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WO2014134314A1 - Sources lumineuses, dispositifs médicaux et méthodes d'éclairage d'un objet étudié - Google Patents

Sources lumineuses, dispositifs médicaux et méthodes d'éclairage d'un objet étudié Download PDF

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Publication number
WO2014134314A1
WO2014134314A1 PCT/US2014/019041 US2014019041W WO2014134314A1 WO 2014134314 A1 WO2014134314 A1 WO 2014134314A1 US 2014019041 W US2014019041 W US 2014019041W WO 2014134314 A1 WO2014134314 A1 WO 2014134314A1
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WIPO (PCT)
Prior art keywords
light source
lasers
aperture
medical device
interest
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/US2014/019041
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English (en)
Inventor
Wasim Haider Chowdhury
Mark A. CASTANARES
Ronald Rodriguez
Brian P. NEUMAN
Dan Stoianovici
Doru Petrisor
Ryan Decker
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Johns Hopkins University
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Johns Hopkins University
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Publication of WO2014134314A1 publication Critical patent/WO2014134314A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/043—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for fluorescence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/063—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements for monochromatic or narrow-band illumination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0669—Endoscope light sources at proximal end of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0241—Pointed or sharp biopsy instruments for prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2015—Miscellaneous features
    • A61B2018/2025—Miscellaneous features with a pilot laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2065—Multiwave; Wavelength mixing, e.g. using four or more wavelengths
    • A61B2018/207—Multiwave; Wavelength mixing, e.g. using four or more wavelengths mixing two wavelengths

Definitions

  • Class IV lasers often include a shutter or other stop adapted and configured to prevent unintentional release of a laser beam when an instrument is not connected with the laser.
  • shutters may allow temporary release of light and can be easily manipulated to allow light to escape.
  • a light source including: a housing including at least one wall defining an aperture and one or more lasers positioned within the housing such that each of the lasers is positioned at an angle with respect to the axis and generates a beam focused on a common focal point along the axis, within the housing, and offset from the aperture.
  • the aperture is adapted and configured to receive an optical fiber along an axis.
  • the beams cannot pass through the aperture unless the optical fiber is positioned within the aperture.
  • the axis can be perpendicular to the wall defining the aperture.
  • the light source can include a single laser.
  • the light source can include a plurality of lasers.
  • the light source can include between 2 and 150 lasers.
  • the light source can include 37 lasers.
  • the plurality of lasers can be actuated individually. Subsets of the plurality of lasers can be actuated collectively.
  • the angle with regard to the axis can vary amongst the plurality of lasers.
  • the angle with regard to the axis can be uniform.
  • the angle can be about 26.5 degrees or less.
  • the angle can be about 11.5 degrees.
  • the angle can be about 8 degrees.
  • the common focal point can be between about 15 mm and about 60 mm from the aperture.
  • the angle can be adjusted to illuminate a desired field of view.
  • At least a subset of the one or more lasers can have a wavelength of about 780 nm.
  • Each of the one or more lasers can be a Class Illb/Class 3B or lower laser.
  • Each of the one or more lasers can be received within a slidable mounting plate defining a plurality of holes.
  • Another aspect of the invention provides a light source and an instrument including an optical fiber.
  • the instrument is removably coupled with the light source such that the optical fiber lies within the aperture.
  • the instrument is a laparoscope or an endoscope.
  • the instrument in another embodiment, includes a camera.
  • the camera can be adapted and configured to image at an emission wavelength of a compound of interest that is excited by a wavelength emitted by the light source.
  • the compound of interest can be YC- 27, the camera can be adapted and configured to image above a wavelength above about 800 nm, and the light source can be adapted and configured to emit light at a wavelength of about 780 nm.
  • the medical device can further include a long pass filter positioned adjacent to the camera or a short pass filter positioned adjacent to a white light source.
  • the medical device can further include a recording device in communication with the camera and adapted and configured to record one or more images captured by the camera.
  • the recording device can be a general purpose computer.
  • the recording device can be a digital video recorder.
  • the instrument can include one or more lenses adapted and configured to focus the light emitted by the light source into a cutting beam.
  • Another aspect of the invention provides a method of illuminating an object of interest including: administering a photosensitive compound to a subject and using the medical device as described herein to apply one or more excitation frequencies to the object of interest.
  • the object of interest can be a prostate.
  • the photosensitive compound can preferentially bind to cancerous cells.
  • the photosensitive compound can preferentially bind to nerve cells.
  • the photosensitive compound can be an iron nanoparticle.
  • the photosensitive compound can be a gold nanoparticle.
  • the signal from the photosensitive compound can be used to perform a guided biopsy.
  • the signal from the photosensitive compound can be used to monitor effects of therapy.
  • the signal from the photosensitive compound can be used to monitor patients in watchful wait.
  • FIGS. 1A-1C depict various views of a light source according to an embodiment of the invention.
  • FIGS. 2A and 2B depict medical devices according to embodiments of the invention.
  • FIG. 3 depicts a method of illuminating an object of interest according to an embodiment of the invention.
  • FIG. 4 depicts a prototype light source according to an embodiment of the invention.
  • FIGS. 5A-5D depict the use of a light source as discussed herein to selectively illuminate the photosensitive compound YC-27 within the prostrate after administration to a mouse.
  • FIGS. 6A and 6B depict the observation of a pig kidney post YC-27 injection.
  • FIGS. 6C and 6D depict the location of a xenograft using NIR guidance.
  • FIG. 7 depicts a comparison of imaging of YC-27/PSMA dilutions with an embodiment of the inventions and the DA VINCI® surgical system.
  • FIG. 8 provides a series of photographs comparing surgeries conducted with and without use of the imaging device described herein.
  • a “healthcare professional” shall be understood to mean any person providing medical care to a patient. Such persons include, but are not limited to, medical doctors, physician' s assistants, nurse practitioners (e.g. an Advanced Registered Nurse Practitioner (ARNP)), nurses, residents, interns, medical students, or the like. Although various licensure requirements may apply to one or more of the occupations listed above in various jurisdictions, the term health care provider is unencumbered for the purposes of this patent application.
  • ALTP Advanced Registered Nurse Practitioner
  • a “subject” shall be understood to include any mammal including, but not limited to, humans, pigs, and mice.
  • Ranges provided herein are understood to be shorthand for all of the values within the range.
  • a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,
  • the light source 100 includes a housing 102 including at least one wall 104 defining an aperture 106.
  • the aperture 106 is adapted and configured to receive an optical fiber 108 along an axis 110.
  • the light source 100 also includes one or more lasers 112 positioned within the housing such that each of the lasers 112 is positioned at an angle with respect to the axis 110 and generates a beam 114 focused on a common focal point 116 along the axis 110, within the housing 102, and offset from the aperture 106.
  • Light source 100 advantageously allows transmission of light to the outside world only through the optical fiber 108 and precludes accidental exposure when the optical fiber 108 becomes dislodged. Because the focal point 116 lies within the housing 102, the laser beams 114 will pass through the focal point 116 and dissipate within the housing 102 if the optical fiber 108 is removed. Stated another way, the laser beams 114 beams cannot pass through the aperture 106 unless an optical fiber 108 is positioned within the aperture 106.
  • axis 110 is perpendicular to the wall 104 defining the aperture 106. Although this approach may be the most efficient to fabricate, one of ordinary skill in the art will readily appreciate that axis 110 can be at an angle with respect to wall 104. In most circumstances, axis 110 will be substantially coaxial with central axes of aperture 106 and/or optical fiber 108.
  • Light source 100 can include a single laser 112 or a plurality of lasers 112.
  • the light source 100 can include between 2 and 150 lasers 112.
  • light source 100 included 37 lasers 112.
  • light source 100 can include other quantities of lasers 112 (e.g. , between 1 and 10, between 10 and 20, between 20 and 30, between 30 and 40, between 40 and 50, between 50 and 60, between 60 and 70, between 70 and 80, between 80 and 90, between 90 and 100, between 100 and 110, between 110 and 120, between 120 and 130, between 130 and 140, between 140 and 150, and the like).
  • Lasers 112 can be mounted in a mounting plate 118 having a one or more holes 120 oriented at an angle with respect to axis 110. Holes 120 can have various angles such that lasers beams 114 generated by lasers 112 mounted within holes 120 each converge on focal point 116. For example, holes closer to axis 116 may have a smaller angle with respect to axis 116 than holes further from axis 116. In one embodiment, holes 120 are arranged in a substantially concentrically circular pattern.
  • mounting plate 118 is slidable within housing 102 so that the position of the focal point 116 can be adjusted to reflect various lengths of optical fibers 108.
  • mounting plate 118 can slide along a path defined by slots 122.
  • the focal point 116 will be between about 15 mm and about 60 mm from the aperture 106. This measurement can be taken from either the internal surface or the external surface of wall 104.
  • Lasers can be actuated individually, in various subsets, or as a single unit. Actuating individual lasers 112 or subsets of lasers 112 can be advantageous for several reasons. First, light entering the optical fiber 108 at relatively small angles with respect to axis 110 will emerge from the working end of the optical fiber 108 at a relatively small angle with respect to an axis defined by the working end of the optical fiber 108 and best illuminate objects that are directly in front of the working end. Likewise, light entering the optical fiber 108 at relatively large angles with respect to axis 110 will emerge from the working end of the optical fiber 108 at a relatively large angle with respect to an axis defined by the working end of the optical fiber 108 and best illuminate objects that are to the side of the working end.
  • lasers 112 may be configured to emit light at various wavelengths and a user may wish to selectively utilize one or more wavelengths to illuminate one or more objects of interest.
  • a healthcare professional may administer a plurality of photosensitive compounds that each bind to a particular type of cell and each have a different excitation frequency. Independent actuation of varying frequencies will allow the healthcare professional to visualize only the desired cells.
  • the net power output of the light can be modulated as needed
  • the particular angles of the lasers 112 can be selected based on the parameters (e.g. , the diameter) of the optical fiber 108. In general, the angles should be less than the critical angle at which internal reflection within a particular optical fiber will not occur.
  • FIG. IB provides additional views of a light source according to embodiments of the invention.
  • FIG. 1C depicts a side view of mounting plate 118 showing the convergence of laser beams 114 on focal point 116.
  • FIG. 2A another aspect of the invention provides a medical device 200a including a light source 100 and an instrument 202 including an optical fiber 108.
  • Instrument 202 can be removably coupled to the light source 100 such that the optical fiber 108 lies within an aperture as described above. This allows for the instrument 202 to be removed for disposal or sterilization after a procedure.
  • the instrument 202 is a laparoscope that can be used for various surgical procedures such as prostatectomies.
  • Instrument 202 can include a camera. Camera can be positioned entirely at the working end 204 of instrument 202 and can include a CCD or CMOS device 206 connected to a monitor and/or recording device 208 by one or more wires 210. Alternatively, camera can be a distributed camera that consists of a lens 206 at the working end 204 coupled to a monitor and/or recording device 208 by one or more fiber optic cables 210. In either form, the camera can be adapted and configured to image at an emission wavelength of a compound of interest that is excited by a wavelength emitted by the light source 100. This adaptation and configuration can be achieved by one or more physical or software filters as will be appreciated by one of skill in the art.
  • instrument 202 is adapted and configured for illumination of one or more objects of interest. In other embodiments, instrument 202 is adapted and configured for treatment of one more objects of interest in accordance with known laser medicine and laser surgery techniques.
  • instrument 202 can include one or more lenses 212 adapted and configured to focus the light emitted by the light source into a cutting beam.
  • FIG. 2B another embodiment of a medical device 200b is depicted.
  • a method 300 of illuminating an object of interest is provided.
  • a photosensitive compound is administered to a subject.
  • the photosensitive compound can be any compound that responds to one or more wavelengths of light. For example, some compounds fluoresce when exposed to particular wavelengths of light.
  • the photosensitive compound preferentially binds to cancerous cells.
  • a photosensitive compound known as YC-27 binds to prostate-specific membrane antigen (PSMA), which is expressed on the surface of prostate cancer cells.
  • PSMA prostate-specific membrane antigen
  • YC- 27 is described in publications such as U.S. Patent Application Publication Nos. 2011/142760 and 2012/009121 and Y. Chen et al., "A low molecular weight PSMA-based fluorescent imaging agent for cancer," 390(3) Biochem. Biophys. Res. Comm. 624-29 (2009).
  • the photosensitive compound binds to other cells.
  • a photosensitive compound that binds to nerve cells would allow healthcare professionals to visualize nerves within an organ and avoid damaging these nerves.
  • One exemplary compound, 3,3'-diethylthiatricarbocyanine iodide (DBT) is described C.Wang et al., 31(7) The Journal of Neuroscience 2382-90 (Feb. 16, 2011).
  • DBT 3,3'-diethylthiatricarbocyanine iodide
  • an aptamer, a small peptide, or any other known small molecule that specifically binds to nerves (without inhibiting nerve function) could be identified and conjugated with a fluorescent dye.
  • exemplary photosensitive compounds include metal nanoparticles such as iron nanoparticles or gold nanoparticles. Such metal nanoparticles rapidly heat when exposed to near infrared (NIR) radiation from a light source as described herein. Heating of metal nanoparticles can increase the sensitivity to adjacent cells to therapeutics.
  • NIR near infrared
  • a medical device as described herein applies one or more excitation frequencies to the object of interest.
  • the excitation frequency of interest may vary between photosensitive compounds.
  • the excitation frequency has a wavelength of about 780 nm.
  • step S306 the object of interest is optionally imaged at an emission wavelength of the photosensitive compound.
  • the emission wavelength is above 800 nm.
  • FIG. 4 a prototype light source as constructed by the inventors is depicted.
  • the prototype includes two fans to facilitate high air flow and dissipate heat.
  • the use of an aluminum block also facilitates heat dissipation.
  • Multiple toggle switches control the net intensity (power) of the laser output.
  • a weighted swing flap blocks aperture to prevent any stray light from escaping if any of the lasers are out of alignment.
  • FIG. 5A-5D a light source as discussed herein was utilized to selectively illuminate the photosensitive compound YC-27 within the PSMA-positive xenograft after administration to a mouse.
  • the white arrow points to a LMD-PSMA tumor, while the yellow arrow points to a LMD tumor.
  • FIG. 5D compares the quantitation of signal from the tumor over background between an embodiment of the invention and the PEARL® imaging system available from LI-COR Biosciences of Lincoln, Kansas.
  • 3E6 LMD or LMD-PSMA cells were injected contra laterally into the upper flanks of an Athylic Nu/Nu mice.
  • the tumors were -0.2 cc, 79.4 ug/Kg YC-27 (50 nmole/Kg) was administered by IV.
  • the animal was imaged with the light source as described herein (5.5 Watt 780nm Laser & NIR optimized sensor for detection) and the PEARL imager at 170 micron resolution.
  • the imaging with the light source was conducted at 10 frames per second, and the stills were captured using a frame grabber.
  • TKX Tetamine HC1 50mg/mL
  • Zolazepam HC1 50mg/mL a 30 kg male Yorkshire pig was anesthetized with 1.32 ml of TKX (Tiletamine HC1 50mg/mL; Zolazepam HC1 50mg/mL;
  • a 1 cc LMD-PSMA xenograft was generated in an Athymic Nu/Nu mouse. 19.1 ug/Kg YC-27 was injected intravenously 24 hours prior to the pig surgery. The tumor was surgically removed and placed behind a peritoneum of the pig. The xenograft was then located in the abdomen of the pig with NIR guidance.
  • dilutions of YC-27 with 1E4 LMD-PSMA cells were plated into a flat bottom black 96 well plate in duplicates & layered with 100 ul of 1% agarose.
  • Two plates were made at the same time and one shipped on ice to Intuitive Surgical, Inc. of Sunnyvale, California while the other was kept at 4° C. Both plates were imaged about the same time 48 hours post plating.
  • One plate was imaged with the DA VINCI® surgical system with its standard high definition system and the FIREFLYTM NIR arm.
  • the second plate was imaged with an embodiment of the invention at 5 frames per second. For both systems, stills were obtained with frame grabber software and pixels counted with ImageJ software available at http://rsb.info.nih.gov/ij.
  • the red line indicates the visual limit of detecting signal over background.
  • animals with established LMD-PSMA xenografts were given 1 nmole YC-27 about 20 hours before the surgery.
  • the first (leftmost) four columns contain photographs of surgeries performed using with NIR guidance so that there was no residual tumor left.
  • the second (rightmost) four columns contain photographs of surgeries performed without NIR guidance. Under white light, both sets looked the same, i.e., it was impossible to determine whether any of the tumors remained under white light.
  • All the animals were imaged with NIR device described herein post-surgery and with the PEARL® imaging system after the animals were sutured. The animals were also imaged seven days post-surgery with the PEARL® imaging system. 1 nmole YC-27 was administered intravenously the day before the imaging.

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  • Physics & Mathematics (AREA)
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  • Veterinary Medicine (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Optics & Photonics (AREA)
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  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Electromagnetism (AREA)
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  • Radiation-Therapy Devices (AREA)

Abstract

L'invention concerne, dans un aspect, une source lumineuse comportant un logement contenant au moins une paroi définissant une ouverture et un ou plusieurs lasers placés à l'intérieur du logement de manière à ce que chacun des lasers soit positionné selon un angle par rapport à l'axe et génère un faisceau concentré sur un point focal commun le long de l'axe, à intérieur du logement, et décalé par rapport à l'ouverture. L'ouverture est adaptée et conçue pour recevoir une fibre optique le long de l'axe. Un autre aspect de l'invention concerne une source lumineuse et un instrument contenant une fibre optique. L'instrument est couplé de manière amovible avec la source lumineuse de manière à ce que la fibre optique se trouve dans l'ouverture.
PCT/US2014/019041 2013-03-01 2014-02-27 Sources lumineuses, dispositifs médicaux et méthodes d'éclairage d'un objet étudié Ceased WO2014134314A1 (fr)

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US201361771456P 2013-03-01 2013-03-01
US61/771,456 2013-03-01
US201361822842P 2013-05-13 2013-05-13
US61/822,842 2013-05-13

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