JPWO2020214826A5 - - Google Patents

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JPWO2020214826A5
JPWO2020214826A5 JP2021561705A JP2021561705A JPWO2020214826A5 JP WO2020214826 A5 JPWO2020214826 A5 JP WO2020214826A5 JP 2021561705 A JP2021561705 A JP 2021561705A JP 2021561705 A JP2021561705 A JP 2021561705A JP WO2020214826 A5 JPWO2020214826 A5 JP WO2020214826A5
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ecg
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Priority claimed from PCT/US2020/028542 external-priority patent/WO2020214826A1/en
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着用者の心臓の電気的活動に応答して少なくとも1つの信号を送信するように構成されている心電図(ECG)装置であって、
使い捨て部であって、
着用者の体に配置するように構成されているベースであって、少なくとも1つの機械的コネクタ部分を含むベースと、
前記着用者の身体に固定され、前記着用者の心臓の電気的活動に応答する1つ又は複数の信号を出力するように構成されている複数のケーブル及び対応する外部ECG電極と、
第1の複数の電気コネクタであって、少なくともいくつかのそれぞれは前記複数のケーブルのうちの1つに関連付けられている第1の複数の電気コネクタと、
を含む使い捨て部と、
前記使い捨て部と機械的及び電気的に嵌合するように構成されている再利用可能部であって、
前記使い捨て部の前記ベースの少なくとも1つの機械的コネクタ部分に取り外し可能に固定するように構成されている少なくとも1つの機械的コネクタ部分を含むハブと、
第2の複数の電気コネクタであって、それぞれは、前記使い捨て部の前記第1の複数の電気コネクタのうちの1つと電気的に接続するように構成されている第2の複数の電気コネクタと、
前記使い捨て部の前記外部ECG電極によって出力される前記1つ又は複数の信号に応答する少なくとも1つの信号を送信するように構成されている出力コネクタポートと、を含む再利用可能部と、を含む心電図(ECG)装置。
An electrocardiogram (ECG) device configured to transmit at least one signal in response to electrical activity of a wearer's heart, comprising:
a disposable part,
a base configured for placement on a wearer's body, the base including at least one mechanical connector portion;
a plurality of cables and corresponding external ECG electrodes secured to the wearer's body and configured to output one or more signals responsive to electrical activity of the wearer's heart;
a first plurality of electrical connectors, at least some of each of which is associated with one of the plurality of cables;
a disposable part comprising
a reusable part configured to mechanically and electrically mate with the disposable part, comprising:
a hub including at least one mechanical connector portion configured to removably secure to at least one mechanical connector portion of the base of the disposable;
a second plurality of electrical connectors, each configured to electrically connect with one of the first plurality of electrical connectors of the disposable; ,
an output connector port configured to transmit at least one signal responsive to the one or more signals output by the external ECG electrodes of the disposable part. Electrocardiogram (ECG) device.
前記使い捨て部は、前記ベース内に少なくとも部分的に配置されている第1の内部ECG電極であって、前記着用者の心臓の電気的活動に応答する1つ又は複数の信号を出力するように構成され、前記第1の複数の電気コネクタのうちの1つと関連付けられている第1の内部ECG電極をさらに含み、
前記出力コネクタポートは、前記使い捨て部の前記第1の内部ECG電極によって出力される前記1つ又は複数の信号に応答する少なくとも1つの信号を送信するようにさらに構成されている、請求項1に記載のECG装置。
The disposable portion is a first internal ECG electrode disposed at least partially within the base for outputting one or more signals responsive to electrical activity of the wearer's heart. further comprising a first internal ECG electrode configured and associated with one of the first plurality of electrical connectors;
2. The output connector port of claim 1, wherein the output connector port is further configured to transmit at least one signal responsive to the one or more signals output by the first internal ECG electrodes of the disposable. ECG apparatus as described.
前記ベースは、前記使い捨て部を前記着用者の身体の皮膚に固定するように構成され、且つ、前記ベースが前記使い捨て部を前記着用者の身体の皮膚に固定し、前記再利用可能部が前記使い捨て部と機械的及び電気的に嵌合されるとき、前記再利用可能部は、前記皮膚に接触しない、請求項に記載のECG装置。 The base is configured to secure the disposable part to the skin of the wearer's body, the base secures the disposable part to the skin of the wearer's body, and the reusable part comprises: 2. The ECG device of claim 1 , wherein the reusable portion does not contact the skin when mechanically and electrically mated with the disposable portion. 前記使い捨て部は、可撓性回路をさらに含み、前記可撓性回路は、前記複数のケーブルに電気的に接続するように構成されている第1の複数の導電性ストリップと第2の複数の導電性ストリップとを備え、前記使い捨て部の前記第1の複数の電気コネクタは、前記可撓性回路の前記第2の複数の導電性ストリップを含む、請求項1からのいずれか1項に記載のECG装置。 The disposable portion further includes a flexible circuit comprising a first plurality of conductive strips and a second plurality of conductive strips configured to electrically connect to the plurality of cables. and conductive strips, wherein said first plurality of electrical connectors of said disposable part comprises said second plurality of conductive strips of said flexible circuit. ECG apparatus as described. 前記使い捨て部の前記可撓性回路は、前記第1及び第2の複数の導電性ストリップから離間されている少なくとも1つの追加の導電性ストリップをさらに含み、
前記再利用可能部は、前記ハブによって動作可能に配置され、且つ、前記使い捨て部の前記可撓性回路の前記少なくとも1つの追加の導電性ストリップと電気的に接続して、前記再利用可能部が前記使い捨て部は認定製品であるかどうかを決定できる、少なくとも1つの追加の電気コネクタをさらに含む、請求項に記載のECG装置。
said flexible circuit of said disposable part further comprising at least one additional conductive strip spaced from said first and second plurality of conductive strips;
said reusable part being operably disposed by said hub and electrically connected to said at least one additional conductive strip of said flexible circuit of said disposable part; 5. The ECG device of claim 4 , further comprising at least one additional electrical connector that can determine whether the disposable is an approved product.
前記使い捨て部は、前記ベース内に少なくとも部分的に配置されている第1の内部ECG電極であって、前記着用者の心臓の電気的活動に応答する1つ又は複数の信号を出力するように構成され、前記第1の複数の電気コネクタのうちの1つと関連付けられている第1の内部ECG電極をさらに含み、
前記出力コネクタポートは、前記使い捨て部の前記第1の内部ECG電極によって出力される前記1つ又は複数の信号に応答する少なくとも1つの信号を送信するようにさらに構成されており、
前記可撓性回路は、第1の開口と、前記第1の開口に沿って配置されている第1の導電性リングとをさらに含み、前記第1の導電性リングは、前記第1の内部ECG電極の一部に電気的に接続するように構成され、前記第1の複数の電気コネクタのうちの前記1つは、前記第1の導電性リングに電気的に結合されている、請求項4又は5に記載のECG装置。
The disposable portion is a first internal ECG electrode disposed at least partially within the base for outputting one or more signals responsive to electrical activity of the wearer's heart. further comprising a first internal ECG electrode configured and associated with one of the first plurality of electrical connectors;
the output connector port is further configured to transmit at least one signal responsive to the one or more signals output by the first internal ECG electrodes of the disposable;
The flexible circuit further includes a first opening and a first conductive ring disposed along the first opening, the first conductive ring extending into the first interior. 4. A device configured to electrically connect to a portion of an ECG electrode, wherein said one of said first plurality of electrical connectors is electrically coupled to said first conductive ring. 6. ECG device according to 4 or 5 .
前記使い捨て部は、前記ベース内に少なくとも部分的に配置され、且つ、前記第1の内部ECG電極から離間されている第2の内部ECG電極をさらに備え、前記第2の内部ECG電極は、接地電極として機能するように構成され、前記第1の複数の電気コネクタのうちの1つは、前記第2の内部ECG電極に関連付けられ、
前記可撓性回路は、第2の開口と、前記第2の開口に沿って配置されている第2の導電性リングとをさらに含み、前記第2の開口は前記第1の開口から離間し、前記第2の導電性リングは、前記第2の内部ECG電極の一部に電気的に接続するように構成されている、請求項に記載のECG装置。
The disposable portion further comprises a second internal ECG electrode disposed at least partially within the base and spaced apart from the first internal ECG electrode, the second internal ECG electrode being grounded. configured to function as electrodes, one of the first plurality of electrical connectors being associated with the second internal ECG electrode;
The flexible circuit further includes a second opening and a second conductive ring positioned along the second opening, the second opening spaced apart from the first opening. 7. The ECG device of claim 6 , wherein said second conductive ring is configured to electrically connect to a portion of said second internal ECG electrode.
前記使い捨て部の前記ベースは、複数のピン支持体をさらに含み、前記複数のピン支持体のそれぞれは、前記再利用可能部が前記使い捨て部と嵌合するときに、前記可撓性回路の前記第2の複数の導電性ストリップのうちの1つが前記再利用可能部の前記第2の複数の電気コネクタのうちの1つに電気的に接触して配置されるように構成されている、請求項からのいずれか1項に記載のECG装置。 The base of the disposable portion further includes a plurality of pin supports, each of the plurality of pin supports aligning the flexible circuit with the flexible circuit when the reusable portion is mated with the disposable portion. wherein one of a second plurality of conductive strips is configured to be placed in electrical contact with one of said second plurality of electrical connectors of said reusable portion. Item 8. The ECG device according to any one of Items 4 to 7 . 前記複数のピン支持体のそれぞれは、可撓性を有し、且つ、真っ直ぐではない、請求項に記載のECG装置。 9. The ECG device of claim 8 , wherein each of the plurality of pin supports is flexible and non-straight . 前記再利用可能部の前記ハブの前記少なくとも1つの機械的コネクタ部分は、少なくとも1つの溝を含み、
前記使い捨て部の前記ベースの前記少なくとも1つの機械的コネクタ部分は、前記再利用可能部の前記少なくとも1つの溝内に取り外し可能に固定されるように構成されている少なくとも1つのクリップを備え
前記少なくとも1つの溝は、前記ハブの第1の端部に配置されている第1の溝と、前記ハブの前記第1の端部の反対側の第2の端部に配置されている第2の溝とを備え、
前記少なくとも1つのクリップは、前記ベースの第1の端部に配置されている第1のクリップと、前記ベースの前記第1の端部の反対側の第2の端部に配置されている第2のクリップとを備えている、請求項1からのいずれか1項に記載のECG装置。
said at least one mechanical connector portion of said hub of said reusable part including at least one groove;
said at least one mechanical connector portion of said base of said disposable part comprising at least one clip configured to be removably secured within said at least one groove of said reusable part ;
The at least one groove comprises a first groove located at a first end of the hub and a second groove located at a second end of the hub opposite the first end. 2 grooves,
The at least one clip comprises a first clip located at a first end of the base and a second clip located at a second end of the base opposite the first end. 10. The ECG device of any one of claims 1-9 , comprising two clips .
前記再利用可能部は、The reusable part comprises:
プロセッサと、a processor;
前記着用者の皮膚を介して温度を測定する第1の温度センサ並びに前記再利用可能部の内側及び外側の少なくとも1つの周囲温度を測定する第2の温度センサとをさらに含み、a first temperature sensor for measuring temperature through the wearer's skin and a second temperature sensor for measuring at least one ambient temperature inside and outside the reusable part;
前記プロセッサは前記第1の温度センサ及び前記第2の温度センサの両方から受信した温度データに基づいて前記着用者の中核体温を決定するように構成されている、請求項1に記載のECG装置。2. The ECG device of claim 1, wherein the processor is configured to determine the core body temperature of the wearer based on temperature data received from both the first temperature sensor and the second temperature sensor. .
前記使い捨て部の前記ベースは、第1の開口部をさらに含み、前記第1の温度センサは、前記再利用可能部が前記使い捨て部と嵌合するときに前記使い捨て部の第1の開口部と整列するように構成され、
前記再利用可能部の下部は、前記再利用可能部が前記使い捨て部と嵌合するときに前記使い捨て部の前記ベースの前記第1の開口部と整列するように構成されている第2の開口部を備え、
前記再利用可能部は、ハウジングをさらに含み、前記ハウジングの一部が前記再利用可能部の前記下部の前記第2の開口部を通って延在し、前記第1の温度センサが前記ハウジング内に配置されている、請求項11に記載のECG装置。
The base of the disposable part further includes a first opening , and the first temperature sensor is positioned in the first opening of the disposable part when the reusable part is mated with the disposable part. configured to align with
A lower portion of the reusable part has a second opening configured to align with the first opening in the base of the disposable part when the reusable part is mated with the disposable part. has a department,
The reusable part further includes a housing, a portion of the housing extending through the second opening in the lower portion of the reusable part, the first temperature sensor positioned within the housing. 12. The ECG device of claim 11 , wherein the ECG device is positioned at the
前記第1の温度センサ及び第2の温度センサの間に配置される回路基板であって、前記再利用可能部が前記使い捨て部と嵌合するときに前記第1の温度センサが前記第2の温度センサより前記着用者の皮膚の近くに配置されるように構成されている回路基板をさらに含む、請求項11又は12に記載のECG装置。 A circuit board positioned between the first temperature sensor and a second temperature sensor, wherein the first temperature sensor is aligned with the second temperature sensor when the reusable part is mated with the disposable part. 13. The ECG device of Claim 11 or 12 , further comprising a circuit board configured to be positioned closer to the wearer's skin than the temperature sensor . 前記再利用可能部は、前記出力コネクタポートに接続されているケーブルをさらに含み、前記使い捨て部又は前記再利用可能部のいずれも電源を含まず、前記再利用可能部は、前記ケーブルが外部電源に接続されているときに前記ケーブルから電源を受け取るように構成されている、請求項1から13のいずれか1項に記載のECG装置。 The reusable part further includes a cable connected to the output connector port, neither the disposable part nor the reusable part includes a power source, and the reusable part includes a cable connected to the external 14. The ECG device of any one of claims 1-13 , configured to receive power from the cable when connected to a power source . 前記再利用可能部は、前記再利用可能部が前記使い捨て部と嵌合したときに前記着用者の加速度を測定するように構成されている動きセンサをさらに備え、前記ECG装置は、前記動きセンサが閾値を超える前記着用者の動きを検出すると、前記着用者の心臓活動及び/又は体温データに応答する生理学的データの収集、処理、及び/又は送信を停止する、請求項1から14のいずれか1項に記載のECG装置。 The reusable part further comprises a motion sensor configured to measure acceleration of the wearer when the reusable part is mated with the disposable part , the ECG device of claims 1 to 14 , stops collecting, processing and/or transmitting physiological data responsive to the wearer's cardiac activity and/or body temperature data upon detecting movement of the wearer in which the wearer's motion exceeds a threshold. An ECG device according to any one of the preceding paragraphs. 前記再利用可能部は、前記再利用可能部が平坦面上に配置されているときに、前記第2の複数の電気コネクタのいずれも前記平坦面に接触しないように構成されている、請求項1から15のいずれか1項に記載のECG装置。 4. The reusable portion is configured such that none of the electrical connectors of the second plurality contact the flat surface when the reusable portion is placed on the flat surface. 16. ECG device according to any one of clauses 1-15 . 使い捨て部を含む心電図(ECG)装置であって、前記使い捨て部は、
1つ又は複数の基板を含み、着用者の体に固定するように構成されているベースと、
前記着用者の身体に固定され、前記着用者の心臓活動に応答する電気信号を検出するように構成されている複数のケーブル及び対応する外部ECG電極と、
前記ベースの一部によって部分的に囲まれ、且つ、第1の複数の導電性ストリップ及び第2の複数の導電性ストリップを含み、前記第1の複数の導電性ストリップのそれぞれは、前記複数のケーブルのそれぞれに電気的に接続され、前記第2の複数の導電性ストリップは、前記着用者の心臓の電気的活動に応答する電気信号を送信するように構成されている可撓性回路と、
を含み、前記ベース、前記複数のケーブル、及び前記可撓性回路が単一構造を形成している心電図(ECG)装置。
An electrocardiogram (ECG) device including a disposable portion, the disposable portion comprising:
a base comprising one or more substrates and configured to be secured to a wearer's body;
a plurality of cables and corresponding external ECG electrodes secured to the wearer's body and configured to detect electrical signals responsive to the wearer's cardiac activity;
partially surrounded by a portion of the base and including a first plurality of conductive strips and a second plurality of conductive strips, each of the first plurality of conductive strips comprising the plurality of conductive strips; a flexible circuit electrically connected to each of the cables, the second plurality of conductive strips configured to transmit electrical signals responsive to electrical activity of the wearer's heart;
and wherein said base, said plurality of cables and said flexible circuit form a unitary structure .
前記使い捨て部は、電池を含まない、請求項17に記載のECG装置。 18. The ECG device of Claim 17 , wherein the disposable portion does not include a battery. 前記使い捨て部は、プロセッサを含まない、請求項17又は18に記載のECG装置。 19. The ECG device of claim 17 or 18 , wherein the disposable portion does not include a processor. 前記使い捨て部は、前記ベースを前記着用者の身体の皮膚に固定できるように構成されている少なくとも1つの基板をさらに含む、請求項17から19のいずれか1項に記載のECG装置。 20. The ECG device of any one of claims 17-19 , wherein the disposable portion further comprises at least one substrate configured to allow the base to be secured to the skin of the wearer's body. 前記少なくとも1つの基板は、熱伝導性材料を含む、請求項20に記載のECG装置。 21. The ECG device of Claim 20 , wherein the at least one substrate comprises a thermally conductive material. 前記使い捨て部は、前記ベース内に少なくとも部分的に配置されている少なくとも1つの内部ECG電極をさらに備え、前記少なくとも1つの内部ECG電極は、前記可撓性回路に電気的に接続されている、請求項17から21のいずれか1項に記載のECG装置。 said disposable portion further comprising at least one internal ECG electrode disposed at least partially within said base, said at least one internal ECG electrode electrically connected to said flexible circuit; 22. The ECG device of any one of claims 17-21 . 前記可撓性回路は、少なくとも1つの開口と、前記少なくとも1つの開口に沿って配置され、且つ、前記少なくとも1つの内部ECG電極の一部に電気的に接続するように構成されている少なくとも1つの導電性リングとをさらに含む、請求項17から22のいずれか1項に記載のECG装置。 The flexible circuit has at least one opening and at least one disposed along the at least one opening and configured to electrically connect to a portion of the at least one internal ECG electrode. 23. The ECG device of any one of claims 17-22 , further comprising two conductive rings. 前記少なくとも1つの内部ECG電極は、2つの内部ECG電極を含み、
前記少なくとも1つの開口は2つの開口を含み、
前記少なくとも1つの導電性リングは、2つの導電性リングを含む、請求項23に記載のECG装置。
said at least one internal ECG electrode comprises two internal ECG electrodes;
said at least one opening comprises two openings;
24. The ECG device of Claim 23 , wherein the at least one conductive ring includes two conductive rings.
前記ベースは、複数のピン支持体を含み、前記複数のピン支持体のそれぞれは、前記可撓性回路の前記第2の複数の導電性ストリップのうちの1つを支持するように構成されている、請求項17から24のいずれか1項に記載のECG装置。 The base includes a plurality of pin supports, each of the plurality of pin supports configured to support one of the second plurality of conductive strips of the flexible circuit. 25. The ECG device of any one of claims 17-24 , wherein the ECG device is 前記複数のピン支持体のそれぞれは、可撓性を有する、請求項25に記載のECG装置。 26. The ECG device of Claim 25 , wherein each of the plurality of pin supports is flexible. 前記複数のピン支持体のそれぞれは、真っ直ぐではない、請求項25又は26に記載のECG装置。 27. The ECG device of Claims 25 or 26 , wherein each of the plurality of pin supports is non-straight. 前記複数のピン支持体のそれぞれは、弧状である、請求項27に記載のECG装置。 28. The ECG device of Claim 27 , wherein each of the plurality of pin supports is arcuate. 前記複数のケーブルは、前記外部ECG電極に取り外し不可能に固定されている、請求項17から28のいずれか1項に記載のECG装置。 29. The ECG device of any one of claims 17-28 , wherein the plurality of cables are permanently secured to the external ECG electrodes.
JP2021561705A 2019-04-17 2020-04-16 Patient monitoring systems, equipment, and methods Pending JP2022529948A (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962835386P 2019-04-17 2019-04-17
US62/835,386 2019-04-17
US201962837195P 2019-04-23 2019-04-23
US62/837,195 2019-04-23
US201962888271P 2019-08-16 2019-08-16
US62/888,271 2019-08-16
US201962923157P 2019-10-18 2019-10-18
US62/923,157 2019-10-18
PCT/US2020/028542 WO2020214826A1 (en) 2019-04-17 2020-04-16 Patient monitoring systems, devices, and methods

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