TW201808366A - 具有顯示器之手動致動注射裝置 - Google Patents

具有顯示器之手動致動注射裝置 Download PDF

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TW201808366A
TW201808366A TW106116573A TW106116573A TW201808366A TW 201808366 A TW201808366 A TW 201808366A TW 106116573 A TW106116573 A TW 106116573A TW 106116573 A TW106116573 A TW 106116573A TW 201808366 A TW201808366 A TW 201808366A
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piston
lead screw
drug
injection device
housing
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TW106116573A
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史蒂芬 海曼
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美商安尼瑪斯公司
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/1424—Manually operated pumps
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
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    • A61M5/31581—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
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    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
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Abstract

提供一種手動操作之藥物注射裝置。該裝置能可靠地投送一準確控制的藥物量。此外，該裝置包括一電池組操作指示裝置，以用於追蹤所投送之藥物劑量的數目。可選地，該裝置包括一棘輪及爪片以防止無意間施配藥物。

Description

具有顯示器之手動致動注射裝置
本發明係關於注射裝置。更具體而言，本發明係關於使液體藥物能夠方便安全地由一患者自行給藥的手動注射裝置。本發明之泵包括一適合用於向泵使用者顯示劑量資訊之指示裝置。
藉由使用可攜式外部輸液泵，已使面對短程或慢性疾病狀況的患者能夠自行投送藥物。此等泵的使用已展現可改善這些患者的生活品質以及整體健康。然而，此等泵的尺寸、成本、及複雜性對使用者可係一缺點。例如，此等注射泵之一些係受電子控制且必須經過程式化以供應所需量之藥物。此使許多使用者無法接受使用此技術。
因此，此技術領域中需要一便利之治療形式，該治療形式使用不需要大量編程或技術技能即可使用的輸液泵。較佳地，此一治療會由一注射裝置執行，該裝置使用容易且為機械式驅動。如果注射裝置能直接附接於身體上且不需任何電子器件來編程其投送速率，將亦為較佳的。藥物較佳係透過一小型薄壁管或套管(cannula)投送穿透皮膚，與習知技術相似。
雖然此一簡單投送裝置的想法很吸引人，但實現此一裝置之前必須克服許多障礙。藥物的供應是一個問題。患者對於藥物用量的變化甚大，因此此一裝置必須能提供一段固定時間(例如三天)的治療。在此一情境中，單一尺寸並無法適用於所有人。更進一步，此類裝置必須可安全穿戴，並且不會發生可能的意外給藥。更進一步，此類裝置必須能可靠地投送一準確控制的藥物量。最後，高度期望一種裝置能提供用於追蹤所投送藥物劑量之數目的方法，以使患者或健康照護者能確保在一給定時段給予正確的藥物量。如果製造此一裝置的成本夠低廉 以使該裝置可在使用後抛棄的話則會更佳。如隨後可見，本文所述的裝置及方法可解決這些以及其他問題。
一種藥物注射裝置，其包含：a.)一殼體；b.)一電池組操作指示裝置，其位於該殼體內，其中該指示裝置提供關於藥物之資訊；c.)一手動操作齒輪機構；d.)一活塞，其包含一活塞端，其中該活塞係回應於該齒輪機構之動作而依一第一方向轉位；e.)一藥物匣，其內具有一由該活塞端啟動之柱塞；f.)一可移除式固持件，其用於將該藥物匣及活塞固持其內；及g.)一感測機構，其用於感測該活塞在該導螺桿上之一位置。
10‧‧‧裝置
11‧‧‧殼體
12‧‧‧指示裝置
13‧‧‧驅動輪
14‧‧‧殼體面板
15‧‧‧鈕扣型電池電池組
16‧‧‧導螺桿基座
17‧‧‧活塞
18‧‧‧活塞端
19‧‧‧旋轉輪
20‧‧‧齒輪機構
22‧‧‧感測器
22’‧‧‧感測器
22”‧‧‧感測器
23‧‧‧卡扣
24‧‧‧齒輪/電路板
25‧‧‧導螺桿軸件/具螺紋軸件
26‧‧‧固持件
27‧‧‧通道
28‧‧‧表面
29‧‧‧底部表面
30‧‧‧匣
31‧‧‧柱塞
32‧‧‧注射端
40‧‧‧回捲工具
41‧‧‧把手
42‧‧‧軸件
43‧‧‧輪
44‧‧‧開口
51‧‧‧棘輪
52‧‧‧爪片
A‧‧‧箭頭
B‧‧‧箭頭
圖1係本發明之裝置的俯視透視圖。
圖2係將圖1之裝置移除一部分之殼體的俯視透視圖。
圖3係圖1之裝置的側面透視圖，該裝置之殼體係以虛線表示，圖示該裝置之內部組件。
圖4係將圖1之裝置移除一部分之殼體的側面透視圖。
圖5係圖1之裝置之齒輪機構的側面透視圖。
圖6係具一活塞及編碼器之圖5之齒輪機構的側面透視圖。
圖7係具光學感測器之圖6之齒輪機構、活塞、及編碼器的側面透視圖。
圖8係實用於圖1之裝置之藥物匣的側面透視圖。
圖9係圖8之齒輪機構於一匣固持件中的側面透視圖。
圖10係圖9之匣固持件之底部表面的側面透視圖。
圖11係將圖1之裝置移除一部分之殼體及顯示器的俯視透視圖。
圖12係將圖1之裝置移除一部分之殼體及組件以圖示導螺桿軸件及活塞完全延伸時的俯視透視圖。
圖13係實用於圖1之裝置之回捲工具的側面透視圖。
圖14係圖示將圖13之回捲工具與圖12之裝置一同使用的圖。
圖15A及圖15B係用於圖1之裝置之一鎖定機構的透視圖。
現請參照圖1，其圖示體現本發明之某些態樣之一第一注射裝置的俯視透視圖。裝置10大致上包括殼體11，其殼體包括在殼體中之一開口內的指示裝置12。亦圖示驅動輪13。如所圖示者，指示裝置12係一顯示器，該顯示器提供關於裝置10所投送之藥物劑量及其中剩餘劑量之資訊。顯示器可描繪數字、文字、圖符、或類似者，但較佳地係一單行數字顯示器。較佳地，顯示器指示裝置10所欲投送之胰島素單位之數量(於圖1中圖示為「2.6」)及裝置內待投送之剩餘藥物單位之數量(於圖1中圖示為「175」)。指示裝置可係任何習知類型之顯示器，例如LCD、LED、OLED、但較佳係一OLED顯示器。如圖2所圖示，裝置內提供有一電源(例如鈕扣型電池電池組15)，其電池組為顯示器、感測器、微控制器、及該裝置之相關聯的電路供電，如下文所述。圖1圖示之殼體11之可移除殼體面板14提供至電池組的出入口。由於本發明之注射裝置之泵機構係手動操作，因此裝置所需之電力極小。
本發明之注射裝置包括一手動操作之齒輪機構。如圖5所示，在一實施例中，齒輪機構20包括驅動輪13，齒輪24自該驅動輪之一表面延伸。雖然圖示一驅動輪，但仍應理解的是，仍可以其他能夠提供旋轉動作的簡單手動操作組件取代驅動輪使用。齒輪24經設計以與導螺桿基座16之螺紋(或輪齒)嚙合，該導螺桿基座之旋轉轉動具螺紋之導螺桿軸件25。驅動輪13之旋轉關聯於導螺桿軸件25經由齒輪24與導螺桿基座16之嚙合或齒輪互動之旋轉。如圖3、圖4、圖6、及圖7所示，具活塞端18之活塞17係可移動地附加至導螺桿軸件25。隨著導螺桿軸件25係藉由齒輪24與導螺桿基座16之齒輪互動而旋轉，活塞17轉位(index)離開(於下文中進一步描述)，意即自導螺桿基座16依一縱向方向沿導螺桿軸件25移動較遠之距離。
為自注射裝置投送藥物，所欲的是導螺桿機構之移動小而精確。活塞17之前向移動或延伸之量可直接自導螺桿螺距計算。舉例而言，導螺桿可係每吋具有56個螺紋之一#2-56螺絲，而導螺桿基座與具螺紋軸件之齒輪比可係一4：1比率。在此例子中，驅動輪13之一次完全轉動關聯於導螺桿基座16之一次¼轉動及活塞17之一次0.0045吋延 伸。來自活塞端18向前移動之壓力驅動一藥物匣中之一柱塞。因此，若軸件25驅動活塞端18進入一藥物匣之量係0.44單位，此移動將導致對使用者注射0.00070立方吋(0.11ml；1.1單位)之藥物。
殼體11內亦包括一感測機構。該感測機構可係任何能夠電連接至指示裝置12之習知機構。如圖3及圖7所示，感測機構包括電路板24，該電路板包括一微控制器及顯示器驅動器(未圖示)。電路板24亦包括一附加至其之感測器22。感測器可係任何感測器類型，例如光學感測器，能夠測量齒輪及活塞之移動。如圖6及圖7所示，使用一包括旋轉輪19之旋轉編碼器。旋轉輪19可含有任何所欲數量之槽縫或轉變，以用於光學感測器。來自光學感測器22之光(例如垂直於旋轉輪19傳送者)一則反射回感測器之一接收器，或者行進穿過感測器。感測器電子器件使用由槽縫引起之傳送中斷來將光轉換成電子信號。舉例而言，圖6所示之輪將提供10次電壓轉變(5上5下)，得出每次輪轉發射10個信號。若一次輪轉係1.1單位之藥物，則顯示器可以約0.1單位之藥物之增量來描繪那些單位。
較佳地，額外提供感測器以用於測量活塞17之最大延伸及回縮。此等感測器(圖示為在圖7之電路板24上之22'及22")指示藥物匣何時空了、或如下文所述般完全回捲。活塞17製造有或塗佈有一將所傳送光反射回感測器之反射材料。隨著活塞沿具螺紋軸件25向前移動並經過一感測器，光束將不會被反射，而提供活塞位置之一指示。在完全向前之位置，沒有來自活塞至感測器22'或者感測器22"之反射，指示活塞完全延伸且因此已作用於藥物匣內之一柱塞以將匣淨空。
任何適合用於儲存待使用之藥物且能夠與活塞17互動以排出藥物的習知藥物匣可係實用於本發明之裝置。較佳地，藥物匣係留持約200至約300單位之藥物的一小型匣，其藥物較佳係胰島素。舉例而言，如圖8所示，匣30其內包括柱塞31。匣之一端(注射端)適合用於連接至一套管、針、或類似者，以用於將物質注射至使用者體內。如圖示，注射端32包括一適合於(例如)連接至一習用魯爾(luer)式連接件之具螺紋之零件。不過，可將任何適合的連接件用於注射端32。
如圖9、圖10、及圖11所示，殼體11內有固持件26以將匣30留持於裝置內。圖11描繪組裝於殼體11內之固持件26中的匣30。如圖示，固持件26經定尺寸及定形狀以使匣30可安置於固持件26之一端內(圖9及圖10)且活塞17安置於一相對端中(圖11)。固持件26防止活塞17回應於導螺桿軸件25藉由齒輪24與導螺桿基座16之齒輪互動之旋轉而旋轉。卡扣23係與固持件26之底部表面29成一整體並自該底部表面延伸之一凸緣，該卡扣毗連殼體11之表面28並抵靠該表面而留持。壓押卡扣23允許固持件26通過表面28下方，並允許該固持件連同匣30自該殼體移除、或允許該固持件連同該匣插入該殼體中。固持件26內的通道27(圖示於圖9)為活塞17及活塞端18提供至柱塞31之出入口。活塞17係藉由手動轉動輪13來延伸且沿具螺紋軸件25轉位並通過通道27，迫使活塞端18移動柱塞31，使得藥物自匣30排出。在圖11中圖示活塞17，其中活塞端18與柱塞31嚙合。
本發明之裝置之一特徵係能夠手動於導螺桿上回捲該活塞，使得裝置在藥物匣空了之後能夠再度使用。圖12描繪將一空藥物匣及其固持件自裝置移除之殼體11，且活塞17係以其沿導螺桿軸件25完全延伸之位置圖示之。若逆齒輪機構執行將活塞17手動返還至其在裝置內的回縮開始位置，會需要轉動活塞數百次以克服槓桿倍數(gearing ratio)並將活塞轉位至其原始位置。有了本發明之裝置，移除固持件及使用回捲工具40(圖示於圖13及圖14中)可用於輕易地將活塞回捲至其開始位置。匣30淨空後，將固持件26連同空的匣30自裝置移除。移除固持件26允許活塞17旋轉。回捲工具40包括把手41、輪43(較佳係周圍有溝槽、鋸齒邊、或類似者以促進抓握)軸件42、及開口44。開口44經定尺寸及定形狀以可釋離地嚙合活塞端18。圖14圖示坐落於活塞端上之回捲工具。隨著將工具依順時針方向轉動，活塞依箭頭A圖示之方向旋轉，使得活塞沿軸件25依箭頭B指示之方向轉位。
本發明之裝置可由一個體穿戴於一腰帶上、一口袋或其他適合之衣物間隔中。由此，可額外提供一可移除之黏著墊以將裝置可移除地附加至使用者的身體。較佳地，裝置係小型且經定尺寸及定形狀以不顯眼地穿戴，且係介於約2.8×1.0×0.9吋至約3.5×1.7×1.6吋。
在一實施例中，可使用一適合之防止活塞17無意間向前轉位的鎖定機構。舉例而言且如圖15A及圖15B所示，驅動輪13上可安裝有棘輪51。在圖15A中，驅動輪13係以虛線形式圖示且經定位以使棘輪51在其下方。除非裝置使用者施加足夠的力量於驅動輪13上以使棘輪51之棘齒推進通過爪片52，否則棘輪51無法轉動，此允許驅動輪旋轉，且最終允許施配藥物。爪片52具有足夠的剛度，以使棘輪51無法依非施配方向轉動。由於需要足夠的力來壓過爪片52，因此防止了驅動輪13無意間轉動、也因此防止了藥物在無意間施配。該棘輪-爪片機構之一次要優點是使用者在轉動驅動輪13時體驗之觸感。當經轉動，每次爪片52經棘輪的一個棘齒壓過時，使用者的手會透過驅動輪13感覺到喀擦及一下。做為又另一優點，每次喀擦會對應至一定量轉動及藥物的施配。
替代地，可使用完全鎖定驅動輪13的方法。此類方法可使用一彈性載力(force loaded)組件(例如一銷針)來嚙合驅動輪13中之一對應孔。使用者要拉出銷針才能夠轉動該輪。
在另一實施例中，可添加視覺、聽覺、或振動警示。可經由指示裝置提供視覺警示。可透過包括於裝置內的一揚聲器提供聽覺警示。可使用一振動馬達以對使用者提供振動警示。這些警示可結合使用、頻率升高、音量升高、或類似者、或其組合。此類警示之電路系統及揚聲器可併入電路板24上。
在又另一實施例中，可提供一發送器以發送資料、警示或二者至另一裝置(例如電話、電腦、伺服器、雲端、或類似者)。適合併入此一泵的發送器係熟知的。較佳地，該發送器係一BlueTooth®低能量發送器。
將顯而易見的是，在所述之本發明之範疇內，對所述之裝置的其他修改和變異係可能的。本發明若有落在本揭露之精神內或均等於申請專利範圍中出現之發明的變化形式，本文亦意圖涵蓋這些變異。

Claims (5)

  1. 一種藥物注射裝置，其包含：a.)一殼體；b.)一電池組操作指示裝置，其位於該殼體內，其中該指示裝置提供關於藥物之資訊；c.)一手動操作齒輪機構；d.)一活塞，其包含一活塞端，其中該活塞係回應於該齒輪機構之動作而依一第一方向轉位；e.)一藥物匣，其內具有一由該活塞端啟動之柱塞；f.)一可移除式固持件，其用於將該藥物匣及活塞固持其內；及g.)一感測機構，其用於感測該活塞在該導螺桿上之一位置。
  2. 如請求項1所述之注射裝置，其中該齒輪機構進一步包含一手動操作驅動輪、一導螺桿基座、及一自該導螺桿基座延伸之導螺桿軸件，且其中該活塞係回應於該驅動輪之轉動而依該第一方向沿該導螺桿軸件轉位。
  3. 如請求項1所述之注射裝置，其進一步包含一回捲工具，其用於將該活塞返還至該導螺桿上之一起始位置。
  4. 如請求項1所述之注射裝置，其進一步包含一棘輪及爪片，其等能夠防止該驅動輪無意間轉動。
  5. 如請求項1所述之注射裝置，其進一步包含一黏著墊於該殼體之一表面上，以用於將該注射裝置黏附至一裝置使用者之一身體。
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