JP6276204B2 - 小型化された薬物送達デバイスのための製造方法 - Google Patents
小型化された薬物送達デバイスのための製造方法 Download PDFInfo
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- JP6276204B2 JP6276204B2 JP2014561538A JP2014561538A JP6276204B2 JP 6276204 B2 JP6276204 B2 JP 6276204B2 JP 2014561538 A JP2014561538 A JP 2014561538A JP 2014561538 A JP2014561538 A JP 2014561538A JP 6276204 B2 JP6276204 B2 JP 6276204B2
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Classifications
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- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
- A61M5/2425—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
Description
本出願は、"Self-Injection Device Having a Miniaturized Drug Delivery Portion and Method of Manufacture Thereof”と題された2012年3月13日出願の米国仮特許出願第61/610184号; "Injection Device Having a Miniaturized Drug Delivery Portion and Method of Manufacture Thereof”と題された2012年6月18日出願の米国仮特許出願第61/661032号; " Method of Manufacture for a Miniaturized Drug Delivery Device”と題された2012年3月13日出願の米国仮特許出願第61/610189号; " Method of Manufacture for a Miniaturized Drug Delivery Device”と題された2012年月18日出願の米国仮特許出願第61/661020号; 及び、" Integrated Injection System and Communication Device”と題された2012年7月10日出願の米国仮特許出願第61/669846号に基づく優先権を主張する。
現在のワクチン接種プログラムは、財政面及び物流面で数多くの問題がある。新興国において、公衆衛生当局は、大規模な予防接種の取り組みを実施する際に、これまでのところ大部分が成功していない。成功の欠如の一つの理由は、専門家が接種を実行するために十分な専門知識を有している、限定された数の予防接種診療所に多数の人口を輸送する際の物流面での困難に由来する。慈善団体や非政府組織がワクチンのコストをカバーするためにかなりの量のお金を提供するが、インフラの欠如は、これらのワクチンが多くの農村人口に到達すること妨げている。
Claims (39)
- 治療薬、薬物、またはワクチン用の送達デバイスを製造する方法であって、フラットパネルウエハを準備するステップと、各リザーバがキャビティを画定する複数のリザーバを前記フラットパネルウエハ内に形成するステップと、前記複数のリザーバの全域にカバー層を付着するステップと、治療薬、薬物、またはワクチンの少なくとも1つで前記複数のリザーバを充填して、複数の充填済みリザーバを形成するステップと、前記複数の充填済みリザーバのそれぞれに隣接してハウジング部を提供して複合層を形成するステップと、
前記複合層を複数の送達デバイスに分離するステップであって、それぞれの送達デバイスがリザーバを含む、ステップと、
を有する方法。 - 前記フラットパネルウエハは、ガラスおよびシリコンのうちの少なくとも1つを含む、請求項1に記載の方法。
- 前記複数のリザーバを前記フラットパネルウエハ内に形成する前記ステップは熱スランピングによって達成される、請求項1または2に記載の方法。
- 前記フラットパネルウエハは400μmの厚さを有する、請求項1から3のいずれか一項に記載の方法。
- 前記フラットパネルウエハが水及び酸素に対して不浸透性である、請求項1から4のいずれか一項に記載の方法。
- 前記フラットパネルウエハが、不活性な材料または不活性な材料で被覆された材料で形成されている、請求項1から5のいずれか一項に記載の方法。
- 前記フラットパネルウエハは、フロート処理及び融解処理のうちの少なくとも1つによって形成される、請求項1から6のいずれか一項に記載の方法。
- 前記フラットパネルウエハは14平方インチから17平方インチの初期寸法を有し、及び、40から50の送達デバイスが前記フラットパネルウエハから製造される、請求項1から7のいずれか一項に記載の方法。
- 前記リザーバのそれぞれが、その中に治療薬、薬物、またはワクチンの100μLから0.5mLから受けるような寸法にされている、請求項1から8のいずれか一項に記載の方法。
- 前記複数のリザーバの各リザーバ内にアクセス孔を形成するステップをさらに含む、請求項1から9のいずれか一項に記載の方法。
- 複数のアクセス孔が同時に前記複数のリザーバ内に形成される、請求項10に記載の方法。
- 前記アクセス孔は、30ゲージのニードルをその中に受容する寸法である、請求項10または11に記載の方法。
- 前記カバー層が前記フラットパネルウエハに接合しまたは熱的にアニールされ、前記複数のリザーバの前記キャビティのそれぞれは前記アクセス孔を介してのみアクセス可能になる、請求項10から12のいずれか一項に記載の方法。
- 複数のリザーバが、前記治療薬、薬物、またはワクチンの少なくとも一つで同時に充填される、請求項1から13のいずれか一項に記載の方法。
- 前記充填済みリザーバを薄いポリマー層で封止するステップをさらに有する、請求項1から14のいずれか一項に記載の方法。
- 前記ハウジング部に隣接して複数のニードルを準備して、その結果、前記複数のニードルのそれぞれが前記複数のリザーバのうちの一リザーバと整列されるようにするステップをさらに有する、請求項1から15のいずれか一項に記載の方法。
- 前記ハウジング部が底部支持層を含む、請求項1から16のいずれか一項に記載の方法。
- 前記複数の充填済みリザーバを形成する前記ステップは、充填用カニューレを前記リザーバに導入するステップ、前記リザーバ内に収容された空気を前記リザーバから前記充填用カニューレを介して除去し、前記リザーバ内を真空にするステップ、及び、前記リザーバ内の前記真空と前記治療薬、薬物、またはワクチンとの間の圧力差の結果として、受動的に、前記治療薬、薬物、またはワクチンを前記リザーバ内へ前記充填用カニューレを通じて引き込むステップ、を含む、請求項1から17のいずれか一項に記載の方法。
- 前記複数の充填済みリザーバを形成する前記ステップは、前記リザーバから前記充填用カニューレを取り外すステップ、及び、前記充填用カニューレによって形成された孔を接着剤フィルムで覆って前記リザーバを封止するステップをさらに含む、請求項18に記載の方法。
- 複数の前記充填用カニューレがカウンターウエハ上に配置されており、前記複数のリザーバを同時に充填するためのリザーバに各充填用カニューレが同時に導入されるように、前記カウンターウエハが構成される、請求項18または19に記載の方法。
- 底部支持層を前記複数のリザーバに隣接して提供するステップをさらに含む、請求項19に記載の方法。
- 治療薬、薬物、またはワクチン用の送達デバイスを製造する方法であって、
フラットパネルウエハを準備するステップと、
各リザーバがキャビティを画定する複数のリザーバを前記フラットパネルウエハ内に形成するステップと、
治療薬、薬物、またはワクチンの少なくとも1つで前記複数のリザーバを充填して、複数の充填済みリザーバを形成するステップと、
前記複数のリザーバに隣接して底部支持層を提供して複合層を形成するステップと、
各ニードルが前記複数のリザーバのうち単一の充填済みリザーバと係合可能な複数のニードルを提供するステップと、
前記複合層を複数の送達デバイスに分離するステップであって、それぞれの送達デバイスがリザーバを含む、ステップと、
を有する方法。 - 前記複数のリザーバを前記フラットパネルウエハ内に形成する前記ステップは熱スランピングによって達成される、請求項22に記載の方法。
- 前記フラットパネルウエハは400μmの厚さを有する、請求項22または23に記載の方法。
- 前記フラットパネルウエハが水及び酸素に対して不浸透性であり、及び、前記フラットパネルウエハが、不活性な材料または不活性な材料で被覆された材料で形成されている、請求項22から24のいずれか一項に記載の方法。
- 前記フラットパネルウエハは、フロート処理及び融解処理のうちの少なくとも1つによって形成される、請求項22から25のいずれか一項に記載の方法。
- 前記フラットパネルウエハは14から17平方インチの初期寸法を有し、及び、40から50の送達デバイスが前記フラットパネルウエハから製造される、請求項22から26のいずれか一項に記載の方法。
- 前記複数のリザーバのそれぞれが、その中に治療薬、薬物、または100μLから0.5mLのワクチンを受けるような寸法にされている、請求項22から27のいずれか一項に記載の方法。
- 前記複数のリザーバの各リザーバ内にアクセス孔を形成するステップをさらに含む、請求項22から28のいずれか一項に記載の方法。
- カバー層が前記フラットパネルウエハに接合しまたは熱的にアニールされ、前記複数のリザーバの前記キャビティのそれぞれは前記アクセス孔のそれぞれを介してのみアクセス可能になる、請求項29に記載の方法。
- 前記複数のリザーバが、前記治療薬、薬物、またはワクチンの少なくとも一つで同時に充填される請求項22から30のいずれか一項に記載の方法。
- 小型化された薬物送達デバイス(10)であって、
フラットパネルウエハから形成されたリザーバ層(12)であって、薬物で充填され且つアクセス孔(18)を備えるリザーバキャビティ(14)を形成し、超薄ポリマー層で覆われているリザーバ層(12)と、
前記リザーバ層に付着された底部構造支持体(22)であって、形状及び大きさが前記リザーバキャビティ(14)に対応する凹部(24)であってニードルソケット(26)を含む凹部(24)、及び、前記ニードルソケット(26)内に配置されたミニニードル(28)であって、該底部構造支持体(22)に固定されて前記リザーバキャビティとの前記アクセス孔(18)を通じた流体連通を確立するミニニードル(28)を含む底部構造支持体(22)と、
前記リザーバ層(12)に付着され及び前記リザーバキャビティを囲むカバー層(20)と、
前記カバー層(20)の上面に固着された上部機能層(32)であって、作動の要素及び排出機構を含む上部機能層(32)と、
を備え、ハウジング(1)内に配置されている、小型化された薬物送達デバイス(10)。 - 前記カバー層(20)は30μmから50μmの厚さを持った超薄ガラス層内にある、請求項32に記載の小型化された薬物送達デバイス(10)。
- 前記リザーバ層(12)がガラスでできている、請求項32または33に記載の小型化された薬物送達デバイス(10)。
- 前記ミニニードル(28)が、流体が前記リザーバキャビティ(14)から漏れることを防止するためのストッパ材をさらに含む、請求項32から34のいずれか一項に記載の小型化された薬物送達デバイス(10)。
- 前記上部機能層(32)は、水を収容する活性化リザーバ(34)、及び、水と接触したときに拡がることができる親水性ビーズ(38)を収容する排出リザーバ(36)を含む、請求項32から35のいずれか一項に記載の小型化された薬物送達デバイス(10)。
- 前記活性化リザーバ(34)は活性化層(35)内に含まれ、及び、前記排出リザーバ(36)は排出層37内に含まれる、請求項36に記載の小型化された薬物送達デバイス(10)。
- 前記上部機能層(32)は前記カバー層(20)と前記活性化層(35)との間に位置する圧力容器層(40)をさらに含む、請求項37に記載の小型化された薬物送達デバイス(10)。
- 前記圧力容器層(40)は前記排出リザーバ(36)が前記リザーバキャビティ(14)に及ぼす圧力を軽減するための空きスペース(42)を含む、請求項38に記載の小型化された薬物送達デバイス(10)。
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US20150057611A1 (en) | 2015-02-26 |
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JP6306523B2 (ja) | 2018-04-04 |
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US10010676B2 (en) | 2018-07-03 |
US10080843B2 (en) | 2018-09-25 |
EP2825500A2 (en) | 2015-01-21 |
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WO2013136185A2 (en) | 2013-09-19 |
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US20150051548A1 (en) | 2015-02-19 |
US20160243307A1 (en) | 2016-08-25 |
EP2825106A1 (en) | 2015-01-21 |
WO2013136176A1 (en) | 2013-09-19 |
ES2741348T3 (es) | 2020-02-10 |
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