TWI667627B - 治療產品輸送系統及配對方法 - Google Patents
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Abstract
本發明提供一種治療產品輸送系統及配對方法,包括將治療產品輸送裝置與一手持裝置配對之方法,手持裝置用以控制與其配對的輸送裝置。方法中包括下列步驟:在輸送裝置端,設定輸送裝置使其與一充電裝置連接,一配對指示符顯示該輸送裝置可用於配對,並利用一無線電收發信機廣播該配對指示符;在手持裝置端,利用配對指示符的廣播發現該輸送裝置,並將手持裝置與該輸送裝置配對。手持裝置會與被發現有廣播一配對指示符的輸送裝置配對,且設定當輸送裝置與充電裝置連接時就會廣播一配對指示符,以減少手持裝置配對到錯誤的輸送裝置(例如其他輸送裝置)的機率。
Description
本發明係有關一種治療產品輸送系統及配對方法,其可將治療產品輸送裝置與一手持裝置配對,以控制治療產品輸送裝置之操作。
傳統上,第1型糖尿病已用每天注射胰島素。然而,這不可避免地導致了胰島素水平不匹配血糖發生在全天的患者的正常和快速變化。一方面,胰島素不足和高血糖水平導致立即的症狀,並有助於長期的並發症。另一方面,過多的胰島素可能導致太少血糖導致意識和抽搐的損失。作為替代注射劑,胰島素幫浦治療的目的是模仿健康胰腺的正常生理學。不像每日多次注射胰島素,胰島素幫浦是能夠提供胰島素,可以根據個體需要進行調整,以補償日常活動和鍛煉程序的恆定背景輸注。所述幫浦還可以被編程以提供推注劑量的胰島素的處理血液中,否則,從飲食導致的大的葡萄糖波動。
通過模仿胰腺的天然生理學,胰島素幫浦治療的目的是保持一個固定正常的血糖水平;可避免飲食造成的高血糖或者過多的胰島素造成的低血糖。胰島素幫浦可由行動裝置設備無線地控制。胰島素幫浦作為一個可攜式裝置,須由電池裝置供電,可能會耗盡電池電力,並可能需要一個第二幫浦裝置,而原始幫浦正在充電。因此,有必要提供一種可以由一個單一的行動裝置來控制多個幫浦裝置。單一控制器中可對多個可再充電單元的提出要求,該要求可以讓使用者及行動裝置知道他們正在控制正確的胰島素幫浦。實現這一點的一種方法是在同一個製程下,預先配對行動裝置和胰島素幫浦.然而,手機和幫浦是需要獨立地製造,使得這種解決方案是不切實際的。
因此,本發明即提出一種治療產品輸送系統及配對方法,具體架構及其實施方式將詳述於下:
本發明提供一種配對治療產品輸送裝置到手持裝置的方法,所述手持裝置被限制地僅能控制治療產品輸送裝置,所述配對方法包括以下步驟:在輸送裝置那一端,治療產品輸送裝置被連接到一個充電裝置,一個配對指示符(pairing indicator)可表示出目前輸送裝置是可配對的狀態,且透過無線電收發信機廣播該配對指示符,在手持裝置那一端,當手持裝置在廣播信號裡的配對指示符(pairing indicator)發現輸送裝置,並將輸送裝置與手持裝置配對在一起。
透過限制手持裝置僅能與廣播中的配對指示符(pairing indicator)來配對,且限制當輸送裝置已經連接到一個充電裝置才可廣播配對指示符(pairing indicator),將可大大降低意外配對錯誤的風險。此外,假設治療產品輸送裝置被別人(非病人)所控制是個潛在嚴重性問題,需以第三者才可最小化該風險。輸送裝置上的手動開關可能被意外按下(且將與其他的手持裝置配對),或僅需一個短暫的機會讓輸送裝置進行配對。相反地,本發明要求充電器(一個額外的硬件元件)來執行配對, 讓意外或故意配對的可能性大大降低。
輸送裝置將可被配對,一直到輸送裝置已經移除充電器,或配對開始,或當輸送裝置已經與充電裝置結合之後的短的超時期限屆滿。 這提供了一個短的,明確定義的配對機會,這需要使用一個專用的充電器的輸送裝置。本發明的實施例能夠實現,必須滿足以下要求-一個使用者可能需要與正在發出更換手持裝置的幫浦配對連線,並且該使用者可能需要與正在發出更換輸送裝置的手持裝置配對連線。
已經有一種方法已被設計用於管理輸液幫浦(infusion pump)與特定病人的手持裝置(handset)控制器之間的配對連線。它是透過交換幫浦(pump)與控制器所產生的獨特的令牌,來實現配對連線。
發現輸送裝置的步驟中更包括(手持裝置)掃描射頻通道,得以找到正在廣播配對指示符且表示可被配對的幫浦。
輸送裝置的與充電器的連接可透過偵測一個或兩個裝置物理連接或電性連接。
當輸送裝置已經與其他的手持裝置配對,該輸送裝置可發出無法配對的配對指示符。這防止了已配對的輸送裝置與其他的手持裝置再進行配對。
手持裝置可透過使用者輸入去激活已配對的輸送裝置,手持裝置可被予許去詢問已配對輸送裝置的狀態,但僅允許觸發手持裝置與輸送裝置之間的治療產品輸送。理想情況下,僅有一個輸送裝置在任何給定的時間內是可以處在激活狀態,換言之,可以有多個成對的輸送裝置,但只有其中的一對可以被激活且能夠從手持裝置接收胰島素遞送指令,使用者輸入可在多對裝置之中去選擇一對手持裝置與輸送裝置。
配對步驟包括了手持裝置與輸送裝置溝通訊息所需生成的令牌(token)。
在輸送裝置和手持裝置之間的通信前,加密金鑰可透過加密醫學數據來產生。醫療數據加密的方法包括了一個或多個基本傳輸速率的一段時間和一個定時和推注劑量的劑量在一段時間。換句話說,歷史劑量信息表明胰島素給藥的模式,例如,一整天都需被加密,以保護患者的醫療數據的隱私。然而,一些輸送裝置的狀態信息是不被加密,如與病人不相關的病情或輸送裝置的操作訊息,例如,未加密形式的狀態信息可以包括一個或多個治療產品的剩餘量的指示,或目前輸送裝置電池的電量水平,或目前基本輸液速率、或輸送裝置單次(注射)的劑量、或警報信號。
該方法可以包括一些通信步驟如從輸送裝置到手持裝置之間,輸送裝置是否被配對的指示,已經與手持裝置配對,或者與其他手持裝置配對。
該方法還包括了裝配保護帽至輸送裝置的步驟,保護帽覆蓋了輸送裝置的電子充電接觸點,且保護帽被裝配至輸送裝置時,該輸送裝置會關閉其無線電收發器。這將可以減少一些功耗,如輸送裝置不被使用時或在運輸過程時的功耗。
因此本發明提供了一種治療產品輸送系統,其包括由患者佩戴的治療產品輸送裝置和可控制輸送裝置運作的手持裝置。手持裝置可被配對的輸送裝置所操作控制,其中,輸送裝置包括一個控制器,可設定功能用於當輸送裝置連接一個充電裝置,配對指示符指示輸送裝置可被配對及無線電收發器正廣播該配對指示符。手持裝置包括一收發器,用於發現基於廣播配對指示器的輸送裝置;控制器用於控制結合所發現的輸送裝置與手持裝置。本發明其他方面的特徵將在後面的實施例描述。
系統
請參考第1圖,其係為本發明治療產品輸送系統之一實施例示意圖,如圖所示,治療產品輸送系統1係用以將一胰島素傳輸至患者體內,然而,本發明並不以此為限,其他治療產品亦可透過本發明所揭露之系統進行傳輸。其中,治療產品輸送系統1包括一治療產品輸送裝置2、一手持裝置3以及一伺服器4。根據本發明之實施例,治療產品輸送裝置2係可供患者穿戴於身上,手持裝置3(類似一智慧型手機)則用以控制所述之治療產品輸送裝置2。其中,治療產品輸送裝置2與手持裝置3間係透過一第一無線傳輸介面5進行通訊溝通,該第一無線傳輸介面5例如可為一低功率之ANT無線電傳輸。至於,手持裝置3與伺服器4間則可透過一第二無線傳輸介面6進行通訊溝通,例如GPRS行動資料傳輸6a與網際網路6b。伺服器4中更包括有一資料庫7,其係用以儲存關於患者之醫藥或其他資訊。其中,治療產品輸送裝置2與手持裝置3皆可由可充電式電池供給電源。如第1圖所示,治療產品輸送裝置2係可插設於一充電架8中,以完成充電於該治療產品輸送裝置2。
輸送裝置
輸送裝置包含兩互可拆卸之部分,如第2圖所示。第一部份為一本體21,其係包含一彈簧22、一加壓件23與一組接觸接腳24。加壓件23包含一位移感測器(如美國專利US2011/0316562所述),接觸接腳24係提供與第二部份之電性連接。本體21亦包含一電池、控制電路與和手持裝置通訊之一收發器,由於此部份無法於第2圖分開清楚顯示,故以元件25表示。第二部份為可拋棄式胰島素藥筒26,其係包含胰島素之一儲存庫27、接觸墊28、一幫浦裝置(蠟致動器,例如在德國專利GB2443261所述)與一閥門裝置,其中接觸墊28係提供經由接腳24與本體21電性連接,幫浦裝置則將胰島素從儲存庫27中吸出,再輸入至病人體內。幫浦裝置與閥門裝置無法於第2圖分開清楚顯示,故以元件29表示。當可拋棄式胰島素藥筒26被移除,並在當儲存庫27已被耗盡,或當藥筒過期,或藥筒裝錯時,輸送裝置之本體21為可重複使用的,一個新藥筒可與本體21嚙合。理論上,藥筒可被重新注入或再次使用會比被拋棄更好。然而,當原來的藥筒被注滿時,藥筒應從本體上移除,使新(滿)藥筒得以使用。
在使用上,本體21與輸送裝置2之藥筒26係實體連接並電性連接,電性連接是經由接觸接腳24與墊接觸28,實體連接則是由夾子或其他可釋放的嚙合機構(圖中未示)來實現。本體21中的控制電路係依據經由無線連接5並從手持裝置3接收的控制訊號來反應,以從電池吸引電流,並經由接觸接腳24與接觸墊28提供電流,以驅動藥筒26內的幫浦裝置,進而從儲存庫27經由閥門裝置吸引液體,將此從輸送裝置2送到病人體內。治療產品之傳輸率由控制電路所控制,藉由控制傳給幫浦裝置之電流的流量與時序,以達到一特定基礎傳輸率或藥丸劑量。雖然手持裝置用來設定基礎傳輸率,但在一次設定後,就不需利用手持裝置3之通訊,即可保持設定基礎傳輸率。如第2圖所示,當本體21與藥筒26嚙合時,儲存庫27係於本體21內被接收,並移開加壓件(與位移感測器)23,且對彈簧22施壓。被施壓的彈簧經由加壓件23提供加壓力給儲存庫27之底部。此加壓力並未以隔離方式經由閥門裝置將儲存庫27中的胰島素加壓至病人體內,但當與幫浦裝置之幫浦動作結合時,加壓力則會對儲存庫27中的胰島素施壓,以在每一幫浦動作前填滿一幫浦室。幫浦動作係經由一出口閥,從幫浦室驅動胰島素之受控量至病人體內。儲存庫為圓筒狀,其係具有第一端與其相對之第二端,第一端即胰島素在幫浦動作時被吸出之處,第二端為底部(可移動)。當加壓件23提供加壓力,使胰島素從儲存庫中吸出時,儲存庫之底部係向內移動(以有效減少儲存庫之尺寸)。加壓件23之位置取決於儲存庫中當下的填充狀態,即有多少的胰島素剩餘在儲存庫中。加壓件23與儲存庫27之底部的位置,皆由位移感測器來判斷。位移感測器能夠產生一訊號,以表示在儲存庫中胰島素之剩餘量。根據對應時間觀測胰島素剩餘量之改變,能判斷胰島素之真實傳輸率。此方式可採用控制電路對應傳輸給幫浦裝置之電流的流量與時序,來提供對真實傳輸率之修正。儲存庫中的胰島素剩餘量會傳送給手持裝置3,以顯示給病人看,同時當病人應該將藥筒淘汰換新時,作為一指示器。本體21中的控制電路亦傳輸電量給手持裝置,使病人知道電池需要充電的時候到了。
輸送裝置亦包含一活動監視器,以進行追蹤練習。此練習在對於胰島素之良好控制之需求上,具有重要的效果。因此精確的追蹤練習是糖尿病之有效管理的重要部份。活動監視器使用在輸送裝置中的一感測器偵測輸送裝置的移動,此可用來表示當使用者從事實體活動的情形。被偵測的活動會經由無線連接5無線傳輸給手持裝置,手持裝置(伺服器)能追蹤並記錄病人之活動狀況。經由線上傳送給伺服器,病人與被允許的醫療專家能比較活動尖峰狀況與血液葡萄糖,以辨識活動如何影響對胰島素之需求。此方式可利用對病人之適當劑量,以設計手持裝置。
由於病人與手持裝置的接觸甚於輸送裝置,故輸送裝置能設計成小型及不引入注意的,甚至不用設計按鈕或不用具有對一控制單元之實體連接。
手持裝置
請參考第3圖,其為本發明中手持裝置之一實施例示意圖,如圖所示,手持裝置3係包括有二收發器,其中一收發器係透過第一無線傳輸介面5而與治療產品輸送裝置2進行溝通,另一收發器則透過第二無線傳輸介面6而與伺服器4進行溝通。手持裝置3中更包括有一用以執行控制程式之處理器,其中控制程式係用以隨時察看患者之狀態並將其狀態回報至中央伺服器4,並且,藉由傳送控制訊號至治療產品輸送裝置2,該控制程式可控制應給予患者之胰島素劑量。手持裝置3更包括有一觸控螢幕34,其係可將資訊顯示並通知予使用者,並且使用者更可藉由此觸控螢幕34之介面而進行輸入資訊、更改基礎傳輸率、與觸發特定藥丸劑量之動作。
除了上述可無線控制幫浦的功能以外,手持裝置3更可整合有一血糖量測計32,其係用以測量患者血液中之葡萄糖含量,檢測方法包括:首先刺穿患者之手指,並收集一小滴其中之血液,以將其置放於一玻片上。之後,將此玻片插入血糖量測計32,在計算後,患者之血液中所包含之葡萄糖數據即可顯示於手持裝置3上。據此,患者可自行決定是否要依據顯示之血糖讀數而選擇觸發藥丸劑量。其中,每次量測之血糖數據皆可自動地透過控制軟體與伺服器4間的溝通而傳遞給患者、醫療人員甚至患者之家庭成員(例如父母)以供參考。一般來說,手持裝置3中可執行多種不同之軟體應用程式,以藉由該些應用程式幫助使用者(或其他經授權的第三人)追蹤患者的飲食、胰島素用量、血糖數據與運動(如前述可自動地由感測器記錄於治療產品輸送裝置2中)等狀況。藉由此種自動收集資料的機制,本發明可利用手持裝置3消弭,或至少減少習見糖尿病人者必須逐日記錄醫藥狀況之麻煩,並且透過伺服器4之作用,本發明可確保正確且詳盡的醫藥資訊可隨時且常態地提供給患者與醫療人員使用。
除此之外,當進行控制時,手持裝置3係先傳送無線訊號予治療產品輸送裝置2,以將專業醫護人員所建議並預先設定好之胰島素基本劑量傳至治療產品輸送裝置2。其中,此基本劑量在設定完成後,係可由使用者根據不同之需求與限制而自行調整之;惟,手持裝置3中之控制軟體係設定為除了使用者以外的第三人,例如醫生,則無法再針對該基本劑量進行調整。除此之外,使用者例如可在攝取碳水化合物或大量運動後,透過手持裝置3而觸發特定藥丸劑量。類似於對基本劑量的設定,該特定藥丸劑量同樣可依據手持裝置3所無線傳輸出來的控制訊號而傳輸至治療產品輸送裝置2而完成設定。之後,使用者即可輸入其最近一段時間內所攝取之碳水化合物量,或者持續進行的運動量,據此,手持裝置3可提供患者是否需對其胰島素之基本劑量進行調整之建議,甚或是是否應觸發一藥丸劑量之建議。如前所述,血糖量測計32係對於應給予之胰島素劑量有一定的影響,而這些資訊都將被傳輸至伺服器4上儲存。除此之外,手持裝置3亦可自治療產品輸送裝置2接收資訊,例如:裝置中是否有錯誤發生、是否應更換新的胰島素藥筒、或電池之剩餘電量等等。
伺服器
從上述描述可瞭解手持裝置3及輸送裝置2可監視和記錄臨床信息,同時根據身體的需要提供胰島素。藉由提供此信息給伺服器4,其可立即讓那些需要用的人看到。特別的是,可移動連線的安全性線上管理入口網站能夠讓患者、臨床醫生和父母即時意識到去改變條件,而糖尿病門診使用該系統可看到所有患者的狀況及即時傳送狀況給門診,透過智慧型手機或診所內部網路可登入使用入口網站。
除了可使得患者瀏覽最新的臨床信息,其亦可提供患者簡單的數據視覺分析,例如辨識血糖趨勢和模式及可立即看到胰島素注射的習慣。在家裡、工作中或者使用智慧手機皆可透過入口網站來瀏覽以上資訊。該伺服器也可傳送SMS訊息給小孩的父母,讓父母知道小孩的健康狀態。患者可透過該系統登入安全的糖尿病管理入口網站,患者一登入便可看到所有形式的圖表資訊去幫助患者了解哪裡需要調整,運動習慣可在圓餅圖上顯示出來,可指出如何及何時遞送患者的胰島素,臨床醫生可看到相同的分析與資訊,透過打電話或發短信來提供患者指導和建議。診所可以從單一儀表螢幕瀏覽系統中所有病人的狀況,包括目前的血糖、平均血糖、胰島素劑量、低頻率和血液測試的習慣,一目了然,任何人皆可輕易得到即時回應。
只需一次點擊,病人的所有數據便會進行分析,繪製成圖表以識別趨勢、模式和問題。使用入口網站,診所可以完全重組已管理的患者資料。文件和電子郵件可被用於檢查最近發生的事件,就診時便可專注在當前和準確的信息中。
手持裝置與輸送裝置之配對
使用者可以預期有一個以上的傳送裝置(幫浦)中,例如有一個可使用,而另一個正在充電。使用者有時可能需要用他的手持裝置配對新的幫浦(例如,因為他已經接收到一個新的幫浦,或一個新的手持裝置)為避免配對到錯誤的幫浦或其他人的幫浦,而有關幫浦被連接到它的充電器。此連接可以是機械連接,例如接觸接腳按壓在幫浦本體之上,或以電子方式將兩個端子互連。應該理解的是,電氣連接是固有的充電器和它被充電的設備之間的任何連接,並且這種連接本身可能形成的基礎的檢測(當該設備連接到充電器,則充電電路開始負責充電充電器)。本領域技術的人將知道的一些技術,用於檢測兩個設備之間的電氣連接,尤其是一個充電器和一個裝置之間,以進行充電。只存在需要形成的配對一次。手持裝置能夠顯示它所配對幫浦的清單,並且使用者能夠從所有幫浦的清單中選擇使用(激活)哪個幫浦。在任何給定時間下,手持裝置將僅控制使用活化和配對幫浦的胰島素輸送,並且它是只可能有一個配對幫浦。
配對(發現)必須與充電器綁定,當使用者將輸送裝置 (delivery device)放置充電座才開始配對處理。輸送裝置到充電器的連接設定為預定週期(例如5分鐘),在此期間是可以配對的,以下這期間配對屆滿即不再能配對(除非輸送裝置取出並重新連接到充電器)。當它被插入到經授權的充電器,該輸送裝置才開始識別。然後才設置在廣播的配對屬性(位元)。在預定時間之後,配對位元將被改變,以使輸送裝置不再可發現,並且不再能夠配對到一個手持裝置。當輸送裝置插入充電器可能觸發廣播本身,或者可以是一個常規的廣播,其中該配對屬性僅僅是來自不可發現的修改,以發現由該輸送裝置插入到充電器。在前者的情況下,它可以理解的是,由於廣播僅發生而輸送設備連接到充電器時,與廣播相關聯的附加功率消耗不會耗盡輸送裝置的電池,因為電池一直在充電中。
一旦輸送裝置已被插入到充電支架,一個軟件應用程式(嚮導)引導使用者該配對過程。使用者選擇“搜尋”幫浦和手持裝置掃描RF信道上的幫浦與其配對位元集合。當幫浦發現手持裝置要求其配對狀態的詳細信息,並接收這些回來。然後,手持裝置可從配對狀態的詳細信息中判斷幫浦是否是新的、已經配對該手持裝置、或幫浦配對到另一個手持裝置。如果更換手持裝置已經發送給使用者,則使用者可以選擇想配對的幫浦,並增加了一個“標籤”或名稱來標識幫浦,供以後使用可能會出現後一種情況。輸送裝置可作為主要設備,可控制它的發現模式(使用配對位元)和交換令牌(tokens),和手持裝置創建一個“主從關係”。配對成功的令牌將被使用在主從設備之間的所有通信,去驗證手持裝置發送的請求到幫浦。換句話說,採用了同意令牌,每個手持裝置和幫浦都能夠確定是否接收一個特定的通信(例如,從一個手持裝置至幫浦的指令,或狀態信息的命令)是從已配對的裝置。當配對時,幫浦將丟棄先前與其他手持裝置配對的令牌,並因此,如果先前的手持裝置試圖控制先前的幫浦,令牌將不匹配且手持裝置將無法發揮以上該幫浦的控制。這解決了已下問題,當幫浦與手持裝置是不配對的情況下,該手持裝置無法獲取關於幫浦的狀態訊息或遞送胰島素指令。由於各種原因,其中包括一個重要的事實,就是錯誤的手持裝置將會侵犯使用者的隱私並導致將錯誤的醫療資料提供給手機的使用者,這可能會導致下游相關的診斷出現問題。該狀態信息可以包括關於遞送的胰島素至患者的量的活動數據。
請參考第4圖,其為手持裝置與幫浦之間的配對活動流程圖。第4圖的左列包含手持裝置進行的步驟,而第4圖的右列包含由輸送裝置(這裡稱為幫浦)所進行的步驟。在步驟S1中,使用者將幫浦入其充電器。幫浦及其充電器之間的機械或電氣接合使得apairing指示符可被手持裝置來發現。配對指示符(pairing indicator)由在幫浦上的aradio收發器廣播出去,並因此接收到附近手持裝置。步驟S2中,使用者使用使用者界面在其手持裝置中選擇一個“增加幫浦”的功能。這會顯示在檢索螢幕上(步驟S3)。在步驟S4中,手持裝置掃描附近所發現的幫浦裝置。在步驟S5中,確定是否有任何新的幫浦已被發現。若否,則搜尋螢幕被更新,以指示沒有新的幫浦已被發現,並且該過程終止(步驟S6)。如果在步驟S5中確定一個或多個新的幫浦已被發現,則在步驟S7手持裝置試圖從找到的每個幫浦中獲得幫浦的細節。在步驟S8中,幫浦裝置回傳幫浦的細節資訊給手持裝置,其中將包括在幫浦裝置的當前配對狀態(如前面所述)。之後(在步驟S9)來確定幫浦裝置是否已與手持裝置配對。若是,則搜尋螢幕被更新,以指示所找到的幫浦已在配對幫浦在聽筒的清單中,那麼該處理結束(步驟S10)。若在步驟S9中確定所找到的幫浦無法與手持裝置配對,那麼在步驟S11中,可確定幫浦是否已經配對到另一個手持裝置。若是,在搜尋螢幕上可更新指示所述幫浦配對到另一手持裝置(步驟S12),且(步驟S13)使用者有機會控制幫浦(來自其他手持裝置)。若使用者選擇不採取控制,那麼該處理結束。若使用者選擇對幫浦控制,則幫浦將在步驟S14被命名(顯示在幫浦的清單)。應該理解的是,當幫浦已經與手持裝置配對完成後是不可以與其他手持裝置來配對(由丟棄與先前配對相關聯的舊令牌,有利於與新的配對相關聯的新令牌,如其他地方所述),從而讓使用者可以有可更換的手持裝置(例如因為舊令牌變得破碎或丟失),而無需更換幫浦設備。若在步驟S11中,它確定該幫浦沒有配對至另一手持裝置(未配對),則在步驟S15中確定一個新的幫浦已發現,並為使用者提供了機會,可加新的幫浦至配對幫浦清單中(步驟S16)。若使用者選擇不將新的幫浦添加到清單中,則該處理結束。若使用者選擇了新的幫浦添加到清單中,則新的幫浦被給在一個名稱(步驟S14)。
一旦幫浦已被命名,將會被顯示在一個手持裝置的通信螢幕上(步驟S17)。在步驟S18,配對請求會被發送至幫浦。作為響應,配對被強制在該幫浦中(步驟S19),並將該幫浦命名。在步驟S20中,票(ticket)從幫浦傳送到手持裝置。在步驟S21中的票是由手持裝置接收,並且響應及更新在該通信螢幕上(步驟S22),為要求使用者確認應添加該幫浦,若使用者拒絕(步驟S23),則處理結束。若使用者確認該幫浦應在步驟S23中被添加,則步驟S24通信螢幕更新,且步驟S25中票會從手持裝置回傳給幫浦。在步驟S26中,票已被幫浦驗證完成。具體地,在步驟S27,判定票是否有效,並且若沒有,則(步驟S28)會將票誤傳送給手持裝置並產生一個錯誤通知,表示該處理結束。若在步驟S27判定該票是有效的, 則幫浦被儲存到資料庫中(步驟S30),並更新在螢幕上,以指示該幫浦已被添加到使用者可用幫浦的清單。
請參考第5-1圖及第5-2圖,其為一使用者A、一使用者介面B和一手持裝置之應用程式C、一幫浦D和充電器E之間的詳細動作和訊息流之示意圖。該流程顯示步驟T1到步驟T33,在步驟T1中,使用者A插入幫浦D至充電器E。幫浦D偵測插入充電器Ë(步驟T2)。然後,在步驟T3中的幫浦D設置成配對模式,在步驟T4中設置和廣播一個配對指示符(配對=開啟)。在幫浦D可被手持裝置所發現的範圍內,廣播的配對指示符可被手持裝置所接收,在步驟T5中,使用者A選擇在手持裝置上使用者介面B的幫浦管理程式。在步驟T6中,使用者介面B要求應用程式C取得當前配對幫浦的清單及顯示給使用者A,如步驟T7所述。在步驟T8中,使用者A發現期望的幫浦沒有幫浦名單上及未被配對,因此選擇透過應用程式B去搜尋幫浦,在步驟T9,使用者界面B會透過手持裝置上的無線電收發信器去要求應用程式C去搜尋幫浦。在步驟T10,應用程式C的打開用來搜尋幫浦的無線通道。在步驟T11中,該幫浦D被找到;在步驟T12,應用C的試圖在所發現的幫浦內獲得更詳細的訊息;因此,在步驟T13中會發送一GetPumpDetails訊息給幫浦D。在步驟T14中,該幫浦的細節資訊會從幫浦D返回到應用程式C。
在此情況下,幫浦D被訊息流所覆蓋在盒M.之外,在步驟T15中,其係為應用程式C判斷發現的幫浦為新的幫浦(未列在已發現的幫浦清單上)。在這種情況下,在步驟T16將一個新幫浦的訊息提供給應用程式B,並向使用者提供輸入幫浦名稱的機會,如步驟T17所述。接著,在步驟T18,使用者A輸入該名稱,並在步驟T19中使用者介面B傳遞指令到應用程式C,以增加一個新的幫浦到可供選擇(配對)的幫浦清單上。在步驟T20中,應用程式C發送強力配對訊息給幫浦D,響應於幫浦D產生的令牌(在步驟T21)並將其返回到應用程式(在步驟T22)。一個確認配對訊息是由應用程式C提供給使用者介面B,觸發使用者介面B去顯示確認配對訊息給使用者A。因此,使用者A可在步驟T25確認配對,從而導致在步驟T26中確認令牌(confirm token)從使用者介面B傳輸至應用程式C,該確認令牌被轉發到幫浦D(步驟T27)。步驟T28中,幫浦D接收並記錄令牌,並在步驟T29發送回一個確認令牌給應用程式C。另外,幫浦D的配對指示符被設定為關閉在步驟T30,以防止幫浦D從被配對到另一個手持裝置。如此一來幫浦D將不再是可發現的。然後,在步驟T31中應用程式C確認令牌被記錄,且訊息會被發送至使用者介面B(在步驟T32),在手持裝置上顯示了配對完成訊息。在步驟T33中,表示配對過程完成。
請參考第6-1圖及第6-2圖,其為一使用者A、一使用者介面B和一手持裝置之應用程式C、一幫浦D和充電器E之間的詳細動作和訊息流之示意圖。在盒N中的訊息涉及到某個幫浦已經在配對幫浦在手機的清單中(通過步驟T1至第5圖的步驟T14)。在這種情況下,在步驟T34(從步驟T14以下),應用程式C可表示幫浦D是已經在配對幫浦的清單中。在步驟T35,應用程式C發送幫浦清單的訊息給使用者介面B,因此在步驟T36中使用者介面B會顯示一幫浦已經與手持裝置配對的訊息,使用者A在步驟T37中確認。
在盒P中的訊息涉及到其中一個發現的幫浦(通過步驟T1至圖5的T14)已配對到另一手持裝置的過程。在這種情況下,其可與新的手持裝置配對,可理解的是,透過限制當幫浦被連接到充電器時,可減少與其他使用者的手持裝置配對的風險。特別是在步驟T38(步驟T14以下),應用程式C判斷幫浦D被配對到另一個手持裝置。在步驟T39,配對到另一手持裝置的訊息是由應用程式C傳送給使用者介面B,因此在步驟ST40向使用者A顯示一條訊息,詢問使用者A是否可讓他們用手持裝置控制幫浦D。在步驟T41,使用者A確認這個需求,並且在步驟T42輸入幫浦的名稱。步驟T43至T57是相同的步驟,因此不再重複。
第4圖至第6圖為治療產品輸送裝置與手持裝置配對之方法之流程圖。單一輸送裝置不可與多個手持裝置配對,因為輸送裝置當其與新的輸送裝置配對後就不可再與先前的輸送裝置配對(通過同意新令牌,可讓手持裝置和幫浦之間通訊)。此外,手持裝置不可同時指示多個治療產品設備,因為手持裝置須裝置配對,指示它來管理治療產品,並且在任何時間下,只有一個裝置可被激活,使用者通常會選擇從手持裝置上的當前配對幫浦清單來激活。手持裝置雖可存取每個配對幫浦(如電流胰島素填充水平和電池充電電平)的資訊,但僅能控制治療產品輸送至已啟動且配對的幫浦。當激活時,會在手持裝置與輸送裝置通信之前先由醫學數據產生一加密金鑰,加密金鑰可為XTEA加密金鑰;加密金鑰使用已知技術可被產生並於輸送裝置與手持裝置之間交換,例如通過使用秘密/網絡金鑰或公共/私密金鑰進行加密。被加密的醫療數據可包括每隔一段時間之一個或多個基本傳輸速率和一個定時的推注劑量,換言之,歷史劑量資訊表明了胰島素給藥的模式,舉例而言,醫療數據一整天都被加密以保護患者的隱私。然而,在某些情況下輸送裝置的資訊係以未加密的形式來傳送,該資訊中不可包含與病人直接相關的病情,但可以輸送裝置的操作信息取代,例如未加密形式的狀態資訊可包括一個或多個在該輸送裝置內的治療產品的剩餘量、該輸送裝置的當前電池充電水平,當前輸送裝置的基本輸液速率、輸送裝置施打藥丸的劑量或警報信號(例如以指示該幫浦已電力不足,該胰島素貯耗盡時,或是幫浦(主體或盒)發出故障訊號)的指示。輸送裝置會被手持裝置激活,因此不需要與充電器,輸送裝置只需完成與手持裝置的配對。
輸送裝置可發送定期的廣播(例如每秒2次廣播),不論該輸送裝置是否已配對、激活、或兩者皆非,也不論輸送裝置目前是否在充電座上。而在某些情況下,如輸送裝置是否是未配對的、或已配對但沒被啟動、或已配對且被啟動,該廣播的內容可能會有所不同,於一實施例中,兩部份的輸送裝置為了將本體插入到充電支架,必須將一次性墨盒移除(因為相同的接觸面被用於將一次性盒與充電器電氣連接),當輸送裝置被插入至支架的情況下時會廣播,包括輸送裝置的標識符及配對位元(設定為允許可被發現/配對5分鐘,或直至與手持裝置配對完成,並設定之後不允許被發現/配對),以指示輸送裝置目前是否有可能與手持裝置配對。當輸送裝置配對後,將其從充電座移除並裝上墨盒,該廣播可以包括標識符和基本狀態信息,指示當前電池水平和輸送裝置的儲層填充狀態。在已配對和輸送裝置啟動情況下,該廣播可以包括指示事發生的標誌(flag)或輸送裝置出現警示(例如電池電量低、貯存低或設備故障),或是指示從輸送裝置傳送到手機的記錄(接著被傳送到伺服器)。接著手持裝置會藉由其可能感興趣的資訊(例如事件或歷史資訊)中的標誌(flag)而被提醒,並發送一個請求狀態訊息給輸送裝置以提供更詳細的資訊,此更詳細的資訊可由檔案形式提供,舉例而言,若已經施打了單次劑量,則檔案中會指示實際給病人施打的推注劑量;在歷史記錄中,該檔案有可能設定出的一個時間(開始和停止時間)和胰島素輸送給病人的劑量的清單,無論從定期劑量和推注劑量,以及活動監控病人在周圍移動的資訊。若提高時效性是必要的,如當警告的條件成立時,則專用警告訊息會被附加在廣播訊息中發送,這也將具有改善可靠性的優點,因為跟單一訊息相比,兩個訊息(專用+廣播)不太可能會丟失。
此外,本發明在輸送裝置上裝設一保護蓋,以避免電性接點被破壞、受潮或被碎屑堵塞住,當保護蓋裝設到輸送裝置上時,輸送裝置將會關閉無線電收發機以減少功耗,例如輸送裝置在運輸過程中不被使用時,使用者不需採取明確的行動來關閉輸送裝置,而輸送裝置可定期廣播其位置資訊給手持裝置。然而,使用者將不需要控制任何配備有保護帽的輸送裝置。儘管本發明的實施例係參考一個胰島素輸送系統,但應理解的是,本發明可以代替應用於其他藥物的輸送。
唯以上所述者,僅為本發明之較佳實施例而已,並非用來限定本發明實施之範圍。故即凡依本發明申請範圍所述之特徵及精神所為之均等變化或修飾,均應包括於本發明之申請專利範圍內。
1‧‧‧治療產品輸送系統
2‧‧‧治療產品輸送裝置
21‧‧‧本體
22‧‧‧彈簧
23‧‧‧加壓件
24‧‧‧接觸接腳
25‧‧‧電池、控制電路及收發器
26‧‧‧可拋棄式胰島素藥筒
27‧‧‧儲存庫
28‧‧‧接觸墊
29‧‧‧幫浦裝置及閥門裝置
3‧‧‧手持裝置
32‧‧‧血糖量測計
34‧‧‧觸控螢幕
4‧‧‧伺服器
5‧‧‧第一無線傳輸介面
6‧‧‧第二無線傳輸介面
6a‧‧‧GPRS行動資料傳輸
6b‧‧‧網際網路
7‧‧‧資料庫
8‧‧‧充電架
第1圖為本發明治療產品輸送系統之一實施例示意圖。 第2圖為本發明中輸送裝置包含兩可拆卸部分之示意圖。 第3圖為本發明中手持裝置之一實施例示意圖。 第4圖為本發明中手持裝置與幫浦之間的配對活動流程圖。 第5-1圖至第5-2圖為本發明中使用者A、使用者介面B和手持裝置之應用程式C、幫浦D和充電器E之間的詳細動作和訊息流之示意圖。 第6-1圖至第6-2圖為本發明中使用者A、使用者介面B和手持裝置之應用程式C、幫浦D和充電器E之間的詳細動作和訊息流之示意圖。
Claims (15)
- 一種治療產品輸送裝置與手持裝置之配對方法,該治療產品輸送裝置係與一手持裝置配對,該手持裝置僅能控制其所配對之複數輸送裝置,該方法包括下列步驟:設定該輸送裝置,使該輸送裝置與一充電裝置連線,一配對指示符(pairing indicator)顯示該輸送裝置可進行配對,並利用一無線電收發器廣播該配對指示符;其中該廣播發生在該輸送裝置連接到該充電裝置之時;該手持裝置依據廣播之該配對指示符發現該輸送裝置;以及將發現之該輸送裝置及該手持裝置配對在一起。
- 如請求項1所述之配對方法,其中發現該輸送裝置之步驟更包括掃描射頻通道,找出具有配對指示符、代表可配對可廣播(broadcasting)之複數幫浦。
- 如請求項2所述之配對方法,其中該輸送裝置到該充電裝置的連線係依據一物理連線或是一物理連接加上一電性連接。
- 如請求項3所述之配對方法,更包括該輸送裝置端之一設定步驟,當該輸送裝置已經與該手持裝置配對時,該配對指示符會顯示該輸送裝置無法配對。
- 如請求項4所述之配對方法,其中該手持裝置係利用一使用者輸入來激活當前與該手持裝置配對之該輸送裝置,被允許之該手持裝置會詢問其所配對之任一該輸送裝置之狀態,但僅允許被激活且配對之該輸送裝置的治療產品可輸送。
- 如請求項5所述之配對方法,其中與該手持裝置配對之該輸送裝置中僅有一個可在給定的任何時間內處於激活狀態。
- 如請求項6所述之配對方法,其中該使用者輸入係用以激活由一播放清單中選擇的該輸送裝置,該播放清單為目前配對到該手持裝置之複數該輸送裝置。
- 如請求項7所述之配對方法,其中該配對步驟包括在輸送裝置與該手持裝置之間訊息傳送時會隨之產生一令牌(token)。
- 如請求項7所述之配對方法,其中該輸送裝置與該手持裝置之間於激活狀態傳送一醫學資料時,會產生可加密醫學資料之一加密金鑰。
- 如請求項9所述之配對方法,其中該醫學資料在至少一個基本傳輸速率下,每隔一段時間便會加密,且每隔一段時間便會定時推注劑量。
- 如請求項9所述之配對方法,其中該輸送裝置之部分狀態資訊係以未加密方式傳送。
- 如請求項11所述之配對方法,其中該狀態資訊以未加密方式傳送係包括至少一指示,包括該輸送裝置中該治療產品之剩餘量、該輸送裝置之目前充電層級、該輸送裝置給藥之一目前基本輸送速率、該輸送裝置目前正在施用的大藥丸劑量、或一警告訊號。
- 如請求項1或2或3或4或5或6或7或8或9或10或11或12所述之配對方法,更包括從被發現之該輸送裝置與該手持裝置通訊之步驟,不論該輸送裝置尚未配對、已與該手持裝置配對或與其他手持裝置配對皆利用該配對指示符顯示。
- 如請求項1或2或3或4或5或6或7或8或9或10或11或12所述之配對方法,更包括在該輸送裝置上裝配一保護帽,該保護帽覆蓋該輸送裝置之複數電子充電接觸點,且該保護帽被裝配至該輸送裝置時,該輸送裝置會關閉該無線電收發器。
- 一種治療產品輸送系統,包括一治療產品輸送裝置及一手持裝置,該治療產品輸送裝置由一病人配戴,該手持裝置用以控制該輸送裝置之操作,該手持裝置僅能操作與其配對的輸送裝置,其中該輸送裝置包括:一控制器,以設定該輸送裝置,使該輸送裝置與一充電裝置連線,一配對指示符(pairing indicator)顯示該輸送裝置可進行配對;一無線電收發信機,廣播該配對指示符;其中該廣播發生在該輸送裝置連接到該充電裝置之時;該手持裝置包括:一收發器,用於發現基於廣播配對指示器的輸送裝置;以及一控制器,用於控制所發現之該輸送裝置與該手持裝置配對在一起。
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- 2014-01-30 GB GB1401591.1A patent/GB2523989B/en not_active Expired - Fee Related
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2015
- 2015-01-30 TW TW104103158A patent/TWI667627B/zh not_active IP Right Cessation
- 2015-01-30 WO PCT/GB2015/050248 patent/WO2015114370A1/en active Application Filing
- 2015-01-30 EP EP15708019.3A patent/EP3099348B1/en active Active
- 2015-01-30 US US15/114,843 patent/US10438696B2/en active Active
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2016
- 2016-03-15 HK HK16103015.7A patent/HK1215119A1/zh unknown
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2019
- 2019-10-03 US US16/592,679 patent/US10777319B2/en active Active
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2020
- 2020-08-14 US US16/993,507 patent/US11386996B2/en active Active
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TW200740148A (en) * | 2006-01-25 | 2007-10-16 | Univ Nat Taiwan Science Tech | Device and method for interacting with autonomous robot |
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US10777319B2 (en) | 2020-09-15 |
US20200373009A1 (en) | 2020-11-26 |
HK1215119A1 (zh) | 2016-08-12 |
WO2015114370A1 (en) | 2015-08-06 |
US20200105408A1 (en) | 2020-04-02 |
EP3099348A1 (en) | 2016-12-07 |
US20160342759A1 (en) | 2016-11-24 |
EP3099348B1 (en) | 2020-12-23 |
GB201401591D0 (en) | 2014-03-19 |
GB2523989A (en) | 2015-09-16 |
GB2523989B (en) | 2020-07-29 |
US10438696B2 (en) | 2019-10-08 |
TW201531993A (zh) | 2015-08-16 |
US11386996B2 (en) | 2022-07-12 |
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