201242582 六、發明說明： 【發明所屬之技術領域】 本發明係有關於植入器具、系統及套組，具體言 之’係有關於用於淚管植入物之植入器具、系統及套組。 【先前技術】 乾眼症為眼科醫師最常診療的疾病之一。咸信超過 :::美國人患有此病況’其通常為滑潤眼部的二夜膜 /關問題所造成。眼液係於眼晴周圍數個腺體中所形 係於上眼驗下的淚腺中產生的。其他眼臉中的 脲筱表坆油脂及黏液層。眨眼將眼淚散佈至全 眼淚流入至眼角中的管道内，通過鼻部。 由於老化過程，淚液膜可能會發生問題。舉例而 言，65歲的人在淚液膜產生的油脂少於18歲的人（最 多少^ 6〇%)。淚賴油職少會使财的水分較快蒸 發，使角膜乾燥。 •寸於不適&使用人工淚液及軟膏 度乾眼症狀:使驗塞錄錢至好可為 ::由以一種稱為淚管或淚點塞的栓塞阻塞此 :二存於眼部較久的時間。淚管塞已顯示能 病患的舒適程度增加並降低人工淚液使 用頻率。 已知的淚點塞通常配置為圓柱形體形式，具有自栓 塞-収伸之盲孔’以以在—插人工具之插入桿上， 舉例而"係如美國專利第5,741，292、5,643,280、 201242582 6,344,047、6,527,780 及 5,335,871 號所示。在插入該栓 塞至淚管中時，該插入桿係用以自該工具釋放該栓塞。 當該栓塞可使用作為控制眼淚流出的技術時，同時 常會施予活性劑至眼部，用於治療眼部疾病或失調。在 美國專利公開第20070299516號中顯示並說明數種淚 點塞實例，其在此藉由引用併入於本專利申請說明書 中。在此栓塞之至少一實例中，一活性劑裝入至此栓塞 之盲孔内。 【發明内容】 利用該活性劑併以淚點塞，針對在治療乾眼症及其 他相關眼部失調的獲得較大療效’需要有效插入工具* 而現有工具係不易使用或效能有限。 因此，本發明之一態樣係一用於植入無盲孔淚點塞 之插入器具，包括裝以一或多種活性劑於盲孔通常會形 成之位置的栓塞。 在另一態樣中，係提供一插入器具。在另一態樣 中，係顯示並說明用於一淚管插入器具之一蓋帽。在一 進一步之態樣中，係提供包括該器具及該蓋帽之淚點塞 插入系統。 在又一態樣中，係提供一種自一栓塞夾持具釋放一 淚點塞之方法。 此外，係提供一種含該栓塞插入器具、蓋帽、栓塞 及使用說明之套組。 【實施方式】 ⑧ 4 201242582 詳細說明麵舉例說明㈣㈣本發明 文中所使用的術語「淚管塞」指一種大小與形狀、二里。本 由上或下淚點而插入眼部的上或下之 1於經 外，針對任何數值或範圍之「大约」或「的裝置。另 指-適當的尺寸容差，其使組件之部分或集^ Η係 :所，之預期目的運作。此外，如本文所述:術 Π」'「使用者以「對象」係指“ 物對象，且並無限制該緒及方法供人類使用之专， 使係將本發日賴於人類病患作為—較佳實關。思Ρ 此文件的揭露部分含經著作權保〜 所有人保留這些部分的所有著作權，包括 所述之使用說明。 个丨民於本文 參照圖1Α ’係顯不輸送或插入淚點塞18 縱轴L_L之透視圖。該系統⑽包括-插:工 八〜具102 ’其包括||具本體刚。該器具本體舰 ::==!最接近持握以使用該器具102 运端107 (即距持握以使用該器 m甘 最遠之末端）。該器具102具有一致動器 〇 ’其設置接近遠端107處。該致動$ 11〇以按紐形 ’可連接至-致動構件112，其經配置以透過—器具本 體中提供之主體開π 114沿縱轴L_L移動。該致動構件 112可以任何組㈣成’只要此組態能使該致動構件⑴ 主體開口 114中沿縱轴a往復運動。較佳的是，該 致動構件112係配置為—大致為Ϊ柱之桿。該致動構件 112經由一臂116連接至該致動$ 11〇，該臂與該縱轴 L-L相對成一角度。該臂116經由至少一適合的鉸件1〇5 201242582 與該致動器110結合，例如無偏動鉸件（unbiased hinge)、彈簧偏動鉸件（spring_biasedhinge)或較佳的 是活動鉸件（livinghinge) 105。 雖然圖1A所示之實施例係裝以一鉸件，其他實施 例可如圖3 A、犯、4 a及犯所示敦以二或多個錢件二 在此實施例的近端106，可提供一擴張構件1〇8以協助 於插入或植入淚點塞180前擴張淚管。該擴張 可為一直徑範圍約15 mm至約之圓錐 (conical taper)。貼附於擴張構件1〇8之軸— 範圍約（Mem至約〇.8cm且長度約1〇酿至約 =直住 之圓柱形軸。該擴張構件1〇8可經由一1^ 接至該致㈣件提㈣ = 當偏壓，以維持在未釋放或非致動位置,2 = 的作用的適當勁度模數。舉例而言，勁度 〇.7醒4至約〜’較佳的是約〗·〇 _:至:為4約5 mm4，更佳的是約4.5 mm4。 至約4.5 該器具102包括蓋帽樓體部分ui， 150，其可裝填-如此處圖Π3所示之特 刚。該蓋帽撐體部分lu具有—外樓體表面的=塞 般係與該蓋帽150之内表面⑽互補。該撐體表面^ 可供以-脊部咖，以和一形成於該蓋帽^表 面160的錢觀互鎖。該互鎖將該蓋帽15(^Ϊ 102栓緊。較佳的是，該蓋帽撐體部分⑴ 120供有一環形嵌槽16 、撐體表面 ± 69B以和一形成於該蓋ψ曰ιςίΊ 之内表面160的環形脊169Α互鎖。 +目150 201242582 關於圖asm，該蓋帽15〇在其外表心7可具 有兩β刀。接近第-蓋帽末端152的第—部分形式 可為大致圓柱。第二部分164圍繞且沿縱軸l_l自接近 該第-部们62¾伸至第二蓋帽末端156，以界定為— 二形式的錐形化表面。該内表面160係與蓋帽 Ο之也/面157她’可具有與外表面157通常為相 似之組態，以圍繞且ΆT T ® 、σ縱軸L-L界定一接以中空圓椎之 二j 中空圓柱在接近蓋帽⑼的第一末端152 部分’其朝向縱軸L-L延伸、較佳的是界 定一壤形脊。 中所不’該第—蓋帽末端⑸圍繞且沿縱 ^ 1疋一第一開口 154，且該第二蓋帽末端150圍 繞且沿縱軸“界定-第二開口 158。該第二開口 158 圖1D :’呈配置而與栓塞180的主體182 (圖1E)為 相同大小或較小，因此呈兩半圓或扣件邊（retainer lip ) 174A及174B形式的第二開口 158可抓住栓塞⑽只 有检塞180的頭部184自蓋帽15〇突出。 如圖1C中所不’該第二蓋帽末端156具有-或多 個狹縫170 ’其沿縱軸L_L延伸而使該狹縫⑺提供 一如圖2B及2D戶斤示、介於第二蓋帽末端156的扣件 邊174A及174B間的直徑分離（diametrical separation)。該狹縫17〇提供第二蓋帽末端i56的第一 扣件邊174A及第二扣件邊174B在釋放栓塞則時具 有類似鬱金香方式的外展能力。 〇〇在一替代實施例中，如圖3A所示，該蓋帽150與 器具300、’^合，且指狀物3〇2可加至該扣件邊i74A及 201242582 174B第二開口，以進一步確保蓋帽150上的栓塞180 確實保留住。 蓋帽150目前參照圖1B及1C說明。在圖1B中， 該蓋帽150可視為一加長主體（elongated body )，其沿 縱軸L-L自近端或第一末端152延伸至遠端或第二末端 156。該蓋帽150的第二末端156界定一大於由第二末 端156界定之遠端或第二開口 158的近端或第一蓋帽開 口 154。該第二開口 158可包括至少兩條狹縫170，其 穿過接近遠端107的蓋帽150之壁172延伸，而使淚點 塞180在膨脹遠端開口 158時能通過遠端開口 158。較 佳的是，加長主體之一部分具有一圍繞且沿縱軸L-L設 置之錐形物，以界定為一大致為圓錐形之外表面157。 加長主體的内表面160可與外表面157分隔，以界定一 適當中空表面（例如圓柱形、圓錐形或其組合）。 較佳的是，該内表面160界定為一大致為中空之圓 錐體。在一較佳實施例中，該蓋帽150其外表面157具 有三部分：（1) 一大致平面片（planar tab ) 151，位於 (2) —大致為圓柱形之部分162，其與（3) —大致為 圓椎形之部分164結合。該内表面160界定該對應中空 圓柱形及圓椎形部分。一或多個沿縱軸L-L定向之環形 圈169A (突出或凹槽）可被提供於蓋帽150的内表面 160上，使該環形圈可與在蓋帽撐體部分111上之對應 環形圈（突出或凹槽）169B互鎖。或者，亦可提供旋 轉式外或内螺紋形式的螺旋圈。 鑑於該器具102係可重覆使用，但蓋帽150及栓塞 180亦單次使用組件，因此提供數種特性。可於接近第 ⑧ 201242582 一蓋帽開口 154處形成一封口 200’以確保每當蓋帽150 裝設至該器具102時，有明顯實體指示蓋帽15〇由於致 動器構件112穿過可具密封作用之封口 200因此已炸無 菌狀態。可裝設一分離的致動器桿202，用於與致動構 件112嚅合。該致動器桿202以具有鋸齒狀外表面之桿 2〇2，可供以與蓋帽内表面160接近第二蓋帽開口 158 些許摩擦固定（frictionfit)，當該致動器桿2〇2於使用 中時，另一栓塞180由於鋸齒狀表面（圖中未顯示）之 作用而無法被裝入至該蓋帽15〇内，其可防止桿202朝 向近端106向後移動。 參照圖2A、2B、2C及2D，現在將說明栓塞igo 自蓋帽150的釋放。如圖2A中所示，該栓塞18〇係裝 設至該蓋帽150，該蓋帽150裝設至該器具1〇2，而致 動益110係於圖1A中所示之未釋放或未致動位置。在 此位置，該栓塞18〇係藉由蓋帽15〇第二開口 158的扣 件邊Π4Α及174B (圖2B)保留住。欲釋放栓塞18〇 以進灯預期的使用時’例如用在接受對象的淚管，該按 鍵110 (圖1A)朝縱軸l-L車由向壓緊，其造成該致動器 構件112,經由該鉸件1〇5沿縱車由L_L朝向遠端第二蓋帽 開口 158移動。因為該致動器構# 112、經配置以大於第 7"開口 158’所以扣件邊174A及174B係被用力推進以 j似鬱金香方式朝外軸向移動。當按鍵削係進—步向 ^由L-L下壓時’致動器構件112持續沿縱軸l =端W的移動，使致動器112相對於栓塞則尾部^ 口。此用力推進該检塞⑽至第二開口 158外。當該致 201242582 持續朝遠端方向移動，201242582 VI. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates to implantable devices, systems, and kits, and more particularly to implant devices, systems, and kits for use in lacrimal implants . [Prior Art] Dry eye syndrome is one of the most frequently diagnosed diseases of ophthalmologists. The letter exceeds ::: Americans suffer from this condition. It is usually caused by a two-night membrane/off problem that smoothes the eyes. The eye fluid is formed in several glands around the eye and is formed in the lacrimal gland examined by the upper eye. Urea 筱 in other eye faces, oil and mucus layer. Blink your tears until the whole tears flow into the tube in the corner of the eye, through the nose. The tear film may be problematic due to the aging process. For example, a 65-year-old person produces less than 18-year-old fat in the tear film (the most ^6%). The tears of the oil will make the water of the money evaporate faster and make the cornea dry. • In case of discomfort & use artificial tears and ointment to dry eye symptoms: make the check deposits as good as possible:: blocked by a plug called a tear duct or punctal plug: two in the eye for a long time time. The punctal plug has been shown to increase patient comfort and reduce the frequency of artificial tear use. Known punctal plugs are typically configured in the form of a cylindrical body having a self-embolling-retracting blind hole for the insertion of a rod into the tool, for example, as in U.S. Patent Nos. 5,741,292, 5,643,280, 201242582. 6,344,047, 6,527,780 and 5,335,871. The insertion rod is used to release the plug from the tool when the plug is inserted into the lacrimal duct. When the embolization can be used as a technique to control the flow of tears, the active agent is often administered to the eye for the treatment of ocular diseases or disorders. Examples of several punctal plugs are shown and described in U.S. Patent Publication No. 20070299516, which is incorporated herein by reference. In at least one embodiment of the plug, an active agent is loaded into the blind bore of the plug. SUMMARY OF THE INVENTION The use of the active agent with punctal plugging is highly effective in the treatment of dry eye and other related ocular disorders requiring an effective insertion tool* and existing tools are not easy to use or have limited efficacy. Accordingly, one aspect of the present invention is an insertion device for implanting a blinded punctal plug, comprising a plug containing one or more active agents at locations where the blind holes are typically formed. In another aspect, an insertion device is provided. In another aspect, a cap for a tear duct insertion device is shown and described. In a further aspect, a punctal plug insertion system including the device and the cap is provided. In yet another aspect, a method of releasing a punctal plug from a plug holder is provided. In addition, a kit is provided that includes the embolic insertion device, cap, plug, and instructions for use. [Embodiment] 8 4 201242582 Detailed Description of Embodiments (4) (D) The present invention The term "tears plug" as used herein refers to a size and shape, two miles. A device that is inserted into the upper or lower part of the eye by the upper or lower punctum, for any value or range of "approx." or "device. Also refers to - the appropriate size tolerance, which causes part of the component or Set ^ Η : 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 所 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 The Department will rely on human patients as the best practice. The disclosure of this document contains copyright protections. ~ All persons retain all copyrights of these parts, including the instructions for use. Referring to Figure 1 Α 'The system shows a perspective view of the vertical axis L_L of the punctal plug 18. The system (10) includes - plug: work eight ~ with 102 'which includes | | with body just. The instrument body ship::= =! The closest grip is to use the end of the appliance 102 (i.e., the end that is the furthest away from the grip to use the device). The appliance 102 has an actuator 〇 'which is disposed near the distal end 107. Moves $11〇 to a button-connectable-actuating member 112 that is configured to transmit The main body opening π 114 provided in the body of the appliance moves along the longitudinal axis L_L. The actuating member 112 can be any set of four (4) as long as this configuration enables the reciprocating movement of the actuating member (1) in the main body opening 114 along the longitudinal axis a. The actuating member 112 is configured as a substantially mast-shaped rod. The actuating member 112 is coupled to the actuation $11〇 via an arm 116 that is at an angle to the longitudinal axis LL. 116 is coupled to the actuator 110 via at least one suitable hinge member 1〇201242582, such as an unbiased hinge, a spring biased hinge, or preferably a living hinge. 105. Although the embodiment shown in FIG. 1A is attached with a hinge, other embodiments may be as shown in FIG. 3A, guilty, 4a, and 2 or more money pieces in the proximal end of this embodiment. 106, an expansion member 1 8 can be provided to assist in the insertion or implantation of the punctal plug 180. The expansion can be a conical taper having a diameter ranging from about 15 mm to about. Attachment to the expansion member The axis of 1〇8—the range is about (Mem to about 〇.8cm and the length is about 1 brewed to about = directly A cylindrical shaft. The expansion member 1 可 8 can be connected to the (4) piece by a (4) = when biased to maintain an appropriate stiffness modulus in the unreleased or non-actuated position, 2 = action. For example, the stiffness 〇.7 awake 4 to about ~ 'better is about 〗 〖: to: 4 about 5 mm4, more preferably about 4.5 mm4. To about 4.5 The appliance 102 includes a cap building The body portion ui, 150, which can be loaded - is as shown in Figure 3 below. The cap support portion lu has a plug-like structure that is complementary to the inner surface (10) of the cap 150. The support surface ^ is provided with a ridge to interlock with a money view formed on the cap surface 160. The interlocking bolts the cap 15 (1). Preferably, the cap support portion (1) 120 is provided with an annular recess 16 , a support surface ± 69B and a cover 形成 ς Ί 形成The annular ridge 169 表面 of the surface 160 is interlocked. 目150 201242582 With respect to the figure asm, the cap 15 可 can have two β knives in its outer core 7. The first partial form near the first cap end 152 can be a substantially cylindrical shape. The portion 164 extends around the longitudinal axis 1-1 from the first portion 623⁄4 to the second cap end 156 to define a tapered surface of the second form. The inner surface 160 is associated with the cap 也 / / face 157 ' can have a configuration that is generally similar to outer surface 157 to define a 中空T T ® , σ longitudinal axis LL defining a hollow cylinder with a hollow cylinder at the first end 152 portion of the cap (9)' The longitudinal axis LL extends, preferably defining a lobe ridge. The first cap end (5) surrounds and follows a longitudinal opening 154, and the second cap end 150 surrounds and along the longitudinal axis. "Definition - second opening 158. The second opening 158 Figure 1 D: 'configured with the plug 18 The body 182 (Fig. 1E) of 0 is the same size or smaller, so that the second opening 158 in the form of two semicircles or retainer lips 174A and 174B can grasp the plug (10) only the head 184 of the plug 180 The cap 15 is protruded. As shown in Fig. 1C, the second cap end 156 has - or a plurality of slits 170' which extend along the longitudinal axis L_L to provide the slit (7) as shown in Figures 2B and 2D. Diametrical separation between the fastener edges 174A and 174B of the second cap end 156. The slit 17 provides the first fastener edge 174A and the second fastener edge 174B of the second cap end i56 to be released The embolization then has a tulip-like abduction capability. In an alternative embodiment, as shown in Figure 3A, the cap 150 is coupled to the instrument 300, and the fingers 3〇2 can be attached to the buckle. The second opening of the edge i74A and 201242582 174B further ensures that the plug 180 on the cap 150 does remain. The cap 150 is now illustrated with reference to Figures 1 B and 1 C. In Figure IB, the cap 150 can be considered an elongated body. Extending from the proximal end or first end 152 to the distal end along the longitudinal axis LL Second end 156. The second end 156 of the cap 150 defines a proximal end or first cap opening 154 that is larger than the distal end or second opening 158 defined by the second end 156. The second opening 158 can include at least two The slit 170 extends through the wall 172 of the cap 150 proximate the distal end 107 such that the punctum plug 180 can pass through the distal opening 158 as the distal opening 158 is expanded. Preferably, one of the elongated bodies has a cone disposed about and along the longitudinal axis L-L to define a generally conical outer surface 157. The inner surface 160 of the elongated body can be spaced from the outer surface 157 to define a suitable hollow surface (e.g., cylindrical, conical, or a combination thereof). Preferably, the inner surface 160 is defined as a generally hollow cone. In a preferred embodiment, the cap 150 has three portions on its outer surface 157: (1) a substantially planar tab 151 located at (2) - a generally cylindrical portion 162, and (3) - A portion 164 that is substantially circularly shaped. The inner surface 160 defines the corresponding hollow cylindrical and conical portion. One or more annular rings 169A (protrusions or grooves) oriented along the longitudinal axis LL can be provided on the inner surface 160 of the cap 150 such that the annular ring can engage the corresponding annular ring on the cap support portion 111 (protruding Or groove) 169B interlocked. Alternatively, a spiral ring in the form of a rotary outer or internal thread may be provided. Since the appliance 102 is reusable, the cap 150 and the plug 180 also use the assembly in a single use, thus providing several features. A mouth 200' can be formed near a cap opening 154 of the 8th 201242582 to ensure that whenever the cap 150 is attached to the implement 102, there is a significant physical indication that the cap 15 is capable of sealing due to the passage of the actuator member 112. The closure 200 is thus fried in sterility. A separate actuator rod 202 can be provided for engagement with the actuating member 112. The actuator rod 202 has a rod 2 〇 2 having a serrated outer surface for providing a slight friction fit with the cap inner surface 160 proximate the second cap opening 158 when the actuator rod 2 〇 2 is used In the middle, the other plug 180 cannot be loaded into the cap 15 due to the action of a serrated surface (not shown) which prevents the rod 202 from moving rearward toward the proximal end 106. Referring to Figures 2A, 2B, 2C and 2D, the release of the plug igo from the cap 150 will now be described. As shown in FIG. 2A, the plug 18 is attached to the cap 150, the cap 150 is attached to the device 1〇2, and the actuation benefit 110 is unreleased or unactuated as shown in FIG. 1A. position. In this position, the plug 18 is retained by the fasteners Α4Α and 174B (Fig. 2B) of the cap 15〇 second opening 158. To release the plug 18 〇 to enter the intended use of the lamp 'for example, in the tear duct of the subject, the button 110 ( FIG. 1A ) is pressed toward the longitudinal axis lL, which causes the actuator member 112 to pass through The hinge 1〇5 moves along the longitudinal carriage from L_L toward the distal second cap opening 158. Because the actuator structure #112 is configured to be larger than the seventh "opening 158', the fastener edges 174A and 174B are forced to move axially outwardly in a j-like manner. When the key is cut into - the step ^ is depressed by L-L, the actuator member 112 continues to move along the longitudinal axis l = end W, causing the actuator 112 to be tailed relative to the plug. This forcefully pushes the check plug (10) out of the second opening 158. When the 201242582 continues to move in the far direction,
動器構件112持續4 制或留在蓋帽15〇， ,,鬥吋驭接斤進行。在 兩者作用（按壓及滑動）通常係同時 進行，在兩作用間有些重疊。 、 ^在圖3Α及3Β之實施例中，該扣件174Α及174β 係與對應之懸臂306連接’而懸臂3〇6係經由彎角臂 (angled匪s)321與一擴張構件1〇8結合。致動臂312 及314係連接至懸臂306以確保致動構件316會受力而 沿縱軸L-L朝向栓塞180的尾部丨82移動。提供加強件 318置於扣件174A及174B和該懸臂306之間，以避免 或限制扣件174A及174B相應懸臂306的屈曲。懸臂 306與彎角臂321係經由一連接脊32〇將各對的臂連 接。如圖1A及2A之實施例，該連接脊32〇可為活動 鉸件。 在圖3實施例之變化中，圖4A及4B提供—種雔 重或雙槓桿器具400，其可包括與致動器主體4〇4結: 的二個懸臂式連接臂402。致動器主體404係連接至— 加長之致動器元件406。將二個連接臂脊408各裝於各 個懸臂402末端。栓塞180可裝設於蓋帽150上。該蓋 帽150可被裝設至雙重槓桿器具400或結合成為雙重積 桿器具400的一部分。在此實施例中亦可提供一擴張構 201242582 件l〇j，使醫師可於插入栓塞18〇前擴張淚管。在操作 日寸藉由轴向朝縱輪施予力量以力口壓該致動器彻 而釋放才王塞180。此造成在沿縱軸調動時各個懸臂 4〇1圍繞其軸旋轉’使該致動器主體4G4強迫加長I致 動印元件406 /σ縱轴L_L調動。如先前實施例，力口長之 致動器元件406之截面（例如圓形、圓錐开)及其類似者） y大於U自150開口，這會在致動器元件4⑼進入時使 蓋巾目150的開σ 158以類似蠻金香的方式外展，因而自 蓋帽釋放栓塞180。 本發明提供之另一變化，顯示於圖5Α及5Β，其中 一，叙件506係利用於器具5〇〇。在此器具5〇〇中，致 動器臂。508係經由—鉸件5〇6係連接至致動器5〇4。該 致動器臂駕係經由—針銷322連接至致動器構件 510。5亥致動器構件51G由於藉由凸座54G形成之開口 而^皮限制沿軸L-L調動。致動器5G4亦可具有一錢件 用於其與擴張構件⑽的連接。如先前之實施例 2提供—蓋帽55G ’其上裝設栓塞⑽。此實施例的 桂塞180釋放與其他實施例相似。 咸k本發明與已知系統相較下的眾多優勢之—，為 ，轉換不同大錢*同組態栓紅間的師 辛苦找尋駐雜塞⑽狀插〜已知插； :^桿。即’在已知工具中，若拾塞不是正確大小 則邊師必須❹另—已預先裝敎確大小栓塞之工 具’或者醫師賴將栓塞從已知n綠 :栓塞至-已知工具的插入桿中。在後者例子= 的小尺寸對於醫師定位並插人已知=The actuator member 112 continues to be held or left in the cap 15〇, and the bucket is engaged. The two actions (pressing and sliding) are usually performed simultaneously, with some overlap between the two actions. In the embodiment of FIGS. 3A and 3B, the fasteners 174A and 174β are connected to the corresponding cantilever 306', and the cantilever 3〇6 is coupled to an expansion member 1〇8 via an angled arm 321 . . Actuating arms 312 and 314 are coupled to cantilever 306 to ensure that actuation member 316 is forced to move toward longitudinal axis L-L toward tail portion 82 of plug 180. A stiffener 318 is provided between the fasteners 174A and 174B and the cantilever 306 to avoid or limit buckling of the respective cantilever 306 of the fasteners 174A and 174B. The cantilever 306 and the angled arm 321 connect the arms of each pair via a connecting ridge 32. 1A and 2A, the connecting ridge 32A can be a movable hinge. In a variation of the embodiment of Fig. 3, Figs. 4A and 4B provide a helium or double lever appliance 400 that can include two cantilevered connecting arms 402 that are coupled to the actuator body 4〇4. The actuator body 404 is coupled to an elongated actuator element 406. Two connecting arm ridges 408 are attached to the ends of each cantilever 402. The plug 180 can be mounted on the cap 150. The cap 150 can be mounted to the dual lever appliance 400 or incorporated as part of the dual rod assembly 400. An expanded configuration of 201242582 l〇j can also be provided in this embodiment to allow the physician to dilate the tear duct prior to insertion of the embolization. At the operating day, the actuator is fully biased by axially applying force to the longitudinal wheel to release the king plug 180. This causes each of the booms 4'1 to rotate about its axis as it moves along the longitudinal axis' causing the actuator body 4G4 to forcibly lengthen the I-moving element 406 / σ vertical axis L_L. As in the previous embodiment, the cross-section (e.g., circular, conical open) and the like of the actuator element 406 of the force-port length y are larger than the opening of the U-150, which would cause the cover to be 150 when the actuator element 4 (9) enters. The open σ 158 is abducted in a manner similar to the scent of gold, thus releasing the plug 180 from the cap. Another variation provided by the present invention is shown in Figures 5A and 5A, one of which is used in appliance 5〇〇. In this device 5, the actuator arm. The 508 is connected to the actuator 5〇4 via a hinge 5〇6. The actuator arm is coupled to the actuator member 510 via a pin 322. The 5H actuator member 51G is mobilized along the axis L-L due to the opening formed by the boss 54G. The actuator 5G4 can also have a piece of money for its connection to the expansion member (10). As in the previous embodiment 2, the cap 55G' is provided with a plug (10). The release of the Guishen 180 of this embodiment is similar to the other embodiments. Salt k This invention has many advantages compared with the known system - for, the conversion of different big money * with the configuration of the tie between the red and the teacher to find the resident plug (10) inserted ~ known plug; : ^ rod. That is, 'in known tools, if the plug is not the correct size, then the division must slap another tool that has been pre-installed with a good size embolization' or the physician will insert the plug from the known n green: embolization to - insertion of the known tool In the pole. In the latter case = the small size is known to the physician for positioning and insertion =
S 11 201242582 正確大小栓塞是極大的挑戰。相反地，本文教示之實施 例能使醫師簡單地拉出錯誤大小的蓋帽150並裝設正 確大小蓋帽150，而不會在貼附正確大小栓塞18〇有極 大的視覺或實體操作困難。 為能予以醫師或健康照護提供者（「HCP」）額外的 使用彈性，蓋帽150及栓塞180可以不同組態提供，例 如圖6A、6B及6C中所示。在圖6A中，一增長型栓塞 (extended length plug) 600 可與蓋帽 150 併用。該蓋 帽可為抽向夾钳蓋帽（axially clamped cap ) 602 (圖6B ) 或分裂縫蓋帽（split-seam cap ) 604 (圖6C )形式。 為使HCP使用上獲得更大彈性，可提供hcp —適 合的套組，例如圖7的形式。在此套組7〇〇中，提供一 外殼（例如吹模成型盒），其含有至少一具有器具1〇2， 其具有裝設至蓋帽150的適合大小之栓塞該外殼 内提供裝於單一無菌包裝或無菌分裝包（即：多個單一 無菌包裝）、具有不同栓塞大小（例如：〇 3 mm、0.4 mm、 0‘5 mm、0·6 mm、0·7 mm、〇·8 mm、0.9 mm 等等，具 有適當大小指標，並印於蓋帽上）的額外蓋帽。套組 700的使用說明（「IFU」）704係以使用者易讀的形式提 供，例如紙張媒介或電子媒介（例如：記憶卡或 CD-ROM)形式。整個外殼及其内含物可使用法規核准 之消毒技術消毒。 該IFU 704最少包含確保蓋帽15〇完整貼附於器具 102、具有裝设於蓋帽15〇尖端内的正確尺寸栓塞18〇 的步驟；若栓塞180尺寸錯誤或裝設於器具1〇2的蓋帽 150尖端組態錯誤，則移除蓋帽15〇 ;將正確蓋帽15〇 201242582 及栓f I80組態裝至器具102;擴張淚管、插入栓塞180 至淚官並致動該器具1〇2的致動器n〇，以釋放或植入 栓塞180至對象的淚管中。 ^較佳的是，IFU 704包括下列操作說明以握 釓筆方式用大姆指和手指握住施用器具（1〇〇)，食指剛 好在釋放鍵上（11〇)。此時，使用者不應按下按鍵。（2) 輕壓釋放鍵（11〇)直到感覺「緩和停止」（s〇ft_st〇p) 為止；此為釋放前位置。淚管塞（180)在此位置時應 部分突出，使軸（182)露出。（3)以和緩、向下、旋 轉移動方式，插入栓塞，直到外緣（184)相對於淚管 開口為齊平。確認栓塞的外緣尚未埋於淚管環之下。若 已埋於淚管環之下，向止輕拉插入器，直到外緣已正確 雄、合。（4)栓塞（180)正確定位，完全壓下並握住施 用器上的釋放鍵。（5)在握住釋放鍵時，移走施用器。 丟棄已使用之插入器至「拋棄式針盒」。（6)使用錄°子 輕輕下推栓塞的轴領（186)(栓塞頂部），以確保該栓 塞係完全插入且該轴領與眼瞼邊緣齊平。 雖然本文已顯示並說明本發明較佳實施例，但該等 實施例僅提供作為例示。熟悉此技術者現將意識到不偏 離本發明的情況下的各種變化、改變與置換。可利用本 文說明的本發明實施例之各種替代以實施本發明。下面 的申請專利範圍旨在界定本發明範圍，以及該等申請專 利範圍範及其相等物内涵蓋之方法及結構。 【圖式簡單說明】 13 201242582 圖1A描繪具有淚點塞、淚點蓋帽及插入器具之淚 點塞插入糸統不範實施例之透視圖。 圖1Β描繪圖1Α例示系統之剖面透視圖。 圖1C描繪圖1A插入糸統遠部之特寫透視圖。 圖1D描繪與圖1B插入器具併用之例示性淚管塞 的特寫透視圖。 圖2A描繪圖1A器具變化的平視圖，其中該栓塞 描繪裝架至蓋帽且未自器具釋放。 圖2B描繪剖面線2B-2B所視之組件剖面圖。 圖2C描繪圖2B實施例於栓塞釋放順序時的平視 圖。 圖2D描繪剖面線2C-2C所視之組件剖面圖。 圖3A及3B分別描繪本文中說明及描繪的例示性 系統另一變化之圖解視圖。 圖4A描繪圖3A及3B實施例的又另一變化之平視 圖。 圖4B描繪圖4A貫施例的透視圖。 圖5A及5B分別描繪插入器具又另一實施例之剖 視側圖。 圖6A-6C係各種可利用於各種本文中所述之例示 性器具以留住淚點塞的蓋帽及栓塞之例示性透視圖。 圖7描繪用於本文中所述之各種實施例之例示性 套組。 【主要元件符號說明】 100...系統 201242582 102.. .插入工具 104.. .器械本體 105…鉸件 106.. .近端 107.. .遠端 109…懸臂構件 108…擴張構件 110.. .致動器 111.. .蓋帽撐體部位 112.. .致動構件 114.. .主體開口 116.. .臂 120.. .外撐體表面 150.. .蓋帽 151.. .平面片 152.. .第一蓋帽末端 154.. .第一開口 156…第二末端 157.. .外表面 158.. .第二開口 160.. .内表面 162.. .第一部位 164.. .第二部位 169A...嵌槽 169B...脊部 170.. .狹縫 201242582 172…壁 174A...扣件邊 174B...扣件邊 180.. .淚點塞 182.. .主體 184.. .外緣 186.. .轴領 200."封口 202.. .致動器桿 300.. .器具 302.. .指狀物 306.. .懸臂 312.. .致動臂 314.. .致動臂 316.. .致動構件 318.. .加強件 320.. .連接脊 321.. .彎角臂 322.. .針銷 400…雙槓桿器械 402.. .懸臂式連接臂 404.. .致動器主體 406.. .加長之致動器元件 408…連接臂脊 410.. .致動器 500.. .器械 201242582 504.. .致動器 506…鉸件 508.. .致動器臂 510…致動器構件 540.. .凸座 550.. .蓋帽 600…增長型栓塞 602.. .軸向爽钳蓋帽 604.. .分裂縫蓋帽 700.. .套組 704.. .使用說明S 11 201242582 The correct size embolism is a great challenge. Conversely, the embodiments taught herein enable the physician to simply pull out the erroneously sized cap 150 and install the correct size cap 150 without attaching the correct size plug 18 with significant visual or physical operational difficulties. Cap 150 and plug 180 can be provided in different configurations for additional flexibility of use by a physician or health care provider ("HCP"), as shown in Figures 6A, 6B and 6C. In Figure 6A, an extended length plug 600 can be used with the cap 150. The cap may be in the form of an axially clamped cap 602 (Fig. 6B) or a split-seam cap 604 (Fig. 6C). In order to achieve greater flexibility in the use of HCP, hcp - a suitable set, such as the form of Figure 7, can be provided. In this kit 7A, there is provided an outer casing (e.g., a blow molded box) containing at least one having an appliance 1〇2 having a suitably sized plug mounted to the cap 150. The outer casing is provided for attachment to a single sterility Packaging or aseptic packaging (ie: multiple single aseptic packages) with different plug sizes (eg 〇3 mm, 0.4 mm, 0'5 mm, 0·6 mm, 0·7 mm, 〇·8 mm, Extra caps with 0.9 mm and so on, with appropriate size indicators and printed on the cap. The instructions for use of the kit 700 ("IFU") 704 are provided in a user-readable form, such as a paper medium or an electronic medium (eg, a memory card or CD-ROM). The entire enclosure and its contents can be sterilized using regulatory approved disinfection techniques. The IFU 704 includes at least a step of ensuring that the cap 15 is fully attached to the appliance 102, having the correct size plug 18〇 disposed within the tip of the cap 15; if the plug 180 is sized incorrectly or cap 150 mounted to the appliance 1〇2 If the tip configuration is wrong, the cap 15 is removed; the correct cap 15〇201242582 and the plug f I80 configuration are attached to the appliance 102; the tear duct is expanded, the plug 180 is inserted to the tear and the actuation of the appliance 1〇2 is actuated. The device is configured to release or implant the plug 180 into the tear duct of the subject. Preferably, the IFU 704 includes the following operating instructions to hold the applicator (1〇〇) with the thumb and fingers in a gripping manner, the index finger being just on the release button (11〇). At this point, the user should not press a button. (2) Press the release button (11〇) until you feel “moderate stop” (s〇ft_st〇p); this is the position before release. The tear duct plug (180) should partially protrude in this position to expose the shaft (182). (3) Insert the plug in a gentle, downward, rotational movement until the outer edge (184) is flush with respect to the tear duct opening. Confirm that the outer edge of the embolization is not buried under the tear duct ring. If it is buried under the tear duct loop, gently pull the inserter until the outer edge is properly male and female. (4) The plug (180) is properly positioned, fully depressed and hold the release button on the applicator. (5) Remove the applicator while holding the release button. Discard the used inserter to the Disposable Needle Box. (6) Using the dial, gently push down on the shaft collar (186) of the plug (top of the plug) to ensure that the plug is fully inserted and the collar is flush with the edge of the eyelid. Although the preferred embodiment of the invention has been shown and described, the embodiments are provided by way of illustration only. Those skilled in the art will now recognize various changes, modifications and permutations without departing from the invention. Various alternatives to the embodiments of the invention described herein may be utilized to practice the invention. The scope of the invention is intended to be defined by the scope of the claims BRIEF DESCRIPTION OF THE DRAWINGS 13 201242582 FIG. 1A depicts a perspective view of a punctal plug insertion system having a punctal plug, a punctum cap, and an insertion device. Figure 1 is a cross-sectional perspective view of the exemplary system of Figure 1; Figure 1C depicts a close-up perspective view of the distal portion of Figure 1A inserted into the system. Figure 1 D depicts a close-up perspective view of an exemplary punctal plug in use with the insertion device of Figure 1B. Figure 2A depicts a plan view of the variation of the appliance of Figure 1A, wherein the plug depicts the mount to the cap and is not released from the appliance. Figure 2B depicts a cross-sectional view of the assembly as viewed from section line 2B-2B. Figure 2C depicts a top plan view of the embodiment of Figure 2B in the embolic release sequence. Figure 2D depicts a cross-sectional view of the assembly as viewed from section line 2C-2C. 3A and 3B depict diagrammatic views, respectively, of another variation of the illustrative system illustrated and described herein. Figure 4A depicts a top plan view of yet another variation of the embodiment of Figures 3A and 3B. Figure 4B depicts a perspective view of the embodiment of Figure 4A. Figures 5A and 5B depict, respectively, cross-sectional side views of yet another embodiment of an insertion device. Figures 6A-6C are exemplary perspective views of various caps and plugs that can be utilized with various illustrative devices described herein to retain punctal plugs. Figure 7 depicts an exemplary kit for use with the various embodiments described herein. [Major component symbol description] 100...System 201242582 102.. Insertion tool 104.. Instrument body 105... Reaming 106.. Proximal end 107.. Remote end 109... Cantilever member 108... Expansion member 110. Actuator 111.. Cap support portion 112.. Actuation member 114.. Body opening 116.. Arm 120.. External support surface 150.. Cap 151.. Flat sheet 152... First cap end 154.. first opening 156... second end 157.. outer surface 158.. second opening 160.. inner surface 162... first portion 164.. The second portion 169A...the recess 169B...the ridge 170..slot 201242582 172...the wall 174A...the fastener side 174B...the fastener side 180.. . the punctal plug 182.. . Main body 184.. rim 186.. shaft collar 200. " Seal 202.. Actuator rod 300.. Apparatus 302.. Finger 306.. Cantilever 312.. Actuator arm 314.. Actuating arm 316.. Actuating member 318.. Reinforcement 320.. Connecting ridge 321.. Angled arm 322.. Pin 400... Double lever instrument 402.. Cantilever Connecting arm 404.. Actuator body 406.. Lengthened actuator element 408... Connecting arm ridge 410.. Actuator 500.. . Apparatus 201242582 5 04.. Actuator 506...Remote 508.. Actuator arm 510...Actuator member 540..Protruding 550.. Cap 600...Growing plug 602.. axial clamp cap 604.. . Split crack cap 700.. . Set 704.. . Instructions for use