JP5631215B2 - 血糖管理維持システム - Google Patents
血糖管理維持システム Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/412—Detecting or monitoring sepsis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16804—Flow controllers
- A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
Description
指示体は、調べられている媒体中で起きていることについて伝える。指示体システムは、指示体を含む検知システムの特定のタイプである。可動式指示体システムの例はプローブであり、一方、固定式指示体システムはセンサーであることができる。本発明のある実施形態によって使用される指示体システムは、被分析物結合部分と操作可能的に結合される蛍光色素体を含み、被分析物の結合によって蛍光色素体濃度における見掛けの光学的変化(例えば、発光強度)が引き起こされる。更に、比例的pH検知が可能となるように、蛍光色素体はスペクトル特性において検出可能な差を示す異なる酸形態および塩基形態を有することが望ましい。例えば、HPTS−TriLysMA(下で詳細に記載する)などの蛍光色素と操作可能的に結合される3,3’−oBBV(下で詳細に記載する)などのグルコース結合部分は、蛍光色素の発光強度を消光させ、その消光の程度はグルコースが結合すると低減され、グルコース濃度に関連して発光強度が増大することになる。好ましい実施形態において、指示体システムは、少なくとも2個のアニオン基を有する色素と、少なくとも2個のボロン酸を有する消光体とを含む。更に好ましい実施形態において、指示体システムは、互いに反応(消光)するために検知部分が物理的に十分近いままであるように、検知部分(例えば、色素−消光体)を固定するための手段も含む。生体内検知が望ましいので、そのような固定化手段は好ましくは水性環境(例えば、血管内)において不溶性であり、標的被分析物に対して透過性であり、検知部分に対して非透過性である。典型的には、固定化手段は非水溶性有機ポリマーマトリックスを含む。例えば、HPTS−TriLysMA色素および3,3’−oBBV消光体がDMAA(N,N−ジメチルアクリルアミド)ヒドロゲルマトリックス(下で詳細に記載する)中に有効に固定され、それによって生体内においてpHおよびグルコースを検知することができる。
「蛍光色素体」は、特定波長の光を当てると、より長い波長での光を放出する、即ち、それが蛍光発光する物質を指す。蛍光色素体としては、これらに限定されないが、蛍光有機色素、有機金属化合物、金属キレート、蛍光共役ポリマー、量子ドットまたはナノ粒子、および上記のものの組み合わせが挙げられる。場合によっては、蛍光有機色素を単に蛍光色素と呼ぶ。蛍光色素体は、ポリマーに結合している別個の部分または置換基であってもよい。
本発明の広範な態様に従って、被分析物結合部分は、被分析物結合の量に関連した形で、被分析物に結合でき、(例えば、発光信号強度の変化として)蛍光色素体の濃度を測定できる少なくとも2つの機能性を提供する。ある実施形態においては、被分析物結合部分は消光体と会合する。「消光体」は、それが存在する場合、色素の発光を低減する化合物を指す。消光体(Q)は、分離した化合物、第2の分離した化合物または重合性化合物に転化可能な反応中間体より選択されるか、または、Qは、前記反応中間体または重合性化合物より調製されるポリマー中のペンダント基または鎖単位であって、そのポリマーは水溶性または水分散性であるか、または、不溶性ポリマーであり、このポリマーは架橋されていてもよい。
b)1個以上のボロン酸基が1個の窒素に結合している第1の芳香族部分に結合し、1個のボロン酸および反応性基が第2の芳香族基に結合し、その第2の芳香族基は第2の窒素に結合している;
c)1個のボロン酸基および反応性基が1個の窒素に結合している第1の芳香族基の第1の芳香族部分に結合し、ボロン酸基および反応性基が第2の窒素に結合している第2の芳香族部分に結合する;および
d)1個のボロン酸がそれぞれの窒素に結合し、反応性基がヘテロ芳香環に結合する。
Zは反応性基であり、
R’はベンジル環上のオルト、メタまたはパラ位の−B(OH)2であり、
R”はH−であり、あるいは、R”は本明細書中で定義される通りのカップリング基、または、フルオロ−またはメトキシ−などのボロン酸の酸性度を変えるために特に使用される置換基であり、
Lは、ビオロゲンをポリマーまたはマトリックスに結合するために使用される反応性基に検知部分を共有結合する2価部分である。Lの例としては、直接結合、または1〜8個の炭素原子を有し、スルホンアミド[−SO2NH−]、アミド[−(C=O)N−]、エステル[−(C=O)−O−]、エーテル[−O−]、スルフィド[−S−]、スルホン[−SO2−]、フェニレン[−C6H4−]、ウレタン[−NH(C=O)−O−]、尿素[−NH(C=O)NH−]、チオ尿素[−NH(C=S)−NH−]、アミド[−(C=O)NH−]、アミン[−NR−(式中、Rは1〜6個の炭素原子を有するアルキルと定義される)]などより選択される1個以上の2価の結合基を末端に有するか、炭素鎖中に有していてもよい低級アルキレンから、それぞれ独立に、選択されるものが挙げられる。
ある実施形態では、流体が移動しない生体外で用いるために、検知成分は個々の(分離した)成分として使用される。色素および消光体は液体溶液中で一緒に混合され、被分析物が加えられ、蛍光強度の変化が測定され、そして、これらの成分は廃棄される。滲出を防止するために検知成分を捕捉するために使用できるポリマーマトリックスは存在する必要がない。検知成分は固定されていてもよく、これによって、移動流中の被分析物を測定するために使用することが可能になる。
比例的pH検知は知られている。例えば、米国特許出願公開第2006/0105174号明細書;同第2005/0090014号明細書を参照のこと。それらは、その全体の内容が参照により本明細書に組み込まれる。ある実施形態において、指示体システムは2つの形態(酸型および塩基型)で存在する蛍光色素体(例えば、蛍光指示色素)を含む。2つの波長での発光強度の比は、蛍光色素体濃度から独立に、pHを測定するために使用することができる。比例的pH検知に適する蛍光指示色素は(1)2つの励起波長(酸型および共役塩基型に対応する)および単一の発光波長を示す色素(例えば、HPTS色素);(2)単一の励起波長および2つの発光波長(酸型および塩基型);または(3)2つの励起−2つの発光色素であることができる。幾つかの色素、例えばSNARFまたはSNAFL色素などは、2つの発光特性および2つの励起特性の両方を有する場合がある。しかしながら、二重−二重色素、例えば、SNARFは、単一−二重、または二重−単一として使用できる。
本発明のある実施形態では、検知装置は、少なくとも1つの光源と、検出器と、蛍光レポーター色素システムを含むセンサーとを含む。ある実施形態では、蛍光レポーター色素システムは、被分析物結合消光体と操作可能的に結合している蛍光色素を含む。色素は消光体と共有結合していても、単に消光体と会合していてもよい。色素および消光体は操作可能的に結合しており、このことは、操作中、消光体が色素と相互作用し、色素の蛍光を変えるのに十分なほどに色素に近接していることを意味する。ある実施形態では、色素および消光体は、被分析物透過性ヒドロゲルまたは他のポリマーマトリックス内に一緒に閉じ込められていてよい。適切な波長の光により励起される場合、蛍光色素は光(例えば、蛍光)を発光する。光の強度は、被分析物結合の量によって変わる消光の程度に依存する。他の実施形態において、蛍光色素および消光体は、互いに共有結合する代わりに、ヒドロゲルまたは他のポリマーマトリックスに共有結合していてもよい。
図3は、蛍光色素(この場合はHPTS)の励起/吸収スペクトルの一例を示す。異なるpHで得られた蛍光色素の吸収スペクトルから、λ酸、λ塩基およびλ等吸収点を決定することができる。より低いpH(例えば、より酸性の条件)では、約405nmのピークは約460nmのピークより高く、従って、酸型の蛍光色素の吸収極大である。より高いpH(例えば、より塩基性の条件)では、約460nmのピークは約405nmのピークより高く、従って、塩基型の蛍光色素の吸収極大である。λ等吸収点は、吸収がpHに依存しない波長であり、例えば、HPTSでは約422nmである。
図4は、HPTS/MABP4を使用する比例的pH検知とI(塩基)/I(等吸収点)比の、グルコース濃度に依存しない関係を示す。MABP4の構造は以下の通りである。
図6は、溶液中の異なるpHでのSNARF−1の吸収スペクトルを示す。SNARFは、Molecular Probes社からの市販の色素の商標名である。これらの実験は、SNARF−1を使用して行った。図7および図8は、514nm励起/587nm発光(図7)または514nm励起/625nm発光(図8)で決定された異なるpHの溶液中のSNARF−1/3,3’−oBBVのグルコース応答曲線を示す。図9は、514nmの単一励起波長および587nmおよび625nmの発光波長で決定されたI(塩基)/I(酸)比を使用して、溶液中、SNARF−1/3,3’−oBBVを用いた、異なるグルコース濃度でのpHの比例的検知を示す。よって、消光体3,3’−oBBV(溶液中)と操作可能的に結合した二重−二重色素SNARF−1を単一励起体−二重発光体の蛍光色素体として使用し、比例的にpHを、そしてグルコースの両者を決定することができる。
図10は、異なるpHでのHPTS−triLysMA/3,3’−oBBVを含むDMAAヒドロゲル指示体システムのグルコース応答を示す。図11は、I(塩基)/I(酸)比を使用して、同一のヒドロゲルを用いた、異なるグルコース濃度でのpHの比例的検知を示す。この指示体システムは、生理学的pH範囲に渡って、線形のpH曲線を与えることが分かる。この例では、ヒドロゲルを光ファイバーの端部に埋め込んだ。酸および塩基発光信号は、手持ち式の検出器を使用して測定した。
図12は、I(塩基)/I(酸)比を使用して、HPTS−triCysMA/3,3’−oBBVを含むDMAAヒドロゲル指示体システムを用いた、異なるグルコース濃度でのpHの比例的検知を示す。この指示体システムは、生理学的pH範囲に渡って、線形のpH曲線を与えることが分かる。この例では、ヒドロゲルを光ファイバーの端部に埋め込んだ。酸および塩基発光信号は、手持ち式の検出器を使用して測定した。
他の実施形態において、蛍光共鳴エネルギー移動(FRET)の現象を利用することにより、グルコース濃度を決定することができる。FRETは、供与体蛍光色素体から受容体分子へのエネルギーの移動である。分子間相互作用によって供与体蛍光色素体が受容体にエネルギーを移動できるように、受容体分子が少なくとも一部を吸収する波長において蛍光を発する供与体蛍光色素体が受容体に近接している場合に、FRETが起きる。蛍光色素体の蛍光寿命は、ここで、蛍光寿命は蛍光色素体が励起状態のままである時間であるが、FRETによって変化する。よって、蛍光色素体の蛍光寿命を測定することよって、蛍光色素体が受容体に結合しているかどうかを決定することが可能になる。
将来的な臨床研究において、Van Den Berghe(米国特許出願公開第2002/0107178号明細書)は、入院以降に集中的なインシュリン治療を使用して、より厳密な代謝によってCIPNPの罹患率を低減できるという仮説を検証した。2000年2月2日から4月25日の間で、400人の患者がこの研究に含められた。彼らを、2つのインシュリン(Novo NordiskのActrapid H M NovoLet)治療計画の一方に無作為に割り当てた。
上記のVan Den Bergheのデータと結論、およびFurnaryと同僚らによる先行刊行物(例えば、Zerrら、Ann Thorac Surg、1997年、63巻:356〜361頁参照)は、厳密な血糖管理によって、著しく合併症を低減でき、ICU滞在を短縮でき、結果を改善できることを示唆している。残念ながら、著しい利益にも関わらず、介入前に血液グルコースレベルを250mg/dL以上にまで増加させることは、許容できる臨床ICUの実務だと依然考えられている。医療およびICU従事者が、重症疾患患者において、血液グルコースを、例えば、好ましい目標濃度の約80〜110mg/dl内で厳密に管理しようとしたくない理由は幾つかある。第一に、高レベルの血液グルコースは適応ストレス応答の一部である場合があり、ストレス中の低い血液グルコースレベルは免疫系および治癒に対して潜在的に有害であると一部の開業医は信じている(Mizock B、A.Am J Med、1995年、98巻:75〜84頁)。実際問題として、インシュリン投与後の連続的なグルコースのモニタリング、および血液グルコース濃度の変化の速度および方向(上昇、または低下)の信頼できる指示がなければ、ICUスタッフは、インシュリンによって誘発される急性低血糖症のリスクよりもむしろ、比較的高い血糖を許容して失敗する傾向がある。前述に鑑み、血液グルコース濃度がpHの変化について補正され、血液グルコースにおける変化の速度および方向を表示できるモニターにセンサーが操作可能的に連結されており、正確で連続的なグルコースのモニタリングが可能である血管内グルコースセンサーを使用することにより、重症疾患ICU患者における厳密な血糖管理の臨床的利益を促進および増加できると本出願人は仮定した。
65歳の男性が、開胸手術の後、集中治療室に入院する。彼が落ち着いた後、GluCath光ファイバーセンサーを血管内に配置する。センサーは、この光ファイバーセンサーの遠位領域に沿って配置されたヒドロゲル内に固定され、3,3’−oBBV消光体に操作可能的に結合したHPTS−triCysMA色素を含む。センサーの近位端は、光源と、グルコース濃度、および血液グルコースレベルにおける変化の速度および方向を連続的に、かつ即時に表示するように構成されたプログラム化可能なモニターとに連結される。モニターは、血液グルコースが目標範囲外(80mg/dl未満または110mg/dlを超える)になった場合、警報を発するようにプログラムされている。血液グルコース動向の速度および方向と、血液グルコース濃度の連続読み取りにより、ICU従事者は、介入が必要であるかを決定することができる。センサーがオンラインになると、直ちに、血液グルコース濃度がモニター上に300mg/dlと読み取られ、上昇していく。ICU看護師は、血液グルコースレベルを目標範囲内にまで下げるために計算された用量で、インシュリンを投与する。数分以内に、血液グルコースは低下し始める。グルコースの低下が速過ぎて、目標の低濃度である80mg/dlを通り越してしまうことを医師は危惧する。2時間以内に、血液グルコース濃度は100mg/dlとなり、安定する。数時間の通常の看護の後、血液グルコース濃度が上昇し始める。グルコース濃度が110mg/dlを超えると、ICU従事者に、グルコースレベルが上昇していることをモニターの警報が警告する。ICU看護師は、血液グルコースを所定の範囲内にまで低下させるのに十分な量のインシュリンを投与する。ICU内において、その後の7日間、患者の血液グルコース濃度の厳密な管理をICU従事者は維持することができる。回復は順調で、重症疾患多発性神経障害または他の合併症は観察されない。
Claims (20)
- それを必要とする患者において、血糖管理を維持するシステムであって、
グルコース結合部分に結合するグルコースの量およびpHに関連する光学的シグナルを即時に発生するように構成された、蛍光色素体とグルコース結合部分を含む化学的指示システムを含む、患者の体内に配置されるように構成された光学的グルコースセンサーと、
該グルコースセンサーに操作可能的に連結され、光学的シグナルを検知し、光学的シグナルから血液グルコース濃度を計算し、計算された血液グルコース濃度を表示するように構成されたモニターと、
表示された血液グルコース濃度が所定の濃度範囲外に変化する場合に、血液グルコース調節剤を投与するための送達装置と
を含み、
該送達装置は、血液グルコース濃度を所定の濃度範囲内に戻すのに十分な量の血液グルコース調節剤を送達し、それにより血糖管理を維持するように構成されているシステム。 - 該モニターは、さらに、血液グルコース濃度が所定の濃度範囲外に変化する場合、可視警報、可聴警報、または、その両方を発生するように構成されている請求項1に記載のシステム。
- 該モニターは、さらに、血液グルコース濃度が所定の濃度範囲外に変化する前に、血液グルコース調節剤を血液グルコース濃度の上昇または低下の傾向を反転するのに十分な量で投与できるように、血液グルコース濃度における変化の速度および方向を決定し、表示するように構成されている請求項1に記載のシステム。
- 該モニターは、さらに、血液グルコース濃度の変化の速度が所定の値を超えた場合、警報を発生するように構成されている請求項3に記載のシステム。
- 該所定の濃度範囲は、約60〜約130mg/dlグルコースである請求項1〜4のいずれか一項に記載のシステム。
- 該所定の濃度範囲は、約80〜約110mg/dlである請求項1〜5のいずれか一項に記載のシステム。
- 該血液グルコース調節剤は、インシュリン、グルコース、またはそれらの類似体または誘導体である請求項1〜6のいずれか一項に記載のシステム。
- 該蛍光色素体は、蛍光色素、有機金属化合物、金属キレート、蛍光共役ポリマー、量子ドットまたはナノ粒子、および上記のものの組み合わせから成る群より選択される請求項1に記載のシステム。
- 該蛍光色素は、約400nm以上の波長の光によって励起できる請求項8に記載のシステム。
- 該蛍光色素は、光酸化、加水分解および生分解に対して安定である請求項8または9に記載のシステム。
- 該蛍光色素はHPTS−TriCysMAを含む請求項8に記載のシステム。
- 該グルコース結合部分は3,3’−oBBVを含む請求項1に記載のシステム。
- 該蛍光色素体および該グルコース結合部分は、半透膜中に固定されている請求項1に記載のシステム。
- 該蛍光色素体および該グルコース結合部分は、ヒドロゲルマトリックス中に固定されている請求項1に記載のシステム。
- 該グルコースセンサーは光ファイバーを含む請求項1に記載のシステム。
- さらに、光源を含む請求項1に記載のシステム。
- グルコースのグルコース結合部分への結合は、血液グルコース濃度に関連した蛍光寿命の変化を引き起こす請求項1〜16のいずれか一項に記載のシステム。
- 該化学的指示システムは、さらに、グルコース結合部分に結合するグルコースの量および血液pHに関連する光学的シグナルを即時に同時に発生するように構成されている請求項1〜16のいずれか一項に記載のシステム。
- 該モニターは、さらに、血液グルコース濃度を表示する前に、血液pHの変化に合わせて血液グルコース濃度を補正するように構成されている請求項18に記載のシステム。
- それを必要とする患者において、血糖管理を維持するシステムであって、
光ファイバーの遠位端部分に沿って配置された指示システムを含み、血液グルコース濃度と血液pHとを同時に測定できるグルコースセンサーを含み、
該指示システムは、pHによって少なくとも第1および第2の異なる形態で存在し、この異なる形態は各々の第1および第2の発光に基づいて識別できる蛍光色素と、蛍光色素に操作可能的に結合したグルコース結合部分とを含み、
グルコース結合は、蛍光発光強度または蛍光発光寿命の光学的変化を引き起こし、この光学的変化は血液グルコース濃度に関連したものであり、
第1および第2の発光の比率は血液グルコース濃度に依存しないものであり、
該グルコースセンサーに操作可能的に連結され、発光シグナルをモニターし、光学的変化に基づいて血液グルコース濃度を決定し、酸型および塩基型の発光の比率に基づいて血液pHを決定し、血液pHの変化に合わせて血液グルコース濃度を即時に補正するように構成された制御装置を含むシステム。
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Cited By (2)
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WO2016200104A1 (ko) * | 2015-06-12 | 2016-12-15 | 서울대학교산학협력단 | 바이오 센서 및 그 형성 방법과 글루코오스 조절 시스템, 상기 글루코오스 조절 시스템의 형성 방법, 및 상기 글루코오스 조절 시스템을 이용한 글루코오스 조절 방법 |
KR101789687B1 (ko) * | 2015-06-12 | 2017-10-25 | 서울대학교산학협력단 | 글루코오스 조절 시스템, 상기 글루코오스 조절 시스템의 형성 방법, 및 상기 글루코오스 조절 시스템을 이용한 글루코오스 조절 방법 |
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US20120116191A1 (en) | 2012-05-10 |
EP2217316A1 (en) | 2010-08-18 |
US8535262B2 (en) | 2013-09-17 |
US8088097B2 (en) | 2012-01-03 |
WO2009067626A1 (en) | 2009-05-28 |
EP2217316A4 (en) | 2013-01-16 |
JP2011504399A (ja) | 2011-02-10 |
US20140018646A1 (en) | 2014-01-16 |
US8979790B2 (en) | 2015-03-17 |
US20090177143A1 (en) | 2009-07-09 |
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