JP6017568B2 - 子宮治療装置 - Google Patents
子宮治療装置 Download PDFInfo
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- JP6017568B2 JP6017568B2 JP2014534827A JP2014534827A JP6017568B2 JP 6017568 B2 JP6017568 B2 JP 6017568B2 JP 2014534827 A JP2014534827 A JP 2014534827A JP 2014534827 A JP2014534827 A JP 2014534827A JP 6017568 B2 JP6017568 B2 JP 6017568B2
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- 0 CCC1=CC2C1*CC(CC[C@](CCC(CCCCCC*C)[C@](C)C(C)C(C)*)C*1=CC[C@](C)CC1*)C2 Chemical compound CCC1=CC2C1*CC(CC[C@](CCC(CCCCCC*C)[C@](C)C(C)C(C)*)C*1=CC[C@](C)CC1*)C2 0.000 description 3
- GIXMAJOHVMTXKL-XQPVXRMQSA-N CCNC(C1C(C)C2C1)C2[C@](C)(C1)C1[IH]C Chemical compound CCNC(C1C(C)C2C1)C2[C@](C)(C1)C1[IH]C GIXMAJOHVMTXKL-XQPVXRMQSA-N 0.000 description 1
- DEJPTSSPFWGBIZ-UHFFFAOYSA-N C[O]=C1CCCC1 Chemical compound C[O]=C1CCCC1 DEJPTSSPFWGBIZ-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- A61B5/033—Uterine pressure
- A61B5/035—Intra-uterine probes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
- A61B5/4318—Evaluation of the lower reproductive system
- A61B5/4325—Evaluation of the lower reproductive system of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
- A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
- A61B2018/00285—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00559—Female reproductive organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
- A61B2018/048—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in gaseous form
Description
本出願は、「子宮に蒸気を送達する完全性試験方法及び装置(Integrity Testing Method and Apparatus for Delivering Vapor to the Uterus)」と題する2011年10月7日に出願された米国仮特許出願第61/544,890号明細書の米国特許法第119条に基づく利益を主張し、この出願は参照により本明細書に組み込まれる。
[付記1]
患者の子宮に対して処置を行う方法であって、
子宮完全性試験を行うステップであって、前記子宮完全性試験が、
前記患者の前記子宮内に子宮装置を挿入するステップと、
前記子宮装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮内に送達される際の前記ガス又は流体の流量を測定するステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
を含む、ステップと、
前記子宮完全性試験を行い、前記子宮が封止されていると判断した後、前記子宮装置に対して開存性試験を行うステップであって、前記開存性試験が、
前記子宮装置の前記流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮装置の流出内腔により前記子宮からガス又は流体を除去するステップと、
ガス又は流体の流量が、前記子宮装置の前記流出内腔において観察された場合、前記子宮装置が詰まっておらず子宮内に埋め込まれていないと判断するステップと、
を含む、ステップと、
を含む方法。
[付記2]
前記子宮装置が子宮アブレーション装置である、付記1に記載の方法。
[付記3]
流体流が、前記流出内腔の流量計において観察される、付記1に記載の方法。
[付記4]
前記子宮が封止されていると判断する前記ステップが、前記流量が所定期間内に流量閾値未満に低下した場合に前記子宮が封止されていると判断することを更に含む、付記1に記載の方法。
[付記5]
前記子宮装置の前記流入内腔内の一方向弁が、前記子宮から前記子宮装置を通って戻る逆流を低減するか又はなくす、付記1に記載の方法。
[付記6]
前記一方向弁が、子宮収縮に応じる逆流及び正弦波形を防止する、付記5に記載の方法。
[付記7]
前記子宮が封止されていると判断する前記ステップが、前記所定期間後に前記流量がゼロまで低減した場合に前記子宮が封止されていると判断することを更に含む、付記1に記載の方法。
[付記8]
前記送達するステップが、前記子宮装置の前記流入内腔から前記子宮内にガス又は流体を、安全閾値圧によって境界が定められた定圧で送達することを更に含む、付記1に記載の方法。
[付記9]
前記安全閾値圧が凡そ70mmHgである、付記8に記載の方法。
[付記10]
前記流量閾値が2ml/分乃至5ml/分である、付記1に記載の方法。
[付記11]
前記開存性試験中、ガス又は流体の戻り流が前記子宮装置の前記流出内腔内で観察されない場合に、前記子宮装置が詰まっているか又は組織内に埋め込まれていると判断するステップを更に含む、付記1に記載の方法。
[付記12]
前記子宮完全性試験中、前記流量が低レベルと高レベルとの間で変動する場合、前記子宮が、低い方の圧力で封止され高い方の圧力で開放される穿孔を有していると判断するステップを更に含む、付記1に記載の方法。
[付記13]
前記子宮完全性試験中、前記子宮が封止されていると判断する前記ステップが、前記流量の平均が凡そゼロになるか、又は前記流量平均が所定期間にわたって閾値未満である場合に、前記子宮が封止されていると判断することを更に含む、付記1に記載の方法。
[付記14]
前記子宮が封止されており、前記子宮アブレーション装置が詰まっておらず組織内に埋め込まれていないと判断した後、子宮組織を焼灼するように、加熱された凝縮可能な蒸気を前記子宮に送達するステップを更に含む、付記2に記載の方法。
[付記15]
前記子宮のサイズを推定するように、前記完全性試験で送達されたガス又は流体の体積を評価するステップを更に含む、付記1に記載の方法。
[付記16]
前記子宮内の前記子宮装置の遠位先端の位置を推定するように、前記完全性試験で送達されたガス又は流体の体積を評価するステップを更に含む、付記1に記載の方法。
[付記17]
前記子宮内の前記子宮装置の遠位先端の位置を推定するように、前記完全性試験で送達されたガス又は流体の流量を評価するステップを更に含む、付記1に記載の方法。
[付記18]
前記体積の評価が、前記遠位先端が間違った通路にあることを示す、付記16に記載の方法。
[付記19]
前記流量の評価が、前記遠位先端が間違った通路にあることを示す。付記17に記載の方法。
[付記20]
前記体積の評価が、前記遠位先端が、患者の腹膜腔内にあることを示す、付記16に記載の方法。
[付記21]
前記流量の評価が、前記遠位先端が前記患者の腹膜腔内にあることを示す、付記20に記載の方法。
[付記22]
前記子宮完全性試験のガス又は流体を送達する前記ステップが、前記子宮装置の流入内腔及び流出内腔から前記子宮にガス又は流体を送達することを更に含む、付記1に記載の方法。
[付記23]
子宮完全性試験を行う前記ステップが、
前記子宮アブレーション装置の流出内腔によって前記子宮からガス又は流体を除去するステップと、
前記流出内腔内のガス又は流体の流出流量を測定するステップと、
前記子宮内に送達されるガス又は流体の前記流量を前記流出内腔内のガス又は流体の前記流出流量と比較して、前記子宮内の漏れの存在に対して動的測定を可能にするステップと、
を更に含む、付記1に記載の方法。
[付記24]
前記開存性試験のガス又は流体を除去する前記ステップが、前記子宮装置の前記流入内腔から遠位に位置決めされた前記子宮装置の流出内腔によって前記子宮からガス又は流体を除去することを更に含む、付記1に記載の方法。
[付記25]
前記送達ステップが、前記子宮アブレーション装置のモジュールコントローラによって自動的に開始される、付記14に記載の方法。
[付記26]
子宮アブレーション装置用の開存性試験を行う方法であって、
患者の子宮内に前記子宮アブレーション装置を挿入するステップと、
前記子宮アブレーション装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮アブレーション装置の流出内腔によって前記子宮からガス又は流体を除去するステップと、
ガス又は流体の戻り流が、前記子宮アブレーション装置の前記流出内腔において観察される場合に、前記子宮アブレーション装置が詰まっておらず組織内に埋め込まれていないと判断するステップと、
を含む方法。
[付記27]
患者の子宮に対して処置を行う方法であって、
子宮完全性試験を行うステップであって、前記子宮完全性試験が、
前記患者の前記子宮内に子宮アブレーション装置を挿入するステップと、
前記子宮アブレーション装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮内に送達される際の前記ガス又は流体の流量を測定するステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
前記子宮完全性試験を行い、前記子宮が封止されていると判断した後、子宮内圧の変化をモニタリングして収縮が発生しているか否かを判断するステップと、
を含む、ステップを含む方法。
[付記28]
患者の子宮に対して処置を行う方法であって、
子宮完全性試験を行うステップであって、前記子宮完全性試験が、
前記患者の前記子宮内に子宮アブレーション装置を挿入するステップと、
前記子宮アブレーション装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮内に送達される際の前記ガス又は流体の流量を測定するステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
子宮収縮に応答して、一方向弁により前記流入内腔を通る逆流をなくすステップと、
を含む、ステップを含む方法。
[付記29]
前記一方向弁が、子宮収縮若しくは弛緩、前記患者による移動、又は医師若しくは医療スタッフによる前記患者若しくは流入内腔の操作によってもたらされる、前記流入内腔の流量計における雑音を低減する、付記28に記載の方法。
[付記30]
患者の子宮に対して処置を行う方法であって、
子宮完全性試験を行うステップであって、前記子宮完全性試験が、
前記患者の前記子宮内に子宮装置を挿入するステップと、
前記子宮装置の流入内腔から前記子宮内に流体を送達するステップと、
前記子宮内に送達される際の前記流体の送達流量を測定するステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
前記子宮装置によって前記子宮に流体を既知の流量で提供するステップと、
前記子宮装置の近位の既知のオリフィスを通して前記流体を分流させるステップと、
前記子宮腔の完全性を評価するように、分流する分流流量を測定するステップと、
を含む、ステップを含む方法。
[付記31]
前記子宮装置が子宮アブレーション装置である、付記30に記載の方法。
[付記32]
患者の子宮に対して処置を行う方法であって、
前記患者の前記子宮内に子宮アブレーション装置を挿入するステップと、
前記子宮アブレーション装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮内に送達される際の前記ガス又は流体の流量を測定するステップと、
前記子宮を前記送達されたガス又は流体で膨張させるステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
子宮収縮に応答して、一方向弁により前記流入内腔を通る逆流をなくすステップと、
ガス又は流体の戻り流が前記子宮アブレーション装置の流出内腔において観察された場合に、前記子宮アブレーション装置が詰まっておらず組織内に埋め込まれていないと判断するステップと、
前記子宮アブレーション装置が詰まっておらず前記子宮が封止されていると判断する前記ステップの直後に、前記子宮アブレーション装置を用いて、膨張圧を低減することなく前記患者の前記子宮を治療するステップと、
を含む方法。
[付記33]
患者の子宮に対して処置を行う方法であって、
前記患者の前記子宮内に子宮アブレーション装置を挿入するステップと、
前記子宮アブレーション装置の流入内腔から前記子宮内にガス又は流体を送達するステップと、
前記子宮内に送達される際の前記ガス又は流体の流量を測定するステップと、
前記子宮を前記ガス又は流体の流れによって膨張させるステップと、
前記流量が流量閾値未満に低下した場合に前記子宮が封止されていると判断するステップと、
子宮収縮に応答して、一方向弁により前記流入内腔を通る逆流をなくすステップと、
ガス又は流体の戻り流が前記子宮アブレーション装置の流出内腔において観察された場合に、前記子宮アブレーション装置が詰まっておらず組織内に埋め込まれていないと判断するステップと、
前記患者の子宮内の膨張圧を低減することなく、前記子宮アブレーション装置が詰まっておらず前記子宮が封止されていると判断する前記ステップの直後に、前記子宮アブレーション装置を用いて前記患者の前記子宮を治療するステップと、
を含む方法。
[付記34]
子宮治療装置であって、
患者の子宮内に挿入されるようにサイズが決められ且つ構成されたシャフトと、
前記シャフトの長さに沿って配置された流入内腔及び流出内腔と、
前記流入内腔の遠位端に配置された少なくとも1つの流入ポートと、
前記流出内腔の遠位端に配置された少なくとも1つの流出ポートと、
前記流入内腔及び前記流出内腔に作動的に結合されたガス/流体源と、
前記ガス/流体源と前記シャフトとの間に配置された少なくとも1つの流量計と、
前記ガス/流体源から前記流入内腔を通って前記子宮内にガス又は流体を送達し、前記少なくとも1つの流量計を用いて、前記子宮内に送達される際のガス又は流体の完全性流量を検出し、前記完全性流量が完全性流量閾値未満に低下した場合に前記子宮が封止されていると判断するように構成されたコントローラと、
を具備し、
前記コントローラが又、前記子宮が封止されていると判断された場合に、前記流入内腔を通って前記子宮内にガス又は流体を送達し、前記流出内腔を用いて前記子宮からガス又は流体を除去し、前記少なくとも1つの流量計を用いてガス又は流体の開存性流量を検出し、前記開存性流量に基づいて、前記子宮治療装置が詰まっておらず組織内に埋め込まれていないと判断するように構成されている、子宮治療装置。
[付記35]
患者の子宮内に挿入されるようにサイズが決められ且つ構成されたシャフトと、
前記シャフトの長さに沿って配置された流入内腔及び流出内腔と、
前記流入内腔の遠位端に配置された少なくとも1つの流入ポートと、
前記流出内腔の遠位端に配置された少なくとも1つの流出ポートと、
前記流入内腔及び前記流出内腔に作動的に結合されたガス/流体源と、
前記ガス/流体源と前記シャフトとの間に配置された少なくとも1つの流量計と、
前記子宮からガス又は流体が除去されるのを可能にすることなくガス又は流体が前記ガス/流体源から前記子宮内に流れるのを可能にし、前記少なくとも1つの流量計によって測定されるガス又は流体の完全性流量をモニタリングすることにより、子宮完全性試験を行うように構成されたコントローラと、
を具備し、
前記コントローラが、ガス又は流体が前記ガス/流体源から前記子宮内に流れるのを可能にし、前記ガス又は流体を前記子宮から除去し、前記少なくとも1つの流量計によって測定されるガス又は流体の開存性流量をモニタリングすることにより、開存性試験を行うように更に構成されている、子宮治療装置。
[付記36]
前記ガス/流体源と前記流入内腔との間に配置された第1弁と、
前記ガス/流体源と前記流出内腔との間に配置された第2弁と、
を更に具備し、
前記コントローラが、前記第1弁を開放し前記第2弁を閉鎖することにより前記子宮完全性試験を行うように構成され、前記コントローラが、前記第1弁及び前記第2弁を開放することにより前記開存性試験を行うように構成されている、付記35に記載の装置。
[付記37]
前記ガス/流体源と前記流入内腔との間に配置された第1弁と、
前記ガス/流体源と前記流出内腔との間に配置された第2弁及び第3弁と、
を更に具備し、
前記コントローラが、前記第1弁及び前記第2弁を開放し前記第3弁を閉鎖してガス又は流体が前記流入内腔及び前記流出内腔の両方を通って前記子宮内に流れるのを可能にすることにより、前記子宮完全性試験を行うように構成され、前記コントローラが、前記第1弁及び前記第3弁を開放し前記第2弁を閉鎖してガス又は流体が前記流入内腔を通って前記子宮内に流れ込むのを可能にし、且つガス又は流体を、前記流出内腔を通って前記子宮から除去するようにすることにより、前記開存性試験を行うように構成されている、付記35に記載の装置。
Claims (4)
- 子宮治療装置であって、
患者の子宮内に挿入されるようにサイズが決められ且つ構成されたシャフトと、
前記シャフトの長さに沿って配置された流入内腔及び流出内腔と、
前記流入内腔の遠位端に配置された少なくとも1つの流入ポートと、
前記流出内腔の遠位端に配置された少なくとも1つの流出ポートと、
前記流入内腔及び前記流出内腔に作動的に結合されたガス/流体源と、
前記ガス/流体源と前記シャフトとの間に配置された少なくとも1つの流量計と、
前記ガス/流体源から前記流入内腔を通って前記子宮内にガス又は流体を送達し、前記少なくとも1つの流量計を用いて、前記子宮内に送達される際のガス又は流体の完全性流量を検出し、前記完全性流量が完全性流量閾値未満に低下した場合に前記子宮が封止されていると判断するように構成されたコントローラと、
を具備し、
前記コントローラが又、前記子宮が封止されていると判断された場合に、前記流入内腔を通って前記子宮内にガス又は流体を送達し、前記流出内腔を用いて前記子宮からガス又は流体を除去し、前記少なくとも1つの流量計を用いてガス又は流体の開存性流量を検出し、前記開存性流量に基づいて、前記子宮治療装置が詰まっておらず組織内に埋め込まれていないと判断するように構成されている、子宮治療装置。 - 患者の子宮内に挿入されるようにサイズが決められ且つ構成されたシャフトと、
前記シャフトの長さに沿って配置された流入内腔及び流出内腔と、
前記流入内腔の遠位端に配置された少なくとも1つの流入ポートと、
前記流出内腔の遠位端に配置された少なくとも1つの流出ポートと、
前記流入内腔及び前記流出内腔に作動的に結合されたガス/流体源と、
前記ガス/流体源と前記シャフトとの間に配置された少なくとも1つの流量計と、
前記子宮からガス又は流体が除去されるのを可能にすることなくガス又は流体が前記ガス/流体源から前記子宮内に流れるのを可能にし、前記少なくとも1つの流量計によって測定されるガス又は流体の完全性流量をモニタリングすることにより、子宮完全性試験を行うように構成されたコントローラと、
を具備し、
前記コントローラが、ガス又は流体が前記ガス/流体源から前記子宮内に流れるのを可能にし、前記ガス又は流体を前記子宮から除去し、前記少なくとも1つの流量計によって測定されるガス又は流体の開存性流量をモニタリングすることにより、開存性試験を行うように更に構成されている、子宮治療装置。 - 前記ガス/流体源と前記流入内腔との間に配置された第1弁と、
前記ガス/流体源と前記流出内腔との間に配置された第2弁と、
を更に具備し、
前記コントローラが、前記第1弁を開放し前記第2弁を閉鎖することにより前記子宮完全性試験を行うように構成され、前記コントローラが、前記第1弁及び前記第2弁を開放することにより前記開存性試験を行うように構成されている、請求項2に記載の装置。 - 前記ガス/流体源と前記流入内腔との間に配置された第1弁と、
前記ガス/流体源と前記流出内腔との間に配置された第2弁及び第3弁と、
を更に具備し、
前記コントローラが、前記第1弁及び前記第2弁を開放し前記第3弁を閉鎖してガス又は流体が前記流入内腔及び前記流出内腔の両方を通って前記子宮内に流れるのを可能にすることにより、前記子宮完全性試験を行うように構成され、前記コントローラが、前記第1弁及び前記第3弁を開放し前記第2弁を閉鎖してガス又は流体が前記流入内腔を通って前記子宮内に流れ込むのを可能にし、且つガス又は流体を、前記流出内腔を通って前記子宮から除去するようにすることにより、前記開存性試験を行うように構成されている、請求項2に記載の装置。
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