TWI653069B - 活塞桿以及包含活塞桿的藥物輸送裝置 - Google Patents
活塞桿以及包含活塞桿的藥物輸送裝置 Download PDFInfo
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- TWI653069B TWI653069B TW103107805A TW103107805A TWI653069B TW I653069 B TWI653069 B TW I653069B TW 103107805 A TW103107805 A TW 103107805A TW 103107805 A TW103107805 A TW 103107805A TW I653069 B TWI653069 B TW I653069B
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- piston rod
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- A61M5/178—Syringes
- A61M5/31—Details
- 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
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M5/31515—Connection of piston with piston rod
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- A—HUMAN NECESSITIES
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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
- A61M5/178—Syringes
- A61M5/31—Details
- 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
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
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- A—HUMAN NECESSITIES
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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
- A61M5/178—Syringes
- A61M5/31—Details
- 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
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61M5/178—Syringes
- A61M5/31—Details
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61M5/178—Syringes
- A61M5/31—Details
- 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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
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Abstract
該軸承組件(1)包括在一周邊(3)內的一接觸面(2),其係包圍一中心(4),以及配置於該周邊內的一耦合特徵用以可旋轉地接合一活塞桿中垂直於該接觸面的一組件。該耦合特徵包括由該周邊向該中心延伸的至少一撓性特徵(8),以及該撓性特徵經配置成藉由在朝向該接觸面之一方向施加於該撓性特徵上的一力可向該周邊偏斜以及藉由在相反方向施加於該撓性特徵上的一力可向該中心偏斜。該撓性特徵可具有促進組裝以及與該活塞桿之另一組件結合防止分解的一斜面(9)。該活塞桿之該組件可為導螺桿,以及該活塞桿可用於藥物輸送裝置。
Description
本發明係一種用於藥物輸送裝置的活塞桿之軸承組件,且包含該軸承組件的活塞桿及藥物輸送裝置。
藥物輸送裝置,特別是筆型注射裝置,包括用來由容器(例如,藥物匣盒)射出藥物劑量以及裝設成為藥物匣盒之一部份的塞子。該塞子係用活塞桿驅動,它可設有用於設定劑量以及用於推進活塞桿以輸送設定劑量的機構。在一些筆型注射裝置中,該活塞桿包括在劑量分配期間推進時旋轉的一導螺桿(lead screw)。由於最好避免該塞子旋轉,因此該活塞桿對於塞子在分配期間會有相對旋轉。在此情形下,活塞桿與塞子直接接觸可能產生大磨擦損耗以及需要相當強的驅動力。用適當的軸承可避免此一缺點。此外,最好讓塞子與活塞桿的接觸面積儘可能大,因為小接觸區或點接觸容易導致塞子在分配期間變形,因而減少劑量準確度。因此,在活塞桿與塞子之間配置一軸承組件為較佳。可形成與塞子之大表面區接
合以及只與與活塞桿之小表面區接觸的軸承組件,以便促進活塞桿之組件(例如,導螺桿)與軸承組件的相對旋轉。該軸承組件必須能夠以相對低的組裝力組裝至導螺桿以及沒有損壞組件的風險。該軸承組件在組裝後或在裝置的使用壽命期間必須不會脫落導螺桿,因為這可能導致劑量不準確。該等軸承特徵必須足夠強健以抵擋自動組裝及散裝的嚴苛。
美國專利第US 2007/0093761 A1號揭示一種適用於藥物輸送裝置的驅動機構,其係包括活塞桿及包圍該活塞桿大體呈柱形的驅動套筒。該活塞桿的螺紋經設計成可在沿著驅動套筒內表面延伸的螺旋凹槽內工作。該活塞桿的另一螺紋延伸穿過插件的帶螺紋開口。該驅動套筒的軸向運動造成活塞桿根據該插件的螺紋來旋轉,從而推進該活塞桿因而驅動匣盒中的活塞。用抵接匣盒活塞的壓力腳(pressure foot)裝設軸承於該活塞桿上。
本發明的目標是要減少用於藥物輸送裝置的轉動活塞桿與塞子之間的磨擦損耗。
達成此目標是用如申請專利範圍第1項所述之軸承組件,如申請專利範圍第8項所述包括軸承組件之活塞桿以及如申請專利範圍第12項所述之藥物輸送裝置。其他具體實施例來自附屬項。
在一型態中,本發明係有關於一種用於藥物輸送裝置
的活塞桿之軸承組件。該軸承組件包括一接觸面,包圍一中心的一周邊,以及配置於該周邊內的一耦合特徵用以可旋轉地接合一活塞桿中垂直於該接觸面的一組件。該耦合特徵包括由該周邊向該中心延伸的一撓性特徵,以及該撓性特徵經配置成藉由在朝向該接觸面之一方向施加於該撓性特徵上的一力可向該周邊偏斜以及藉由在相反方向施加於該撓性特徵上的一力可向該中心偏斜。可能只有一個撓性元件、兩個撓性元件或兩個以上的撓性元件。
在該軸承組件的一具體實施例中,該撓性特徵有相對於該接觸面傾斜的數個斜面,該等斜面向該中心接近該接觸面。
在另一具體實施例中,該撓性特徵為該軸承組件的一整合部份。
在另一具體實施例中,該撓性特徵由至少一撓性臂、鉤、叉、齒狀物或凸出元件形成。
在另一具體實施例中,該中心包括一開口,以及該撓性特徵限制該開口。
在另一具體實施例中,該開口在該撓性特徵向該周邊偏斜時擴大。
在另一具體實施例中,該撓性特徵經配置成該軸承組件對於該中心有180度旋轉對稱性。
在另一型態,本發明係有關於一種包含該軸承組件的活塞桿。
在該活塞桿的一具體實施例中,該活塞桿中被該撓性特徵可旋轉地接合的該組件為一導螺桿。
在該活塞桿的另一具體實施例中,該活塞桿中被該撓
性特徵可旋轉地接合的該組件包括有一懸伸凸緣(overhanging flange)的一耦合器(coupler),以及該軸承組件在該撓性特徵堵塞該凸緣下接合該耦合器。
在該活塞桿的另一具體實施例中,該活塞桿中被該撓性特徵可旋轉地接合的該組件至少在該軸承組件之該周邊附近的一接觸區接觸該軸承組件。
在另一型態,本發明係有關於一種包含該軸承組件的藥物輸送裝置,該軸承組件可安裝至一活塞桿的一組件。該藥物輸送裝置可為注射裝置、筆型裝置,特別是,筆型注射裝置。
如本文所使用的,用語“藥物”係指包含至少一醫學上活性化合物的醫藥配方,其中,在一具體實施例中,該醫學上活性化合物有達1500Da的分子量及/或為縮氨酸(peptide)、蛋白質、多醣(polysaccharide)、疫苗、DNA、RNA、酶、抗體或其片段、荷爾蒙或寡核苷酸(oligonucleotide)、或上述醫學上活性化合物的混合物,其中,在另一具體實施例中,該醫學上活性化合物適於治療及/或預防糖尿病或與糖尿病有關的併發症,例如糖尿病性視網膜病變(diabetic retinopathy),血栓栓塞症(thromboembolism disorders),例如深靜脈或肺血栓栓塞(pulmonary thromboembolism)、急性冠狀動脈綜合症(acute coronary syndrome,ACS)、心絞痛(angina)、心肌梗塞(myocardial infarction)、癌症、黃斑部病變(macular degeneration)、發炎,花粉過敏,動脈粥樣硬化(atherosclerosis)及/或類風濕關節炎(rheumatoid arthritis),其中,在另一具體實施例中,該醫學上活性化合物包
含用於治療及/或預防糖尿病或與糖尿病有關之併發症(例如,糖尿病性視網膜病變)的至少一縮氨酸,其中,在又一具體實施例中,該醫學上活性化合物包含至少一人類胰島素(human insulin)或人類胰島素類似物或衍生物,胰高血糖素樣縮氨酸(glucagon-like peptide,GLP-1)或彼等之類似物或衍生物,或促胰島素分泌肽-3(exendin-3)或促胰島素分泌肽(exendin-4)或促胰島素分泌肽-3或促胰島素分泌肽-4的類似物或衍生物。
胰島素類似物的例子有:Gly(A21)、Arg(B31)、Arg(B32)人類胰島素;Lys(B3)、Glu(B29)人類胰島素;Lys(B28)、Pro(B29)人類胰島素;Asp(B28)人類胰島素;人類胰島素,其中用Asp、Lys、Leu、Val或Ala取代在B28位的脯胺酸(proline),以及其中可用Pro取代在B29位的Lys;Ala(B26)人類胰島素;Des(B28-B30)人類胰島素;Des(B27)人類胰島素;以及Des(B30)人類胰島素。
胰島素衍生物的例子有:B29-N-肉豆蔻醯基-des(B30)人類胰島素;B29-N-棕櫚醯基-des(B30)人類胰島素;B29-N-肉豆蔻醯基人類胰島素;B29-N-棕櫚醯基人類胰島素;B28-N-肉豆蔻醯基LysB28ProB29人類胰島素;B28-N-棕櫚醯基-LysB28ProB29人類胰島素;B30-N-肉豆蔻醯基-ThrB29LysB30人類胰島素;B30-N-棕櫚醯基-ThrB29LysB30人類胰島素;B29-N-(N-棕櫚醯基-Y-麩胺醯基)-des(B30)人類胰島素;B29-N-(N-石膽基-Y-麩胺醯基)-des(B30)人類胰島素;B29-N-((ω-羧基十七醯基)-des(B30)人類胰島素;以及B29-N-(ω-羧基十七醯基)人類胰島素。
促胰島素分泌肽-4(Exendin-4)例如意指促胰島素分泌
肽-4(1-39)、有如下順序的縮氨酸:氫基-組胺酸-甘胺酸-穀胺酸-甘胺酸-酪胺酸-苯丙胺酸-酪胺酸-絲胺酸-天冬胺酸-亮胺酸-絲胺酸-賴胺酸-穀胺醯胺-蛋胺酸-穀胺酸-穀胺酸-穀胺酸-丙胺酸-纈胺酸-精胺酸-亮胺酸-苯丙胺酸-異白胺酸-穀胺酸-色胺酸-亮胺酸-賴胺酸-天冬胺醯胺-甘胺酸-甘胺酸-脯胺酸-絲胺酸-絲胺酸-甘胺酸-丙胺酸-脯胺酸-脯胺酸-脯胺酸-絲胺酸-胺基(H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2)。
促胰島素分泌肽-4衍生物為例如由下列清單選出的化合物:氫基-(賴胺酸)4-des脯胺酸36,des脯胺酸37促胰島素分泌肽-4(1-39)-胺基(H-(Lys)4-des Pro36,des Pro37 Exendin-4(1-39)-NH2)、氫基-(賴胺酸)5-des脯胺酸36,des脯胺酸37促胰島素分泌肽-4(1-39)-胺基(H-(Lys)5-des Pro36,des Pro37 Exendin-4(1-39)-NH2)、des脯胺酸36促胰島素分泌肽-4(1-39)(des Pro36 Exendin-4(1-39))、des脯胺酸36[天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Asp28]Exendin-4(1-39))、des脯胺酸36[異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[IsoAsp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽
-4(1-39)(des Pro36[Met(O)14,Asp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14,異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39))、des脯胺酸36[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39))、des脯胺酸36[色胺酸(二氧基)25,異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14色胺酸(二氧基)25,異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39));或des脯胺酸36[天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Asp28]Exendin-4(1-39))、des脯胺酸36[異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[IsoAsp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14,Asp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14,異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39))、des脯胺酸36[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39))、des脯胺酸36[色胺酸(二氧基)25,異天冬胺酸28]促胰島素分泌肽
-4(1-39)(des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39))、des脯胺酸36[蛋胺酸(氧基)14色胺酸(二氧基)25,異天冬胺酸28]促胰島素分泌肽-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39)),其中-賴胺酸6-胺基(-Lys6-NH2)群可鍵結至促胰島素分泌肽-4衍生物的C端;或有下列順序的促胰島素分泌肽-4衍生物:des脯胺酸36促胰島素分泌肽-4(1-39)-賴胺酸6-胺基(AVE0010)(des Pro36 Exendin-4(1-39)-Lys6-NH2(AVE0010))、分泌肽-4(1-39)-賴胺酸6-胺基(H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2)、des天冬胺酸28脯胺酸36,脯胺酸37,脯胺酸38促胰島素分泌肽-4(1-39)-胺基(des Asp28 Pro36,Pro37,Pro38Exendin-4(1-39)-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸38[天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-(Lys)6-des Pro36,Pro38[Asp28]Exendin-4(1-39)-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2)、des脯胺酸36,脯胺酸37,脯胺酸38[天冬胺酸28]促胰島素分泌肽
-4(1-39)-(賴胺酸)6-胺基(des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-賴胺酸6-胺基(H-(Lys)6-des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2)、氫基-des天冬胺酸28脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25]促胰島素分泌肽-4(1-39)-胺基(H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2)、氫基-天冬胺酸-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2)、des脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(des Pro36,Pro37,
Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-天冬胺酸-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-賴胺酸6-胺基(H-(Lys)6-des Pro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2)、des蛋胺酸(氧基)14天冬胺酸28脯胺酸36,脯胺酸37,脯胺酸38促胰島素分泌肽-4(1-39)-胺基(des Met(O)14 Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2)、des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(des Pro36,Pro37,
Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-Asn-(Glu)5 des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-賴胺酸6-des脯胺酸36[蛋胺酸(氧基)14,色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-賴胺酸6-胺基(H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2)、氫基-des天冬胺酸28脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,色胺酸(二氧基)25]促胰島素分泌肽-4(1-39)-胺基(H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2)、des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(des
Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2)、氫基-(賴胺酸)6-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(S1-39)-(賴胺酸)6-胺基(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2)、氫基-天冬胺醯胺-(穀胺酸)5-des脯胺酸36,脯胺酸37,脯胺酸38[蛋胺酸(氧基)14,色胺酸(二氧基)25,天冬胺酸28]促胰島素分泌肽-4(1-39)-(賴胺酸)6-胺基(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2);或前述促胰島素分泌肽-4衍生物中之任一的醫藥上可接受鹽或溶劑合物(solvate)。
荷爾蒙的例子有:垂體荷爾蒙或下丘腦荷爾蒙或調節性活性縮氨酸以及如列於Rote Liste(2008版)第50章的拮抗物,例如促性腺激素(Gonadotropine)(促濾泡素(Follitropin)、促黃體素(Lutropin)、絨毛膜性腺激素(Choriongonadotropin)、促月經素(Menotropin)),生長激素(Somatropine,Somatropin),去氨加壓素(Desmopressin),特利加壓素(Terlipressin),人工促性腺素戈那瑞林(Gonadorelin),人工促性腺素曲普瑞林(Triptorelin),人工促性線素亮丙瑞林(Leuprorelin),噴鼻劑布舍瑞林(B使用者elin),促性腺素拮抗劑那法瑞林(Nafarelin),人工促黃體素戈舍瑞林(Goserelin)。
多醣的例子為糖胺聚糖(glucosaminoglycane),例如玻尿酸(hyaluronic acid)、肝素(heparin)、低分子量肝素或超低分子量肝素或其衍生物,或上述多醣的硫酸化型(例如,聚硫酸化型),及/
或其醫藥上可接受鹽。聚硫酸化低分子量肝素的醫藥上可接受鹽例如為依諾肝素鈉(enoxaparin sodium)。
抗體為球狀血漿蛋白質(globular plasma protein)(約150kDa),也習稱共享基本結構的免疫球蛋白(immunoglobulin)。由於它們有加至胺基酸殘基的糖鏈,它們為醣蛋白。每個抗體的基本功能單元為免疫球蛋白(Ig)單體(只有一個Ig單元);分泌抗體也可為有兩個Ig單元而與IgA一樣的雙體(dimeric),有4個Ig單元的四體(tetrameric),例如硬骨魚類IgM,或有5個Ig單元的五體(pentameric),例如哺乳動物IgM。
Ig單體為由4個聚縮氨酸鏈組成的“Y”形分子;用在半胱胺酸殘基(cysteine residue)間之二硫鍵(disulfide bond)連接的兩個相同重鏈(heavy chain)與兩個相同輕鏈(light chain)。每個重鏈約有440個胺基酸長;每個輕鏈約有220個胺基酸長。重鏈及輕鏈各自含有使其折疊穩定的鏈內二硫鍵。每個鏈由稱作Ig域的結構域構成。該等域含有約70至110個胺基酸以及根據它們的大小及功能分成數類(例如,可變或V,以及恆定或C)。它們有性狀免疫球蛋白折疊,其中兩個β摺板(β sheet)產生“三明治”形狀,其係藉由保持半胱胺酸與其他帶電胺基酸(charged amino acid)的相互作用而固定在一起。
有5種用α,δ,ε,γ及μ表示的哺乳動物Ig重鏈。重鏈的類型定義抗體的同型(isotype);這些鏈分別在IgA、IgD、IgE、IgG及IgM抗體中找到。
不同重鏈的差別在大小及組合物;α與γ含有約450個胺基酸,以及δ約有500個胺基酸,而μ與ε約有550個胺基酸。
每個重鏈有兩個區,即恆定區(CH)與可變區(VH)。在一物種中,恆定區在所有同型相同的抗體中實質相同,但是在有不同同型的抗體中不同。重鏈γ、α及δ有由3個串聯Ig域構成的恆定區,以及用於增加彈性的鉸鏈區(hinge region);重鏈μ及ε有由4個免疫球蛋白域構成的恆定區。該重鏈的可變區不同於由不同B細胞產生的抗體,但是與由單一B細胞或B細胞株(B cell clone)產生的所有抗體相同。每個重鏈的可變區約有110個胺基酸長以及由單一Ig域構成。
在哺乳動物中,有兩種以λ及κ表示的免疫球蛋白輕鏈。輕鏈有兩個連續域:一個為恆定域(CL)與一個為可變域(VL)。輕鏈的約略長度為211至217個胺基酸。每個抗體含有永遠相同的兩個輕鏈;在哺乳動物的每個抗體中只有一種輕鏈,κ或λ。
雖然所有抗體的一般結構極為類似,給定抗體的獨特性質是由可變(V)區決定,如上述。更特別的是,各有3個輕鏈(VL)及3個重鏈(VH)的可變環負責抗原的結合,亦即,它的抗原特異性(antigen specificity)。這些環被稱作互補決定區(CDR)。因為源於VH及VL域的CDR有助於抗原結合位(antigen-binding site),最終抗原特異性是由重鏈與輕鏈的組合決定,而不是其中之任一單獨決定。
如以上所定義,“抗體片段”含有至少一抗原結合片段,而且與由該片段衍生的完整抗體有實質一樣的功能及特異性。木瓜蛋白酶的有限酵素分解(proteolytic digestion)把Ig原型劈分成3個片段。兩個相同的胺基端片段,各自含有一條整個L鏈與大約半條的H鏈,為抗原結合片段(Fab)。第三片段,大小類似但是含有這兩個重鏈中有鏈間二硫鍵的羧基端半部,為可結晶片段(Fc)。該Fc含有
醣類、補體結合及FcR結合位。有限的胃蛋白分解(pepsin digestion)產生含有Fab碎片及鉸鏈區的單一F(ab')2片段,包括H-H鏈間二硫鍵。F(ab')2為抗原結合的二價物(divalent)。可劈分F(ab')2的二硫鍵以便得到Fab'。此外,可融合重鏈及輕鏈的可變區以形成單鏈可變片段(scFv)。
醫藥上可接受之鹽類的例子為酸加成鹽以及鹼鹽。酸加成鹽的例子為氫氯酸鹽或氫溴酸鹽。鹼鹽類的例子為含有一陽離子的鹽類,其中之陽離子係從以下之鹼金族或鹼土族離子中選出,例如鈉離子或鉀離子或鈣離子,或銨離子N+(R1)(R2)(R3)(R4),其中之R1到R4係各自獨立,意指:氫、視需要經取代之C1-C6烷基、視需要經取代之C2-C6烯基、視需要經取代之C6-C10芳基、或視需要經取代之C6-C10雜芳基。醫藥上可接受的其他鹽類範例可參見第十七版的“Remington’s Pharmaceutical Sciences”(1985)(作者:Alfonso R。Gennaro,出版社:美國賓州之Mark Publishing Company,Easton),以及藥理學百科大全(Encyclopedia of Pharmaceutical Technology)。
醫藥上可接受之溶劑合物的例子為水合物。
1‧‧‧軸承組件
2‧‧‧接觸面
3‧‧‧周邊
4‧‧‧中心
5‧‧‧耦合特徵
6‧‧‧活塞桿的組件
7‧‧‧活塞桿
8‧‧‧撓性特徵
9‧‧‧斜面
10‧‧‧開口
11‧‧‧耦合器
12‧‧‧凸緣
13‧‧‧接觸區
14‧‧‧外環
15‧‧‧塞子
16‧‧‧匣盒
17‧‧‧螺紋
以下結合附圖詳述軸承組件及包括該軸承組件之活塞桿的具體實施例。
圖1的上視圖圖示軸承組件之一具體實施例。
圖2為圖1之具體實施例的橫截面圖。
圖3圖示組裝期間包括該軸承組件的活塞桿。
圖4圖示組裝後的圖3活塞桿。
圖5圖示經受分解力的圖4活塞桿。
圖1以上視圖圖示軸承組件之一具體實施例。軸承組件1可具有大體為圓形的形狀,特別是在軸承組件1意欲用於筆型藥物輸送裝置時。至少一撓性特徵8由周邊3延伸至中心4以及形成用來扣緊活塞桿之另一組件的耦合特徵5。在圖1的具體實施例中,耦合特徵5由兩個撓性特徵8形成,其係以相對於該中心4有180度旋轉的旋轉對稱性的方式配置。可輕易地以較低的成本製成像這樣的軸承1。這兩個撓性特徵8各自覆蓋約120°至160°的角度,約150°為較佳。雖然各個撓性特徵8有在組裝期間可充分彈性活動的撓性,然而撓性特徵8在開口10四周的內緣提供抵抗扭曲的穩定性。該穩定性隨著覆蓋角度而增加。此穩定性有助於防止軸承組件1相對於活塞桿7之軸線的傾斜。此外,這確保有足夠大的開口10供有懸伸凸緣12的耦合器11穿過。反之,可能只有一個撓性元件8或兩個以上的撓性元件8。不過,抵抗扭曲的穩定性會隨著撓性元件數而降低。耦合特徵5可離開軸承組件1中心4的開口10。在此情形下,開口10至少部份被耦合特徵5限制。
圖2圖示圖1之具體實施例的橫截面。橫截面的平面垂直於圖1的上視圖。軸承組件1最好包括形成周邊3以及提供軸承組件1之機械穩定性的實心外環14。提供軸承組件1的接觸面2以推頂塞子的對應表面。接觸面2可在外環14的正面上。在周邊3有接觸區13,它可部份覆蓋外環14,撓性特徵8或外環14及撓性特徵8兩者。
此具體實施例的撓性特徵8有相對於接觸面2之平面呈傾斜的斜面9。斜面9向中心4接近接觸面2,使得耦合特徵5
向接觸面2的平面變窄。撓性特徵8可為由周邊3向中心4延伸的撓性臂、鉤、叉、齒狀物或任何其他凸出元件。撓性特徵8最好與軸承組件1整合。斜面9有促進活塞桿之組裝的優點,這由以下說明可明白。
圖3圖示包含軸承組件1及另一組件6的活塞桿7,其係處於正在組裝的狀態。軸承組件1以圖2的橫截面圖示,而該另一組件6以透視圖圖示。例如,該另一組件6可為有螺紋17的導螺桿。螺紋17在驅動機構中可用來推進活塞桿7。該另一組件6相對於軸承組件1沿著在圖3中指向下面的垂直箭頭方向移動。該另一組件6面向軸承組件1的末端包括可類似如插頭(spigot)或針栓(pintle)的耦合器11。耦合器11最好設有一懸伸凸緣12。當該另一組件6被引進軸承組件1的開口10時,耦合器11對撓性特徵8的斜面9施力,如圖3的斜箭頭所示。撓性特徵8因此被徑向向外推,以及開口10充分變寬讓耦合器11通過撓性特徵8的邊緣。
圖4圖示組裝之後的活塞桿7。凸緣12已移到撓性特徵8的邊緣外,撓性特徵8已放鬆回到原始位置以及藉由堵塞凸緣12來軸向鎖定該另一組件6。可使軸承組件1與藥物匣盒16的塞子15接觸。當該另一組件6旋轉時,耦合器11在軸承組件1內可輕易旋轉,同時軸承組件1及塞子15彼此不相互旋轉。接觸區13從而活塞桿7的組件1、6之間的磨擦相對小。如果也用直接在塞子15上的凸緣12施加推進活塞桿7的力,可進一步減少該磨擦,使得外圍接觸區13上的壓力從而減少由該另一組件6施加至軸承組件1的力矩。反之,凸緣12可與塞子15保持一段距離。接觸面2可在外環14面向塞子15的正面上。
撓性特徵8最好配置在軸承組件1的外環14內。外環14保護撓性特徵8不受害於裝置經受衝擊或振動時可能出現的側面負荷(side load)或不受害於組件的直接負載,這可能在自動組裝期間或散裝運輸情形下發生。當活塞桿7在分配期間推向塞子15以及軸承組件1處於壓縮時,沒有負荷作用於撓性特徵8,使得組件1、6牢牢地保持耦合。
如圖4所示,頂著軸承組件1外環14上的接觸區13推動活塞桿7的主要組件6。接觸區13小到足以使活塞桿7之組件1、6之間的磨擦保持在低位準從而施加至軸承組件1的力矩保持在容許極限內。在活塞桿於操作期間會旋轉的情形下,磨擦減少特別有利。使用低磨擦聚合物可進一步減少磨擦。接觸區13向活塞桿的軸線傾斜以及適合主要組件6之對應接觸面的形狀。接觸區13防止軸承組件1在推進時對於活塞桿7之軸線的傾斜,例如在組裝期間及/或在分配操作期間。此外,傾斜接觸面13有助於與活塞桿之軸線成及/或保持一直線地引導軸承組件1。在轉動活塞桿7的情形下,這特別有利。凸緣12與塞子15保持一段距離以及在外環14面向塞子15的正面上有接觸面2。驅動活塞桿7的力因而經由軸承組件1轉移到塞子15,特別是接觸面2。因此,活塞桿7可自由旋轉同時它的推力經由軸承1的接觸面2轉移到塞子15。因此,如果活塞桿在操作期間旋轉時,此具體實施例為較佳。
圖5圖示如何防止活塞桿7分解。如果軸向力對於軸承組件1在用圖5之垂直箭頭指出的方向施加至該另一組件6,組件1、6會稍微分離。由於有此一分離力的作用,以及凸緣12與接觸區2平面的距離增加,圖5圖示軸承組件1上的接觸區13不再被
該另一組件6覆蓋。在此情形下,撓性特徵8接合耦合器11的凸緣12。如果撓性特徵8有如同上述具體實施例的傾斜形狀,與凸緣12有此接合迫使撓性特徵8向內變形以及掘入耦合器11。這防止活塞桿7的組件1、6分解,除非有不尋常的外加大力。
Claims (14)
- 一種活塞桿(7)包括一導螺桿以及一軸承組件(1),其中該軸承組件(1)包括:一接觸面(2),一包圍一中心(4)的周邊(3),以及一配置於該周邊(3)內的耦合特徵(5),用以可旋轉地接合垂直於該接觸面(2)的導螺桿,其中該耦合特徵(5)包括一由該周邊(3)向該中心(4)延伸的撓性特徵(8),以及該撓性特徵(8)經配置成藉由在朝向該接觸面(2)之一方向施加於該撓性特徵(8)上的一力可向該周邊(3)偏斜以及藉由在相反方向施加於該撓性特徵(8)上的一力可向該中心(4)偏斜,其中該導螺桿至少在該軸承組件(1)之該周邊(3)附近的一接觸區(13)接觸該軸承組件(1)。
- 如申請專利範圍第1項所述之活塞桿(7),其中該撓性特徵(8)有相對於該接觸面(2)傾斜的數個斜面(9),該等斜面(9)向該中心(4)接近該接觸面(2)。
- 如申請專利範圍第1項或第2項所述之活塞桿(7),其中該撓性特徵(8)為該軸承組件(1)的一整合部份。
- 如申請專利範圍第1項所述的活塞桿(7),其中該撓性特徵(8)由至少一撓性臂、鉤、叉、齒狀物或凸出元件形成。
- 如申請專利範圍第1項所述之活塞桿(7),其中 該中心(4)包括一開口(10),以及該撓性特徵(8)限制該開口(10)。
- 如申請專利範圍第5項所述之活塞桿(7),其中該開口(10)在該撓性特徵(8)向該周邊(3)偏斜時擴大。
- 如申請專利範圍第1項所述之活塞桿(7),其中該撓性特徵(8)經配置成該軸承組件(1)相對於該中心(4)有180度旋轉對稱性。
- 如申請專利範圍第1項所述之活塞桿(7),其中該導螺桿包括有一懸伸凸緣(12)的一耦合器(11),以及該軸承組件(1)在該撓性特徵(8)堵塞該凸緣(12)下接合該耦合器(11)。
- 如申請專利範圍第1項所述之活塞桿(7),其中該接觸區(13)朝向該活塞桿(7)的一軸線傾斜。
- 如申請專利範圍第1項所述之活塞桿(7),其中該接觸區(13)適合該導螺桿之對應接觸面的一形狀。
- 一種藥物輸送裝置,其係包括如申請專利範圍第1項至第10項中之任一項所述之一活塞桿(7)。
- 如申請專利範圍第11項所述之藥物輸送裝置,其中該軸承組件(1)安裝至該導螺桿。
- 如申請專利範圍第11項或第12項所述之藥物輸送裝置,該藥物輸送裝置為一注射裝置。
- 如申請專利範圍第11項所述之藥物輸送裝置,該藥物輸送裝置為一筆型裝置。
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Also Published As
Publication number | Publication date |
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CN105025962B (zh) | 2019-04-19 |
WO2014139913A1 (en) | 2014-09-18 |
JP6541579B2 (ja) | 2019-07-10 |
RU2665028C2 (ru) | 2018-08-24 |
IL240301B (en) | 2019-09-26 |
RU2015143043A (ru) | 2017-04-18 |
KR20150126834A (ko) | 2015-11-13 |
HK1213504A1 (zh) | 2016-07-08 |
DK2968782T3 (en) | 2018-08-06 |
RU2015143043A3 (zh) | 2018-02-28 |
EP2968782A1 (en) | 2016-01-20 |
BR112015018944B1 (pt) | 2021-11-23 |
AU2014230959A1 (en) | 2015-09-24 |
KR102293641B1 (ko) | 2021-08-24 |
ES2681421T3 (es) | 2018-09-13 |
MX2015011824A (es) | 2016-01-25 |
AU2014230959B2 (en) | 2018-01-18 |
HUE039598T2 (hu) | 2019-01-28 |
EP2968782B1 (en) | 2018-04-25 |
PL2968782T3 (pl) | 2018-09-28 |
AR095181A1 (es) | 2015-09-30 |
IL240301A0 (en) | 2015-09-24 |
US11213628B2 (en) | 2022-01-04 |
CN105025962A (zh) | 2015-11-04 |
JP2016513506A (ja) | 2016-05-16 |
TW201509467A (zh) | 2015-03-16 |
US20160015901A1 (en) | 2016-01-21 |
BR112015018944A2 (pt) | 2017-07-18 |
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