201249488 ^ 六、發明說明： 【發明所屬之技術領域】 發明領域 本揭示係關於-種無針接取連接器，更特別關於一種 正排量無針接取連接器。 C 4椅;3 發明背景 贼醫療治療經常需要醫療專家將流體引進患者或從 患者抽出流體。例如，患者可需要一需要醫療專家各別從 尿道或靜脈抽出尿或血液之治療。相反地，醫療專家可需 要將藥物或營養品引進患者的靜脈(即，靜脈内）。為了產生 進入或來自患者的流體流動路徑，方法之一需要醫療從事 者使用導管，其中將該導管的一端插入患者中。該導管的 • 其它端經由1V線連接至靜脈内袋子(IV袋子卜無針接取連 接器使用閥，其允許醫療從事者沒有使用針對該導管移除 或加入裝置（例如’ IV袋子）。無針接取連接器的實施例顯示 在第1A及1B圖中。 第1A圖係現在無針接取連接器1〇〇的剖視圖。無針接取 連接器100包括外殼120 ’其在近端處具有母魯爾（Luer)配件 101 ;基座130，其在遠端處具有公魯爾配件1〇2 ;及閥元件 103 ’其座落在外殼120内及在基座no的頂端上。外殼120 與基座130係從硬質塑膠(通常為聚碳酸酯）製得，及閥元件 103係從液態聚矽氧製得，如此其具彈性及可折疊。當在使 用時’公魯爾配件102連接至例如導管或母魯爾，及母魯爾 201249488 配件101連接至流體貯存器（例如，IV袋子）或公魯爾。母魯 爾配件101經由第二公魯爾配件106(其具有中空成員（如顯 示在第1B圖中）及經由母魯爾配件ι〇1的頂端插入）連接至 流體貯存器。公魯爾106之插入將閥元件103向下折疊進體 積104中’以打破密封及產生一流體流動路徑。第汨圖顯示 出在將公魯爾106插入母魯爾1〇1中後，該可折疊式閥元件 103呈折疊的位置。公魯爾106輸送流體（例如，來自…袋 子），其繞著閥元件103流入在公魯爾配件102中的通道及進 入導管或母魯爾中。 在閥元件103内係一間隙（或間隔，無顯示），其填充空 氣。無針接取連接器1〇〇係一正排量裝置，如此當在母魯爾 配件101處製得新連接時，裝置1〇〇從閥的公邊（即緊鄰公 魯爾配件102的邊）吸入流體。當在母魯爾配件1〇1處斷連 時，裝置100從母邊（即，緊鄰母魯爾配件101頂端的邊)推入 流體。正排量的優點為當斷連時，裝置1〇〇將流體排出公魯 爾配件1G2及有效地齊+導管。相較之下，至今在市面上的 某些裝置具有負排量，使得當公魯_ (例如，公魯爾1〇6)斷 連時，此裝置從公魯_2邊吸人小量液體。當從接附至靜 脈患者的導管之公魯爾1〇2邊吸入液體時，可能將血液吸入 導官腔中’及若此血液遺留在導管腔中時，其可凝結成塊 及對患者造成健康問題。正排量連接器藉由當公魯爾（例 如’公魯爾1G6)與無針接取連接器斷連時將流體推出，及 其可折#摘從其折®狀態移至其未折餘“避免此問 題。流體清洗(來自正排量連接ϋ)幫祕止血液進入導管尖 201249488 端因此防止凝血/污染，因此，血流感染。 (第二tr’當無針接取連接器1_母端由公魯爾接取 夺，閥凡件103具足夠彈性，使得其可彎出 動的路k然後在母端處進行斷連後返回其原 因此’無針接取連接器⑽自身再密封及形成平垣Γ面二 可在頂端表Φ1Η)處使㈣拭子消毒。 〃 ▲在使用無針接取連接器⑽將裝置連接至例如 前，無針接取連接器_將包含—些线。在使用益針接二 連接器_解管前移除此空氣，因為否職會魏入患者 中而對患者核傷害。財來說，為了移除此^氣，醫療 從事者倒_缺錄連㈣謂包含錄料射器接附 至該無針接取連接器。然、後，將該鹽液推過無針接取連接 器’因此將空氣從該連接器排出。(此方法已知為灌注 (ΡΗ_) ’及從無針接取連接器移除全部空氣所需要 體的最小體積已知為灌注體積。）某些醫療從事者寧願選擇 具有較小灌注體積之無針接取連接器，以減低在藥物傳遞 上的延遲。 在無針接取連接器經灌注後，醫療從事者通常將公端 102連接至導管(無_。醫療從事者將來自ιν袋子的公魯 爾（無顯示)連接至無針接取連接卜例如，醫療從事者將注 射器106末端連接至母魯爾配件⑼。如顯示在第1B圖中。 在無針接取連接器1财所提到者係外殼120、基座13〇 及閥元件103之形狀。閥元件1〇3具有凸緣1〇5，其為一具有 外徑大於閥元件103主體的部分。外殼m具有肩部阳，、其 201249488 與凸緣105相似《當組合時，凸緣1〇5牢固地頂在基座13〇與 肩部107間，因此在凸緣1〇5與基座13〇間產生密封。密封的 理由係如此’以便可排出在間隔中的空氣而不會有空氣進 入從公魯爾106至公魯爾1〇2的流體流動路徑中。雖然於本 文中無顯示出，在從基座130的螺紋部分延伸至閥元件1〇3 的間隔之y軸方向中有二個排氣孔（其允許空氣進出），該間 隔作為閥元件103經壓縮及不經壓縮而不與流體混合。一旦 組合，外殼120與基座130在界面115處密合。 凸緣105增加閥元件103的整體寬度，及連接器1〇〇允許 流體繞著凸緣105流動，因此使得連接器〗〇()其自身變寛。 結果，當與導管（無顯示）比較時，特別是當對著新生兒皮膚 放置連接器100時，連接器100可看起來大的。連接器1〇〇的 典型用法為在接近導管耦合至連接器1〇〇的位置處，以膠帶 將導官貼至患者皮膚。但是，連接器100的宽形狀可造成連 接器100不舒適地對著皮膚安置。額外地，連接器1〇〇的寬 度可造成大的灌注體積。 【發明内容】 發明概要 多個具體實例包括具有固定至基座的閥元件之連接 态。例如，在一個具體實例中，實施例閥元件與該基座齊 平，其中二個構件配接。在另一個實施例中，該基座與閥 兀件彼此耦合以產生一具有最大外徑小於該外殼的内徑之 組合。 多個具體實例減小或消除凸緣，以便閥元件及連接器 201249488 整體的寬度外觀可減小（當與先前顯示在第1A&1B圖中的 解決方案比較時），用來消除凸緣及將閥元件固定至基座的 貫施例技術包括使用讓閥元件與基座配接之卡扣配件，然 而其它具體實例可使用其它技術。其它具體實例包括製造 連接ι§的方法。 前述已相當廣泛地概述出本發明的特徵及工藝優點， 以便可較好地了解下列發明之詳細說明。於此之後，將描 述本發明的其它特徵及優點，其形成本發明的申請專利範 圍之主題。應該要由熟習該項技術者明瞭，為了進行本發 明相同的目的，所揭示的概念及特定具體實例可容易地使 用作為基礎來修改或設計其它結構。亦應該由熟習該項技 術者涊知到，此相等架構不脫離如在附加的申請專利範圍 中所提出之本發明的精神及範I咸信係本發明的特徵之 新賴特徵(如對其組織及操作方法二者)與進一步目標及優 點將-起從下列描述中（當與伴隨圖形相關聯考慮時）有較 好地了解。但是，要明確地了解，提供該等圖形每幅僅用 於闡明及描述的目的而不想要作為本發明之祕的定義。 圖式簡單說明 為了更完全地了解本發明，現在—起參照下列摇述盘 相關連的伴隨圖形，其十： 〜 第1A圖係現在無針接取連接 出在將公魯爾插入母魯爾中後， 閥元件。 器的剖視圖。第1B圖顯 呈折疊的位置之可折疊 示 式 個具體實例之 第2A及2B圖提供適應根據本發明的 201249488 典型正排量無針接取連接器的展開式闡明。 第3Α及3Β圖提供適應根據本發明的—個具體實例之 典型正排量無針接取連接器的展開式闡明。 第4圖係根據一個具體實例的典型連接器在使用時之 透視闡明。 第5圖係適應根據一個具體實例的典型連接器之截面 闡明，其係將第2Α、Β及3Α、Β圖之截面旋轉九十度。 第6圖係根據一個具體實例之組合及準備好使用的典 型連接器之闡明。 第7圖係適應根據一個具體實例的典型連接器之閫明。 第8圖係用來製造根據一個具體實例之正排量無針連 接器的典型方法之闞明。 C實施方式]| 較佳實施例之詳細說明 第2A及2B圖提供適應根據本發明的一個具體實例之 典型正排量無針接取連接器200的展開式闡明。第2A圖係一 剖視圖’然而第2B圖顯示出連接器2〇〇的外部。 連接器200具有三個基本部分，基座21〇、閥元件220及 外殼230 °外殼230在近端（其連接例如至流體貯存器，諸如 IV袋子）處具有母魯爾配件231。基座210及螺紋232在連接 器200的遠端處形成一公魯爾配件，該公魯爾配件連接至例 如與患者連通的導管。閥元件220包括間隔221，其當經壓 縮及不經壓縮時可填充空氣及排氣至大氣，如在下列更詳 細地解釋。201249488 ^ VI. INSTRUCTIONS: TECHNICAL FIELD OF THE INVENTION The present disclosure relates to a needleless connector, and more particularly to a positive displacement needleless connector. C 4 Chair; 3 BACKGROUND OF THE INVENTION Thieves medical treatment often requires a medical professional to introduce or withdraw fluid from a patient. For example, a patient may need a treatment that requires a medical professional to separately withdraw urine or blood from the urethra or vein. Conversely, medical professionals may need to introduce drugs or nutrients into the patient's vein (i.e., intravenously). In order to create a fluid flow path into or from the patient, one of the methods requires the medical practitioner to use the catheter, wherein one end of the catheter is inserted into the patient. The other end of the catheter is connected to the intravenous bag via a 1V wire (IV bag) needleless connector uses a valve that allows the medical practitioner to not remove or add to the catheter (eg, 'IV bag). An embodiment of the pin-receiving connector is shown in Figures 1A and 1B. Figure 1A is a cross-sectional view of the now needle-free connector 1A. The needle-free connector 100 includes a housing 120' at the proximal end There is a female Luer fitting 101; a base 130 having a male luer fitting 1〇2 at the distal end; and a valve element 103' seated within the outer casing 120 and on the top end of the base no. 120 and the base 130 are made of a hard plastic (usually polycarbonate), and the valve element 103 is made of liquid polyfluorene, so that it is elastic and foldable. When in use, the male luer fitting 102 Connected to, for example, a catheter or female luer, and female Ruhr 201249488 fitting 101 is attached to a fluid reservoir (eg, IV bag) or male luer. Female Ruhr fitting 101 is via a second male luer fitting 106 (which has a hollow member (as shown in Figure 1B) and via the female Ruhr accessory ι The top end of 1 is inserted into the fluid reservoir. The insertion of the male luer 106 folds the valve element 103 down into the volume 104 to break the seal and create a fluid flow path. The figure shows the male Luer 106 After being inserted into the female luer 1〇1, the collapsible valve element 103 is in a folded position. The male luer 106 delivers fluid (eg, from a bag) that flows into the male luer fitting 102 around the valve element 103. The passageway and the inlet conduit or the female luer. There is a gap (or spacing, no display) in the valve element 103, which is filled with air. The needleless connector 1 is a positive displacement device, so when When a new connection is made at the female Luer fitting 101, the device 1〇〇 draws fluid from the male side of the valve (ie, adjacent the side of the male luer fitting 102). When disconnected at the female Ruhr fitting 1〇1, the device 100 pushes the fluid from the female side (ie, the side adjacent the top end of the female Luer fitting 101). The advantage of positive displacement is that when disconnected, the device 1 〇〇 discharges the fluid out of the male Luer fitting 1G2 and effectively aligns the + conduit In contrast, some devices on the market today have negative displacements. When the Dangdang _ (for example, the male Luer 1〇6) is disconnected, the device sucks a small amount of liquid from the side of the public rudder. When inhaling from the male Luer 1〇2 of the catheter attached to the venous patient When liquid is in use, blood may be drawn into the guide cavity' and if the blood remains in the lumen of the catheter, it can condense into pieces and cause health problems to the patient. The positive displacement connector is used by the male Luer (eg 'public Luer 1G6) pushes the fluid out when it is disconnected from the needleless connector, and its foldable from its Fold® state to its unfolded “avoid this problem. Fluid cleaning (from positive displacement connection ϋ) Helps prevent blood from entering the catheter tip 201249488 and thus prevents clotting/contamination and, therefore, bloodstream infection. (Second tr' when the needle-free connector 1_ female end is taken by the male luer, the valve member 103 is sufficiently flexible that it can bend the moving path k and then return after the female end is disconnected The reason for this is that the 'needle-free connector (10) itself is resealed and formed into a flat surface, and the (four) swab can be sterilized at the top surface Φ1Η). ▲ ▲Before connecting the unit to the unit using the needleless connector (10), the needleless connector _ will contain some lines. Remove this air before using the PIN pin connector _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ In terms of money, in order to remove this gas, the medical practitioners 倒 缺 录 (4) that includes the recording ejector attached to the needleless connector. Then, the salt solution is pushed through the needleless connector' so that air is expelled from the connector. (This method is known as perfusion (ΡΗ_)' and the minimum volume required to remove all air from the needle-free connector is known as the perfusion volume.) Some medical practitioners prefer to choose a smaller perfusion volume. The needle is attached to the connector to reduce the delay in drug delivery. After the needle-free connector is priming, the medical practitioner typically connects the male end 102 to the catheter (no _. The medical practitioner connects the male luer (no display) from the ιν bag to the needle-free connection. The medical practitioner connects the end of the syringe 106 to the female Luer fitting (9) as shown in Figure 1B. The needle-free connector 1 is referred to as the outer casing 120, the base 13 and the valve element 103. The valve element 1〇3 has a flange 1〇5 which is a portion having an outer diameter larger than the body of the valve element 103. The outer casing m has a shoulder yang, and its 201249488 is similar to the flange 105. 1〇5 is firmly placed between the base 13〇 and the shoulder 107, thus creating a seal between the flange 1〇5 and the base 13〇. The reason for the seal is such that the air in the space can be discharged without There is air entering the fluid flow path from the male luer 106 to the male luer 1 〇 2. Although not shown herein, in the y-axis direction extending from the threaded portion of the base 130 to the valve element 1 〇 3 There are two venting holes (which allow air in and out), which serves as the valve element 103 Compressed and uncompressed without mixing with the fluid. Once combined, the outer casing 120 is in close contact with the base 130 at the interface 115. The flange 105 increases the overall width of the valve element 103, and the connector 1〇〇 allows fluid to pass around the flange 105 flows, thus causing the connector 〇() to become self-contained. As a result, the connector 100 can look large when compared to a catheter (not shown), particularly when the connector 100 is placed against the newborn's skin. A typical use of the connector 1 is to tape the guide to the patient's skin at a location near the catheter coupling to the connector 1 . However, the wide shape of the connector 100 can cause the connector 100 to be uncomfortably In addition, the width of the connector 1 可 can cause a large perfusion volume. SUMMARY OF THE INVENTION [0007] A number of specific examples include a connection state having a valve element fixed to a base. For example, in a specific In an example, the embodiment valve member is flush with the base, wherein the two members are mated. In another embodiment, the base and the valve member are coupled to each other to produce a housing having a maximum outer diameter that is less than the outer casing. Combination of inner diameters. A number of specific examples reduce or eliminate the flange so that the overall width of the valve element and connector 201249488 can be reduced (when compared to the solution previously shown in Figure 1A & 1B), A common technique for eliminating the flange and securing the valve member to the base includes the use of a snap fit that mates the valve member to the base, although other embodiments may use other techniques. Other specific examples include making a connection. The features and advantages of the invention are set forth in the <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; The subject matter of the present invention should be understood by those skilled in the art, and the disclosed concept and specific embodiments can be readily utilized as a basis for modification or design of other structures. It should also be apparent to those skilled in the art that this equivalent architecture does not depart from the spirit of the invention as set forth in the appended claims, and the novel features of the features of the invention (e.g., Both the organization and the method of operation) and further objects and advantages will be better understood from the following description (when considered in connection with the accompanying figures). However, it is to be expressly understood that each of the figures is provided for the purpose of illustration and description only and is not intended to be a definition of the invention. BRIEF DESCRIPTION OF THE DRAWINGS In order to more fully understand the present invention, reference is now made to the following accompanying figures associated with the following dialing discs, the tenth: ~ 1A figure is now needlelessly connected and connected in the insertion of the male luer into the female Ruhr Medium and rear, valve element. Cutaway view of the device. Figure 1B shows a foldable position of the collapsible embodiment. Figures 2A and 2B provide an expanded version of the 201249488 typical positive displacement needleless connector in accordance with the present invention. Figures 3 and 3 provide an expanded version of a typical positive displacement needleless connector adapted to a particular embodiment of the present invention. Fig. 4 is a perspective view of a typical connector according to a specific example when in use. Fig. 5 is an illustration of a section of a typical connector according to a specific example, which is a rotation of a section of the second Β, Β, and 3 Α, Β 九 90 degrees. Figure 6 is a illustration of a combination of a specific example and a typical connector ready for use. Figure 7 is a representation of a typical connector adapted to a specific example. Fig. 8 is a view showing a typical method for manufacturing a positive displacement needleless connector according to a specific example. C EMBODIMENT] | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Figures 2A and 2B provide an expanded version of a typical positive displacement needleless connector 200 that is adapted to one embodiment of the present invention. Fig. 2A is a cross-sectional view. However, Fig. 2B shows the outside of the connector 2''. The connector 200 has three basic portions, a base 21, a valve member 220, and a housing 230. The housing 230 has a female luer fitting 231 at the proximal end (which is coupled, for example, to a fluid reservoir, such as an IV bag). The base 210 and threads 232 form a male luer fitting at the distal end of the connector 200 that is coupled to a conduit, such as a patient. Valve element 220 includes a space 221 that can be filled with air and vented to the atmosphere when compressed and uncompressed, as explained in more detail below.
S 8 201249488 第3A及3B圖提供適應根據本發明的一個具體實例之 典型的正排量無針接取連接器2〇〇之展開式闡明。第3A圖係 一剖視圖，然而第3B圖顯示出連接器2〇〇的外部，且第3A 及3B圖二者顯示出基座21〇已固定至閥元件22()。 在此具體實例中，基座21〇及閥元件220使用内鎖式公/ 母配件250(為了方便，於本文中指為卡扣配件）耦合在一 起。將閥元件220的頂端（其係卡扣配件25〇的母部分)製成足 夠小’以便在基座210的相應部分（其形成卡扣配件25〇的公 部分)處具有緊的密封式壓擠。在許多具體實例中，在卡扣 配件250處的密封係氣密（至少在正常操作溫度及壓力下）， 以便在連接器200中保持空氣與流體分離。在製造期間，基 座210及閥元件220可藉由手或藉由機器將其用力推在一起 而固疋。在某些具體實例中，約一磅的力量足以製得連接 及約二磅足以打破連接，然而多個具體實例可不同。 雖然第3A及B圖顯示出一卡扣配件250，具體實例的範 圍不如此限制。例如’其它具體實例可使用不同型式的固 疋配件’諸如帶螺紋的組合或其它配件。 在第3A及3B圖的典型具體實例中，基座21〇及閥元件 220的外部表面在卡扣配件250處齊平。對真實世界的裝置 來說，要了解閥元件220及基座210之外部表面將很少精確 地齊平’而是在某些具體實例中，一些容忍量(例如，約2%) 係可接梵。因此，連接器200以卡扣配件250置換習知的正 排量裝置之凸緣(例如，第1A圖的凸緣105)及齊平顯示在第 3A及3B圖中的外表面。因此，閥元件22〇的形狀具有較窄 201249488 的外觀，及可使用在較窄的外觀連接器中。 基座210與閥元件220固定在一起以形成一放入外殼 230中的組合。連接器200使用一稍微”v”形的配件讓基座 210與外殼230配接。互補的表面211及233基本上係v形，但 是具有稍微的曲率且一起安置，以便當將基座210插入外殼 230中時能適當地托住基座210。當插入基座210時，互補的 表面211，233自動對準基座210相對於外殼230排成一直線， 作用如為凸輪。因此，若以偏離一直線之某一任意角度數 插入基座210時’互補的表面211,233(—旦接觸）會將基座 210轉入位置中。結果，基座210精確地座落，及在密合後， 當末端流動通道213連接至基座210的公魯爾輸出口時，空 氣排氣孔212將能夠排氣至大氣。 在此具體實例中，末端流動通道213與空氣排氣孔212 係彼此垂直。因此，在第3B圖中顯示出二個空氣排氣孔212 之一，然而末端流動通道213以截面顯示在第3A圖中。流動 及排氣更詳細地顯示在第4圖中。 第4圖係根據一個具體實例的典型連接器200在使用時 之透視闡明。在第4圖中，流體係從公魯爾連接器41 〇(其與 母魯爾配件231嚙合），經由外殼230 ’經由基座21〇的公魯 爾輸出口及進入母魯爾配件402中而轉移。此實施例可包括 從IV袋子（無顯示)將流體轉移進入患者企流中。當第4圖顯 示出流入患者中時，要了解本發明的多個具體實例亦促進 來自患者的流體流動。 當在母魯爾配件231處無連接時’閥元件230在母魯爾S 8 201249488 Figures 3A and 3B provide an expanded version of a typical positive displacement needleless connector 2 accompanies in accordance with one embodiment of the present invention. Fig. 3A is a cross-sectional view, whereas Fig. 3B shows the exterior of the connector 2, and both of the 3A and 3B shows that the base 21 is fixed to the valve member 22 (). In this particular example, base 21 and valve member 220 are coupled together using an internal lock male/female fitting 250 (referred to herein as a snap fit for convenience). The top end of the valve member 220 (which is the female portion of the snap fitting 25A) is made sufficiently small to have a tight sealing pressure at a corresponding portion of the base 210 that forms the male portion of the snap fitting 25〇 squeeze. In many embodiments, the seal at the snap fitting 250 is airtight (at least at normal operating temperatures and pressures) to maintain air and fluid separation in the connector 200. During manufacture, the base 210 and valve member 220 can be solidified by pushing them together by hand or by machine. In some embodiments, about one pound of force is sufficient to make the connection and about two pounds are sufficient to break the connection, although multiple specific examples may vary. Although Figures 3A and B show a snap fitting 250, the scope of the specific example is not so limited. For example, other specific examples may use different types of solid fittings such as threaded combinations or other fittings. In a typical embodiment of Figures 3A and 3B, the outer surface of the base 21 and valve member 220 are flush at the snap fitting 250. For real-world devices, it is to be understood that the outer surfaces of valve element 220 and base 210 will be less precisely flushed 'but that in some embodiments, some tolerance (eg, about 2%) is acceptable. Brahman. Accordingly, the connector 200 replaces the flange of the conventional positive displacement device (e.g., the flange 105 of Fig. 1A) with the snap fitting 250 and the outer surface that is flush shown in Figs. 3A and 3B. Thus, the shape of the valve member 22A has a narrower appearance of 201249488 and can be used in a narrower appearance connector. The base 210 is secured to the valve member 220 to form a combination that fits into the outer casing 230. The connector 200 mates the base 210 with the outer casing 230 using a slightly "v" shaped fitting. The complementary surfaces 211 and 233 are substantially v-shaped but have a slight curvature and are disposed together to properly hold the base 210 when the base 210 is inserted into the outer casing 230. When inserted into the base 210, the complementary surfaces 211, 233 are automatically aligned with the base 210 in line with respect to the outer casing 230, acting as a cam. Thus, if the pedestal 210 is inserted at any arbitrary number of angles from the straight line, the 'complementary surfaces 211, 233 (the contact) will transfer the susceptor 210 into position. As a result, the base 210 is accurately seated, and after the close, when the end flow passage 213 is connected to the male luer output of the base 210, the air vent 212 will be able to vent to the atmosphere. In this specific example, the end flow passage 213 and the air venting opening 212 are perpendicular to each other. Therefore, one of the two air vent holes 212 is shown in Fig. 3B, however the end flow path 213 is shown in cross section in Fig. 3A. Flow and exhaust are shown in more detail in Figure 4. Fig. 4 is a perspective view of a typical connector 200 according to a specific example when in use. In Fig. 4, the flow system is from the male luer connector 41 (which is engaged with the female luer fitting 231), via the outer casing 230' via the male luer output port of the base 21 and into the female luer fitting 402. And transfer. This embodiment may include transferring fluid from the IV bag (not shown) into the patient's commercial stream. While Figure 4 shows inflow into a patient, it is to be understood that various embodiments of the invention also facilitate fluid flow from the patient. When there is no connection at the female luer fitting 231, the valve element 230 is in the female luer
S 10 201249488 » 配件231的近端處和在肩部234處產生密封。此密封防止當 不使用時流體流過連接器2〇〇。同樣地，在配件231的近端 處之密封產生可擦拔的哈希(Hush)表面。在母魯爾配件23 1 的近端處及在肩部234處之密封顯示在第5圖中。 在使用期間，公魯爾配件401折疊閥元件220及打破在 肩部234處及在配件231的近端處之密封。然後’流體自由 繞著閥元件230及通過外殼230經由近側流動通道403(其形 成外殼230的内部表面）流動。在表面211,233處的密合擋住 流體，以便流體繞著v形流動及進入末端流動通道213中， 其中流體經由基座210的公魯爾輸出口導出。來自間隔221 的空氣經由空氣排氣孔212被排至大氣及進入螺紋艙 404(其係由基座210與外殼230形成的公魯爾配件之部分） * 中。空氣通道係由排氣孔212及外殼230的内部表面所限 • 定，及在表面211，233處的密合產生一密封，其保持空氣流 與該流體流分離。螺紋艙404不氣密（甚至當與母配件402嚙 合時），因此允許當閥元件220經壓縮（如在第4圖中般）或不 經壓縮時，間隔221與週圍的大氣連通。 第5圖係適應根據一個具體實例的典型連接器200之截 面闡明，其係從第2A、B及3A、B圖的截面轉動九十度。注 意’在第5圖中係從間隔221至大氣的空氣通道。該空氣通 道包括單排氣孔501(在基座210中形成）及排氣孔212。單排 氣孔501與排氣孔212形成實質上”Y”形的空氣通道。此係與 先前設計（無顯示）比較，其包括二或更多個在y軸方向（“軸 向”)上形成之分開的排氣孔，其將大氣直接連接至該間隔。 201249488 在習知的製造技術期間，使用注塑成型技術，及使用 將長、細的栓插入模具腔中（當材料係熱時)產生二或更多個 分開的排in當將模具打開時，移除該長、細的检以形 成二或更多個分開的排氣孔。但是，長、細的栓具有在使 用期間斷裂的趨勢。一般規則係較短及較粗的栓持續較長。 相較之下，基座210具有相對寛及短的排氣孔212，其 可藉由相應形狀的金屬片在模具中形成。該空氣通道在每 個排氣孔212中從基座210的中央轴至外表面具有三角形變 寬。相應形狀的金屬片（無顯示）比習知技術的長、細栓還粗 及較短，因此，較少遭遇到斷裂。單通道5〇1製成相對寬， 及將其放置在基座210的部分中（其與卡扣配件250的公部 分相應）。再者’因為單通道501不必需穿越從間隔221至帶 螺紋的艙404之全部長度’其避免夾緊該流體流動路徑。此 外，單通道501不以任何長、細的栓製得。 第6圖係根據一個具體實例之經組合及準備好使用的 典型連接器200之闡明。外殼230可由包括聚碳酸酯、聚苯 乙烯及丙烯腈丁二烯苯乙烯之材料製得。外殼230包括母魯 爾配件231，其在某些具體實例中符合〗s〇標準594。類似 地，在某些具體實例中，在外殼230的遠端處及與基座210 形成之公魯爾組態符合ISO標準594。閥元件220配置在外殼 230内及可由彈性材料（諸如聚矽氧橡膠，其可變形及可生 物相容）製得。 第7圖係適應根據一個具體實例的典型連接器700之闡 明。連接器700類似於連接器2〇〇(例如，第'2-6圖），但是使S 10 201249488 » The seal is created at the proximal end of the fitting 231 and at the shoulder 234. This seal prevents fluid from flowing through the connector 2 when not in use. Likewise, the seal at the proximal end of the fitting 231 creates a smudgeable Hush surface. The seal at the proximal end of the female Luer fitting 23 1 and at the shoulder 234 is shown in Figure 5. During use, the male luer fitting 401 folds the valve element 220 and breaks the seal at the shoulder 234 and at the proximal end of the fitting 231. The fluid then flows freely around the valve element 230 and through the outer casing 230 via the proximal flow passage 403 (which forms the inner surface of the outer casing 230). The close contact at the surfaces 211, 233 blocks the fluid so that the fluid flows around the v-shape and into the end flow channel 213, wherein the fluid is directed through the male luer output of the susceptor 210. Air from the space 221 is vented to the atmosphere via the air venting opening 212 and into the threaded compartment 404 (which is part of the male luer fitting formed by the base 210 and the outer casing 230)*. The air passage is defined by the venting opening 212 and the inner surface of the outer casing 230, and the sealing at the surfaces 211, 233 creates a seal that keeps the air flow separate from the fluid flow. The threaded compartment 404 is not airtight (even when engaged with the female component 402), thus allowing the spacing 221 to communicate with the surrounding atmosphere when the valve element 220 is compressed (as in Figure 4) or not compressed. Fig. 5 is a cross-sectional view of a typical connector 200 according to a specific example, which is rotated ninety degrees from the sections of Figs. 2A, B and 3A, B. Note that in Figure 5, the air passage from the interval 221 to the atmosphere. The air passage includes a single exhaust hole 501 (formed in the base 210) and a vent hole 212. The single row of vents 501 and venting holes 212 form a substantially "Y" shaped air passage. This is compared to the previous design (no display) which includes two or more separate vents formed in the y-axis direction ("axial") that connect the atmosphere directly to the space. 201249488 During the prior art manufacturing process, using injection molding techniques, and using long, thin pins inserted into the mold cavity (when the material is hot) produces two or more separate rows when the mold is opened, In addition to the long, thin inspection, two or more separate vent holes are formed. However, long, thin plugs have a tendency to break during use. The general rule is that the shorter and thicker plugs last longer. In contrast, the susceptor 210 has relatively short and short venting holes 212 that can be formed in the mold by metal sheets of corresponding shapes. The air passage has a triangular width in each of the vent holes 212 from the central axis to the outer surface of the base 210. Correspondingly shaped metal sheets (not shown) are longer and thinner than conventional techniques, and therefore less susceptible to breakage. The single channel 5〇1 is made relatively wide and placed in a portion of the base 210 (which corresponds to the male portion of the snap fitting 250). Again, because the single channel 501 does not have to traverse the entire length from the spacing 221 to the threaded compartment 404, it avoids clamping the fluid flow path. In addition, the single channel 501 is not made of any long, thin pins. Figure 6 is an illustration of a typical connector 200 that is combined and ready for use in accordance with one embodiment. The outer casing 230 can be made of a material including polycarbonate, polystyrene, and acrylonitrile butadiene styrene. The outer casing 230 includes a female luer fitting 231 that, in certain embodiments, conforms to the standard 594. Similarly, in some embodiments, the male luer configuration at the distal end of the outer casing 230 and with the base 210 conforms to ISO standard 594. Valve element 220 is disposed within outer casing 230 and may be fabricated from an elastomeric material such as polyoxyxene rubber which is deformable and biocompatible. Figure 7 is an illustration of a typical connector 700 adapted to a specific example. Connector 700 is similar to connector 2〇〇 (eg, Figures 2-6), but
S 12 201249488 * 用插槽及鍵配件讓外殼730與基座710配接，取代在連接器 200中的特徵之v形配件。在插槽及鍵組態中，基座71〇具有 突出（鍵）’其尺寸經製作以安置進在外殼730的内表面中之 插槽中（或反之亦然）。在製造期間，將基座710及閥元件220 插入外殼730中並轉動其，直到該插槽與該鍵配接。然後， 讓基座710與外殼730密合。具體實例之範圍不限於插槽及 鍵配件或v形配件，在多種具體實例中可使用如任何用來配 接基座與外殼的多種技術。 第8圖係根據一個具體實例，用來製造正排量無針連接 器的典型方法800之闡明。可例如藉由人類及/或一或多個 機器進行方法800。 在區塊801中，將閥元件之遠端固定至基座的近端。該 - 固定在閥元件與基座間產生一密封，其將該間隔與在該第 ， 一與第二魯爾配件間之流體流動路徑分開。區塊801產生一 包括一閥元件及一配接在一起的基座之組合（諸如顯示在 第3A圖中）。在一個實施例中，該閥元件及基座使用卡扣配 件配接，然而可在其它具體實例中使用其它固定技術。 在區塊802中，將該閥元件及基座配置在外殼内。例 如，可使用v形配件（諸如顯示在第3A及3B圖中，其自動對 準基座與外殼），然而可使用其它配件（諸如’鍵及插槽）。 當將該閥及基座配置在外殼内時，閥元件之近端在外殼的 近端處產生一或多個密封。 在區塊803中，永久地固定該基座與外殼。在區塊803 中可使用多種技術，諸如超音波熔接法、塗佈黏著劑及其 13 201249488 類似方法。在此實施例中，該基座與外殼緊緊地安置在一 起以便產生-密封，其在該基座與外殼永久固定後分開* 氣排出路徑與流體流動路徑。多個具體實例不限於顯二二 第8圖中的方法，如可加入、省略、重排或修改多種作:。 某些具體實例可在先前解決方案上享有—或多個優 點。在-個觀點中，消除第】八及_之凸緣減少閱元件及 依次連接ϋ㈣的尺寸。具妹傾_連接器通常預呀 具有較小的灌注體積’同樣地，其可減少流體及浪費且可 對保健專家更具視覺吸引力。額料，某些㈣實例且有 減低的整體寬度，當接近連接⑽導管料至皮 了 通常對患者更舒適。 、 ,、、Ut汁'脚犯彻邋不發明及其優點，應瞭解可於 文中製得多種改變、取代及變更而沒有離開本發明如由 加的申請專利範圍所定義之範圍。再者，本中請案 不想要受限於在專利說明f中所描述之製程、機器、製： 物質的組成物、構件、方法及步驟的特別具體實例。^ 般技藝人士將容易地從本發明之揭轉知，可根據本發 使用目前存在或錢欲發展之製程、_、製造、 組餘、構件、方法或步驟，其與描述 實例貫質上執行相同功能或實質上達成相同結果。二 賴c範圍想要在其範圍内包括此製 益、“、物質的組成物、構件、方法或步驟。 包括於本文中所描述的全部元件、 佳。要幅时娜1⑽㈣2= 〇 14 201249488 分及步驟置換或全然刪除，如將由熟習該項技術者明瞭。 廣泛來說，此文件揭示出一種正排量無針接取連接 器，其包括-具有母魯爾配件的外殼，一具有公魯爾配件 的基座及一閥元件，該閥元件具有一在外殼中產生密封的 近端、-間隔及-固定至基座以排出該間隔之氣體的遠 端；該基座與閥元件彼此耦合以產生一具有最大外徑小= 該外殼的内徑之組合。 概念 此文件已揭示出至少下列概念。 概念1。一種正排量無針接取連接器，其包括： 一具有母魯爾配件的外殼； 一具有公魯爾配件的基座；及 一閥元件，其具有一在該外殼中產生密封的近端、一 間隔及一固定至基座以排出該間隔的氣體之遠端，該基座 與閥元件彼此耗合以產生-具有最A外徑小於該外殼的内 徑之組合。 概念2。如概念1之正排量無針接取連接器，其中該閥 元件的遠端使用卡扣機構固定至該基座。 概念3。如概念1之正排量無針接取連接器，其中該外 殼係使用“v”形配件耦合至該基座。 概念4。如概念1之正排量無針接取連接器，其中該外 殼係使用鍵及插槽配件耦合至該基座。 概念5。如概念1之正排量無針接取連接器，其從該間 隔至該基座的遠端包括一“Y”形排氣路徑。 15 201249488 概念6。如概念5之正排量無針接取連接器，其中該“Υ” 形排氣路徑包括三角形分支。 概念7。一種正排量無針接取連接器，其包括： 一外殼，其在其近端處具有第一魯爾配件； 一基座，其在其遠端處具有第二魯爾配件；及 一閥元件，其具有一近端以在該第一魯爾配件處產生 密封，且固定至該基座以便該閥元件的表面實質上與該基 座表面齊平。 概念8。如概念7之正排量無針接取連接器，其中該外 殼與基座具有相應的配接表面。 概念9。如概念8之正排量無針接取連接器，其中該相 應的配接表面包含ν形的凸輪表面。 概念10。如概念8之正排量無針接取連接器，其中該相 應的配接表面包括插槽及鍵配件。 概念11。如概念7之正排量無針接取連接器，其中該外 殼、閥元件及基座定義出一從該第一魯爾配件至該第二魯 爾配件的流體流動路徑。 概念12。如概念11之正排量無針接取連接器，其中該 閥元件包括一間隔，且該閥元件與基座定義出一連接該間 隔與大氣的空氣通道。 概念13。如概念12之正排量無針接取連接器，其中該 空氣通道與該流體流動路徑呈密封。 概念14。一種正排量無針接取連接器，其包括： 一外殼，其在其近端處具有第一魯爾配件； 16S 12 201249488 * The housing 730 is mated with the base 710 with slots and key fittings instead of the v-shaped fittings of the features in the connector 200. In the slot and key configuration, the base 71 has a protrusion (key) that is sized to fit into a slot in the inner surface of the housing 730 (or vice versa). During manufacture, the base 710 and valve element 220 are inserted into the housing 730 and rotated until the slot mates with the key. Then, the base 710 is brought into close contact with the outer casing 730. The scope of the specific examples is not limited to slots and key fittings or v-shaped fittings, and various techniques for mating the base and the outer casing may be used in various embodiments. Figure 8 is an illustration of a typical method 800 for fabricating a positive displacement needleless connector, according to one embodiment. Method 800 can be performed, for example, by a human and/or one or more machines. In block 801, the distal end of the valve member is secured to the proximal end of the base. The - is fixed between the valve member and the base to create a seal that separates the spacing from the fluid flow path between the first and second luer fittings. Block 801 produces a combination comprising a valve element and a mating pedestal (such as shown in Figure 3A). In one embodiment, the valve element and base are mated using snap fittings, although other securing techniques may be used in other embodiments. In block 802, the valve element and base are disposed within the housing. For example, a v-shaped fitting (such as shown in Figures 3A and 3B that automatically aligns the base to the housing) can be used, although other accessories such as 'keys and slots can be used. When the valve and base are disposed within the housing, the proximal end of the valve member creates one or more seals at the proximal end of the housing. In block 803, the base and outer casing are permanently secured. A variety of techniques can be used in block 803, such as ultrasonic welding, coating adhesives, and the like. In this embodiment, the base and the outer casing are tightly disposed together to create a seal that separates the air discharge path from the fluid flow path after the base is permanently secured to the outer casing. A plurality of specific examples are not limited to the method of the second embodiment, as may be added, omitted, rearranged or modified. Some specific examples may have one or more advantages over previous solutions. In one point of view, the size of the flange reducing component and the ϋ (4) are sequentially eliminated. With the sister tilting connector, the connector usually has a smaller perfusion volume. Similarly, it reduces fluid and waste and is more visually appealing to health care professionals. Forehead, some (iv) examples and have a reduced overall width, which is generally more comfortable for the patient when approaching the (10) catheter material to the skin. , , , , , U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U U Furthermore, the present application is not intended to be limited to the particular embodiments of the compositions, components, methods, and steps of the processes, machines, and processes described in the patent specification. ^ The skilled artisan will readily recognize from the disclosure of the present invention that a process, a _, a manufacturing, a component, a component, a method, or a process that is currently in existence or in a desire to be developed may be used in accordance with the present invention. The same function or substantially the same result. The scope of the C is intended to include such benefits, ", composition of matter, component, method or procedure within its scope. It includes all the components described in this article. It is good to be. 1) (10) (4) 2 = 〇14 201249488 And the step replacement or total deletion, as will be apparent to those skilled in the art. Broadly speaking, this document discloses a positive displacement needleless connector that includes a housing with a female Luer fitting, one having a male a base of the fitting and a valve member having a proximal end that creates a seal in the outer casing, a spacer, and a distal end that is fixed to the base to discharge the spaced gas; the base and the valve member are coupled to each other To produce a combination having a maximum outer diameter = the inner diameter of the outer casing. Concepts This document has revealed at least the following concepts. Concept 1. A positive displacement needleless connector, comprising: a female luer fitting a housing having a male luer fitting; and a valve member having a proximal end that creates a seal in the housing, a spacing, and a distal end of a gas secured to the base to discharge the spacing, base Compatible with the valve elements to produce - a combination having a maximum A outer diameter less than the inner diameter of the outer casing. Concept 2. A positive displacement needleless connector as in Concept 1, wherein the distal end of the valve element uses a snap The mechanism is fixed to the base. Concept 3. A positive displacement needleless connector as in Concept 1, wherein the outer casing is coupled to the base using a "v" shaped fitting. Concept 4. Positive displacement as Concept 1. A needleless connector, wherein the housing is coupled to the base using a key and a socket fitting. Concept 5. A positive displacement needleless connector as in Concept 1, from the spacing to the base The end includes a "Y" shaped exhaust path. 15 201249488 Concept 6. A positive displacement needleless connector as in Concept 5, wherein the "Υ" shaped exhaust path includes a triangular branch. Concept 7. A positive displacement a needleless connector, comprising: a housing having a first luer fitting at a proximal end thereof; a base having a second luer fitting at a distal end thereof; and a valve element having a proximal end to create a seal at the first luer fitting and secured to the base for the The surface of the element is substantially flush with the surface of the base. Concept 8. A positive displacement needleless connector as in Concept 7, wherein the housing has a corresponding mating surface with the base. Concept 9. Concept 8 Positive displacement needleless connector, wherein the corresponding mating surface comprises a v-shaped cam surface. Concept 10. The positive displacement needleless connector of Concept 8, wherein the corresponding mating surface includes a plug Slot and key fittings Concept 11. The positive displacement needleless connector of Concept 7, wherein the housing, valve member and base define a fluid from the first Luer fitting to the second Luer fitting Flow path. Concept 12. The positive displacement needleless connector of Concept 11, wherein the valve element includes a gap and the valve element defines a gas passage connecting the space to the atmosphere. A positive displacement needleless connector such as Concept 12, wherein the air passage is sealed from the fluid flow path. Concept 14. A positive displacement needleless connector includes: a housing having a first luer fitting at a proximal end thereof;
S 201249488 -基座，其在其遠端處具有第二㈣配件；及 -閥元件，料有L找第—魯_ 祕，且《互鎖式卡扣配件固定至該基座的近端。 概念i5。如概念14之正排量無針接取連接器， 自闊元件的間隔之空氣通道包括單-路徑，其轴向配置^ 該基座形成卡扣配件部分之一部分中。 概念16。如概念15之正排量無針接取連接器，其” 空氣通道進-步包括從鱗—路徑至大氣的分支。〇Χ 概念17。如概念16之正排量無針接取連接器 分支係三角形。 、亥 概念18。一種組合一無針接取連接器的方法，該無針 接取連接器包括-外殼’其在其近端處具有第爾配 件；一基座，其在其遠端處具有第二魯爾配件；及—閥元 件，其具有一間隔及一在該第一魯爾配件處產生第—密封 的近端，該方法包括： 將該閥元件的遠端固定至該基座的近端，在該間元件 與基座間產生第二密封’其分隔開該間隔與在該第—與第 二魯爾配件間之流體流動路徑，其中該閥元件與基座之外 表面齊平，其中該等外表面接觸；及 將該閥元件與基座配置在該外殼内。 概念19。如概念18之方法，其中將該閥元件的遠端固 定至該基座的近端，其包括： 將互鎖式卡扣配件用力推在一起。 概念20。如概念18之方法’更包括： 17 201249488 將該基座永久固定至該外殼。 【圖式簡I說明】 第1A圖係現在i針接 .、，、針接取連接器的剖視圖。第汨圖顯示 出在將公魯爾插入母魯爾中 宫阳中後’呈折疊的位置之可折疊式 B月分.杜。 第2Α及2B1J提供適應根據本發明的—個具體實例之 典型正排量無針接取連接㈣展開式闊明。 第3Α及3Β ®提供適應根據本發明的—個具體實例之 典型正排量無針接取連接器的展開式關明。 第4圖係根據一個具體實例的典型連接器在使用時之 透視闡明。 第5圖係適應根據—個具體實例的典型連接器之截面 闡明，其係將第2Α、Β及3Α、Β圖之截面旋轉九十度。 第6圖係根據一個具體實例之組合及準備好使用的典 型連接器之闡明。 第7圖係適應根據一個具體實例的典型連接器之闡明。 第8圖係用來製造根據一個具體實例之正排量無針連 接器的典型方法之闡明。 【主要元件符號說明】 100…無針接取連接器 101…母魯爾配件 102...公魯爾配件 105·.·凸緣 106…第二公魯爾配件 107...肩部 103...閥元件 110…頂端表面 104…體積 201249488 120...外殼 234...肩部 130...基座 250...内鎖式公/母配件 200...無針接取連接器 401...公魯爾配件 210...基座 402...母魯爾配件 211...表面 403...流動通道 212...空氣排氣孔 404...螺紋艙 213...末端流動通道 501...單通道 220...閥元件 700...連接器 221…間隔 710...基座 230...外殼 730...外殼 231...母魯爾配件 800...方法 232...螺紋 801、802、803...區塊 233...表面 19S 201249488 - a base having a second (four) fitting at its distal end; and - a valve element, having a L-final, and an interlocking snap fitting secured to the proximal end of the base. Concept i5. As with the positive displacement needleless connector of Concept 14, the spaced air passages of the wide elements include a single-path, axially configured to form the base into one of the portions of the snap fitting portion. Concept 16. For example, the concept of a positive displacement needleless connector, the "air channel advancement step includes a branch from the scale-path to the atmosphere. 〇Χ Concept 17. The positive displacement needleless connector branch of Concept 16 Triangle, 18. Concept of a combination of a needle-free connector, the needle-free connector includes a housing - having a Dier fitting at its proximal end, and a base at its distal end a second luer fitting at the end; and a valve element having a spacing and a proximal end that produces a first seal at the first luer fitting, the method comprising: securing the distal end of the valve element to the a proximal end of the base, creating a second seal between the element and the base that separates the spacing from the fluid flow path between the first and second luer fittings, wherein the valve element is external to the base The surface is flush, wherein the outer surfaces are in contact; and the valve member and the base are disposed within the outer casing. Concept 19. The method of Concept 18, wherein the distal end of the valve member is secured to the proximal end of the base , which includes: Pushing the interlocking snap fittings together. Read 20. The method of Concept 18' includes: 17 201249488 Permanently fix the base to the outer casing. [Illustration of the figure I] Figure 1A is a cross-sectional view of the current pin, connector, and pin connector. The second figure shows the foldable B-month. Du after the insertion of the male luer into the female Luer Zhonggongyang. The second and the 2B1J provide a specific example according to the invention. Typical positive displacement needleless access connections (4) Expandable styles. Sections 3 and 3 provide an expanded view of a typical positive displacement needleless connector that accommodates a specific example in accordance with the present invention. The typical connector according to a specific example is illustrated in perspective when used. Figure 5 is a cross-sectional illustration of a typical connector according to a specific example, which is a rotation of the second, Β, and 3Α, Β Fig. 6 is a diagram illustrating a combination of a specific example and a typical connector ready for use. Fig. 7 is an illustration of a typical connector according to a specific example. Fig. 8 is for manufacturing according to a specific Positive displacement of the example Description of the typical method of the connector. [Main component symbol description] 100... Needle-free connector 101... Female Luer accessory 102... Male Luer fitting 105·.·Flange 106...Second male Luer fitting 107...shoulder 103...valve element 110...top surface 104...volume 201249488 120...shell 234...shoulder 130...base 250...interlocked male/female accessory 200. .. needleless connector 401... male luer fitting 210... pedestal 402... female luer fitting 211... surface 403... flow passage 212... air vent 404 ...the threaded compartment 213...the end flow channel 501...the single channel 220...the valve element 700...the connector 221...the spacing 710...the base 230...the outer casing 730...the outer casing 231 ...Female Luer Accessory 800... Method 232... Threads 801, 802, 803... Block 233... Surface 19