Gluocose sensing system with auxiliary display
Abstract
A system for sensing patient blood glucose data is provided. The system includes sensors, a user interface, and any auxiliary equipment. If the connection between the sensor and the user interface is by wire, the sensor will continue to be powered when the wire is separated. Communication between the sensor and the user interface may be wireless. The auxiliary device can be a patient monitoring device, or other display or signaling device that displays information about blood glucose data collected by the sensor. The sensor is connected to sensor electronics, which includes a sensor power supply, a voltage regulator, and optionally a memory and processor.
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Projected expiry passed 19 July 2025, 1.2 years ago.
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105 claims: 7 independent, 98 dependent
- 1リアルタイムで血糖データを感知するリアルタイムセンサと、 ユーザインターフェースと、 前記センサに連結された第1の端部と前記ユーザインターフェースに連結された第2の端部とを有して、前記センサを前記ユーザインターフェースに連結するワイヤとを備え、 前記ユーザインターフェースが、前記ワイヤを通して前記センサと通信するように構成され、かつ、前記センサを前記ユーザインターフェースから分断するため、前記ワイヤが、前記センサおよび前記ユーザインターフェースの少なくとも1つから分離可能であることを特徴とする、ヒトの血糖濃度を感知するシステム。
- 2前記ユーザインターフェースと通信するように構成された患者監視装置をさらに備えることを特徴とする、請求項1に記載のシステム。
- 3前記ユーザインターフェースおよび前記患者監視装置が単一のユニットに組み込まれることを特徴とする、請求項2に記載のシステム。
- 4前記ユーザインターフェースおよび前記患者監視装置がそれぞれ、前記患者監視装置と前記ユーザインターフェースとの間の無線通信用の無線送受信器を含むことを特徴とする、請求項2に記載のシステム。
- 5前記ユーザインターフェースが、前記センサに電力を提供する少なくとも1つの充電式電池を含み、前記患者監視装置が、前記少なくとも1つの充電式電池を充電するための電力を前記ユーザインターフェースに提供する電力源を含むことを特徴とする、請求項4に記載のシステム。
- 6前記センサがセンサ電源を含み、前記ユーザインターフェースが前記センサから分断されたとき、前記センサは電力供給され続けており、かつ動作可能なままであることを特徴とする、請求項5に記載のシステム。
- 7前記センサと通信するように構成された患者監視装置をさらに備えることを特徴とする、請求項1に記載のシステム。
- 8前記センサと前記患者監視装置の間の無線通信のため、前記センサが無線送信器を含み、前記患者監視装置が無線受信器を含むことを特徴とする、請求項7に記載のシステム。
- 9前記ユーザインターフェースが前記センサに電力を供給する電源を含むことを特徴とする、請求項1に記載のシステム。
- 10前記ユーザインターフェースの前記電源が変圧器を含むことを特徴とする、請求項9に記載のシステム。
- 11前記センサと電気的に連通しているセンサエレクトロニクスをさらに備えることを特徴とする、請求項1に記載のシステム。
- 12前記センサがコネクタを含み、前記センサエレクトロニクスが前記コネクタを使用して前記センサに連結されることを特徴とする、請求項11に記載のシステム。
- 13前記センサエレクトロニクスが、前記センサに電力を供給する電力源を含むことを特徴とする、請求項11に記載のシステム。
- 14前記センサが前記センサエレクトロニクスに連結されているときに、前記電力源が作動されることを特徴とする、請求項13に記載のシステム。
- 15前記センサエレクトロニクスの前記電力源が、少なくとも1つの充電式電池を含み、前記ユーザインターフェースが、前記センサエレクトロニクスが前記ユーザインターフェースに連結されているときに前記センサエレクトロニクスの前記電池を再充電するため、前記センサエレクトロニクスに電力を提供する電源を含むことを特徴とする、請求項13に記載のシステム。
- 16前記センサエレクトロニクスが前記センサ用の参照値を格納する参照メモリを含むことを特徴とする、請求項11に記載のシステム。
- 17前記センサ用の前記参照値が工場供給の参照値であることを特徴とする、請求項16に記載のシステム。
- 18前記参照メモリが不揮発性であることを特徴とする、請求項16に記載のシステム。
- 19前記参照メモリがフラッシュメモリであることを特徴とする、請求項18に記載のシステム。
- 20前記フラッシュメモリが取外し可能なフラッシュメモリカードに含まれることを特徴とする、請求項19に記載のシステム。
- 21前記参照値が血糖測定器から得られた値であることを特徴とする、請求項16に記載のシステム。
- 22前記血糖測定器が前記センサエレクトロニクスに連結されることを特徴とする、請求項21に記載のシステム。
- 23前記血糖測定器および前記センサが単一のハウジングに組み込まれることを特徴とする、請求項22に記載のシステム。
- 24前記参照値が血糖データを校正するための値であることを特徴とする、請求項16に記載のシステム。
- 25前記センサエレクトロニクスが前記ユーザインターフェースから分離されたとき、前記センサエレクトロニクスが電力を保持し、かつ前記参照値を保持することを特徴とする、請求項16に記載のシステム。
- 26前記センサエレクトロニクスが、第2のユーザインターフェースと通信するように構成されたことを特徴とする、請求項16に記載のシステム。
- 27前記センサが皮下センサであることを特徴とする、請求項1に記載のシステム。
- 28前記ユーザインターフェースが手持ち型装置であることを特徴とする、請求項1に記載のシステム。
- 29前記ユーザインターフェースが出力装置を含み、データが前記出力装置に送信されることを特徴とする、請求項1に記載のシステム。
- 30前記出力装置が表示装置であることを特徴とする、請求項29に記載のシステム。
- 31前記ユーザインターフェースがデータを受信するように構成された入力装置を含むことを特徴とする、請求項1に記載のシステム。
- 32前記入力装置が血糖測定器であることを特徴とする、請求項31に記載のシステム。
- 33前記入力装置がキーパッドであることを特徴とする、請求項31に記載のシステム。
- 34前記入力装置がパーソナルコンピュータであることを特徴とする、請求項31に記載のシステム。
- 35血糖データを感知するセンサと、 前記センサと電気的に連通しているセンサエレクトロニクスと、 前記センサエレクトロニクスと無線で連通しているユーザインターフェースと、 前記ユーザインターフェースと連通している患者監視装置とを備えることを特徴とする、ヒトの血糖濃度を感知するシステム。
- 36前記患者監視装置と前記ユーザインターフェースの間の通信が無線であることを特徴とする、請求項35に記載のシステム。
- 37前記患者監視装置と前記ユーザインターフェースの間の通信が有線であることを特徴とする、請求項35に記載のシステム。
- 38前記患者監視装置が前記ユーザインターフェースを含むことを特徴とする、請求項35に記載のシステム。
- 39前記センサエレクトロニクスがセンサ電源を含むことを特徴とする、請求項35に記載のシステム。
- 40前記センサが前記センサエレクトロニクスに連結されているとき、前記センサ電源が作動されることを特徴とする、請求項39に記載のシステム。
- 41前記センサエレクトロニクスが、参照値が格納されたメモリを含むことを特徴とする、請求項35に記載のシステム。
- 42前記参照値が工場入力の参照値であることを特徴とする、請求項41に記載のシステム。
- 43参照値が格納された前記メモリがフラッシュメモリであることを特徴とする、請求項41に記載のシステム。
- 44前記参照値が血糖測定器からの値であることを特徴とする、請求項41に記載のシステム。
- 45前記血糖測定器が前記センサエレクトロニクスに連結されることを特徴とする、請求項44に記載のシステム。
- 46前記血糖測定器および前記センサが単一のハウジングに組み込まれることを特徴とする、請求項45に記載のシステム。
- 47前記参照値が、前記ユーザインターフェースに入力され、前記センサエレクトロニクスに送信されることを特徴とする、請求項41に記載のシステム。
- 48前記参照値が前記血糖データを校正するための値であることを特徴とする、請求項41に記載のシステム。
- 49前記メモリが不揮発性メモリであることを特徴とする、請求項41に記載のシステム。
- 50前記センサエレクトロニクスが無線送信器をさらに含み、前記ユーザインターフェースが無線受信器をさらに含むことを特徴とする、請求項35に記載のシステム。
- 51前記センサエレクトロニクスが無線送信器をさらに含み、前記ユーザインターフェースが無線受信器をさらに含み、前記患者監視装置が第3の無線受信器をさらに含むことを特徴とする、請求項35に記載のシステム。
- 52前記センサがリアルタイムで血糖データを感知するリアルタイムセンサであることを特徴とする、請求項35に記載のシステム。
- 53前記センサエレクトロニクスが識別コードを格納し、前記センサエレクトロニクスが、前記識別コードを前記ユーザインターフェースに送信するように構成され、前記ユーザインターフェースが、前記センサからのデータを格納する前に前記識別コードに基づいて前記センサを識別するように構成されていることを特徴とする、請求項35に記載のシステム。
- 54前記センサが皮下センサであることを特徴とする、請求項35に記載のシステム。
- 55前記センサエレクトロニクスがグルコース測定データを格納する測定メモリを含むことを特徴とする、請求項35に記載のシステム。
- 56血糖データを感知するセンサと、 前記センサと電気的に連通しているセンサエレクトロニクスと、 前記センサエレクトロニクスと無線で連通しているユーザインターフェースと、 前記センサエレクトロニクスと連通している患者監視装置とを備えることを特徴とする、ユーザの血糖濃度を感知するシステム。
- 57前記ユーザインターフェースが無線送信器を含み、前記患者監視装置が無線受信器を含み、前記患者監視装置と前記ユーザインターフェースの間の通信が無線であることを特徴とする、請求項56に記載のシステム。
- 58前記患者監視装置がユーザインターフェースを含むことを特徴とする、請求項56に記載のシステム。
- 59前記センサエレクトロニクスがセンサ電源を含むことを特徴とする、請求項56に記載のシステム。
- 60前記センサエレクトロニクスが、工場入力の参照値が格納された不揮発性メモリを含むことを特徴とする、請求項56に記載のシステム。
- 61前記センサエレクトロニクスが、血糖測定器からの参照値を格納する不揮発性メモリを含み、前記参照値が前記血糖データを校正するためのものであることを特徴とする、請求項56に記載のシステム。
- 62前記センサエレクトロニクスが識別コードを格納し、前記センサエレクトロニクスが、前記識別コードを前記ユーザインターフェースに送信するように構成され、前記ユーザインターフェースが、前記センサからのデータを格納する前に前記識別コードに基づいて前記センサを識別するように構成されていることを特徴とする、請求項56に記載のシステム。
- 63前記センサが、リアルタイムで血糖データを感知するリアルタイム皮下センサであることを特徴とする、請求項56に記載のシステム。
- 64血糖データを感知するセンサと、 前記センサに連結され、前記センサと通信するように構成されたセンサエレクトロニクスであって、前記センサに電力を供給するセンサ電源と、前記センサで感知された血糖データを表す情報を格納し、かつ前記センサから受信した血糖データを校正する参照値を格納するメモリとを含むセンサエレクトロニクスと、 前記センサエレクトロニクスと通信するように構成され、前記センサエレクトロニクスの前記メモリに情報を入力する入力部を含むユーザインターフェースとを備えることを特徴とする、患者の血糖データを感知するシステム。
- 65前記ユーザインターフェースと通信するように構成され、前記センサで感知された血糖データを表す情報を表示する表示装置を含む患者監視装置をさらに備えることを特徴とする、請求項64に記載のシステム。
- 66前記センサエレクトロニクスのメモリが、少なくとも過去4時間のセンサデータを格納することを特徴とする、請求項64に記載のシステム。
- 67前記センサエレクトロニクスと前記ユーザインターフェースの間の無線通信のため、前記センサエレクトロニクスが無線送信器を含み、前記ユーザインターフェースが無線受信器を含むことを特徴とする、請求項64に記載のシステム。
- 68前記センサと前記ユーザインターフェースの間の有線通信のため、前記センサエレクトロニクスを前記ユーザインターフェースに接続する取外し可能なワイヤをさらに含むことを特徴とする、請求項64に記載のシステム。
- 69前記ユーザインターフェースおよび前記患者監視装置がそれぞれ、前記ユーザインターフェースと前記患者監視装置の間の無線通信のための無線送受信器を含むことを特徴とする、請求項64に記載のシステム。
- 70前記センサ電源が少なくとも1つの電池を含むことを特徴とする、請求項64に記載のシステム。
- 71前記少なくとも1つの電池が再充電可能であり、前記ユーザインターフェースまたは前記患者監視装置の少なくとも1つが、前記少なくとも1つの電池を充電する電力を前記センサエレクトロニクスに提供する電力源を含むことを特徴とする、請求項70に記載のシステム。
- 72前記センサエレクトロニクスが前記ユーザインターフェースおよび前記患者監視装置と通信していないとき、前記センサエレクトロニクスが前記センサに電力を供給し続け、前記センサが、血糖データを感知し、かつ前記センサが感知した血糖データを表す情報を格納し続けることを特徴とする、請求項64に記載のシステム。
- 73前記患者監視装置が、前記ユーザインターフェースに電力を提供する電力源を含むことを特徴とする、請求項64に記載のシステム。
- 74前記センサがリアルタイムで血糖データを感知するリアルタイムセンサであることを特徴とする、請求項64に記載のシステム。
- 75前記センサエレクトロニクスが有線通信のためのコネクタを含み、前記センサ電源が、前記センサが前記コネクタによって装置に接続されるとすぐに作動されることを特徴とする、請求項64に記載のシステム。
- 76前記センサエレクトロニクスが、前記センサから受信した血糖データを処理するプロセッサを含むことを特徴とする、請求項64に記載のシステム。
- 77前記参照値が前記システムのユーザによって入力されることを特徴とする、請求項64に記載のシステム。
- 78前記参照値が、前記システムのユーザが変更できない工場供給の参照値であることを特徴とする、請求項64に記載のシステム。
- 79前記参照値が不揮発性メモリに格納されることを特徴とする、請求項64に記載のシステム。
- 80前記不揮発性メモリがフラッシュメモリであることを特徴とする、請求項79に記載のシステム。
- 81前記フラッシュメモリが取外し可能なフラッシュメモリカードに含まれることを特徴とする、請求項80に記載のシステム。
- 82前記参照値が血糖測定器から得られることを特徴とする、請求項64に記載のシステム。
- 83前記血糖測定器が前記センサエレクトロニクスに連結されることを特徴とする、請求項82に記載のシステム。
- 84前記血糖測定器および前記センサが単一のハウジングに組み込まれることを特徴とする、請求項83に記載のシステム。
- 85前記センサエレクトロニクスが、血糖データを校正するプロセッサと、校正された血糖データが格納される校正メモリとを含むことを特徴とする、請求項64に記載のシステム。
- 86前記センサがリアルタイムで血糖データを感知するリアルタイムセンサであることを特徴とする、請求項64に記載のシステム。
- 87前記センサが皮下センサであることを特徴とする、請求項64に記載のシステム。
- 88リアルタイムで血糖データを感知するリアルタイムセンサと、 前記センサに動作電力を供給する、前記センサに連結された再充電可能な電源を含むセンサエレクトロニクスとを備え、 前記センサエレクトロニクスが、(a)ユーザインターフェースに連結され、次にユーザインターフェースから分断され、(b)前記ユーザインターフェースが前記センサエレクトロニクスに連結されているとき、および前記センサエレクトロニクスが前記ユーザインターフェースに連結されていないとき、前記センサに電力を供給し、ならびに、(c)前記ユーザインターフェースが前記センサエレクトロニクスに連結されているとき、前記ユーザインターフェースによって充電されるように構成されたことを特徴とする、ヒトの血糖濃度を感知するための装置。
- 89前記センサエレクトロニクスが、前記ユーザインターフェースとの有線通信にさらに構成されたことを特徴とする、請求項88に記載の装置。
- 90前記再充電可能な電源が少なくとも1つの充電式電池を備えることを特徴とする、請求項88または89に記載の装置。
- 91前記センサエレクトロニクスが、無線通信リンクを通して患者監視装置と通信するように構成されたことを特徴とする、請求項88に記載の装置。
- 92前記センサエレクトロニクスが、前記センサとの有線接触のためのコネクタを含み、前記再充電可能な電源が、前記センサが前記コネクタによって前記センサエレクトロニクスに接続されるとすぐに作動されることを特徴とする、請求項88に記載の装置。
- 93前記センサエレクトロニクスが、前記センサから受信した血糖データを処理するプロセッサを含むことを特徴とする、請求項88に記載の装置。
- 94前記センサエレクトロニクスが、前記センサで感知した血糖データを表す情報を格納し、かつ前記センサから受信した血糖データを校正するための参照値を格納するメモリを含むことを特徴とする、請求項88に記載の装置。
- 95前記メモリが、前記センサから受信した血糖データを校正するため、血糖測定器から得られた参照値をさらに格納することを特徴とする、請求項94に記載の装置。
- 96前記メモリがフラッシュメモリであることを特徴とする、請求項94に記載の装置。
- 97前記フラッシュメモリが取外し可能なフラッシュメモリカードに含まれることを特徴とする、請求項96に記載の装置。
- 98前記センサエレクトロニクスが前記血糖データを校正するプロセッサを含むことを特徴とする、請求項94に記載の装置。
- 99前記メモリが校正された血糖データをさらに格納することを特徴とする、請求項98に記載の装置。
- 100血糖データを感知するセンサと、 前記センサに連結され、前記センサに電力を供給する少なくとも1つの電池を含むセンサエレクトロニクスであって、前記センサが感知した血糖データに基づいたグルコース情報を格納するメモリをさらに含むセンサエレクトロニクスと、 前記センサエレクトロニクスに連結され、かつ非無線で連通しているユーザインターフェースであって、前記センサエレクトロニクスの前記メモリに参照情報を入力する入力装置を含むユーザインターフェースとを備え、 前記ユーザインターフェースが前記センサエレクトロニクスから分離可能であり、前記センサエレクトロニクスが前記センサに電力を供給し、前記ユーザインターフェースが前記センサエレクトロニクスから分離されたとき前記センサが動作可能であることを特徴とする、システム。
- 101前記センサがリアルタイムで血糖データを感知するリアルタイムセンサであることを特徴とする、請求項100に記載のシステム。
- 102前記電池が、前記ユーザインターフェースが前記センサエレクトロニクスから分離されていないときに充電される充電式電池であることを特徴とする、請求項100または101に記載のシステム。
- 103前記センサエレクトロニクスおよび前記ユーザインターフェースがそれぞれ、前記センサエレクトロニクスと前記ユーザインターフェースの間の無線通信用の無線送受信器を含むことを特徴とする、請求項100に記載のシステム。
- 104前記センサエレクトロニクスおよび前記ユーザインターフェースの少なくとも1つと連通している患者監視装置をさらに含み、前記患者監視装置が、前記センサで感知した血糖データに基づいた情報を表示する表示装置を含むことを特徴とする、請求項100に記載のシステム。
- 105前記ユーザインターフェースおよび患者監視装置が単一のハウジング内に組み込まれたことを特徴とする、請求項100に記載のシステム。
Independent claims105
90 paragraphs, as filed
The present invention generally relates to detection systems that include sensors, user interfaces and auxiliary devices for physiological properties. More specifically, the present invention relates to a blood glucose sensor that, when separated from communication with a user interface, continues to be powered and perform a function. The auxiliary device may be a display device.
Test strip meters are used to measure blood glucose levels in patients who do not have metabolic control. Frequent use of test strip meters requires a large labor force, although frequent measurements are required to interfere with and control glucose levels. For example, in today's hospitals, nurses need to take blood glucose readings from many patients every hour. Equipment and processes for automated and frequent measurements are needed to mitigate nursing labor.<patcit num="1"><text>U.S. Pat. No. 5,390,671</text></patcit><patcit num="2"><text>U.S. Pat. No. 5,391,250</text></patcit><patcit num="3"><text>U.S. Pat. No. 5,482,473</text></patcit><patcit num="4"><text>U.S. Pat. No. 5,856,53</text></patcit><patcit num="5"><text>U.S. Patent Application No. 10/273767 (published as U.S. Patent Publication No. 2004/0074785A1 dated April 22, 2004)</text></patcit><patcit num="6"><text>U.S. Pat. No. 5,497,772</text></patcit><patcit num="7"><text>U.S. Pat. No. 5,660,163</text></patcit><patcit num="8"><text>U.S. Pat. No. 5,750,926</text></patcit><patcit num="9"><text>U.S. Pat. No. 5,791,344</text></patcit><patcit num="10"><text>U.S. Pat. No. 5,917,346</text></patcit><patcit num="11"><text>U.S. Pat. No. 5999848</text></patcit><patcit num="12"><text>U.S. Pat. No. 5999849</text></patcit><patcit num="13"><text>U.S. Pat. No. 6043437</text></patcit><patcit num="14"><text>U.S. Pat. No. 6081736</text></patcit><patcit num="15"><text>U.S. Pat. No. 6088608</text></patcit><patcit num="16"><text>U.S. Pat. No. 6,119028</text></patcit><patcit num="17"><text>U.S. Pat. No. 6,259,937</text></patcit><patcit num="18"><text>U.S. Pat. No. 6,472,122</text></patcit><patcit num="19"><text>U.S. Pat. No. 6671554</text></patcit><patcit num="20"><text>U.S. Patent Application No. 10/034627 (published as U.S. Patent Publication 2003/0078560A1 dated April 24, 2003)</text></patcit><patcit num="21"><text>U.S. Patent Application No. 10/311186 (Published as U.S. Patent Publication No. 2004/0061232A1 dated April 1, 2004)</text></patcit><patcit num="22"><text>U.S. Patent Application No. 10/671996 (published as U.S. Patent Publication 2004/0061234A1 dated April 1, 2004)</text></patcit><patcit num="23"><text>U.S. Patent Application No. 10/335574 (Published as U.S. Patent Publication No. 2004/0064156A1 dated April 1, 2004)</text></patcit><patcit num="24"><text>U.S. Patent Application No. 10/334686 (published as U.S. Patent Publication No. 2004/0064133A1 dated April 1, 2004)</text></patcit><patcit num="25"><text>U.S. Patent Application No. 10/365279 (published as U.S. Patent Publication 2003/0220552 dated November 27, 2003)</text></patcit><patcit num="26"><text>US Patent Application No. 09/465715 (published as PCT International Publication US99 / 21703 on April 13, 2000)</text></patcit><patcit num="27"><text>U.S. Patent Application No. 10/141375 (published as U.S. Patent Publication No. 2002/0161288 on October 31, 2002)</text></patcit><patcit num="28"><text>U.S. Patent Application No. 10/806114</text></patcit><patcit num="29"><text>U.S. Pat. No. 6,734,371</text></patcit><patcit num="30"><text>U.S. Patent Application No. 09/465715</text></patcit><patcit num="31"><text>U.S. Pat. No. 4,562,571</text></patcit><patcit num="32"><text>U.S. Pat. No. 4,678,408</text></patcit><patcit num="33"><text>U.S. Pat. No. 4,695,903</text></patcit><patcit num="34"><text>U.S. Pat. No. 5080653</text></patcit><patcit num="35"><text>U.S. Pat. No. 5097122</text></patcit><patcit num="36"><text>U.S. Pat. No. 6,554,798</text></patcit>
<p> Medical detectors designed to measure a patient's physiological characteristics generally consist of a sensor and a user interface for configuring the sensor and observing the data from the sensor. Generally, a sensor requires power, which is supplied by a user interface or electronics that attaches the sensor to the user's body. In some environments, it is inconvenient for humans to wear sensors and associated electronics or user interfaces, especially if the electronics are large, such as wall-mounted displays. For example, hospitals typically have patient monitoring devices that display data about the patient, such as heart rate and blood pressure. If the sensor communicates with a patient monitoring device, it may be necessary or desirable to remove the sensor. However, the patient removes the sensor as needed or requested, especially if it is difficult to remove the sensor, or if the sensor is a single-use device that must be replaced with a new sensor each time it is removed. Sometimes you can't. Therefore, there is a need for a new system that allows patients to continuously wear the sensor without the persistent inconvenience of the user interface.</p>
<p> In embodiments of the invention, a sensing system is provided to measure the physiological characteristics of a patient. Physiological properties are preferably blood glucose levels, but in addition to or instead of blood glucose levels, oxygen, potassium, hydrogen index (pH), lactate, one or more minerals, specimens, chemicals, proteins. , Concentrations of molecules, vitamins, etc., and / or other physical properties such as temperature, pulse rate, respiratory rate, pressure.</p><p> The detection system includes a sensor and a user interface. The detection system may further include an auxiliary device. The sensor may be a subcutaneous sensor, a vascular sensor, or a non-invasive sensor. The user interface may be a handheld device such as a handheld computer, personal data assistant (PDA), telephone, remote control, or the like. The auxiliary device is preferably a patient monitoring device.</p><p> The sensor may be a blood glucose sensor wiredly connected to the user interface, the user interface being wiredly connected to an auxiliary device, preferably a patient monitoring device. The sensor may preferably be a real-time sensor. The user interface may power the sensor and / or the monitoring device may power the sensor. Alternatively, the monitoring device may recharge the user interface, which powers the sensor. The user interface may be separated from the patient monitoring device while the sensor is still powered and operating. The user interface may wirelessly transmit data to the monitoring device. Alternatively, the glucose sensor may be wired to both the user interface and the patient monitoring device. The sensor may be powered by the user interface, by a monitoring device, or both.</p><p> The blood glucose sensor and sensor electronics may be wired to the user interface. The sensor and sensor electronics can be separated from the user interface. When the sensor and sensor electronics are separated from the user interface, the sensor may continue to be powered by the sensor electronics. The sensor electronics may be recharged when attached to the user interface. Sensors and sensor electronics may retain power, reference values (eg for calibration), and sensor measurements when separated from the first user interface. The sensor and sensor electronics can then be attached to the second user interface, thereby downloading the sensor measurements to be displayed, and the sensor and sensor electronics can be attached to the second user interface. No recalibration and warm-up required.</p><p> The user interface or monitoring device may use a transformer to power the sensor electronics, thereby providing a grounding separation between the user interface and the sensor electronics. The sensor electronics may include a connector for a wired connection to a user interface or monitoring device. The user interface may include a wired connection for connecting to the patient monitoring device.</p><p> The sensor may include a connector for connecting to the sensor electronics. Once the sensor is connected, the power supply for the sensor electronics may be activated.</p><p> Further, according to the present invention, the blood glucose sensor and sensor electronics may communicate with a user interface that communicates with the monitoring device. The communication may be wired or wireless. Blood glucose sensors and sensor electronics may communicate with both user interfaces and monitoring devices.</p><p> Sensor electronics may include factory-supplied reference values for the sensor. Factory-supplied reference values may be stored in non-volatile memory, which can also be put into the user interface to calibrate the sensor signal. The reference value can be transmitted directly from the glucose meter to the sensor electronics or user interface. The reference value can be downloaded to a personal computer or manually entered into the personal computer and then uploaded to the user interface and optionally sent to sensor electronics. The reference value can be manually entered into the user interface and optionally sent to the sensor electronics.</p><p> Sensor electronics may include one or more of a sensor power supply, regulator, signal processor, measurement processor, measurement memory, and reference memory. The user interface is one of the mechanisms that receive data from the user interface power supply, user interface processor, reference memory, measurement processor, measurement memory, signal processor, regulator, and / or output device. It may include one or more. Either or both of the user interface and sensor electronics may include a wireless communication mechanism.</p>
Embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the drawings, similar reference numerals represent corresponding parts.
In the following description, reference to the accompanying drawings, they form part of the description and illustrate some embodiments of the invention. It is understood that other embodiments may be used and structural and operational changes may be made without departing from the scope of the invention.
As shown in the drawings for illustrative purposes, the invention includes a physiologic trait sensor, such as a blood glucose sensor, that produces physiologic trait data that is transmitted to one or more devices, such as a user interface and / or ancillary devices. , May be embodied in a detector of physiological properties. Physiological property data may be displayed on the auxiliary device.
Physiological properties are commonly used in hospitals to detect when a patient needs a change in treatment and to quantify the change in treatment needed. For example, patient blood glucose levels may be measured to determine if they have lost metabolic control. If they have lost metabolic control, caregivers can use blood glucose measurements to determine changes to treatment. Hospital patients suffer from trauma, surgical stress, stroke, heart disease, myocardial infarction, hypertension, diabetes, organ transplantation, infections, sepsis, kidney disease, pregnancy, physical distress, mental distress, emotional distress, etc. , May lack metabolic control.
In other embodiments, a lactate sensor may be used to detect the lactate concentration in the patient's blood. Lactate concentration can be used to detect if a patient has a myocardial infarction or if the patient is septic. An increase in lactate levels may indicate that the patient is more pulmonary bloody, and a decrease in lactate levels may indicate that the patient is recovering from sepsis. Lactate levels can also be used to determine how effectively the patient's tissue is using oxygen. As tissue oxygen exchange decreases, lactate levels increase and caregivers can detect that the patient is getting worse.
1A-1H show a wired connection between the sensor 100 and one or more devices according to an embodiment of the present invention. One or more devices may include at least one user interface 200 and may also include one or more auxiliary devices 300. There may be a connector between the wired components (not shown). As shown in FIG. 1A, the present invention may consist of a sensor 100 communicating with a user interface 200. The sensor 100 is powered by the user interface 200, and the sensor 100 measures physiological characteristics such as blood glucose concentration.
The sensor may continuously measure physiological properties so that the latest information on the measurement is periodically displayed on one or more devices. Sensor measurements may be displayed in real time and therefore as soon as the measurements are available. Alternatively, one or more measurements may be collected before the measurements are displayed. The measurements may be stored until all the measurements are obtained and then displayed. The measurement may be delayed before it is displayed.
Sensors also include, or instead of, blood glucose levels, concentrations of oxygen, potassium, hydrogen index (pH), lactates, one or more minerals, specimens, chemicals, proteins, molecules, vitamins, etc., and / Alternatively, other physical properties such as temperature, pulse rate, respiratory rate, and pressure can be measured. Sensors are incorporated herein by reference in U.S. Pat. Nos. 5390671, 5391250, 5482473, and 5585353, and U.S. Patent Application No. 10/273767 (U.S.A., dated April 22, 2004). It may be an electrochemical sensor that is inserted into the subcutaneous tissue of the body through the skin, such as the sensor described in Patent Publication 2004/0074785A1). Alternatively, the sensor may be a blood contact type sensor. For example, sensors are incorporated herein by reference in US Pat. Nos. 5,497,772, 5660163, 5750926, 5791344, 5917346, 5999848, 5999849, 6043437, 6081736. No. 6088608, 6119028, 6259937, 6472122, and 6671554, and US Patent Application No. 10/034627 (published as US Patent Publication 2003/0078560A1 dated April 24, 2003). ), No. 10/311186 (published as US Patent Publication 2004/0061232A1 dated April 1, 2004), No. 10/671996 (published as US Patent Publication 2004/0061234A1 dated April 1, 2004) ), No. 10/335574 (published as US Patent Publication 2004/0064156A1 dated April 1, 2004), No. 10/334686 (published as US Patent Publication 2004/0064133A1 dated April 1, 2004) ), And a thin-film vascular sensor as described in No. 10/365279 (published as US Patent Publication No. 2003/0220552 dated November 27, 2003). Good. Alternatively, the sensor may be an optical sensor, as well as a sensor described in US Patent Application No. 09/465715 (published April 13, 2000 as PCT International Publication US99 / 21703), which is incorporated herein by reference. It may be non-invasive and therefore non-penetrating into the body. The sensor may preferably be a real-time sensor. As used herein, the terms "real-time" and "real-time sensor" sense values virtually continuously over a long period of time, and use those values later for almost all of the collected values. It refers to a sensor that is available when a value is sensed and collected, rather than having to be downloaded in order to do so. For example, a real-time blood glucose sensor senses glucose levels every 10 seconds over a long period of 24 hours and makes the values available every 5 minutes (eg, processing, charting, and displaying), so users of insulin pumps. Can fine-tune the delivery of insulin on demand and start or stop it. Patients therefore use a pump to make near-immediate treatment adjustments based on real-time continuous glucose readings displayed every 5 minutes and by looking at a 24-hour glucose trend graph. be able to. For example, the sensor is as described in US Patent Application No. 10/141375, which is incorporated herein by reference (published as US Patent Publication No. 2002/0161288, dated October 31, 2002). Well, the figure of the displayed data may be as described in US Patent Application No. 10/806114, which is incorporated herein by reference. It may be a musensor. As used herein, the terms "real-time" and "real-time sensor" sense values virtually continuously over a long period of time, and use those values later for almost all of the collected values. It refers to a sensor that is available when a value is sensed and collected, rather than having to be downloaded in order to do so. For example, a real-time blood glucose sensor senses glucose levels every 10 seconds over a long period of 24 hours and makes the values available every 5 minutes (eg, processing, charting, and displaying), so users of insulin pumps. Can fine-tune the delivery of insulin on demand and start or stop it. Patients therefore use a pump to make near-immediate treatment adjustments based on real-time continuous glucose readings displayed every 5 minutes and by looking at a 24-hour glucose trend graph. be able to. For example, the sensor is as described in US Patent Application No. 10/141375, which is incorporated herein by reference (published as US Patent Publication No. 2002/0161288, dated October 31, 2002). Well, the figure of the displayed data may be as described in US Patent Application No. 10/806114, which is incorporated herein by reference. It may be a musensor. As used herein, the terms "real-time" and "real-time sensor" sense values virtually continuously over a long period of time, and use those values later for almost all of the collected values. It refers to a sensor that is available when a value is sensed and collected, rather than having to be downloaded in order to do so. For example, a real-time blood glucose sensor senses glucose levels every 10 seconds over a long period of 24 hours and makes the values available every 5 minutes (eg, processing, charting, and displaying), so users of insulin pumps. Can fine-tune the delivery of insulin on demand and start or stop it. Patients therefore use a pump to make near-immediate treatment adjustments based on real-time continuous glucose readings displayed every 5 minutes and by looking at a 24-hour glucose trend graph. be able to. For example, the sensor is as described in US Patent Application No. 10/141375, which is incorporated herein by reference (published as US Patent Publication No. 2002/0161288, dated October 31, 2002). Well, the figure of the displayed data may be as described in US Patent Application No. 10/806114, which is incorporated herein by reference. Based on Im's continuous glucose readings and by looking at the 24-hour glucose trend graph, pumps can be used to make near-immediate therapeutic adjustments. For example, the sensor is as described in US Patent Application No. 10/141375, which is incorporated herein by reference (published as US Patent Publication No. 2002/0161288, dated October 31, 2002). Well, the figure of the displayed data may be as described in US Patent Application No. 10/806114, which is incorporated herein by reference. Based on Im's continuous glucose readings and by looking at the 24-hour glucose trend graph, pumps can be used to make near-immediate therapeutic adjustments. For example, the sensor is as described in US Patent Application No. 10/141375, which is incorporated herein by reference (published as US Patent Publication No. 2002/0161288, dated October 31, 2002). Well, the figure of the displayed data may be as described in US Patent Application No. 10/806114, which is incorporated herein by reference.
In a preferred embodiment, sensor measurements are displayed every 5 minutes. Alternatively, they may be displayed more frequently, such as every 2 minutes, every minute, or every 30 seconds. In other embodiments, the sensor values are displayed less frequently, such as every 7 minutes, every 8 minutes, every 10 minutes, every 15 minutes, every 20 minutes, every 30 minutes, every hour, and so on. The nurse periodically observes the patient's current blood glucose level and changes the insulin delivery rate (eg, by intravenous or subcutaneous delivery to increase or decrease the rate at which the pump delivers insulin into the patient's body), additional Providing insulin bolus (eg, injecting additional insulin into the patient's body or into the patient's intravenous line, or programming the insulin pump to inject additional insulin doses), altering the patient's food intake (eg) For example, increase or decrease the rate at which glucose is delivered to the patient's body, or alter the rate of tube feeding, or provide a sick diet for ingestion), drugs for the treatment of type 2 diabetes, steroids, anti-rejection The patient's treatment may be adjusted, such as by changing the amount of drugs that affect the insulin activity used by the patient, such as sex drugs and antibiotics. The nurse may check the patient's glucose level hourly and adjust the treatment if necessary. Alternatively, the nurse may check for more frequent adjustments, such as every 30 minutes, every 20 minutes, every 10 minutes, and so on. This is especially appropriate when the patient's glucose level is not within the normal range. Alternatively, the nurse may check for less frequent adjustments, such as every 2 hours, every 3 hours, every 4 hours, every 6 hours, and so on. This is when the patient's glucose level is within the normal range, or when the patient's glucose is normal for a period of time such as 1 hour, 2 hours, 4 hours, or 8 hours, or the patient's treatment. However, it is more suitable when the period has not been changed, such as 2 hours, 4 hours, 8 hours, or 12 hours. In a further alternative, the nurse may rely on an alarm to inform the patient to be inspected. For example, do nurses need treatment adjustments?
The normal range of blood glucose levels for patients in hospitals is generally 80-120 milligrams (mg / dl) of glucose per deciliter of blood. Depending on the caregiver, the upper limit of the range is about 140 mg / dl, 145 mg / dl, 150 mg / dl, 160 mg / dl, etc., and the lower limit of the range is about 70 mg / dl, 80 mg / dl, 90 mg / dl, 100 mg / dl, Maintain a higher normal range, such as 110 mg / dl. For other caregivers, the upper limit of the range is about 110 mg / dl, 100 mg / dl, 90 mg / dl, 80 mg / dl, etc., and the lower limit of the range is about 80 mg / dl, 70 mg / dl, 60 mg / dl, 50 mg / dl. Maintain a lower normal range, such as.
The caregiver may use the current blood glucose level to regulate the patient's treatment in order to keep the patient's glucose within the normal range. For example, if the patient's glucose level is above the upper limit of the normal range, the caregiver may increase the rate at which insulin is delivered into the patient's body. Conversely, if the patient's glucose level is below the lower limit of the normal range, the caregiver may reduce the insulin delivery rate.
Alternatively, the caregiver may consider both the current glucose level and at least one past value to determine the adjustment of the patient to treatment. For example, if the current glucose level is too high and the previous glucose level is lower, the caregiver may substantially increase the insulin rate because the patient's glucose is too high and elevated.
The caregiver may use long-term trend information or a chart plot of glucose levels to determine if the patient's treatment should be changed. Alternatively, treatment may be changed automatically when the patient's glucose level is out of the normal range.
The user interface 200 allows the user to interact with the sensor. The user interface includes output devices such as liquid crystal display (LCD), light emitting diode (LED), touch screen, dot matrix display device, plasma display device, alarm, buzzer, speaker, voice maker, voice synthesizer, vibrator, etc. , Keypad, one or more buttons, keyboard, mouse, joystick, radio frequency (RF) receiver, infrared (IR) receiver, optical receiver, one or more input devices such as microphones. .. The user interface may be a handheld device such as a handheld computer, personal digital assistant (PDA), mobile phone or other radiotelephone, remote control. Alternatively, the user interface may be a personal computer (PC), a desktop computer, a laptop computer, and the like.
As shown in FIG. 1B, the user interface 200 may further communicate with an auxiliary device 300 such as a patient monitoring device. Patient monitoring devices include either display or other instruction system for use in other medical environments such as hospitals, doctor's offices, or home care. For example, some patient monitoring devices are used in a hospital environment to monitor the physiological characteristics of a patient, such as the patient monitoring device described in US Pat. No. 6,633,471, which is incorporated herein by reference. is there.
Arrows from user interface 200 indicate that data is transmitted to auxiliary device 300 and not vice versa, but this is not intended to be limited in any way. In any of the drawings, the transmission of data may occur in either direction or in both directions. Communication may be through a wired connection or by wireless method. Radio methods include radio frequency (RF) communications, infrared (IR) communications, optical communications, or other wireless methods useful in the present invention, such as those conceived by one of ordinary skill in the art without undue experimentation. Including methods.
As shown in FIG. 1C, the user interface 200 may communicate with one or more auxiliary devices 300. One or more auxiliary devices 300 may communicate with each other in addition to communicating with the user interface 200 and / or the sensor 100.
As shown in FIG. 1D, the sensor 100 may communicate directly with the auxiliary device 300. The user interface 200 may therefore communicate with the auxiliary device 300, which may communicate with the sensor 100. Further, as shown in FIG. 1E, the sensor 100 may communicate with both the user interface 200 and the auxiliary device 300.
1F and 1G show the configuration of an embodiment of the present invention according to the data flow of FIG. 1B. As shown in FIG. 1F, the sensor 100 may be tethered to the user interface 200 with wire 900, and the user interface 200 may be tethered to the auxiliary device 300 with wire 900. As shown in FIG. 1G, the sensor 100 may be tethered to the user interface 200 via wire 900, or the user interface 200 may wirelessly communicate with the auxiliary device 300.
Since one or more of the auxiliary devices may communicate with the personal computer or server, the sensor measurements are transmitted to the personal computer or server. As shown in FIG. 1H, one or more of the auxiliary devices 300 may communicate with a personal computer or server 500, and the blood glucose (BG) reference or laboratory measurement from the BG meter 700 is a personal computer. Will be sent to. Thus, the reference measurement may be sent to the personal computer or server 500 and then to the user interface 200. These reference measurements may be used to calibrate the sensor data. As shown in FIG. 1H, the user interface 200 may communicate with the personal computer or server 500 via one or more other auxiliary devices 300, such as a patient monitoring device. Communication between the BG meter 700 and the user interface 200 can also be via one or more of the auxiliary devices 300. As also shown in FIG. 1H, the user interface 200 may communicate via the docking station 220. The BG meter 700 can also be placed inside the docking station 720. Sensor measurements may be stored on the server and made available to one or more PCs. Therefore, in one embodiment, the sensor information can be downloaded to the first PC and the reference measurements of the BG meter can be downloaded or input to the second PC, the first PC and the second PC. Can communicate with each other (eg via a server), reference measurements can be sent to the user interface, sensor measurements and / or reference measurements can be made on any of the PCs connected to the shared server. You can see it in. One or more devices, such as user interfaces and / or BG meters, may use one or more cradle to connect the devices to a PC. Alternatively, the reference measurement is sent to the PC, the processed sensor signal is sent to the PC, and the PC is set. Calculate the sensor measurement. Alternatively, the user interface may communicate with a personal computer using radio frequency (RF) (not shown). Examples of devices that facilitate communication with a personal computer are, but are not limited to, the ComLink sold by Medtronic MiniMed, which can be used to send and / or receive signals. , IR cradle, communication link device such as RF device. For example, ComLink has a transmitter / receiver that receives an RF signal from a user interface and then transfers the received information to a personal computer by wire.
2A-2S show the data flow of an embodiment of the invention in which the sensor communicates with the sensor electronics and it communicates with the user interface. The sensor is tethered to the sensor electronics, which may communicate with the user interface and / or auxiliary device through the tethered connection or wirelessly. Sensor electronics are described in more detail below. As shown in FIG. 2A, the sensor 100 may communicate with the sensor electronics 120, which communicates with the user interface 200.
In FIG. 2B, the user interface 200 communicates with one or more auxiliary devices 300 and also communicates with the sensor electronics 120. As shown in FIG. 2C, the user interface 200 may communicate with one or more auxiliary devices 300. Auxiliary devices 300 may communicate with each other and / or with user interface 200 and / or sensor electronics 120.
As shown in FIG. 2D, both the user interface 200 and the sensor electronics 120 may communicate with the auxiliary device 300. Further, as shown in FIG. 2E, the sensor electronics 120 may communicate with both the user interface 200 and the auxiliary device 300.
2F-2I, 2L-2O, and 2P-2S are embodiments of the invention according to the data flows of FIGS. 2B, 2D, and 2E, respectively. These indicate that the communication between the devices may be by wire 900 or wireless. In FIGS. 2F and 2G, the sensor 100 and the sensor electronics 120 are connected to each other and to the connector 400. The connector 400 may connect the sensor electronics 120 to a wire 900 that connects to the user interface 200. As shown in FIG. 2F, the user interface 200 may then be tethered to the auxiliary device 300 via wire 900. As shown in FIG. 2G, the user interface 200 may further communicate wirelessly with the auxiliary device 300.
In FIGS. 2H and 2I, the sensor 100 and the sensor electronics 120 are connected to each other but communicate wirelessly to the user interface 200. In this embodiment, the connector may be absent, but it may have sensors and sensor electronics capable of communicating with the user interface in a wired or wireless configuration. Therefore, the sensor and sensor electronics may be connected to a wire connector that is not used when the communication is wireless. In FIGS. 2H and 2I, the sensor 100 is connected to the sensor electronics 120, which communicates wirelessly with the user interface 200. As shown in FIG. 2H, the user interface 200 may then be tethered to the auxiliary device 300 via wire 900. As shown in FIG. 2I, the user interface 200 may further communicate wirelessly with the auxiliary device 300.
In FIGS. 2L and 2M, the sensor 100 and the sensor electronics 120 are connected to each other and to the connector 400. The connector 400 may connect the sensor electronics 120 to the wire 900 that connects to the auxiliary device 300. As shown in FIG. 2L, the auxiliary device 300 may then be tethered to the user interface 200 via wire 900. As shown in FIG. 2M, the auxiliary device 300 may further communicate wirelessly with the user interface 200.
In FIGS. 2N and 2O, the sensor 100 and the sensor electronics 120 are connected to each other, but communicate wirelessly with the auxiliary device 300. In FIGS. 2N and 2O, the sensor 100 is connected to the sensor electronics 120, which communicates wirelessly with the auxiliary device 300. As shown in FIG. 2N, the auxiliary device 300 may then be tethered to the user interface 200 via wire 900. As shown in FIG. 2O, the auxiliary device 300 may further communicate wirelessly with the user interface 200.
In FIGS. 2P, 2Q, and 2R, the sensor 100 and the sensor electronics 120 are connected to each other and to the connector 400. The connector 400 can also connect the sensor electronics 120 to one or more wires 900 that connect to the auxiliary device 300 and / or the user interface 200. As shown in FIG. 2P, the sensor electronics 120 may be connected to both the auxiliary device 300 and the user interface 200 via a wire 900. As shown in FIG. 2Q, the sensor electronics 120 may be connected to the auxiliary device 300 via a wire 900 and wirelessly communicated with the user interface 200. As shown in FIG. 2R, the sensor electronics 120 may be connected to the user interface 200 via a wire 900 and wirelessly communicated with the auxiliary device 300. In FIG. 2S, the sensor 100 is connected to the sensor electronics 120, which wirelessly communicates with the auxiliary device 300 and the user interface 200.
One or more of the auxiliary devices may be a personal computer or server, and sensor measurements may be transmitted to the personal computer or server. In addition, blood glucose (BG) reference or laboratory measurements from the BG meter may be sent to a personal computer or server and then to the user interface. As shown in FIGS. 2J and 2K, the user interface 200 may communicate with the personal computer 500 and the BG meter 700 may communicate with the personal computer 500. Further, as shown in FIGS. 2J and 2K, the user interface 200 may communicate with the personal computer or server 500 via one or more other auxiliary devices 300, such as a patient monitoring device. Communication with the BG meter 700 and the user interface 200 may further be by one or more of the auxiliary devices 300. The user interface 200 may communicate via the docking station 220. The BG meter 700 may also be located inside the docking station 720. In FIG. 2J, the sensor 100 is connected to the sensor electronics 120, which is connected to the connector 400, which connects the sensor electronics 120 to the user interface via the wire 900. As shown in FIG. 2K, the communication between the sensor electronics 120 (connected to the sensor 100) and the user interface 200 can also be wireless. Sensor information may be stored on a server and made available to one or more personal computers. Therefore, in one embodiment, the sensor information can be downloaded to the first personal computer, the reference measurement value of the BG meter can be downloaded or input to the second personal computer, and the first personal computer and the first personal computer. 2 personal computers can communicate with each other (eg through a server), reference measurements can be sent to the user interface, Sensor measurements and / or reference measurements can be viewed on any of the personal computers connected to the shared server. Alternatively, the reference measurement may be sent to the personal computer, the processed sensor signal may be sent to the personal computer, and the personal computer may then calculate the sensor measurement.
As mentioned above, the present invention may include electrical components. For example, electrical components may include one or more power supplies, regulators, signal processors, measurement processors, reference memories, measurement memories, user interface processors, output devices, and input devices. One or more power sources provide power to other components. The regulator supplies the regulated voltage to one or more sensors, and at least one of the one or more sensors produces a sensor signal indicating the concentration of the physiological characteristic being measured. The signal processor then processes the sensor signal that produces the processed sensor signal. The measurement processor then calibrates the processed sensor signal using the reference value from the reference memory, thereby generating the sensor measurement value. Next, the measurement memory stores the sensor measurement value. Finally, the sensor readings are sent to the user interface processor, which transfers the sensor readings to the output device.
One or more power sources may be batteries. Alternatively, the one or more power sources may be one or more batteries, a voltage regulator, alternating current from an outlet, a transformer, a rechargeable battery, and the like. The regulator may be a voltage regulator. Alternatively, the regulator may be a current regulator or other regulator. The power source for operating the sensor or charging the battery in the sensor electronics is an AC power source (eg 110 volt or 220 volt), a DC power source (eg 12 volt DC battery), or a pulsating DC power source. (For example, a power charger that provides a pulsating DC current that reapplies voltage to the battery and removes lead sulfate deposits from the plate) may be included.
The signal processor may perform one or more functions such as conversion, clipping, addition, filtering, and smoothing of an analog signal to a digital signal of a sensor signal.
The measurement processor performs one or more functions such as calibration (converting processed sensor signals into measurements), standardization, filtering, clipping, addition, smoothing, analysis, etc., but not limited to them. You may. The measurement processor may further analyze whether the sensor is producing a signal that exhibits physiological properties or that the sensor is no longer functioning properly. For example, the measurement processor detects that the processed sensor signal is too high, too low, too fast changing, or too noisy for a properly functioning sensor, and therefore replaces the sensor. It may indicate that it should be. The measurement processor also has sensor measurements that are too high, too low, too fast, too fast, too fast, or too fast in light of their current values, or their current values. It may be analyzed whether an alarm is generated depending on the characteristics of the sensor measurement value, such as whether it decreases too rapidly, is too high for a predetermined duration, or is too low for a predetermined duration. .. In addition, the measurement processor may evaluate the remaining battery life.
The reference memory may include one or more reference values for converting the processed sensor signal into sensor measurements. For example, 1 microamp is equal to 40 milligrams (mg / dl) of glucose per deciliter of fluid, or 2 nanoamperes is equal to 10 mmol (mmol / l) of glucose per liter of fluid. Reference measurements are paired with the processed sensor signal for each reference measurement and are periodically input to the input device for the life of the sensor, and each pair of reference measurement and processed sensor signal is a reference value. Is stored in the reference memory as. Therefore, the measurement processor may convert the sensor signal processed using the new reference value into a sensor measurement. Alternatively, the reference value may be factory-installed. Therefore, no periodic reference measurements are needed. In addition, the reference memory may contain both factory-installed and periodic reference values.
The user interface processor may transfer sensor measurements from the measurement memory to the output device. The user interface processor may also accept input from the input device. If the sensor contains memory, the user interface may send parameters from the input to the sensor for storage in memory. Inputs are specific configuration parameters that may change later but may be fixed, one or more high thresholds, one or more low thresholds, one or more trend ratios, alarm confirmations, alarms. It may include one or more of the minimum time between, snooze duration, sensor serial number, code, identification number (ID), password, username, patient identification, reference measurements, and so on. The user interface processor also displays the latest sensor measurements, displays the latest reference measurements, displays a graph of sensor measurements, displays thresholds, activates alarms, alarms. You may tell the output device what to do, such as one or more of displaying messages such as messages, error messages, commands, descriptions, recommendations, and status. In addition, the user interface processor calibrates, standardizes, filters, clips, adds, smoothes, calculates whether the sensor is producing signals that exhibit physiological properties, or the sensor is no longer functioning properly, the rest. One or more of the processing or analysis functions may be performed, such as assessing the battery life of the device and determining whether to generate an alarm based on the characteristics of the sensor measurements.
If one or more electronic components are present in the same device, one or more of the electrical components may be a single, such as a combination of user interface processors, measurement processors, and signal processors, or a combination of measurement memory and reference memory. May be combined with electrical components of. Alternatively, the components may be independent, regardless of which device they are in.
The sensor may need to receive regulated power for a specified duration before it can generate a stable signal, in other words it must warm up. Also, if the regulated power is removed from the sensor and the power is restored before the measurements can be used, the sensor must warm up again. Alternatively, each time the sensor warms up, a new reference measurement may have to be entered and paired with the processed sensor signal to create a new reference value stored in reference memory. .. Reference values are needed to calibrate the processed sensor signals to sensor measurements. In addition, a periodic reference value may be required, and when a new reference value is needed, the processed sensor signal will be available if a stable (warmed up) processed sensor signal is not available. New reference measurements may need to be collected when they become available and stable. On the other hand, the processed sensor signal cannot be used to generate sensor measurements. In other words, if it is time for a new reference measurement to maintain calibration and the sensor signal to pair with the new reference measurement is not available, the sensor loses calibration and the sensor signal. Must be recalibrated when is available. Also, more than one reference value may need to be collected before the sensor measurements are considered calibrated.
Sensors can be isolated from the user interface and / or patient monitoring equipment for extended periods of time, especially in hospital environments. For example, patients are moved regularly between the room and bed when they may not be connected to any patient monitoring device (eg, surgical patients are moved from hospitalization to surgery, then to recovery, and so on. ). In some cases, calibrations are scheduled at specific intervals. One of these intervals may occur when the sensor connected to the sensor electronics is separated from the user interface and / or patient monitoring device. In such situations, it is useful to have a method of calibrating the sensor and sensor electronics while being isolated from the user interface and / or patient monitoring device. For example, the sensor may include a blood glucose (BG) meter that assists in calibration. The BG meter may be without a display device, for example to reduce extra size and weight. The BG meter included in the sensor then provides a reference value for calibration to the sensor electronics. It is also possible to connect the sensor electronics to the BG meter or use a wireless connection to the BG meter to receive the reference value.
3A-3C and 4A-4C show physical embodiments of aspects of the present invention. Figures 3A-3C show sensors with and without sensor electronics with connector 400, so they may be wired to one or more devices. In the above-described embodiment shown in FIGS. 1A to 1H, there is a connector 400 between the sensor 100 and a device (not shown). FIG. 3A shows a simple sensor according to the invention as embodied in FIGS. 1A-1H. The sensor 100 includes a connector 400. The sensor 100 is not always connected to the device by wire. For example, as shown in FIGS. 3C, 4A, and 4B, the sensor 100 shown in FIG. 3A may be coupled to sensor electronics. However, especially in this embodiment, the sensor 100 does not include sensor electronics.
There are numerous ways to include sensor electronics in the sensors of the present invention. As shown in FIG. 3B, the sensor 100 may include a connector 400 and the sensor electronics may be an integral part of the sensor. In FIG. 3B, the electrical components, especially the regulator 1090 and the sensor power supply 1210, are shown directly on the sensor 100. Alternatively, the sensor electronics 120 may be connected to the sensor 100 by a connector 450, as shown in FIG. 3C. The sensor electronics 120 of FIG. 3C includes one or more electrical components such as a regulator 1090 and a sensor power supply 1210, and may be wired to one or more devices via connector 400.
Figures 4A-4C show sensors intended to be used for wireless communication with one or more devices. As shown in FIG. 4A, the sensor 100 may be connected to the sensor electronics 120 by a connector 450. The sensor electronics 120 may include one or more electrical components such as a regulator 1090 and a sensor power supply 1210. As shown in FIG. 4B, the sensor may be connected to the sensor electronics 120, which includes a portion connected to the sensor via a connector 450, and may be wired connected to a separate portion 140, which includes the sensor electronics. Sensor electronics are shown to have electrical components on only one part, but have some electrical components on one part of the sensor and other electrical components on another. It is possible to have. The embodiment shown in FIG. 4B is described in detail in US Patent Application No. 09/465715, filed December 17, 1999, which is incorporated herein by reference. As shown in FIG. 4C, the sensor electronics may be an integral part of the sensor 100.
Various wireless communication protocols may be used. Some protocols are for one-way communication and others are for intercommunication. In one-way communication, the transmitter may have a transmitter and the receiver may have a receiver. In a bidirectional protocol, each device generally has a transmitter / receiver, but each device can have a transmitter / receiver and a receiver. In any wireless embodiment, a transmitter / receiver may be used in place of the receiver and transmitter, as the transmitter / receiver can act as a receiver and / or transmitter. is there.
If the sensor electronics 120 (wired or wireless) is separated from the sensor 100 by a connector 450 as shown in Figures 3C, 4A, and 4B, then when the sensor electronics are attached to the sensor, the sensor electronics from the sensor power supply. Power may be supplied first. Therefore, the storage life of the sensor power supply is increased. Alternatively, the sensor electronics may be constantly powered. Sensor electronics are powered by a sensor power source when the user interface is connected to the sensor electronics, when a magnetic switch is activated, when a mechanical switch is activated, or when triggered by other means. May be good.
The load cycle of the sensor power supply may vary depending on whether the sensor electronics are connected to or isolated from the user interface and / or patient monitoring device. For example, when the sensor electronics are isolated, the load cycle may be reduced (eg, by using fewer electrical components, reducing data acquisition, etc.), which is the larger sensor power supply. Allows storage life. If the sensor and sensor electronics lose power over a long period of time, the calibration process may have to be repeated. The sensor electronics may include circuits for detecting low battery levels and may be coupled to an alarm that is activated when the low battery levels reach a certain threshold.
5A-5H are block diagrams of electronic components according to an embodiment of the present invention. In the embodiment shown in FIG. 5A, the user interface 200 is tethered to the sensor 100. The tether may be interrupted by the connector 400 so that the sensor 100 and the user interface 200 can be separated. Sensor 100 does not include the power supply shown in Figure 5A. When the patient separates the sensor from the user interface 200, the sensor no longer receives power from the regulator, which may require time to warm up again and recalibrate when reconnected to the user interface. May be needed.
The user interface power supply 1030 may supply power to the user interface 200 and may also supply power to the sensor 100. Regulator 1090 supplies a regulated voltage to sensor 100, which produces a sensor signal indicating the concentration of physiological properties being measured. The signal processor 1080 then processes the sensor signal to generate the processed sensor signal. The measurement processor 1070 then calibrates the processed sensor signal using the reference value from the reference memory 1050, thereby generating the sensor measurement value. Next, the measurement memory 1060 stores the sensor measurement value. Finally, the sensor readings are sent to the user interface processor 1040, which transfers the sensor readings to the output device 1010. Reference values, and other useful data, may be entered via input device 1020.
As shown in FIG. 5B, the auxiliary device 300 may be tethered to the sensor 100 and the tether may be interrupted by the connector 400 so that the sensor 100 and the user interface 200 can be separated. Thus, the patient wearing the sensor does not need to remain tethered to a device such as a user interface or auxiliary device. The user can wear the sensor and be temporarily or permanently separated from other devices. This can be useful when the patient needs to leave the vicinity of one or more devices. For example, the sensor may be tethered to a fixed device such as a wall-mounted or bed-mounted display, and the patient must leave the room for treatment. As shown in FIG. 5B, the auxiliary device may include an auxiliary device power supply 1110, a regulator 1090, and a signal processor 1080 so that the auxiliary device can process the sensor signal.
In the above embodiment where the sensor does not include a power source, the sensor will not receive power when it is separated from other devices. The tether includes one or more wires that transmit the regulated voltage to the sensor and also transmit the sensor signal to the signal processor. For certain types of sensors, the sensor must be warmed up again when it is reconnected to the user interface. If the reference memory is included in the user interface, one or more reference values may be measured periodically as collected and stored in the reference memory. However, if the sensor is detached from the user interface when new reference values are needed, the sensor will need to be calibrated when reconnected.
As described above with reference to FIGS. 1B-1H, one or more devices other than the sensor may communicate with each other. One or more devices other than sensors, such as auxiliary devices and user interfaces, may share tethered connections such as wires. As used herein, the term "wire" means any physical conductor capable of transmitting information by non-wireless means, including, for example, one or more conventional wires, series or parallel cables, fiber optic cables, and the like. Means and includes them. The term "wire" also includes any physical conductor capable of transmitting regulated voltage, power, etc. In addition, the tethered connection may include at least one connector so that at least one device can be separated from the other. One or more of the non-sensor devices, such as auxiliary devices and user interfaces, may communicate wirelessly, such as by RF, IR, subsonic, etc., as shown in FIG. 1G.
Alternatively, as shown in FIGS. 5C-5H, the user interface may be connected to the sensor electronics, which may be connected to the sensor. When the power supply and regulator are with the sensor (as part of the sensor electronics), when the sensor is separated from the user interface, the sensor continues to be powered and can hold the calibration. Therefore, the sensor does not need to require warm-up time and does not need to be recalibrated when reconnected to the same user interface that was previously connected.
The sensor power supply may be a battery that can operate for at least the entire life of the sensor. For example, the life of the sensor may be, for example, about 2, 3, 4, 5, 7, 10, 20, 20, 30, 45, 60, 1 year, and so on. Alternatively, the life of the sensor may be shorter than 2 days, such as about 36 hours, 30 hours, 24 hours, 12 hours, 6 hours, 3 hours. The sensor power supply may be rechargeable. For example, the sensor power supply may be recharged when the sensor electronics are connected to the user interface. In addition, the sensor power supply has a total duration of 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, etc., when the sensor electronics are separated from the user interface. The size may be determined in time. The sensor power supply may include one or more transformers, capacitors, power cells, solar cells, replaceable batteries, and the like. Alternatively, the sensor power source is a replaceable battery.
In the embodiment shown in FIG. 5C, the sensor electronics 120 includes a sensor power supply 1210 and a regulator 1090. Therefore, when the sensor 100 is separated from the user interface 200, the sensor 100 continues to be powered. Since the sensor electronics do not include a storage device, no sensor data is stored while the sensor 100 is not connected to the user interface 200.
As shown in FIG. 5E, it is possible to carry the reference value on the sensor 100 so that the reference value is maintained on the sensor 100 even when the sensor 100 is no longer connected to the user interface 200. In this embodiment, the sensor power supply 1210 and the regulator 1090 and the reference memory 1050 are included in the sensor electronics 120 that is with the sensor 100 when separated from the user interface 200 at the connector 400. When the sensor 100 is separated from the user interface 200, the sensor 100 may continue to be powered and hold the calibration. Therefore, the sensor 100 does not require recalibration when reconnected. Further, the calibration values can be carried with the sensor 100 and transmitted to different user interfaces, so that the sensor 100 may be connected to different user interfaces and remain calibrated. When BG meter readings are required for calibration, they are input to the user interface 200 and sent to the reference memory 1050 of the sensor electronics 120. If BG meter readings are not required, reference memory 1050 may include factory-installed reference values for the sensor. In the particular embodiment shown in FIG. 5E, no sensor data is collected while the sensor 100 is not connected to the user interface.
As shown in FIGS. 5D and 5F, the sensor electronics 120 may include a signal processor 1080. Signal processors simplify tethered connections because they can convert weak analog sensor signals (which can be particularly sensitive to noise) into digital signals that can be very noise sensitive. To do. In many cases, the wire acts like an antenna, collecting radio frequency signals and the like, thereby adding noise to the signal carried by the wire.
As shown in FIGS. 5E-5H, the user interface 200 may be tethered to the sensor electronics 120, which may include a reference memory 1050. As shown in FIGS. 5E and 5G, one or more reference values may be measured periodically, entered into user interface 200, and transferred to reference memory 1050. If the sensor 100 is separated from the user interface 200 when a new reference value is needed, the sensor 100 will need to be calibrated when it is reconnected. As shown in FIGS. 5E and 5G, the power supply 1210, regulator 1090, and reference memory 1050 may be included in the sensor electronics 120. When the sensor 100 is separated from the user interface 200, the sensor 100 continues to be powered and holds the calibration. Therefore, the sensor does not require recalibration or warm-up when reconnected. In addition, the calibration value can be carried with the sensor and sent to the second user interface, so that the sensor is separated from the first user interface and then connected to and calibrated with the second user interface. It may be up to.
As shown in FIGS. 5E and 5F, sensor electronics 120 includes reference memory 1050, sensor power supply 1210, and regulator 1090, but not measurement memory 1060. Since the measurement memory 1060 is not included in the sensor electronics 120, no sensor data is collected while the sensor 100 is not connected to the user interface. Further, if the sensor electronics 120 is separated from the user interface 200 when periodic reference measurements are needed and new reference measurements are needed, the sensor 100 loses calibration and the sensor electronics 120 is in the user interface. A new reference measurement is required when reconnected to.
As shown in FIG. 5G, the sensor electronics 120, the reference memory 1050, sensor power supply 1210, regulator 1090, a signal processor 1080, the measurement processor 1070, and a measurement memory 1060 contains may also do. Since the measurement memory 1060 is included in the sensor electronics 120, sensor data is collected even when the sensor 100 is not connected to the user interface. Therefore, the patient wearing the sensor may move around freely when separated from the user interface and, when reconnecting, send all sensor data to the user interface for analysis and display. Can be done. However, if periodic reference measurements are needed and the sensor electronics are separated from the user interface when new reference measurements are needed, the sensor loses calibration and the sensor electronics are reconnected to the user interface. A new reference measurement is needed at that time.
Periodic reference values may not be needed. One or more reference values may be stored in reference memory at the factory. Further, since the reference memory may be a non-volatile memory such as a flash memory, it does not require power to maintain the reference value as shown in FIG. 5H. Therefore, the reference values may be factory-installed on each sensor and do not require power to maintain the reference values in the reference memory. The reference memory 1050 may be included in the sensor electronics 120, as shown in FIGS. 5E, 5F, 5G, and 5H. Therefore, the sensor does not have to be separated from the user interface, connected to a second one, and does not require calibration. However, if power is lost when separated from the user interface as shown in Figure 5H, the sensor may require a warm-up period.
Alternatively, one or more factory-installed reference values may be stored in volatile memory at each sensor to maintain in-memory reference values as shown in Figures 5E, 5F, and 5G. , Power is needed. The reference memory and sensor power supply may optionally be included in the sensor electronics. Therefore, the sensor may be separated from the user interface, connected to a second one, and may not require calibration, and the sensor requires a warm-up period if it does not lose power when separated from the user interface. It does not have to be.
The tether may include one or more wires or one or more fiber optic cables and the like. Alternatively, if the sensor electronics include a sensor power supply and regulator, the tether does not have to include wires, cables, etc., so the wires are not needed to carry power to the sensor.
As shown in FIGS. 6A-6E and as described above with respect to FIGS. 2A-2S and 4A-4C, the speaker electronics 120 may include radio frequency (RF) transmitters or transmitters, or infrared (IR) transmitters or transmitters and receivers. It may include a mechanism 1205 for wireless communication, such as a device, a light emitting diode (LED), a sound wave transmitter such as a speaker. Sensor electronics, including wireless communication capabilities, are a subset of all sensor electronics and are referred to as wireless sensor electronics. Thus, the sensor may be physically connected to the wireless sensor electronics to establish a wired connection between the wireless sensor electronics and the sensor, but the wireless sensor electronics and the sensor are not tethered to the user interface or auxiliary device. Therefore, the user can wear the sensor and move around freely, physically separated from other devices. This can be useful when the patient needs to be away from the vicinity of one or more devices. For example, if the patient wears a sensor with wireless sensor electronics that communicates with a fixed device such as a wall-mounted or bed-mounted display, the patient separates the sensor electronics from any device. You may leave the room for treatment without need. Communication between the sensor electronics and one or more devices may be interrupted or later reestablished. For example, the sensor electronics may be temporarily out of RF communication range with the wall-mounted device, or may be temporarily out of IR communication with one or more devices.
The sensor wireless communication mechanism may be a processor that handles the communication protocol and manages the inflow and outflow of information in the reference memory and the measurement memory. The measurement memory may include one or more of calibrated measurements, times and dates associated with the measurements, uncalibrated measurements, diagnostic information, alarm history, error history, settings, and the like. The settings may be determined by the user using the keypad on the user interface and the settings are sent to the memory of the sensor electronics. In addition, the sensor radio communication mechanism may be a processor that evaluates measurements calibrated according to user-defined settings and sends the results of the evaluation to the user interface. For example, the user may set an alarm threshold that is transmitted to be stored in the memory of the sensor electronics. The sensor radio communication mechanism then compares the calibrated measurement to the alarm threshold, and if the calibrated measurement exceeds the alarm threshold, the communication system sends an alarm message to the user interface. Finally, the user interface displays an alarm message.
The alarm may work even when the sensor and sensor electronics are separated from the user interface and / or patient monitoring device. Thus, the patient is warned if he / she becomes hyperglycemic or hypoglycemic, even when not connected to the user interface and / or patient monitoring device. For example, sensor electronics may be linked to an alarm. As mentioned above, the alarm threshold may be stored in the memory of the sensor electronics. If the calibrated measurement exceeds the alarm threshold, an alarm linked to the sensor electronics may be activated. Similarly, sensor electronics will alarm if the battery is low, the sensor is not working properly, communication with another device is lost, an error occurs, or a warning is needed. May be activated. The alarm may be an audible alarm, a visible alarm, a tactile alarm (such as a vibration alarm), or any combination thereof. In certain embodiments, sensor electronics are. Contains one or more parts to alert the user.
User-defined parameters such as alarm threshold, minimum time between alarms, alarm snooze time, trend alarm threshold, patient ID, one or more identification codes, password, etc. are sent from the user interface to sensor electronics and sensor electronics. It may be stored in the memory of. Therefore, when the patient moves to a new position and the sensor electronics establishes communication with the second user interface, the settings established for a particular patient are not lost. User-defined settings are sent to a second user interface when communication with the sensor electronics is first established. Each set of sensor electronics may have a unique ID, code, name, serial number, etc., which is sent to the user interface so that the user interface can identify which sensor electronics it is communicating with. .. A unique ID for the sensor electronics may need to be entered into the user interface before the user interface can recognize the communication from the sensor electronics. Therefore, if the user interface detects communication from more than one sensor electronics, the user interface can determine which signal to respond to based on the unique ID contained in the communication. In addition, the user interface and / or auxiliary device may have one or more unique IDs, so that the device, user interface, and sensor electronics can each decide whether to accept communication from each other. .. For example, the patient monitoring device may be programmed to accept communications from the user interface or sensor electronics as long as the communications include a unique ID that represents a particular sensor. Therefore, the two patients shared a room and the transmission from the first patient's sensor electronics was received by the second patient's user interface and / or patient monitoring device. If so, the second patient user interface and / or patient monitoring device ignores the communication. However, the first patient user interface and / or patient monitoring device accepts communications from the first patient's sensor electronics. In another embodiment, the ID number of the user interface is input to the patient monitoring device, and the patient monitoring device accepts only the communication including the ID number of the user interface.
6A to 6E show the same embodiments as those of FIGS. 5A to 5H. However, as shown in FIGS. 6A-6C, the sensor electronics 120 includes the sensor wireless communication mechanism 1205, and the user interface 200 includes the user interface wireless communication mechanism 1005. As shown in Figure 6A, the sensor power supply 1210 and regulator 1090 are part of the sensor electronics 120. Therefore, power is always supplied to the sensor 100. As shown in FIG. 6B, the signal processor 1080 may reside within the sensor electronics 120, so that the sensor 100 continues to be powered, but can also be processed. In certain embodiments, the signal processor 1080 includes an AD converter. Therefore, digital communication can be used to send the processed sensor signal to the user interface 200.
When the sensor is powered and warmed up by the sensor power supply and regulator, the sensor continues to be powered and warmed up sufficiently so that no matter how many different devices it communicates with, it does not need to be warmed up again. .. One or more reference values may be measured periodically and stored in reference memory once collected. If the wireless sensor electronics cannot establish communication with the user interface when new reference values are needed, the sensor will need to be calibrated when communication is reestablished.
As shown in FIG. 6C, a sensor power supply 1210, a regulator 1090, and a reference memory 1050 may be present with the sensor 100. Therefore, if the sensor 100 loses communication with the user interface 200 (for example, because the patient walks too far away from the user interface), the sensor continues to be powered and retains calibration. Therefore, sensor 100 does not require recalibration or warm-up time when reestablishing communication with user interface 200. Further, since the calibration value is carried with the sensor 100 and can be transmitted to the second user interface, the sensor 100 may establish communication with the second user interface and remain calibrated. As shown in FIG. 6D, wireless sensor electronics may include reference memory 1050, sensor power supply 1205, regulator 1090, signal processor 1080, and wireless communication mechanism 1205, but not measurement memory 1060. Since the measurement memory is not included in the wireless sensor electronics, no sensor data is collected while the wireless sensor electronics are not communicating with the user interface. In addition, if periodic reference measurements are needed and communication cannot be established between the wireless sensor electronics and the user interface when new reference measurements are needed, the sensor loses calibration and is wireless. When sensor electronics and user interfaces establish communication, new reference measurements are needed.
As shown in FIG. 6E, in addition to the sensor power supply 1210, a regulator 1090, reference memory 1050, measurement memory 1070, and measurement processor 1060 may be present with the sensor 100. When communication between the sensor electronics 120 and the user interface 200 is lost, the sensor 100 continues to be powered, holding calibrations and collecting and storing measurements. Therefore, sensor 100 does not require recalibration or warm-up when communication with any user interface is established. Patients wearing sensors are free to move around and when wireless sensor electronics establish communication with the user interface, all sensor data can be sent to the user interface for analysis and display. .. However, if periodic reference measurements are needed and the wireless sensor electronics and user interface cannot establish communication when new reference measurements are needed, the sensor loses calibration and the wireless sensor electronics is the user interface. When communicating with, a new reference measurement is needed.
Alternatively, no periodic reference value is needed. One or more reference values may be stored in reference memory at the factory. Further, the reference memory is non-volatile, such as a flash memory, and therefore does not need power to maintain the reference value. Therefore, the reference values may be factory-installed on each sensor and do not require power to maintain the reference values in the reference memory. The reference memory may be included in the wireless sensor electronics. Therefore, no calibration is required when the sensor electronics establish communication with the user interface.
Alternatively, one or more factory-installed reference values may be stored in the volatile reference memory of the wireless sensor electronics included in each sensor. In this case, power may be required to maintain the reference value in memory. Alternatively, the reference memory and sensor power supply are included in the wireless sensor electronics.
If the reference values are factory-installed, they may be included on a CD, floppy (registered trademark) disk, or other removable storage device. If the reference values are stored on a CD, for example, they may be downloaded to a personal computer and then to the user interface and / or sensor electronics. The reference value may also be stored in a removable or non-removable non-volatile storage device. For example, if the reference value is stored in a removable non-volatile storage device, the memory may be contained in a flash memory card. Flash memory cards may be configured for use in user interfaces and / or sensor electronics. The reference value may be stored in a non-volatile or volatile memory included in the sensor electronics at the factory. In this case, if the memory contained in the sensor electronics is volatile, the sensor electronics should include a power source so that the sensor electronics hold a reference value during delivery and storage. A set of sensor electronics may contain reference values for calibrating a large number of sensors. For example, if the sensor electronics are delivered with a large number of sensors, the reference value may calibrate all of those sensors.
As shown in FIG. 7, the user interface 200 and / or the sensor electronics 120 may include slots 260 and 160 for the flash memory card 600. The flash memory card 600 may include a factory-entered reference value or a later-entered reference value. In addition, the flash memory card 600 may store additional desired data. A flash memory card 600 may be included when the user interface 200 and / or the sensor electronics 120 are shipped from the factory or reseller. Alternatively, the flash memory card 600 may be purchased separately for use with the user interface 200 and / or the sensor electronics 120. In addition, flash memory cards may be used in patient monitoring devices.
As mentioned above with respect to FIGS. 6C, 6D, and 6E, the wireless sensor electronics 120 may include reference memory 1050. One or more reference values may be measured periodically, entered into the user interface, and sent to reference memory 1050. If communication cannot be established between the wireless sensor electronics 120 and the user interface 210 when new reference values are needed, the sensor 100 will need to be calibrated when reconnected. Alternatively, the reference measurement is transmitted directly to the wireless sensor electronics 120. Some examples include: A BG meter equipped with an IR transmitter transmits a reference measurement to wireless sensor electronics, including an IR receiver. A BG meter equipped with RF communication capability transmits a BG value to wireless sensor electronics equipped with an RF receiver. The laboratory sample measuring machine also analyzes the blood sample, and the analysis result is transmitted to the RF transmitter that transmits the result to the wireless sensor electronics.
Instead of the types of memory described above, a removable non-volatile reference memory may be factory-contained with reference values for calibrating one or more sensors. The removable non-volatile reference memory may be a flash medium such as a flash card or a memory stick. The reference memory may be housed in the user interface and / or sensor electronics. The removable non-volatile reference memory may be housed in a device such as an auxiliary device, meter, BG meter, palm pilot, telephone, PDA, handheld device, patient monitoring device, module connected to the device. If the new sensor cannot be calibrated with the removable non-volatile reference memory currently in the device, the sensor will incorporate the new removable non-volatile reference memory used in the device.
Auxiliary devices may power the user interface, which in turn powers the sensor. The user interface may have a rechargeable power source that powers the user interface whenever power is not supplied by the auxiliary device. For example, an auxiliary device such as a patient monitoring device may power the user interface along a wire through a connector, the user interface has a power source, the sensor is connected to the user interface by a wire, and the auxiliary device. The power from powers the voltage regulator in the user interface, which powers the sensor. If the user interface is separated from the auxiliary device, the user interface power supply continues to power the sensor. Alternatively, whenever the auxiliary device is connected to the user interface, the auxiliary device may charge the user interface, and the user interface may or may not be connected to the user interface. Power may be supplied.
The sensor may be powered by sensor electronics, which are powered by a device such as an auxiliary device or user interface. The sensor electronics may have a rechargeable power source that maintains power supply to the sensor whenever power is not supplied by the device.
The power required to operate the sensor may be generated by a device such as a user interface or auxiliary device, carried on one or more wires, passed through a transformer, and supplied to the sensor. Alternatively, power may be passed through regulators such as voltage regulators and current regulators before being supplied to the sensor. The transformer may be located within the device, or the transformer may be part of a wire or cable connecting the sensor to the device. The transformer may also be in the sensor electronics. The transformer maintains power supply to the sensor as long as it is connected to the device. The transformer helps remove the ground connection between the device and the sensor, thus insulating the patient from the ground voltage in the device.
The sensor signal may be passed to one or more devices before being processed. For example, the sensor signal can be carried along the wire to the user interface and then along the wire to the auxiliary device before being processed. In another embodiment, the sensor signal is carried to a computer, sent to a second computer via a server or router, and then processed.
The user interface may process sensor measurements to generate insulin delivery commands. The insulin delivery command may be the infusion rate. Alternatively, the insulin delivery command may be the amount of insulin.
Auxiliary devices may process sensor measurements to generate insulin delivery commands. Alternatively, sensor electronics may process sensor measurements to generate insulin delivery commands.
The insulin delivery command may be generated within a device that includes a measurement processor. Alternatively, the insulin delivery command may be generated by a device that receives sensor measurements, such as an auxiliary device, a pump, or the like. Alternatively, the insulin delivery command is set forth in U.S. Pat. Nos. 4,562,551, 4678408, 4685903, 5080653, 5097122, and 6554798, which are incorporated herein by reference. Produced by an insulin infusion pump.
Although the above description refers to a particular embodiment of the invention, it will be appreciated that a number of modifications may be made without departing from the spirit of the invention. The appended claims are intended to include such modifications within the true scope and gist of the present invention.
The embodiments disclosed herein are therefore considered to be exemplary in all respects and not intended to be limiting, and the scope of the invention is indicated by the appended claims rather than the description above. Therefore, all changes that have the same meaning and scope as the claims shall be included within that scope.
<figref num="1A">It is a communication flow diagram of the sensor and the user interface by one Embodiment of this invention.</figref><figref num="1B">It is a communication flow diagram of a sensor, a user interface, and an auxiliary device according to one Embodiment of this invention.</figref><figref num="1C">It is a communication flow diagram of a sensor, a user interface, and an auxiliary device according to one Embodiment of this invention.</figref><figref num="1D">It is a communication flow diagram of a sensor, a user interface, and an auxiliary device according to one Embodiment of this invention.</figref><figref num="1E">It is a communication flow diagram of a sensor, a user interface, and an auxiliary device according to one Embodiment of this invention.</figref><figref num="1F">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 1B.</figref><figref num="1G">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 1B.</figref><figref num="1H">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 1C.</figref><figref num="2A">FIG. 5 is an information flow diagram of a sensor, sensor electronics, and user interface according to an embodiment of the present invention.</figref><figref num="2B">FIG. 5 is an information flow diagram of a sensor, sensor electronics, user interface, and display device according to an embodiment of the present invention.</figref><figref num="2C">FIG. 5 is an information flow diagram of a sensor, sensor electronics, user interface, and display device according to an embodiment of the present invention.</figref><figref num="2D">FIG. 5 is an information flow diagram of a sensor, sensor electronics, user interface, and display device according to an embodiment of the present invention.</figref><figref num="2E">FIG. 5 is an information flow diagram of a sensor, sensor electronics, user interface, and display device according to an embodiment of the present invention.</figref><figref num="2F">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2B.</figref><figref num="2G">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2B.</figref><figref num="2H">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2B.</figref><figref num="2I">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2B.</figref><figref num="2J">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2C.</figref><figref num="2K">It is a figure which shows one Embodiment of this invention by the information flow diagram of FIG. 2C.</figref><figref num="2L">It is a figure which shows one Embodiment of this invention by the information flow figure of FIG. 2D.</figref><figref num="2M">It is a figure which shows one Embodiment of this invention by the information flow figure of FIG. 2D.</figref><figref num="2N">It is a figure which shows one Embodiment of this invention by the information flow figure of FIG. 2D.</figref><figref num="2O">It is a figure which shows one Embodiment of this invention by the information flow figure of FIG. 2D.</figref><figref num="2P">FIG. 2 is a diagram showing an embodiment of the present invention according to the information flow diagram of FIG. 2E.</figref><figref num="2Q">FIG. 2 is a diagram showing an embodiment of the present invention according to the information flow diagram of FIG. 2E.</figref><figref num="2R">FIG. 2 is a diagram showing an embodiment of the present invention according to the information flow diagram of FIG. 2E.</figref><figref num="2S">FIG. 2 is a diagram showing an embodiment of the present invention according to the information flow diagram of FIG. 2E.</figref><figref num="3A">It is a figure which shows the sensor by one Embodiment of this invention.</figref><figref num="3B">It is a figure which shows the sensor which incorporated the electronics by one Embodiment of this invention.</figref><figref num="3C">FIG. 5 shows a sensor connected to previously separate sensor electronics, including a wire for connecting to another device, according to an embodiment of the invention.</figref><figref num="4A">FIG. 5 shows a sensor connected to previously separate sensor electronics, including a transmitter, according to an embodiment of the invention.</figref><figref num="4B">FIG. 5 shows a sensor connected to previously separate sensor electronics, including a transmitter, according to an embodiment of the invention.</figref><figref num="4C">FIG. 5 shows a sensor and electronics housed in a housing including a transmitter according to an embodiment of the present invention.</figref><figref num="5A">It is a block diagram of a user interface and a sensor according to one Embodiment of this invention.</figref><figref num="5B">FIG. 3 is a block diagram of a user interface, an auxiliary device, and a sensor according to an embodiment of the present invention.</figref><figref num="5C">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="5D">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="5E">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="5F">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="5G">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="5H">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="6A">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="6B">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="6C">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="6D">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="6E">FIG. 3 is a block diagram of a user interface, a sensor, and sensor electronics according to an embodiment of the present invention.</figref><figref num="7">It is a figure which shows the sensor and the sensor electronics, the user interface, and the flash memory card by one Embodiment of this invention.</figref>
Code description
100 Sensor 120 Sensor Electronics 160, 260 Slots 200 User Interface 220, 720 Docking Station 300 Auxiliary Device 400, 450 Connector 500 Personal Computer or Server 600 Flash Memory Card 700 BG Meter 900 Wire 1005 User Interface Wireless Communication Mechanism 1010 Output Device 1020 Input Device 1030 User Interface Power Supply 1040 User Interface Processor 1050 Reference Memory 1060 Measurement Memory 1070 Measurement Processor 1080 Signal Processor 1090 Regulator 1110 Auxiliary Device Power Supply 1205 Sensor Wireless Communication Mechanism 1205 Mechanism for Wireless Communication 1210 Sensor Power Supply
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Priority claims9
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| CA2574168A1 | Canada | A1 | |
| CA2850893A1 | Canada | A1 | |
| CA3057712A1 | Canada | A1 | |
| WO2006020212A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2006020212A3 | World Intellectual Property Organization (WIPO) | A3 | |
| EP1788928A2 | European Patent Office (EPO) | A2 | |
| US2007244383A1 | United States of America | A1 | |
| US2008064943A1 | United States of America | A1 | |
| US7344500B2 | United States of America | B2 | |
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| US2010191086A1 | United States of America | A1 | |
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| EP2754391A1 | European Patent Office (EPO) | A1 | |
| CA2574168C | Canada | C | |
| CA2850893C | Canada | C | |
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Numbers
- Publication
- 2008508029
- Publication, DOCDB
- 2008508029
- Publication, EPODOC
- JP2008508029
- Application
- 2007523629
- Application, DOCDB
- 2007523629
- Application, EPODOC
- JP20070523629
Titles2
- Japanese
- 補助表示装置を備えた検出システム、装置、方法
- English
- Detection systems, devices and methods with auxiliary display
Classification
- CPC, 7
- A61B5/0002
- A61B5/145
- A61B5/14532
- A61B5/412
- A61B2560/0209
- A61B2560/0443
- A61B2560/0456
- IPC, 3
- A61B5 1473
- A61B5 1455
- A61B5 00
Designated states4
- Regional, 4
- Zimbabwe
- Turkmenistan
- Türkiye
- Togo