US20050154308A1 - Disposable transducer seal - Google Patents

Disposable transducer seal Download PDF

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Publication number
US20050154308A1
US20050154308A1 US10/750,369 US75036903A US2005154308A1 US 20050154308 A1 US20050154308 A1 US 20050154308A1 US 75036903 A US75036903 A US 75036903A US 2005154308 A1 US2005154308 A1 US 2005154308A1
Authority
US
United States
Prior art keywords
membrane
seal
retainer
transducer
transducer housing
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.)
Abandoned
Application number
US10/750,369
Other languages
English (en)
Inventor
Jens Quistgaard
Charles Desilets
Gregory Darlington
Tim Etchells
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.)
Solta Medical Inc
Original Assignee
LipoSonix Inc
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 LipoSonix Inc filed Critical LipoSonix Inc
Priority to US10/750,369 priority Critical patent/US20050154308A1/en
Assigned to LIPOSONIX, INC. reassignment LIPOSONIX, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DARLINGTON, GREGORY PAUL, DESILETS, CHARLES S., ETCHELLS, TIM, QUISTGAARD, JENS U.
Priority to US11/027,491 priority patent/US7311679B2/en
Priority to CNB2004800389781A priority patent/CN100531676C/zh
Priority to AU2004311472A priority patent/AU2004311472B2/en
Priority to JP2006547603A priority patent/JP4733054B2/ja
Priority to KR1020067013777A priority patent/KR20060130093A/ko
Priority to EP04816060A priority patent/EP1699362A4/fr
Priority to CA002551349A priority patent/CA2551349A1/fr
Priority to BRPI0418247-2A priority patent/BRPI0418247A/pt
Priority to PCT/US2004/044084 priority patent/WO2005065422A2/fr
Publication of US20050154308A1 publication Critical patent/US20050154308A1/en
Priority to US11/935,481 priority patent/US7905844B2/en
Priority to US13/023,360 priority patent/US20110213280A1/en
Assigned to SILICON VALLEY BANK reassignment SILICON VALLEY BANK SECURITY AGREEMENT Assignors: LIPOSONIX, INC.
Assigned to SILICON VALLEY BANK reassignment SILICON VALLEY BANK SECURITY INTEREST - MEZZANINE LOAN Assignors: LIPOSONIX, INC.
Assigned to LIPOSONIX, INC. reassignment LIPOSONIX, INC. RELEASE OF SECURITY INTEREST IN PATENTS Assignors: SILICON VALLEY BANK
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4422—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to hygiene or sterilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4438—Means for identifying the diagnostic device, e.g. barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22045—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire fixed to the catheter; guiding tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A61B17/2251—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
    • A61B2017/2253—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient using a coupling gel or liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0008—Destruction of fat cells

Definitions

  • the present invention pertains to a sealing device for retaining degassed water within an ultrasound transducer housing.
  • Ultrasound transducers require a coupling medium to connect the transducer to a patient in order to prevent the reflection and refraction of ultrasound waves when those waves cross a border between densities of two objects.
  • Coupling agents are used to eliminate large scale air bubbles between the transducer and the patient.
  • mineral oils, hydro-gels and even water can be used to couple a transducer to a patient.
  • the coupling agent should be more strictly controlled so that even minute air bubbles are eliminated.
  • HIFU high intensity focused ultrasound
  • Atmospheric water for example, contain approximately 8.5 PPM (parts per million) O 2 , and 14.5 PPM N 2 as well as other dissolved gasses.
  • DO dissolved oxygen
  • the common method used by the industry is to prepare the fluid by passing it through a filtration and de-ionisation process to remove impurities and particulates that may precipitate out, contaminate or provide nucleation sites for bubbles.
  • the coupling fluid is then degassed to some minimum level before introduced into the system. Typically degassing is performed by bulk cavitation under a vacuum or boiling at atmospheric or sub atmospheric pressure and then sealing the degassed fluid in a container.
  • gasses come out of solution or enter the cooling system are various, some examples of the more common range from pressure changes within the cooling system caused by physical restriction or atmospheric conditions. Local pressure changes such as rectified diffusion from HIFU or temperature changes will bring gas out of solution as will displacement of the partial pressure of one gas by another, or by material leaching. Other methods by which gas may enter the system include diffusion through the tubing, seals and structure of the cooling system in the same way a balloon deflates, trapping micro bubbles within the surface structure and pockets of the cooling system, chemical reactions between materials in the cooling system, or as a by product of bacterial growth within the cooling system.
  • Precautions such as using low permeability materials for the tubing are regularly employed, but even with such precautions, the re-gas rate can become a major issue.
  • Other methods used to reduce the effects of re-gassing include the introduction of surfactants or wetting agents to prevent bubble formation, using larger volumes of fluids, and the use of hydrophilic and/or hydrophobic polymers such as Polyvinaylpyyolidone (PVP).
  • PVP Polyvinaylpyyolidone
  • a disposable transducer seal that comprises a membrane that is substantially transparent to ultrasound energy.
  • the membrane is non-porous to water and acoustic coupling fluids.
  • a retainer has an annular configuration. There is also a means to mate the retainer with a transducer housing.
  • the device of the present invention is a disposable transducer seal (seal).
  • the seal is designed for use with a system for the reduction in adipose tissue.
  • the seal comprises a membrane, a retainer and a means for attaching the seal to a transducer housing.
  • the transducer housing is shaped similar to an inverted cup having a gap space for degassed water.
  • the seal is used to retain the degassed water in the gap space without the water spilling onto a patient during an ultrasound procedure.
  • the seal is intended to provide both an air tight seal, and a barrier to prevent cross contamination of the different fluids on opposite sides of the membrane.
  • the membrane is composed of a compound being essentially or substantially transparent to ultrasound energy.
  • the membrane may be composed of naturally occurring materials such as latex rubber, or a synthetic material like a thin film plastic or rubber. Thermoforming plastics produce good membranes since the thickness of the membrane tends to be uniform. Uniformity in the membrane of the seal reduces scattering of the ultrasound signal during a procedure.
  • a thermoforming polyimide provides a good example. For manufacturing considerations and for optimal performance, the synthetic polyimide is preferred.
  • the membrane may be flexible or inflexible as long as it is drawn taunt about the retainer. While the membrane may be inflexible, it is preferred the membrane be a little flexible so that it can conform to the curves of a patients body more readily.
  • Some flexibility also allows the membrane to respond to fluid pressure changes during procedures. This responsiveness during a procedure helps maintain a constant pressure environment for the fluid, since the membrane may expand a little or contract a little due to variations in pressure in the system.
  • the membrane serves as an acoustic window, so it is desirable that the membrane is substantially transparent to ultrasound energy. Smoothness in its surfaces during manufacturing will help reduce signal scattering or attenuation, thus improving performance of the membrane.
  • a plastic membrane having desirable acoustic properties is required, and if that plastic is thermo-formable it allows for a greater uniform thickness in the manufacturing of the membrane. Uniform thickness also helps to reduce signal scattering or other loss of the ultrasound signal passing through the membrane.
  • the retainer may be assembled from any medically approved material. However since the retainer may be in direct contact with the patient, it is preferred to be made of a material that is easily formable (such as an extruded plastic, or moldable plastic) so that the sealing device may be discarded after a single use.
  • the membrane is drawn taunt over the retainer, or drawn taunt and the retainer is placed down about the membrane so that the membrane remains taunt during a medical procedure.
  • the seal has a means for mating with a transducer housing.
  • the means may be such as the retainer is shaped as an interlocking ring with the transducer housing having a conforming receiving aperture.
  • the transducer housing may have clips for latching on to tabs on the retainer.
  • Other means of mating to the transducer include a magnetic lock, a screw in pin, a temporary adhesive, an interference fitting male and female part (one being on the retainer, the corresponding part on the transducer housing).
  • the retainer may also include a means for identifying the sealing device to the transducer housing, or its attached ultrasound system.
  • the means may be an electronic device such as an encoded chip or flex circuit, or it may be linked to the mating means, such that if the mating is not properly done the transducer housing and corresponding ultrasound system will not recognize the retainer and therefore remain in a safe mode.
  • Either the membrane or the retainer may also have a clear window.
  • the window is a small gap space designed to correspond to the location of an optical emitter and photo-optical receiver such that an acoustic gel having a safety dopant can be detected by the transducer housing or ultrasound system through the sealing device.
  • FIG. 1 illustrates several possible designs.
  • the retainer 592 of the disposable transducer seal 590 has an annular configuration.
  • the membrane 594 is drawn tightly around the retainer 592 . Regardless of the material construction of the membrane, it is necessary for the membrane to be drawn tightly about the retainer and held in place.
  • the retainer serves to maintain the shape and rigidity of the membrane during use.
  • the membrane is a softer material, such as a latex rubber, then the retainer serves to keep the membrane taunt.
  • the membrane has no slack in it, so there is no play or deformation of the membrane during use.
  • a limited amount of deformity is desirable so the membrane can flex slightly to be concave or convex relative to the transducer.
  • ripples in the membrane material, folds or even a somewhat flimsy shape to the membrane may have adverse effects on the transmission of ultrasound energy during a procedure.
  • the configuration is a circular ring, square, rectangle or other loop as required to seal a transducer housing.
  • the annular configuration depends on the aperture of the transducer housing the seal must mate with.
  • the precise shape will vary from one transducer housing to another. The shapes shown are merely illustrative and not to be taken as limiting in any sense.
  • FIG. 2 illustrates a cross section of the sealing device. As can be seen the membrane is drawn tightly either within the retainer ( FIG. 2A ) or across the surface face of the retainer ( 2 B). Optional elements include the encoder chip 596 illustrated in both drawings.
  • FIG. 3 illustrates the mating of the seal 590 to a transducer housing 500 .
  • the housing is shaped similar to an inverted cup containing an electronics and motor assembly for moving and controlling the transducer and any additional electronic components that may be integrated into the housing.
  • the seal 590 is placed over an open aperture on the transducer housing.
  • the design of the transducer housing is such that the transducer is placed aperture end toward the patient, and the transducer can abut the skin of the patient.
  • the transducer housing may be used in two modes. One of those modes involves the use of degassed water circulating about the transducer within the transducer housing. A seal is needed in this mode of operation to prevent the degassed water from leaking out, and to prevent air from leaking in.
  • the seal is mated to the transducer housing.
  • the mating means may be any number of mechanical connections that allow for the air and water tight seal described above. Once the seal is in place, the cavity in the transducer housing may be flooded with degassed water without water escaping.
  • the seal may also have an electronic or mechanical recognition device such that the transducer housing will recognize the proper placement of the seal and move the ultrasound machine from a safe mode to an active mode.
  • an optical window may be placed either in the membrane or in the retainer so that any kind of optical sensor or safety device using an optical sensor may still detect the proper safety material across the seal.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Acoustics & Sound (AREA)
  • Surgical Instruments (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Transducers For Ultrasonic Waves (AREA)
US10/750,369 2003-12-30 2003-12-30 Disposable transducer seal Abandoned US20050154308A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
US10/750,369 US20050154308A1 (en) 2003-12-30 2003-12-30 Disposable transducer seal
PCT/US2004/044084 WO2005065422A2 (fr) 2003-12-30 2004-12-29 Joint de transducteur jetable
EP04816060A EP1699362A4 (fr) 2003-12-30 2004-12-29 Joint de transducteur jetable
BRPI0418247-2A BRPI0418247A (pt) 2003-12-30 2004-12-29 vedação de transdutor descartável, aparelho para manter uma barreira entre um alojamento do transdutor e um ambiente externo, e, métodos para preparação de um alojamento do transdutor para ultra-som, para fazer um dispositivo de vedação do transdutor e para vedação de um alojamento do transdutor usando um dispositivo de vedação do transdutor
AU2004311472A AU2004311472B2 (en) 2003-12-30 2004-12-29 Disposable transducer seal
JP2006547603A JP4733054B2 (ja) 2003-12-30 2004-12-29 ディスポーザブルの変換器シール
KR1020067013777A KR20060130093A (ko) 2003-12-30 2004-12-29 일회용 트랜스듀서 씰
US11/027,491 US7311679B2 (en) 2003-12-30 2004-12-29 Disposable transducer seal
CA002551349A CA2551349A1 (fr) 2003-12-30 2004-12-29 Joint de transducteur jetable
CNB2004800389781A CN100531676C (zh) 2003-12-30 2004-12-29 使用后可废弃的传感器密封装置
US11/935,481 US7905844B2 (en) 2003-12-30 2007-11-06 Disposable transducer seal
US13/023,360 US20110213280A1 (en) 2003-12-30 2011-02-08 Disposable transducer seal

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10/750,369 US20050154308A1 (en) 2003-12-30 2003-12-30 Disposable transducer seal

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/027,491 Continuation-In-Part US7311679B2 (en) 2003-12-30 2004-12-29 Disposable transducer seal

Publications (1)

Publication Number Publication Date
US20050154308A1 true US20050154308A1 (en) 2005-07-14

Family

ID=34739097

Family Applications (4)

Application Number Title Priority Date Filing Date
US10/750,369 Abandoned US20050154308A1 (en) 2003-12-30 2003-12-30 Disposable transducer seal
US11/027,491 Active 2024-10-26 US7311679B2 (en) 2003-12-30 2004-12-29 Disposable transducer seal
US11/935,481 Active 2025-11-07 US7905844B2 (en) 2003-12-30 2007-11-06 Disposable transducer seal
US13/023,360 Abandoned US20110213280A1 (en) 2003-12-30 2011-02-08 Disposable transducer seal

Family Applications After (3)

Application Number Title Priority Date Filing Date
US11/027,491 Active 2024-10-26 US7311679B2 (en) 2003-12-30 2004-12-29 Disposable transducer seal
US11/935,481 Active 2025-11-07 US7905844B2 (en) 2003-12-30 2007-11-06 Disposable transducer seal
US13/023,360 Abandoned US20110213280A1 (en) 2003-12-30 2011-02-08 Disposable transducer seal

Country Status (9)

Country Link
US (4) US20050154308A1 (fr)
EP (1) EP1699362A4 (fr)
JP (1) JP4733054B2 (fr)
KR (1) KR20060130093A (fr)
CN (1) CN100531676C (fr)
AU (1) AU2004311472B2 (fr)
BR (1) BRPI0418247A (fr)
CA (1) CA2551349A1 (fr)
WO (1) WO2005065422A2 (fr)

Cited By (63)

* Cited by examiner, † Cited by third party
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US20050154314A1 (en) * 2003-12-30 2005-07-14 Liposonix, Inc. Component ultrasound transducer
US20060030780A1 (en) * 2004-08-03 2006-02-09 Jean-Francois Gelly System and method providing controllable attenuation of an ultrasound probe
US20070010805A1 (en) * 2005-07-08 2007-01-11 Fedewa Russell J Method and apparatus for the treatment of tissue
US20070219448A1 (en) * 2004-05-06 2007-09-20 Focus Surgery, Inc. Method and Apparatus for Selective Treatment of Tissue
US20070239077A1 (en) * 2006-03-09 2007-10-11 Haim Azhari Method and system for lipolysis and body contouring
US20080039724A1 (en) * 2006-08-10 2008-02-14 Ralf Seip Ultrasound transducer with improved imaging
US20080058682A1 (en) * 2006-03-09 2008-03-06 Haim Azhari Device for ultrasound monitored tissue treatment
US20080077056A1 (en) * 2006-09-21 2008-03-27 Shuhei Kagosaki HIFU probe for treating tissue with in-line degassing of fluid
US20090048514A1 (en) * 2006-03-09 2009-02-19 Slender Medical Ltd. Device for ultrasound monitored tissue treatment
US20090240146A1 (en) * 2007-10-26 2009-09-24 Liposonix, Inc. Mechanical arm
EP2165737A1 (fr) * 2008-09-18 2010-03-24 Koninklijke Philips Electronics N.V. Appareil de traitement aux ultrasons doté d'un couvercle de protection
US20100274161A1 (en) * 2007-10-15 2010-10-28 Slender Medical, Ltd. Implosion techniques for ultrasound
EP2281508A1 (fr) * 2008-04-25 2011-02-09 Hitachi Medical Corporation Dispositif de diagnostic à ultrasons
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US20110184322A1 (en) * 2010-01-22 2011-07-28 Slender Medical Ltd. Method and device for treatment of keloids and hypertrophic scars using focused ultrasound
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US9572497B2 (en) 2008-07-25 2017-02-21 Helmholtz Zentrum Munchen Deutsches Forschungszentrum Fur Gesundheit Und Umwelt (Gmbh) Quantitative multi-spectral opto-acoustic tomography (MSOT) of tissue biomarkers
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US7311679B2 (en) 2007-12-25
US20050154313A1 (en) 2005-07-14
CA2551349A1 (fr) 2005-07-21
CN1897879A (zh) 2007-01-17
CN100531676C (zh) 2009-08-26
JP4733054B2 (ja) 2011-07-27
AU2004311472A1 (en) 2005-07-21
WO2005065422A3 (fr) 2005-10-20
US20110213280A1 (en) 2011-09-01
US7905844B2 (en) 2011-03-15
AU2004311472B2 (en) 2010-07-22
EP1699362A2 (fr) 2006-09-13
US20080064961A1 (en) 2008-03-13
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WO2005065422A2 (fr) 2005-07-21

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