JP2020534099A - 複数の作動モードを備えた移植式医療用装置 - Google Patents
複数の作動モードを備えた移植式医療用装置 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37276—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by means for reducing power consumption during telemetry
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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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
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- 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
- A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37512—Pacemakers
Abstract
Description
本発明の別の例では、リードレス型心臓ペースメーカ(LCP)は、ハウジング、患者の1以上の生理学的パラメータを感知するための1以上の生理学的センサ、2以上の電極であってそのうち少なくとも2つが患者の心臓にペーシングパルスを送達するためのものである電極、並びにハウジング内に配置されて低電力モード及び高電力モードで作動するように構成されたレシーバ、を備えることが可能であり、高電力モードでは、前記レシーバは外部装置から抗不整頻拍ペーシング(ATP)コマンドを受け取ることが可能であり、かつ低電力モードでは、前記レシーバは外部装置からATPコマンドを受け取ることができない。LCPは、1以上の生理学的センサ、2以上の電極、及びレシーバに作動可能に接続された演算回路を、さらに備えることができる。演算回路は、1以上の生理学的センサによって感知された1以上の生理学的パラメータの少なくとも一部に基づいて測定された患者の心拍数の少なくとも一部に基づいて、レシーバを低電力モードと高電力モードとの間で切り替えるように構成可能である。演算回路はさらに、レシーバが高電力モードであるときに外部装置から抗不整頻拍ペーシング(ATP)コマンドを受け取っているレシーバに応答して、電極のうち2以上によってATP治療を提供することもできる。
上記の実施形態のいずれかの代替として、又は追加として、1以上の生理学的センサは1以上の心臓電気センサからなることが可能であり、かつ1以上の生理学的パラメータは、1以上の心臓電気センサによって生じた1以上の電気信号からなる。
上記の実施形態のいずれかの代替として、又は追加として、LCPは、レシーバが高い電力レベルにあるときに外部装置から受信されたコマンドに従って作動するように構成可能である。
本発明は、添付図面に関する以降の説明を考慮することでより十分に理解され得る。
全ての数値は本明細書中においては明示的に表示されるか否かにかかわらず用語「約」によって修飾されるものと見なされる。用語「約」は一般に、当業者がその挙げられた値と等価である(すなわち、同じ機能又は結果を有している)と考えるであろうある範囲の数を指す。多くの場合、用語「約」は最も近い有効数字に丸められる数を含み得る。
本明細書及び添付の特許請求の範囲において使用されるように、単数形「1つの(a)」、「1つの(an)」及び「その(the)」は、内容がそうでないことを明らかに示していないかぎり、複数の指示物を含む。本明細書及び添付の特許請求の範囲において使用されるように、用語「又は、若しくは(or)」は一般に、内容がそうでないことを明らかに示していないかぎり、「及び/又は(and/or)」を含んでいる意味で使用される。
Claims (15)
- 移植式医療用装置であって、
コントローラを具備し、
高電力モード及び低電力モードを有しているレシーバを具備し、
高電力モードでは、前記レシーバは、外部装置から通信を受け取ることが可能であるとともに受け取った通信を前記コントローラに渡すことが可能であり、
低電力モードでは、前記レシーバは、当該レシーバの最大電力レベル未満で作動するものであり、
前記コントローラに出力を提供する生理学的センサを具備し、
前記コントローラは、前記生理学的センサの出力の少なくとも一部に基づいて前記レシーバが高電力モードであるか低電力モードであるかを制御するように構成される、移植式医療用装置。 - 低電力モードにおいて、前記レシーバは、前記外部装置からの通信を受け取ること及び受け取った通信を前記コントローラに渡すことはできず、かつ、移植式医療用装置は、前記レシーバが低電力モードであるときに前記外部装置とは独立に作動するように構成される、請求項1に記載の移植式医療用装置。
- 前記外部装置からの通信はコマンドからなり、かつ、前記コントローラは、前記コマンドの少なくとも一部に基づいて前記レシーバが高電力モードであるか低電力モードであるかを制御するようにさらに構成される、請求項1に記載の移植式医療用装置。
- 移植式医療用装置は、前記レシーバが高電力モードであるときに前記外部装置からコマンドを受け取るように構成されており、かつ、移植式医療用装置は、高電力モードから低電力モードに切り替えるときにヒステリシス関数を使用するように構成される、請求項1に記載の移植式医療用装置。
- 前記コントローラは、
前記生理学的センサの出力に基づいて生理学的パラメータ値を同定するように構成されるとともに、
同定された生理学的パラメータ値を少なくとも一部に条件とした1以上のルールに基づいて、前記レシーバが高電力モードであるか低電力モードであるかを制御するように構成される、請求項1に記載の移植式医療用装置。 - 同定される生理学的パラメータ値は心拍数の値であり、前記1以上のルールは、心拍数の値が心拍数の閾値を上回る場合には、前記レシーバが高電力モードに設定されることになっていることと、心拍数の値が心拍数の閾値未満である場合には、前記レシーバが低電力モードに設定されることになっていることとを指定する、請求項5に記載の移植式医療用装置。
- 同定される生理学的パラメータ値は心拍数の値であり、前記1以上のルールは、心拍数の値が心拍数の閾値を上回る場合には、前記レシーバが第1の比率で低い電力レベルから高い電力レベルに断続的に設定される高電力モードに当該レシーバが設定されることになっていることと、心拍数の値が心拍数の閾値未満である場合には、前記レシーバが第2の比率で低い電力レベルから高い電力レベルに断続的に設定される低電力モードに当該レシーバが設定されることになっていることとを指定し、第1の比率は第2の比率より大きい、請求項5に記載の移植式医療用装置。
- 同定される生理学的パラメータ値は心拍数の値であり、前記1以上のルールは、心拍数の値が心拍数の閾値を上回る場合には、前記レシーバが低い電力レベルよりも多く高い電力レベルに設定される高電力モードに当該レシーバが設定されることになっていることと、心拍数の値が心拍数の閾値未満である場合には、前記レシーバが高い電力レベルよりも多く低い電力レベルに設定される低電力モードに当該レシーバが設定されることになっていることとを指定する、請求項5に記載の移植式医療用装置。
- 同定される生理学的パラメータ値は、心拍数の値、pH値、温度値、ECG波形の値、加速度計の値、患者の姿勢のうちの1つである、請求項5に記載の移植式医療用装置。
- 移植式医療用装置はリードレス型心臓ペースメーカである、請求項1に記載の移植式医療用装置。
- リードレス型心臓ペースメーカであって、
ハウジングを具備し、
患者の1以上の生理学的パラメータを感知するための1以上の生理学的センサを具備し、
2以上の電極を具備し、前記電極のうち少なくとも2つが患者の心臓にペーシングパルスを送達するためのものであり、
前記ハウジング内に配置されて低電力モード及び高電力モードで作動するように構成されたレシーバを具備し、
高電力モードでは、前記レシーバは外部装置からATPコマンドを受け取ることが可能であり、
低電力モードでは、前記レシーバは外部装置からATPコマンドを受け取ることが不可能であり、
前記1以上の生理学的センサと、前記2以上の電極と、前記レシーバとに作動可能に接続された演算回路を具備し、前記演算回路は、
前記1以上の生理学的センサによって感知された1以上の生理学的パラメータの少なくとも一部に基づいて測定された患者の心拍数の少なくとも一部に基づいて、前記レシーバを低電力モードと高電力モードとの間で切り替えるように構成されるとともに、
前記レシーバが高電力モードであるときに前記外部装置からATPコマンドを受け取っているレシーバに応答して、前記電極のうち2以上によって抗不整頻拍ペーシング(ATP)治療を提供するように構成される、リードレス型心臓ペースメーカ。 - 前記演算回路は、
心拍数がATPの心拍数の閾値を超えた場合には、前記レシーバを高電力モードに設定するように構成されるとともに、
心拍数がATPの心拍数の閾値を超えない場合には、前記レシーバを低電力モードに設定するように構成される、請求項11に記載のリードレス型心臓ペースメーカ。 - 前記演算回路は、
心拍数が心拍数の閾値を超えた場合には、前記レシーバを高電力モードに切り替え、かつ、高電力モードでは、前記レシーバを低い電力レベルよりも多く高い電力レベルに設定するように構成されるとともに、
心拍数が心拍数の閾値を超えない場合には、前記レシーバを低電力モードに切り替え、かつ、低電力モードでは、レシーバを高い電力レベルよりも多く低い電力レベルに設定するように構成される、請求項11に記載のリードレス型心臓ペースメーカ。 - 前記1以上の生理学的センサが前記電極のうち2以上を具備している、請求項11に記載のリードレス型心臓ペースメーカ。
- 1以上の生理学的センサは機械センサからなり、かつ1以上の生理学的パラメータは、機械センサによって生じた1以上の機械的信号からなる、請求項11に記載のリードレス型心臓ペースメーカ。
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EP3684465A1 (en) | 2020-07-29 |
CN111107899A (zh) | 2020-05-05 |
EP3684465B1 (en) | 2021-07-14 |
US20190099605A1 (en) | 2019-04-04 |
US11235163B2 (en) | 2022-02-01 |
WO2019060302A1 (en) | 2019-03-28 |
JP6938778B2 (ja) | 2021-09-22 |
CN111107899B (zh) | 2024-04-02 |
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