TWI722645B - 血糖試片及其相關量測方法 - Google Patents
血糖試片及其相關量測方法 Download PDFInfo
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Abstract
一種血糖測試片,包括一基片、一校正點、一測試點與一非揮發性記憶體。校正點位於該基片上,且該校正點塗上一化學試劑。測試點位於該基片上,且該測試點塗上該化學試劑。非揮發性記憶體位於該基片上並儲存一校正參數。於一校正程序時,將一校正溶液滴至該校正點,並根據該校正溶液與該化學試劑的反應結果計算出該校正參數後,將該校正參數儲存於該非揮發性記憶體。
Description
本發明是有關於一種測試片與測試方法,且特別是有關於一種血糖試片及其相關量測方法。
對於需要長時間控制血糖的糖尿病患來說,血糖機是自我監測血糖值的必備工具。而醫生也可以根據血糖值來給予糖尿病患個別的用藥建議,進而控制血糖值在穩定的範圍。
一般來說,血糖機需要搭配血糖試片。使用者先將其血液滴在血糖試片上,再將血糖試片插入血糖機,而血糖機內部的量測電路即可量測血糖試片上血液的血糖值,並呈現於血糖機的螢幕。而使用者即可由血糖機的螢幕來得知其血糖值。
請參照第1圖,其所繪示為習知血糖試片示意圖。血糖試片100的基片(base substrate)180上具有一測試點(test site)120以及多條電極140、160接觸於測試點120。其中,測試點120上塗上(coated)化學試劑(chemical reagent)。
當使用者將血液滴在血糖試片100的測試點120時,血液即與測試點120上的化學試劑進行反應,而反應物的電阻值會隨著血液中血糖濃度的大小而改變。之後,使用者再將血糖試片100插入血糖機,而血糖機即可偵測出血糖值。
舉例來說,血糖機內部的量測電路提供測試電壓(test voltage)至電極140、160,並根據產生的電流值來換算出血液中的血糖值。或者,血糖機內部的量測電路提供測試電流(test current)至電極140、160,並根據產生的電壓值來換算出血液中的血糖值。當然,上述血糖試片100並不限訂於僅有2條電極140、160,血糖試片100也可以有更多電極連接至測試點120供血糖機內部的量測電路來進行血糖的量測。
由於化學試劑的濃度可能受到外在環境因素的影響,導致血糖機所量測的血糖值出現誤差。因此,在血糖試片的製造過程中,製造商將反應試劑塗在一批次的所有血糖試片(例如一批次為1005片血糖試片)後,製造商會由這些血糖試片中抽取出小部分的血糖試片(例如抽取1至5片血糖試片)來進行校正程序,並獲得一校正參數。而該批次的剩餘血糖試片即利用該校正參數來進行校正。舉例來說,上述該批次的血糖試片以50片進行包裝出售時,製造商會在20盒外包裝盒上列印出該批次血糖試片的校正參數。
當使用者購買其中一盒血糖試片後,在使用該盒血糖試片之前,使用者需要將外包裝盒上列印的校正參數輸入血糖機後。之後,當血糖試片插入血糖機後,血糖機即可根據該校正參數來換算出血糖值。
同理,當使用者用完該盒血糖試片後,再次購買另外一盒血糖試片時,使用者需要將新購買外包裝盒上的校正參數更新至血糖機,血糖機即可根據該更新的校正參數來換算出血糖值。
然而,如果使用者未將新購買外包裝盒上的校正參數更新至血糖機,則血糖機會根據先前舊的校正參數而偵測出不正確的血糖值。
由上述的說明可知,習知血糖試片的校正方式為整批次的血糖試片共用同一校正參數。實際上,利用上述的方式所偵測出的血糖值,其最大誤差仍可能到達30%,並將造成臨床上的誤判。
本發明係有關於一種血糖試片,包括:一基片;一校正點,位於該基片上,且該校正點塗上一化學試劑;一測試點,位於該基片上,且該測試點塗上該化學試劑;一非揮發性記憶體,位於該基片上並儲存一校正參數;其中,於一校正程序時,將一校正溶液滴至該校正點,並根據該校正溶液與該化學試劑的一第一反應結果計算出該校正參數後,將該校正參數儲存於該非揮發性記憶體。
本發明係有關於一種血糖試片的量測方法,該血糖試片包括一校正點、一測試點以及一非揮發性記憶體。該血糖試片的量測方法包括下列步驟:將一化學試劑分別塗在該血糖試片的該校正點與該測試點;將一校正溶液滴在該校正點,並根據該校正溶液與該化學試劑的一第一反應結果來獲得一校正參數並儲存於該血糖試片的該非揮發性記憶體中;以及
將一血液滴在該測試點,並根據該血液與該化學試劑的一第二反應結果以及該非揮發性記憶體中的該校正參數來計算出一輸出血糖值。
為了對本發明之上述及其他方面有更佳的瞭解,下文特舉較佳實施例,並配合所附圖式,作詳細說明如下:
100、200、300、400:血糖試片
120、220、320、420:測試點
140、160:電極
180、280、380、480:基片
210、310、410:校正點
212、214、222、224、232、234、236、238:電極
230、330、430:非揮發性記憶體
340、440:量測電路
342:通信埠
450:電源模組
460:輻射模組
S520~S524:步驟流程
第1圖為習知血糖試片示意圖;第2A圖為本發明血糖試片的第一實施例;第2B圖為利用本發明血糖試片的血糖量測方法流程圖;第3圖為本發明血糖試片的第二實施例;以及第4圖為本發明血糖試片的第三實施例。
請參照第2A圖,其所繪示為本發明血糖試片的第一實施例。血糖試片200的基片280上具有一校正點(calibration site)210、一測試點220、一非揮發性記憶體(non-volatile memory,簡稱NVM)230以及多條電極212、214、222、224、232、234、236、238。其中,電極212、214接觸於校正點210,電極222、224接觸於測試點220,電極232、234、236、238連接於非揮發性記憶體230。
根據本發明的第一實施例,在血糖試片200的製造過程中,製造商會在校正點210與測試點220分別塗上化學試劑。接著,於校正程序
時,將校正溶液(calibration solution)滴在校正點210。由於校正溶液具有已知的血糖濃度,所以校正溶液與化學試劑反應後,將校正電路(未繪示)連接至電極212、214即可偵測出特定的數值,並換算出該血糖試片200的校正參數。而校正電路(未繪示)更經由電極232、234、236、238,將校正參數儲存於非揮發性記憶體230。換言之,製造商所製造的每一片血糖試片200都會進行校正程序,且每一片血糖試片200內的非揮發性記憶體230中都儲存對應的校正參數。
當使用者將血液滴在血糖試片200的測試點220時,血液即與測試點220上的化學試劑進行反應,而反應物的電阻值會隨著血液中血糖濃度的大小而改變。之後,使用者再將血糖試片200插入血糖機。
舉例來說,血糖機內部的量測電路提供測試電壓至電極222、224,並根據產生的電流值來換算出血液中的預估血糖值。或者,血糖機內部的量測電路提供測試電流至電極222、224,並根據產生的電壓值來換算出血液中的預估血糖值。
另外,血糖機內部的量測電路經由電極232、234、236、238來讀取非揮發性記憶體230儲存的校正參數,並將預估血糖值轉換為輸出血糖值,並呈現於血糖機的螢幕。
請參照第2B圖,其所繪示為利用本發明血糖試片的血糖量測方法流程圖。首先,將化學試劑分別塗在血糖試片200的校正點210與測試點220(步驟S520)。接著,進行校正程序,將校正溶液滴在校正點210,並根據校正溶液與化學試劑的反應結果來獲得一校正參數並儲存於血糖試片的非揮發性記憶體230中(步驟S522)。將血液滴在測試點220,並根據
血液與化學試劑的反應結果以及非揮發性記憶體230中的校正參數來計算出一輸出血糖值(步驟S524)。
由於本發明第一實施例的血糖試片200中具有非揮發性記憶體230用以儲存該血糖試片200的校正參數,因此血糖機計算出的輸出血糖值會更準確。
再者,上述血糖試片200並不限定於僅有2條電極212、214連接至校正點210,也不限定於僅有2條電極222、224連接至測試點220,在此領域的技術人員也可以利用更多電極連接至校正點210與測試點220。
另外,本發明的血糖試片200也可以讓使用者來進行校正程序。舉例來說,製造商販售血糖試片200時會附帶校正溶液,而使用者可自行地進行校正程序。也就是說,使用者將校正溶液滴在校正點210後,將血糖試片200插入血糖機。血糖機計算出校正參數後,將校正參數儲存於血糖試片200的非揮發性記憶體230。之後,當使用者在量測血糖時,即將血液滴在測試點220,而血糖機內的量測電路即根據血液與化學試劑的反應以及非揮發性記憶體230中的校正參數來計算出一輸出血糖值。
當然,本發明更可將量測電路設計於血糖試片內,並利用一般的電子裝置即可顯示血糖值。請參照第3圖,其所繪示為本發明血糖試片的第二實施例。血糖試片300的基片380上具有一校正點310、一測試點320、一量測電路340、一非揮發性記憶體330與一通信埠(communication port)342。其中,血糖試片300的校正點310與測試點320分別塗上化學試劑,且血糖試片300的通信埠342可連接至電子裝置(未繪示),舉例來說通信埠342為USB埠。
如第3圖所示,多條導線連接於量測電路340與校正點310之間,多條導線連接於量測電路340與測試點320之間,多條導線連接於量測電路340與非揮發性記憶體330之間。另外,且量測電路340具有一通信埠342。
根據本發明的第二實施例,當血糖試片300插入具有相同通信埠342的電子裝置後,血糖試片300中的量測電路340即接收電源電壓Vpp與Vss而正常運作。此時,使用者或者製造商即可進行校正程序。舉例來說,電子裝置可為電腦或者手機。
於校正程序時,使用者或製造商將校正溶液滴在校正點310。由於校正溶液具有已知的血糖濃度,因此校正溶液與化學試劑反應後,量測電路340即可換算出該血糖試片300的校正參數,且量測電路340更將校正參數更儲存於非揮發性記憶體330。換言之,第二實施例的血糖試片300可由使用者或者製造商來進行校正程序,且每一片血糖試片300內皆有對應的校正參數儲存在非揮發性記憶體330中。
相同地,將血液滴在血糖試片300的測試點320後,使用者可將血糖試片300插入具有相同通信埠342的電子裝置。而血糖試片300中的量測電路340即接收電源電壓Vpp與Vss而正常運作,且使用者即可量測血糖值。
當使用者將血液滴在血糖試片300的測試點320時,血液即與測試點320上的化學試劑進行反應,而量測電路340即可計算出血液中的預估血糖值。再者,量測電路340更讀取非揮發性記憶體330的校正參數,將預估血糖值轉換為輸出血糖值。之後,經由通信埠342的資料線data,
量測電路340更將輸出血糖值傳遞至連接的電子裝置(未繪示),使得輸出血糖值呈現於電子裝置的螢幕。
相同地,第2B圖的血糖試片的血糖量測方法流程也同樣適用於第二實施例的血糖試片300。此處不再贅述。
由以上的說明可知,本發明第二實施例的血糖試片300中具有量測電路340,且非揮發性記憶體330中記錄校正參數。因此,血糖試片300可進行校正程序以及量測血糖。另外,血糖試片300具有通信埠342,所以量測電路340計算出的輸出血糖值即可傳遞至電子裝置,使得輸出血糖值呈現於電子裝置的螢幕。
當然,本發明的血糖試片也可以利用無線傳輸,將計算出的輸出血糖值傳遞至電子裝置。請參照第4圖,其所繪示為本發明血糖試片的第三實施例。血糖試片400的基片480上具有一校正點410、一測試點420、一量測電路440、一非揮發性記憶體430與一電源模組(power module)450與一輻射模組(radiation module)460。其中,血糖試片400的校正點410與測試點420分別塗上化學試劑,且血糖試片400的電源模組450可提供電源至量測電路440,輻射模組460利用無線傳輸技術,將輸出血糖值傳遞至外部電子裝置。
如第4圖所示,量測電路440連接至校正點410、測試點420、非揮發性記憶體430、電源模組450與輻射模組460。其中,電源模組450可為感應線圈模組(induction coil module),輻射模組460為藍芽模組、WiFi模組、RF模組、或NFC模組。
根據本發明的第三實施例,當血糖試片400的電源模組450產生電源至量測電路440時,量測電路440即可正常運作。此時,使用者或者製造商即可進行校正程序。
舉例來說,將血糖試片400靠近具備近場通訊(Near-Field Communication,簡稱NFC)的電子裝置,血糖試片400中的電源模組450即感應出電源至量測電路440。當然,本發明並不限定於電源模組450的實際架構,電源模組450也可利用電池模組來實現。
於校正程序時,使用者或製造商將校正溶液滴在校正點410。由於校正溶液具有已知的血糖濃度,因此校正溶液與化學試劑反應後,量測電路440即可換算出該血糖試片400的校正參數,且量測電路440更將校正參數更儲存於非揮發性記憶體430。換言之,第三實施例的血糖試片400可由使用者或者製造商來進行校正程序,且每一片血糖試片400內皆有對應的校正參數儲存在非揮發性記憶體430中。
利用相同的方式,使用者也可利用血糖試片400來量測血糖值。亦即,使用者將血液滴在血糖試片400的測試點420時,血液即與測試點420上的化學試劑進行反應,而量測電路440即可計算出血液中的預估血糖值。再者,量測電路440更根據非揮發性記憶體430的校正參數,將預估血糖值轉換為輸出血糖值。
之後,量測電路440經由輻射模組460將輸出血糖值傳遞至電子裝置(未繪示),使得電子裝置將輸出血糖值呈現於螢幕。
相同地,第2B圖的血糖試片的血糖量測方法流程也同樣適用於第三實施例的血糖試片400。此處不再贅述。
由以上的說明可知,本發明第三實施例的血糖試片400中具有量測電路440,且非揮發性記憶體430中記錄校正參數。因此,血糖試片400可進行校正程序以及量測血糖。另外,血糖試片400具有輻射模組460,所以量測電路440計算出的輸出血糖值即可利用無線傳輸技術傳遞至電子裝置,使得輸出血糖值呈現於電子裝置的螢幕。
由以上的說明可知,本發明提出一種具電子元件的血糖試片。由於每一片血糖試片皆逐一進行校正程序,並將校正參數儲存於非揮發性記憶體中,如此將可大幅提高測量血糖值的精確度。另外,當血糖試片電子化後,使用者無須隨身攜帶傳統的血糖機,並可大幅提升使用者的方便性。
綜上所述,雖然本發明已以較佳實施例揭露如上,然其並非用以限定本發明。本發明所屬技術領域中具有通常知識者,在不脫離本發明之精神和範圍內,當可作各種之更動與潤飾。因此,本發明之保護範圍當視後附之申請專利範圍所界定者為準。
200:血糖試片
210:校正點
212、214、222、224、232、234、236、238:電極
220:測試點
230:非揮發性記憶體
280:基片
Claims (13)
- 一種血糖試片,包括:一基片;一校正點,位於該基片上,且該校正點塗上一化學試劑;一測試點,位於該基片上,且該測試點塗上該化學試劑;以及一非揮發性記憶體,位於該基片上並儲存一校正參數;其中,於一校正程序時,將一校正溶液滴至該校正點,並根據該校正溶液與該化學試劑的一第一反應結果計算出該校正參數後,將該校正參數儲存於該非揮發性記憶體。
- 如申請專利範圍第1項所述之血糖試片,其中將一血液滴至該測試點,並根據該血液與該化學試劑的一第二反應結果以及該校正參數計算出一輸出血糖值。
- 如申請專利範圍第1項所述之血糖試片,更包括一量測電路位於該基片上,且該量測電路連接至該校正點、該測試點與該非揮發性記憶體,其中於該校正程序時,該量測電路根據該校正溶液與該化學試劑的該第一反應結果計算出該校正參數後,並將該校正參數儲存於該非揮發性記憶體。
- 如申請專利範圍第3項所述之血糖試片,其中將該血液滴至該測試點後,該量測電路根據該血液與該化學試劑的一第二反應結果以及該校正參數計算出該輸出血糖值。
- 如申請專利範圍第4項所述之血糖試片,其中量測電路具有一通信埠,連接至一電子裝置,且該量測電路將該輸出血糖值經由該通信埠傳遞至該電子裝置,使得該電子裝置的一螢幕上呈現該輸出血糖值。
- 如申請專利範圍第5項所述之血糖試片,其中該電子裝置經由該通信埠提供一電源至該量測電路,使該量測電路正常運作。
- 如申請專利範圍第4項所述之血糖試片,更包括一電源模組位於該基片上以及一輻射模組位於該基片上,其中該量測電路連接至該電源模組與該幅射模組,且該電源模組提供一電源至該量測電路,使該量測電路正常運作。
- 如申請專利範圍第7項所述之血糖試片,其中該量測電路將該輸出血糖值經由該輻射模組傳遞至該電子裝置,使得該電子裝置的一螢幕上呈現該輸出血糖值。
- 一種血糖試片的量測方法,該血糖試片包括一校正點、一測試點以及一非揮發性記憶體,該量測方法包括下列步驟:將一化學試劑分別塗在該血糖試片的該校正點與該測試點;將一校正溶液滴在該校正點,並根據該校正溶液與該化學試劑的一第一反應結果來獲得一校正參數並儲存於該血糖試片的該非揮發性記憶體中;以及將一血液滴在該測試點,並根據該血液與該化學試劑的一第二反應結果以及該非揮發性記憶體中的該校正參數來計算出一輸出血糖值。
- 如申請專利範圍第9項所述之量測方法,其中該血糖試片更包括一量測電路,該量測電路根據該第一反應結果來獲得該校正參數並儲 存於該非揮發性記憶體中,且該量測電路根據該第二反應結果以及該非揮發性記憶體中的該校正參數來計算出該輸出血糖值。
- 如申請專利範圍第10項所述之量測方法,更包括下列步驟:利用該量測電路的一通信埠連接至一電子裝置,且該量測電路經由該通信埠傳遞該輸出血糖值至該電子裝置,使得該電子裝置的一螢幕呈現該輸出血糖值。
- 如申請專利範圍第10項所述之量測方法,其中該血糖試片更包括一電源模組連接至該量測電路與一幅射模組量連接至該量測電路,且該電源模組提供一電源至該量測電路,使該量測電路正常運作。
- 如申請專利範圍第12項所述之之量測方法,更包括下列步驟:該量測電路將該輸出血糖值經由該輻射模組傳遞至該電子裝置,使得該電子裝置的一螢幕上呈現該輸出血糖值。
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