Vial access and injection system
Abstract
The mixing and feeding device will be described. The device comprises a housing with both open ends and a container access member having at least one penetrating fluid conduit and extending substantially outward from one end of the housing. The device has at least one penetrating fluid conduit and includes a fluid supply device access member that extends substantially outward from the other end of the housing provided with the container access member. The fluid supply device access member and the container access member communicate with each other in fluid. [Selection diagram] Fig. 2

Term
Projected expiry 21 August 2028.
- Priority
- Filed
- Published
- Today
- Projected expiry
46 claims: 6 independent, 40 dependent
- 1第1の開端部及び第2の開端部を有するハウジングと、 少なくとも1つの貫通する流体導管を有し、かつ前記ハウジングの前記第1の開端部からほぼ外方に延在するバイアルアクセス部材と、 少なくとも1つの貫通する流体導管を有し、前記ハウジングの前記第2の開端部に向かって延在し、かつ前記バイアルアクセス部材と流体連通する注射器アクセス部材と を備えている混合及び送給装置。
- 2前記ハウジング内に設けられ、注射器の投与用部材を受け入れるように構成され、かつ前記注射器の投与用部材を前記注射器アクセス部材から取り外し可能とするように構成された受入れ手段をさらに備えている請求項1に記載の混合及び送給装置。
- 3前記注射器アクセス部材が、前記注射器の投与用部材によって得られる流量よりも大きな流量となるように画成された大流量のバイパス導管として構成されている、請求項1に記載の混合及び送給装置。
- 4前記注射器アクセス部材と前記バイアルアクセス部材とが、相互接続流体導管を介して流体連通している、請求項1に記載の混合及び送給装置。
- 5前記バイアルアクセス部材が通気管路を備え、前記通気管路が前記ハウジングの周囲の大気環境に連通可能に構成されている、請求項1に記載の混合及び送給装置。
- 6前記通気管路と流体連通したフィルタをさらに備えている請求項5に記載の混合及び送給装置。
- 7少なくとも1つの貫通する流体導管を有し、かつ前記ハウジングの第1の開端部からほぼ外方に延在する別のバイアルアクセス部材をさらに備えている請求項1に記載の混合及び送給装置。
- 8前記別のバイアルアクセス部材が通気管路を備えており、前記通気管路が前記ハウジングの周囲の大気環境に連通可能に構成されている、請求項7に記載の混合及び送給装置。
- 9前記通気管路に流体連通したフィルタをさらに備えている請求項8に記載の混合及び送給装置。
- 10前記ハウジングに接続され、前記バイアルアクセス部材から離して配置され、かつ装置操作前又は操作中に、バイアルを前記バイアルアクセス部材から離れた位置で着脱可能とするように構成されたバイアル取付け手段をさらに備えている請求項1に記載の混合及び送給装置。
- 11前記ハウジングに接続され、前記注射器アクセス部材から離して配置され、かつ装置操作前又は操作中に、注射器を前記注射器アクセス部材から離れた位置で着脱可能とするように構成された注射器取付け手段をさらに備えている請求項1に記載の混合及び送給装置
- 12前記ハウジングに接続され、かつ前記バイアルアクセス部材から離して配置されたバイアル取付け手段と、前記ハウジングに接続され、かつ前記注射器アクセス部材から離して配置された注射器取付け手段とをさらに備えている請求項1に記載の混合及び送給装置。
- 13前記ハウジングにおける前記注射器取付け部材の近傍に配置され、かつ注射器の前記投与用部材の近傍に配置された対応する位置合せ部材を取り外し可能に受け入れる構成となっている少なくとも1つの位置合せ部材をさらに備えている請求項1に記載の混合及び送給装置。
- 14前記受入れ手段が、注射器の前記投与用部材に密封可能に接続されたカバーを収容するように構成されている、請求項2に記載の混合及び送給装置。
- 15前記受入れ手段が、注射器の前記投与用部材の近傍にてニードル安全機構を収容するように構成されている、請求項2に記載の混合及び送給装置。
- 16第1の開端部及び第2の開端部を有するハウジングと、 少なくとも1つの貫通する流体導管を有し、かつ前記第1の開端部からほぼ外方に延在する容器アクセス部材と、 少なくとも1つの貫通する流体導管を有し、前記第2の開端部にほぼ向かって延在し、かつ前記容器アクセス部材と流体連通する流体供給装置アクセス部材と、 前記ハウジング内に設けられ、流体供給装置の投与用部材を受け入れるように構成され、かつ前記流体供給装置の投与用部材を前記流体供給装置アクセス部材から取り外し可能に構成された受入れ手段と を備えている混合及び送給装置。
- 17前記容器アクセス部材は、前記流体供給装置の投与用部材によって得られる流量よりも大きな流量となるように画成された大流量のバイパス導管となっている、請求項16に記載の混合及び送給装置。
- 18前記流体供給装置アクセス部材及び前記容器アクセス部材が、相互接続流体導管を介して流体連通されている、請求項16に記載の混合及び送給装置。
- 19前記容器アクセス部材が通気管路を備えており、前記通気管路が前記ハウジングの周囲の大気環境に連通可能に構成されている、請求項16に記載の混合及び送給装置。
- 20前記通気管路と流体連通しているフィルタをさらに備えている請求項19に記載の混合及び送給装置。
- 21前記ハウジングに接続され、前記容器アクセス部材から離して配置され、かつ装置操作前又は操作中に、容器を前記容器アクセス部材から離れた位置で着脱可能とするように構成された容器取付け手段をさらに備えている請求項16に記載の混合及び送給装置。
- 22前記ハウジングに接続され、前記流体供給装置アクセス部材から離して配置され、かつ装置操作前又は操作中に、流体供給装置を前記流体供給装置アクセス部材から離れた位置で着脱可能とするように構成された流体供給装置取付け手段をさらに備えている請求項16に記載の混合及び送給装置。
- 23前記ハウジングに接続され、かつ前記容器アクセス部材から離して配置された容器取付け手段と、前記ハウジングに接続され、かつ前記流体供給装置アクセス部材から離して配置された流体供給装置取付け手段とをさらに備えている請求項16に記載の混合及び送給装置。
- 24前記ハウジングにおける前記流体供給装置取付け部材の近傍に配置され、流体供給装置の前記投与用部材の近傍に配置された対応する位置合せ部材を取り外し可能に受け入れる構成となっている少なくとも1つの位置合せ部材をさらに備えている請求項16に記載の混合及び送給装置。
- 25前記受入れ手段が、前記投与用部材に操作可能に接続されたカバーを収容するように構成されている、請求項16に記載の混合及び送給装置。
- 26前記受入れ手段が、前記投与用部材に操作可能に接続されたニードル安全機構を収容するように構成されている、請求項16に記載の混合及び送給装置。
- 27第1の開端部及び第2の開端部を有するハウジングと、少なくとも1つの貫通する流体導管を有し、かつ前記第1の開端部からほぼ外方に延在する容器アクセス部材と、少なくとも1つの貫通する流体導管を有し、前記第2の開端部にほぼ向かって延在し、かつ前記容器アクセス部材と流体連通している流体供給装置アクセス部材とを備えている混合及び送給装置と、 先端部に位置する投与用部材と、前記流体供給装置アクセス部材を受け入れるように構成され、かつ前記先端部に位置する密封可能なアクセス用ポートとを備え、前記第2の開端部に着脱可能に構成された流体供給装置と、 任意で前記第1の開端部に着脱可能に構成され、かつ任意で送給可能な物質を含んでいる少なくとも1つの容器と を備えている組立体。
- 28前記ハウジング内に設けられ、前記流体供給装置の投与用部材を受け入れるように構成され、かつ前記流体供給装置の投与用部材を前記流体供給装置アクセス部材から取り外し可能に構成された受入れ手段をさらに備えている請求項27に記載の組立体。
- 29前記流体供給装置が、前記注射器の投与用部材に取り外し可能に収容される基端部を有するプランジャーを備えている請求項27に記載の組立体。
- 30前記容器アクセス部材が、前記流体供給装置の投与用部材によって得られる流量よりも大きな流量となるように画成されている大流量のバイパス導管となっている、請求項27に記載の組立体。
- 31前記流体供給装置のアクセス用ポートが穿孔可能な部材となっている、請求項27に記載の組立体。
- 32前記穿孔可能な部材が、予めスリットの入った弁、隔膜、又は弁付きコネクタとなっている、請求項31に記載の組立体。
- 33前記流体供給装置アクセス部材及び前記容器アクセス部材が、相互接続流体導管を介して流体連通されている、請求項27に記載の組立体。
- 34前記容器アクセス部材が通気管路を備え、前記通気管路が前記ハウジングの周囲の大気環境に連通可能に構成されている、請求項27に記載の組立体。
- 35前記通気管路と流体連通したフィルタをさらに備えている請求項34に記載の組立体。
- 36前記ハウジングにおける前記流体供給装置アクセス部材の近傍に配置され、かつ流体供給装置の投与用部材の近傍に配置された対応する位置合せ部材を取り外し可能に受け入れる構成となっている少なくとも1つの位置合せ部材をさらに備えている請求項28に記載の組立体。
- 37前記ハウジングに接続され、前記容器アクセス部材から離して配置され、かつ装置操作前又は操作中に、容器を前記容器アクセス部材から離れた位置で着脱可能とするように構成された容器取付け手段をさらに備えている請求項27に記載の組立体。
- 38前記ハウジングに接続され、前記流体供給装置アクセス部材から離して配置され、かつ装置操作前又は操作中に、流体供給装置を前記流体供給装置アクセス部材から離れた位置で着脱可能とするように構成された流体供給装置取付け手段をさらに備えている請求項27に記載の組立体。
- 39前記流体供給装置が注射器となっている、請求項27に記載の組立体。
- 40前記受入れ手段が、前記投与用部材に密封可能に接続されたカバーを収容するように構成されている、請求項28に記載の組立体。
- 41前記投与用部材が、鈍端カニューレ、鋭端カニューレ、及び噴霧ノズルから成る群から選択されたものから構成されている、請求項27に記載の組立体。
- 42前記投与用部材が弁付きアダプターとなっている、請求項27に記載の組立体。
- 43前記受入れ手段が、前記投与用部材の近傍にてニードル突刺安全機構を収容するように構成されている、請求項27に記載の組立体。
- 44前記注射器がニードル突刺安全機構を備えている、請求項39に記載の組立体。
- 45前記安全機構が、ユーザによって作動されるか、又は受動的に作動されるように構成されている、請求項44に記載の組立体。
- 46ニードルカバーアセンブリと、 前記ニードルカバーアセンブリに接続されたラッチと、 前記ラッチと協働するように係合しているラッチ用棚形状部と、 投与用部材の近傍に位置し、かつ前記ラッチに作動可能に連結する変形可能部材と を備えているニードル安全機構であって、 プランジャーを前記変形可能部材に接触されることによって、前記ラッチが前記ラッチ用棚形状部から離れて、前記ニードルカバーアセンブリが展開するように構成されている、ニードル安全機構。
Independent claims46
69 paragraphs, as filed
[Cross-reference of related applications] This application is filed on August 21, 2007, US Provisional Patent Application No. 60 / 965,555, US Provisional Patent Application No. 61 / 003,676 filed on November 19, 2007, and February 25, 2008. It claims the gains of US Provisional Patent Application No. 61 / 066,974 filed in Japan, all of which are hereby incorporated by reference in their entirety.
[Field of invention] The present disclosure relates to a mixing and feeding device for injectable agents.
Lyophilized liquid drugs, and similar liquid drugs, are usually supplied in drug vials, which are made of elastomer and have standard container dimensions such as, eg. The container dimensions are 20 mm in diameter and 13 mm in diameter. For medication of these agents, if the patient is dosed through a route such as intramuscular, intravenous, intradermal, etc., a feeder is attached to the syringe and then, for example, the patient is dosed using a needle. There is a need to. Needles used to administer a drug to a patient are often different from needles or access devices used to access one or more vials. Certain types of needles, such as anti-coring needles, have been used for drug vials and are probably unsuitable for use when injecting into patients. For example, a pharmacist may use a high flow needle to remove a diluent from one source and inject the diluent into a frozen drug vial. The vial will be used for mixing and returning to the syringe (perhaps a new syringe). After this, the needles often used to prepare the drug are removed and discarded, and certain types of alternatives suitable for injection into the patient (eg, intramuscularly in the deltoid muscle). Replacing the germicidal needle, this new capped needle will deliver the drug to the patient from a syringe filled with the prepared drug. Mixing and preparation in the formulation of drugs varies widely, and some drugs may require careful mixing or flow through needles of specific dimensions. Since lyophilized drugs are expensive, it is necessary to minimize or nearly eliminate the amount remaining in drug vials.
The design and materials of the elastomeric containers for vials vary widely, requiring the user to adapt the appropriate needle or access device to the drug vial. The work of injecting a drug varies depending on both the location and type of injection. Since the preparation of the drug is often performed by a pharmacist or nurse, not the prescriber and / or the admin of the drug, there will be many steps in the process that will result in error. In addition, many tasks can take a long time to prepare, which can increase the cost of the task and complicate the task. Eventually, frequent needle replacement for drug preparation and dosing increases the risk of needle puncture damage.
Described here are vial access devices that address some of the challenges described above. The vial access device described herein reduces the number of steps and possible errors in the preparation and dosing of the drug delivered to the patient via a needle, spray nozzle, or lure connector. The vial access device described herein provides a high flow channel, which facilitates and facilitates drug preparation and protects the drug and / or blood product from mechanical damage or hemolysis. The vial access device described herein will protect the needle or element for injection during preparation, maintain its cleanliness and sharpness, and ensure the patient's preparation for dosing. The vial access device described herein can prevent or nearly eliminate unintended and / or accidental needle puncture by the user and healthcare professional by accommodating the needle safety mechanism.
As one form, a mixing and feeding device is described. The device includes a housing with a first open end and a second open end, and a vial access member with at least one penetrating fluid conduit. The vial access member extends substantially outward from one end of the housing. The device includes a syringe access member with at least one penetrating fluid conduit. The syringe access member extends substantially outward from the other end of the housing provided with the vial access member. The syringe access member and the vial access member are in fluid communication with each other. In one form, the device further comprises a receiving means within the housing. The receiving means is configured to receive a member for administration of the syringe.
As another form, the assembly is described. The assembly comprises a mixing and feeding device, a fluid feeding device, and a container having a material that can optionally be fed. The mixing and feeding device has a housing with a first open end and a second open end, and a container having at least one penetrating fluid conduit and extending substantially outward from one end of the housing. It is equipped with an access member. The device comprises a fluid supply device access member having at least one penetrating fluid conduit and extending substantially outward from the other end of the housing having the container access member. The fluid supply device access member and the container access member communicate with each other in fluid. The fluid supply device is configured to be removable from the fluid supply device mounting means. The fluid supply device is configured to receive an administration member located at the tip, an access port located at the tip and an access port located at the tip, and a syringe member located at the proximal end. It is equipped with a plunger having a base end that is slidably housed toward it. Further, the present assembly is configured to be detachably attached to and detachably attached to the container mounting means, and includes at least one container containing a substance which can be arbitrarily fed.
<figref num="1">It is a perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="2">FIG. 5 is a perspective view of an embodiment of an access device / fluid supply device / vial assembly shown in an unlocked aspect prior to access.</figref><figref num="3">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="4">FIG. 6 is a schematic representation of an embodiment of a vial access device / fluid supply device assembly shown in an unlocked aspect prior to access.</figref><figref num="5">It is a perspective view of the embodiment of the vial access device / fluid supply device / vial assembly shown in the locked aspect before access.</figref><figref num="6">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="7">FIG. 6 is a schematic representation of an embodiment of a vial access device / fluid supply device assembly shown in an unlocked aspect prior to access.</figref><figref num="8">It is a perspective view of the embodiment of the vial access device / fluid supply device assembly shown in the aspect before access.</figref><figref num="9">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="10">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="11">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="12">It is an exploded perspective view of the embodiment of the vial access device / fluid supply device assembly.</figref><figref num="13">13 and 13A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="14">14 and 14A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="15">15 and 15A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="16">16 and 16A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="17">17 and 17A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="18">18 and 18A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="19">19 and 19A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="20">20 and 20A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="21">21 and 21A are a plan view and a cross-sectional view of the embodiment of the vial access device as viewed from a specific direction.</figref><figref num="22">22 and 22A are a plan view and a cross-sectional view of the embodiment of the syringe as viewed from a specific direction.</figref><figref num="23">23 and 23A are a plan view and a cross-sectional view of the embodiment of the syringe as viewed from a specific direction.</figref><figref num="24">24 and 24A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="25">25 and 25A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="26">26 and 26A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="27">27 and 27A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="28">28 and 28A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="29">29 and 29A are a plan view and a partial cross-sectional view of an embodiment of a syringe / vial access device assembly as viewed from a specific direction.</figref><figref num="30">30 and 30A are a plan view and a partial cross-sectional view of the embodiment of the needle puncture safety mechanism as viewed from a specific direction.</figref><figref num="31">31 and 31A are a plan view and a partial cross-sectional view of an embodiment of the needle puncture safety mechanism as viewed from a particular direction, which is shown before the needle is accessed by the patient.</figref><figref num="32">32 and 32A are a plan view and a partial cross-sectional view of the embodiment of the needle puncture safety mechanism as viewed from a specific direction, showing the needle completely punctured by the patient.</figref><figref num="33">33 and 33A are a plan view and a partial cross-sectional view of the embodiment of the needle puncture safety mechanism as viewed from a specific direction, showing the needle away from the patient and with the safety mechanism deployed.</figref><figref num="34">34 and 34A are plan and cross-sectional views of the embodiment of the needle puncture safety mechanism, as viewed from a particular direction, shown before the needle is accessed by the patient.</figref><figref num="35">35 and 35A are plan and cross-sectional views of the embodiment of the needle puncture safety mechanism viewed from a particular direction, showing the needle fully punctured by the patient.</figref><figref num="36">36 and 36A are plan views and cross-sectional views of an embodiment of the needle puncture safety mechanism viewed from a particular direction, showing the needle away from the patient and with the safety mechanism deployed.</figref><figref num="37">37 and 37A are a plan view and a partial cross-sectional view of an embodiment of a needle puncture safety mechanism having a needle cover as viewed from a specific direction.</figref><figref num="38">38 and 38A are a plan view and a partial cross-sectional view of an embodiment of a needle puncture safety mechanism having a needle cover as viewed from a specific direction.</figref><figref num="39">39 and 39A show the specific direction of the embodiment of the needle puncture safety mechanism, which is shown with the plunger in the proximal position after the needle has been completely punctured by the patient and before deployment. It is a plan view and a partial cross-sectional view seen from.</figref><figref num="40">40 and 40A show the plunger in the distal position after the needle has been completely punctured by the patient and before deployment, from the particular direction of the embodiment of the needle puncture safety mechanism. It is a seen plan view and a partial sectional view.</figref><figref num="41">41 and 41A are a plan view and a partial cross-sectional view of an embodiment of a needle puncture safety mechanism having a needle cover as viewed from a specific direction.</figref><figref num="42">42 and 42A are a plan view and a partial cross-sectional view of an embodiment of a needle puncture safety mechanism having a needle cover as viewed from a specific direction.</figref><figref num="43">43 and 43A show the plunger in the proximal position after the needle has been completely punctured by the patient and before deployment, the needle puncture safety mechanism of FIGS. 41 and 41A. It is a plan view and a partial cross-sectional view seen from the specific direction of the embodiment.</figref><figref num="44">44 and 44A show the plunger in the distal position after the needle has been completely punctured by the patient and before deployment, of the needle puncture safety mechanism of FIGS. 41 and 41A. It is a plan view and a partial cross-sectional view seen from the specific direction of the embodiment.</figref><figref num="45">It is a perspective view of the embodiment of the needle piercing safety mechanism of FIGS. 41 and 41A shown in the developed aspect.</figref><figref num="46">It is a perspective view of the embodiment of a needle cover.</figref><figref num="47">It is a perspective view of the embodiment of the needle piercing safety mechanism shown in the undeployed aspect.</figref><figref num="48">It is a perspective view of the embodiment of the needle piercing safety mechanism shown in the developed aspect.</figref><figref num="49">FIG. 5 is a perspective view of an embodiment of a needle puncture safety mechanism shown in a fully deployed aspect.</figref><figref num="50">It is a perspective view of the embodiment of the needle piercing safety mechanism shown in the undeployed aspect.</figref><figref num="51">FIG. 5 is a perspective view of an embodiment of a needle puncture safety mechanism shown in a folded and unfolded manner.</figref>
Disclosed herein are devices for mixing and feeding. The device comprises a housing with both open ends and a container access member with at least one penetrating fluid conduit. The container access member extends approximately outward from one open end of the housing. The housing also includes a fluid supply access member with at least one penetrating fluid conduit. The fluid feeder access member extends substantially towards the other open end of the housing. The fluid supply device access member and the container access member communicate with each other in fluid. The device further includes a receiving means in the housing. The receiving means is configured to receive the dosing member of the fluid supply device. The access device is configured to provide an interface between the contents of the container and the fluid supply device. The access device is configured such that the fluid supply device and the container are openly and hermetically fitted to the access device and communicate with each other.
<Access housing> The access device includes a housing with an open end and a container access member with at least one fluid conduit. The container access member extends substantially outward from one end of the housing. The device also includes a fluid supply device access member with at least one penetrating fluid conduit. The fluid supply device access member extends substantially outward from the opposite end of the housing provided with the container access member. The fluid supply device access member and the puncture access member communicate with each other in fluid.
The fluid feeder access member bypasses the dosing member of the fluid feeder so that a large flow rate of fluid can be delivered during suction and the integrity of the dosing member is maintained during fluid preparation. ,It is configured. The fluid feeder access member and access housing may include any number of components that are hermetically connectable to each other. In one form, the access device is a vial access device configured to receive a drug vial. The drug vial contains a punctureable diaphragm and the like. The vial access device includes a puncture member that extends from the end of its housing. The vial access device is configured such that the vial access member punctures the diaphragm of the vial to access the vial.
The vial access device preferably has one or more puncture members. At least one of these puncture members has an open conduit on its proximal side. The tip of the puncture member is advantageously mounted within the access housing via an interconnect conduit, thereby providing fluid communication between a container such as a drug vial and a fluid feeder such as a syringe. It is configured in. The puncture member is configured to support and puncture standard drug vials filled with powdered or lyophilized or liquid diluents. On the other hand, the syringe has a configuration suitable for delivering a liquid diluent and a drug solution between the vial and the syringe. At least one conduit is open with a vial access member and is configured to provide fluid communication with the interconnect conduit. It may be configured to allow ventilation to the atmosphere by the puncture member.
The vial access device may further include mounting means for allowing the vial access device to be attached to and detached from the vial. The vial access device may also include a plurality of flexible main tabs extending towards the second end of the device. These tabs form at its base end a vial mounting latch used to make the element removable to the vial. Each tab provided with a vial mounting latch may have a secondary tab extending from the primary tab towards the first end. The secondary tab has an end that can be provided with gripping means integrated with the tab. The element may include a tab used to guide the vial access adapter to the drug vial without providing a mounting latch. The vial access adapter is configured to be removed from the drug vial and kept attached to the fluid feeder.
In one form, a vial access instrumentation is sealable interface in other open end of the location, which is configured for standard syringe interface. Specifically, the sealable interface may be designed to hermetically fit into a standard syringe or a dedicated syringe. The sealable interface may be configured to be semi-permanently attached to the syringe or not removable when engaged with the syringe. A sealable interface attached semi-permanently to the syringe can reduce the requirements and / or cost of the tool. The housing and its integrated or attached components may be made of any of a variety of materials. Preferably, the housing is made of a material that is biocompatible and can withstand exposure to various sterilization methods and intended fluid media. Examples of materials used for housing include, but are not limited to, polycarbonate, polyethylene, polypropylene, PBT and the like. If desired, glass or carbon fiber, fillers, or other reinforcing media may be added to these plastics to increase rigidity.
<Fluid supply device access member> The access housing includes a fluid device access member and is configured to access the fluid supply device via the access member. The access member has at least one fluid conduit. The access member extends substantially towards the other open end of the access housing. The fluid supply device access member and the container access member are in fluid communication with each other.
In one form, the fluid supply device is a syringe having a member for administration, and the fluid supply device access member is a syringe access member. The syringe access member has at least one fluid conduit. The syringe access member extends approximately towards the other open end of the access housing. The syringe access member and the container access member are in fluid communication with each other.
The syringe access member comprises a flow path that bypasses the syringe member for administration. For example, the vial access device provides a fluid bypass for the syringe needle. The vial access device may be configured such that the flow rate when the fluid is drawn into the fluid supply device is larger than the flow rate when the administration means of the fluid administration device is used. The fluid bypass will also maintain the integrity of the dosing member (eg, needle sharpness) until final dosing is required. The fluid bypass may consist of a fluid path within the vial access device that communicates fluid to an access port (described herein) into the proximal end of the syringe barrel adjacent to the dosing member. This causes the fluid to substantially bypass the dosing component during feeding and / or mixing. The access port may be a self-closing, sealable passage provided in the syringe barrel such that fluid is supplied only through the needle during the injection stroke. This makes it possible, for example, to reduce the needle size of the fluid feeder and reduce patient discomfort during injection.
<Acceptance means> The access housing may define a receiving means in the housing. The receiving means is configured to receive the dosing member of the fluid supply device within the access housing. In one form, the receiving means is composed of an inner portion of a housing that provides an administration member, including a needle cover, eg, a sheathed area for accommodating the needle. The receiving means may include an area surrounding the outside of the fluid supply device access member. In one form, the receiving means is configured to work with a fluid feeder access member to provide an isolated flow path so that the fluid medium does not come into direct contact with the outer surface of the dosing member or its cover. That is, the receiving means isolates the administering means. Therefore, the outer surface of the means of administration will be kept clean during the preparation of the drug prior to injection into the patient, unaffected by the drug.
<Fluid supply device> The fluid supply device stores the fluid drawn from the container or guided to the container and / or the fluid to be administered to the patient. The components of the fluid supply device include a first open end that includes an ergonomic flange, a second end that has any number of openings for fluid communication, and an inner part that provides a sealable sliding interface. , With a base end lower housing having an outer portion. The lower housing is configured to fit a latch / alignment element to ensure mounting and / or position (shape) control when mated with the housing of the access device.
In one form, the fluid supply device is a syringe. The syringe comprises at least one access port capable of receiving the fluid feeder access member of the access housing. The access port facilitates drawing fluid through the bypass fluid passage of the syringe access member and feeding the fluid to the syringe while bypassing the administration member. The access port may be a two-way port that allows fluid to be delivered from the fluid supply device to the container. The syringe comprises a plunger having a first end and a second end. The first end may have ergonomic gripping means and the second end may have any number of function extensions. The mounting means for mounting the syringe stopper may be provided on the distal end side of the second end or integrated with the second end. The syringe stopper may have any number of continuous sealing elements around its outer portion to provide a slidable seal within the syringe barrel. The syringe stopper may be made of any of a variety of materials, such as those that are biocompatible, sterile, and capable of withstanding exposure of the system to the intended fluid medium. These materials preferably have elasticity and are reasonably deformable. Examples of this include, but are not limited to, elastomers such as rubber, silicones, thermoplastic elastomers, or thermosetting elastomers.
<Access port> The access port provides fluid communication between the fluid supply device access member and the fluid supply device. The access port is preferably resealable. In one form, the access port is a self-closing, sealable access port located at the proximal end of a fluid supply device adjacent to the dosing member. This causes the fluid to substantially bypass the dosing component during feeding and / or mixing. The sealable access port may consist of a sealing means, a pre-slitted diaphragm portion, and a thin film area, or an assembly thereof. In one form, the sealable access port is a pre-slitted diaphragm that has been extruded to give an generally parabolic, double beak, or similar shaped assembly (these are resealed). Pre-slits may be provided to allow possible and reusable access). In one form, the access port is a "double beak" check valve. In another form, the access port is a parabolic extruded, pre-slitted diaphragm that can further function as a check valve.
In one form, the sealable access port is composed of or integrated with a deformable thin film. As further described here, the deformable thin film can act substantially liquidtight, resulting in the activation of the needle puncture safety mechanism. The access port may be any of a variety of materials, such as those that are biocompatible, sterile, and capable of withstanding exposure of the system to the intended fluid medium. These materials are preferably elastic and reversibly deformable. Examples of this include, but are not limited to, elastomers such as rubber, silicones, thermoplastic elastomers, or thermosetting elastomers.
<Fluid supply device lower housing> The lower housing has a suspension portion across its inner diameter. This suspended portion comprises a deformable portion that provides communication between the fluid supply device and the operating needle puncture safety mechanism. The suspension portion may be an elastomeric thin film that functions to maintain a clean, leak-proof syringe. Further, the lower housing may be configured to attach the fluid supply device to the access device. For spring-armed needle puncture safety protection mechanisms, the lower housing may be configured to provide a locking means to the spring and / or capture mechanism. The lower housing is preferably configured so as not to block the flow path to the fluid supply device.
The lower housing includes mounting means that allow a sealable bond to the fluid supply device, an elastomeric portion that creates an airtight seal during joining, a mounting member that substantially joins the dosing member, and a fluid dosing member. It is provided with one or a series of openings that allow access to the access port of the fluid supply device.
<Fluid administration member> The fluid administration member provides fluid communication between the fluid feeder and the patient, or may be used to access the vial. In one form, the fluid dosing member is a hollow puncture member. The fluid dosing member is preferably any of the needles, blunt-ended cannulas, spray nozzles, male valve adapters, female valve adapters, lure connectors, or lure connectors and the options listed as these fluid dosing members. It is an assembly of the heel. In one form, the fluid dosing member is a needle of any size or any gauge (standard size) commonly used for dosing. The fluid administration member generally comprises a first open end and a second open end. In one form, the second end is configured to be provided with a sharp or puncture end. The fluid administration member may be made of metal or may be made of plastic. In one form, the fluid dosing member is made of stainless steel.
In one form, the dosing member is further composed of an dosing member cover. The dosing member cover is configured to provide needle puncture protection and / or to maintain the sterilization of the dosing member before use. In one form, the dosing member cover is mechanically closed by the dosing member and / or the attachment member of the dosing member. This sealing relationship can prevent air from being sucked or expelled during fluid preparation. In one form, the needle cover is housed within the receiving means of the access housing. The needle cover may be composed of any of a variety of materials, such as biocompatible and / or sterilizing materials.
<Needle piercing safety mechanism> The needle cover described above can provide some level of protection for the user's needle puncture prior to injection into the patient. In addition, another level of needle puncture safety may be provided to the fluid feeder. For example, once the device has been used, the needle puncture safety mechanism may be configured to passively deploy at least a cover device or cover mechanism that covers the tip of the needle. In other embodiments, the needle puncture safety mechanism is activated by the user to deploy a cover device or cover mechanism that at least covers the tip of the needle and protects the user or the like from accidental puncture of the needle. It may be configured in. In addition, during manufacturing, the needle assembly is housed in a vial access device, which can be combined with this needle penetration safety mechanism to provide greater safety during assembly. Examples of passive needle puncture mechanisms include, but are not limited to, not only mechanisms that disengage the internal needle puncture protector at the end of the stroke as defined herein, but also well-known passive and active needle puncture protectors (eg, passive and active needle puncture protectors). , Buttons, slides, doors, etc.).
In one form, the needle puncture safety mechanism comprises means for passively deploying the mechanism at or near the end of the drug supply stroke of the plunger. In one form, the needle puncture safety mechanism comprises at least one protrusion. This at least one protrusion is coordinated with the deformable area of the lower housing to move the detachable latch near the base end of the syringe, releasing the stored energy. The protrusion is located at the end of the syringe and with the corresponding latching means by contacting the deformable area of the lower housing at the end of the stroke, i.e. when reaching the bottom of the syringe barrel. It should be configured to interact. When the fluid is completely injected from within the syringe and when it has substantially reached the end of the stroke, i.e., substantially at the bottom of the syringe barrel, the at least one protrusion releases the latching means. The components of the needle piercing safety mechanism are deployed, and the needle tip cover is sent toward the needle tip.
In one form, the needle tip cover, as part of it, comprises a latch that fits into the mating latch means (or shelf-shaped portion) within the lower housing of the syringe or near the proximal end of the syringe. When a release force is applied, the latch arm is configured to release the stored energy and move the needle tip cover. That is, an external force applied directly or indirectly to the latch releases the needle tip cover of the safety mechanism (actuated by the stored energy means), thereby delivering the needle tip cover towards the needle tip. It will be.
In one form, the needle tip cover element comprises an open inner portion, an outer portion, and a first end and a second end. The outer portion has mounting means for the spring and the first end has one or more latching means. The needle tip cover preferably comprises a guide hole that slides along the needle. When the guide hole of the needle tip cover passes through the needle tip portion, the spring incorporated so as to be misaligned with respect to the needle center line causes the needle tip cover to be misaligned and moved to the needle tip portion. The spring may be in the form of a conventional metal wire, or of any material, such as, but not limited to, elastomer or plastic, bellows, spiral coil with a flat end for mounting, double helix, It may be composed of one material, or may be composed of a plurality of materials.
In one form, the needle puncture safety mechanism may include a twisting member to which a load is applied to obtain the stored energy. This stored energy will be released to the end of the plunger stroke. Examples of twisting members include, but are not limited to, twisting springs, leaf springs, or tension springs. One or more of these springs are coupled so that when the needle puncture safety mechanism is released, a force is applied to the connected member to transition from the folded mode to the expanded mode. .. The twisting member may be in the form of steel, plastic, or elastomer.
<Alignment means> The access device disclosed herein may include a positioning control unit and / or an alignment control unit for the fluid supply device access member of the access device in order to properly fit the fluid supply device. For example, a rotary cam control unit may be used. The rotary cam control requires the user to twist the access device in order for the fluid supply device to be fully seated to obtain an operating mode. The operating mode is defined as a mode in which the needle can be bypassed and sucked by the fluid access member penetrating the access port. In another aspect, the locking latch of the syringe and the latch shelf shape on the other side of the vial access adapter, which define the working and non-working modes, allow the user to latch in order to make a transition between these modes. Needs to be activated. In this way, the access port will not be accessed until it has been used. Therefore, just before use, the user will move the fluid supply device from the built-in position (pre-access position) to the "use" position (access position). The alignment shape portion may be configured to further provide proper alignment of the fluid supply device access member with respect to the access port.
<Manufacturing> In all of the proposed embodiments, members made by injection molding can be used except for needles. The intent of the design is that what is designed is molded as a simple open / closed tool in order to reduce tool cost and cycle time. The spiral metal spring is not injection molded, but may be an elastomer bellows spring. Many clip designs are configured to be molded as simple open / closed tools with the aim of reducing tool costs and cycle times. If the fineness of the shape cannot be obtained by molding as a simple tool, the components may be joined by ultrasonic welding, adhesives, or mechanical fixation. In addition, two-shot molding techniques may be used where it is advantageous to use dissimilar materials (ie, syringe diaphragm portions). In the case of the embodiment using the cap means as described here, the cap means has an appropriate sealing property, but may be connected so as to be removed without applying a large force. Adhesives may be required to substantially join the components, especially when designed to fit syringes in stock. Adhesives may be used to substantially join the relevant components, in particular to substantially join the fittings connected to the lure connection. Examples of adhesives include, but are not limited to, cyanoacrylates, two-component epoxies, thermoactive resins, UV curable adhesives, and hot melts. Bonding is not limited, but may be achieved by using solvent bonding, ultrasonic welding, and / or thermal staking.
<Use of vial access device> In the above description, the fluid supply device is represented by a syringe, but any fluid supply device may be used. An exemplary assembly comprises a syringe assembly with a needle and a vial access device that detachably accepts and seals the syringe at one end. The vial access device is configured to detachably accept the drug vial at the other end. Optionally, holding means are used to secure and attach the vial and / or syringe to the vial access device. Such means may provide audible, visual, or tactile signs for accurate assembly. Optionally, the vial access device may include one or more removal tabs as defined herein to facilitate continuous removal and / or installation of multiple vials. During assembly, the assembly will establish a fluid path that provides fluid communication between the syringe and the vial. The fluid communication between the syringe and the vial is via a route that bypasses the syringe needle or means of administration. For example, the vial access device houses the syringe needle or other means of administration so that it is sheathed and / or isolated from fluid communication between the syringe and the vial within the adapter. In one form, the fluid communication between the syringe and the vial consists of a fluid pathway bypass.
In one embodiment, an assembly having a syringe and a vial hermetically connected to a vial access device has two modes of operation, i.e. a non-operating mode in which fluid delivery from the vial is prevented or substantially eliminated. And / or allow an operating mode in which the needle of the syringe is bypassed. Bypassing the needle is done through a secondary flow path, which allows a large flow rate to be supplied by a conduit with a diameter larger than the diameter of the syringe needle. Bypass will be achieved by an access member with an isolated flow path inside the vial access device. During system operation, the access member is configured to pierce a pre-slitted diaphragm located near the syringe needle, thereby connecting directly to the interior of the syringe barrel.
After the syringe assembly is filled, the syringe assembly may be removed from the vial access device. The pre-slitted diaphragm of the syringe will self-close when removed. Also, a needle cover may be housed in the vial access adapter and incorporated around the needle to prevent air from being sucked or expelled during fluid preparation and to provide safe and clean transport. .. Once the needle cover has been removed, an injectable drug supply via the needle should be provided.
In other forms, the assembly with the syringe, needle cover, vial, and vial access device may be adapted to allow for three positional aspects.
1. A locking aspect in which the syringe and vial access device are prevented or prohibited from moving axially parallel to each other, but can rotate relative to each other. This position lock can be used to prevent unintended rotation until a moderate torque or a preset torque is applied. Examples of this lock include, but are not limited to, tight fits, snap fits, and the like.
2. A pre-access aspect in which fluid feeding from the vial is prevented or prohibited, but axial translation is possible.
3. A mode of bypass access that allows fluid communication between the accessed vial and the syringe. This has been accomplished via interconnected internal conduits within the vial access device. This interconnect internal conduit is terminated by a spiked or blunt syringe access member with at least one fluid conduit. The access member can penetrate the puncture diaphragm adjacent to the administration member. An example of this puncture diaphragm is, but is not limited to, a pre-slitted diaphragm. A snap-fitting latch mechanism such as a lock / unlock tab that provides tactile feedback when access through the diaphragm is achieved may be used. This latch can be configured so that the syringe disengages from the vial access device when pushed.
After the vial access device is used and the syringe contains the liquid or reconstituted material of the vial, the assembly with the syringe, needle cover, and needle puncture safety mechanism is configured to allow two modes of operation. It is good to be there.
1. A delivery mode in which the filled syringe is removed from the vial access device. In this aspect, a needle cover may be used to prevent contamination and to protect against unintended needle puncture.
2. A post-injection safety aspect in which the attached needle puncture safety mechanism is deployed passively or manually, as described herein.
As mentioned herein, methods using this vial access device will typically reduce the number of steps associated with drug access, drug preparation, and dosing. In addition, the embodiments detailed herein ensure optimal preparation and supply of the drug. Because the design of the vial access spike reduces waste, the high flow path avoids mechanical disruption of the drug, eliminates user dependence, and accommodates the needle or other means of administration within the assembly. And because the complexity is reduced.
Hereinafter, various exemplary embodiments will be described with reference to the drawings. FIG. 1 is a perspective view of a first embodiment of a vial access / injection assembly. The syringe (101) is hermetically coupled to the vial access device (102). The vial access device (102) includes a container access member (103), a plurality of mounting means (104) and a plurality of guide tabs (110) arranged concentrically around the container access member. The mounting means facing each other are composed of locking means (105). The mounting means may also include a tab (106) extending from the end of the mounting means. A gripping means (107) is shown on the tip side of the tab (106). The syringe (101) comprises a barrel (108) and a plunger rod (109).
FIG. 2 is a perspective view of the vial access / injection system assembly shown in the pre-access aspect. The syringe (301) is hermetically coupled to a vial access device (302) fixedly attached to the vial (303). FIG. 3 is an exploded view of the vial access device (302) showing the needle cover (305) and the needle piercing safety mechanism (304).
FIG. 4 is a schematic view of an assembly of a syringe / vial access device shown in a rotated state in a pre-access aspect. The syringe element alignment means (320) is pulled out from the rotation holding means (355) of the vial access device. The clip (364) ensures the connection between the vial access device and the syringe and prevents their axial movement.
FIG. 5 is a perspective view of a second form of the vial access / injection system shown in the locked embodiment. The syringe (401) is connected to the vial access device (402), which is fixedly attached to the vial (403). The clip (466) is provided with a tab (467) to prevent excessive expansion. FIG. 6 is an exploded view of FIG. 5 with the vial omitted, showing the vial access device (402), needle cover (405), and needle puncture safety mechanism (404) of the assembly shown in FIG. FIG. 7 is a schematic view of the assembly shown in FIG. 4 in the pre-access aspect.
FIG. 8 is a perspective view of an embodiment of a vial access / fluid feeder assembly showing a vial access device (501), a syringe (502), and alignment means (540a) (540b). FIG. 9 is an exploded perspective view of FIG. 8 showing a syringe (502), a vial access device (501), and a luer cap (503). FIG. 10 shows a vial access with a spray nozzle (639) as an administration member and a cap (603) that are hermetically secured to a lure (640) adjacent to the access port (642) of the syringe (502). -It is an exploded perspective view of the injection system.
FIG. 11 shows a vial access fluid supply showing a hollow needle dosing member (740) and a cap (703) that are hermetically secured to the lure (640) of the syringe (502) adjacent to the access port (642). It is an exploded perspective view of the embodiment of an apparatus assembly. FIG. 12 shows a vial access device (501) and a syringe (802) with an integrated spray nozzle dosing member (842) located adjacent to the access port (840), along with a cap (803). It is an exploded perspective view of the embodiment of the fluid supply device assembly.
FIG. 13 is a cross-sectional view of an embodiment of the access device. The access device includes a housing (132) and a container access member (133). The housing includes the vial mounting portion described above, a fluid supply device access member (134) having a fluid conduit (135), a receiving means (136) parallel to the central axis, and a housing for joining the housing to the container access member. It has a joint shape portion (137). The access member has a spike shape with an internal line (138) and a fluid line (139) for receiving the dosing member, and when incorporated into the housing, the internal line (138) receives. Arranged in line with the means (136) and sealed with the receiving means, the fluid line ((139) will communicate with the fluid conduit (135). The conduit (135) may have a larger cross-sectional area than the dosing member.
14 and 14A are a plan view and a cross-sectional view taken from a specific direction of the access device having the ventilation means, respectively. The ventilation line (143) communicates with the fluid supply device access member (144). A ventilation filter (145) is placed in the ventilation line for fluid communication. 15 and 15A are cross-sectional views of a form of access device showing an alternative ventilation configuration. A vent line (243) vents into the housing receiving means. A ventilation filter (245) is arranged in this ventilation line with fluid communication.
16, FIGS. 16, 17 and 17A are plan views and cross-sectional views of the access device embodiment as viewed from a particular direction, showing the receiving means for receiving the administration member of the needle puncture safety mechanism and the fluid supply device. is there. The vial access device is a first open end (325) and a second open end (326) terminated by a container access member (327) having at least one fluid line (328) and attached to the vial. A second end (326) having a plurality of mounting means (329) with locking means (330) for, a receiving means (331), and an alignment means (aligned to the tip side of the first open end). It comprises a housing (332) with 333a) and a clip (334) with ergonomic gripping means (335). The clip comprises a finger pad portion (362) that allows the clip to be arced to remove the connected syringe, and an outer portion with an ergonomic gripping means (335). An interconnect conduit (337) fluidly connects the container access member (327) and the fluid supply device access member (338). The fluid supply device access member (338) has at least one opening (339) on the distal end side of its proximal end. The access device has a ventilation conduit (340). The ventilation conduit (340) is open to the tip end of the container access member for ventilation and connects at least one opening (341) to the environment surrounding the vial access device. The ventilation conduit (340) comprises a filter (342). 18, FIG. 18A, FIG. 19 and FIG. 19A are a plan view and a cross-sectional view of the access device as viewed from a specific direction showing ventilation inside the access device. A filter (442) is located within the vent (469). The interconnect conduit (337a) fluidly connects the container access member (327a) and the fluid supply device access member (338a). The fluid supply device access member (338a) has at least one opening (339a) on the distal end side of its proximal end. The access device is It has an air vessel (340a). The ventilation conduit (340a) is open to the tip end of the end of the container access member and fluidly connects to at least one opening (341a) in the housing. The ventilation conduit (340a) is equipped with a filter (342a). Also, a protrusion (463) integrated into the clip (434) is shown. The protrusion (463) is to prevent excessive stress when a force is applied to the finger pad (462) region.
20, FIG. 20A, FIG. 21 and FIG. 21A have a second open end (518) and a second attachment means (521) with corresponding locking means (522) for attachment to a vial or container. It is a plan view and a cross-sectional view seen from a specific direction of an access device which shows an open end part (519). The access device has a container access member (520) that extends substantially outward from the second end. This access member has at least one conduit (523) open on the distal end side of its proximal end (524). Receiving means (525) is located inside the housing. The outer portion (526) of the access device has an ergonomic gripping means (528) and an ergonomic gripping means (527) on the distal end side of the first open end. An interconnect conduit (529) provides fluid communication between the base end of the vessel access member and the fluid feeder access member (530), which is shown in the form of a spiked or blunt-ended cannula. .. The fluid supply device access member has at least one opening (531) on the distal end side of its proximal end (532). The tab (537) has a gripping means (539) extending to the distal end side of the base end (538) of the mounting means to remove the mounted container or Bayer from the access device. The ventilation conduit (533) is open on the distal end side of the end of the container access member and is terminated by a ventilation opening (534) to the surrounding environment of the vial access device. The ventilation conduit (533) comprises a filter (535). The ventilation conduit may be optionally provided with a check valve. Examples of check valves include one-way check valves such as "top hat type", "double beak type", "umbrella type", and "flat disc type".
22 and 22A show a first closed end (505), a means of administration (506) that allows fluid communication between the syringe and its outside, a plunger connection (508), and an access port (5). 509), a second open end (510) with a plunger holding means (511) located on the tip side, and an outer portion with a protruding flange means (513) located on the tip side of the second end. It is a plan view and a cross-sectional view of the syringe (502) viewed from a specific direction, showing the alignment means (514) located on the tip end side of the first end portion. A stopper (515) with a slidable seal ring (516) is connected to the plunger rod (517). The access port may be configured in any form of access, eg, unrestricted, pre-slitted form, or any other punctureable member. The lure connection may be locked or unlocked.
23 and 23A show the first closed end (805), the dosing member (806), the spray nozzle (841), and the syringe (802) showing the access port (809) from a particular direction. It is a plan view and a sectional view as seen. The second open end (810) is located on the tip side of the second open end with the plunger holding means (811) located on the tip side to prevent the stopper and plunger rod from coming out of the syringe. Has a protruding flange (813). In addition, the syringe has an alignment means (814) located on the distal end side of the first end. A stopper (815) with a seal ring (816) is attached to the plunger rod (817).
24, 24A, 25 and 25A are a plan view and a cross-sectional view of the vial access device / syringe assembly (having a needle puncture safety mechanism) as viewed from a specific direction. One or more latch members (129) extend from the tip cover element (199). While the spring is in the compressed mode, the latch member (129) is latched in cooperation with the shelf-shaped portion (131) of the syringe lower housing. FIG. 25A shows a non-actuated needle puncture safety mechanism in an incorporated embodiment. The syringe access member (134) is shown adjacent to the pre-slitted access port (120) of the access port portion. The outer syringe seal (112) interacts with the internal raised shape (141) to provide a sign of the initial non-operational mode. This seal is configured to slide against the internal seal wall (142) of the vial access housing. The syringe and syringe cover (146) are housed inside the housing receiving means shown in the non-working mode.
26 and 26A are a plan view and a cross-sectional view of the embodiment shown in the operating mode of FIGS. 24 and 24 as viewed from a specific direction. The seal (112) is fully seated inside the housing of the vial access device (102) in this mode of operation. The syringe access member (134) pierces a pre-slitted access port (120), thereby opening a fluid path and fluid communication between the syringe (101) and the interconnect conduit (197) of the vial access device. Is possible. The vial mounting device (102) is pre-loaded with a first open end (195) having a sealable interface (208) and a second end (193) terminating with a spiked vial access member (233). It is provided with a syringe access member (134) extending from the inside of the housing of the device (102) to access a slitted access port (120) or the like. The vial access member may include any number of outward openings and any number of internal conduits. At least one internal conduit is in fluid communication with the inner part that provides the interconnect conduit. The syringe access member may have any form that allows fluid communication with the access port by piercing an access port or the like having a slit in advance. The second end of the housing comprises a plurality of mounting means (204) having guide tabs (210) arranged concentrically around the spiked portion. The facing mounting means are composed of locking means (205). The mounting means may include a removable tab (206) extending from the end of the mounting tab. The gripping means (207) on the tip side of the removal tab is optional. 27 and 27A show a vial access member (233) in which the syringe access member (234) has an external slot and the receiving means (250) for the needle / needle cover is not isolated from the fluid conduit (252). An alternative embodiment of FIG. 25A, located within, is shown.
28 and 28A are viewed from a particular orientation of the vial access device and syringe assembly (with needle puncture mechanism) in a non-working pre-access aspect that prevents fluid communication between the syringe access member and the syringe. It is a plan view and a cross-sectional view. As shown, the syringe access member (336) is aligned with the syringe access port (317) for puncture. 29 and 29A are views of a particular orientation of the vial access device and syringe assembly (with needle puncture mechanism) in an actuating bypass access configuration that allows fluid communication between the syringe access member and the syringe. It is a figure and a sectional view. As shown, the syringe access member (336) pierces the syringe access port (317) to provide fluid communication between the syringe (301) and the interconnect conduit (337) of the vial access device (302). It is possible.
30 and 30A are a plan view and a cross-sectional view of a syringe having a needle puncture mechanism as viewed from a specific direction. The syringe includes a plunger rod (109), stopper (111), syringe barrel (108), syringe outer seal (112), lower housing (114), hollow needle (115), needle tip cover (116), and spring. (117) is provided. The plunger rod may be provided with a flange (118) at one end and a protrusion (119) at the other end. The plunger rod is connected to the stopper. The syringe barrel is connected to the syringe outer seal (112). The syringe outer seal (112) comprises a pre-slitted access port (120), a deformable member (121) having a centrally located fluid conduit (122), and a syringe outer outer seal means (113). I have. The lower housing (114) is joined to the syringe barrel and may be configured to mechanically join the syringe outer seal (112) to the syringe barrel. The lower housing includes a hub (123) for hollow needles and an access conduit (124) to a pre-slitted access port (120). Fixing means (128) secures the spring (117) to the lower housing (114). The needle tip cover (116) is shown in the first non-actuated mode. In this aspect, the needle tip cover (116) has two open ends, one of which is provided with a guide hole (127) for the needle tip and a fixing means (128b) for the spring. ing.
31-33A show the state before the needle was punctured into the skin (147), the needle was sufficiently punctured into the skin (147) and the syringe plunger was seated at the base (150) of the syringe barrel (108). It is a series of cross-sectional views of a syringe having a needle puncture mechanism, showing a state of being pulled out and a state of being pulled out from the skin, respectively. Referring to FIG. 32A, at the end of the stroke after dosing, the protrusion (119) of the plunger rod (109) contacts the deformable member (121) of the syringe outer seal (112) and further on the needle tip cover. It acts to move the latch (130) from the shelf-shaped portion (151) of the lower housing (114). Referring to FIG. 33A, when the needle separates from the skin, the needle tip cover (116) is disengaged, and the spring (117) feeds out the needle tip cover (116) so as to cover the needle tip (148). It has become. The spring is misaligned from the needle and incorporated so that when the needle tip cover reaches its moving end, the needle and the guide hole (127) of the needle tip cover are similarly misaligned.
34-36A are a series of cross-sectional views of another embodiment of the needle puncture mechanism showing a state before being punctured by the skin, a state of being punctured by the skin, and a state of being separated from the skin. Specifically, FIG. 34A shows a needle puncture safety mechanism with a needle (370). This needle puncture safety mechanism is integrated with a female lure (366) for attachment to a standard male lure syringe (not shown). The needle puncture safety mechanism has an integrated access port (368) that bypasses the needle (370). The housing 300 has a configuration suitable for connection with the vial access device described here. A latch mechanism with a plurality of arms (31), each with a meshed portion (32), is shown in an extended state in which the arms are not spring-loaded. The needle tip cover (33) has a fitting shelf shaped portion (38) that receives a meshed shaped portion (32) that holds the spring (34) in a compressed state. FIG. 35A is a cross-sectional view of the needle puncture safety mechanism shown with the needle completely punctured into the skin (35). The arm (31) is spring-loaded to its unique shape. FIG. 36A is a cross-sectional view of the needle puncture safety mechanism with the needle away from the skin (35). The spring (34) is released, the needle tip cover (33) covers the needle tip (36), and the guide hole (37) is configured to be misaligned from the needle tip.
37-38A are plan and cross-sectional views of another embodiment of a syringe having a removable needle cover and a needle puncture safety mechanism as viewed from a particular direction. FIG. 37A shows a syringe with a needle cover (305), a needle puncture safety mechanism (304), and an attached lower housing (307). The syringe (301) has an open end (314) with an arbitrary number of tip-side holding means (315) and an outer portion (359) with a protruding flange (316). The syringe (301) comprises an elastomer stopper (321) with any number of seal rings (322) attached to the plunger rod (323). The lower housing (307) has an inner portion (311) that receives the needle puncture safety mechanism (304). The needle piercing safety mechanism (304) also includes a latch shelf shape portion (312) for fixing the latch (324) of the needle piercing safety mechanism in the inactive state. The lower housing (307) also connects at least one vial access device with a deformable member (313) and an access port (317) that allows fluid communication to the syringe when pierced by the access member. It is equipped with means (318). The lower housing (307) includes a hub portion (319) that sealably connects to the needle and / or needle cover. The lower housing (307) comprises an alignment means (320). The fluid conduit (308) provides fluid communication with a hollow needle (309) having a pointed proximal end. FIG. 38A shows the state in which the latch (324) of the needle puncture safety mechanism is connected to the latch shelf shape portion (312) of the lower housing in a folded non-deployment mode.
39 to 40A are plan views and cross-sectional views of the embodiment of FIGS. 37 to 38A as viewed from a specific direction, showing the operation of the needle puncture safety mechanism. FIG. 39A shows a state in which a syringe (301) having a needle puncture safety mechanism (304) is punctured into the skin (356). Since the syringe stopper (321) reaches the second end (314) of the syringe, the fluid will be drained through the hollow needle (309). Upon reaching the end of its stroke, the syringe stopper contacts the deformable member (313) and disengages the latch (324) from the latch shelf shape (312) of the needle puncture safety mechanism, thereby showing FIG. 40A. As shown, the needle puncture safety mechanism will be activated and deployed. FIG. 49 is a perspective view of the needle puncture safety mechanism of FIGS. 39-40 in a fully unfolded mode after the needle has been removed from the skin. The locking tab (357) and locking shelf shape (358) prevent the safety mechanism from being folded to expose the needle (309).
41-42A are plan and cross-sectional views of the removable needle cover and other embodiments of the needle puncture safety mechanism as viewed from a particular direction. FIG. 41A shows the needle cover (405) and the needle puncture safety mechanism (404). In FIG. 42A, the syringe is shown as having an access port with an alternative shape (465) that prevents coring and allows for high flow rates. Examples of this geometry of the access port include, but are not limited to, embossed convex means, concave means, or assemblies thereof. 43-44A and 45 show a series of movements of the needle puncture safety mechanism (404) in the working and final aspects of FIGS. 41-42A. When the syringe stopper (421) reaches the end of the stroke, it contacts the deformable member (413) and disengages the latch (424) from the latch shelf shape (412) of the needle puncture safety mechanism, thereby causing the needle. The piercing safety mechanism (404) will be activated and deployed. The locking tab (457) and the locking shelf shape (458) on the other side prevent the safety mechanism from being folded to expose the needle (409).
FIG. 46 shows a first open end (343), an inner portion (344) having a seal ring (345) on the tip side of the first open end, a second closed end (346), and ribs or ribs. FIG. 5 is a perspective view of a needle cover including an outer portion (347) having a gripping means (348). The first open end and inner portion of the needle cover are configured to hermetically fit into the hub of the hollow needle of the syringe. The cover has a shape and / or dimensions corresponding to the receiving means of the access device.
47 and 48 are perspective views of the needle puncture safety mechanism (304) of FIGS. 37-40A shown in the folded and unfolded modes, respectively. The hinges and shapes shown allow the safety mechanism to be folded to minimize its overall dimensions. The needle puncture safety mechanism (304) has a first end (349) that joins to the lower housing that is compatible with the syringe and a second end (350) that forms a semi-enclosed space (351). And at least one hinge (352) between the first and second ends, at least one latch (324), and a spring element (354) that receives a torsional load. At least one locking tab (357) prevents rotation around the hinge (352) by engaging with the locking shelf shape (358) when the safety mechanism is extended as shown in FIG. 48. As shown above, it is configured to receive a load.
50 and 51 are perspective views of the needle puncture safety mechanism (404) of FIGS. 43 to 45A shown in the folded and unfolded modes, respectively. The locking tab (460) and locking latch (461) are shown after unfolding with the energy stored in the hinge (464) and the member (454) that receives the torsional load. The hinges and shaped parts allow the safety mechanism to be folded with its overall dimensions minimized.
Although the present invention has been described in detail with reference to specific embodiments, it will be apparent to those skilled in the art that various modifications and modifications may be made without departing from the spirit and scope of the invention. Characterized by "comprising", "including", "containing", or "containing" as used herein. The term "characterized by" and its grammatical equivalents are comprehensive terms or modifiable that do not exclude additional elements and undescribed elements or additional method steps and undescribed method steps. It is a term. "Comprising" should be construed to include the more restrictive terms "consisting of" and "consisting essentially of". "Consisting" used in the specification The term "of" and its grammatical equivalents exclude any element, step, or component not specified in the claims. As used herein, the term "consisting essentially of" and its grammatical equivalents cover the scope of a particular material or step and one or more fundamental novelties of the claimed invention. It is limited to those that do not substantially affect the characteristics of.
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Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| JP2022079665A | Cited by | Japan | Search report |
| JP2020501676A | Cited by | Japan | Search report |
| JP2021504029A | Cited by | Japan | Search report |
| JP2002524217A | Cites | Japan | Examiner |
| JP2003126269A | Cites | Japan | Examiner |
| JP2004097253A | Cites | Japan | Examiner |
| JP2004195227A | Cites | Japan | Examiner |
12 members in 5 offices
Priority claims19
| Document | Office | Kind | Date |
|---|---|---|---|
| 60965555 | United States of America | – | |
| 96555507 | United States of America | P | |
| 96555507 | United States of America | P | |
| 367607 | United States of America | P | |
| 367607 | United States of America | P | |
| 61003676 | United States of America | – | |
| 61066974 | United States of America | – | |
| 6697408 | United States of America | P | |
| 6697408 | United States of America | P | |
| 2008073870 | United States of America | W | |
| 2008073870 | United States of America | W | |
| 2007003676 | – | – | – |
| 2007965555 | – | – | – |
| 2008066974 | – | – | – |
| 2008073870 | – | – | – |
| US20070003676P | – | – | – |
| US20070965555P | – | – | – |
| US20080066974P | – | – | – |
| WO2008US73870 | – | – | – |
Members12
| Document | Office | Kind | |
|---|---|---|---|
| CA2704933A1 | Canada | A1 | |
| WO2009026443A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2009026443A3 | World Intellectual Property Organization (WIPO) | A3 | |
| WO2009067531A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP2188004A2 | European Patent Office (EPO) | A2 | |
| JP2010536498AThis record | Japan | A | |
| US2011152832A1 | United States of America | A1 | |
| US2011264037A1 | United States of America | A1 | |
| US8475404B2 | United States of America | B2 | |
| US8636703B2 | United States of America | B2 | |
| JP5506681B2 | Japan | B2 | |
| EP2188004A4 | European Patent Office (EPO) | A4 |
21 legal events, as the office reported them to INPADOC
Over the term
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|---|---|---|
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| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
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Numbers
- Publication
- 2010536498
- Publication, DOCDB
- 2010536498
- Publication, EPODOC
- JP2010536498
- Application
- 2010522028
- Application, DOCDB
- 2010522028
- Application, EPODOC
- JP20100522028
Titles2
- Japanese
- バイアルアクセス・注射システム
- English
- Vial access / injection system
Classification
- CPC, 17
- A61M11/00
- A61J1/2096
- A61M5/3134
- A61M5/31511
- A61M5/3202
- A61M5/3275
- A61M5/345
- A61M2005/3128
- A61M2005/3249
- A61M2005/3261
- A61M2005/3263
- A61M11/006
- A61J1/201
- A61J1/2055
- A61J1/2075
- A61J1/2051
- A61J1/2082
- IPC, 2
- A61M5 32
- A61M5 28
Designated states4
- Regional, 4
- Zimbabwe
- Turkmenistan
- Türkiye
- Togo