JP2023029490A - 早産を防ぐ装置 - Google Patents
早産を防ぐ装置 Download PDFInfo
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- JP2023029490A JP2023029490A JP2022211750A JP2022211750A JP2023029490A JP 2023029490 A JP2023029490 A JP 2023029490A JP 2022211750 A JP2022211750 A JP 2022211750A JP 2022211750 A JP2022211750 A JP 2022211750A JP 2023029490 A JP2023029490 A JP 2023029490A
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Abstract
Description
本特許出願は、2015年1月10日に出願された米国特許仮出願第62/102,018号、件名「女性生殖器系への微生物叢の移植の方法及び装置(METHODS AND DEVICES FOR TRANSFER OF MICROBIOTA TO A FEMALE REPRODUCTIVE SYSTEM)」、2015年2月16日に出願された米国特許仮出願第62/116,568号、件名「早産を防ぐ方法及び装置(METHODS AND DEVICES TO PREVENT PREMATURE BIRTH)」、2015年6月18日に出願された米国特許仮出願第62/181,208号、件名「早産を防ぐ方法及び装置(METHODS AND DEVICES TO PREVENT PREMATURE BIRTH)」、並びに2015年7月20日に出願された米国特許仮出願第62/194,798号、件名「早産を防ぐ方法及び装置(METHODS AND DEVICES TO PREVENT PREMATURE BIRTH)」の優先権を主張するものであり、これらはそれぞれ、参照により全内容が本明細書に組み込まれている。
本明細書中において言及される全ての刊行物及び特許出願は、その全内容が、それぞれ個々の刊行物又は特許出願が参照により具体的且つ個別に示されて組み込まれる場合と同程度に、参照により本明細書に組み込まれる。
ドナー材料の提供前、ドナー材料の提供後、又は提供前と提供後の両方において、見込みドナーのスクリーニングが行われてよい。以下の諸条件は、見込みドナーを除外する為のスクリーニングで使用可能な条件の例である。最近(例えば、過去6か月間)の抗生物質の曝露。免疫不全であること。自己免疫疾患の履歴。進行中の免疫調節治療。進行中の腫瘍治療。女性生殖管の慢性疾患(例えば、再発性細菌性膣炎)。過去の不運な妊娠転帰(例えば、感染性早産があったこと)。性感染症の履歴。高リスク性行為の履歴。違法薬物の使用歴。既知の最新の伝染病。代謝条件(例えば、BMI>30)。
ドナー材料は、微生物を含む材料を含み、女性生殖器系及び/又は妊娠組織及び/又は胎児組織及び/又は胎児液から収集される。ドナー材料の非限定的な例として、子宮頸管粘液、膣分泌物、膣排せつ物、羊水、胎盤、絨毛羊膜などがある。ドナー材料を収集する技術の非限定的な例として、吸引、スワブ法などがある。
レシピエントへの移植の前に、ドナー材料の処理が行われてよい。場合によっては、ドナー材料は、稀釈剤などの別の材料と組み合わされてよい。例えば、ドナー材料は、生理食塩水と組み合わされてよい。前記材料は、ブレンダで混合されてよい。
治療の目的の非限定的な例として、体外受精に関連する転帰の改善(例えば、着床の可能性、及び/又は臨床的妊娠、及び/又は生児出生の改善)、妊娠に関連する転帰の改善(例えば、満期産の可能性の改善、及び/又は、早産、及び/又は早期早産、及び/又は感染性早産、及び/又は微生物叢関連早産、及び/又は早期破水の可能性を減らすこと)、女性生殖器系に関連する転帰の改善(例えば、再発性細菌性膣炎及び/又は慢性子宮内膜炎の解消)などがある。
微生物叢移植を受ける資格の付与の為に、見込みレシピエントのスクリーニングが行われてよい。例えば、スクリーニング処理の一環として、患者の産科履歴が分析されてよく、過去の感染性早期早産が、患者選択の組み入れ基準の構成要素として採用されてよい。組み入れ基準の構成要素として採用されてよい他の因子として、過去の体外受精試行での芳しくない転帰(例えば、胎芽移植カテーテル先端部からのビリダンス型連鎖球菌のリカバリに伴う移植の失敗)、及び/又は女性生殖器系の構成要素の感染(例えば、再発性細菌性膣炎)などがある。患者の女性生殖器系における潜在的な標的場所の微生物叢の評価が行われてよい。スクリーニングは、見込みレシピエントの女性生殖器系の微生物叢の分析を含んでよく、例えば、培養ベースの方法、及び/又は分子法(例えば、ポリメラーゼ連鎖反応測定法)による分析を含んでよい。所定の基準に基づく、その微生物叢が好ましくないという判定、及び/又は、所定の基準に基づく、その微生物叢が微生物叢移植処置に適用できるという判定が、見込みレシピエントを、資格を付与されるレシピエントとして選択する上での前提条件であってよい。スクリーニングは、見込みレシピエントの遺伝子スクリーニングを含んでよく、これは、例えば、見込み患者の、微生物叢に関連する早産のリスクに関連付けられる因子を評価する為に行われる。見込み患者が好中球減少症である場合には、資格を付与される患者から除外されてよい。
レシピエント材料は、ヒト微生物叢、及び/又はヒト由来微生物叢、及び/又は微生物叢材料、及び/又は成長促進剤、及び/又は微生物叢のサブセットの成長促進剤、及び/又は成長遅延剤、及び/又は微生物叢のサブセットの成長遅延剤、及び/又は所望の微生物叢プロファイルを促進する材料を含む。レシピエント材料は又、生理食塩水などの希釈剤及び/又はグリセロールなどの添加物を含んでよい。レシピエント材料の非限定的な例として、ドナー材料及びヒト由来微生物叢があり、例えば、上述のように、ドナーの女性生殖器系から採取されたサンプルから処理されたヒト由来微生物叢がある。
場合によっては、レシピエント材料は、計画された妊娠の前、且つ/又は妊娠中、且つ/又は妊娠後にレシピエントに投与されてよい。
レシピエント材料の送達は、患者の女性生殖器系内の特定の領域を標的としてよい。標的の非限定的な例として、膣、子宮頸部、及び子宮の領域などがある。更に、レシピエント材料は、微生物叢がそこから女性生殖器系へ広がる可能性が高いことが知られているか、そのように考えられている場所に送達されてよい。例えば、レシピエント材料は、経口投与されるか、患者の消化管に挿入されてよい。
子宮頸部の子宮頸膣部に微生物障壁を送達する装置であって、
コーティング材を搬送するように構成された第1のルーメン(送達ルーメン)を含む細長ボディと、
ハンドルを有する近位端領域と、
前記細長ボディの遠位端にあって、前記子宮頸膣部に対して一直線に並ぶように構成された塗布器であって、前記塗布器の内面の中心領域が、前記塗布器が前記子宮頸膣部に対して一直線に並んだときに、前記子宮頸膣部上の、子宮頸管の開口部と向き合って配置されるように構成されている、前記塗布器と、
前記中心領域の外側に配置されていて、前記内面を通り抜ける1つ以上の送達アパーチャであって、前記第1のルーメンから前記子宮頸膣部にコーティング材を送達するように構成された前記1つ以上の送達アパーチャと、
を含む装置。
〔付記2〕
子宮頸管内の子宮頸管粘液栓を破壊することなく子宮頸部の子宮頸膣部に微生物障壁を送達する装置であって、
第1のルーメン(送達ルーメン)を含む細長ボディと、
ハンドルを有する近位端領域、及び前記第1のルーメン(送達ルーメン)とつながっているコーティング材用チャンバと、
前記細長ボディの遠位端にあって、前記子宮頸膣部の上に嵌まって前記コーティング材を前記子宮頸膣部上に塗布するが前記子宮頸管内には塗布しないように構成されたカップ状塗布器であって、前記カップ状塗布器の内面の中心領域が、前記カップ状塗布器が前記子宮頸膣部の上方にあるときに、前記子宮頸管の開口部と向き合って配置されるように構成されている、前記カップ状塗布器と、
前記内面を通り抜ける1つ以上の送達アパーチャであって、前記中心領域の外側にあるか、前記カップ状塗布器が前記子宮頸膣部の上方にあるときに前記中心領域に垂直に、且つ前記子宮頸管内へコーティング材が射出されるのを防ぐ向きになっている前記送達アパーチャと、
を含む装置。
〔付記3〕
子宮頸管内の子宮頸管粘液栓を破壊することなく子宮頸部の子宮頸膣部に微生物障壁を送達する装置であって、
第1のルーメン(送達ルーメン)を含む、湾曲又は屈曲した細長ボディと、
ハンドルを有する近位端領域、及び前記第1のルーメン(送達ルーメン)とつながっているコーティング材用チャンバと、
前記細長ボディの遠位端にあって、前記子宮頸膣部の上に嵌まって前記コーティング材を前記子宮頸膣部上に塗布するが前記子宮頸管内には塗布しないように構成されたカップ状塗布器であって、前記カップ状塗布器の内面の中心領域が、前記カップ状塗布器が前記子宮頸膣部の上方にあるときに、前記子宮頸膣部上の、子宮頸管の開口部と向き合って配置されるように構成されている、前記カップ状塗布器と、
前記中心領域の外側に配置されていて、前記内面を通り抜ける複数の送達アパーチャであって、前記子宮頸管内の子宮頸管粘液栓を破壊することなく前記第1のルーメンから前記子宮頸膣部にコーティング材を送達するように構成された前記送達アパーチャと、
を含む装置。
〔付記4〕
前記塗布器上の、又は前記塗布器を通るオーバフローチャネルを更に含み、前記オーバフローチャネルは、前記細長ボディの中を通る第2のルーメン(戻りルーメン)とつながっている、付記1から3のいずれか一項に記載の装置。
〔付記5〕
前記1つ以上の送達アパーチャから射出される前記コーティング材の流体圧力を減らすように構成されたバッフルを更に含む、付記1から4のいずれか一項に記載の装置。
〔付記6〕
前記塗布器の内面上又は内面内にあって、前記1つ以上の送達アパーチャから射出される前記コーティング材の流体圧力を減らすように構成されたスポンジ状バッフルを更に含む、付記1から4のいずれか一項に記載の装置。
〔付記7〕
前記1つ以上の送達アパーチャは、コーティング材が前記1つ以上の送達アパーチャを通って子宮頸管内に射出されるのを防ぐ為に、前記内面の前記中心領域の周囲に配列された複数の送達アパーチャを含む、付記1から6のいずれか一項に記載の装置。
〔付記8〕
前記細長ボディは曲がっているか曲がることが可能である、付記1から7のいずれか一項に記載の装置。
〔付記9〕
前記塗布器は前記細長ボディとつながっており、調節可能な首領域が、前記細長ボディに対する前記カップ状塗布器の相対角度の調節を可能にするように構成されている、付記1から8のいずれか一項に記載の装置。
〔付記10〕
前記塗布器は、前記カップ状塗布器が前記子宮頸膣部の上方にあるときに空気を逃がすように構成された隙間又はチャネルを含む、付記2から9のいずれか一項に記載の装置。
〔付記11〕
前記1つ以上の送達アパーチャから塗布される前記コーティング材の圧力を制限するように構成された圧力制限器を更に含む、付記1から10のいずれか一項に記載の装置。
〔付記12〕
前記塗布器は、前記塗布器を通しての前記子宮頸膣部の可視化を可能にする為に、前記塗布器の少なくとも一部にわたって透明である、付記1から11のいずれか一項に記載の装置。
〔付記13〕
子宮頸管粘液栓を破壊することなく患者の子宮頸部の子宮頸膣部に微生物障壁を塗布する方法であって、
塗布器が前記子宮頸膣部に隣接するように、膣から塗布装置を挿入するステップと、
前記子宮頸膣部の上にコーティング材を塗布することと、同時に、前記コーティング材が膣壁に接触したり、子宮頸管内に突出して前記子宮頸管粘液栓を破壊したりすることを防ぐことと、により、前記微生物障壁を形成するステップと、
を含む方法。
〔付記14〕
子宮頸管粘液栓を破壊することなく子宮頸部の子宮頸膣部に微生物障壁を塗布する方法であって、
患者に頸膣部の感染がないことを確認するステップと、
カップ状塗布器が前記子宮頸膣部の上方になるように、前記膣から塗布装置を挿入するステップと、
前記子宮頸膣部の上にコーティング材を塗布することと、同時に、前記コーティング材が膣壁に接触したり、子宮頸管内に突出して前記子宮頸管粘液栓を破壊したりすることを防ぐことと、により、前記微生物障壁を形成するステップと、
を含む方法。
〔付記15〕
前記子宮頸管粘液栓の破壊を防ぐ為に、前記塗布装置からの前記塗布されるコーティング材の圧力、流量、又は圧力及び流量を制限するステップを更に含む、付記13から14のいずれか一項に記載の方法。
〔付記16〕
前記微生物障壁を形成する前に、前記膣に感染がないことを確認するステップを更に含む、付記13から15のいずれか一項に記載の方法。
〔付記17〕
前記微生物障壁を形成する前に、絨毛羊膜が破壊されていないことを確認するステップを更に含む、付記13から16のいずれか一項に記載の方法。
〔付記18〕
前記塗布装置を通して前記子宮頸部を可視化するステップを更に含む、付記13から17のいずれか一項に記載の方法。
〔付記19〕
余剰コーティング材を除去して前記塗布装置に戻すステップを更に含む、付記13から18のいずれか一項に記載の方法。
〔付記20〕
前記コーティングを塗布する前記ステップは、前記塗布装置のカップ状端部から、前記カップ状端部の内面上の1つ以上のアパーチャを通して前記コーティングを塗布することを含み、前記1つ以上のアパーチャは、コーティング材が子宮頸管内に直接塗布されないように、前記内面に対して相対的に中心から外れている、付記13から19のいずれか一項に記載の方法。
〔付記21〕
前記コーティング材を塗布する前記ステップは、前記子宮頸膣部にコーティング材を、約0.5mmから約1cmの厚さまで塗布することを含む、付記13から20のいずれか一項に記載の方法。
〔付記22〕
前記挿入するステップ及び前記形成するステップを1週間後から6週間後の間に繰り返すことを更に含む、付記13から21のいずれか一項に記載の方法。
〔付記23〕
前記コーティング材を塗布する前記ステップは、前記コーティング材を噴霧することを含む、付記13から22のいずれか一項に記載の方法。
〔付記24〕
前記塗布装置を挿入する前記ステップは、前記塗布装置を使用して前記子宮頸膣部を前記膣から機械的に隔離することを含む、付記13から23のいずれか一項に記載の方法。
Claims (1)
- 女性生殖器系内での微生物の移動または増殖を防止または治療するために使用される装置であって、
膣内の第1の部位から子宮頸部、子宮頸管、もしくは子宮の内部またはそれに隣接する第2の部位への微生物の移動または増殖を防止するために、女性生殖器系の女性生殖管内に完全に挿入され、前記女性生殖管内に完全に配置された状態で少なくとも6時間放置されるように構成された閉塞要素であり、栄養素、分子、体液、または材料もしくは生物学的材料の移動が可能となるように、前記第1の部位と前記第2の部位の間で妨げられない少なくとも1つの経路を提供する閉塞要素であり、前記女性生殖管内の体積を想定するように構成された閉塞要素、
を含む装置。
Applications Claiming Priority (9)
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US20200384162A1 (en) * | 2017-04-28 | 2020-12-10 | Sanyo Chemical Industries, Ltd. | Sealing agent for genitals |
US11129790B2 (en) | 2017-05-19 | 2021-09-28 | Northeastern University | Chemo-enzymatic site-specific modification of peptides and proteins to form cleavable conjugates |
GB201804165D0 (en) * | 2018-03-15 | 2018-05-02 | Assure Medical Ltd | Urethal delivery device |
US11497647B2 (en) | 2018-04-24 | 2022-11-15 | Emory University | Anatomical support systems, devices, and related methods |
WO2019226441A1 (en) | 2018-05-19 | 2019-11-28 | Crafton Ashley | Hannah cervical cup |
CN109124440B (zh) * | 2018-08-10 | 2020-10-30 | 山西白求恩医院 | 一种儿科皮肤病患处清洗器 |
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US11872395B2 (en) | 2019-06-18 | 2024-01-16 | Obstetric Solutions, Llc | Pessary device and methods for preventing premature births |
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KR102571791B1 (ko) * | 2021-03-22 | 2023-08-28 | 가톨릭대학교 산학협력단 | 산모 맞춤형 조산 예방용 페서리 및 이의 제조방법 |
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US11819648B2 (en) | 2023-11-21 |
JP2018504256A (ja) | 2018-02-15 |
WO2016112388A1 (en) | 2016-07-14 |
CA2970831C (en) | 2024-01-09 |
US20200360674A1 (en) | 2020-11-19 |
EP3242707A1 (en) | 2017-11-15 |
EP3242707A4 (en) | 2018-09-26 |
AU2016205037B2 (en) | 2020-09-03 |
US20180001066A1 (en) | 2018-01-04 |
CN107106825A (zh) | 2017-08-29 |
AU2016205037A1 (en) | 2017-07-06 |
US10773062B2 (en) | 2020-09-15 |
US20240100311A1 (en) | 2024-03-28 |
US20160199630A1 (en) | 2016-07-14 |
JP2021010762A (ja) | 2021-02-04 |
US20170036000A1 (en) | 2017-02-09 |
CA2970831A1 (en) | 2016-07-14 |
US9764120B2 (en) | 2017-09-19 |
US9474885B2 (en) | 2016-10-25 |
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