a second filler suitably comprises said radiopaque material.
  • Said fiducial marker may include 5- 20wt% of said first filler, 15-60wt% of said second filler and 20-80wt% of said bio-compatible polymeric material.
  • tnere is provided the use of a member which comprises a said radiopaque material encapsulated in a bio-compatible polymeric material as a fiducial marker.
  • the member may be a fiducial marker as described in said first aspect.
  • the fiducial marker may be as described according to said first aspect.
  • a method of obtaining images of predetermined positions of a human or animal body comprising imaging a human or animal body in which has been positioned one or a plurality (preferably a plurality) of fiducial markers according to said first aspect.
  • a method of making a fiducial marker comprising encapsulating a said radiopaque material in a bio-compatible material.
  • the method may include chopping extruded material to define fiducial markers of appropriate dimensions.
  • the invention extends to a pack comprising a fiducial marker according to said first aspect contained in a packaging material.
  • the packaging material could be sterile .
  • a fiducial marker may be prepared by selection of a polyetheretherketone (PEEK OPTIMA LT3 polymer obtained from Invibio Limited, UK) and a highly pure grade of zirconium dioxide of suitable particle size. The combination may then be introduced into a twin screw melt extrusion compounder and a lace produced having a diameter of 2 to 3 mm. The lace may then be passed to a conveyer, cooled and chopped into granules. The granules may be introduced into an extruder and monofilaments produced which may then be chopped to produce fiducial markers of predetermined lengths comprising polyetheretherketone polymer with zirconium dioxide substantially homogenously dispersed throughout the polymer.
  • PEEK OPTIMA LT3 polymer obtained from Invibio Limited, UK
  • markers described can be imaged using CT, MRI and X- ray techniques. In each case, images include less distortion and/or starburst and/or other artefacts compared to other known markers.
  • a standard wire coating technique may be used to coat a 0.12mm diameter stainless steel wire with a homogenous mixture comprising PEEK OPTIMA LT3 polymer (50wt%) and zirconium dioxide (50wt%).
  • the coated wire may be cut to size to define a fiducial marker comprising a wire core and an outer homogenous sheaf of PEEK OPTIMA LT3 polymer and zirconium dioxide.
  • the stainless steel wire core may be replaced with tantalum or titanium; or the amount of zirconium dioxide may be adjusted (e.g. in the range 30-70wt%) .
  • the metal wire may be replaced with metal powder, for example of stainless steel, tungsten or tantalum, at up to 20wt% of the entire marker.
  • metal powder for example of stainless steel, tungsten or tantalum
  • An example of such a marker may include up to 20wt% of metal powder, 30 to 70wt% of zirconium dioxide and the balance being PEEK OPTIMA LT3. The materials are mixed to define a homogenous mass and extruded to define an elongate marker having a diameter of 1mm.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un marqueur de position visible par une vaste gamme de techniques d'imagerie, qui comprend un matériau radio-opaque, comprenant des fractions zirconium, encapsulé dans un matériau polymère biocompatible, par exemple une polyaryléthercétone telle qu'une polyétheréthercétone.
PCT/GB2008/001347 2007-04-20 2008-04-17 Marqueur de position Ceased WO2008129249A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA002684564A CA2684564A1 (fr) 2007-04-20 2008-04-17 Marqueur de position
EP08737008A EP2139420A2 (fr) 2007-04-20 2008-04-17 Marqueur de position

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0707671.4 2007-04-20
GBGB0707671.4A GB0707671D0 (en) 2007-04-20 2007-04-20 Fiducial marker

Publications (2)

Publication Number Publication Date
WO2008129249A2 true WO2008129249A2 (fr) 2008-10-30
WO2008129249A3 WO2008129249A3 (fr) 2008-12-24

Family

ID=38135153

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2008/001347 Ceased WO2008129249A2 (fr) 2007-04-20 2008-04-17 Marqueur de position

Country Status (4)

Country Link
EP (1) EP2139420A2 (fr)
CA (1) CA2684564A1 (fr)
GB (1) GB0707671D0 (fr)
WO (1) WO2008129249A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2471508A (en) * 2009-07-02 2011-01-05 Invibio Ltd Composite enclosure with specific WVTR and impact strength, used in an implantable device
WO2013191510A1 (fr) * 2012-06-22 2013-12-27 서울대학교 산학협력단 Matériau métallique médical pour insertion in vivo, comprenant un moyen permettant d'éviter les mouvements in vivo
KR101544490B1 (ko) * 2013-09-05 2015-08-13 서울대학교산학협력단 체내 이동방지 수단이 구비된 체내삽입용 의료용구

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6174330B1 (en) * 1997-08-01 2001-01-16 Schneider (Usa) Inc Bioabsorbable marker having radiopaque constituents
US6520952B1 (en) * 2000-03-23 2003-02-18 Neich Medical Co., Ltd. Ceramic reinforced catheter
ATE343403T1 (de) * 2003-02-10 2006-11-15 Heraeus Gmbh W C Verbesserte metalllegierung für medizinische geräte und implantate
US7761138B2 (en) * 2004-03-12 2010-07-20 Boston Scientific Scimed, Inc. MRI and X-ray visualization
US20050283226A1 (en) * 2004-06-18 2005-12-22 Scimed Life Systems, Inc. Medical devices
US20060204445A1 (en) * 2005-03-11 2006-09-14 Anthony Atala Cell scaffold matrices with image contrast agents
GB0521536D0 (en) * 2005-10-22 2005-11-30 Invibio Ltd Fiducial marker

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2471508A (en) * 2009-07-02 2011-01-05 Invibio Ltd Composite enclosure with specific WVTR and impact strength, used in an implantable device
WO2013191510A1 (fr) * 2012-06-22 2013-12-27 서울대학교 산학협력단 Matériau métallique médical pour insertion in vivo, comprenant un moyen permettant d'éviter les mouvements in vivo
KR101544490B1 (ko) * 2013-09-05 2015-08-13 서울대학교산학협력단 체내 이동방지 수단이 구비된 체내삽입용 의료용구

Also Published As

Publication number Publication date
GB0707671D0 (en) 2007-05-30
EP2139420A2 (fr) 2010-01-06
WO2008129249A3 (fr) 2008-12-24
CA2684564A1 (fr) 2008-10-30

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