WO2011153260A1 - System for illuminating a body orifice - Google Patents
System for illuminating a body orifice Download PDFInfo
- Publication number
- WO2011153260A1 WO2011153260A1 PCT/US2011/038790 US2011038790W WO2011153260A1 WO 2011153260 A1 WO2011153260 A1 WO 2011153260A1 US 2011038790 W US2011038790 W US 2011038790W WO 2011153260 A1 WO2011153260 A1 WO 2011153260A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- speculum
- fluid
- proximal end
- distal end
- body wall
- Prior art date
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Classifications
-
- 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
- A61B1/227—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 for ears, i.e. otoscopes
Definitions
- This invention relates generally to the medical field, and more specifically to an improved system for illuminating a body orifice in the medical field.
- Ear wax, or cerumen is a normal secretion that becomes a problem in certain circumstances. For instance, excessive and impacted ear wax is a clinical concern because it can obstruct visualization of the tympanic membrane for health assessments. Furthermore, if ear wax is in contact with the tympanic membrane, it can cause discomfort and occasionally vertigo, tinnitus, or chronic cough. As another example, impacted cerumen may cause a conductive hearing loss, resulting in reduced hearing ability and interfering with formal hearing assessments.
- ear candling a process involving placing a hollow candle in the ear canal and lighting one end of the candle, with the intent of allowing heat to create a pressure differential that draws cerumen out of the ear.
- irrigation is a common procedure that involves expelling fluid from a syringe directly into the ear canal to dislodge and wash out ear wax.
- irrigation is a common procedure that involves expelling fluid from a syringe directly into the ear canal to dislodge and wash out ear wax.
- irrigation is a common procedure that involves expelling fluid from a syringe directly into the ear canal to dislodge and wash out ear wax.
- irrigation is a common procedure that involves expelling fluid from a syringe directly into the ear canal to dislodge and wash out ear wax.
- this messy and time-consuming procedure is performed without the ability to visualize or easily control the direction of the fluid, and risks complications such as a perforated ear drum.
- FIGURE 1 is a perspective view of the system of a first preferred embodiment
- FIGURES 2A and 2B are perspective views of the fluidic pump system and the base with speculum, respectively, of the system of a first preferred embodiment
- FIGURES 3A-3D are various views of the speculum of the system of a first preferred embodiment
- FIGURES 4A-4C are schematics of variations of bore cross-sections in the speculum of the system of a first preferred embodiment
- FIGURES 5A-5C are schematics of the base in the system of a preferred embodiment
- FIGURE 6 is a variation of the base in the system of a preferred embodiment
- FIGURE 7 is a variation of the speculum in the system of a first preferred embodiment
- FIGURES 8A-8B are perspective and top views, respectively, of the system of a second preferred embodiment
- FIGURES 9A-9E are various views of the speculum of the system of a second preferred embodiment
- FIGURE 10 is a schematic of the magnifier of the base in the system of a second preferred embodiment
- FIGURES 11A-11E are schematics of the method of using the system of a preferred embodiment.
- FIGURE 12 is a schematic of the steps of an optional step in the method of using the system of a preferred embodiment.
- the system for illuminating a body orifice is used to increase visualization of the body orifice, preferably to aid removal of an obstruction in the body orifice.
- the system is used to aid removal of ear wax, or cerumen, from an ear canal of a patient.
- the system may be used to aid removal of excessive, impacted ear wax, and/or to aid removal of ear wax prior to an audiology exam to increased specificity of the audiology exam.
- the system is safer, less time- consuming, more comfortable for the patient, and more affordable than conventional ear wax removal treatments.
- the system is primarily described in the context of ear wax removal from the ear canal, the system may alternatively be used to aid removal of obstructions from any suitable body orifice or passageway, such as the nose or throat. Furthermore, the system may be used to increase visualization of the body orifice for health assessment, or any suitable purpose.
- the system for illuminating a body orifice includes: an optical waveguide speculum 110 including a distal end 112 insertable into the body orifice, a proximal end 114 wider than the distal end 112, and an at least partially circumferential body wall 120 defining a bore 122 passing from the proximal end 114 of the speculum to the distal end 112 of the speculum; and a base 140 that couples to the proximal end 114 of the speculum and receives a light OTLS-P14-PCT source 150 adjacent to the speculum, such that the speculum 110 is configured to propagate light from the light source along the body wall 120, thereby illuminating the body orifice.
- the body wall 120 of the speculum includes an inner surface and an outer surface, and defines at least partially between the inner and outer surfaces a fluidic channel 124 configured to deliver fluid from the proximal end 114 of the speculum to the distal face of the speculum, and a suction channel 126 configured to drain fluid from the distal face of the speculum to the proximal end 114 of the speculum.
- the speculum 110 is designed to be disposable or used a limited number of times (e.g. disposed after use with one patient) and the base 140 is designed to be reusable (e.g. for use with multiple patients).
- the speculum and the base are both designed to be reusable (e.g. sterilized between multiple patients) or the speculum and base are both designed to be disposable or used a limited number of times.
- the speculum 110 functions to propagate or carry light throughout its body, thereby illuminating the body orifice when the speculum 110 is inserted in the body orifice.
- the speculum 110 may further function to manipulate the structure of the body orifice.
- the speculum 110 may straighten the ear canal when inserted into the ear canal.
- the speculum preferably has an approximately frustoconical body shape, with a distal end 112 insertable into the body orifice, a proximal end 114 wider than the distal end 112, and at least a partial circumferential body wall 120 having an inner surface 120a and an outer surface 120b.
- the body wall 120 may be thicker at the proximal end 114 of the OTLS-P14-PCT speculum than at the distal end 112 of the speculum.
- the speculum body may include an elongated neck portion between the proximal and distal ends, such that the body wall 120 has approximately the same diameter or width along the neck portion.
- the diameter of the neck portion may be approximately equal to, or slight larger than, the diameter of the distal end of the body, and substantially narrower than the proximal end 114 of the body.
- the neck portion of the speculum body may have any suitable diameter, and the speculum may be any suitable general shape.
- the speculum body is preferably an optical waveguide such that it propagates light throughout its body due to total internal reflection and/or other i34material properties.
- the speculum body may be made of a transparent polymeric material such as acrylic or polycarbonate, or of another suitable light-propagating material such as glass.
- the speculum body may be manufactured in an injection molding process, machining process, or any suitable process.
- the speculum body in particular the inner surface 120a of the body wall
- the bore 120 defines a bore 122 passing from the proximal end 114 of the body to the distal end of the body.
- the bore 122 provides a passageway through which the body orifice may be more easily visualized, through the sides of the body wall 120 and/or through the distal end 112 of the speculum body.
- the user may view the body orifice from the proximal end of the speculum (FIGURE 3C).
- the proximal end and distal end of the body are preferably open such that the bore 122 is a through hole on both ends, but alternatively the proximal and/or distal end of the body may be closed such that the bore is a blind hole or a hollow cavity closed on both ends.
- the bore 122 is preferably wider at a proximal end 114 than at the distal end 112.
- the body wall 120 preferably defines at least partially between the inner and outer surfaces of the body wall a plurality of channels. Some or all of the channels may be contoured to follow the curvature of the frustoconical body.
- the plurality of channels includes a fluidic channel 124 configured to delivery fluid from the proximal end of the body to the distal face, and a suction channel 126 configured to drain fluid from the distal face to the proximal end of the body.
- the plurality of channels may further include any suitable kind of channel such as for guiding an extraction tool used for manually removing or dislodging an obstruction in the orifice.
- the fluidic channel 124 enables a medical practitioner or other user to irrigate or introduce fluid into the body canal, such as for dislodging at least a portion of an obstruction (e.g., some or all of impacted ear wax in the ear canal) or cleaning the body orifice.
- the suction channel 126 enables the user to drain or remove the fluid from the introduced fluid from the body canal, any dislodged portions of the obstruction, and/or other particles, preferably through suction or other pressure differential.
- the fluid and particles may additionally and/or alternatively be removed through continued flushing of fluid into the body orifice, gravity, or any suitable manner.
- the fluidic channel 124 and suction channel 126 preferably extend fully from a proximal face on the proximal end 114 of the speculum 110 to a distal face on the distal end 112 of the speculum 110.
- the fluidic channel 124 preferably has an inlet 124a on the proximal end of the speculum that couples to a fluid supply
- the suction OTLS-P14-PCT channel 126 preferably has an inlet 126a on the proximal end of the speculum that couples to a fluid receptacle.
- one or more of the plurality of channels may depart from the body wall 120 at some location along the channel length.
- the fluidic channel 124 or suction channel 126 may terminate on the side of the body wall.
- the fluidic channel 124 and suction channel 126 may be at least partially external or separate from the speculum.
- the fluidic channel and/or suction channel may include separate tubing that are coupled to the inner surface, outer surface, or within the body wall of the speculum, to carry fluid to and from the body orifice.
- the fluidic channel 124 and suction channel 126 may be similar in diameter, but one of the channels may be slightly larger than the other. Furthermore, each channel may be of uniform diameter or varying diameter along its length. For example, the distal end 112 of the fluidic channel 124 may be narrowed, similar to a nozzle to influence flow rate and/or force of the fluid exiting the fluidic channel 124.
- the channels may further include fluid control elements such as valves to modulate fluid flow rate.
- the fluidic and suction channels are preferably generally smaller in diameter than the bore 122.
- the bore 122 has a larger cross-sectional area than the cross- sectional area of the fluidic channel 124 and the suction channel 126, which may help increase visualization of the body orifice.
- the bore 122 at the distal end 112 of the speculum body the bore 122 preferably has an approximate lune shape that is more than half the cross-sectional area of the speculum 110.
- the bore 122 may have a circular, semicircular, or other suitable cross-sectional shape.
- the fluidic channel 124 and suction channel 126 may be located such that on the distal end 112 of the speculum body, the cross-sections of the fluidic and suction channels are located in the concavity of the lune cross-section of the bore 122.
- the bore, fluidic channel 124, and suction channel 126 may alternatively have any suitable shape and relative size.
- the base 140 of the system functions to illuminate the speculum 110, and may further function to provide a handhold for the user of the system.
- the base 140 couples to the speculum 110 and receives (e.g., include or be coupled to) a light source such that the speculum 110 propagates light from the light source through the speculum body, thereby illuminating the body orifice when inserted in the orifice.
- the base 140 may further receive a magnifier aligned with the bore 122 that magnifies the view of the ear canal or other body orifice.
- the base 140 is a handheld enclosure.
- the base 140 may include hand contours, such as side contours, to better accommodate a handheld grasp of the base by the user.
- the base 140 preferably includes a cradle 142, slot, or other receptacle to which the speculum 110 couples.
- the cradle 142 may be arcuate to receive the circular proximal portion of the speculum 110.
- the base 140 and speculum 110 may removably couple to one another based on interference from relative dimensions such as with a snap fit, OTLS-P14-PCT and/or may removably couple to one another with a fastener such as threads, pins, clips, latches, straps, tabs and slots, adhesive, or any suitable means for coupling.
- a fastener such as threads, pins, clips, latches, straps, tabs and slots, adhesive, or any suitable means for coupling.
- the base 140 and speculum 110 may be more permanently coupled to one another (e.g. press fit or permanent adhesive).
- the base 140 preferably receives a plurality of light sources 150 integrated in the base 140 and arranged such that the lights are adjacent to the proximal end 114 of the speculum 110, such as within the cradle or other part of the base 140 that couples to the speculum 110.
- the light sources may include light-emitting diodes (LEDs), optical fibers, fluorescent materials, or any suitable light source.
- the plurality of light sources are coupled to or embedded behind the cradle 142 of the base, such that a proximal face of the speculum 110 receives light from the light sources.
- the light sources are in an arcuate arrangement adjacent to at least a portion of the circumferential body wall 120, and may be spaced circumferentially equally apart such that the speculum 110 propagates light in a more uniform matter.
- the light sources may be in any suitable arrangement along the base.
- the base 140 preferably includes electronics 152 that power and control the light sources.
- the electronics may include user controls that power the light sources on and off, such as a switch 154 on a side contour for easy user accessibility. Other user controls may include switches, sliders, or other interactive elements that adjust light intensity, light color, and/or any suitable characteristic of the light sources.
- the electronics 152 may include controls for selectively OTLS-P14-PCT powering only a particular portion of the light sources, to increase positional control of the light that is passed to the speculum 110.
- the electronics may also include a power source such as a battery, circuitry for recharging the battery (e.g.
- circuit boards and/or another portion of the electronics 152 may be enclosed within two coupleable portions of the base, but may alternatively be in any suitable location.
- the base 140 may receive or couple to one or more external light sources.
- the base may include a slot or other light receptacle that receives an external ring of lights, handheld flashlight, or any suitable external light sources to be placed adjacent to the speculum 110.
- the base may include optical fibers, mirrors, or any other suitable light-directing elements that direct light to the speculum 110.
- the magnifier 160 of the base 140 functions to magnify the view of the body orifice and/or obstructions in the body orifice.
- the magnifier 160 is coupled to base 140 proximate to the speculum 110, and preferably aligned with the bore 122 of the speculum.
- the magnifier 160 is an optical lens system.
- the optical lens system may include a single convex lens (e.g. providing 10X or any suitable level of magnification) or a dual lens system with lenses placed in series.
- the optical lens system includes multiple lenses placed in a binocular setup for viewing with two eyes.
- the magnifier 160 is OTLS-P14-PCT preferably inserted in a slot 162 in the base.
- the magnifier may be rotatable in the base, such as to allow the user to adjust the position and/or orientation of the magnifier.
- the base 140' is a frame or any suitable structure that couples to the speculum 110, receives or includes a plurality of light sources, and/or includes a magnifier 160 aligned with the speculum 110, similar to the handheld enclosure embodiment of the base.
- the base is a frame having a first end that includes a magnifier and a second end that includes a ring of light sources.
- the light sources may be a ring of LEDs encased in a plastic ring or other protective cover.
- the second end couples directly to the speculum 110, such that the speculum 110 receives and propagates light from the light sources on the second end of the frame.
- the frame may be approximately cylindrical, a rectangular prism, or any suitable shape.
- the system of the first preferred embodiment may further include a fluid pump system 170 that functions to control flow of fluid through the fluidic channel 124 and/or suction channel 126.
- the fluid pump system 170 is preferably coupled to at least the fluidic channel 124 and a fluid supply (e.g. container of water, saline, or other suitable fluid for irrigation or other purposes) and controls fluid flow from the fluid supply through the fluidic channel.
- the fluid pump system is preferably further coupled to the suction channel.
- the fluid pump system is preferably a closed fluidic system with an outlet 174 that introduces fluid into the body orifice through the fluidic channel 124 of the speculum and an inlet 172 that receives fluid from the body orifice through the suction channel 126 of the speculum.
- the fluidic pump system may include a positive displacement pump such as a peristaltic pump, or any suitable kind of fluid pump or flow actuator.
- the fluidic pump system may include manually-powered flow actuators such as a syringe or hand pump.
- the closed fluidic system may further include a filter
- the filter may include a mesh screen, valves, a centrifuge, or any suitable filtering means to remove particles (e.g. dislodged ear wax, dirt, or skin particles) from the drained fluid.
- the filter may be coupled directly to the flow actuator, tubing, or any suitable portion of the fluidic pump system.
- the 110 or other portion of the system further includes a tool guide 132, passing along the speculum towards the distal end 112 of the speculum, that helps guide and provide controlled movement of an extraction tool 134 used for removing obstructions in the body orifice.
- the extraction tool 134 is preferably a thin-handled, elongated tool with a tip adapted to capture or dislodge the obstruction, such as an angled curette tip, a hook tip, or forceps.
- the tool guide may be one or more of several variations. In a first variation, the tool guide is a groove, such as a linear slot, having a width approximately the width of (preferably slightly wider than) the extraction tool.
- the tool guide is an enclosed channel within the body of the wall, similar to the fluidic OTLS-P14-PCT and suction channels.
- the tool guide is an external channel coupled to the inner surface or outer surface of the body wall 120 of the speculum.
- the tool guide and/or extraction tool may include a stopper or other mechanisms that limit the extent to which the extraction tool may enter the stopper, thereby limiting the extent to which the extraction tool may enter the body orifice.
- a portion of the extraction tool may abut a portion of the tool guide to help prevent the extraction tool from extending too far into the ear canal and causing damage to the ear drum.
- the tool guide and/or extraction tool may include ruled, measured tick marks or indications that allow the user to monitor the extent to which the extraction tool is inserted.
- the fluidic channel 124 and/or suction channel 126 may include a targeting mechanism 128 that indicates the location that the fluidic channel 124 will introduce or drain fluid, which may be useful to strategically aim the jet of fluid from the fluidic channel at a particular location.
- the fluidic channel and/or suction channel may include an optical fiber, approximately centrally located within the channel, that propagates a light signal to a precise point within the body orifice. The light signal from the targeting mechanism is visible to the user through the bore, such as for targeting a particular portion of impacted ear wax for irrigation and dislodgement.
- the targeting mechanism may be any suitable mechanism.
- the light sources coupled to the base may include a targeting light source OTLS-P14-PCT
- the system 200 for illuminating a body orifice includes: an optical waveguide speculum 210 with an approximately frustoconical profile and including a distal end 212 insertable into the body orifice, a proximal end 214 wider than the distal end, a body wall 220 with a fully circumferential portion 220b and a partially circumferential portion 220a; and a base 240 that couples to the proximal end of the speculum 210 and receives a light source adjacent to the speculum 210.
- the speculum 210 is configured to propagate light from the light source along the body wall.
- the system of the second preferred embodiment is preferably similar to that of the first preferred embodiment, except as described below.
- the system of the second preferred embodiment may lack the fluidic channel and/or suction channel of the first embodiment.
- the speculum 210 of the second preferred embodiment may be used to illuminate and gain access to a body orifice, such as in applications in which irrigation for removing an obstruction is not necessary or in which an external irrigation system (such as a manually-controlled syringe placed within the speculum) may be used.
- the speculum 210 is preferably similar to that of the first preferred embodiment, except as described below.
- the speculum 210 preferably includes a generally frustoconical OTLS-P14-PCT profile and includes a body wall 220 with a fully circumferential portion 220b proximate to the distal end 212 of the body and a partially circumferential portion 220a proximate to the proximal end 214 of the body.
- the fully circumferential portion 220a preferably defines a bore 222.
- the partially circumferential portion 220a preferably is a "cutaway" portion of the frustoconical shape of the speculum 210, that may function to allow for greater an easier access into the bore and inner surface of the speculum.
- the partially circumferential portion 220a is preferably a longer portion of the speculum than the fully circumferential portion 220b, but the two portions may have any relative lengths.
- the profile of the partially circumferential portion of the body wall is an arc measuring less than 270 degrees, and more preferably of approximately 180 degrees (i.e. the partially circumferential portion extends approximately halfway around the circumference of the frustoconical speculum shape).
- the speculum 210 may further include a debris collector
- the debris collector may a lower or circumferential channel on the proximal portion of the speculum that receives gauze, an adhesive gel membrane, cup, or other receptacle.
- the debris collector preferably captures and contains particles (e.g. ear wax) that falls and/or is washed out of the body canal through the speculum.
- the base 240 of the second preferred embodiment is preferably similar to that of the first preferred embodiment, except that the magnifier 260 of the second preferred embodiment may have a cutout, such as for more visibility into the bore of the OTLS-P14-PCT speculum 210 and/or greater physical access into the speculum.
- the magnifier 260 includes a circular segment 262 of an optical lens.
- the magnifier 260 is a circular lens with approximately one quarter removed.
- the magnifier is preferably rotatable within the base, which may allow the user to adjust the orientation of the cutout in the magnifier.
- Additional embodiments of the system include any combination of aspects of the first and second preferred embodiments, including any combination of the variations of the speculum, base, fluidic channel, suction channel, light sources, magnifier, and fluidic pump systems.
- the speculum of the first preferred embodiment may include a debris collector similar to the speculum of the second preferred embodiment.
- the speculum of the second preferred embodiment may include a fluidic channel and/or suction channel similar to the speculum of the first preferred embodiment.
- a method 300 of using the system of the first preferred embodiment to remove an obstruction in a body orifice includes the steps of: inserting a distal end of an approximately frustoconical optical waveguide speculum into the body orifice S310; coupling a proximal end of the speculum to a light source S320; allowing the inserted speculum to propagate light from the light source S322, thereby illuminating at least a portion of the body orifice; directing fluid through a fluidic channel S330 coupled to the speculum into the body orifice, thereby dislodging at least a portion of the obstruction from the body orifice; draining pumped fluid and the dislodged obstruction from the body orifice S340 through a suction channel coupled to OTLS-P14-PCT the speculum; filtering the drained fluid S350; and redirecting the filtered fluid through the fluidic channel S260 into the body or
- the method may further include guiding an extraction tool towards the obstruction S370 and/or indicating a targeted location of directed fluid S380.
- indicating a targeted location of directed fluid may include coupling a second light source to a second waveguide and allowing the waveguide to propagate light from the second light source towards the targeted location of directed fluid.
- a method of using the system of the second preferred embodiment may be similar to method 300, except the method of using the system of the second preferred embodiment may omit the steps of directing fluid through a fluid channel, draining the pumped fluid, filtering the drained fluid, and redirecting the filtered fluid.
- the method of using the second preferred embodiment may additionally and/or alternatively include manually providing fluid into the speculum such as with a syringe.
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Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2011800337113A CN103079457A (en) | 2010-06-01 | 2011-06-01 | System for illuminating a body orifice |
JP2013513306A JP2013531518A (en) | 2010-06-01 | 2011-06-01 | System for irradiating a body opening |
EP11790348.4A EP2629657A4 (en) | 2010-06-01 | 2011-06-01 | System for illuminating a body orifice |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US39667910P | 2010-06-01 | 2010-06-01 | |
US61/396,679 | 2010-06-01 | ||
US13/150,915 | 2011-06-01 | ||
US13/150,915 US8840546B2 (en) | 2010-06-01 | 2011-06-01 | System for accessing a body orifice |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2011153260A1 true WO2011153260A1 (en) | 2011-12-08 |
Family
ID=45022644
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2011/038790 WO2011153260A1 (en) | 2010-06-01 | 2011-06-01 | System for illuminating a body orifice |
Country Status (5)
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US (1) | US8840546B2 (en) |
EP (1) | EP2629657A4 (en) |
JP (1) | JP2013531518A (en) |
CN (1) | CN103079457A (en) |
WO (1) | WO2011153260A1 (en) |
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US20130023914A1 (en) * | 2011-07-18 | 2013-01-24 | Clearear, Inc. | System for accessing body orifice and method |
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CN106333640B (en) * | 2016-08-24 | 2018-02-09 | 汕头大学医学院第一附属医院 | Cavernous body duct rinses observation electric auriscope |
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CN109259721B (en) * | 2018-09-08 | 2021-01-15 | 刘建华 | Bronchoscope with function of taking a breath |
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USD966508S1 (en) * | 2020-04-30 | 2022-10-11 | Yingjie Sun | Otoscope protective cap |
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- 2011-06-01 JP JP2013513306A patent/JP2013531518A/en active Pending
- 2011-06-01 CN CN2011800337113A patent/CN103079457A/en active Pending
- 2011-06-01 WO PCT/US2011/038790 patent/WO2011153260A1/en active Application Filing
- 2011-06-01 EP EP11790348.4A patent/EP2629657A4/en not_active Withdrawn
- 2011-06-01 US US13/150,915 patent/US8840546B2/en not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
JP2013531518A (en) | 2013-08-08 |
US20110295073A1 (en) | 2011-12-01 |
EP2629657A4 (en) | 2014-06-04 |
EP2629657A1 (en) | 2013-08-28 |
CN103079457A (en) | 2013-05-01 |
US8840546B2 (en) | 2014-09-23 |
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