JP5706504B2 - 摂取可能な事象マーカシステム - Google Patents
摂取可能な事象マーカシステム Download PDFInfo
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- JP5706504B2 JP5706504B2 JP2013232093A JP2013232093A JP5706504B2 JP 5706504 B2 JP5706504 B2 JP 5706504B2 JP 2013232093 A JP2013232093 A JP 2013232093A JP 2013232093 A JP2013232093 A JP 2013232093A JP 5706504 B2 JP5706504 B2 JP 5706504B2
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- 230000009747 swallowing Effects 0.000 description 1
- 230000035900 sweating Effects 0.000 description 1
- 208000019270 symptomatic heart failure Diseases 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 230000006794 tachycardia Effects 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 125000003396 thiol group Chemical group [H]S* 0.000 description 1
- 238000012549 training Methods 0.000 description 1
- 238000013518 transcription Methods 0.000 description 1
- 230000035897 transcription Effects 0.000 description 1
- JEJAMASKDTUEBZ-UHFFFAOYSA-N tris(1,1,3-tribromo-2,2-dimethylpropyl) phosphate Chemical compound BrCC(C)(C)C(Br)(Br)OP(=O)(OC(Br)(Br)C(C)(C)CBr)OC(Br)(Br)C(C)(C)CBr JEJAMASKDTUEBZ-UHFFFAOYSA-N 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
- 239000012808 vapor phase Substances 0.000 description 1
- 239000003981 vehicle Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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- 239000011782 vitamin Substances 0.000 description 1
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- 239000001993 wax Substances 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
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- A61B1/012—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 characterised by internal passages or accessories therefor
- A61B1/018—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 characterised by internal passages or accessories therefor for receiving instruments
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- 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
- A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
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- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
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- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3275—Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
- G01N27/3277—Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction being a redox reaction, e.g. detection by cyclic voltammetry
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01M—PROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY
- H01M6/00—Primary cells; Manufacture thereof
- H01M6/005—Devices for making primary cells
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- H01Q1/27—Adaptation for use in or on movable bodies
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- A61B2560/0214—Operational features of power management of power generation or supply
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Biomedical Technology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
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- Manufacturing & Machinery (AREA)
- Pulmonology (AREA)
- Signal Processing (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
- Electrotherapy Devices (AREA)
- Soil Working Implements (AREA)
Description
本願は、米国特許法119条(e)に従い、以下の出願に基づく優先権を主張する:米国仮特許出願第60/877,780号(2007年2月1日出願)、米国仮特許出願第60/889,871号(2007年2月14日出願)、米国仮特許出願第60/889,868号(2007年2月14日出願)、米国仮特許出願第60/941,144号(2007年6月1日出願)、米国仮特許出願第60/949,198号(2007年7月11日出願)、米国仮特許出願第60/949,223号(2007年7月11日出願)、米国仮特許出願第60/949,208号(2007年7月11日出願)、米国仮特許出願第60/956,694号(2007年8月18日出願)。これらの出願の開示は、参照により本明細書に援用される。
本発明は、例えば、以下を提供する。
(項目1)
標的生理学的部位との接触時に信号を発信し、かつ活性薬剤を含まない摂取可能な事象マーカ組成物と、
該摂取可能な事象マーカにより生成された信号を受信するように構成される信号受信機であって、生体の動きに実質的に影響を及ぼさないように、該生体に安定的に関連付けられるサイズの受信機と
を備える、システム。
(項目2)
上記IEMは、信号生成機能ブロックおよび電源機能ブロックの両方を含む集積回路を備える、項目1に記載のシステム。
(項目3)
上記電源機能ブロックは、第1および第2の異種電極材料を含む、項目2に記載のシステム。
(項目4)
上記第1および第2の電極材料は、上記集積回路を含む固体支持体の異なる表面上に存在する、項目3に記載のシステム。
(項目5)
上記信号受信機は、少なくとも1つの電極を備える、項目1に記載のシステム。
(項目6)
上記信号受信機は、2つの電極を備える、項目1に記載のシステム。
(項目7)
上記信号受信機は、発電要素をさらに備える、項目1に記載のシステム。
(項目8)
上記信号受信機は、データ記憶要素をさらに備える、項目1に記載のシステム。
(項目9)
上記信号受信機は、生理学的センサをさらに備える、項目1に記載のシステム。
(項目10)
上記生理学的センサは、呼吸、心拍数、温度、および血圧から成る群から選択されるデータを提供するように構成される、項目9に記載のシステム。
(項目11)
上記信号受信機は、
(i)信号を受信するように構成される第1および第2の電極と、
(ii)信号復調器と、
(iii)信号送信機と、
(iv)データ記憶要素と、
(v)電源と
を備える、項目1に記載のシステム。
(項目12)
上記信号受信機は、(i)信号を受信するように構成される第1および第2の電極、(ii)信号復調器、(iii)信号送信機、および(iv)データ記憶要素から成る群から選択される要素のうちの少なくとも1つを備える集積回路を含む、項目11に記載のシステム。
(項目13)
上記信号受信機は、クロック要素をさらに備える、項目12に記載のシステム。
(項目14)
上記信号受信機は、前置増幅器をさらに備える、項目13に記載のシステム。
(項目15)
上記信号受信機は、マイクロプロセッサをさらに備える、項目14に記載のシステム。
(項目16)
上記第1および第2の電極は、信号を受信するように、かつバイオマーカを感知するように構成される、項目11に記載のシステム。
(項目17)
上記バイオマーカは、心電図、心拍数、呼吸速度、および流体状態から成る群から選択される、項目16に記載のシステム。
(項目18)
上記信号受信機は、上記第1および第2の電極とは異なる生理学的センサをさらに備える、項目16に記載のシステム。
(項目19)
上記第1および第2の電極とは異なる上記生理学的センサは、温度センサ、圧力センサおよび検体検出器、運動センサ、または歪みゲージから成る群から選択される、項目18に記載のシステム。
(項目20)
上記システムは、上記信号受信機からデータを受信するように構成される外部データ受信機をさらに備える、項目1に記載のシステム。
(項目21)
上記外部データ受信機は、データ記憶要素、データ処理要素、データ表示要素、データ伝送要素、通知機構、およびユーザインターフェースのうちの少なくとも1つをさらに備える、項目20に記載のシステム。
(項目22)
上記外部データ受信機は、ベッドサイドモニタ、PDA、携帯電話機、およびPCから成る群から選択される、項目21に記載のシステム。
(項目23)
標的生理学的部位との接触時に信号を発信し、かつ活性薬剤を含まない摂取可能な事象マーカ組成物。
(項目24)
上記IEMは、信号生成機能ブロックおよび電源機能ブロックの両方を含む集積回路を備える、項目23に記載の摂取可能な事象マーカ。
(項目25)
上記電源機能ブロックは、第1および第2の異種電極材料を含む、項目24に記載の摂取可能な事象マーカ。
(項目26)
上記第1および第2の電極材料は、上記集積回路を含む固体支持体の異なる表面上に存在する、項目25に記載の摂取可能な事象マーカ。
(項目27)
上記事象マーカは、短絡耐性直列電池を備える電池要素を備える、項目23に記載の摂取可能な事象マーカ。
(項目28)
上記短絡耐性直列電池は、2つ以上の電池構造から構成される、項目27に記載の摂取可能な事象マーカ。
(項目29)
上記電池構造の各々は、陽極および陰極を有するチャンバを備える、項目28に記載の摂取可能な事象マーカ。
(項目30)
上記チャンバは、流入ポートおよび流出ポートを含む、項目29に記載の摂取可能な事象マーカ。
(項目31)
上記ポートのうちの少なくとも1つは、半透膜を備える、項目30に記載の摂取可能な事象マーカ。
(項目32)
上記2つ以上の電池構造は、共通境界を共有する、項目28に記載の摂取可能な事象マーカ。
(項目33)
上記2つ以上の電池構造は、共通境界を共有しない、項目28に記載の摂取可能な事象マーカ。
(項目34)
上記摂取可能な事象マーカは、プレーナ処理プロトコルを使用して生成される電池要素を備える、項目23に記載の摂取可能な事象マーカ。
(項目35)
上記識別子は、標的部位に存在する標的部位流体との接触時に作動する、項目34に記載の摂取可能な事象マーカ。
(項目36)
上記識別子は、
(i)固体支持体と、
(ii)第1および第2の電極であって、
(a)上記固体支持体の同一の表面上に少なくとも部分的に存在するか、または
(b)相互に接合される異なる固体支持体上に存在する、
該第1および第2の電極と
を備える、項目35に記載の摂取可能な事象マーカ。
(項目37)
上記第1および第2の電極は、上記固体支持体の同一の表面上に存在する、項目36に記載の摂取可能な事象マーカ。
(項目38)
上記摂取可能な事象マーカは、上記固体支持体の上面上の陽極の側面に位置する2つの陰極を備える、項目37に記載の摂取可能な事象マーカ。
(項目39)
上記摂取可能な事象マーカは、上記固体支持体の上面に全体的に存在する陰極と、該固体支持体の該上面上に部分的に存在し、かつ別の表面上に部分的に存在する陽極とを備える、項目38に記載の摂取可能な事象マーカ。
(項目40)
上記識別子は、上記固体支持体の上面上の共通陰極の上に配置される2つ以上の陽極を備える、項目38に記載の摂取可能な事象マーカ。
(項目41)
上記識別子は、上記固体支持体の上面上の共通陰極の下に配置される2つ以上の陽極を備える、項目38に記載の摂取可能な事象マーカ。
(項目42)
上記識別子は、陰極および陽極によって境界付けられるチャンバを備え、上記陽極は、1つ以上の開口部を備える、項目38に記載の摂取可能な事象マーカ。
(項目43)
上記第1および第2の電極は、相互に接合される異なる固体支持体上に存在する、項目37に記載の摂取可能な事象マーカ。
(項目44)
薬学的組成物の識別子によって生成される信号を受信するように構成され、かつ生体の動きに実質的に影響を及ぼさないように、該生体に安定的に関連付けられるようなサイズの信号受信機。
(項目45)
上記信号受信機は、発電要素をさらに備える、項目44に記載の信号受信機。
(項目46)
上記信号受信機は、データ記憶要素をさらに備える、項目44に記載の信号受信機。
(項目47)
上記信号受信機は、生理学的センサをさらに備える、項目44に記載の信号受信機。
(項目48)
上記生理学的センサは、呼吸、心拍数、温度、および血圧から成る群から選択されるデータを提供するように構成される、項目47に記載の信号受信機。
(項目49)
上記信号受信機は、少なくとも1つの電極を備える、項目44に記載の信号受信機。
(項目50)
上記信号受信機は、2つの電極を備える、項目49に記載の信号受信機。
(項目51)
上記信号受信機は、少なくとも3つの電極を備える、項目50に記載の信号受信機。
(項目52)
上記信号受信機は、
(i)信号を受信するように構成される第1および第2の電極と、
(ii)信号復調器と、
(iii)信号送信機と、
(iv)データ記憶要素と、
(v)電源と
を備える、項目44に記載の信号受信機。
(項目53)
上記信号受信機は、(i)信号を受信するように構成される第1および第2の電極、(ii)信号復調器、(iii)信号送信機、および(iv)データ記憶要素から成る群から選択される要素のうちの少なくとも1つを備える集積回路を含む、項目52に記載の信号受信機。
(項目54)
上記信号受信機は、クロック要素をさらに備える、項目53に記載の信号受信機。
(項目55)
上記信号受信機は、前置増幅器をさらに備える、項目54に記載の信号受信機。
(項目56)
上記信号受信機は、マイクロプロセッサをさらに備える、項目55に記載の信号受信機。
(項目57)
上記第1および第2の電極は、信号を受信するように、かつバイオマーカを感知するように構成される、項目53に記載の信号受信機。
(項目58)
上記バイオマーカは、心電図、心拍数、呼吸速度、および流体状態から成る群から選択される、項目57に記載の信号受信機。
(項目59)
上記信号受信機は、上記第1および第2の電極とは異なる生理学的センサをさらに備える、項目53に記載の信号受信機。
(項目60)
上記第1および第2の電極とは異なる上記生理学的センサは、温度センサ、圧力センサおよび検体検出器、運動センサ、または歪みゲージから成る群から選択される、
項目59に記載の信号受信機。
(項目61)
(a)標的生理学的部位との接触時に信号を発信し、かつ活性薬剤を含まない摂取可能な事象マーカを、被験者に投与するステップと、
(b)該識別子から発信された信号を、信号受信機で検出するステップと
を含む、方法。
(項目62)
上記方法は、上記被験者の少なくとも1つのバイオマーカを感知するために、上記信号受信機を使用するステップをさらに含む、項目61に記載の方法。
(項目63)
上記方法は、上記信号受信機から外部データ受信機にデータを伝送するステップをさらに含む、項目62に記載の方法。
(項目64)
上記方法は、上記識別子により生成された信号を検出するための受信機を、上記被験者の位置に埋め込むステップをさらに含む、項目61に記載の方法。
(項目65)
上記方法は、上記被験者の局所位置に上記受信機を関連付けるステップをさらに含む、項目61に記載の方法。
(項目66)
上記方法は、病状に関し、被験者を治療する方法である、項目65に記載の方法。
(項目67)
上記病状は、心臓血管病状である、項目66に記載の方法。
(項目68)
上記方法は、上記薬剤に対する上記被験者の応答を評価するステップをさらに含む、項目67に記載の方法。
(項目69)
上記評価するステップは、多数のバイオマーカからのデータに基づく生理学的指標を生成するステップをさらに含む、項目68に記載の方法。
(項目70)
上記方法は、上記評価するステップに基づいて、上記被験者の治療レジメンを調整するステップをさらに含む、項目69に記載の方法。
(項目71)
標的生理学的部位との接触時に信号を発信し、かつ活性薬剤を含まない摂取可能な事象マーカと、信号受信機とを備えるキット。
(項目72)
上記キットは、2つ以上の摂取可能な事象マーカを備える、項目71に記載のキット。
(項目73)
上記2つ以上の摂取可能な事象マーカは、区別可能である、項目72に記載のキット。
本発明の実施形態は、摂取可能な事象マーカ組成物を含み、この組成物は、それに安定的に関連付けられる識別子を有する。IEM組成物の識別子は、識別子の標的生理学的部位との接触時に、検出可能信号を生成する(すなわち、発信する)ものである。本組成物の識別子は、標的生理学的位置、例えば胃との接触時に作動する(すなわち、電源が入る)限り、特定の実施形態および組成物の目的の用途に応じて異なってもよい。したがって、識別子は、標的身体(すなわち、生理学的)部位に接触する際に、信号を発信する識別子であり得る。識別子は、作動後、例えば、標的部位との接触時に検出可能信号を提供可能である任意の構成要素またはデバイスであってもよい。特定の実施形態では、識別子は、例えば、上記に要約したように、組成物が標的生理学的部位に接触すると信号を発信する。
の電子回路40の2つの出力は、信号伝送電極であるE0 41およびE1 42である。代替実施形態では、信号生成要素30は、単一電極を含む。代替実施形態では、通信用のコイルが提供され得る。特定の実施形態では、構造、例えば、電流が移動する経路を画定するチップより大きい膜が提供される。
led oscillator; VCO)を含む。VCOは、アドレスが割り当てられ、かつ制御電圧でVCOを制御することが可能であるデジタル回路により制御可能である。このデジタル制御回路は、作動構成要素および発振器を含むチップに内蔵可能である。アドレスを符号化するために振幅変調または位相偏移変調を使用して、識別信号は伝送される。
動作すると、発振器61は、相互に反対であるクロック信号62および反転クロック信号63を生成する。これらの2つのクロック信号は、計数器64に進み、計数器64は、単に、クロック周期の数を単に計算し、その数を多数のレジスタに格納する。ここで示す例において、8ビットの計数器が用いられる。したがって、計数器64の出力は、「00000000」の値で始まり、第1のクロック周期において「00000001」に変化し、「11111111」まで継続する。計数器64の8ビットの出力は、アドレスマルチプレクサ(mux)65の入力部に連結される。一実施形態では、mux65は、回路において配線接続可能であるアドレスインタプリタを含み、制御電圧を生成して発振器61を制御する。Mux65は、計数器64の出力を使用して、シリアルビットストリームでアドレスを再現し、さらに、信号/伝送駆動回路に供給する。また、Mux65を使用して、信号伝送のデューティサイクルを制御することが可能である。一実施形態では、mux65は、計数器64によって生成されたクロック数を使用して、16分の1の時間にのみ信号伝送を作動させる。このような低デューティサイクルは、電力を節約し、また、他のデバイスが、その信号を妨害せずに伝送することを可能にする。所定のチップのアドレスは、8ビット、16ビット、または32ビットであることが可能である。
クロック周期の間続く。対応するように、論理的な「1」伝送は、データ-クロック周期
の立ち下がりエッジで開始し、16クロック周期の間続く。他のデューティサイクル構成および符号化スキームも可能であることに留意されたい。
ップの中央に位置する。このように、伝送ドライバからMg電極1002に流れる電流は、制御-論理回路領域1008から離隔するように逸らされ、これによって、トランジス
タにおける任意のラッチアップが回避される。
絶縁することが可能である。
上述の識別子構成要素に加え、摂取可能な事象マーカは、生理学的に許容される担体成分、例えば、識別子の摂取を支援し、および/または対象の標的部位に到達するまで識別子を保護する組成物または運搬媒体に存在し得る(すなわち、それに組み合わせられる)。「生理学的に許容される担体成分」は、摂取可能である固体または流体(例えば、液体)であり得る組成物を意味する。
特定の実施形態では、摂取可能な事象マーカは、薬学的活性薬剤を含まない。したがって、摂取可能な事象マーカを構成する識別子および任意の担体または他の成分は、活性薬剤を含まない。
上記に検討するように、IEMに加え、本発明のシステムは、IEMの識別子から信号を受信するように構成される、すなわち、IEMの摂取後に、IEMの標的生理学的部位との接触時に、IEMから発信される信号を受信するように構成される信号受信機を含む。信号受信機は、例えば、下記に検討するように、信号生成要素によって生成される信号の特質に応じて大幅に異なってもよい。したがって、信号受信機は、上記に示すように、RF信号、磁気信号、導電性(近接場)信号、音響信号等を含むが、これらに限定されない多種多様の異なる種類の信号を受信するように構成されてもよい。
tion Detector」である米国特許出願第11/324,196号; 名称が「Method and Apparatus for Enhancing Cardiac Pacing」である米国特許出願第10/764,429号、名称が「Methods and Systems for Measuring Cardiac Parameters」である米国特許出願第10/764,127号、名称が「Method and System for Remote Hemodynamic Monitoring」である米国特許出願第10/764,125号; 名称が「Implantable Hermetically Sealed Structures」である国際出願第PCT/ US2005/046815号;名称が「Fiberoptic
Tissue Motion Sensor」である米国出願第11/368,259号; 名称が「Implantable Pressure Sensors」である国際出願第PCT/US2004/041430; 名称が「Implantable Doppler Tomography System」である米国特許出願第11/249,152号、および米国仮特許出願第60/617,618号に対する優先権の主張; 名称が 「Cardiac Motion Characterization by Strain Gauge 」である国際出願第PCT/USUS05/39535号がさらに含まれるが、これらに限定されない。これらの出願は、参照により本明細書に援用される。
lead;MSL)である。対象の埋め込み型デバイスには、埋め込み型パルス発生器(例えば、ICD)、神経刺激デバイス、埋め込み型ループレコーダ等がさらに含まれるが、これらに限定されない。
noise ratio; SNR)が十分である場合、サンプリングレートは、低値に保持可能である。SNRが、復号化プロセス中に設定閾値未満に減少する場合、サンプリングレートは、増加され得る。このように、サンプリングレートは、復元信号の精度を妥協せずに、可能な限り低く維持可能である。サンプリングレートを可能な限り低く能動的に調整することによって、アルゴリズムは電力を節約する。このような体内伝送復号器のさらなる側面は、名称が「In-Vivo Transmission Decode
r」である係属米国仮特許出願第60/866,581号に提供され、その出願の開示は、参照により本明細書に援用される。
digital converter;ADC)79、前置増幅器80、任意の参照電極(共通モードキャンセル回路)81、および電極82も示す。
本発明のIEMシステムの方法において、個体が、対象の個体的事象をマークまたは注記したい場合に、個体は、本発明の1つ以上の摂取可能な事象マーカを摂取する。本マーカは、所望の結果をもたらすことが可能である任意の簡便な手段を使用して、被験者によって摂取されてもよく、この場合、投与経路は、例えば、上記に検討するように、組成物の特定のフォーマットに部分的に依存し、例えば、IEM組成物を飲み込むことによって、摂取可能な事象マーカを摂取することを伴う。多種多様の異なる種類の個体は、方法を実施することができる。概して、このような個体は、「哺乳動物」または「哺乳類」であり、これらの用語は、肉食動物(例えば、イヌおよびネコ)、齧歯目(例えば、マウス、モルモット、およびネズミ)、ならびに霊長類(例えば、ヒト、チンパンジー、および猿)の類目を含む哺乳綱内にある生命体を説明するように広義に使用される。代表的実施形態において、被験者はヒトである。
有用である本摂取可能な事象マーカ、システム、および方法は、多種多様の異なる用途において用いられてもよく、その用途は、本質的に、医療および非医療の両方であってもよい。異なる例証的用途について、以下により詳しく検討する。
device;IMD)の性能を監視すること、患者の健康を監視すること、および/またはIMDを介して患者に療法を遠隔供給することとを可能にする医療情報通信システムにおいて使用されてもよい。本発明の信号受信機は、例えば、バンドエイド型または埋め込み型フォーマット等の外部フォーマットにおいて、IMDと通信し、また、患者の身体の外部に位置する通信モジュール、携帯電話、および/または携帯情報端末(PAD)との双方向通信が可能である。本システムは、IMD、通信モジュールおよび/または携帯電話および/またはPDAを含む信号受信機、遠隔コンピュータシステム、および双方向通信が可能である通信システムを備えてもよく、この場合、通信モジュール、携帯電話、および/またはPDAは、IMDから情報を受信ことが可能であり、または、上記に検討するように、患者の内部または外部にある信号受信機を介して、そこに情報を中継することが可能である。
特定の実施形態では、本システムは、データを格納するための要素、すなわち、データ記憶要素をさらに含み、本要素は、ベッドサイドモニタ、PDA、スマートフォン等の外部デバイス上に存在する。典型的には、データ記憶要素は、コンピュータ可読媒体である。本明細で使用する際、用語の「コンピュータ可読媒体」は、実行および/処理するために、命令および/またはデータをコンピュータに提供することに関与する任意の記憶媒体または伝送媒体である。記憶媒体の例として、デバイスがコンピュータの内部または外部に存在するかにかかわらず、フロッピー(登録商標)ディスク、磁気テープ、CD-RO
M、ハードディスクドライブ、ROMもしくは集積回路、磁気光学ディスク、またはPCMCIA等のコンピュータ可読カード、およびその同等物が挙げられる。情報を含むファイルは、コンピュータ可読媒体上に「格納」されてもよく、この場合、「格納」は、コンピュータによって後にアクセス可能および読み出し可能になるように、情報を記録することを意味する。コンピュータ可読媒体に関し、「永久メモリ」は、永久であるメモリをいう。永久メモリは、コンピュータまたはプロセッサへの電力供給の終了によって消去されない。コンピュータハードドライブROM(すなわち、仮想メモリとして使用されないROM)、CD-ROM、フロッピー(登録商標)ディスク、およびDVDの全ては、永久
メモリの例である。ランダムアクセスメモリ(Random Access Memory;RAM)は、非永久メモリの例である。永久メモリにおけるファイルは、編集可能かつ再書き込み可能であり得る。
また、本方法を実施するためのキットも提供される。キットは、本発明のIEMシステムの構成要素、例えば、上述のように、1つ以上のIEM(区別可能なIEMの組を含む)、1つ以上の受信機、第3の外部デバイス等を含んでもよい。加えて、キットは、1つ以上の投与組成物、例えば、薬学情報対応型の投与組成物、またはIEMと同時投与される組成物を含んでもよい。キットに提供される1つ以上の薬理学的物質の投与量は、単一の用途または多数の用途に十分であり得る。したがって、本キットの特定の実施形態では、単回投与量の薬理学的物質がキットに存在し、特定の他の実施形態では、複数回投与量の薬理学的物質が存在してもよい。複数回投与量の薬理学的物質を有するこれらの実施形態では、単一の容器、例えば、単一の管、ボトル、バイタル、およびその同等物にパッケージ化されてもよく、または1回以上の投与量は、特定のキットが薬理学的物質の複数の容器を有するように、個々にパッケージ化されてもよい。
記憶媒体上に存在する電子記憶データファイルとして存在する。さらに他の実施形態では、実際の指示書は、キットに存在しないが、遠隔ソースから、例えばインターネットを介して指示書を入手する手段が提供される。本実施形態の例として、指示書が閲覧可能であり、および/またはそこから指示書をダウンロード可能であるウェブアドレスを含むキットが挙げられる。指示書に関し、指示書を入手する本手段は、適切な基板上に記録される。
Claims (7)
- 摂取可能な事象マーカであって、
2つの電極を含み、体液と接触したときに電池電圧を供給する電池セクションと、
識別コードを生成するIC回路と
を含み、
前記IC回路は、
前記識別コードを表すコード化された信号を生成する制御論理と、
インピーダンス検出回路であって、前記2つの電極間のインピーダンスを検出し、そして、インピーダンスの低下を検出したときに前記IC回路を活性化するインピーダンス検出回路と
を含む、摂取可能な事象マーカ。 - 請求項1に記載の摂取可能な事象マーカであって、
前記インピーダンス検出回路は、インピーダンスが10kオームより小さくなったときに前記IC回路を活性化する、摂取可能な事象マーカ。 - 請求項1に記載の摂取可能な事象マーカであって、
制御論理に結合された発振器であって、クロック周波数を産生する発振器
を更に含む、摂取可能な事象マーカ。 - 請求項3に記載の摂取可能な事象マーカであって、
前記IC回路の動作は、
前記インピーダンス検出回路により活性化されるまで前記IC回路がオフとなっている第1段階と、
前記IC回路がオンとなっており、かつ、前記発振器を安定させるために前記識別コードの生成を行わない第2段階と、
前記識別コードが生成される第3段階と、
前記IC回路がオフとなる第4段階と
を含む、摂取可能な事象マーカ。 - 請求項1に記載の摂取可能な事象マーカであって、
一意的な識別の生成は、ON時と、前記ON時よりも長いOFF時とを有する周期パターンを含む、摂取可能な事象マーカ。 - 請求項1に記載の摂取可能な事象マーカであって、
前記IC回路は、前記2つの電極から前記体液を流れる電流を変化させることにより、前記2つの電極を介して前記識別コードを生成する、摂取可能な事象マーカ。 - 請求項1に記載の摂取可能な事象マーカであって、
前記電池セクションは、前記電極が前記体液と結合したときに、ボルタ電池を形成して前記電池電圧を産生する、摂取可能な事象マーカ。
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IL237897B (en) | 2018-06-28 |
CA2676407A1 (en) | 2008-08-07 |
JP5524626B2 (ja) | 2014-06-18 |
ES2930588T3 (es) | 2022-12-19 |
IL200021A0 (en) | 2010-04-15 |
WO2008095183A3 (en) | 2008-12-18 |
JP2014054558A (ja) | 2014-03-27 |
PT3785599T (pt) | 2022-10-21 |
US20100185055A1 (en) | 2010-07-22 |
JP2015107342A (ja) | 2015-06-11 |
US8858432B2 (en) | 2014-10-14 |
US10441194B2 (en) | 2019-10-15 |
WO2008095183A2 (en) | 2008-08-07 |
EP2107883A2 (en) | 2009-10-14 |
MY165532A (en) | 2018-04-02 |
MY165368A (en) | 2018-03-21 |
US20150051465A1 (en) | 2015-02-19 |
IL200021A (en) | 2015-05-31 |
EP3785599A1 (en) | 2021-03-03 |
AU2008210291B2 (en) | 2013-10-03 |
SG178740A1 (en) | 2012-03-29 |
KR20090105960A (ko) | 2009-10-07 |
EP3785599B1 (en) | 2022-08-03 |
AU2008210291A1 (en) | 2008-08-07 |
JP2010524512A (ja) | 2010-07-22 |
DK3785599T3 (da) | 2022-11-07 |
CN101686800A (zh) | 2010-03-31 |
EP2107883A4 (en) | 2013-07-03 |
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