JP7450706B2 - 子宮腔におけるiud送達及び配置用の外転カテーテルのための装置及び方法 - Google Patents
子宮腔におけるiud送達及び配置用の外転カテーテルのための装置及び方法 Download PDFInfo
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- JP7450706B2 JP7450706B2 JP2022520500A JP2022520500A JP7450706B2 JP 7450706 B2 JP7450706 B2 JP 7450706B2 JP 2022520500 A JP2022520500 A JP 2022520500A JP 2022520500 A JP2022520500 A JP 2022520500A JP 7450706 B2 JP7450706 B2 JP 7450706B2
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/18—Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/146—Occluders for the cervical canal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
- A61M25/0075—Valve means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0119—Eversible catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1065—Balloon catheters with special features or adapted for special applications having a balloon which is inversely attached to the shaft at the distal or proximal end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/14—Female reproductive, genital organs
- A61M2210/1425—Uterine tubes
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Reproductive Health (AREA)
- Vascular Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Endoscopes (AREA)
- Surgical Instruments (AREA)
Description
[0016]
a.液体貯蔵部42を加圧する。
b.外転バルーンシステム2の遠位端を患者の頸部に位置決め又は配置する。
c.使用中、外転バルーンシステム2の位置を制御する。
d.内側カテーテル8及びバルーン膜6を前進させる。
e.流体貯蔵部42から更に水圧をポンピングすることにより外転バルーン18の直径を拡大する。
f.内側カテーテル8及びバルーン膜6を後退させる。
g.圧力解放制御部60を活性化して外転カテーテルシステムから圧力を除去又は解放する。
1.シリンジ74をシステムハンドル30に装填することができる。システムハンドル30は単独の再利用可能な物品とすることができ、使用前に、外転カテーテル及び媒質155が充填されたシリンジをシステムの残り部分に取り付けることができる。あるいはシステムハンドル30は、システムの残り部分と予め組み立てた状態、予め充填した状態、又はそれらを組み合わせた状態で、エンドユーザに供給され得る。
2.外転カテーテルシステム2の遠位端を子宮頚膣部に配置することができる。
3.ラチェットハンドル68を押すことができる。ラチェットの最初の1~2回のクリックによって(すなわちロック歯止めがラチェット歯を通過する時)、シリンジプランジャ94を押し、外転バルーン18を加圧することができる。外転バルーン18は4~6気圧まで加圧され得る。
4.ラチェットハンドル68を更に押す(又は、解放して回転可能にリセットしてから更に押す)ことができる。ラチェットハンドル68のこのような次の複数回のクリックは、内側カテーテル8の前進を示し得る。これは、ラチェット機構が内側カテーテル8上で歯車を回転させること、及び/又はリニアラックを平行移動させて内側カテーテル8を前進させることによって達成され得る。
5.ラチェットハンドルを更に押す(又は、解放して回転可能にリセットしてから更に押す)ことができる。外転バルーンが完全に展開及び外転するまで、内側カテーテル8は前進し続けることができる。内側カテーテル8の遠位端に拡張バルーン62を位置決めすることができる。
6.ラチェットハンドル68を更に押すことができる。ラチェットのこのような次のクリックにより、外転バルーン18を減圧するか又はIUD(図示せず)を送達することができる。
7.ラチェットハンドル68を更に押すことができる。ラチェットのこのような次のクリックによって、シリンジ74の加圧出口を外転バルーン18から拡張バルーン62に変えることができる。あるいは、この動作によってIUD(図示せず)を送達することができる。これは例えば以下によって達成され得る。
a.ラチェット機構によって弁を回転させる、
b.弁を手動で回転させる、及び/又は
c.例えば図8A及び図8Bに示されているように、内側カテーテル近位膨張孔154又はポートが膨張媒質に露出される位置まで内側カテーテル8を前進させる。
8.ラチェットハンドル68を更に押すことができる。ラチェットのこのような次の複数回のクリックは拡張バルーン62の膨張を示し得る。
9.拡張バルーン62は、これを覆っている外転バルーン18を破裂させ得る。
10.生物学的内腔拡張における力の量は、圧力逃し弁によって、又は拡張バルーン62内に配置され得る媒質155の容量によって調節することができる。拡張圧力は、システムハンドルケース34内の又はこれに取り付けられた圧力計によって監視できる。拡張バルーン62は、約6気圧~約20気圧まで頸部を拡張することができる。拡張バルーン62は、最初に約10気圧~約12気圧を送出し、頸部が拡張して拡張プロセスが完了したら圧力を低減させることができる。システムは、媒質圧力14の数値化又は測定とは無関係に、既知の容積の媒質155を拡張バルーン62内へ送出することも可能である。
11.拡張プロセスを超音波又は放射線撮像によって観察してもよい。
12.システムハンドル30上の圧力解放ボタンを活性化して、内側カテーテル内腔10内の媒質容積12の拡張圧力を除去又は低減することができる。
13.シリンジプランジャ94を後退させて、内側カテーテル内腔10及び拡張バルーン62を真空に引き、例えば頸部から拡張バルーン62を緩め、及び/又は拡張バルーン62を収縮させて、例えば頸部からの外転バルーンシステム2の除去を容易にすることができる。
14.例えば頸部において追加の拡張力が望まれる場合、外転バルーンシステム2を再び加圧することができる。例えば、頸部において更なる狭窄が視認された場合、更なる狭窄のエリアに拡張バルーン62を再配置し膨張させることができる。
a.外転カテーテルシステムを加圧する
b.外転バルーンシステム2を患者の頸部に位置決めする
c.処置の間、外転バルーンシステム2の位置を維持する
d.内側カテーテル8及び外転バルーン18を前進させる
e.外転バルーン膜24又は内側カテーテル8を超えて伸長させた後、子宮腔等の体腔内へ配置するため移植カテーテル156を提示する(present)
f.内側カテーテル8及び外転バルーン18を後退させる、及び/又は
g.圧力解放レバーを活性化して(例えば切り替えて)、媒質容積12から水圧又は空気圧を除去又は解放する。
[0250]
Claims (14)
- 女性の生殖器官内にデバイスを送達するためのシステムであって、
内腔及び遠位内腔ポートを有し、後退構成及び伸長構成を有する内側カテーテルと、
前記内側カテーテルに取り付けられた外転バルーンであって、前記内側カテーテルが前記伸長構成にある場合に前記外転バルーンの少なくともある長さは前記内側カテーテルの遠位端を過ぎて延出し、前記内側カテーテルが前記伸長構成にある場合に前記内側カテーテルの前記遠位端を過ぎて延出する前記外転バルーンの前記長さは逆止め弁を含む、外転バルーンと、
前記内側カテーテルの半径方向外側の外側カテーテルであって、前記外転バルーンの第1の端部は前記外側カテーテルに取り付けられており、前記外転バルーンの第2の端部は前記内側カテーテルに取り付けられている、外側カテーテルと、
前記内側カテーテル内のプッシャであって、前記後退構成において、前記外側カテーテル、前記外転バルーン及び前記内側カテーテルが後退すると、前記プッシャは前記システムの筐体に対する位置を維持する、プッシャと、
前記内側カテーテル内のIUDと、
を備えるシステム。 - 前記プッシャは、プッシャハブを備える、請求項1に記載のシステム。
- 前記プッシャは、灌流源に接続される、請求項1に記載のシステム。
- 前記システムは、前記外転バルーン内に負圧が送出されると共に前記IUDが前記内側カテーテルから解放されるにつれて、前記プッシャが前記IUDを延出するように構成されている、請求項1に記載のシステム。
- 前記システムは、前記外転バルーン内に負圧を送出すると共に前記IUDを前記内側カテーテルから解放するように構成されている、請求項1に記載のシステム。
- 灌流源を更に備え、
前記システムは、前記IUDを前記内側カテーテルから解放すると共に、前記内側カテーテルを介して前記生殖器官内に灌流を与えるように構成されている、請求項1に記載のシステム。 - 前記内側カテーテルを介して前記生殖器官内に灌流を与えるように構成された灌流源を更に備える、請求項1に記載のシステム。
- 女性の生殖器官内にデバイスを送達するためのシステムであって、
内腔及び遠位内腔ポートを有し、後退構成及び伸長構成を有する内側カテーテルと、
前記内側カテーテルに取り付けられた外転バルーンであって、前記内側カテーテルが前記伸長構成にある場合に前記外転バルーンの少なくともある長さは前記内側カテーテルの遠位端を過ぎて延出する、外転バルーンと、
前記内側カテーテルの半径方向外側の外側カテーテルであって、前記外転バルーンの第1の端部は前記外側カテーテルに取り付けられ、前記外転バルーンの第2の端部は前記内側カテーテルに取り付けられている、外側カテーテルと、
前記内側カテーテル内のプッシャであって、前記後退構成において、前記外側カテーテル、前記外転バルーン及び前記内側カテーテルが後退すると、前記プッシャは前記システムの筐体に対する位置を維持する、プッシャと、
IUDと、
を備え、前記内側カテーテルは前記IUDを前記生殖器官内に送達するように構成されている、
システム。 - 前記プッシャは、プッシャハブを備える、請求項8に記載のシステム。
- 前記プッシャは、灌流源に接続される、請求項8に記載のシステム。
- 前記システムは、前記外転バルーン内に負圧が送出されると共に前記IUDが前記内側カテーテルから解放されるにつれて、前記プッシャが前記IUDを延出するように構成されている、請求項8に記載のシステム。
- 前記システムは、前記外転バルーン内に負圧を送出すると共に前記IUDを前記内側カテーテルから解放するように構成されている、請求項8に記載のシステム。
- 灌流源を更に備え、
前記システムは、前記IUDを前記内側カテーテルから解放すると共に、前記内側カテーテルを介して前記生殖器官内に灌流を与えるように構成されている、請求項8に記載のシステム。 - 前記内側カテーテルを介して前記生殖器官内に灌流を与えるように構成された灌流源を更に備える、請求項8に記載のシステム。
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US20210251800A9 (en) | 2021-08-19 |
EP4041107A1 (en) | 2022-08-17 |
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US20210106457A1 (en) | 2021-04-15 |
CA3160029A1 (en) | 2021-04-15 |
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JP2022541680A (ja) | 2022-09-26 |
KR102480355B1 (ko) | 2022-12-23 |
WO2021072261A1 (en) | 2021-04-15 |
US20230149207A1 (en) | 2023-05-18 |
CN114828761A (zh) | 2022-07-29 |
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