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TW202120020A - 植針模組及具有植針模組的植入裝置 - Google Patents

植針模組及具有植針模組的植入裝置 Download PDF

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TW202120020A
TW202120020A TW109125114A TW109125114A TW202120020A TW 202120020 A TW202120020 A TW 202120020A TW 109125114 A TW109125114 A TW 109125114A TW 109125114 A TW109125114 A TW 109125114A TW 202120020 A TW202120020 A TW 202120020A
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needle
implant
implantation
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elastic
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黃椿木
陳界行
張冠霖
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華廣生技股份有限公司
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Abstract

一種植針模組及具有植針模組的植入裝置，用於確保植針植入皮膚前之植針初始行程順暢，該植針模組包含一主體件、一植針輔助座、一植針組件及一感測器組件，該主體件包括一容置孔及多數滑槽，該植針輔助座包括一座體及複數彈性片，各該彈性片具有一凸出部，各該滑槽具有一沿植入方向呈漸寬之壁面，各該彈性片的凸出部彈性抵接且呈點接觸於各該壁面，該植針輔助座於植入前透過各該凸出部與各該滑槽的壁面的干涉配合而限位固定，使植針穩定，以避免該植針於該植針初始行程產生偏心，可提升植針穩定性且減少疼痛感。

Description

植針模組及具有植針模組的植入裝置
本發明是有關於一種植入裝置，特別是指一種可量測葡萄糖濃度的感測器植入生物皮下並持續獲取生理訊號的植針模組及具有植針模組的植入裝置。
現有一種可將感測器植入生物皮下的植入裝置( US10,413,183專利案)，植入裝置5000包括一鎖環座5004、一可滑動地穿設於鎖環座5004內部的柱塞5002、一安裝於柱塞5002內部的撞針座5136、一安裝於柱塞5002與撞針座5136之間的非預壓撞針彈簧5138、一套設於撞針座5136內部的針座5146、一彈抵於撞針座5136與針座5146之間的針座彈簧5144。
前案之植入裝置欲操作植針時，使用者必需壓下柱塞5002，使非預壓縮的撞針彈簧5138形成壓縮狀態，並利用柱塞肋5152使所對應的卡扣臂5142偏轉，解除柱塞肋515與卡扣臂5142的限位關係，利用非預壓縮撞針彈簧5138的彈力恢復帶動撞針座5136及針座5146向下進行植針。
當完成植針後，撞針座5136仍處於植針位置時，此時，使用者必須放開對柱塞5002的下壓，使柱塞5002向上移動，解除針座5146的限位關係，再利用預壓縮的針座彈簧5144的彈力釋放使針座5146帶動刺穿構件5110朝柱塞5002內部縮回，感測器5108留置於人體皮膚表面。
在上述進行植針的操作過程中，該針座5146沿該撞針座5136下移的過程中，該針座5146容易產生歪斜，導致刺穿構件5110也歪斜地刺入人體皮膚，且在刺入人體及自人體縮回時刺穿構件5110會產生拉扯，並增加人體疼痛感，有待改善。
因此，本發明的一目的，即在提供一種可提升植針穩定性且減少疼痛感的植針模組。
本發明的另一目的，即在提供一種可提升植針穩定性且減少疼痛感的具有植針模組的植入裝置。
於是，本發明的植針模組，用於確保植針植入皮膚前之植針初始行程順暢，該植針模組包含一主體件、一植針輔助座、一植針組件及一感測器組件。該主體件包括一沿一軸線設置的容置孔，以及多數圍繞該軸線且位於該容置孔外側且與該容置孔互相連通的滑槽，該植針輔助座包括一座體，以及複數連接於該座體的彈性片，該座體可沿該容置孔滑動，該等彈性片可沿所對應的滑槽滑動，其中各該彈性片具有一凸出部，該植針組件包括一植針座，以及一連接於該植針座的植針，該植針座安裝於該座體，該植針之一尖端與皮膚間之距離定義為植針初始行程，該感測器組件包括一固定座，以及一安裝於該固定座的感測器，其中，各該滑槽具有一沿植入方向呈漸寬之壁面，各該彈性片的凸出部彈性抵接且呈點接觸於各該壁面；藉此，該植針輔助座於植入前透過各該凸出部與各該滑槽的壁面的干涉配合而限位固定，使植針穩定，以避免該植針於該植針初始行程產生偏心。
本發明的具有植針模組的植入裝置，用於確保植針植入皮膚前之植針初始行程順暢，該植入裝置包含一致動模組及一植針模組，該致動模組包括一內襯、一設置於該內襯內部的主體蓋、一連接於該主體蓋的植入座、一彈抵於該主體蓋與該植入座之間的第一彈性件、一設置於該主體蓋與該植入座之間的抽針座、一彈抵於該抽針座與該植入座之間的第二彈性件，該植針模組用於確保植針植入皮膚前之植針初始行程順暢，該植針模組具有一主體件、一植針輔助座、一植針組件及一感測器組件，該主體件具有一沿一軸線設置的容置孔，以及多數圍繞該軸線且位於該容置孔外側且與該容置孔互相連通的滑槽，該植針輔助座具有一座體，以及複數連接於該座體且具彈性的彈性片，該座體可沿該容置孔滑動，該等彈性片可沿所對應的滑槽滑動，其中各該彈性片具有一凸出部，該植針組件具有一植針座，以及一連接於該植針座的植針，該植針座安裝於該座體，該植針之一尖端與皮膚間之距離定義為植針初始行程，該感測器組件具有一固定座，以及一安裝於該固定座的感測器，其中，各該滑槽具有一沿植入方向呈漸寬之壁面，各該彈性片的凸出部彈性抵接且呈點接觸於各該壁面；藉此，該植針輔助座於植入前透過各該凸出部與各該滑槽的壁面的干涉配合而限位固定，使植針穩定，以避免該植針於該植針初始行程產生偏心。
本發明的功效在於：該植針模組係透過將植針組件設置於植針輔助座上，並藉由植針輔助座上彈性片的凸出部與壁面的干涉配合來穩固植針組件，以確保植針於植針初始行程的穩定性以及準直度，避免植針因偏心而在植針過程中所造成的拉扯疼痛感。
在本發明被詳細描述之前，應當注意在以下的說明內容中，類似的元件是以相同的編號來表示。
參閱圖1至圖5，本發明植入裝置的一第一實施例，用於確保植針植入皮膚前之植針初始行程順暢，該植入裝置包含一外殼單元100、一致動模組200及一植針模組30。
該外殼單元100包括一上蓋10，以及一可與該上蓋10緊密蓋合的底蓋20。
該致動模組200包括一設置於該上蓋10內部的內襯12、一設置於該內襯12內部的主體蓋32、一連接於該主體蓋32的植入座33、一彈抵於該主體蓋32與該植入座33之間的第一彈性件34、一設置於該主體蓋32與該植入座33之間的抽針座35、一彈抵於該抽針座35與該植入座33之間的第二彈性件37。該內襯12具有一對鄰近於底部的嵌卡部124。該第一彈性件34與第二彈性件37可為預壓縮彈簧。該內襯12之內周面具有一對掣動部123，該主體蓋32具有一朝該植入座33凸伸的限位件323，該植入座33具有一對呈倒鉤狀的限位組件334，以及一對分別受該等掣動部123掣動的卡扣部335。
該植針模組30用於確保植針植入皮膚前之植針初始行程順暢，該植針模組30具有一主體件31、一植針輔助座38、一植針組件36、一底座50及一感測器組件70。
該主體件31具有一對分別可與嵌卡部124互相卡扣的卡制部311、一沿一軸線L設置的容置孔312、多數圍繞該軸線L且位於該容置孔312外側且與該容置孔312互相連通的滑槽313，以及一對扣止部314。藉由該植入座33之卡扣部335抵制於主體件31之扣止部314，使該植入座33與該主體件31間形成一植針限位結構A。該等滑槽313圍繞該軸線L呈間隔設置，本實施例中滑槽313的數量有三個。各該滑槽313具有一沿一植入方向F呈漸寬之壁面315，各該滑槽313之壁面315相對於該軸線L的斜度介於0度至3度之間。
該植針輔助座38具有一座體381、複數連接於該座體381且具彈性的彈性片382，以及多數凸設底部且呈凸榫狀的連結部383。該座體381可沿該容置孔312滑動，該等彈性片382可沿所對應的滑槽313滑動，其中各該彈性片382具有一凸出部385，各該彈性片382的凸出部385彈性抵接且呈點接觸於各該壁面315。每一彈性片382各具有二凹口384並呈H形，其中該等凹口384分別設於各該彈性片382的頂部與底部，透過該等凹口384的設置，允許該等彈性片382具有沿垂直於軸線L的徑向被壓縮且被壓縮後具有朝外部彈抵的能力。在其他實施例中，彈性片數量也可為兩個，且該等彈性片相隔180度。
該植針組件36具有一安裝於該抽針座35與該座體381之間的植針座361，以及一連接於該植針座361的植針362，該植針座361與該抽針座35呈分離式斷點設計，可以避免因為製造組配之公差而導致植針座361與該抽針座35的偏心情形。如圖18所示，該植針362之一尖端363與皮膚間之距離定義為植針初始行程H。本實施例中，該植針組件36的植針初始行程H不大於1mm。
該底座50可卸離地限位於主體件31之底部，且底座50可透過黏貼片黏附於生物皮表。
該感測器組件70具有一固定座71，以及一安裝於該固定座71的感測器72。固定座71具有多數呈凹孔狀且供該等連結部383嵌入的套合部711。
為供進一步瞭解本發明各元件配合所產生的作用、運用技術手段，以及所預期達成的功效，將再說明如下，相信當可由此而對本發明有更深入且具體的瞭解。
再者，如圖3及圖4，當本發明的植入裝置第一實施例整體組配完成時，該內襯12與該主體蓋32間保持一間距D，該植入座33的卡扣部335抵制於主體件31的扣止部314，使植入座33位於一植針前位置。而該第一彈性件34被預壓縮於植入座33與主體蓋32之間並形成壓縮蓄力，而第二彈性件37則被預壓縮於抽針座35與植入座33之間並蘊藏回釋彈力，透過該限位件323對該限位組件334產生的徑向約束限制，該抽針座35也位於一植針前位置，感測器組件70的套合部711與連結部383呈緊配套合，使得固定座71連接於植針輔助座38，且植針輔助座38又緊配合連接於植針組件36的植針座361，因此，植針組件36可隱藏於主體件31內部且受該底座50所遮避，且底座50相對於主體件31產生定位。該抽針座35受該植入座33約束而形成一抽針限位結構B。
當本發明第一實施例之植入裝置欲進行自動植針，將感測器72植入生物皮下時，其操作說明如下：
配合參圖6及圖7，使用者先將該底座50定位於所要植入的生物部位，當使用者尚未按壓上蓋10時，因植入座33與主體件31之間的植針限位結構A尚未解除，而保持於一植針前位置。續參圖8及圖9，當施力按壓上蓋10，使掣動部123掣動植入座33的卡扣部335向內側彎曲變形而自主體件31之扣止部314脫離，解除主體件31與植入座33的植針限位結構A，同時，卡制部311與對應的嵌卡部124產生勾合，該上蓋10相對於主體件31之底部產生嵌接定位。
配合參圖10及圖11，當主體件31與該植入座33的植針限位結構A解除後，被預壓縮的該第一彈性件34的彈力得以釋放，供該植入座33往下位移至植針位置，且該感測器組件70被該植入座33帶動而位於一植針後位置，該感測器72也隨該植針362植入生物皮下，該感測器組件70的固定座71被定位於該底座50上而留置於生物表面，當完成自動植針時，因該植入座33的限位組件334與主體件31的限位件323分離，使得抽針座35與植入座33的抽針限位結構B被解除，藉由被預壓縮第二彈性件37的彈力釋放，使抽針座35朝一抽針方向R位移，帶動植針組件36縮移至植入座33與植針輔助座38之間，使植針組件36不會外露，達到植針362隱藏設計的效果，完成自動抽針(參圖12及圖13)，並且利用套合部711與連結部383呈緊配套合的作用，使植針輔助座38與感測器組件70的固定座71連接。且透過植針過程將感測器組件70定位於底座50上，同時藉由底座50的黏結片52將底座50黏貼於生物皮表(如圖14及圖15所示，底座50已自主體件31底部脫離)。
又如圖16及圖17，使用者在完成植針操作後，可將原本拆下的底蓋20再蓋回上蓋10底部，讓使用者依照醫療廢棄物丟棄規範進行丟棄。
再如圖3至圖5，以及圖18所示，在植針行程中，植入的初速度尚未能提供植針的準直度，因此在此階段利用該彈性片382的凸出部385與壁面315的干涉配合以確保植針的準直度，待植入速度由初速度提升為加速度後便能提供植針362於植入時的準直度，此時呈點接觸的凸出部385可迅速脫離與漸寬壁面315的干涉配合，且當植針362向下植入而接觸到生物皮表時便可具有一支撐的植入點，因此穩定植針初始行程H便可將植針362準直且穩定地快速植入生物皮下。此外，該植針輔助座38在植針前利用各該彈性片382之該等凹口384，允許各該彈性片382具有沿垂直於軸線L的徑向被壓縮且被壓縮後具有朝外部彈抵的能力，並搭配各該凸出部385與各該滑槽313的壁面315的干涉配合而限位固定，可避免植針組件36在未固定之情況下植入而造成左右偏擺、拉扯的情況，以提昇植針行程穩定性，同時減少患者的疼痛感。
再如圖19所示，本發明植入裝置的一第二實施例，與該第一實施例的差異在於:該植針輔助座38’的每一彈性片382’具有一開口朝上的凹口384’，該等凹口384’由各該彈性片382’的頂部朝底部凹設。利用各該彈性片382’所設的該等凹口384’，允許各該彈性片382’具有沿垂直於軸線L的徑向被壓縮且被壓縮後具有朝外部彈抵的能力。
如圖20所示，本發明植入裝置的一第三實施例，與該第二實施例的差異在於:該植針輔助座38”的每一彈性片382”具有一開口朝下的凹口384”，該等凹口384”由各該彈性片382”的底部朝頂部凹設。利用各該彈性片382’所設的該等凹口384’，允許各該彈性片382”具有沿垂直於軸線L的徑向被壓縮且被壓縮後具有朝外部彈抵的能力。
綜上所述，本發明的該植針模組30係透過將植針組件36設置於植針輔助座38上，並藉由植針輔助座38上彈性片382的凸出部385與壁面315的干涉配合來穩固植針組件36，以確保植針362於植針初始行程的穩定性以及準直度，避免植針362因偏心而在植針過程中所造成的拉扯疼痛感。
惟以上所述者，僅為本發明的實施例而已，當不能以此限定本發明實施的範圍，凡是依本發明申請專利範圍及專利說明書內容所作的簡單的等效變化與修飾，皆仍屬本發明專利涵蓋的範圍內。
100:外殼單元 10:上蓋 20:底蓋 200:致動模組 12:內襯 123:掣動部 124:嵌卡部 32:主體蓋 323:限位件 33:植入座 334:限位組件 335:卡扣部 34:第一彈性件 35:抽針座 37:第二彈性件 30:植針模組 31:主體件 311:卡制部 312:容置孔 313:滑槽 314:扣止部 315:壁面 38:植針輔助座 381:座體 382:彈性片 383:連結部 384:凹口 385:凸出部 36:植針組件 361:植針座 362:植針 363:尖端 50:底座 70:感測器組件 71:固定座 711:套合部 72:感測器 L:軸線 A:植針限位結構 B:抽針限位結構 H:植針初始行程 F:植入方向
本發明的其他的特徵及功效，將於參照圖式的實施方式中清楚地呈現，其中： 圖1是本發明植入裝置一第一實施例的一立體分解圖； 圖2是第一實施例的一不完整的部分構件立體分解圖； 圖3是第一實施例的一剖視示意圖，說明在一待植針狀態； 圖4是沿圖3中之線Ⅳ-Ⅳ的一剖面圖； 圖5是第一實施例中植針模組的仰視立體分解示意圖； 圖6是第一實施例的一使用示意圖，說明卸除一底蓋且呈待植針狀態； 圖7是沿圖6中之線Ⅶ-Ⅶ的一剖面圖； 圖8是第一實施例的一操作示意圖，說明在一植針瞬間狀態； 圖9是沿圖8中之線Ⅸ-Ⅸ的一剖面圖； 圖10是第一實施例的又一操作示意圖，說明在一植入後瞬間狀態； 圖11是沿圖10中之線ⅩⅠ-ⅩⅠ的一剖面圖； 圖12是第一實施例的再一操作示意圖，說明在一植針瞬間狀態； 圖13是沿圖12中之線ⅩⅢ-ⅩⅢ的一剖面圖； 圖14是第一實施例的另一操作示意圖，說明在一分離後狀態； 圖15是沿圖14中之線ⅩⅤ-ⅩⅤ的一剖面圖； 圖16是第一實施例的又再一操作示意圖，說明在一用畢後將底蓋蓋回原狀態； 圖17是沿圖16中之線ⅩⅦ-ⅩⅦ的一剖面圖； 圖18是第一實施例的一植針示意圖； 圖19是本發明植入裝置一第二實施例的一植針輔助座；及 圖20是本發明植入裝置一第三實施例的一植針輔助座。
200:致動模組
12:內襯
124:嵌卡部
32:主體蓋
33:植入座
34:第一彈性件
35:抽針座
37:第二彈性件
30:植針模組
31:主體件
311:卡制部
38:植針輔助座
381:座體
382:彈性片
36:植針組件
361:植針座
362:植針
363:尖端
50:底座
70:感測器組件
71:固定座
72:感測器
L:軸線

Claims (20)

  1. 一種植針模組，用於確保植針植入皮膚前之植針初始行程順暢，該植針模組包含： 一主體件，包括一沿一軸線設置的容置孔，以及多數圍繞該軸線且位於該容置孔外側且與該容置孔互相連通的滑槽； 一植針輔助座，包括一座體，以及複數連接於該座體的彈性片，該座體可沿該容置孔滑動，該等彈性片可沿所對應的滑槽滑動，其中各該彈性片具有一凸出部； 一植針組件，包括一植針座，以及一連接於該植針座的植針，該植針座安裝於該座體，未植針前，該植針之一尖端與皮膚間之距離定義為植針初始行程；及 一感測器組件，包括一固定座，以及一安裝於該固定座的感測器，其中該固定座係設置於該植針輔助座之該座體上，且該植針係穿設於該固定座並包覆該感測器； 其中，各該滑槽具有一壁面，各該彈性片的凸出部彈性抵接且呈點接觸於各該壁面；藉此，該植針輔助座於植入前透過各該凸出部與各該滑槽的壁面的干涉配合而限位固定，使植針穩定，以避免該植針於該植針初始行程產生偏心。
  2. 如請求項1所述的植針模組，其中，該植針輔助座的每一彈性片具有至少一開口朝上的凹口，該等凹口由各該彈性片的頂部朝底部凹設。
  3. 如請求項1所述的植針模組，其中，該植針輔助座的每一彈性片具有至少一開口朝下的凹口，該等凹口由各該彈性片的底部朝頂部凹設。
  4. 如請求項1所述的植針模組，其中，該植針輔助座的每一彈性片具有二凹口，該等凹口分別設於該彈性片的頂部與底部。
  5. 如請求項1所述的植針模組，其中，該主體件的滑槽數量為兩個，該植針輔助座的彈性片數量為兩個。
  6. 如請求項1所述的植針模組，其中，該主體件的滑槽數量為三個，該植針輔助座的彈性片數量為三個。
  7. 如請求項1所述的植針模組，其中，該主體件的該等滑槽圍繞該軸線呈間隔設置，該植針輔助座的該等彈性片圍繞該軸線呈間隔設置。
  8. 如請求項1所述的植針模組，其中，各該滑槽之該壁面係沿植入方向漸寬之壁面。
  9. 如請求項8所述的植針模組，其中，各該滑槽之該壁面相對於該軸線的斜度介於0度至3度之間。
  10. 如請求項1所述的植針模組，其中，該植針組件的植針初始行程不大於1mm。
  11. 一種植入裝置，包含： 一致動模組，包括一內襯、一設置於該內襯內部的主體蓋、一連接於該主體蓋的植入座、一彈抵於該主體蓋與該植入座之間的第一彈性件、一設置於該主體蓋與該植入座之間的抽針座、一彈抵於該抽針座與該植入座之間的第二彈性件；及 一植針模組，組裝配合於該致動模組，用於確保植針植入皮膚前之植針初始行程順暢，該植針模組包含： 一主體件，包括一沿一軸線設置的容置孔，以及多數圍繞該軸線且位於該容置孔外側且與該容置孔互相連通的滑槽； 一植針輔助座，包括一座體，以及複數連接於該座體且具彈性的彈性片，該座體可沿該容置孔滑動，該等彈性片可沿所對應的滑槽滑動，其中各該彈性片具有一凸出部； 一植針組件，包括一植針座，以及一連接於該植針座的植針，該植針座安裝於該座體，未植針前，該植針之一尖端與皮膚間之距離定義為植針初始行程；及 一感測器組件，包括一固定座，以及一安裝於該固定座的感測器，其中該固定座係設置於該植針輔助座之該座體上，且該植針係穿設於該固定座並包覆該感測器； 其中，各該滑槽具有一壁面，各該彈性片的凸出部彈性抵接且呈點接觸於各該壁面；藉此，該植針輔助座於植入前透過各該凸出部與各該滑槽的壁面的干涉配合而限位固定，使植針穩定，以避免該植針於該植針初始行程產生偏心。
  12. 如請求項11所述的植入裝置，其中，該植針輔助座的每一彈性片具有至少一開口朝上的凹口，該等凹口由各該彈性片的頂部朝底部凹設。
  13. 如請求項11所述的植入裝置，其中，該植針輔助座的每一彈性片具有至少一開口朝下的凹口，該等凹口由各該彈性片的底部朝頂部凹設。
  14. 如請求項11所述的植入裝置，其中，該植針輔助座的每一彈性片具有二凹口，該等凹口分別設於該彈性片的頂部與底部。
  15. 如請求項11所述的植入裝置，其中，該主體件的滑槽數量為兩個，該植針輔助座的彈性片數量為兩個。
  16. 如請求項11所述的植入裝置，其中，該主體件的滑槽數量為三個，該植針輔助座的彈性片數量為三個。
  17. 如請求項11所述的植入裝置，其中，該主體件的該等滑槽圍繞該軸線呈間隔設置，該植針輔助座的該等彈性片圍繞該軸線呈間隔設置。
  18. 如請求項11所述的植入裝置，其中，各該滑槽之該壁面係沿植入方向漸寬之壁面。
  19. 如請求項18所述的植入裝置，其中，各該滑槽之該壁面相對於該軸線的斜度介於0度至3度之間。
  20. 如請求項11所述的植入裝置，其中，該植針組件的植針初始行程不大於1mm。
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