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WO2008148165A1 - Dispositif médical échogène - Google Patents

Dispositif médical échogène Download PDF

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Publication number
WO2008148165A1
WO2008148165A1 PCT/AU2008/000812 AU2008000812W WO2008148165A1 WO 2008148165 A1 WO2008148165 A1 WO 2008148165A1 AU 2008000812 W AU2008000812 W AU 2008000812W WO 2008148165 A1 WO2008148165 A1 WO 2008148165A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
indentation
needle
wavelength
section
Prior art date
Application number
PCT/AU2008/000812
Other languages
English (en)
Inventor
Rowan Thomas Deam
David Tibor Julian Liley
Original Assignee
Swinburne University Of Technology
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 AU2007903056A external-priority patent/AU2007903056A0/en
Application filed by Swinburne University Of Technology filed Critical Swinburne University Of Technology
Publication of WO2008148165A1 publication Critical patent/WO2008148165A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments
    • 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
    • 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
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures

Definitions

  • the present invention relates to a medical device having enhanced ultrasonic reflectivity (or echogenicity).
  • Medical devices such as needles, are commonly positioned in vivo using ultrasonic imaging. It has previously been proposed to modify the surface of a needle to enhance diffuse specular reflection of incident ultrasonic waves from its periphery. Previously proposed echogenic surface modifications generally need to be made around the entire peripheral extension of the needle and/or need to be made with a precise shape in plan. Making echogenic surface modifications around the entire peripheral extension of a thin needle, and/or ensuring they are made on a thin needle with a precise plan shape is difficult and complex.
  • a medical device which is provided over only part of its periphery with at least one indentation which in plan is non-circular with a major extent of greater than about a quarter of the wavelength of incident ultrasonic waves but less than the peripheral extension of the medical device, and which in cross- section has a depth and a width of about the quarter wavelength.
  • the at least one indentation can be wholly or partially provided directly in the medical device itself and/or between at least two asperities provided on the medical device.
  • the at least one indentation and/or the at least two asperities can be microtexturing and/or microstructures.
  • the present invention also provides a method of making a medical device including the step of providing the medical device over only part of its periphery with at least one indentation which in plan is non-circular with a major extent of greater than about a quarter of the wavelength of incident ultrasonic waves but less than the peripheral extension of the medical device, and which in cross-section has a depth and a width of about the quarter wavelength.
  • the at least one indentation can be wholly or partially formed directly in the medical device itself and/or between at least two asperities formed on the medical device.
  • the at least one indentation and/or the at least two asperities can be microtexturing and/or microstructures.
  • microtexturing and/or microstructures can be formed before, during or after fabrication of the medical device.
  • microtexturing and/or microstructures can be formed using a microfabrication process selected from laser ablation, embossing, etching, injection moulding, casting, soft lithography, diamond turning, laser ablation, UV lithography, photolithography, e-beam lithography, ion-beam lithography, printing, spotting, electrode discharge machining, grinding, and combinations thereof.
  • a microfabrication process selected from laser ablation, embossing, etching, injection moulding, casting, soft lithography, diamond turning, laser ablation, UV lithography, photolithography, e-beam lithography, ion-beam lithography, printing, spotting, electrode discharge machining, grinding, and combinations thereof.
  • the medical device can be generally elongate and the at least one indentation can be provided over only part of a transverse cross-section of the medical device.
  • the transverse cross-section can be generally circular, elliptic, square or rectangular.
  • the medical device can be generally hollow and the transverse cross-section can be defined by thin peripheral walls.
  • the shape and size of the at least one indentation at least partially enhance diffuse specular reflection of incident ultrasonic waves from the periphery of the medical device.
  • the at least one indentation can at least partially enhance diffuse specular reflection of incident ultrasonic waves towards an ultrasonic transducer when the at least one indentation faces either generally away from or generally towards the ultrasonic transducer.
  • the wavelength of incident ultrasonic waves can be in a range of about 100 ⁇ m to 1600 ⁇ m.
  • the quarter wavelength can therefore be in a range of about 25 ⁇ m to 400 ⁇ m.
  • the at least one indention in cross-section can be generally U-shaped.
  • a plurality of spaced-apart indentations can be provided over only part of the periphery of the medical device in a regular or irregular surface pattern.
  • the mutual spacing of the plurality of indentations can be greater than about the quarter wavelength, for example, in a range of about 100 ⁇ m to 500 ⁇ m.
  • the medical device can be selected from a needle, a biopsy needle, a cannula, a stylet, a stent, a guide wire, a dilator, an introducer, forceps, a tissue marker, a catheter, an angiography device, an angioplasty device, and a pump.
  • Figure 1 is a side view of a needle having partially circumferential echogenic indentations made thereon;
  • Figure 2 is a cross-section view of the needle of Figure 1 with the partially circumferential echogenic indentions shown by grey shading and broken lines; and Figures 3 and 4 are perspective views of a needle and an ultrasonic transducer operating in respective long and short axis modes; - A -
  • Figures 5 to 10 are sequences of ultrasound images of indented and smooth needles at various angles of incidence to an ultrasonic transducer in long and short axis operating modes;
  • Figures 11 to 13 are images of echogenic microtexturing and microstructures fabricated in or on needles using different microfabrication techniques.
  • Figure 1 illustrates a needle 100 having a plurality of spaced-apart indentations 110 each of which only partially extends around the circumference of the needle 100.
  • the indentations 110 can be made in the needle 100 using conventional techniques, for example, laser etching using a computer-controlled excimer laser.
  • the indentations 110 can be generally U-shaped with a depth and a width of about a quarter of the wavelength of incident ultrasonic waves from an ultrasonic transducer (not shown).
  • the depth and width of the indentations can be in a range of about 25 ⁇ m to 400 ⁇ m.
  • the mutual spacing of the indentations 110 can be greater than about the quarter wavelength, for example, in a range of about 100 ⁇ m to 500 ⁇ m.
  • each indentation 110 in plan has a generally non-circular, elongate shape.
  • the major extent of each indentation 110 in plan is less than the circumferential extension of the needle 100, but greater than about a quarter of the wavelength of incident ultrasonic waves. This obviates the need to make the indentations 110 over the entire circumference of the needle 100.
  • the shape and size of the indentations 110 individually and/or collectively at least partially enhance diffuse specular reflection of incident ultrasonic waves from the circumferential surface of the needle 100.
  • the indentations 110 can at least partially enhance diffuse specular reflection of incident ultrasonic waves towards an ultrasonic transducer when the indentations 1 10 face both generally away from and generally towards the ultrasonic transducer.
  • Figures 3 and 4 illustrate the needle 100 in use with an ultrasonic transducer 200 operating in respective long and short axis modes.
  • the short axis mode provides easier clinical access, but the long axis mode provides enhanced images.
  • Figures 5 to 10 are sequential example ultrasound images of an indented needle 100 and a smooth needle at a 10° angle of incidence to the normal of the emitting surface of an ultrasonic transducer 200 operating in long and short axis operating modes.
  • Figures 6, 7, 9 and 10 illustrate that the acoustic signature of the indented needle 100 is at least partially enhanced relative to the acoustic signature of the smooth needle in both the long and short axis modes of the ultrasonic transducer 200 when the indentations 110 face both generally away from and generally towards the ultrasonic transducer 200.
  • the echogenic indentations of the present invention can be alternatively implemented in any conventional medical device that is ultrasonically positioned, for example, a biopsy needle, a cannula, a stylet, a stent, a guide wire, a dilator, an introducer, forceps, a tissue marker, a catheter, an angiography device, an angioplasty device, and a pump.
  • the echogenic indentations can be formed in medical devices and/or parts thereof made from metals, polymers, ceramics, and composites and combinations thereof.
  • the echogenic indentations can be provided as microtexturing in the medical device itself and/or as part of microstructures provided on the medical device.
  • the microtexturing and/or the microstructure can include surface indentations and/or surface asperities.
  • the microtexturing and/or the microstructure can be formed on the medical device before, during or after its fabrication.
  • microstructures can be fabricated on the needle shaft material at any stage of the needle fabrication process. That is, microstructures can be integrated into the needle as the first step of production or as the final step of production, prior to any cleaning and packaging, or at some point between.
  • the echogenic indentations of the invention are formed on a needle using laser ablation.
  • Figure 11 illustrates echogenic indentations formed by direct laser ablation of the needle material by frequency tripled Nd: YAG laser.
  • microtexturing that is created in the shaft of the needle for the purpose of increasing the visibility of the needle during ultra-sound imaging can alternatively be formed using other conventional microfabrication tools and processes.
  • the echogenic indentations of the invention are formed by microtexturing on a needle.
  • the microtexturing is formed by creating an etch resistant mask on the needle shaft, patterning that mask to expose the stainless steel needle, and chemically etching microstructures into the needle.
  • This process starts by dip coating the end of a pre-fabricated, commercially-available 22G x 65mm nerve block needle in a photo-resist material (AZ5214E).
  • the dip coating creates a layer of material that, after baking for 30 minutes at ⁇ 120°C to cure the material, is approximately 15 ⁇ m thick.
  • the polymer coated needle is then presented to a frequency tripled Nd:YAG laser (Avia, Coherent Inc) with a spot size of ⁇ 30 ⁇ m in diameter.
  • the laser beam is scanned over the upper most surface of the needle to remove the photoresist in the desired pattern.
  • the photoresist is completely removed over the irradiated areas so that the stainless steel needle material is exposed.
  • the needle is then placed in a bath of hydrochloric acid at room temperature and etched for 45 minutes to achieve the 25 ⁇ m deep and 50 ⁇ m wide microtexturing illustrated in Figure 12.
  • This microfabrication process can be improved, for example, the rate of the chemical etch can be increased by using an electrochemical etch process.
  • One such process uses electrochemical etching to accelerate the pattern transfer process.
  • microstructures can be fabricated by patterning a layer of polymer on the needle surface (i.e., not structuring the metallic needle at all).
  • Figure 13 illustrates echogenic indentations between asperities formed as microstructures ablated by a frequency tripled Nd:YAG laser in a layer of photoresist material on the surface of the needle.
  • echogenic indentations can be fabricated in a photoresist with a number alternative processes such as diamond turning, laser ablation (at various wavelengths, depending on the material being patterned), UV photolithography, e-beam and ion-beam lithography, and printing type processes. Most of these processes, in addition to electrode discharge machining, and grinding using custom cutting wheels can be used to create suitable microstructures directly into metal medical devices, such as needles.
  • UV lithography, laser ablation, embossing, injection moulding, casting and soft lithography process are some of the processes suitable for creating a polymer structure directly onto metal medical devices, such as needles.
  • the latter processes can also be used to integrate echogenic microtexturing and/or microstructures into polymer parts, such as stents, catheters, etc.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif médical, qui est muni, sur seulement une partie de sa périphérie, d'au moins une dentelure qui, dans le plan, est non circulaire avec une partie principale supérieure à environ un quart de la longueur d'onde des ondes ultrasonores incidentes mais inférieure à l'extension périphérique du dispositif médical, et qui, en coupe transversale, a une profondeur et une largeur d'environ le quart de la longueur d'onde.
PCT/AU2008/000812 2007-06-06 2008-06-06 Dispositif médical échogène WO2008148165A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2007903056 2007-06-06
AU2007903056A AU2007903056A0 (en) 2007-06-06 Echogenic medical device

Publications (1)

Publication Number Publication Date
WO2008148165A1 true WO2008148165A1 (fr) 2008-12-11

Family

ID=40093084

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2008/000812 WO2008148165A1 (fr) 2007-06-06 2008-06-06 Dispositif médical échogène

Country Status (1)

Country Link
WO (1) WO2008148165A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011037813A1 (fr) * 2009-09-24 2011-03-31 Boston Scientific Scimed, Inc. Mécanisme à aiguille échogène
WO2012148265A1 (fr) 2011-04-26 2012-11-01 Encapson B.V. Revêtement destiné à améliorer la visibilité aux ultrasons
US9681852B2 (en) 2012-10-31 2017-06-20 Encapson B.V. Medical devices with coatings for enhanced echogenicity
US10076307B2 (en) 2013-06-20 2018-09-18 Avent, Inc. Echogenic article with compound indentations

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4401124A (en) * 1981-08-13 1983-08-30 Technicare Corporation Reflection enhancement of a biopsy needle
US4977897A (en) * 1988-08-17 1990-12-18 Robert Hurwitz Amniocentesis needle with improved sonographic visibility
US5490521A (en) * 1993-08-31 1996-02-13 Medtronic, Inc. Ultrasound biopsy needle
US6053870A (en) * 1997-11-08 2000-04-25 Angiodynamics, Inc. Ultrasonic visible surgical needle
US7083566B2 (en) * 2000-05-15 2006-08-01 Ge Healthcare Limited Grooved brachytherapy sources

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4401124A (en) * 1981-08-13 1983-08-30 Technicare Corporation Reflection enhancement of a biopsy needle
US4977897A (en) * 1988-08-17 1990-12-18 Robert Hurwitz Amniocentesis needle with improved sonographic visibility
US5490521A (en) * 1993-08-31 1996-02-13 Medtronic, Inc. Ultrasound biopsy needle
US6053870A (en) * 1997-11-08 2000-04-25 Angiodynamics, Inc. Ultrasonic visible surgical needle
US7083566B2 (en) * 2000-05-15 2006-08-01 Ge Healthcare Limited Grooved brachytherapy sources

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011037813A1 (fr) * 2009-09-24 2011-03-31 Boston Scientific Scimed, Inc. Mécanisme à aiguille échogène
WO2012148265A1 (fr) 2011-04-26 2012-11-01 Encapson B.V. Revêtement destiné à améliorer la visibilité aux ultrasons
US9681852B2 (en) 2012-10-31 2017-06-20 Encapson B.V. Medical devices with coatings for enhanced echogenicity
US10166005B2 (en) 2012-10-31 2019-01-01 Encapson B.V. Medical devices with coatings for enhanced echogenicity
US10076307B2 (en) 2013-06-20 2018-09-18 Avent, Inc. Echogenic article with compound indentations
US10231702B2 (en) 2013-06-20 2019-03-19 Avent, Inc. Echogenic article with compound indentations
US10898165B2 (en) 2013-06-20 2021-01-26 Avent, Inc. Echogenic article with compound indentations

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